<section article="gho" article_name="Health Occupations" number="12-101" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="1" subtitle_name="Definitions; General Provisions"> <level label="a"> <text>In this title the following words have the meanings indicated.</text> </level> <level label="b"> <text>“Authorized prescriber” means any licensed dentist, licensed dental hygienist with prescriptive authority under § 4–206.4 of this article, licensed physician, licensed podiatrist, licensed veterinarian, advanced practice registered nurse with prescriptive authority under Title 8 of this article, licensed nurse anesthetist, or other individual authorized by law to prescribe prescription or nonprescription drugs or devices.</text> </level> <level label="c"> <text>“Biological product” has the meaning stated in 42 U.S.C. § 262.</text> </level> <level label="d"> <text>“Board” means the State Board of Pharmacy.</text> </level> <level label="d–1"> <text>“Clinical research pharmacy” means a pharmacy that meets the requirements for a clinical research pharmacy permit under § 12–401.1(c) of this title.</text> </level> <level label="d–2"> <text>“Clinical research pharmacy permit” means a permit issued by the Board to establish and operate a clinical research pharmacy.</text> </level> <level label="d–3"> <text>“Compounded nonsterile preparations” means products compounded in accordance with USP 795.</text> </level> <level label="e"> <text>“Compounded sterile preparations” means biologics, diagnostics, drugs, nutrients, and radiopharmaceuticals that, under USP 797, must be compounded using aseptic techniques.</text> </level> <level label="f"> <level label="1"> <text>“Compounding” means the preparation, mixing, assembling, packaging, or labeling of a drug or device:</text> <level label="i"> <text>As the result of a practitioner’s prescription drug order or initiative based on the practitioner/patient/pharmacist relationship in the course of professional practice; or</text> </level> <level label="ii"> <text>For the purpose of, or incident to, research, teaching, or chemical analysis and not for the sale or dispensing of the drug or device.</text> </level> </level> <level label="2"> <text>“Compounding” includes the preparation of drugs or devices in anticipation of a prescription drug order based on routine, regularly observed prescribing patterns.</text> </level> </level> <level label="g"> <level label="1"> <text>“Delegated pharmacy act” means an activity that constitutes the practice of pharmacy delegated by a licensed pharmacist under this title and regulations adopted by the Board.</text> </level> <level label="2"> <text>“Delegated pharmacy act” does not include:</text> <level label="i"> <text>An act within the parameters of a therapy management contract as provided under Subtitle 6A of this title;</text> </level> <level label="ii"> <text>Except as provided in § 12–6B–06 of this title, the administration of a vaccination in accordance with § 12–508 of this title;</text> </level> <level label="iii"> <text>The delegation of a pharmacy act by a registered pharmacy technician, pharmacy student, or pharmacy technician trainee;</text> </level> <level label="iv"> <text>A pharmacy activity performed by a pharmacy student in accordance with § 12–301(b) of this title;</text> </level> <level label="v"> <text>A pharmacy activity performed by an applicant for a license to practice pharmacy in accordance with regulations adopted by the Board;</text> </level> <level label="vi"> <text>A decision–making task that requires the professional judgment of a pharmacist; and</text> </level> <level label="vii"> <text>The performance of other functions prohibited in regulations adopted by the Board.</text> </level> </level> </level> <level label="h"> <level label="1"> <text>“Device” means a device used in the diagnosis, treatment, or prevention of disease.</text> </level> <level label="2"> <text>“Device” does not include any:</text> <level label="i"> <text>Surgical or dental instrument;</text> </level> <level label="ii"> <text>Physical therapy equipment;</text> </level> <level label="iii"> <text>X–ray apparatus; or</text> </level> <level label="iv"> <text>Component part or accessory of any of these items.</text> </level> </level> </level> <level label="i"> <text>“Direct supervision” means that a licensed pharmacist is physically available, notwithstanding appropriate breaks, on–site and in the prescription area or in an area where pharmacy services are provided to supervise the practice of pharmacy and delegated pharmacy acts.</text> </level> <level label="j"> <text>“Dispense” or “dispensing” means the procedure which results in the receipt of a prescription or nonprescription drug or device by a patient or the patient’s agent and which entails the:</text> <level label="1"> <text>Interpretation of an authorized prescriber’s prescription for a drug or device;</text> </level> <level label="2"> <text>Selection and labeling of the drug or device prescribed pursuant to that prescription; and</text> </level> <level label="3"> <text>Measuring and packaging of the prescribed drug or device in accordance with State and federal laws.</text> </level> </level> <level label="k"> <level label="1"> <text>“Distribute” means the process resulting in the provision of a prescription or nonprescription drug or device to a separate, intervening individual, licensed and practicing under this article, prior to administration of the provided drug or device to the patient pursuant to a prescription issued by an authorized prescriber.</text> </level> <level label="2"> <text>“Distribute” does not include the operations of a person who holds a permit issued under § 12–6C–03 of this title.</text> </level> </level> <level label="l"> <text>“Drug” has the meaning stated in § 21–101 of the Health – General Article.</text> </level> <level label="l–1"> <text>“Injectable medication for treatment of a sexually transmitted infection” means a medication that:</text> <level label="1"> <text>Is administered by injection other than intravenously;</text> </level> <level label="2"> <text>Treats a sexually transmitted infection; and</text> </level> <level label="3"> <text>Is not a vaccine.</text> </level> </level> <level label="m"> <text>“Interchangeable biological product” means a biological product that is:</text> <level label="1"> <text>Licensed and determined by the United States Food and Drug Administration to meet the standards for interchangeability under 42 U.S.C. § 262(k)(4); or</text> </level> <level label="2"> <text>Determined to be therapeutically equivalent as stated in the latest edition of or supplement to the United States Food and Drug Administration’s approved drug products with therapeutic equivalence evaluations (the “Orange Book”).</text> </level> </level> <level label="n"> <text>“License” means, unless the context requires otherwise, a license issued to a pharmacist by the Board to practice pharmacy.</text> </level> <level label="o"> <text>“Licensed pharmacist” means, unless the context requires otherwise, a pharmacist who is licensed by the Board to practice pharmacy.</text> </level> <level label="o–1"> <level label="1"> <text>“Maintenance injectable medication” means a medication that:</text> <level label="i"> <text>Is administered by injection other than intravenously; and</text> </level> <level label="ii"> <text>Treats a chronic need, condition, or disorder.</text> </level> </level> <level label="2"> <text>“Maintenance injectable medication” includes a medication for the treatment of a psychiatric disorder or substance use disorder, contraception, and vitamins.</text> </level> </level> <level label="o–2"> <text>“Nicotine replacement therapy medication” means a drug or product, regardless of whether it is available over the counter, that:</text> <level label="1"> <text>Delivers nicotine to an individual; and</text> </level> <level label="2"> <text>Is approved by the federal Food and Drug Administration for the sole purpose of aiding in tobacco cessation or smoking cessation.</text> </level> </level> <level label="p"> <text>“Nonprescription drug” means a drug which may be sold without a prescription and which is labeled for use by the consumer in accordance with the requirements of the laws and regulations of this State and the federal government.</text> </level> <level label="q"> <text>“Nonresident pharmacy” means a pharmacy located outside this State that, in the normal course of business, as determined by the Board, ships, mails, or delivers drugs or devices to a person in this State pursuant to a prescription.</text> </level> <level label="r"> <text>“Pharmaceutical care” means the provision of a patient’s drug regimen for the purpose of achieving definite outcomes related to the cure or prevention of a disease, elimination or reduction of a patient’s symptoms, or arresting or slowing of a disease process by identifying, resolving, or preventing actual or potential drug therapy problems and which may include patient counseling and providing information to licensed and certified health care providers.</text> </level> <level label="s"> <text>“Pharmacist” means an individual who practices pharmacy regardless of the location where the activities of practice are performed.</text> </level> <level label="t"> <text>“Pharmacy” means an establishment in which prescription or nonprescription drugs or devices are compounded, dispensed, or distributed.</text> </level> <level label="u"> <text>“Pharmacy permit” means a permit issued by the Board to establish and operate a pharmacy.</text> </level> <level label="v"> <text>“Pharmacy student” means an individual who is enrolled as a student in a school or college of pharmacy approved by the Board or accredited by the Accreditation Council for Pharmacy Education.</text> </level> <level label="w"> <text>“Pharmacy technician trainee” means an individual engaged in a Board approved pharmacy technician training program.</text> </level> <level label="x"> <level label="1"> <text>“Practice pharmacy” means to engage in any of the following activities:</text> <level label="i"> <text>Providing pharmaceutical care;</text> </level> <level label="ii"> <text>Compounding, dispensing, or distributing prescription drugs or devices;</text> </level> <level label="iii"> <text>Compounding or dispensing nonprescription drugs or devices;</text> </level> <level label="iv"> <text>Monitoring prescriptions for prescription and nonprescription drugs or devices;</text> </level> <level label="v"> <text>Providing information, explanation, or recommendations to patients and health care practitioners about the safe and effective use of prescription or nonprescription drugs or devices;</text> </level> <level label="vi"> <text>Identifying and appraising problems concerning the use or monitoring of therapy with drugs or devices;</text> </level> <level label="vii"> <text>Acting within the parameters of a therapy management contract, as provided under Subtitle 6A of this title;</text> </level> <level label="viii"> <text>Administering vaccinations in accordance with § 12–508 of this title or self–administered drugs or maintenance injectable medications in accordance with § 12–509 of this title;</text> </level> <level label="ix"> <text>Delegating a pharmacy act to a registered pharmacy technician, pharmacy student, or an individual engaged in a Board approved pharmacy technician training program;</text> </level> <level label="x"> <text>Supervising a delegated pharmacy act performed by a registered pharmacy technician, pharmacy student, or an individual engaged in a Board approved pharmacy technician training program;</text> </level> <level label="xi"> <text>Providing drug therapy management in accordance with § 19–713.6 of the Health – General Article;</text> </level> <level label="xii"> <text>Prescribing and dispensing contraceptive medications and self–administered contraceptive devices approved by the U.S. Food and Drug Administration;</text> </level> <level label="xiii"> <text>Prescribing and dispensing nicotine replacement therapy medications; or</text> </level> <level label="xiv"> <text>If the pharmacist is registered with the Nonoccupational Postexposure Prophylaxis (nPEP) Standing Order Program established under § 13–5302 of the Health – General Article, dispensing nonoccupational postexposure prophylaxis (nPEP) medication approved by the U.S. Food and Drug Administration and in accordance with “Updated Guidelines for Antiretroviral Postexposure Prophylaxis After Sexual, Injection Drug Use, or Other Nonoccupational Exposure to HIV – United States 2016” or subsequent guidelines published by the federal Centers for Disease Control and Prevention.</text> </level> </level> <level label="2"> <text>“Practice pharmacy” does not include the operations of a person who holds a permit issued under § 12–6C–03 of this title.</text> </level> </level> <level label="y"> <text>“Registered pharmacy intern” means an individual who is registered with the Board to practice pharmacy under the direct supervision of a pharmacist.</text> </level> <level label="z"> <text>“Registered pharmacy technician” means an individual who is registered with the Board to perform delegated pharmacy acts.</text> </level> <level label="z–1"> <text>“Registration” means, unless the context requires otherwise, a registration issued by the Board to perform delegated pharmacy acts under the supervision of a licensed pharmacist.</text> </level> <level label="z–2"> <level label="1"> <text>“Self–administered drug” means a drug that is regularly administered by the patient for whom the drug is prescribed or by an individual who is not otherwise authorized to administer drugs under this article.</text> </level> <level label="2"> <text>“Self–administered drug” includes:</text> <level label="i"> <text>Eyedrops; and</text> </level> <level label="ii"> <text>A drug that is administered by an intramuscular injection or a subcutaneous injection.</text> </level> </level> </level> <level label="aa"> <text>“Supervision” means reviewing the work, guiding and directing the activities, and monitoring the performance of an individual.</text> </level> <level label="bb"> <text>“USP–NF” means the United States Pharmacopeia and the National Formulary.</text> </level> <level label="cc"> <text>“USP 795” means the standards set forth in the United States Pharmacopeia, General Chapter 795, “Pharmaceutical Compounding – Nonsterile Preparations”.</text> </level> <level label="dd"> <text>“USP 797” means the standards set forth in the United States Pharmacopeia, General Chapter 797, “Pharmaceutical Compounding – Sterile Preparations”.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-102" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="1" subtitle_name="Definitions; General Provisions"> <level label="a"> <level label="1"> <text>In this section the following terms have the meanings indicated.</text> </level> <level label="2"> <text>“In the public interest” means the dispensing of drugs or devices by a licensed dentist, physician, nurse or midwife, or podiatrist to a patient when a pharmacy is not conveniently available to the patient.</text> </level> <level label="3"> <text>“Nurse or midwife” means an individual licensed or certified by the Board of Nursing under Title 8 of this article.</text> </level> <level label="4"> <text>Except as provided in § 15–302.2 of this article, “personally preparing and dispensing” means that the licensed dentist, physician, nurse or midwife, or podiatrist:</text> <level label="i"> <text>Is physically present on the premises where the prescription is filled; and</text> </level> <level label="ii"> <text>Performs a final check of the prescription before it is provided to the patient.</text> </level> </level> </level> <level label="b"> <text>This title does not limit the right of an individual to practice a health occupation that the individual is authorized to practice under this article.</text> </level> <level label="c"> <level label="1"> <text>This subsection does not apply to a licensed dentist who obtains a permit from the State Board of Dental Examiners under subsection (h) of this section.</text> </level> <level label="2"> <text>This title does not prohibit:</text> <level label="i"> <text>A licensed veterinarian from:</text> <level label="1"> <text>Personally preparing and dispensing the veterinarian’s prescriptions; or</text> </level> <level label="2"> <text>Dispensing, in accordance with § 2–313(c) of the Agriculture Article, compounded nonsterile preparations or compounded sterile preparations provided by a pharmacy;</text> </level> </level> <level label="ii"> <text>A licensed dentist, physician, or podiatrist from personally preparing and dispensing the dentist’s, physician’s, or podiatrist’s prescriptions when:</text> <level label="1"> <text>The dentist, physician, or podiatrist:</text> </level> <level label="A"> <text>Has applied to the board of licensure in this State which licensed the dentist, physician, or podiatrist;</text> </level> <level label="B"> <text>Has demonstrated to the satisfaction of that board that the dispensing of prescription drugs or devices by the dentist, physician, or podiatrist is in the public interest;</text> </level> <level label="C"> <text>Has received a written permit from that board to dispense prescription drugs or devices except that a written permit is not required in order to dispense starter dosages or samples without charge; and</text> </level> <level label="D"> <text>Posts a sign conspicuously positioned and readable regarding the process for resolving incorrectly filled prescriptions or includes written information regarding the process with each prescription dispensed;</text> </level> <level label="2"> <text>The person for whom the drugs or devices are prescribed is a patient of the prescribing dentist, physician, or podiatrist;</text> </level> <level label="3"> <text>The dentist, physician, or podiatrist does not have a substantial financial interest in a pharmacy; and</text> </level> <level label="4"> <text>The dentist, physician, or podiatrist:</text> </level> <level label="A"> <text>Complies with the dispensing and labeling requirements of this title;</text> </level> <level label="B"> <text>Records the dispensing of the prescription drug or device on the patient’s chart;</text> </level> <level label="C"> <text>Allows the Office of Controlled Substances Administration to enter and inspect the dentist’s, physician’s, or podiatrist’s office at all reasonable hours and in accordance with § 12–102.1 of this subtitle;</text> </level> <level label="D"> <text>On inspection by the Office of Controlled Substances Administration, signs and dates an acknowledgment form provided by the Office of Controlled Substances Administration relating to the requirements of this section;</text> </level> <level label="E"> <text>Except for starter dosages or samples without charge, provides the patient with a written prescription, maintains prescription files in accordance with § 12–403(c)(13) of this title, and maintains a separate file for Schedule II prescriptions;</text> </level> <level label="F"> <text>Does not direct patients to a single pharmacist or pharmacy in accordance with § 12–403(c)(8) of this title;</text> </level> <level label="G"> <text>Does not receive remuneration for referring patients to a pharmacist or pharmacy;</text> </level> <level label="H"> <text>Complies with the child resistant packaging requirements regarding prescription drugs under Title 22, Subtitle 3 of the Health – General Article;</text> </level> <level label="I"> <text>Complies with drug recalls;</text> </level> <level label="J"> <text>Maintains biennial inventories and complies with any other federal and State record–keeping requirements relating to controlled dangerous substances;</text> </level> <level label="K"> <text>Purchases prescription drugs from a pharmacy or wholesale distributor who holds a permit issued by the Board of Pharmacy, as verified by the Board of Pharmacy;</text> </level> <level label="L"> <text>Annually reports to the respective board of licensure whether the dentist, physician, or podiatrist has personally prepared and dispensed prescription drugs within the previous year; and</text> </level> <level label="M"> <text>Completes ten continuing education credits over a 5–year period relating to the preparing and dispensing of prescription drugs, offered by the Accreditation Council for Pharmacy Education (ACPE) or as approved by the Secretary, in consultation with each respective board of licensure, as a condition of permit renewal;</text> </level> </level> <level label="iii"> <text>A licensed physician from dispensing a topical medication without obtaining the permit required under item (ii)1C of this paragraph or completing the continuing education required under item (ii)4M of this paragraph when the physician:</text> <level label="1"> <text>Otherwise complies with item (ii) of this paragraph; and</text> </level> <level label="2"> <text>Has obtained a special written permit under § 14–509 of this article;</text> </level> </level> <level label="iv"> <text>A licensed physician who complies with the requirements of item (ii) of this paragraph from personally preparing and dispensing a prescription written by:</text> <level label="1"> <text>A physician assistant who complies with Title 15, Subtitle 3 of this article; or</text> </level> <level label="2"> <text>An advanced practice registered nurse with prescriptive authority under Title 8 of this article and is working with the physician in the same office setting;</text> </level> </level> <level label="v"> <text>A hospital–based clinic from dispensing prescriptions to its patients;</text> </level> <level label="vi"> <text>An individual licensed or certified under Title 8 of this article from personally preparing and dispensing a drug or device as authorized under Title 8 of this article; or</text> </level> <level label="vii"> <text>A health care provider licensed under this article from having an ownership interest in a clinical research pharmacy if:</text> <level label="1"> <text>The operations of the clinical research pharmacy are limited to the requirements for a clinical research pharmacy permit in § 12–101 of this subtitle;</text> </level> <level label="2"> <text>A pharmacist licensed under this subtitle:</text> </level> <level label="A"> <text>Is present on–site during all hours of operation of the clinical research pharmacy; and</text> </level> <level label="B"> <text>Is responsible for all compounding, dispensing, and oversight of pharmacy services; and</text> </level> <level label="3"> <text>Any health care provider with a substantial ownership interest in the clinical research pharmacy does not:</text> </level> <level label="A"> <text>Direct patients to a single pharmacist or pharmacy in accordance with § 12–403(c)(8) of this title; or</text> </level> <level label="B"> <text>Receive remuneration for referring patients to a pharmacist or pharmacy.</text> </level> </level> </level> </level> <level label="d"> <text>This title does not prohibit:</text> <level label="1"> <text>A licensed veterinarian from personally dispensing a drug or device sample to a patient of the veterinarian; or</text> </level> <level label="2"> <text>A licensed dentist, licensed physician, or licensed podiatrist from personally dispensing a drug or device sample to a patient of the licensed dentist, licensed physician, or licensed podiatrist if:</text> <level label="i"> <text>The sample complies with the labeling requirements of § 12–505 of this title;</text> </level> <level label="ii"> <text>No charge is made for the sample; and</text> </level> <level label="iii"> <text>The authorized prescriber enters an appropriate record in the patient’s chart.</text> </level> </level> </level> <level label="e"> <level label="1"> <text>This title does not prohibit:</text> <level label="i"> <text>A dentist, physician, nurse or midwife, or podiatrist from administering a prescription drug or device in the course of treating a patient;</text> </level> <level label="ii"> <text>A licensed dental hygienist from administering medication under § 4–206.4 of this article; or</text> </level> <level label="iii"> <text>A nurse anesthetist from administering medication under § 8–513 of this article.</text> </level> </level> <level label="2"> <text>For the purposes of paragraph (1)(i) of this subsection, “administering” means the direct introduction of a single dosage of a drug or device at a given time, whether by injection or other means, and whether in liquid, tablet, capsule, or other form.</text> </level> </level> <level label="f"> <level label="1"> <text>This title does not prohibit a dentist, physician, nurse or midwife, or podiatrist from personally dispensing a starter dosage of a prescription drug or device to a patient of the dentist, physician, nurse or midwife, or podiatrist, provided that:</text> <level label="i"> <text>The starter dosage complies with the labeling requirements of § 12–505 of this title;</text> </level> <level label="ii"> <text>No charge is made for the starter dosage; and</text> </level> <level label="iii"> <text>The dentist, physician, nurse or midwife, or podiatrist enters an appropriate record on the patient’s chart.</text> </level> </level> <level label="2"> <text>For the purposes of paragraph (1) of this subsection, “starter dosage” means an amount of drug or device sufficient to begin therapy:</text> <level label="i"> <text>Of short duration of 72 hours or less; or</text> </level> <level label="ii"> <text>Prior to obtaining a larger quantity of the drug or device to complete the therapy.</text> </level> </level> </level> <level label="g"> <text>This title does not prohibit a dentist, physician, nurse or midwife, or podiatrist from dispensing a prescription drug or device in the course of treating a patient:</text> <level label="1"> <text>At a medical facility or clinic that is operated on a nonprofit basis;</text> </level> <level label="2"> <text>At a health center that operates on a campus of an institution of higher education; or</text> </level> <level label="3"> <text>At a public health facility, a medical facility under contract with a State or local health department, or a facility funded with public funds.</text> </level> </level> <level label="h"> <text>This title does not prohibit a licensed dentist who obtains a permit from the State Board of Dental Examiners that allows the licensed dentist to dispense only prescription strength home fluoride products, dentin/enamel remineralizing products, and antimicrobial rinse from dispensing the product or rinse when:</text> <level label="1"> <text>The product or rinse is dispensed to a patient of the licensed dentist;</text> </level> <level label="2"> <text>The licensed dentist enters an appropriate record in the patient’s chart that the product or rinse was dispensed to the patient; and</text> </level> <level label="3"> <text>The licensed dentist affixes a label on the product or rinse container that includes:</text> <level label="i"> <text>The name of the patient; and</text> </level> <level label="ii"> <text>Unless already printed on the container:</text> <level label="1"> <text>The expiration date of the product or rinse; and</text> </level> <level label="2"> <text>The instructions for using the product or rinse.</text> </level> </level> </level> </level> <level label="i"> <text>This title does not apply to a person who only dispenses:</text> <level label="1"> <text>Prescription devices that do not contain a prescription drug;</text> </level> <level label="2"> <text>Prescription devices within which the only prescription drug is medical oxygen;</text> </level> <level label="3"> <text>Durable medical equipment, as defined by the Centers for Medicare and Medicaid Services; or</text> </level> <level label="4"> <text>Prosthetics, orthotics, and related supplies.</text> </level> </level> <level label="j"> <text>This title does not prohibit a licensed dentist from dispensing a full course of antibiotics to a patient for infection control if:</text> <level label="1"> <text>The patient is receiving pro bono dental care;</text> </level> <level label="2"> <text>There is no charge for the antibiotics;</text> </level> <level label="3"> <text>The licensed dentist enters an appropriate record of the treatment in the patient’s chart; and</text> </level> <level label="4"> <text>The licensed dentist affixes a label on the antibiotic container that includes:</text> <level label="i"> <text>The name of the patient; and</text> </level> <level label="ii"> <text>Unless already printed on the container:</text> <level label="1"> <text>The expiration date of the antibiotic; and</text> </level> <level label="2"> <text>The instructions for taking the antibiotic.</text> </level> </level> </level> </level> <level label="k"> <text>This title does not limit the right of a general merchant to sell:</text> <level label="1"> <text>Any nonprescription drug or device;</text> </level> <level label="2"> <text>Any commonly used household or domestic remedy; or</text> </level> <level label="3"> <text>Any farm remedy or ingredient for a spraying solution, in bulk or otherwise.</text> </level> </level> <level label="l"> <text>The Board of Pharmacy, the Board of Dental Examiners, the Board of Physicians, and the Board of Podiatric Medical Examiners annually shall report to the Office of Controlled Substances Administration:</text> <level label="1"> <text>The names and addresses of its licensees who are authorized to personally prepare and dispense prescription drugs; and</text> </level> <level label="2"> <text>The names and addresses of its licensees who have reported, in accordance with subsection (c)(2)(ii)4L of this section, that they have personally prepared and dispensed prescription drugs within the previous year.</text> </level> </level> <level label="m"> <text>A dentist, physician, or podiatrist who fails to comply with the provisions of this section governing the dispensing of prescription drugs or devices shall:</text> <level label="1"> <text>Have the dispensing permit revoked; and</text> </level> <level label="2"> <text>Be subject to disciplinary actions by the appropriate licensing board.</text> </level> </level> </section> <section article="gho" article_name="Health Occupations" number="12-102.1" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="1" subtitle_name="Definitions; General Provisions"> <level label="a"> <text>This section does not apply to a licensed dentist who obtains a permit from the State Board of Dental Examiners under § 12–102(h) of this subtitle.</text> </level> <level label="b"> <text>The Office of Controlled Substances Administration shall enter and inspect the office of a dentist, physician, or podiatrist who holds:</text> <level label="1"> <text>An initial dispensing permit:</text> <level label="i"> <text>Within 6 months after receiving the report required under § 12–102(l)(1) of this subtitle; and</text> </level> <level label="ii"> <text>At least one more time during the duration of the permit; and</text> </level> </level> <level label="2"> <text>A renewed dispensing permit at least two times during the duration of the permit.</text> </level> </level> <level label="c"> <text>The Office of Controlled Substances Administration promptly shall report the results of the inspections required under subsection (b) of this section to the respective board of licensure.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-102.2" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="1" subtitle_name="Definitions; General Provisions"> <level label="a"> <text>This section does not apply to a licensed dentist who obtains a permit from the State Board of Dental Examiners under § 12–102(h) of this subtitle.</text> </level> <level label="b"> <text>The Board of Dental Examiners, the Board of Physicians, and the Board of Podiatric Medical Examiners shall charge a fee to a dentist, physician, or podiatrist who holds a dispensing permit in an amount that will produce funds to approximate but not exceed the documented costs to the Office of Controlled Substances Administration for inspections of dispensing permit holders.</text> </level> <level label="c"> <text>Revenues collected by the Board of Dental Examiners, the Board of Physicians, and the Board of Podiatric Medical Examiners under this section shall be paid into the General Fund of the State.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-201" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="2" subtitle_name="State Board of Pharmacy"> <text>There is a State Board of Pharmacy in the Department.</text> </section> <section article="gho" article_name="Health Occupations" number="12-202" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="2" subtitle_name="State Board of Pharmacy"> <level label="a"> <level label="1"> <text>The Board consists of 13 members.</text> </level> <level label="2"> <text>Of the 13 Board members:</text> <level label="i"> <text>Ten shall be licensed pharmacists, including:</text> <level label="1"> <text>Two who at the time of appointment practice primarily in chain store pharmacies;</text> </level> <level label="2"> <text>Two who at the time of appointment practice primarily in independent pharmacies;</text> </level> <level label="3"> <text>Two who at the time of appointment practice primarily in an acute–care hospital;</text> </level> <level label="4"> <text>One who at the time of appointment practices primarily in a pharmacy that provides services to a long–term care facility;</text> </level> <level label="5"> <text>One who at the time of appointment practices primarily in a pharmacy that specializes in the provision of home infusion/home care services; and</text> </level> <level label="6"> <text>Two pharmacists at–large;</text> </level> </level> <level label="ii"> <text>One shall be a registered pharmacy technician; and</text> </level> <level label="iii"> <text>Two shall be consumer members.</text> </level> </level> <level label="3"> <level label="i"> <text>The Governor shall appoint the chain store pharmacist members, with the advice of the Secretary, from a list of names submitted to the Secretary and the Governor by the Maryland Association of Chain Drug Stores.</text> </level> <level label="ii"> <text>The Governor shall appoint the independent pharmacist members, with the advice of the Secretary, from a list of names submitted to the Secretary and the Governor by the Maryland Pharmacists Association and the Maryland Pharmaceutical Society.</text> </level> <level label="iii"> <text>The Governor shall appoint the acute–care hospital pharmacist members, with the advice of the Secretary, from a list of names submitted to the Secretary and the Governor by the Maryland Society of Health–System Pharmacists.</text> </level> <level label="iv"> <text>The Governor shall appoint the long–term care facility pharmacist member, with the advice of the Secretary, from a list of names submitted to the Secretary and the Governor by the Maryland Chapter of the American Society of Consultant Pharmacists.</text> </level> <level label="v"> <text>The Governor shall appoint the home infusion/home care pharmacist member, with the advice of the Secretary, from a list of names submitted to the Secretary and the Governor by the Maryland Society of Health–System Pharmacists.</text> </level> <level label="vi"> <text>The Governor shall appoint the at–large pharmacist members, with the advice of the Secretary, from a list of all names submitted to the Maryland Pharmacists Association, and then forwarded to the Secretary and the Governor.</text> </level> <level label="vii"> <text>The Governor shall appoint the registered pharmacy technician member, with the advice of the Secretary, from a list of all names submitted to the Secretary and the Governor by the Maryland Society of Health–System Pharmacists and the Maryland Pharmacists Association.</text> </level> <level label="viii"> <text>Except for the at–large vacancies, the number of names on each list submitted to the Secretary and the Governor under this paragraph shall be three times the number of vacancies.</text> </level> </level> <level label="4"> <text>For each pharmacist vacancy and each registered pharmacy technician vacancy:</text> <level label="i"> <text>The Board shall notify all licensed pharmacists, registered pharmacy technicians, and other interested parties of record in the State of the vacancy to solicit nominations to fill the vacancy and provide information for contacting a representative of the group that submits the list of names to the Governor under paragraph (3) of this subsection; and</text> </level> <level label="ii"> <text>Except for the at–large vacancies, each association that is responsible for submitting a list of nominees to the Secretary and the Governor under this section shall:</text> <level label="1"> <text>Issue a nomination form upon the request of any licensed pharmacist and consider all nominations received by the association’s deadline;</text> </level> <level label="2"> <text>Form a committee, which recognizes diversity within the State in geographic distribution, sex, race, and age, comprised of at least five pharmacists to review nominations, interview all qualified nominees in a meeting open to the public, and select three names for each vacancy to be submitted to the Secretary and the Governor; and</text> </level> <level label="3"> <text>In the event that fewer than three qualified nominees are submitted to the association, select any additional names that are needed to complete the list required to be submitted to the Secretary and the Governor under this section.</text> </level> </level> </level> <level label="5"> <text>The Governor shall appoint the consumer members with the advice of the Secretary and the advice and consent of the Senate.</text> </level> <level label="6"> <text>Each member of the Board shall be a resident of this State.</text> </level> <level label="7"> <text>A member of the Board shall be recused from all aspects of the licensing exam if that Board member:</text> <level label="i"> <text>Is a member of the board of trustees at a school of pharmacy;</text> </level> <level label="ii"> <text>Is a teacher at a school of pharmacy; or</text> </level> <level label="iii"> <text>Acquires the member’s primary source of income through employment by a school of pharmacy.</text> </level> </level> </level> <level label="b"> <text>Each pharmacist member and each registered pharmacy technician member of the Board shall:</text> <level label="1"> <text>Be skilled and competent in practicing pharmacy; and</text> </level> <level label="2"> <text>Have at least 5 years of active pharmacy practice.</text> </level> </level> <level label="c"> <text>Each consumer member of the Board:</text> <level label="1"> <text>Shall be a member of the general public;</text> </level> <level label="2"> <text>May not be or ever have been a pharmacist or in training to become a pharmacist;</text> </level> <level label="3"> <text>May not have a household member who is a pharmacist or in training to become a pharmacist;</text> </level> <level label="4"> <text>May not participate or ever have participated in a commercial or professional field related to practicing pharmacy;</text> </level> <level label="5"> <text>May not have a household member who participates in a commercial or professional field related to practicing pharmacy; and</text> </level> <level label="6"> <text>May not have had within 2 years before appointment a substantial financial interest in a person regulated by the Board.</text> </level> </level> <level label="d"> <text>While a member of the Board, a consumer member may not have a substantial financial interest in a person regulated by the Board.</text> </level> <level label="e"> <text>Before taking office, each appointee to the Board shall take the oath required by Article I, § 9 of the Maryland Constitution.</text> </level> <level label="f"> <level label="1"> <text>The term of a member is 4 years.</text> </level> <level label="2"> <text>The terms of members are staggered as required by the terms provided for members of the Board on July 1, 1981.</text> </level> <level label="3"> <text>At the end of a term, a member continues to serve until a successor is appointed and qualifies.</text> </level> <level label="4"> <text>A member who is appointed after a term has begun serves only for the rest of the term and until a successor is appointed and qualifies.</text> </level> <level label="5"> <text>To the extent practicable, the Governor shall fill any vacancy on the Board within 60 days of the date of the vacancy.</text> </level> <level label="6"> <text>A member may not serve more than 2 consecutive full terms.</text> </level> </level> <level label="g"> <level label="1"> <text>The Governor may remove a member for incompetence or misconduct.</text> </level> <level label="2"> <text>Upon the recommendation of the Secretary, the Governor may remove a member whom the Secretary finds to have been absent from 2 successive Board meetings without adequate reason.</text> </level> </level> </section> <section article="gho" article_name="Health Occupations" number="12-203" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="2" subtitle_name="State Board of Pharmacy"> <level label="a"> <text>From among its members, the Board annually shall elect a president, a secretary, and a treasurer.</text> </level> <level label="b"> <text>The Board shall determine:</text> <level label="1"> <text>The manner of election of officers; and</text> </level> <level label="2"> <text>The duties of each officer.</text> </level> </level> </section> <section article="gho" article_name="Health Occupations" number="12-204" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="2" subtitle_name="State Board of Pharmacy"> <level label="a"> <text>A majority of the members then serving on the Board is a quorum to do business.</text> </level> <level label="b"> <text>The Board shall determine the times and places of its meetings.</text> </level> <level label="c"> <text>Each member of the Board is entitled to:</text> <level label="1"> <text>Compensation in accordance with the budget of the Board; and</text> </level> <level label="2"> <text>Reimbursement for expenses at a rate determined by the Board.</text> </level> </level> <level label="d"> <level label="1"> <text>The Board may employ a staff in accordance with the budget of the Board.</text> </level> <level label="2"> <text>The Board may designate 1 of its staff as an executive director.</text> </level> </level> </section> <section article="gho" article_name="Health Occupations" number="12-205" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="2" subtitle_name="State Board of Pharmacy"> <level label="a"> <text>In addition to the powers set forth elsewhere in this title, the Board may adopt:</text> <level label="1"> <text>Rules and bylaws that are necessary to do its business;</text> </level> <level label="2"> <text>Rules and regulations to carry out the provisions of this title;</text> </level> <level label="3"> <text>Rules and regulations that are necessary to protect the public health, safety, and welfare and that establish standards for practicing pharmacy and operating pharmacies, including rules and regulations that govern:</text> <level label="i"> <text>Methods of advertising and promotion; and</text> </level> <level label="ii"> <text>Standards for filling and refilling prescriptions; and</text> </level> </level> <level label="4"> <text>A code of conduct that specifies which behaviors are either required or prohibited in the practice of pharmacy.</text> </level> </level> <level label="b"> <text>In addition to the duties set forth elsewhere in this title, the Board shall:</text> <level label="1"> <text>Keep a record that includes:</text> <level label="i"> <text>The name and place of the business or the home address of each licensed pharmacist, each registered pharmacy technician, and each registered pharmacy intern;</text> </level> <level label="ii"> <text>The facts concerning the issuance of that pharmacist’s license;</text> </level> <level label="iii"> <text>The facts concerning the issuance of that pharmacy technician’s registration; and</text> </level> <level label="iv"> <text>The facts concerning the issuance of that pharmacy intern’s registration;</text> </level> </level> <level label="2"> <text>Prepare and deliver to the Governor, the Secretary, and the Maryland Pharmacists Association an annual report that:</text> <level label="i"> <text>Summarizes the condition of pharmacy in this State; and</text> </level> <level label="ii"> <text>Includes a record of the proceedings of the Board; and</text> </level> </level> <level label="3"> <text>Disclose any information contained in a record to any health occupations regulatory board or agency of this State or another state if the health occupations regulatory board or agency of this State or another state requests the information in writing.</text> </level> </level> <level label="c"> <text>In addition to the duties set forth elsewhere in this title, the Board may initiate such programs and projects as deemed necessary to inform or protect the public.</text> </level> <level label="d"> <level label="1"> <text>The Board shall adopt standards for approving examinations under § 12-6B-02(b)(4) of this title.</text> </level> <level label="2"> <text>The Board shall approve any examination that meets the standards adopted under paragraph (1) of this subsection including:</text> <level label="i"> <text>Employer based pharmacy technician examinations;</text> </level> <level label="ii"> <text>Nationally recognized pharmacy technician examinations; and</text> </level> <level label="iii"> <text>Examinations for certification as a pharmacy technician.</text> </level> </level> </level> </section> <section article="gho" article_name="Health Occupations" number="12-206" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="2" subtitle_name="State Board of Pharmacy"> <level label="a"> <text>There is a State Board of Pharmacy Fund.</text> </level> <level label="b"> <level label="1"> <text>The Board may set reasonable fees for the issuance and renewal of licenses and registrations and its other services.</text> </level> <level label="2"> <text>The fees charged shall be set so as to produce funds to approximate the cost of maintaining the Board.</text> </level> <level label="3"> <text>Funds to cover the compensation and expenses of the Board members shall be generated by fees set under this section.</text> </level> </level> <level label="c"> <level label="1"> <text>The Board shall pay all funds collected under this title to the Comptroller of the State.</text> </level> <level label="2"> <text>The Comptroller shall distribute the fees to the State Board of Pharmacy Fund.</text> </level> </level> <level label="d"> <level label="1"> <text>The Fund shall be used to cover the actual documented direct and indirect costs of fulfilling the statutory and regulatory duties of the Board as provided by the provisions of this article.</text> </level> <level label="2"> <text>The Fund is a continuing, nonlapsing fund, not subject to § 7-302 of the State Finance and Procurement Article.</text> </level> <level label="3"> <text>Any unspent portions of the Fund may not be transferred or revert to the General Fund of the State, but shall remain in the Fund to be used for the purposes specified in this article.</text> </level> <level label="4"> <text>No other State money may be used to support the Fund.</text> </level> </level> <level label="e"> <level label="1"> <text>A designee of the Board shall administer the Fund.</text> </level> <level label="2"> <text>Moneys in the Fund may be expended only for any lawful purpose authorized under the provisions of this article.</text> </level> </level> <level label="f"> <text>The Board may allocate moneys from the Fund to a pharmacist rehabilitation committee described in § 12-317 of this title.</text> </level> <level label="g"> <text>The Legislative Auditor shall audit the accounts and transactions of the Fund as provided in § 2-1220 of the State Government Article.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-207" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="2" subtitle_name="State Board of Pharmacy"> <text>A person shall have the immunity from liability described under § 5-713 of the Courts and Judicial Proceedings Article for giving information to the Board or otherwise participating in its activities.</text> </section> <section article="gho" article_name="Health Occupations" number="12-301" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="3"> <level label="a"> <text>Except as otherwise provided in this title or §§ 10–14A–03 and 10–14B–03 of the State Government Article, an individual shall be licensed by the Board before the individual may practice pharmacy in this State.</text> </level> <level label="b"> <text>This section does not apply to a pharmacy student participating in an experiential learning program of a college or school of pharmacy under the supervision of a licensed pharmacist.</text> </level> <level label="c"> <text>This section does not apply to a registered pharmacy intern practicing under the direct supervision of a licensed pharmacist.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-302" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="3"> <level label="a"> <text>To qualify for a license, an applicant shall be an individual who meets the requirements of this section.</text> </level> <level label="b"> <text>The applicant shall be of good moral character.</text> </level> <level label="c"> <text>The applicant shall be at least 18 years old.</text> </level> <level label="d"> <text>The applicant shall submit to a criminal history records check in accordance with § 12–302.1 of this subtitle.</text> </level> <level label="e"> <text>The applicant shall:</text> <level label="1"> <text>Be a graduate of a school or college of pharmacy that is approved by the Board or accredited by the American Council on Pharmaceutical Education; and</text> </level> <level label="2"> <text>Have completed the professional experience program that the Board requires.</text> </level> </level> <level label="f"> <text>Except as otherwise provided in this title, the applicant shall pass an examination given by the Board under this subtitle.</text> </level> <level label="g"> <level label="1"> <text>In this subsection, “foreign school or college of pharmacy” means a school or college of pharmacy that is not located in any state in the United States.</text> </level> <level label="2"> <text>The Board may waive the requirements of subsection (e)(1) of this section for an applicant who is a graduate of a foreign school or college of pharmacy, provided that the applicant passes an examination approved by the Board in addition to the examinations otherwise given by the Board under this subtitle.</text> </level> </level> <level label="h"> <level label="1"> <text>Except as otherwise provided in this subsection, the Board shall require, as part of its examination or licensing procedures, an applicant for a license to practice pharmacy to demonstrate an oral competency in the English language by passing a Board approved standardized test of oral competency.</text> </level> <level label="2"> <text>The Board shall adopt regulations that establish a procedure for testing an individual who because of the individual’s speech or hearing impairment is unable to complete satisfactorily a Board approved standardized test of oral competency.</text> </level> <level label="3"> <text>If any disciplinary charge or action that relates to a problem with the oral communication of the English language is brought against a licensee under this title, the Board shall require the licensee to pass a Board approved standardized test of oral competency.</text> </level> <level label="4"> <text>The Board may not require an applicant for a license to practice pharmacy, who is or was previously licensed in another state to practice pharmacy, to demonstrate an oral competency in the English language, if the other state’s examination and licensing procedures at the time the applicant was licensed in the other state included an oral competency component.</text> </level> <level label="5"> <text>Graduation from a recognized English–speaking professional school accredited by the Accreditation Council for Pharmacy Education is acceptable as proof of proficiency in the oral communication of the English language under this subsection.</text> </level> </level> </section> <section article="gho" article_name="Health Occupations" number="12-302.1" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="3"> <level label="a"> <text>In this section, “Central Repository” means the Criminal Justice Information System Central Repository of the Department of Public Safety and Correctional Services.</text> </level> <level label="b"> <text>An applicant shall apply to the Central Repository for a State and national criminal history records check.</text> </level> <level label="c"> <text>As part of the application for a criminal history records check, an applicant shall complete and submit to the Central Repository:</text> <level label="1"> <text>A complete set of legible fingerprints taken in a format approved by the Director of the Central Repository and the Director of the Federal Bureau of Investigation;</text> </level> <level label="2"> <text>The fee authorized under § 10–221(b)(7) of the Criminal Procedure Article for access to Maryland criminal history records; and</text> </level> <level label="3"> <text>The mandatory processing fee required by the Federal Bureau of Investigation for a national criminal history records check.</text> </level> </level> <level label="d"> <text>In accordance with §§ 10–201 through 10–229 of the Criminal Procedure Article, the Central Repository shall forward to the Board and the individual the individual’s criminal history record information.</text> </level> <level label="e"> <text>Information obtained from the Central Repository under this section:</text> <level label="1"> <text>Is confidential;</text> </level> <level label="2"> <text>May not be redisseminated; and</text> </level> <level label="3"> <text>May be used only for the licensing purpose authorized by this title.</text> </level> </level> <level label="f"> <text>The subject of a criminal history records check under this section may contest the contents of the criminal history record information issued by the Central Repository as provided in § 10–223 of the Criminal Procedure Article.</text> </level> <level label="g"> <text>If criminal history record information is reported to the Central Repository after the date of the initial criminal history records check, the Central Repository shall provide to the Board and the individual revised criminal history record information for the individual.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-303" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="3"> <level label="a"> <text>To apply for a license, an applicant shall:</text> <level label="1"> <text>Submit an application to the Board on the form that the Board requires;</text> </level> <level label="2"> <text>Pay the application fees set by the Board; and</text> </level> <level label="3"> <text>Submit to a criminal history records check in accordance with § 12–302.1 of this subtitle.</text> </level> </level> <level label="b"> <text>An application shall be signed and verified by the applicant as to completion of the required professional experience program.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-304" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="3"> <level label="a"> <text>An applicant who otherwise qualifies for a license is entitled to be examined as provided in this section.</text> </level> <level label="b"> <text>The Board shall give examinations to applicants at least twice a year, at the times and places that the Board determines.</text> </level> <level label="c"> <text>The Board shall notify each qualified applicant of the time and place of examination.</text> </level> <level label="d"> <text>The Board shall determine the subjects, scope, form, and passing score for examinations given under this subtitle.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-305" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="3"> <level label="a"> <text>Subject to the provisions of this section, the Board may waive any examination requirement of this title for an applicant who is licensed to practice pharmacy in any other state, if that state grants a similar waiver to licensees of this State.</text> </level> <level label="b"> <text>The Board may grant a waiver under this section only if the applicant:</text> <level label="1"> <text>Is of good moral character;</text> </level> <level label="2"> <text>Pays the application fees set by the Board; and</text> </level> <level label="3"> <text>Provides adequate evidence that the applicant:</text> <level label="i"> <text>Meets the qualifications otherwise required by this title; and</text> </level> <level label="ii"> <text>Became licensed or registered in the other state to practice pharmacy only after passing an examination that is approved by the Board.</text> </level> </level> </level> <level label="c"> <text>The Board shall adopt by regulation an examination to be administered to applicants who are licensed to practice pharmacy in any other state.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-306" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="3"> <level label="a"> <text>The Board shall issue a license to any applicant who meets the requirements of this title.</text> </level> <level label="b"> <level label="1"> <text>On receipt of the criminal history record information of an applicant for licensure forwarded to the Board in accordance with § 12–302.1 of this subtitle, in determining whether to grant a license, the Board shall consider:</text> <level label="i"> <text>The age at which the crime was committed;</text> </level> <level label="ii"> <text>The circumstances surrounding the crime;</text> </level> <level label="iii"> <text>The length of time that has passed since the crime;</text> </level> <level label="iv"> <text>Subsequent work history;</text> </level> <level label="v"> <text>Employment and character references; and</text> </level> <level label="vi"> <text>Other evidence that demonstrates whether the applicant poses a threat to the public health or safety.</text> </level> </level> <level label="2"> <text>The Board may not issue a license if the criminal history record information required under § 12–302.1 of this subtitle has not been received.</text> </level> </level> </section> <section article="gho" article_name="Health Occupations" number="12-307" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="3"> <level label="a"> <text>A license authorizes the licensee to practice pharmacy while the license is effective.</text> </level> <level label="b"> <text>Except as otherwise provided in this section, a pharmacist may engage in dispensing or distributing only from a pharmacy holding a pharmacy permit issued by the Board.</text> </level> <level label="c"> <level label="1"> <text>Pursuant to regulations adopted by the Board, a licensed pharmacist may engage in dispensing or distributing from a setting not holding a pharmacy permit only upon receiving the prior approval of the Board.</text> </level> <level label="2"> <text>The Board shall adopt regulations that authorize a pharmacist to dispense or distribute from a remote location for the benefit of a health care facility that uses a remote automated medication system in accordance with § 12–605 of this title.</text> </level> </level> <level label="d"> <text>A licensed pharmacist may delegate pharmacy acts to a registered pharmacy technician, pharmacy student, or pharmacy technician trainee only if the delegated pharmacy acts:</text> <level label="1"> <text>Are directly supervised by a licensed pharmacist;</text> </level> <level label="2"> <text>Are not required to be performed by a licensed pharmacist;</text> </level> <level label="3"> <text>Are within the education, training, experience, and area of practice of the delegating licensed pharmacist; and</text> </level> <level label="4"> <text>Are appropriate to the education, training, and experience of the registered pharmacy technician, pharmacy student, or pharmacy technician trainee.</text> </level> </level> <level label="e"> <text>A licensed pharmacist may delegate the entry of prescription–related data into databases or patient charts to be performed at a remote location to a registered pharmacy technician or a registered pharmacy intern if:</text> <level label="1"> <text>The registered pharmacy technician or registered pharmacy intern has immediate electronic access to a pharmacist who can provide assistance as needed; and</text> </level> <level label="2"> <text>The data entry:</text> <level label="i"> <text>Is not required to be performed by a licensed pharmacist;</text> </level> <level label="ii"> <text>Is within the education, training, experience, and area of practice of the delegating licensed pharmacist;</text> </level> <level label="iii"> <text>Is appropriate to the education, training, and experience of the registered pharmacy technician or the registered pharmacy intern; and</text> </level> <level label="iv"> <text>If the data entry involves access to protected patient information under the federal Health Insurance Portability and Accountability Act of 1996, can be performed in a manner that maintains the confidentiality of patient information.</text> </level> </level> </level> </section> <section article="gho" article_name="Health Occupations" number="12-308" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="3"> <level label="a"> <level label="1"> <text>A license expires on the date set by the Board unless it is renewed for an additional term as provided in this section.</text> </level> <level label="2"> <text>A license may not be renewed for a term longer than 2 years.</text> </level> </level> <level label="b"> <level label="1"> <text>Except as provided in paragraph (2) of this subsection, the Board shall send to each licensee, at least 1 month before a license expires, a renewal notice by electronic means to the last known e–mail address of the licensee.</text> </level> <level label="2"> <text>If requested by a licensee, the Board shall send to the licensee a renewal notice by first–class mail to the last known address of the licensee.</text> </level> <level label="3"> <text>If a renewal notice sent by electronic means under paragraph (1) of this subsection is returned to the Board as undeliverable, the Board shall send to the licensee a renewal notice by first–class mail to the last known address of the licensee.</text> </level> <level label="4"> <text>A renewal notice sent under this subsection shall state:</text> <level label="i"> <text>The date on which the current license expires;</text> </level> <level label="ii"> <text>The date by which the renewal application must be received by the Board for the renewal to be issued and mailed before the license expires; and</text> </level> <level label="iii"> <text>The amount of the renewal fee.</text> </level> </level> </level> <level label="c"> <text>Before the license expires, the licensee periodically may renew it for an additional term set by the Board in its regulations, if the licensee:</text> <level label="1"> <text>Otherwise is entitled to be licensed;</text> </level> <level label="2"> <text>Pays to the Board a renewal fee set by the Board; and</text> </level> <level label="3"> <text>Submits to the Board:</text> <level label="i"> <text>A renewal application on the form that the Board requires; and</text> </level> <level label="ii"> <text>Satisfactory evidence of compliance with the continuing education requirements set under this subtitle for license renewal.</text> </level> </level> </level> <level label="d"> <text>Beginning July 1, 2027, the Board shall require all licensees who were initially licensed without a criminal history records check to submit to a criminal history records check in accordance with § 12–302.1 of this subtitle on renewal as set forth in regulations adopted by the Board.</text> </level> <level label="e"> <text>The Board shall renew the license of and issue a renewal certificate to each licensee who meets the requirements of this section.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-309" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="3"> <level label="a"> <text>Except as permitted in subsections (b) and (c) of this section, the Board may not renew the license and issue a certificate of renewal to any pharmacist until the pharmacist presents evidence of having completed 30 hours of approved continuing pharmaceutical education within the preceding 2 years.</text> </level> <level label="b"> <text>The Board may renew the license and issue a certificate of renewal to a pharmacist who presents acceptable evidence that the pharmacist was unable to comply with subsection (a) of this section.</text> </level> <level label="c"> <text>The Board may renew the license and issue a certificate of renewal for the first renewal period following the issuance of the original license without requiring a pharmacist to complete any continuing pharmaceutical education, if the pharmacist obtains a license within 1 year of the completion of the pharmacist’s pharmaceutical education.</text> </level> <level label="d"> <text>The Board shall evaluate and approve programs of continuing pharmaceutical education submitted to the Board by the person who intends to offer the program.</text> </level> <level label="e"> <text>Each program of continuing pharmaceutical education shall consist of at least 1 continuing education unit, which is 1 hour of participation in an organized continuing educational experience, including postgraduate studies, institutes, seminars, lectures, conferences, workshops, correspondence courses, cassette programs, programmed learning courses, audiovisual programs, and any other form of presentation that is approved by the Board.</text> </level> <level label="f"> <text>Any aspect of the practice of pharmacy may be the subject of a program of continuing pharmaceutical education, including pharmaceutics (compounding), pharmacology, pharmaceutical chemistry, biochemistry, physiology, microbiology, pharmacy administration, and professional practice management.</text> </level> <level label="g"> <text>Each program of continuing pharmaceutical education submitted to the Board of Pharmacy for approval shall:</text> <level label="1"> <text>Have a definite stated objective;</text> </level> <level label="2"> <text>Be presented in an organized manner by a qualified instructor or resource person; and</text> </level> <level label="3"> <text>Include a method of program evaluation that is suitable to the type of program being presented.</text> </level> </level> <level label="h"> <text>Each person who offers a program of continuing pharmaceutical education shall:</text> <level label="1"> <text>Provide a means for registration by the participants;</text> </level> <level label="2"> <text>Maintain a record of participation for at least 3 years; and</text> </level> <level label="3"> <text>Furnish each participant with adequate documentation of satisfactory completion of the program, including:</text> <level label="i"> <text>The name of the participant;</text> </level> <level label="ii"> <text>The name of the sponsor;</text> </level> <level label="iii"> <text>The type of program completed;</text> </level> <level label="iv"> <text>The number of continuing education hours or units completed; and</text> </level> <level label="v"> <text>The date of completion.</text> </level> </level> </level> <level label="i"> <text>For purposes of evaluation, members of the Board may attend and participate in any continuing pharmaceutical education program approved for credit.</text> </level> <level label="j"> <text>A pharmacist who completes a program of continuing pharmaceutical education that is not previously approved by the Board may request the Board, in writing, to approve the program for credit.</text> </level> <level label="k"> <text>The Board shall adopt regulations that are necessary to carry out the purposes of this section.</text> </level> <level label="l"> <text>Any continuing education program that is currently approved by the American Council on Pharmaceutical Education automatically qualifies for continuing education credit.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-310" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="3"> <level label="a"> <text>The Board shall reinstate the license of a pharmacist whose license has been expired for less than 2 years, if the pharmacist:</text> <level label="1"> <text>Meets the renewal and reinstatement requirements set by rule and regulation of the Board; and</text> </level> <level label="2"> <text>Pays to the Board the reinstatement fee set by the Board.</text> </level> </level> <level label="b"> <text>The Board shall reinstate the license of a pharmacist whose license has been expired for 2 years or more if the pharmacist:</text> <level label="1"> <text>Meets the reinstatement requirements established by the Board in its rules or regulations;</text> </level> <level label="2"> <text>Satisfies the requirements of subsection (a) of this section; and</text> </level> <level label="3"> <text>Submits to a criminal history records check in accordance with § 12–302.1 of this subtitle.</text> </level> </level> </section> <section article="gho" article_name="Health Occupations" number="12-311" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="3"> <text>Each licensee shall display the license conspicuously in the office or place of business of the licensee.</text> </section> <section article="gho" article_name="Health Occupations" number="12-312" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="3"> <level label="a"> <text>Unless the Board agrees to accept the surrender of a license, a licensed pharmacist may not surrender the license nor may the license lapse by operation of law while the licensee is under investigation or while charges are pending against the pharmacist.</text> </level> <level label="b"> <text>The Board may set conditions on its agreement with the pharmacist under investigation or against whom charges are pending to accept surrender of the pharmacist’s license.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-313" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="3"> <level label="a"> <text>In this section, “convicted” includes a determination of guilt, a guilty plea, or a plea of nolo contendere followed by a sentence.</text> </level> <level label="b"> <text>Subject to the hearing provisions of § 12–315 of this subtitle, the Board, on the affirmative vote of a majority of its members then serving, may deny a license to any applicant for a pharmacist’s license, reprimand any licensee, place any licensee on probation, or suspend or revoke a license of a pharmacist if the applicant or licensee:</text> <level label="1"> <text>Fraudulently or deceptively obtains or attempts to obtain a license for the applicant or licensee or for another;</text> </level> <level label="2"> <text>Fraudulently or deceptively uses a license;</text> </level> <level label="3"> <text>Aids an unauthorized individual to practice pharmacy or to represent that the individual is a pharmacist, a registered pharmacy intern, or a registered pharmacy technician;</text> </level> <level label="4"> <text>Delegates pharmacy acts to an unauthorized individual;</text> </level> <level label="5"> <text>Provides professional services while:</text> <level label="i"> <text>Under the influence of alcohol; or</text> </level> <level label="ii"> <text>Using any narcotic or controlled dangerous substance, as defined in § 5–101 of the Criminal Law Article, or other drug that is in excess of therapeutic amounts or without valid medical indication;</text> </level> </level> <level label="6"> <text>Submits a false statement to collect a fee;</text> </level> <level label="7"> <text>Willfully makes or files a false report or record as part of practicing pharmacy;</text> </level> <level label="8"> <text>Willfully fails to file or record any report that is required by law;</text> </level> <level label="9"> <text>Willfully impedes or obstructs the filing or recording of any report that is required by law;</text> </level> <level label="10"> <text>Willfully induces another to fail to file or record any report that is required by law;</text> </level> <level label="11"> <text>Provides or causes to be provided to any authorized prescriber prescription forms that bear the name, address, or other means of identification of a pharmacist or pharmacy;</text> </level> <level label="12"> <text>Provides remuneration to an authorized prescriber for referring an individual to a pharmacist or pharmacy for a product or service to be provided by that pharmacist or pharmacy;</text> </level> <level label="13"> <text>Agrees with an authorized prescriber, a registered pharmacy intern, or registered pharmacy technician to prepare or dispense a secret formula prescription;</text> </level> <level label="14"> <text>Except as to an association that has remained in continuous existence since July 1, 1963, associates as a partner, coowner, or employee of a pharmacy that is owned wholly or substantially by an authorized prescriber or group of authorized prescribers;</text> </level> <level label="15"> <text>Dispenses any drug, device, or diagnostic for which a prescription is required without a written, oral, or electronically transmitted prescription from an authorized prescriber;</text> </level> <level label="16"> <text>Except as provided in § 12–506 of this title, unless an authorized prescriber authorizes the refill, refills a prescription for any drug, device, or diagnostic for which a prescription is required;</text> </level> <level label="17"> <text>Violates any provision of § 12–505 of this title, which concerns the labeling requirements for prescriptions for drugs, devices, or diagnostics;</text> </level> <level label="18"> <text>Violates any provision of § 12–603 of this title, which concerns the home dialysis distribution program;</text> </level> <level label="19"> <text>Advertises or otherwise publicly claims to dispense prescriptions or practice pharmacy in a superior manner;</text> </level> <level label="20"> <text>Advertises in a manner that tends to deceive or defraud the public;</text> </level> <level label="21"> <text>Is professionally, physically, or mentally incompetent;</text> </level> <level label="22"> <text>Is convicted of or pleads guilty or nolo contendere to a felony or to a crime involving moral turpitude, whether or not any appeal or other proceeding is pending to have the conviction or plea set aside;</text> </level> <level label="23"> <text>Is convicted of a violation of this title;</text> </level> <level label="24"> <text>Is disciplined by a licensing or disciplinary authority of any state or country or convicted or disciplined by a court of any state or country, or disciplined by any branch of the uniformed services or the U.S. Department of Veterans Affairs, for an act that would be grounds for disciplinary action under the Board’s disciplinary statutes;</text> </level> <level label="25"> <text>Violates any rule or regulation adopted by the Board;</text> </level> <level label="26"> <text>Refuses, withholds from, denies, or discriminates against an individual with regard to the provision of professional services for which the licensee is licensed and qualified to render because the individual is HIV positive;</text> </level> <level label="27"> <text>Violates any provision of § 12–507 of this title;</text> </level> <level label="28"> <text>Provides or causes to be provided confidential patient information to any person without first having obtained the patient’s consent, as required by § 12–403(c)(13) of this title and by Title 4, Subtitle 3 of the Health – General Article;</text> </level> <level label="29"> <text>Fails to cooperate with a lawful investigation conducted by the Board or the Office of Controlled Substances Administration;</text> </level> <level label="30"> <text>Delegates pharmacy acts to a registered pharmacy technician, pharmacy student, or a pharmacy technician trainee outside the scope of education, training, experience, and area of practice of a licensed pharmacist;</text> </level> <level label="31"> <text>Delegates pharmacy acts that are inappropriate for a registered pharmacy technician, pharmacy student, or pharmacy technician trainee who does not have the education, training, or experience to perform the delegated pharmacy acts;</text> </level> <level label="32"> <text>Fails to dispense or dispose of prescription drugs or medical supplies in accordance with Title 15, Subtitle 6 of the Health – General Article; or</text> </level> <level label="33"> <text>Fails to appropriately supervise a registered pharmacy intern.</text> </level> </level> <level label="c"> <level label="1"> <text>The Board shall revoke the license of a licensee who is convicted under § 5–702 of the Criminal Law Article.</text> </level> <level label="2"> <text>The Board may reinstate the license of a person whose license has been revoked under this section in accordance with the regulations adopted by the Board.</text> </level> </level> </section> <section article="gho" article_name="Health Occupations" number="12-314" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="3"> <level label="a"> <text>If after a hearing under § 12-315 of this subtitle the Board finds that there are grounds under § 12-313 of this subtitle to reprimand any licensee, place any licensee on probation, or suspend or revoke a license, the Board may impose a penalty not exceeding $10,000:</text> <level label="1"> <text>Instead of reprimanding the licensee, placing the licensee on probation, or suspending or revoking the license; or</text> </level> <level label="2"> <text>In addition to reprimanding the licensee, placing the licensee on probation, or suspending or revoking the license.</text> </level> </level> <level label="b"> <text>The Board shall adopt rules and regulations to set standards for the imposition of penalties under this section.</text> </level> <level label="c"> <text>The Board shall pay any penalty collected under this section into the General Fund of this State.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-315" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="3"> <level label="a"> <text>Except as otherwise provided in the Administrative Procedure Act, before the Board takes any action under § 12-313 of this subtitle or § 12-6B-09 of this title, it shall give the individual against whom the action is contemplated an opportunity for a hearing before the Board.</text> </level> <level label="b"> <text>The Board shall give notice and hold the hearing in accordance with the Administrative Procedure Act.</text> </level> <level label="c"> <text>The hearing notice to be given to the individual shall be sent by certified mail, return receipt requested, bearing a postmark from the United States Postal Service, to the last known address of the individual at least 20 days before the hearing.</text> </level> <level label="d"> <text>The individual may be represented at the hearing by counsel.</text> </level> <level label="e"> <text>Over the signature of an officer or the executive director of the Board, the Board may issue subpoenas and administer oaths in connection with any investigation under this title and any hearings or proceedings before it.</text> </level> <level label="f"> <text>If, without lawful excuse, a person disobeys a subpoena from the Board or an order by the Board to take an oath or to testify or answer a question, then, on petition of the Board, a court of competent jurisdiction may punish the person as for contempt of court.</text> </level> <level label="g"> <text>If after due notice the individual against whom the action is contemplated fails or refuses to appear, nevertheless the Board may hear and determine the matter.</text> </level> <level label="h"> <text>The hearing of charges against a person may not be stayed or challenged by procedural defects alleged to have occurred prior to filing of the charges.</text> </level> <level label="i"> <level label="1"> <text>This subsection does not apply to a civil action brought by a party to a proceeding before the Board who claims to be aggrieved by the decision of the Board.</text> </level> <level label="2"> <text>Except by the express stipulation and consent of all parties to a proceeding before the Board or any of its investigatory bodies, in a civil or criminal action:</text> <level label="i"> <text>The proceedings, records, or files of the Board or any of its investigatory bodies are not discoverable and are not admissible in evidence; and</text> </level> <level label="ii"> <text>Any order passed by the Board is not admissible in evidence.</text> </level> </level> <level label="3"> <text>If any medical or hospital record or any other exhibit is subpoenaed and otherwise is admissible in evidence, the use of that record or exhibit in a proceeding before the Board or any of its investigatory bodies does not prevent its production in any other proceeding.</text> </level> </level> </section> <section article="gho" article_name="Health Occupations" number="12-316" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="3"> <level label="a"> <text>Except as provided in this section for an action under § 12–313 of this subtitle or § 12–6B–09 or § 12–6D–11 of this title, any person aggrieved by a final decision of the Board in a contested case, as defined in the Administrative Procedure Act, may petition for judicial review as allowed by the Administrative Procedure Act.</text> </level> <level label="b"> <text>Any person aggrieved by a final decision of the Board under § 12–313 of this subtitle or § 12–6B–09 or § 12–6D–11 of this title may not appeal to the Secretary but may take a direct judicial appeal as provided in the Administrative Procedure Act.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-317" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="3"> <level label="a"> <text>In this section, “pharmacist rehabilitation committee” means a group that:</text> <level label="1"> <text>Includes at least one pharmacist; and</text> </level> <level label="2"> <text>Is recognized by the Board.</text> </level> </level> <level label="b"> <text>For purposes of this section, a pharmacist rehabilitation committee evaluates and provides assistance to any pharmacist, registered pharmacy intern, or registered pharmacy technician in need of treatment and rehabilitation for alcoholism, drug abuse, chemical dependency, or other physical, emotional, or mental condition.</text> </level> <level label="c"> <level label="1"> <text>Except as otherwise provided in this section, the proceedings, records, and files of a pharmacist rehabilitation committee are not discoverable and are not admissible in evidence in any civil action arising out of matters that are being or have been reviewed and evaluated by the pharmacist rehabilitation committee.</text> </level> <level label="2"> <text>Paragraph (1) of this subsection does not apply to any record or document that is considered by the pharmacist rehabilitation committee and that otherwise would be subject to discovery and introduction into evidence in a civil trial.</text> </level> <level label="3"> <text>For purposes of this subsection, civil action does not include a proceeding before the Board or judicial review of a proceeding before the Board.</text> </level> </level> <level label="d"> <text>A person who acts in good faith and within the scope of jurisdiction of a pharmacist rehabilitation committee is not civilly liable for any action as a member of the pharmacist rehabilitation committee or for giving information to, participating in, or contributing to the function of the pharmacist rehabilitation committee.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-318" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="3"> <level label="a"> <text>In this section, “pharmacy review committee” means an advisory committee appointed by the Board from a pool of Board approved pharmacists to aid the Board in licensing and disciplinary matters.</text> </level> <level label="b"> <text>A pharmacy review committee shall:</text> <level label="1"> <text>Evaluate and seek to improve the quality of pharmaceutical care provided by providers of pharmaceutical care;</text> </level> <level label="2"> <text>Evaluate the need for and the level of performance of pharmaceutical care provided by providers of pharmaceutical care;</text> </level> <level label="3"> <text>Evaluate the qualifications, competence, and performance of providers of pharmaceutical care; or</text> </level> <level label="4"> <text>Evaluate and act on matters that relate to the discipline of any provider of pharmaceutical care.</text> </level> </level> <level label="c"> <level label="1"> <text>This subsection does not apply to:</text> <level label="i"> <text>A civil action brought by a party to the proceedings of the pharmacy review committee who claims to be aggrieved by the decision of the pharmacy review committee; or</text> </level> <level label="ii"> <text>Any record or document that is considered by the pharmacy review committee and that otherwise would be subject to discovery and introduction into evidence in a civil trial.</text> </level> </level> <level label="2"> <text>The proceedings, records, and files of a pharmacy review committee are not discoverable and are not admissible in evidence in any civil action arising out of matters that are being reviewed and evaluated by the pharmacy review committee.</text> </level> </level> <level label="d"> <text>A person who acts in good faith and within the scope of jurisdiction of a pharmacy review committee is not civilly liable for any action as a member of the pharmacy review committee or for giving information to, participating in, or contributing to the function of the pharmacy review committee.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-319" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="3"> <level label="a"> <text>An action may be maintained in the name of this State or the Board to enjoin:</text> <level label="1"> <text>The unauthorized practice of pharmacy; or</text> </level> <level label="2"> <text>Conduct that is a ground for disciplinary action under § 12-313 of this subtitle or § 12-6B-09 of this title.</text> </level> </level> <level label="b"> <text>An action may be brought by:</text> <level label="1"> <text>The Board, in its own name;</text> </level> <level label="2"> <text>The Attorney General, in the name of the State; or</text> </level> <level label="3"> <text>The State’s Attorney, in the name of the State.</text> </level> </level> <level label="c"> <text>An action under this section shall be brought in the county where the defendant resides or engages in the actions sought to be enjoined.</text> </level> <level label="d"> <text>Proof of actual damages or that a person will sustain damage if an injunction is not granted is not required for an action under this section.</text> </level> <level label="e"> <text>An action under this section is in addition to and not instead of criminal prosecution for unauthorized practice of pharmacy under § 12-701 of this title or disciplinary action under § 12-313 of this subtitle or § 12-6B-09 of this title.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-320" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="3"> <level label="a"> <text>In investigating an allegation brought against a licensee, registered pharmacy intern, or registered pharmacy technician under this title, if the Board has reason to believe that a licensee, registered pharmacy intern, or registered pharmacy technician may cause harm to a person affected by the licensee’s practice, the acts of a registered pharmacy intern, or the acts of a registered pharmacy technician, the Board on its own initiative may direct the licensee, registered pharmacy intern, or registered pharmacy technician to submit to an appropriate examination by a health care provider designated by the Board.</text> </level> <level label="b"> <text>In return for the privilege given to a licensee to practice pharmacy, a registered pharmacy intern to practice pharmacy under the direct supervision of a pharmacist, or a registered pharmacy technician to perform delegated pharmacy acts in the State, the licensee, registered pharmacy intern, or registered pharmacy technician is deemed to have:</text> <level label="1"> <text>Consented to submit to an examination under this section, if requested by the Board in writing; and</text> </level> <level label="2"> <text>Waived any claim of privilege as to the testimony or examination reports of a health care provider.</text> </level> </level> <level label="c"> <text>The failure or refusal of a licensee, a registered pharmacy intern, or registered pharmacy technician to submit to an examination required under this section is prima facie evidence of the licensee’s inability to practice pharmacy competently, the registered pharmacy intern’s inability to practice pharmacy competently under the direct supervision of a pharmacist, or the registered pharmacy technician’s inability to perform delegated pharmacy acts, unless the Board finds that the failure or refusal was beyond the control of the licensee, registered pharmacy intern, or registered pharmacy technician.</text> </level> <level label="d"> <text>The Board shall pay the cost of any examination made under this section.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-401" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="4" subtitle_name="Pharmacy Permits"> <level label="a"> <text>A person shall hold a pharmacy permit issued by the Board before the person may establish or operate a pharmacy in this State.</text> </level> <level label="b"> <text>A separate pharmacy permit is required for each pharmacy that a person establishes or operates.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-401.1" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="4" subtitle_name="Pharmacy Permits"> <level label="a"> <text>A person shall hold a clinical research pharmacy permit issued by the Board before the person may establish or operate a clinical research pharmacy in the State.</text> </level> <level label="b"> <text>A separate clinical research pharmacy permit is required for each clinical research pharmacy that a person establishes or operates.</text> </level> <level label="c"> <text>The Board may issue a clinical research pharmacy permit to a pharmacy that:</text> <level label="1"> <text>Exclusively compounds, dispenses, or distributes prescription or nonprescription drugs as part of scientific research conducted under protocols established by an institutional review board that meet U.S. Food and Drug Administration guidelines;</text> </level> <level label="2"> <text>Compounds, dispenses, or distributes pharmaceuticals solely incident to the research being conducted and consistent with related protocols;</text> </level> <level label="3"> <text>Is not open to the general public for retail pharmaceutical services and is strictly limited to dispensing to participants in a clinical trial;</text> </level> <level label="4"> <text>Complies with security and storage protocols established by United States Pharmacopeia and the Board; and</text> </level> <level label="5"> <text>Satisfies any other requirement established by the Board in regulation.</text> </level> </level> <level label="d"> <level label="1"> <text>The Board shall adopt regulations to carry out this section.</text> </level> <level label="2"> <text>The regulations adopted by the Board shall include:</text> <level label="i"> <text>Required standards for the operation of a clinical research pharmacy;</text> </level> <level label="ii"> <text>Application procedures;</text> </level> <level label="iii"> <text>Standards for the suspension and revocation of a clinical research pharmacy permit; and</text> </level> <level label="iv"> <text>Requirements related to the entry and inspection of clinical research pharmacies.</text> </level> </level> </level> <level label="e"> <text>Except as otherwise provided in this title, an individual may not be required to obtain a license, certification, or other authorization to practice under this article to own or have an ownership interest in a clinical research pharmacy.</text> </level> <level label="f"> <level label="1"> <text>The ownership or possession of an ownership interest in a clinical research pharmacy by an individual who is not licensed, certified, or otherwise authorized to practice under this article may not be the sole basis for the Board to initiate a disciplinary action against the individual.</text> </level> <level label="2"> <text>The applicable health occupations board may investigate an allegation that an individual employed by a clinical research pharmacy:</text> <level label="i"> <text>Is practicing a profession regulated by the health occupations board under this article without a license, certificate, or other authorization or with an unauthorized person; or</text> </level> <level label="ii"> <text>Has violated a provision of this article under the jurisdiction of the health occupations board.</text> </level> </level> </level> <level label="g"> <text>A health care provider with a substantial ownership interest in a clinical research pharmacy may not:</text> <level label="1"> <text>Serve as a clinical investigator for a scientific research protocol conducted by the clinical research pharmacy; or</text> </level> <level label="2"> <text>Impede or impair a pharmacist’s ability to fully exercise the pharmacist’s professional judgment.</text> </level> </level> <level label="h"> <text>This section does not limit:</text> <level label="1"> <text>The right of an individual to practice a health occupation that the individual is authorized to practice under this article; or</text> </level> <level label="2"> <text>The right of a person to establish or operate a pharmacy under other provisions of this title.</text> </level> </level> </section> <section article="gho" article_name="Health Occupations" number="12-402" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="4" subtitle_name="Pharmacy Permits"> <text>To qualify for a pharmacy permit, an applicant shall satisfy the Board that the pharmacy for which the application is made will be operated in accordance with the standards specified in § 12-403 of this subtitle.</text> </section> <section article="gho" article_name="Health Occupations" number="12-403" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="4" subtitle_name="Pharmacy Permits"> <level label="a"> <text>This section does not apply to a licensed dentist who obtains a permit from the State Board of Dental Examiners under § 12–102(h) of this title.</text> </level> <level label="b"> <text>This section does not require a nonresident pharmacy to violate the laws or regulations of the state in which it is located.</text> </level> <level label="c"> <text>Except as otherwise provided in this section, a pharmacy for which a pharmacy permit has been issued under this title:</text> <level label="1"> <text>Shall be operated in compliance with the law and with the rules and regulations of the Board;</text> </level> <level label="2"> <text>Shall be located and equipped so that the pharmacy may be operated without endangering the public health or safety;</text> </level> <level label="3"> <text>Shall ensure that a licensed pharmacist be immediately available on the premises to provide pharmacy services at all times the pharmacy is in operation;</text> </level> <level label="4"> <text>Shall be supervised by a licensed pharmacist who is responsible for the operations of the pharmacy at all times the pharmacy is in operation;</text> </level> <level label="5"> <text>Shall provide complete pharmaceutical service by preparing and dispensing all prescriptions that reasonably may be expected of a pharmacist;</text> </level> <level label="6"> <text>Shall provide services to the general public and may not restrict or limit its services to any group of individuals unless granted a waiver from this requirement by the Board;</text> </level> <level label="7"> <text>May not offer pharmaceutical services under any term or condition that tends to interfere with or impair the free and complete exercise of professional pharmaceutical judgment or skill;</text> </level> <level label="8"> <text>May not make any agreement that denies a patient a free choice of pharmacist or pharmacy services;</text> </level> <level label="9"> <text>May not participate in any activity that is a ground for Board action against a licensed pharmacist under § 12–313 of this title, a registered pharmacy technician under § 12–6B–09 of this title, or a registered pharmacy intern under § 12–6D–11 of this title;</text> </level> <level label="10"> <level label="i"> <text>Shall maintain at all times a current reference library that is appropriate to meet the needs of:</text> <level label="1"> <text>The practice specialty of that pharmacy; and</text> </level> <level label="2"> <text>The consumers the pharmacy serves; and</text> </level> </level> <level label="ii"> <text>Shall comply with any regulations adopted by the Board establishing the types of texts required to be included in the reference libraries in each of the various practice specialty pharmacies;</text> </level> </level> <level label="11"> <level label="i"> <text>Shall maintain at all times the minimum professional and technical equipment and sanitary appliances that are necessary in a pharmacy:</text> <level label="1"> <text>To prepare and dispense prescriptions properly; and</text> </level> <level label="2"> <text>To otherwise operate a pharmacy; and</text> </level> </level> <level label="ii"> <text>Shall:</text> <level label="1"> <text>Be equipped with the minimum equipment and appliances specified by the Board under this section; and</text> </level> <level label="2"> <text>Be kept in a clean and orderly manner;</text> </level> </level> </level> <level label="12"> <text>Shall store all prescription or nonprescription drugs or devices properly and safely subject to the rules and regulations adopted by the Board;</text> </level> <level label="13"> <text>Shall:</text> <level label="i"> <text>Make and keep on file for at least 5 years a record of each prescription prepared or dispensed in the pharmacy;</text> </level> <level label="ii"> <text>Disclose the records and files maintained of prescriptions for drugs or devices that identify or may be readily associated with the identity of a patient only in accordance with the provisions of Title 4, Subtitle 3 of the Health – General Article; and</text> </level> <level label="iii"> <text>Keep additional records as required by the rules and regulations adopted by the Board;</text> </level> </level> <level label="14"> <text>Except as otherwise provided under federal law, shall establish and maintain mechanisms to ensure that all prescription drugs or devices used within institutions that provide acute, subacute, or long–term care, or within their related corporate subsidiaries, but stored outside a pharmacy, are stored properly and safely, subject to rules and regulations adopted by the Board and policies established by the institution;</text> </level> <level label="15"> <text>Shall provide such personnel, automation, and technology as are necessary to allow the licensed pharmacist employee sufficient time to utilize the pharmacist’s knowledge and training and to perform competently the functions of a licensed pharmacist as required by law;</text> </level> <level label="16"> <text>Shall provide such personnel, automation, and technology as are necessary to comply with the labeling requirements specified in § 12–505 of this title;</text> </level> <level label="17"> <text>With regard to a prescription drug that is delivered in this State by the United States mail, a common carrier, or a delivery service and is not personally hand delivered directly to a patient or to the agent of the patient at the residence of the patient or at another location designated by the patient, shall:</text> <level label="i"> <text>Provide a general written notice in each shipment of a prescription drug that alerts a consumer that, under certain circumstances, a medication’s effectiveness may be affected by exposure to extremes of heat, cold, or humidity; and</text> </level> <level label="ii"> <text>Provide a specific written notice in each shipment of a prescription drug that provides a consumer with a toll–free or local consumer access telephone number accessible during regular hours of operation, which is designed to respond to consumer questions pertaining to medications;</text> </level> </level> <level label="18"> <level label="i"> <text>May maintain a record log of any prescription that is requested to be filled or refilled by a patient in accordance with the provisions of Title 4, Subtitle 3 of the Health – General Article;</text> </level> <level label="ii"> <text>If the prescription record of a patient includes the patient’s Social Security number, shall keep the Social Security number confidential;</text> </level> <level label="iii"> <text>May not list in the record log the type of illness, disability, or condition that is the basis of any dispensing or distribution of a drug by a pharmacist; and</text> </level> <level label="iv"> <text>May not list a patient’s Social Security number, illness, disability, or condition, or the name and type of drug received in the record log if the log is available to other pharmacy customers;</text> </level> </level> <level label="19"> <text>May not allow an unauthorized individual to represent that the individual is a pharmacist, a registered pharmacy intern, or registered pharmacy technician;</text> </level> <level label="20"> <text>Shall provide information regarding the process for resolving incorrectly filled prescriptions in accordance with existing regulations by:</text> <level label="i"> <text>Posting a sign that is conspicuously positioned and readable by consumers at the point where prescription drugs are dispensed to consumers; or</text> </level> <level label="ii"> <text>Including written information regarding the process with each prescription dispensed;</text> </level> </level> <level label="21"> <text>Shall dispense or dispose of prescription drugs or medical supplies in accordance with Title 15, Subtitle 6 of the Health – General Article;</text> </level> <level label="22"> <level label="i"> <text>May provide to an ophthalmologist for office use, without a patient–specific prescription:</text> <level label="1"> <text>Compound antibiotics for the emergency treatment of bacterial endophthalmitis or viral retinitis; and</text> </level> <level label="2"> <text>Compound antivascular endothelial growth factor agents for the emergency treatment of neovascular glaucoma, wet macular degeneration, or macular edema; and</text> </level> </level> <level label="ii"> <text>Shall require the ophthalmologist to inform the pharmacy of the identity of any patient to whom the drugs are administered; and</text> </level> </level> <level label="23"> <text>Subject to § 12–510 of this title, may provide compounded nonsterile preparations or compounded sterile preparations without a patient–specific prescription to a licensed veterinarian who intends to dispense the compounded nonsterile preparations or compounded sterile preparations in accordance with § 2–313(c) of the Agriculture Article.</text> </level> </level> <level label="d"> <level label="1"> <text>The Board may waive any of the requirements of this section for a school of pharmacy located in the State, accredited by the Accreditation Council for Pharmacy Education (ACPE), for nuclear pharmacy and dental pharmacy experimental and teaching programs.</text> </level> <level label="2"> <text>The Board may waive the requirements of subsection (c)(5) and (6) of this section for pharmacies that are engaged in pharmaceutical specialties which are recognized by the Board under rules and regulations adopted by the Board.</text> </level> <level label="3"> <text>The Board may waive the requirements of subsection (c)(3) through (6) and (15) of this section for pharmacies that only dispense devices in accordance with rules and regulations adopted by the Board.</text> </level> <level label="4"> <text>The Board shall waive the requirements of subsection (c)(20) of this section for a pharmacy owned and operated by a hospital, nursing facility, or clinic to which the public does not have access to purchase pharmaceuticals on a retail basis.</text> </level> </level> <level label="e"> <text>A nonresident pharmacy shall:</text> <level label="1"> <text>Hold a pharmacy permit issued by the Board; and</text> </level> <level label="2"> <text>Have a pharmacist on staff who is:</text> <level label="i"> <text>Licensed by the Board; and</text> </level> <level label="ii"> <text>Designated as the pharmacist responsible for providing pharmaceutical services to patients in the State.</text> </level> </level> </level> <level label="f"> <level label="1"> <text>In order to obtain a pharmacy permit from the Board, a nonresident pharmacy shall:</text> <level label="i"> <text>Submit an application to the Board on the form that the Board requires;</text> </level> <level label="ii"> <text>Pay to the Board an application fee set by the Board;</text> </level> <level label="iii"> <text>Submit a copy of the most recent inspection report resulting from an inspection conducted by the regulatory or licensing agency of the state in which the nonresident pharmacy is located;</text> </level> <level label="iv"> <text>On the required permit application, identify the name and current address of an agent located in this State officially designated to accept service of process; and</text> </level> <level label="v"> <text>If a nonresident pharmacy will dispense compounded sterile preparations to patients in the State, obtain and submit to the Board a report of an inspection that:</text> <level label="1"> <text>Demonstrates compliance with USP 797; and</text> </level> <level label="2"> <text>Within 90 days before the date of application, is conducted by a Board designee or other entity approved by the Board.</text> </level> </level> </level> <level label="2"> <text>A nonresident pharmacy shall report a change in the name or address of the resident agent in writing to the Board 30 days prior to the change.</text> </level> </level> <level label="g"> <text>Notwithstanding subsection (b) of this section, a nonresident pharmacy shall:</text> <level label="1"> <text>Comply with the requirements of subsection (c)(2), (7) through (12), and (19) of this section when:</text> <level label="i"> <text>Dispensing prescription drugs or prescription devices to a patient in this State; or</text> </level> <level label="ii"> <text>Otherwise engaging in the practice of pharmacy in this State;</text> </level> </level> <level label="2"> <text>On an annual basis and within 30 days after a change of office, corporate officer, or pharmacist, disclose to the Board the location, names, and titles of all principal corporate officers and all pharmacists who are dispensing prescriptions for drugs or devices to persons in this State;</text> </level> <level label="3"> <text>Comply with all lawful directions and requests for information from the regulatory or licensing agency of the state in which it is located and all requests for information made by the Board pursuant to this section;</text> </level> <level label="4"> <text>Maintain at all times a valid, unexpired permit to conduct a pharmacy in compliance with the laws of the state in which it is located;</text> </level> <level label="5"> <text>Maintain its records of prescription drugs or devices dispensed to patients in this State so that the records are readily retrievable;</text> </level> <level label="6"> <text>During its regular hours of operation, but not less than 6 days a week, and for a minimum of 40 hours per week, provide toll–free telephone service to facilitate communication between patients in this State and a pharmacist or an individual who:</text> <level label="i"> <text>Has access to the patient’s prescription records; and</text> </level> <level label="ii"> <text>Is required to refer patients in the State to the responsible pharmacist licensed in the State, as appropriate;</text> </level> </level> <level label="7"> <text>Disclose its toll–free telephone number on a label affixed to each container of drugs or devices;</text> </level> <level label="8"> <text>Comply with the laws of this State relating to the confidentiality of prescription records if there are no laws relating to the confidentiality of prescription records in the state in which the nonresident pharmacy is located;</text> </level> <level label="9"> <text>Comply with the requirements of subsection (c)(17) and (20) of this section; and</text> </level> <level label="10"> <text>If dispensing compounded sterile preparations to patients in the State, comply with:</text> <level label="i"> <text>USP 797; and</text> </level> <level label="ii"> <text>Regulations adopted by the Board governing the compounding of sterile preparations.</text> </level> </level> </level> <level label="h"> <text>Subject to the hearing provisions of § 12–411 of this subtitle, if a pharmacy or a nonresident pharmacy is operated in violation of this section, the Board may suspend the applicable pharmacy permit until the pharmacy complies with this section.</text> </level> <level label="i"> <text>The Board may waive the following requirements for nonresident pharmacies that only dispense devices in accordance with rules and regulations adopted by the Board:</text> <level label="1"> <text>Subsections (e)(2) and (g)(6)(ii) of this section; and</text> </level> <level label="2"> <text>If not applicable, subsections (f)(1)(iii) and (g)(4) of this section.</text> </level> </level> </section> <section article="gho" article_name="Health Occupations" number="12-404" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="4" subtitle_name="Pharmacy Permits"> <level label="a"> <text>To apply for a pharmacy permit, an applicant shall:</text> <level label="1"> <text>Submit an application to the Board on the form that the Board requires; and</text> </level> <level label="2"> <text>Pay to the Board an application fee set by the Board.</text> </level> </level> <level label="b"> <text>For each pharmacy permit for which a person applies, the person shall submit a separate application and pay a separate application fee.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-405" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="4" subtitle_name="Pharmacy Permits"> <level label="a"> <text>The Board shall issue a pharmacy permit to any applicant who meets the requirements of this title.</text> </level> <level label="b"> <text>If the Board denies a pharmacy permit to an applicant, it shall give the applicant written notice of its decision and the reasons for the denial.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-406" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="4" subtitle_name="Pharmacy Permits"> <level label="a"> <text>A pharmacy permit authorizes the pharmacy permit holder to establish and operate the pharmacy while the pharmacy permit is effective.</text> </level> <level label="b"> <level label="1"> <text>Subject to paragraphs (2) and (3) of this subsection, a pharmacy permit holder may conduct wholesale distribution, if:</text> <level label="i"> <text>The wholesale distribution business does not exceed 5% of the pharmacy permit holder’s annual sales; and</text> </level> <level label="ii"> <text>The pharmacy permit holder:</text> <level label="1"> <text>Maintains records of wholesale distribution separately from its other records; and</text> </level> <level label="2"> <text>Makes the records of wholesale distribution available for inspection by the Board.</text> </level> </level> </level> <level label="2"> <text>A pharmacy permit holder that obtains a waiver from the Board under § 12–403(d) of this subtitle may conduct wholesale distribution only with another pharmacy permit holder.</text> </level> <level label="3"> <text>A retail pharmacy that holds a pharmacy permit may conduct wholesale distribution only with:</text> <level label="i"> <text>Another pharmacy permit holder; and</text> </level> <level label="ii"> <text>A wholesale distributor if the retail pharmacy:</text> <level label="1"> <text>Reports to the Board that the retail pharmacy is conducting wholesale distribution with a wholesale distributor; and</text> </level> <level label="2"> <level label="A"> <text>Maintains records of wholesale distribution with wholesale distributors separately from its records of wholesale distribution with pharmacy permit holders; and</text> </level> </level> <level label="B"> <text>Makes the records of wholesale distribution available for inspection by the Board.</text> </level> </level> </level> </level> </section> <section article="gho" article_name="Health Occupations" number="12-407" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="4" subtitle_name="Pharmacy Permits"> <level label="a"> <text>A pharmacy permit expires on the May 31 after its effective date, unless the pharmacy permit is renewed for a 2–year term as provided in this section.</text> </level> <level label="b"> <level label="1"> <text>Except as provided in paragraph (2) of this subsection, on or before March 1 of the year the permit expires, the Board shall send to each pharmacy permit holder a renewal notice for each pharmacy permit by electronic means to the last known e–mail address of the pharmacy permit holder.</text> </level> <level label="2"> <text>If requested by a pharmacy permit holder, the Board shall send to the pharmacy permit holder a renewal notice for each pharmacy permit by first–class mail to the last known address of the pharmacy permit holder.</text> </level> <level label="3"> <text>If a renewal notice sent by electronic means under paragraph (1) of this subsection is returned to the Board as undeliverable, the Board shall send to the pharmacy permit holder a renewal notice for each pharmacy permit by first–class mail to the last known address of the pharmacy permit holder.</text> </level> <level label="4"> <text>A renewal notice sent under this subsection shall state:</text> <level label="i"> <text>The date on which the current pharmacy permit expires;</text> </level> <level label="ii"> <text>The date by which the renewal application must be received by the Board for the renewal to be issued and mailed before the pharmacy permit expires; and</text> </level> <level label="iii"> <text>The amount of the renewal fee.</text> </level> </level> </level> <level label="c"> <text>Before the pharmacy permit expires, the pharmacy permit holder periodically may renew it for an additional 2–year term, if the pharmacy permit holder:</text> <level label="1"> <text>Otherwise is entitled to the pharmacy permit;</text> </level> <level label="2"> <text>Pays to the Board a renewal fee set by the Board; and</text> </level> <level label="3"> <text>Submits a renewal application to the Board on the form that the Board provides.</text> </level> </level> <level label="d"> <text>The Board shall renew the pharmacy permit of each pharmacy permit holder who meets the requirements of this section.</text> </level> <level label="e"> <text>If application for renewal is not made on or before May 1, the pharmacy permit shall expire on the last day of its term and the Board may not reinstate the pharmacy permit unless the applicant:</text> <level label="1"> <text>Provides reason, sufficient to the Board, for the failure to file within the time required; and</text> </level> <level label="2"> <text>Pays, in addition to the renewal fee, a late fee set by the Board.</text> </level> </level> </section> <section article="gho" article_name="Health Occupations" number="12-408" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="4" subtitle_name="Pharmacy Permits"> <level label="a"> <text>A pharmacy permit is not transferable.</text> </level> <level label="b"> <text>Each pharmacy permit shall be displayed conspicuously in the pharmacy for which it is issued.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-409" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="4" subtitle_name="Pharmacy Permits"> <level label="a"> <text>Subject to the hearing provisions of § 12–411 of this subtitle, the Board may suspend or revoke any pharmacy permit, if the pharmacy:</text> <level label="1"> <text>Is conducted so as to endanger the public health or safety;</text> </level> <level label="2"> <text>Violates any of the standards specified in § 12–403 of this subtitle; or</text> </level> <level label="3"> <text>Otherwise is not conducted in accordance with the law.</text> </level> </level> <level label="b"> <level label="1"> <text>A nonresident pharmacy is subject to the disciplinary actions stated in this subtitle.</text> </level> <level label="2"> <text>The Board may fine a nonresident pharmacy in accordance with § 12–410 of this subtitle or deny, revoke, or suspend the permit of a nonresident pharmacy for any violation of § 12–403(e) through (h) of this subtitle.</text> </level> </level> </section> <section article="gho" article_name="Health Occupations" number="12-410" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="4" subtitle_name="Pharmacy Permits"> <level label="a"> <text>If after a hearing under § 12-411 of this subtitle the Board finds that there are grounds under § 12-409 of this subtitle to suspend or revoke a permit, the Board may impose a penalty not exceeding $10,000:</text> <level label="1"> <text>Instead of suspending the permit; or</text> </level> <level label="2"> <text>In addition to suspending or revoking the permit.</text> </level> </level> <level label="b"> <text>The Board shall adopt rules and regulations to set standards for the imposition of penalties under this section.</text> </level> <level label="c"> <text>The Board shall pay any penalty collected under this section into the General Fund of this State.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-411" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="4" subtitle_name="Pharmacy Permits"> <level label="a"> <text>Except as otherwise provided in the Administrative Procedure Act, before the Board takes any action under § 12-409 of this subtitle or any action to suspend or revoke a pharmacy permit under any other section of this title, it shall give the person against whom the action is contemplated an opportunity for a hearing before the Board.</text> </level> <level label="b"> <text>The Board shall give notice and hold the hearing in accordance with the Administrative Procedure Act.</text> </level> <level label="c"> <text>If after due notice the person against whom the action is contemplated fails or refuses to appear, nevertheless the Board may hear and determine the matter.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-412" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="4" subtitle_name="Pharmacy Permits"> <level label="a"> <text>Any person whose application for a pharmacy permit has been denied or whose pharmacy permit has been suspended or revoked under this title may petition for judicial review as allowed by the Administrative Procedure Act.</text> </level> <level label="b"> <text>If an appeal is taken under this section, the Board may stay its order of suspension or revocation pending the decision of the court.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-413" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="4" subtitle_name="Pharmacy Permits"> <level label="a"> <text>During business hours, the Secretary, the Board, or the agents of either may enter any permit holder’s pharmacy and inspect for compliance with federal and State laws and regulations:</text> <level label="1"> <text>Any drugs or devices, dentifrices, domestic remedies, and toilet articles that are in the pharmacy;</text> </level> <level label="2"> <text>Any records or publications that are required to be kept by a pharmacy under this title; and</text> </level> <level label="3"> <text>The facility.</text> </level> </level> <level label="b"> <text>At the direction of the Secretary, the Board, the Chief of the Office of Controlled Substances Administration, or their agents may enter a permit holder’s pharmacy at any time and investigate with law enforcement officers pursuant to a valid warrant.</text> </level> <level label="c"> <text>A person may not hinder an inspection or an investigation conducted under this section.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-501" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="5" subtitle_name="Practice of Pharmacy and Operation of Pharmacies"> <level label="a"> <text>A pharmacist may refuse to dispense or refill a prescription if the decision is based on professional judgment, experience, knowledge, or available reference materials.</text> </level> <level label="b"> <level label="1"> <text>Except as provided in paragraph (2) of this subsection, if a pharmacist refuses to dispense or refill a prescription, the pharmacist shall, to the extent practicable, notify the authorized prescriber that the prescription or refill was refused within 72 hours after the refusal.</text> </level> <level label="2"> <text>Paragraph (1) of this subsection does not apply if a pharmacist is unable to determine the name of the authorized prescriber.</text> </level> </level> </section> <section article="gho" article_name="Health Occupations" number="12-502" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="5" subtitle_name="Practice of Pharmacy and Operation of Pharmacies"> <level label="a"> <text>In the operation of a pharmacy, only a licensed pharmacist or an individual engaging in a professional experience program and acting under the direct supervision of a licensed pharmacist may provide information to the public or a health care practitioner concerning prescription or nonprescription drugs or devices including information as to their therapeutic values, potential side effects, and use in the treatment and prevention of diseases.</text> </level> <level label="b"> <text>A licensed pharmacist shall give a patient who requests, in person or by telephone, the current price of a prescription drug or device that the pharmacy offers for sale to the public.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-503" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="5" subtitle_name="Practice of Pharmacy and Operation of Pharmacies"> <level label="a"> <text>An authorized prescriber who issues a prescription shall indicate on the prescription the date of its issuance.</text> </level> <level label="b"> <text>Unless otherwise instructed by the authorized prescriber who issues the prescription, a pharmacist may not dispense any drug or device on a prescription presented more than 120 days after the date the prescription was issued.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-504" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="5" subtitle_name="Practice of Pharmacy and Operation of Pharmacies"> <level label="a"> <text>In this section, “brand name” means the proprietary name a manufacturer places on a drug or device product or its container.</text> </level> <level label="b"> <level label="1"> <text>Subject to the provisions of this subtitle, a pharmacist, or the pharmacist’s designee, who is under the direct supervision of the pharmacist, shall inform a retail consumer to the best of the pharmacist’s or the pharmacist’s designee’s knowledge of the availability of a generically equivalent drug, a therapeutically equivalent brand name drug that is the lowest–cost alternative to the originally prescribed generically equivalent drug, or an interchangeable biological product and shall inform a retail consumer of the approximate cost difference of the lowest–cost alternative as compared to the originally prescribed drug.</text> </level> <level label="2"> <text>The Board shall adopt procedures for:</text> <level label="i"> <text>A consumer to notify the Board when a pharmacist fails to provide the information required under paragraph (1) of this subsection; and</text> </level> <level label="ii"> <text>Advising a pharmacist to bring the pharmacist into compliance with the requirements of paragraph (1) of this subsection.</text> </level> </level> <level label="3"> <text>Paragraph (1) of this subsection does not apply:</text> <level label="i"> <text>When the authorized prescriber states expressly that the prescription is to be dispensed only as directed;</text> </level> <level label="ii"> <text>To a pharmacist who works in a pharmacy, whether centralized or decentralized, which primarily serves public or private institutional recipients; or</text> </level> <level label="iii"> <text>When the cost of the prescription is reimbursed by a third party payer, including medical assistance.</text> </level> </level> </level> <level label="c"> <text>The Board shall maintain a link on its website to the current lists of biological products determined by the United States Food and Drug Administration to be interchangeable with a specific biological product.</text> </level> <level label="d"> <level label="1"> <text>A pharmacist may substitute a generically equivalent drug or device product, a therapeutically equivalent brand name drug or device product to the originally prescribed generically equivalent drug or device product, or an interchangeable biological product, of the same dosage form and strength, for the drug or device product originally prescribed, if:</text> <level label="i"> <text>The authorized prescriber does not state expressly that the prescription is to be dispensed only as directed;</text> </level> <level label="ii"> <text>The substitution is:</text> <level label="1"> <text>Recognized in the United States Food and Drug Administration’s current list of approved drug or device products with therapeutic equivalence evaluations; or</text> </level> <level label="2"> <text>An interchangeable biological product for the drug or device product originally prescribed; and</text> </level> </level> </level> <level label="iii"> <text>The consumer is charged less for the substituted drug or device or interchangeable biological product than the price of the originally prescribed drug or device.</text> </level> <level label="2"> <text>If a retail consumer is using prescription drug coverage for the prescription, the determination of whether the consumer would be charged less for the substituted drug or device or interchangeable biological product shall be based on the consumer’s prescription drug benefit and formulary, if that information is readily available.</text> </level> </level> <level label="e"> <text>If a drug or device product or an interchangeable biological product is substituted under this section, the pharmacist shall:</text> <level label="1"> <text>Notify the patient in writing, or maintain a record that indicates the patient has been notified in writing or orally, that the drug or device product or interchangeable biological product dispensed is a generic equivalent of, a brand name drug or device product that is therapeutically equivalent to, or is interchangeable with the originally prescribed drug or device product; and</text> </level> <level label="2"> <text>Record on the prescription and keep a record of the name and manufacturer of the substituted drug or device product or interchangeable biological product.</text> </level> </level> <level label="f"> <text>The Department may list any additional drug or device products that are determined by the Department to meet requirements that are adequate to assure product quality and therapeutic equivalence, after an opportunity for public comment as provided in Title 10, Subtitle 1 of the State Government Article.</text> </level> <level label="g"> <text>The Department may disqualify a drug or device product or an interchangeable biological product on the United States Food and Drug Administration’s current list from being used in Maryland as a substitute if the Department determines that the drug or device or interchangeable biological product is therapeutically nonequivalent or not interchangeable, respectively, or has a negative physical or biological effect on the consumer of that drug or device product or interchangeable biological product:</text> <level label="1"> <text>After providing an opportunity for public comment as provided in Title 10, Subtitle 1 of the State Government Article; or</text> </level> <level label="2"> <text>Prior to providing an opportunity for public comment, if the Department believes that a particular generic drug or device product or interchangeable biological product constitutes an imminent danger to the public health, safety or welfare, and the Department:</text> <level label="i"> <text>Provides an opportunity for public comment as provided in Title 10, Subtitle 1 of the State Government Article within 30 days of disqualifying the drug or device product or interchangeable biological product; and</text> </level> <level label="ii"> <text>After providing an opportunity for public comment, determines whether the drug or device product or interchangeable biological product should remain disqualified.</text> </level> </level> </level> <level label="h"> <text>For a drug or device product or an interchangeable biological product that the Department has disqualified from being used in Maryland as a substitute under subsection (g) of this section, the Department shall provide an opportunity for public comment as provided in Title 10, Subtitle 1 of the State Government Article before reinstating the drug or device product or interchangeable biological product for use in Maryland as a substitute.</text> </level> <level label="i"> <text>A pharmacist who substitutes a drug or device product or an interchangeable biological product in compliance with this section incurs no greater liability in filling the prescription by dispensing the equivalent drug or device product or interchangeable biological product than would be incurred in filling the prescription by dispensing the originally prescribed drug or device.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-504.1" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="5" subtitle_name="Practice of Pharmacy and Operation of Pharmacies"> <level label="a"> <text>Except as provided in subsection (d) of this section, within 5 business days after dispensing a biological product to a patient, the dispensing pharmacist or the pharmacist’s designee shall communicate the specific biological product dispensed, including the name and manufacturer of the biological product, to the prescriber.</text> </level> <level label="b"> <text>Except as provided in subsection (c) of this section:</text> <level label="1"> <text>The communication required under subsection (a) of this section shall be provided by making an entry that is electronically accessible to the prescriber through:</text> <level label="i"> <text>An interoperable electronic medical records system;</text> </level> <level label="ii"> <text>An electronic prescribing technology;</text> </level> <level label="iii"> <text>A pharmacy benefits management system; or</text> </level> <level label="iv"> <text>A pharmacy record; and</text> </level> </level> <level label="2"> <text>Making an entry through a mechanism listed in paragraph (1) of this subsection is presumed to provide the communication to the prescriber required under subsection (a) of this section.</text> </level> </level> <level label="c"> <text>If the mechanisms listed in subsection (b)(1) of this section are not available, the communication required under subsection (a) of this section may be provided by facsimile, telephone, electronic transmission, or other means.</text> </level> <level label="d"> <text>The communication requirement under subsection (a) of this section does not apply if:</text> <level label="1"> <text>The United States Food and Drug Administration has not approved an interchangeable biological product for the biological product prescribed to the patient; or</text> </level> <level label="2"> <text>A refill prescription is not changed from the biological product dispensed on the most recent filling of the prescription.</text> </level> </level> </section> <section article="gho" article_name="Health Occupations" number="12-505" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="5" subtitle_name="Practice of Pharmacy and Operation of Pharmacies"> <level label="a"> <text>Except for a drug or device dispensed to an inpatient in a hospital or related institution, each container of a drug or device dispensed shall be labeled in accordance with this section.</text> </level> <level label="b"> <text>In addition to any other information required by law, the label shall include:</text> <level label="1"> <text>The date the prescription is filled; and</text> </level> <level label="2"> <text>Unless otherwise required by the prescriber:</text> <level label="i"> <text>For drugs or devices dispensed in a container other than the manufacturer’s original packaging, an expiration date of the drugs or devices which shall be the lesser of:</text> <level label="1"> <text>1 year from the date of dispensing;</text> </level> <level label="2"> <text>The month and year when the drugs or devices expire;</text> </level> <level label="3"> <text>The appropriate expiration date for repackaged drugs or devices; or</text> </level> <level label="4"> <text>A shorter period as determined by the pharmacist;</text> </level> </level> <level label="ii"> <text>For drugs or devices dispensed in the manufacturer’s original packaging, an expiration date of the drugs or devices which shall be:</text> <level label="1"> <text>The expiration date set by the manufacturer; or</text> </level> <level label="2"> <text>A shorter period as determined by the pharmacist;</text> </level> </level> <level label="iii"> <text>Any appropriate special handling instructions regarding proper storage of the drugs or devices; and</text> </level> <level label="iv"> <text>Subject to the provisions of subsection (c) of this section, the name and strength of the drugs or devices.</text> </level> </level> </level> <level label="c"> <level label="1"> <text>Except as provided in paragraph (2) of this subsection, the label shall indicate the same name for the drug or device as that used by the authorized prescriber.</text> </level> <level label="2"> <text>If, under § 12–504 of this subtitle, the pharmacist substitutes a drug or device product for that named by the authorized prescriber, the label shall indicate both the name of the drug or device product and the name of the manufacturer or distributor of the drug or device dispensed.</text> </level> </level> <level label="d"> <level label="1"> <text>Except as provided in this subsection, if an authorized prescriber dispenses a drug or device, the prescriber shall label each container of the drug or device.</text> </level> <level label="2"> <text>In addition to any other information required by law, the authorized prescriber shall include on the label:</text> <level label="i"> <text>The name and strength of the drug or device;</text> </level> <level label="ii"> <text>The date the prescription is dispensed;</text> </level> <level label="iii"> <text>An expiration date of the drug or device which shall be the lesser of:</text> <level label="1"> <text>1 year from the date of dispensing;</text> </level> <level label="2"> <text>The month and year when the drug or device expires; or</text> </level> <level label="3"> <text>A shorter period as determined by the authorized prescriber; and</text> </level> </level> <level label="iv"> <text>Any appropriate special handling instructions regarding proper storage of the drug or device.</text> </level> </level> <level label="3"> <text>The labeling requirements of this subsection do not apply if the authorized prescriber dispenses the drug or device:</text> <level label="i"> <text>To an inpatient in a hospital or related institution;</text> </level> <level label="ii"> <text>In an emergency situation; or</text> </level> <level label="iii"> <text>As a sample drug or device dispensed in the regular course of the authorized prescriber’s practice.</text> </level> </level> </level> <level label="e"> <text>So long as any of the original contents remain in the container, a person may not alter, deface, or remove any label required by this section.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-505.1" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="5" subtitle_name="Practice of Pharmacy and Operation of Pharmacies"> <level label="a"> <text>The Board shall adopt regulations necessary to ensure that an individual who is blind, visually impaired, or otherwise print disabled has appropriate access to prescription labels, bag tags, and medical guides:</text> <level label="1"> <text>At no additional cost to the individual;</text> </level> <level label="2"> <text>In a format option through which the information is fully accessible to the individual; and</text> </level> <level label="3"> <text>Within a time frame comparable to the time frame within which the information is provided to an individual who is not visually impaired.</text> </level> </level> <level label="b"> <text>In adopting regulations under subsection (a) of this section, the Board shall give visually impaired individuals an opportunity to provide input regarding the content of the regulations.</text> </level> <level label="c"> <text>The regulations adopted under subsection (a) of this section shall:</text> <level label="1"> <text>Follow the guidelines and recommendations in the “Prescription Drug Labels: Actions Needed to Increase Awareness of Best Practices for Accessible Labels for Individuals Who are Blind or Visually Impaired” report that was issued by the U.S. Government Accountability Office in December 2016; and</text> </level> <level label="2"> <text>Include a method for providing notice to customers that accessible prescription labels, bag tags, and medical guides are available, including notice regarding the availability of the prescription labels, bag tags, and medical guides in audio format.</text> </level> </level> </section> <section article="gho" article_name="Health Occupations" number="12-506" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="5" subtitle_name="Practice of Pharmacy and Operation of Pharmacies"> <level label="a"> <text>A pharmacist may refill a prescription for a drug or device for which the refill has not been authorized if:</text> <level label="1"> <text>The pharmacist:</text> <level label="i"> <text>Attempts to obtain an authorization from the authorized prescriber; and</text> </level> <level label="ii"> <text>Is not able readily to obtain the authorization;</text> </level> </level> <level label="2"> <text>The refill of the prescription is not for a controlled dangerous substance;</text> </level> <level label="3"> <text>The drug or device is essential to the maintenance of life;</text> </level> <level label="4"> <level label="i"> <text>The drug or device is essential to the continuation of therapy in chronic conditions; and</text> </level> <level label="ii"> <text>In the pharmacist’s professional judgment, the interruption of the therapy reasonably might produce an undesirable health consequence, be detrimental to the patient’s welfare, or cause physical or mental discomfort;</text> </level> </level> <level label="5"> <text>The pharmacist:</text> <level label="i"> <text>Enters on the back of the prescription or on another appropriate uniformly maintained, readily retrievable record, such as a medication record, the date and the quantity of the drug or device dispensed; and</text> </level> <level label="ii"> <text>Signs or initials the record; and</text> </level> </level> <level label="6"> <text>The pharmacist notifies the authorized prescriber of the refill of the prescription within 72 hours of dispensing the drug or device.</text> </level> </level> <level label="b"> <text>If a pharmacist refills a prescription under subsection (a) of this section, the pharmacist may provide only 1 refill of the prescription and the refill quantity dispensed shall be in conformity with the prescriber’s directions for use and may not exceed a 14-day supply or unit of use.</text> </level> <level label="c"> <text>If the federal or a state government declares a state of emergency, a pharmacist working in Maryland may refill a prescription for a drug for which the refill has not been authorized if:</text> <level label="1"> <text>As a result of the emergency, the pharmacist is unable to obtain an authorization from the authorized prescriber;</text> </level> <level label="2"> <text>The refill of the prescription is not for a controlled dangerous substance;</text> </level> <level label="3"> <text>The quantity dispensed does not exceed a 30–day supply or unit of use; and</text> </level> <level label="4"> <text>The pharmacist notifies the authorized prescriber of the refill of the prescription within 7 days of dispensing the drug.</text> </level> </level> </section> <section article="gho" article_name="Health Occupations" number="12-507" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="5" subtitle_name="Practice of Pharmacy and Operation of Pharmacies"> <level label="a"> <text>A pharmacist who provides prescription services to medical assistance recipients shall offer to discuss with each medical assistance recipient or caregiver who presents a prescription order for outpatient drugs any matter which, in the exercise of the pharmacist’s professional judgment, the pharmacist deems significant, which may include the following:</text> <level label="1"> <text>The name and description of the medication;</text> </level> <level label="2"> <text>The route, dosage form, dosage, route of administration, and duration of drug therapy;</text> </level> <level label="3"> <text>Special directions and precautions for preparation, administration, and use by the patient;</text> </level> <level label="4"> <text>Common severe side or adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur;</text> </level> <level label="5"> <text>Techniques for self-monitoring drug therapy;</text> </level> <level label="6"> <text>Proper storage;</text> </level> <level label="7"> <text>Prescription refill information; and</text> </level> <level label="8"> <text>Action to be taken in the event of a missed dose.</text> </level> </level> <level label="b"> <text>The offer to discuss may be made in the manner determined by the professional judgment of the pharmacist, which shall include either:</text> <level label="1"> <text>A face-to-face communication with the pharmacist; or</text> </level> <level label="2"> <text>At least 2 of the following:</text> <level label="i"> <text>A sign posted so it can be seen by patients;</text> </level> <level label="ii"> <text>A notation affixed to or written on the bag in which the prescription is to be dispensed;</text> </level> <level label="iii"> <text>A notation contained on the prescription container; or</text> </level> <level label="iv"> <text>Communication by telephone.</text> </level> </level> </level> <level label="c"> <text>Nothing in this section shall be construed as requiring a pharmacist to provide consultation if the medical assistance recipient or caregiver refuses the consultation.</text> </level> <level label="d"> <text>A pharmacist must make a reasonable effort to obtain, record, and maintain, at the individual pharmacy, at least the following information regarding a medical assistance recipient:</text> <level label="1"> <text>Name, address, telephone number, date of birth or age, and gender;</text> </level> <level label="2"> <text>Individual history when significant, including disease state or states, known allergies and drug reactions, and a comprehensive list of medications and relevant devices; and</text> </level> <level label="3"> <text>Pharmacist comments relevant to the individual’s drug therapy which may be recorded either manually or electronically in the patient’s profile.</text> </level> </level> <level label="e"> <text>This section shall apply only to medical assistance recipients presenting prescriptions for covered outpatient drugs.</text> </level> <level label="f"> <text>The requirements of this section do not apply to refill prescriptions.</text> </level> <level label="g"> <text>The Secretary, after consultation with the Maryland Pharmacists Association and the Maryland Association of Chain Drug Stores, shall adopt regulations in accordance with pharmacy practices in Maryland to implement the provisions of this section.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-508" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="5" subtitle_name="Practice of Pharmacy and Operation of Pharmacies"> <level label="a"> <level label="1"> <text>Subject to paragraph (4) of this subsection, a pharmacist may order a vaccination for or administer a vaccination to an individual who is at least 3 years old if:</text> <level label="i"> <text>The vaccine is:</text> <level label="1"> <text>An influenza vaccine;</text> </level> <level label="2"> <text>A COVID–19 vaccine; or</text> </level> <level label="3"> <text>Used in response to a public health emergency;</text> </level> </level> <level label="ii"> <text>The pharmacist has completed a practical training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education and includes:</text> <level label="1"> <text>Hands–on injection techniques;</text> </level> <level label="2"> <text>Clinical evaluation of indications and contraindications of vaccines; and</text> </level> <level label="3"> <text>The recognition and treatment of emergency reactions to vaccines;</text> </level> </level> <level label="iii"> <text>The pharmacist has a current certificate in basic cardiopulmonary resuscitation;</text> </level> <level label="iv"> <text>The pharmacist has completed a minimum of 2 hours of continuing pharmaceutical education related to immunizations that is approved by the Accreditation Council for Pharmacy Education as part of the license renewal requirements under § 12–309 of this title;</text> </level> <level label="v"> <text>The pharmacist complies with the record–keeping and reporting requirements in paragraph (5) of this subsection and any corresponding regulations adopted by the Board; and</text> </level> <level label="vi"> <text>If the vaccination is administered to an individual under the age of 18 years, or ordered for administration by an adult caregiver to an individual under the age of 18 years, the pharmacist informs the child vaccination patient and adult caregiver who is accompanying the child of the importance of well–child visits with a pediatric primary care provider and refers the patient to a pediatric primary care provider when appropriate.</text> </level> </level> <level label="2"> <text>Subject to paragraph (4) of this subsection, a pharmacist who has met the requirement of paragraph (1)(ii) through (vi) of this subsection may administer to an individual who is at least 7 years old a vaccination that is:</text> <level label="i"> <text>Recommended by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices;</text> </level> <level label="ii"> <text>Approved or authorized by the U.S. Food and Drug Administration; or</text> </level> <level label="iii"> <text>Recommended by the Secretary of Health in accordance with § 18–112 of the Health – General Article.</text> </level> </level> <level label="3"> <text>Subject to paragraph (4) of this subsection, a pharmacist who has met the requirement of paragraph (1)(ii), (iii), and (iv) of this subsection may administer to an adult a vaccination that is recommended in the Centers for Disease Control and Prevention’s Health Information for International Travel.</text> </level> <level label="4"> <text>A pharmacist shall administer a vaccination under paragraph (1), (2), or (3) of this subsection under a written protocol that:</text> <level label="i"> <text>Is vaccine specific; and</text> </level> <level label="ii"> <text>Meets criteria established by the Department, in consultation with the Board, the Board of Physicians, and the Board of Nursing, in regulation.</text> </level> </level> <level label="5"> <text>A pharmacist shall:</text> <level label="i"> <text>Report all vaccinations administered or ordered by the pharmacist to the ImmuNet Program established under § 18–109 of the Health – General Article;</text> </level> <level label="ii"> <text>If the vaccination has been administered in accordance with a prescription, document at least one effort to inform the individual’s authorized prescriber that the vaccination has been administered; and</text> </level> <level label="iii"> <text>Except for an influenza vaccination administered under paragraph (1) of this subsection, if the authorized prescriber is not the individual’s primary care provider or if the vaccination has not been administered in accordance with a prescription, document at least one effort to inform the individual’s primary care provider or other usual source of care that the vaccination has been administered.</text> </level> </level> </level> <level label="b"> <text>The Board shall:</text> <level label="1"> <text>Set reasonable fees for the administration of vaccinations under this section; and</text> </level> <level label="2"> <text>Adopt regulations that require a pharmacist to submit a registration form to the Board that includes verification that the pharmacist:</text> <level label="i"> <text>Has successfully completed a certification course approved by the Board; and</text> </level> <level label="ii"> <text>Is certified in basic cardiopulmonary resuscitation and obtained the certification through in–person classroom instruction.</text> </level> </level> </level> </section> <section article="gho" article_name="Health Occupations" number="12-509" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="5" subtitle_name="Practice of Pharmacy and Operation of Pharmacies"> <level label="a"> <text>In addition to the authority granted to a pharmacist under § 12–508 of this subtitle, a pharmacist, in accordance with regulations adopted by the Board, may administer:</text> <level label="1"> <text>A self–administered drug to a patient that is prescribed by an authorized prescriber; and</text> </level> <level label="2"> <text>Subject to subsection (b) of this section, a maintenance injectable medication or an injectable medication for treatment of a sexually transmitted infection that is not a biological product to a patient:</text> <level label="i"> <text>That is prescribed by an authorized prescriber;</text> </level> <level label="ii"> <text>In accordance with a standing order issued by an authorized public health official; or</text> </level> <level label="iii"> <text>In accordance with a protocol under Subtitle 6A of this title.</text> </level> </level> </level> <level label="b"> <text>A pharmacist may not administer an initial dose of a maintenance injectable medication product or an injectable medication for treatment of a sexually transmitted infection under subsection (a)(2) of this section unless the pharmacist receives written approval from the prescriber.</text> </level> <level label="c"> <level label="1"> <text>On or before September 1, 2021, the Board, in consultation with the State Board of Physicians and the State Board of Nursing, shall adopt regulations establishing standard procedures:</text> <level label="i"> <text>For notifying a patient about payment for services before the pharmacist administers a maintenance injectable medication or an injectable medication for treatment of a sexually transmitted infection;</text> </level> <level label="ii"> <text>That a pharmacist must use to administer:</text> <level label="1"> <text>A maintenance injectable medication after an initial dose is administered by the prescriber; or</text> </level> <level label="2"> <text>An injectable medication for treatment of a sexually transmitted infection;</text> </level> </level> <level label="iii"> <text>That a pharmacist must use to administer an initial dose of a maintenance injectable medication or an injectable medication for treatment of a sexually transmitted infection if the administration of the initial dose is authorized under subsection (b) of this section; and</text> </level> <level label="iv"> <text>For communicating to the prescriber whether a medication was administered to a specific patient and relevant information about the patient’s condition.</text> </level> </level> <level label="2"> <text>The regulations shall require a pharmacist to:</text> <level label="i"> <text>Except as provided in paragraph (3) of this subsection, complete a training program approved by the Board for:</text> <level label="1"> <text>Administering maintenance injectable medications and injectable medications for treatment of a sexually transmitted infection; and</text> </level> <level label="2"> <text>Managing the populations the pharmacist serves, the medications being administered, and the current guidelines relating to these populations and medications;</text> </level> </level> <level label="ii"> <text>Follow the standard procedures established by the Board; and</text> </level> <level label="iii"> <text>After administering a maintenance injectable medication or an injectable medication for treatment of a sexually transmitted infection:</text> <level label="1"> <text>Notify the prescriber that the maintenance injectable medication or injectable medication for treatment of a sexually transmitted infection was administered and of any relevant details about the patient’s condition;</text> </level> <level label="2"> <text>Provide the patient with a written record of the maintenance injectable medication or injectable medication for treatment of a sexually transmitted infection administered;</text> </level> <level label="3"> <text>Record in any electronic or written health record on the patient maintained by the pharmacist:</text> </level> <level label="A"> <text>The administering of the maintenance injectable medication or injectable medication for treatment of a sexually transmitted infection; and</text> </level> <level label="B"> <text>Any pertinent details about the patient’s condition; and</text> </level> <level label="4"> <text>Notify the patient of the need to attend any upcoming appointments the patient has scheduled with the prescriber.</text> </level> </level> </level> <level label="3"> <text>The regulations shall waive the requirement to complete a training program for a pharmacist who already has undergone the training as part of the pharmacist’s formal educational program.</text> </level> </level> </section> <section article="gho" article_name="Health Occupations" number="12-510" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="5" subtitle_name="Practice of Pharmacy and Operation of Pharmacies"> <level label="a"> <text>Except as provided in subsection (b) of this section, a pharmacist may provide compounded nonsterile preparations or compounded sterile preparations without a patient–specific prescription to a licensed veterinarian who intends to dispense the compounded nonsterile preparations or compounded sterile preparations in accordance with § 2–313(c) of the Agriculture Article if the pharmacist:</text> <level label="1"> <text>Complies with USP 795 or USP 797, as applicable;</text> </level> <level label="2"> <text>Labels the compounded nonsterile preparations or compounded sterile preparations with:</text> <level label="i"> <text>The name and strength of the compounded nonsterile preparations or compounded sterile preparations or a list of the active ingredients and the strength of the active ingredients in the compounded nonsterile preparations or compounded sterile preparations;</text> </level> <level label="ii"> <text>An appropriate beyond–use date as determined by the pharmacist in accordance with USP–NF standards for pharmacy compounding;</text> </level> <level label="iii"> <text>The quantity of compounded nonsterile preparations or compounded sterile preparations; and</text> </level> <level label="iv"> <text>The name, address, and license number of the pharmacy; and</text> </level> </level> <level label="3"> <text>Complies with applicable federal law and regulations.</text> </level> </level> <level label="b"> <level label="1"> <text>This subsection does not apply to dispensing compounded nonsterile preparations or compounded sterile preparations dispensed for a patient–specific prescription.</text> </level> <level label="2"> <text>A pharmacy may not provide compounded nonsterile preparations or compounded sterile preparations compounded using bulk drug substances to a licensed veterinarian:</text> <level label="i"> <text>In an amount greater than 10% of the total amount of drug products sold or dispensed from the pharmacy; or</text> </level> <level label="ii"> <text>If the compounded nonsterile preparations or compounded sterile preparations are copies or close approximations to products approved by the federal Food and Drug Administration.</text> </level> </level> <level label="3"> <text>For purposes of the limitation established in paragraph (2)(i) of this subsection:</text> <level label="i"> <text>The calculation shall be made on an annual basis and use the number of dosage units sold or dispensed; and</text> </level> <level label="ii"> <text>For nonresident pharmacies, the total amount of drug products sold or dispensed shall be the pharmacy’s total business within the State.</text> </level> </level> </level> </section> <section article="gho" article_name="Health Occupations" number="12-511" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="5" subtitle_name="Practice of Pharmacy and Operation of Pharmacies"> <level label="a"> <text>In this section, “contraceptives” means contraceptive medications and self–administered contraceptive devices approved by the U.S. Food and Drug Administration.</text> </level> <level label="b"> <text>A pharmacist who meets the requirements of the regulations adopted under this section may prescribe and dispense contraceptives.</text> </level> <level label="c"> <level label="1"> <text>On or before September 1, 2018, the Board, in consultation with the State Board of Physicians, the State Board of Nursing, the Maryland Chapter of the American College of Obstetricians and Gynecologists, the Maryland Chapter of the American Academy of Pediatrics, the Maryland Pharmacists Association, the Maryland Affiliate of the American College of Nurse–Midwives, the Maryland Nurses Association, Planned Parenthood of Maryland, the Maryland Association of Chain Drug Stores, and other interested health professional associations and stakeholders, shall adopt final regulations establishing:</text> <level label="i"> <text>Standard procedures that a pharmacist must use to select the appropriate contraceptive to prescribe for a patient or to refer the patient to a primary care practitioner or reproductive health care practitioner for treatment; and</text> </level> <level label="ii"> <text>The conditions under which a pharmacist may prescribe and dispense contraceptives.</text> </level> </level> <level label="2"> <text>The regulations shall require a pharmacist to:</text> <level label="i"> <text>Except as provided in paragraph (3) of this subsection, complete a training program approved by the Board for prescribing and dispensing contraceptives;</text> </level> <level label="ii"> <text>Provide a self–screening risk assessment tool that a patient must use before a pharmacist may prescribe contraceptives for the patient;</text> </level> <level label="iii"> <text>Follow the standard procedures established by the Board; and</text> </level> <level label="iv"> <text>After prescribing and dispensing contraceptives for a patient:</text> <level label="1"> <text>Refer the patient for any additional care to:</text> </level> <level label="A"> <text>The patient’s primary care practitioner or reproductive health care practitioner; or</text> </level> <level label="B"> <text>If the patient does not have a primary care practitioner or reproductive health care practitioner, a family planning provider or a licensed clinician who provides reproductive health care services;</text> </level> <level label="2"> <text>Provide the patient with:</text> </level> <level label="A"> <text>A written record of the contraceptives dispensed; and</text> </level> <level label="B"> <text>Written information about the importance of seeing the patient’s primary care practitioner or reproductive health care practitioner to obtain recommended tests and screenings;</text> </level> <level label="3"> <text>Record the prescribing and dispensing of the contraceptives in any electronic health record maintained on the patient by the pharmacist; and</text> </level> <level label="4"> <text>Provide the patient with a copy of the record of the encounter that includes the patient’s completed self–assessment tool and the contraceptive prescribed and dispensed or the basis for not prescribing and dispensing a contraceptive.</text> </level> </level> </level> <level label="3"> <text>The regulations shall waive the requirement to complete a training program for a pharmacist who already has undergone the training as part of the pharmacist’s formal educational program.</text> </level> <level label="4"> <text>The regulations shall prohibit a pharmacist from prescribing contraceptives before January 1, 2019.</text> </level> </level> </section> <section article="gho" article_name="Health Occupations" number="12-512" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="5" subtitle_name="Practice of Pharmacy and Operation of Pharmacies"> <level label="a"> <text>In this section, “authorized prescriber” has the meaning stated in § 12–101 of this title.</text> </level> <level label="b"> <text>This section does not apply to:</text> <level label="1"> <text>A controlled dangerous substance as defined in § 5–101 of the Criminal Law Article; or</text> </level> <level label="2"> <text>The first prescription or change in a prescription for a drug that an authorized prescriber prescribes for a patient.</text> </level> </level> <level label="c"> <text>Except as provided in subsection (d) of this section, a pharmacist may dispense, in a single dispensing and exercising the professional judgment of the pharmacist, a quantity of a prescription drug that:</text> <level label="1"> <text>Is up to the total number of dosage units authorized by the prescriber on the original prescription and any refills of the prescription;</text> </level> <level label="2"> <text>Except for a contraceptive dispensed on or after January 1, 2020, does not exceed a 90–day supply of the prescription drug; and</text> </level> <level label="3"> <text>For a contraceptive dispensed on or after January 1, 2020, does not exceed a 12–month supply of the prescription drug.</text> </level> </level> <level label="d"> <text>A pharmacist may not dispense, in a single dose, a quantity of a prescription drug that exceeds the limit prescribed by a prescriber when the prescriber has indicated that the prescription be dispensed only as prescribed.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-513" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="5" subtitle_name="Practice of Pharmacy and Operation of Pharmacies"> <level label="a"> <text>Before the closing of a pharmacy for more than 7 consecutive days, at least 14 days before the anticipated closing of the pharmacy, the owner of the pharmacy shall provide notice of the closing by:</text> <level label="1"> <text>Posting a notice:</text> <level label="i"> <text>That is conspicuously positioned in the pharmacy and readable by pharmacy customers; and</text> </level> <level label="ii"> <text>If applicable, on the pharmacy’s website; and</text> </level> </level> <level label="2"> <text>Providing written and verbal notice to each customer who picks up a prescription or refill.</text> </level> </level> <level label="b"> <text>Each notice shall indicate:</text> <level label="1"> <text>The date of the anticipated closing of the pharmacy, if available;</text> </level> <level label="2"> <text>The name of the pharmacy to which the closing pharmacy will transfer pharmacy customers’ prescriptions and records; and</text> </level> <level label="3"> <text>That a pharmacy customer may request the closing pharmacy to send the pharmacy customer’s prescriptions and records to another pharmacy.</text> </level> </level> <level label="c"> <text>The Board shall adopt regulations to:</text> <level label="1"> <text>Define “closing of a pharmacy”; and</text> </level> <level label="2"> <text>Provide exceptions to the requirements of this section.</text> </level> </level> </section> <section article="gho" article_name="Health Occupations" number="12-514" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="5" subtitle_name="Practice of Pharmacy and Operation of Pharmacies"> <level label="a"> <text>A pharmacist who meets the requirements of the regulations adopted under this section may prescribe and dispense nicotine replacement therapy medications.</text> </level> <level label="b"> <level label="1"> <text>On or before September 1, 2023, the Board shall adopt regulations establishing:</text> <level label="i"> <text>Standard procedures that a pharmacist shall use to:</text> <level label="1"> <text>Prescribe and dispense to a patient the appropriate nicotine replacement therapy medication; and</text> </level> <level label="2"> <text>Refer the patient to a primary care practitioner for treatment; and</text> </level> </level> <level label="ii"> <text>The conditions under which a pharmacist may prescribe and dispense nicotine replacement therapy medication.</text> </level> </level> <level label="2"> <text>The regulations shall require a pharmacist to:</text> <level label="i"> <text>Except as provided in paragraph (3) of this subsection, complete a training program approved by the Board for prescribing and dispensing nicotine replacement therapy medication;</text> </level> <level label="ii"> <text>Follow the standard procedures established by the Board; and</text> </level> <level label="iii"> <text>After prescribing and dispensing to a patient nicotine replacement therapy medication:</text> <level label="1"> <text>Refer the patient for any additional care to the patient’s primary care practitioner;</text> </level> <level label="2"> <text>Provide the patient with:</text> </level> <level label="A"> <text>A written record of the nicotine replacement therapy medication dispensed; and</text> </level> <level label="B"> <text>Information on the importance of the patient seeing the patient’s primary care practitioner; and</text> </level> <level label="3"> <text>Record the prescribing and dispensing of the nicotine replacement therapy medication in any electronic health record maintained for the patient by the pharmacist.</text> </level> </level> </level> <level label="3"> <text>The regulations shall waive the requirement to complete the training program under paragraph (2)(i) of this subsection for a pharmacist who already has undergone the training as part of the pharmacist’s formal educational program.</text> </level> </level> </section> <section article="gho" article_name="Health Occupations" number="12-601" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6" subtitle_name="Board Regulation of Drugs, Medicines, and Other Products"> <level label="a"> <text>Subject to the hearing provisions of § 12–315 of this title, for a violation of this subtitle, Subtitle 6C of this title, or any regulation adopted under Subtitle 6C of this title, the Board may:</text> <level label="1"> <text>Deny a permit to an applicant;</text> </level> <level label="2"> <text>Reprimand a permit holder;</text> </level> <level label="3"> <text>Place a permit holder on probation; or</text> </level> <level label="4"> <text>Suspend or revoke a permit.</text> </level> </level> <level label="b"> <text>A person aggrieved by a final action of the Board under this subtitle or Subtitle 6C of this title may appeal as provided under Title 10, Subtitle 2 of the State Government Article.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-603" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6" subtitle_name="Board Regulation of Drugs, Medicines, and Other Products"> <level label="a"> <level label="1"> <text>In this section the following words have the meanings indicated.</text> </level> <level label="2"> <text>“Dialysis drugs and devices” means:</text> <level label="i"> <text>Dialysate and dialysis solutions;</text> </level> <level label="ii"> <text>Dialyzers, delivery systems, and their accessory equipment necessary to administer these products;</text> </level> <level label="iii"> <text>Heparin;</text> </level> <level label="iv"> <text>Local anesthetics and any other drugs and devices approved by the Board under subsection (g) of this section;</text> </level> <level label="v"> <text>Needles;</text> </level> <level label="vi"> <text>Syringes; and</text> </level> <level label="vii"> <text>Sterile sodium chloride and sterile potassium chloride.</text> </level> </level> <level label="3"> <text>“Home dialysis distribution permit” means a permit issued by the Board to distribute dialysis drugs and devices to the homes of dialysis patients.</text> </level> </level> <level label="b"> <level label="1"> <text>Except as provided under this subsection, a person shall hold a home dialysis distribution permit issued by the Board before the person may distribute dialysis drugs and devices to the home of a dialysis patient.</text> </level> <level label="2"> <text>A licensed pharmacist may distribute dialysis drugs and devices under this section without the home dialysis distribution permit otherwise required by this section.</text> </level> </level> <level label="c"> <text>To qualify for a home dialysis distribution permit, an applicant shall satisfy the Board that the applicant will distribute dialysis drugs and devices in compliance with subsection (h) of this section.</text> </level> <level label="d"> <text>To apply for a home dialysis distribution permit, an applicant shall:</text> <level label="1"> <text>Submit an application to the Board on the form that the Board requires; and</text> </level> <level label="2"> <text>Pay to the Board a fee set by the Board.</text> </level> </level> <level label="e"> <text>The Board shall issue a home dialysis distribution permit to any applicant who meets the requirements of this section.</text> </level> <level label="f"> <text>A home dialysis distribution permit issued under this section authorizes the home dialysis distribution permit holder to distribute dialysis drugs and devices to the home of a dialysis patient while the home dialysis distribution permit is effective.</text> </level> <level label="g"> <level label="1"> <text>The Board may approve local anesthetics and other drugs and devices for distribution as dialysis drugs and devices under this section.</text> </level> <level label="2"> <text>The Board may adopt rules and regulations to assure safe, proper, and uninterrupted distribution of dialysis drugs and devices, including rules and regulations as to:</text> <level label="i"> <text>Maintaining facilities that are adequate to assure proper security and control of dialysis drugs and devices;</text> </level> <level label="ii"> <text>Keeping records;</text> </level> <level label="iii"> <text>Labeling dialysis drugs and devices;</text> </level> <level label="iv"> <text>Receipts and returns from patients for dialysis drugs and devices;</text> </level> <level label="v"> <text>Reports to the Board; and</text> </level> <level label="vi"> <text>Restrictions on specific dialysis drugs or devices, including limitations on the amounts that may be distributed.</text> </level> </level> </level> <level label="h"> <text>A person authorized to distribute dialysis drugs and devices under this section may distribute only dialysis drugs and devices:</text> <level label="1"> <text>That the Board, after consultation with the State Commission on Kidney Disease, has approved as effective and safe for their intended use;</text> </level> <level label="2"> <text>Under supervision of a person who the Board considers qualified to safeguard and protect the public health;</text> </level> <level label="3"> <text>To an individual:</text> <level label="i"> <text>Who has irreversibly lost function of the individual’s kidneys and requires regular treatment; and</text> </level> <level label="ii"> <text>Who has completed a full course of training in providing the individual’s own dialysis treatment given by:</text> <level label="1"> <text>A home dialysis training facility; or</text> </level> <level label="2"> <text>An end stage renal disease clinic certified under Medicare; and</text> </level> </level> </level> <level label="4"> <text>In compliance with the rules and regulations adopted by the Board under this section.</text> </level> </level> <level label="i"> <text>Subject to the Administrative Procedure Act, the Board may suspend or revoke the home dialysis distribution permit of any home dialysis distribution permit holder who fails to comply with subsection (h) of this section.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-604" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6" subtitle_name="Board Regulation of Drugs, Medicines, and Other Products"> <level label="a"> <text>The Secretary, the Board, or the agents of either, during business hours, may:</text> <level label="1"> <text>Enter any place where drugs, devices, diagnostics, cosmetics, dentifrices, domestic remedies, or toilet articles are manufactured, packaged, stocked, or offered for sale; and</text> </level> <level label="2"> <text>Inspect the drugs, devices, diagnostics, cosmetics, dentifrices, domestic remedies, and toilet articles there.</text> </level> </level> <level label="b"> <level label="1"> <text>A pharmacy in this State issued a permit by the Board and subject to inspection under subsection (a) of this section shall be inspected annually.</text> </level> <level label="2"> <text>A nonresident pharmacy:</text> <level label="i"> <text>Is subject to inspection under subsection (a) of this section by the Secretary, the Board, or the agents of either; and</text> </level> <level label="ii"> <text>On application for and renewal of a pharmacy permit in this State, shall submit a copy of the most recent inspection report resulting from an inspection conducted by the regulatory or licensing agency of the state in which the nonresident pharmacy is located.</text> </level> </level> </level> <level label="c"> <text>A person may not hinder an inspection conducted under this section.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-605" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6" subtitle_name="Board Regulation of Drugs, Medicines, and Other Products"> <level label="a"> <level label="1"> <text>In this section the following words have the meanings indicated.</text> </level> <level label="2"> <text>“Health care facility” means a related institution as defined in § 19–301 of the Health – General Article.</text> </level> <level label="3"> <text>“Remote automated medication system” means an automated mechanical system that is located in a health care facility that does not have an on–site pharmacy and in which medication is stored in a manner that may be patient–specific.</text> </level> <level label="4"> <text>“Starter dose” means a dose of medication removed from a remote automated medication system within the first 24 hours after it is ordered.</text> </level> </level> <level label="b"> <level label="1"> <text>A pharmacist shall be responsible for the safe and efficient dispensing, repackaging, delivery, control, bar coding, transaction records, dispensation records, labeling, and accountability for all medications in a remote automated medication system located in a health care facility that does not have a pharmacy present on–site.</text> </level> <level label="2"> <text>If a pharmacist is not physically present where the remote automated medication system is located in a health care facility, the pharmacist shall have access to the system by electronic and visual means in order to ensure the safe and efficient dispensing, repackaging, delivery, control, bar coding, transaction records, dispensation records, labeling, and accountability for all medications in the system.</text> </level> </level> <level label="c"> <text>If a health care facility uses a remote automated medication system, a pharmacist shall review for accuracy, completeness, and appropriateness all medication orders after being entered into the system.</text> </level> <level label="d"> <level label="1"> <text>If a remote automated medication system, the pharmacy permit holder that manages the system, and the health care facility where the system is located meet the requirements of this subsection:</text> <level label="i"> <text>A health care facility that uses a system does not need to have a pharmacist physically present to review the selection, packaging, or repackaging of medications by the system;</text> </level> <level label="ii"> <text>If the starter dose is reviewed by a pharmacist within 24 hours of delivery from a system, a system may deliver a starter dose or a dose in response to an emergency without prior review by a pharmacist; and</text> </level> <level label="iii"> <text>A system may allow simultaneous access to multiple drug strengths, dosage forms, or drug entities if contained within a patient–specific package.</text> </level> </level> <level label="2"> <text>A remote automated medication system shall at least:</text> <level label="i"> <text>Use bar code technology to ensure accuracy in loading and selection of medications in the system;</text> </level> <level label="ii"> <text>Have electronic reporting capability regarding the identity of all persons with access to the system and regarding all medications removed from the system; and</text> </level> <level label="iii"> <text>Before administration of a medication to a patient by an individual authorized to administer medication under this article, provide:</text> <level label="1"> <text>A picture of the medication if available; or</text> </level> <level label="2"> <text>If a picture is not available, a written report that describes the medication.</text> </level> </level> </level> <level label="3"> <text>The health care facility where the system is located shall have at least:</text> <level label="i"> <text>A pharmacist available for consultation 24 hours per day;</text> </level> <level label="ii"> <text>Technical assistance regarding operation of the system available 24 hours per day; and</text> </level> <level label="iii"> <text>A quality assurance program as described under subsection (e) of this section.</text> </level> </level> <level label="4"> <text>The pharmacy permit holder that manages a remote automated medication system shall provide a comprehensive training program to all persons with access to the system.</text> </level> </level> <level label="e"> <level label="1"> <text>A pharmacist that operates a remote automated medication system, in consultation with the health care facility where the system is located, shall develop and implement a quality assurance program in accordance with regulations adopted by the Board.</text> </level> <level label="2"> <text>The quality assurance program developed under this subsection shall include:</text> <level label="i"> <text>Policies and procedures at both the pharmacy where the system receives an order and the health care facility where the system administers the medication regarding operation of the system;</text> </level> <level label="ii"> <text>Daily inspection of the integrity of the system;</text> </level> <level label="iii"> <text>A plan for addressing medication errors;</text> </level> <level label="iv"> <text>A plan for reviewing incidents regarding inappropriate use and access to the system;</text> </level> <level label="v"> <text>Proper labeling procedures that comply with applicable State and federal laws;</text> </level> <level label="vi"> <text>Policies and procedures for the safe handling and return of unused medications; and</text> </level> <level label="vii"> <text>Any other requirements determined by the Board and set forth in regulations.</text> </level> </level> </level> <level label="f"> <level label="1"> <text>A pharmacist that operates a remote automated medication system shall limit access to the system to individuals authorized to access the system by requiring individual security codes for all functions.</text> </level> <level label="2"> <text>A record shall be kept of each transaction containing user identification information.</text> </level> </level> <level label="g"> <level label="1"> <text>A pharmacist who operates a remote automated medication system shall maintain maintenance logs and repair records for the system.</text> </level> <level label="2"> <text>In a power outage or otherwise unforeseen situation, a pharmacist shall ensure that:</text> <level label="i"> <text>A back–up power source for the system is available by a connection with the health care facility’s generator; and</text> </level> <level label="ii"> <text>Only a registered nurse or a licensed practical nurse has access to the medications contained within the system.</text> </level> </level> </level> </section> <section article="gho" article_name="Health Occupations" number="12-6A-01" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6A" subtitle_name="Therapy Management Contracts"> <level label="a"> <text>In this subtitle the following words have the meanings indicated.</text> </level> <level label="b"> <text>“Authorized prescriber” means a licensed physician, licensed podiatrist, certified midwife licensed under Title 8, Subtitle 6D of this article, or certified advanced practice nurse with prescriptive authority under § 8–508 of this article.</text> </level> <level label="c"> <text>“Group model health maintenance organization” has the meaning stated in § 19–713.6 of the Health – General Article.</text> </level> <level label="d"> <text>“Health maintenance organization” has the meaning stated in § 19–701(g) of the Health – General Article.</text> </level> <level label="e"> <level label="1"> <text>“Institutional facility” means a facility other than a nursing home whose primary purpose is to provide a physical environment for patients to obtain inpatient or emergency care.</text> </level> <level label="2"> <text>“Institutional facility” does not include an urgent care facility that is not part of a facility.</text> </level> </level> <level label="f"> <text>“Prescriber–pharmacist agreement” means an agreement between an authorized prescriber and a licensed pharmacist that is disease–state specific and specifies the protocols that may be used.</text> </level> <level label="g"> <text>“Protocol” means a course of treatment predetermined by the authorized prescriber and licensed pharmacist according to generally accepted medical practice for the proper completion of a particular therapeutic or diagnostic intervention.</text> </level> <level label="h"> <text>“Therapy management contract” means a voluntary arrangement that is:</text> <level label="1"> <text>Disease–state specific;</text> </level> <level label="2"> <text>Agreed on by:</text> <level label="i"> <text>One licensed pharmacist and the licensed pharmacist’s designated alternate licensed pharmacists;</text> </level> <level label="ii"> <text>One authorized prescriber and alternate designated authorized prescribers involved directly in patient care; and</text> </level> <level label="iii"> <text>One patient receiving care from an authorized prescriber and a licensed pharmacist pursuant to a prescriber–pharmacist agreement and protocol under this subtitle; and</text> </level> </level> <level label="3"> <text>Related to treatment using drug therapy, laboratory tests, or medical devices, under defined conditions or limitations for the purpose of improving patient outcomes.</text> </level> </level> </section> <section article="gho" article_name="Health Occupations" number="12-6A-02" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6A" subtitle_name="Therapy Management Contracts"> <text>A therapy management contract is not required for the management of patients in an institutional facility or in a group model health maintenance organization.</text> </section> <section article="gho" article_name="Health Occupations" number="12-6A-03" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6A" subtitle_name="Therapy Management Contracts"> <level label="a"> <text>An authorized prescriber and a licensed pharmacist who wish to enter into therapy management contracts shall have a prescriber–pharmacist agreement.</text> </level> <level label="b"> <text>A licensed pharmacist who has entered into a prescriber–pharmacist agreement shall submit to the Board of Pharmacy a copy of the prescriber–pharmacist agreement and any subsequent modifications made to the prescriber–pharmacist agreement or the protocols specified in the prescriber–pharmacist agreement.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-6A-04" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6A" subtitle_name="Therapy Management Contracts"> <level label="a"> <text>Subject to subsection (b) of this section, a pharmacist is authorized to enter into a prescriber–pharmacist agreement if the pharmacist:</text> <level label="1"> <text>Is a licensed pharmacist;</text> </level> <level label="2"> <text>Has a Doctor of Pharmacy Degree or equivalent training as established in regulations adopted under this subtitle;</text> </level> <level label="3"> <text>Is approved by the Board to enter into a prescriber–pharmacist agreement with an authorized prescriber in accordance with this subtitle; and</text> </level> <level label="4"> <text>Meets the requirements that are established by regulations adopted under this subtitle.</text> </level> </level> <level label="b"> <text>A pharmacist may enter into a prescriber–pharmacist agreement that authorizes a pharmacist to treat an opioid use disorder using controlled dangerous substances drug therapy if the pharmacist:</text> <level label="1"> <text>Individually registers with the federal Drug Enforcement Agency;</text> </level> <level label="2"> <text>Individually registers with the Office of Controlled Substances Administration;</text> </level> <level label="3"> <text>Completes any applicable training required by federal or State laws; and</text> </level> <level label="4"> <text>Follows a protocol that meets the requirements of § 12–6A–06 of this subtitle.</text> </level> </level> </section> <section article="gho" article_name="Health Occupations" number="12-6A-05" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6A" subtitle_name="Therapy Management Contracts"> <level label="a"> <text>Subject to the regulations adopted under this subtitle, a licensed pharmacist may enter into a therapy management contract initiated by an authorized prescriber.</text> </level> <level label="b"> <text>A licensed pharmacist may not employ or provide economic incentives to an authorized prescriber for the purpose of entering into a prescriber–pharmacist agreement or a therapy management contract.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-6A-06" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6A" subtitle_name="Therapy Management Contracts"> <level label="a"> <text>A protocol under this subtitle:</text> <level label="1"> <text>May authorize:</text> <level label="i"> <text>For protocols by a licensed physician and licensed pharmacist, the initiation of drug therapy under written, disease–state specific protocols;</text> </level> <level label="ii"> <text>The modification, continuation, and discontinuation of drug therapy under written, disease–state specific protocols;</text> </level> <level label="iii"> <text>The ordering of laboratory tests; and</text> </level> <level label="iv"> <text>Other patient care management measures related to monitoring or improving the outcomes of drug or device therapy; and</text> </level> </level> <level label="2"> <text>May not authorize acts that exceed the scope of practice of the parties to the therapy management contract.</text> </level> </level> <level label="b"> <text>A protocol shall prohibit the substitution of a chemically dissimilar drug product by the pharmacist for the product prescribed by the authorized prescriber, unless permitted in the therapy management contract.</text> </level> <level label="c"> <text>A protocol that authorizes controlled dangerous substances drug therapy shall require the pharmacist to request relevant data from the Prescription Drug Monitoring Program before initiating or modifying a controlled dangerous substances drug therapy.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-6A-07" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6A" subtitle_name="Therapy Management Contracts"> <level label="a"> <text>A therapy management contract shall apply only to conditions for which protocols have been agreed to by an authorized prescriber and a licensed pharmacist in accordance with the regulations adopted under this subtitle.</text> </level> <level label="b"> <text>A therapy management contract shall include:</text> <level label="1"> <text>A statement that none of the parties involved in the therapy management contract have been coerced, given economic incentives, excluding normal reimbursement for services rendered, or involuntarily required to participate;</text> </level> <level label="2"> <text>Notice to the patient indicating:</text> <level label="i"> <text>That the patient may terminate the therapy management contract at any time; and</text> </level> <level label="ii"> <text>The procedure by which the patient may terminate the therapy management contract;</text> </level> </level> <level label="3"> <text>A procedure for periodic review by the authorized prescriber, of the drugs modified pursuant to the agreement or changed with the consent of the authorized prescriber; and</text> </level> <level label="4"> <text>Reference to a protocol, which will be provided to the patient on request.</text> </level> </level> <level label="c"> <level label="1"> <text>A therapy management contract may be entered into in writing or orally.</text> </level> <level label="2"> <text>If a therapy management contract is entered into orally, the parties to the therapy management contract shall reduce the agreement to writing within 30 days after entering into the therapy management contract.</text> </level> <level label="3"> <text>A therapy management contract may be in electronic form.</text> </level> </level> <level label="d"> <text>Any party to the therapy management contract may terminate the contract at any time.</text> </level> <level label="e"> <text>The Board may assess a fee, as established in regulation, for approval of a pharmacist to enter into a prescriber–pharmacist agreement.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-6A-08" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6A" subtitle_name="Therapy Management Contracts"> <level label="a"> <text>The authorized prescriber shall maintain complete patient records with respect to the therapy management contract.</text> </level> <level label="b"> <text>The authorized prescriber’s patient record shall be fully updated in writing by the licensed pharmacist in a timely manner, as provided in the prescriber–pharmacist agreement.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-6A-09" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6A" subtitle_name="Therapy Management Contracts"> <text>Nothing in this subtitle supersedes the provisions of § 5–902 of the Criminal Law Article.</text> </section> <section article="gho" article_name="Health Occupations" number="12-6A-10" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6A" subtitle_name="Therapy Management Contracts"> <level label="a"> <text>Subject to subsection (b) of this section, the Board, together with the Board of Physicians and in consultation with the Board of Podiatric Medical Examiners and the Board of Nursing, shall jointly develop and adopt regulations to implement the provisions of this subtitle.</text> </level> <level label="b"> <text>The regulations adopted under subsection (a) of this section:</text> <level label="1"> <text>Shall include provisions that:</text> <level label="i"> <text>Define the criteria for prescriber–pharmacist agreements; and</text> </level> <level label="ii"> <text>Establish guidelines concerning the use of protocols, including communication, documentation, and other relevant factors; and</text> </level> </level> <level label="2"> <text>May not require a health occupations board to approve a prescriber–pharmacist agreement or the protocols specified in a prescriber–pharmacist agreement.</text> </level> </level> </section> <section article="gho" article_name="Health Occupations" number="12-6B-01" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6B" subtitle_name="Registered Pharmacy Technicians"> <level label="a"> <text>Except as otherwise provided in this title or §§ 10–14A–03 and 10–14B–03 of the State Government Article, an individual shall be registered and approved by the Board as a pharmacy technician before the individual may perform delegated pharmacy acts.</text> </level> <level label="b"> <text>This section does not apply to:</text> <level label="1"> <text>A pharmacy technician trainee under the direct supervision of a licensed pharmacist provided that the individual does not perform delegated pharmacy acts for more than 6 months; or</text> </level> <level label="2"> <text>A pharmacy student who:</text> <level label="i"> <text>Is currently completing the first year of a professional pharmacy education program; and</text> </level> <level label="ii"> <text>Under the direct supervision of a licensed pharmacist, performs delegated pharmacy acts in accordance with regulations adopted by the Board.</text> </level> </level> </level> </section> <section article="gho" article_name="Health Occupations" number="12-6B-02" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6B" subtitle_name="Registered Pharmacy Technicians"> <level label="a"> <text>To qualify for registration an applicant shall be an individual who:</text> <level label="1"> <text>Is currently certified by a national pharmacy technician certification program and complies with subsection (b)(6) of this section; or</text> </level> <level label="2"> <text>Meets the requirements of this section.</text> </level> </level> <level label="b"> <text>The applicant shall:</text> <level label="1"> <text>Be of good moral character;</text> </level> <level label="2"> <text>Be at least 17 years old;</text> </level> <level label="3"> <level label="i"> <level label="1"> <text>Be a high school graduate or have attained a high school equivalency; or</text> </level> <level label="2"> <text>Be enrolled and in good standing at a high school; or</text> </level> </level> <level label="ii"> <text>Meet the requirements in subsection (d) of this section;</text> </level> </level> <level label="4"> <text>Have successfully passed an examination approved by the Board;</text> </level> <level label="5"> <text>Complete a pharmacy technician training program approved by the Board that:</text> <level label="i"> <text>Includes 160 hours of work experience; and</text> </level> <level label="ii"> <text>Is no longer than 6 months’ duration; and</text> </level> </level> <level label="6"> <text>Submit a request for a State criminal history records check.</text> </level> </level> <level label="c"> <text>The Board may not approve an application until the State criminal history records check is completed.</text> </level> <level label="d"> <text>If an applicant does not meet the requirements of subsection (b)(3) through (5) of this section, the applicant qualifies for registration if:</text> <level label="1"> <text>The applicant has worked in the pharmacy area of a pharmacy operated by the same pharmacy permit holder since January 1, 2006;</text> </level> <level label="2"> <text>The pharmacy permit holder for whom the applicant works attests in writing that the applicant has worked in the pharmacy area operated by the pharmacy permit holder continuously since January 1, 2006;</text> </level> <level label="3"> <text>A pharmacist who has supervised the applicant for at least 6 months attests in writing that the individual has performed competently; and</text> </level> <level label="4"> <text>The applicant otherwise meets the requirements of subsection (b) of this section.</text> </level> </level> <level label="e"> <text>An individual, at least 16 years and 6 months old, may begin fulfilling the pharmacy technician registration requirements under this subtitle.</text> </level> <level label="f"> <level label="1"> <text>Subject to the provisions of this subsection, the Board may waive any requirement of this subtitle for an individual who is registered as or has worked as a pharmacy technician in another state.</text> </level> <level label="2"> <text>The Board may grant a waiver under this subsection only if the applicant:</text> <level label="i"> <text>Pays the application fee required under § 12-6B-03 of this subtitle; and</text> </level> <level label="ii"> <level label="1"> <text>Provides sufficient evidence that the applicant was registered in a state with registration or licensing requirements that are substantially similar to the registration requirements of this subtitle; or</text> </level> <level label="2"> <text>Has worked as a pharmacy technician in another state and satisfies any additional requirements established by the Board in regulation.</text> </level> </level> </level> </level> </section> <section article="gho" article_name="Health Occupations" number="12-6B-02.1" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6B" subtitle_name="Registered Pharmacy Technicians"> <level label="a"> <text>In this section, “Central Repository” means the Criminal Justice Information System Central Repository of the Department of Public Safety and Correctional Services.</text> </level> <level label="b"> <text>An applicant shall apply to the Central Repository for a State and national criminal history records check.</text> </level> <level label="c"> <text>As part of the application for a criminal history records check, an applicant shall complete and submit to the Central Repository:</text> <level label="1"> <text>A complete set of legible fingerprints taken in a format approved by the Director of the Central Repository and the Director of the Federal Bureau of Investigation;</text> </level> <level label="2"> <text>The fee authorized under § 10–221(b)(7) of the Criminal Procedure Article for access to Maryland criminal history records; and</text> </level> <level label="3"> <text>The mandatory processing fee required by the Federal Bureau of Investigation for a national criminal history records check.</text> </level> </level> <level label="d"> <text>In accordance with §§ 10–201 through 10–229 of the Criminal Procedure Article, the Central Repository shall forward to the Board and the individual the individual’s criminal history record information.</text> </level> <level label="e"> <text>Information obtained from the Central Repository under this section:</text> <level label="1"> <text>Is confidential;</text> </level> <level label="2"> <text>May not be redisseminated; and</text> </level> <level label="3"> <text>May be used only for the licensing purpose authorized by this title.</text> </level> </level> <level label="f"> <text>The subject of a criminal history records check under this section may contest the contents of the criminal history record information issued by the Central Repository as provided in § 10–223 of the Criminal Procedure Article.</text> </level> <level label="g"> <text>If criminal history record information is reported to the Central Repository after the date of the initial criminal history records check, the Central Repository shall provide to the Board and the individual revised criminal history record information for the individual.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-6B-03" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6B" subtitle_name="Registered Pharmacy Technicians"> <level label="a"> <text>An applicant for registration shall:</text> <level label="1"> <text>Submit an application to the Board on the form that the Board requires;</text> </level> <level label="2"> <text>Unless otherwise qualified under § 12-6B-02(a) or (d) of this subtitle, provide documentation of the completion of a pharmacy technician training program under § 12-6B-02(b)(5) of this subtitle;</text> </level> <level label="3"> <text>Unless otherwise qualified under § 12-6B-02(a) or (d) of this subtitle, provide documentation of having successfully completed an examination approved by the Board;</text> </level> <level label="4"> <text>Submit to a request for a State criminal history records check; and</text> </level> <level label="5"> <text>Pay the application fees set by the Board.</text> </level> </level> <level label="b"> <text>The application shall be signed by the applicant.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-6B-04" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6B" subtitle_name="Registered Pharmacy Technicians"> <level label="a"> <text>The Board shall register as a pharmacy technician any applicant who meets the requirements of this subtitle.</text> </level> <level label="b"> <level label="1"> <text>The Board may set reasonable fees for the issuance and renewal of registrations and other services.</text> </level> <level label="2"> <text>The fees charged shall be set so as to approximate the cost of registering pharmacy technicians.</text> </level> </level> </section> <section article="gho" article_name="Health Occupations" number="12-6B-05" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6B" subtitle_name="Registered Pharmacy Technicians"> <level label="a"> <text>A registered pharmacy technician shall notify the Board of each plea of guilty for, conviction of, or entry of a plea of nolo contendere for a felony or a crime involving moral turpitude, regardless of whether:</text> <level label="1"> <text>An adjudication of guilt or sentencing or imposition of sentence is withheld; or</text> </level> <level label="2"> <text>Any appeal or other proceeding is pending regarding the matter.</text> </level> </level> <level label="b"> <text>The registered pharmacy technician shall notify the Board within 7 days of the conviction or entry of the plea.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-6B-06" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6B" subtitle_name="Registered Pharmacy Technicians"> <level label="a"> <text>Registration authorizes a registered pharmacy technician to perform delegated pharmacy acts as defined in § 12–101 of this title while the registration is effective.</text> </level> <level label="b"> <text>A registered pharmacy technician or a pharmacy technician trainee may not:</text> <level label="1"> <text>Act within the parameters of a therapy management contract as provided under Subtitle 6A of this title;</text> </level> <level label="2"> <text>Make decisions that require the professional judgment of a pharmacist;</text> </level> <level label="3"> <text>Delegate a pharmacy act that was delegated to the registered pharmacy technician or individual engaging in a Board approved technician training program; or</text> </level> <level label="4"> <text>Perform other functions prohibited by regulations adopted by the Board.</text> </level> </level> <level label="c"> <level label="1"> <text>A registered pharmacy technician may administer, in accordance with § 12–508 of this title:</text> <level label="i"> <text>An influenza, COVID–19, or pneumonia vaccination to an individual at least 18 years old; and</text> </level> <level label="ii"> <text>A respiratory syncytial virus or shingles vaccination to an individual at least 50 years old.</text> </level> </level> <level label="2"> <text>Except as provided in paragraph (1) of this subsection, a registered pharmacy technician may not administer a vaccination in accordance with § 12–508 of this title.</text> </level> </level> <level label="d"> <text>A pharmacy technician trainee may not administer a vaccination in accordance with § 12–508 of this title.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-6B-07" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6B" subtitle_name="Registered Pharmacy Technicians"> <level label="a"> <level label="1"> <text>Unless the registration is renewed for an additional term as provided in this section, registration expires on the date set by the Board.</text> </level> <level label="2"> <text>The ability of a registered pharmacy technician to function as a pharmacy technician terminates on the date of expiration of the pharmacy technician’s registration unless renewed.</text> </level> <level label="3"> <text>Registration may not be renewed for a term longer than 2 years.</text> </level> </level> <level label="b"> <level label="1"> <text>Except as provided in paragraph (2) of this subsection, the Board shall send to each registered pharmacy technician, at least 1 month before a registration expires, a renewal notice by electronic means to the last known e–mail address of the registered pharmacy technician.</text> </level> <level label="2"> <text>If requested by a registered pharmacy technician, the Board shall send to the registered pharmacy technician a renewal notice by first–class mail to the last known address of the registered pharmacy technician.</text> </level> <level label="3"> <text>If a renewal notice sent by electronic means under paragraph (1) of this subsection is returned to the Board as undeliverable, the Board shall send the registered pharmacy technician a renewal notice by first–class mail to the last known address of the registered pharmacy technician.</text> </level> <level label="4"> <text>A renewal notice sent under this subsection shall state:</text> <level label="i"> <text>The date on which the current registration expires;</text> </level> <level label="ii"> <text>The date by which the renewal application must be received by the Board for the renewal to be issued and mailed before the registration expires; and</text> </level> <level label="iii"> <text>The amount of the renewal fee.</text> </level> </level> </level> <level label="c"> <text>A registered pharmacy technician periodically may renew a pharmacy technician’s registration for an additional 2–year term, if the registered pharmacy technician:</text> <level label="1"> <text>Otherwise is entitled to be registered as a pharmacy technician;</text> </level> <level label="2"> <text>Submits to the Board a renewal application on the form that the Board requires;</text> </level> <level label="3"> <text>Meets the continuing education requirements set by the Board under this section; and</text> </level> <level label="4"> <text>Pays to the Board a renewal fee set by the Board.</text> </level> </level> <level label="d"> <text>In addition to any other qualifications and requirements established by the Board, the Board shall establish continuing education requirements as a condition to the renewal of registrations under this section.</text> </level> <level label="e"> <text>The Board shall renew the registration of each pharmacy technician who meets the requirements of this section.</text> </level> <level label="f"> <level label="1"> <text>Except as provided in paragraph (2) of this subsection, the registration of a pharmacy technician who qualified for registration under § 12–6B–02(d) of this subtitle permanently expires on the date the registered pharmacy technician’s employment terminates with the pharmacy permit holder that made the attestation required under § 12–6B–02(d) of this subtitle.</text> </level> <level label="2"> <text>Paragraph (1) of this subsection does not apply to the registration of a pharmacy technician who:</text> <level label="i"> <text>At the time of termination, notifies the Board of the termination date;</text> </level> <level label="ii"> <text>Resumes working as a pharmacy technician within 1 year of the termination date; and</text> </level> <level label="iii"> <text>Notifies the Board of the date the registered pharmacy technician begins employment after the termination date.</text> </level> </level> </level> </section> <section article="gho" article_name="Health Occupations" number="12-6B-08" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6B" subtitle_name="Registered Pharmacy Technicians"> <level label="a"> <text>Each registered pharmacy technician shall:</text> <level label="1"> <text>Display the pharmacy technician’s registration in the office or place of business in which the pharmacy technician is working; or</text> </level> <level label="2"> <text>Have the registration on the pharmacy technician’s person available for viewing.</text> </level> </level> <level label="b"> <text>When performing delegated pharmacy acts, the registered pharmacy technician shall wear identification that conspicuously identifies the registered pharmacy technician as a registered pharmacy technician.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-6B-09" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6B" subtitle_name="Registered Pharmacy Technicians"> <text>Subject to the hearing provision of § 12–315 of this title, the Board may deny a pharmacy technician’s registration to any applicant, reprimand a registered pharmacy technician, place any pharmacy technician’s registration on probation, or suspend or revoke a pharmacy technician’s registration if the applicant or pharmacy technician registrant:</text> <level label="1"> <text>Performs an act that is restricted to a licensed pharmacist;</text> </level> <level label="2"> <text>Fraudulently or deceptively obtains or attempts to obtain a pharmacy technician’s registration for the applicant or assists or attempts to assist another in fraudulently or deceptively obtaining a pharmacy technician’s registration;</text> </level> <level label="3"> <text>Fraudulently uses a pharmacy technician’s registration;</text> </level> <level label="4"> <text>Knowingly aids an unauthorized individual to practice pharmacy or to represent that the individual is a licensed pharmacist or registered pharmacy technician;</text> </level> <level label="5"> <text>Performs delegated pharmacy acts while:</text> <level label="i"> <text>Under the influence of alcohol; or</text> </level> <level label="ii"> <text>Using any narcotic or controlled dangerous substance, as defined in § 5–101 of the Criminal Law Article, or other drug that is in excess of therapeutic amounts or without valid medical indication;</text> </level> </level> <level label="6"> <text>Submits a false statement to collect a fee;</text> </level> <level label="7"> <text>Willfully makes or files a false report or record as part of the registered pharmacy technician’s duties or employment;</text> </level> <level label="8"> <text>Willfully fails to file or record any report that is required by law;</text> </level> <level label="9"> <text>Willfully impedes or obstructs the filing or recording of any report that is required by law;</text> </level> <level label="10"> <text>Willfully induces another to fail to file or record any report that is required by law;</text> </level> <level label="11"> <text>Provides or causes to be provided to any authorized prescriber prescription forms that bear the name, address, or other means of identification of a pharmacist or pharmacy;</text> </level> <level label="12"> <text>Provides remuneration to an authorized prescriber for referring an individual to a licensed pharmacist, registered pharmacy technician, or pharmacy for a product or service to be provided by that licensed pharmacist, registered pharmacy technician, or pharmacy;</text> </level> <level label="13"> <text>Agrees with an authorized prescriber or pharmacist to prepare or dispense a secret formula prescription;</text> </level> <level label="14"> <text>Except as to an association that has remained in continuous existence since July 1, 1963, associates as a partner, co–owner, or employee of a pharmacy that is owned wholly or substantially by an authorized prescriber or group of authorized prescribers;</text> </level> <level label="15"> <text>Knowingly aids a pharmacist in dispensing any drug, device, or diagnostic for which a prescription is required without a written, oral, or electronically transmitted prescription from an authorized prescriber;</text> </level> <level label="16"> <text>Unless an authorized prescriber authorizes the refill, refills a prescription for any drug, device, or diagnostic for which a prescription is required;</text> </level> <level label="17"> <text>Violates any labeling requirements in this title;</text> </level> <level label="18"> <text>Violates any provision of § 12–603 of this title, which concerns the home dialysis distribution program;</text> </level> <level label="19"> <text>Advertises or otherwise publicly claims to dispense prescriptions in a superior manner;</text> </level> <level label="20"> <text>Advertises in a manner that tends to deceive or defraud the public;</text> </level> <level label="21"> <text>Is physically or mentally incompetent;</text> </level> <level label="22"> <text>Pleaded guilty or nolo contendere to, or has been found guilty of, a felony or a crime involving moral turpitude, regardless of whether:</text> <level label="i"> <text>An adjudication of guilt or sentencing or imposition of sentence is withheld; or</text> </level> <level label="ii"> <text>Any appeal or other proceeding is pending regarding the matter;</text> </level> </level> <level label="23"> <text>Violates any provision of this title;</text> </level> <level label="24"> <text>Is disciplined by a licensing, registering, or disciplinary authority of any state or country or convicted or disciplined by a court of any state or country for an act that would be grounds for disciplinary action under the Board’s disciplinary statutes;</text> </level> <level label="25"> <text>Violates any regulation adopted by the Board;</text> </level> <level label="26"> <text>Refuses, withholds from, denies, or discriminates against an individual with regard to the provision of professional services for which the registered pharmacy technician is registered and qualified to render because the individual is HIV positive;</text> </level> <level label="27"> <text>Participates in any activity that is grounds for Board action under § 12–313 or § 12–409 of this title;</text> </level> <level label="28"> <text>Provides or causes to be provided confidential patient information to any person without first having obtained the patient’s consent, as required by § 12–403(c)(13) of this title and by Title 4, Subtitle 3 of the Health – General Article;</text> </level> <level label="29"> <text>Fails to cooperate with a lawful investigation conducted by the Board or the Office of Controlled Substances Administration;</text> </level> <level label="30"> <text>Performs delegated pharmacy acts in an incompetent manner; or</text> </level> <level label="31"> <text>Performs delegated pharmacy acts that are inappropriate based on the registered pharmacy technician’s education, training, and experience.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-6B-10" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6B" subtitle_name="Registered Pharmacy Technicians"> <level label="a"> <text>If after a hearing under § 12-315 of this title, the Board finds that there is a ground under § 12-6B-09 of this subtitle to reprimand a registered pharmacy technician, place a pharmacy technician’s registration on probation, or suspend or revoke a pharmacy technician’s registration, the Board may impose a penalty not exceeding $2,500:</text> <level label="1"> <text>Instead of reprimanding the registered pharmacy technician, placing the registered pharmacy technician on probation, or suspending or revoking the pharmacy technician’s registration; or</text> </level> <level label="2"> <text>In addition to reprimanding the registered pharmacy technician, placing the registered pharmacy technician on probation, or suspending or revoking the pharmacy technician’s registration.</text> </level> </level> <level label="b"> <text>The Board shall adopt regulations to set standards for the imposition of penalties under this section.</text> </level> <level label="c"> <text>The Board shall pay any penalty collected under this section into the General Fund of this State.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-6B-11" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6B" subtitle_name="Registered Pharmacy Technicians"> <level label="a"> <text>Unless the Board agrees to accept the surrender of a pharmacy technician’s registration, a registered pharmacy technician may not surrender the pharmacy technician’s registration nor may the pharmacy technician’s registration lapse by operation of law while the registered pharmacy technician is under investigation or while charges are pending against the registered pharmacy technician.</text> </level> <level label="b"> <text>The Board may set conditions on its agreement with the registered pharmacy technician under investigation or against whom charges are pending to accept the surrender of the pharmacy technician’s registration.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-6B-12" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6B" subtitle_name="Registered Pharmacy Technicians"> <text>Except as otherwise provided in this title, an individual may not work, attempt to work, or offer to work as a registered pharmacy technician in this State unless registered with the Board.</text> </section> <section article="gho" article_name="Health Occupations" number="12-6B-13" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6B" subtitle_name="Registered Pharmacy Technicians"> <level label="a"> <text>An individual may not obtain a pharmacy technician’s registration by making a false representation.</text> </level> <level label="b"> <text>On conviction of an individual for making a false representation to the Board in order to register as a pharmacy technician, the pharmacy technician’s registration is void.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-6B-14" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6B" subtitle_name="Registered Pharmacy Technicians"> <level label="a"> <text>Except as otherwise provided in this subtitle, an individual may not represent to the public by title, by description of services, methods, or procedures, or otherwise, that the individual is registered to work as a registered pharmacy technician unless registered in accordance with this subtitle.</text> </level> <level label="b"> <text>Except as otherwise provided in this subtitle, an individual may not use the terms “registered pharmacy technician” or “pharmacy technician” with the intent to represent that the individual is authorized to work as a registered pharmacy technician unless registered as a pharmacy technician under this subtitle.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-6C-01" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6C" subtitle_name="Wholesale Distributor Permitting and Prescription Drug Integrity Act"> <level label="a"> <text>In this subtitle the following words have the meanings indicated.</text> </level> <level label="b"> <text>“Authenticate” means to affirmatively verify, before any wholesale distribution of a prescription drug occurs, that each transaction listed on the pedigree for the prescription drug has occurred.</text> </level> <level label="c"> <text>“Authorized distributor of record” means a wholesale distributor with whom a manufacturer has established an ongoing relationship to distribute the manufacturer’s prescription drug.</text> </level> <level label="d"> <text>“Co–licensed partner” means a person in a relationship in which two or more persons have the right to engage in the manufacturing or marketing of a prescription drug, consistent with the U.S. Food and Drug Administration’s implementation of the federal Prescription Drug Marketing Act.</text> </level> <level label="e"> <text>“Co–licensed product” means a product of co–licensed partners.</text> </level> <level label="f"> <text>“Designated representative” means an individual who:</text> <level label="1"> <text>Is designated by a wholesale distributor;</text> </level> <level label="2"> <text>Serves as the primary contact of the wholesale distributor with the Board; and</text> </level> <level label="3"> <text>Is actively involved in and aware of the daily operation of the wholesale distributor.</text> </level> </level> <level label="g"> <text>“Drop shipment” means the sale of a prescription drug:</text> <level label="1"> <text>To a wholesale distributor by:</text> <level label="i"> <text>The manufacturer of the prescription drug; or</text> </level> <level label="ii"> <text>The manufacturer’s co–licensed partner, third party logistics provider, or manufacturer’s exclusive distributor; and</text> </level> </level> <level label="2"> <text>Through which:</text> <level label="i"> <text>The wholesale distributor or a pharmacy warehouse takes title to but not physical possession of the prescription drug;</text> </level> <level label="ii"> <text>The wholesale distributor invoices the pharmacy, pharmacy warehouse, or other person authorized by law to dispense or administer the prescription drug to a patient; and</text> </level> <level label="iii"> <text>The pharmacy, pharmacy warehouse, or other authorized person receives delivery of the prescription drug directly from:</text> <level label="1"> <text>The manufacturer; or</text> </level> <level label="2"> <text>The manufacturer’s third party logistics provider or the manufacturer’s exclusive distributor.</text> </level> </level> </level> </level> <level label="h"> <text>“Facility” means a facility of a wholesale distributor where prescription drugs are stored, handled, repackaged, or offered for sale.</text> </level> <level label="i"> <text>“Intracompany sales” means a:</text> <level label="1"> <text>Transaction or transfer of prescription drugs between a division, subsidiary, parent, or affiliated or related company under common ownership and control of a corporate entity, other than a transaction or transfer of prescription drugs from a pharmacy to a wholesale distributor; or</text> </level> <level label="2"> <text>Transaction or transfer of a co–licensed product between co–licensed partners.</text> </level> </level> <level label="j"> <text>“Manufacturer” means a person licensed or approved by the U.S. Food and Drug Administration to engage in the manufacture of prescription drugs or prescription devices, consistent with the definition of “manufacturer” under the U.S. Food and Drug Administration’s regulations and guidelines implementing the Prescription Drug Marketing Act.</text> </level> <level label="k"> <text>“Manufacturer’s exclusive distributor” means a person who:</text> <level label="1"> <text>Contracts with a manufacturer to provide or coordinate warehousing, distribution, or other services on behalf of the manufacturer; and</text> </level> <level label="2"> <text>Takes title to the manufacturer’s prescription drug, but does not have general responsibility to direct the sale or disposition of the manufacturer’s prescription drug.</text> </level> </level> <level label="l"> <text>“Normal distribution channel” means a chain of custody for a prescription drug that, directly or by drop shipment, goes:</text> <level label="1"> <text>From:</text> <level label="i"> <text>A manufacturer of the prescription drug; or</text> </level> <level label="ii"> <text>The manufacturer’s co–licensed partner, third party logistics provider, or manufacturer’s exclusive distributor; and</text> </level> </level> <level label="2"> <text>To:</text> <level label="i"> <text>A pharmacy or other designated person authorized by law to dispense or administer the prescription drug to a patient;</text> </level> <level label="ii"> <text>A wholesale distributor to a pharmacy or other designated person authorized by law to dispense or administer the prescription drug to a patient;</text> </level> <level label="iii"> <text>A wholesale distributor to a pharmacy warehouse to the pharmacy warehouse’s intracompany pharmacy or other designated person authorized by law to dispense or administer the prescription drug to a patient;</text> </level> <level label="iv"> <text>A pharmacy warehouse to the pharmacy warehouse’s intracompany pharmacy or other designated person authorized by law to dispense or administer the prescription drug to a patient; or</text> </level> <level label="v"> <text>An authorized distributor of record to another authorized distributor of record solely for distribution to an office–based health care practitioner authorized by law to dispense or administer the prescription drug to a patient.</text> </level> </level> </level> <level label="m"> <text>“Ongoing relationship” means a relationship that exists between a wholesale distributor, including any affiliated group of the wholesale distributor, as defined in § 1504 of the Internal Revenue Code, and a manufacturer when the wholesale distributor:</text> <level label="1"> <text>Has a written agreement currently in effect with the manufacturer evidencing the ongoing relationship; and</text> </level> <level label="2"> <text>Is listed on the manufacturer’s current list of authorized distributors of record.</text> </level> </level> <level label="n"> <text>“Pedigree” means a document or electronic file containing information that records each wholesale distribution of a prescription drug.</text> </level> <level label="o"> <text>“Pharmacy warehouse” means a physical location for storage of prescription drugs that:</text> <level label="1"> <text>Serves as a central warehouse; and</text> </level> <level label="2"> <text>Performs intracompany sales or transfers of the prescription drugs to a group of pharmacies that are under common ownership and control with the pharmacy warehouse.</text> </level> </level> <level label="p"> <text>“Prescription device” means any device required by federal law or regulation to be dispensed only by a prescription.</text> </level> <level label="q"> <level label="1"> <text>“Prescription drug” means any drug required by federal law or regulation to be dispensed only by a prescription.</text> </level> <level label="2"> <text>“Prescription drug” includes:</text> <level label="i"> <text>A biological product; and</text> </level> <level label="ii"> <text>Finished dosage forms and bulk drug substances subject to § 503(b) of the Federal Food, Drug, and Cosmetic Act.</text> </level> </level> <level label="3"> <text>“Prescription drug” does not include blood and blood components intended for transfusion or biological products that are also medical devices.</text> </level> </level> <level label="r"> <level label="1"> <text>“Repackage” means to repackage or otherwise change the container, wrapper, or labeling of a prescription drug to further the distribution of the prescription drug.</text> </level> <level label="2"> <text>“Repackage” does not include changes to a container, wrapper, or labeling of a prescription drug completed by the pharmacist responsible for dispensing the prescription drug to a patient.</text> </level> </level> <level label="s"> <text>“Repackager” means a person who repackages prescription drugs.</text> </level> <level label="t"> <text>“Third party logistics provider” means a person who:</text> <level label="1"> <text>Contracts with a manufacturer to provide or coordinate warehousing, distribution, or other services on behalf of the manufacturer; but</text> </level> <level label="2"> <text>Does not take title to the prescription drug or have general responsibility to direct the prescription drug’s sale or disposition.</text> </level> </level> <level label="u"> <level label="1"> <text>“Wholesale distribution” means the distribution of prescription drugs or prescription devices to persons other than a consumer or patient.</text> </level> <level label="2"> <text>“Wholesale distribution” does not include:</text> <level label="i"> <text>Intracompany sales;</text> </level> <level label="ii"> <text>The sale, purchase, distribution, trade, or transfer of a prescription drug or an offer to sell, purchase, distribute, trade, or transfer a prescription drug for emergency medical reasons;</text> </level> <level label="iii"> <text>The sale, purchase, distribution, trade, or transfer of a prescription drug or prescription device by the Department for public health purposes;</text> </level> <level label="iv"> <text>The distribution of samples of a prescription drug by a manufacturer’s representative;</text> </level> <level label="v"> <text>Prescription drug returns conducted by a hospital, health care entity, or charitable institution in accordance with 21 C.F.R. § 203.23;</text> </level> <level label="vi"> <text>The sale of minimal quantities of prescription drugs by retail pharmacies to licensed health care practitioners for office use;</text> </level> <level label="vii"> <text>The sale, purchase, or trade of a prescription drug, an offer to sell, purchase, or trade a prescription drug, or the dispensing of a prescription drug in accordance with a prescription;</text> </level> <level label="viii"> <text>The sale, transfer, merger, or consolidation of all or part of the business of a pharmacy to or with another pharmacy, whether accomplished as a purchase and sale of stock or business assets;</text> </level> <level label="ix"> <text>The sale, purchase, distribution, trade, or transfer of a prescription drug from one authorized distributor of record to one additional authorized distributor of record if:</text> <level label="1"> <text>The manufacturer has stated in writing to the receiving authorized distributor of record that the manufacturer is unable to supply the prescription drug; and</text> </level> <level label="2"> <text>The supplying authorized distributor of record states in writing that the prescription drug being supplied had until that time been exclusively in the normal distribution channel;</text> </level> </level> <level label="x"> <text>The delivery of, or offer to deliver, a prescription drug by a common carrier solely in the common carrier’s usual course of business of transporting prescription drugs, if the common carrier does not store, warehouse, or take legal ownership of the prescription drug; or</text> </level> <level label="xi"> <text>The sale or transfer from a pharmacy or pharmacy warehouse of expired, damaged, returned, or recalled prescription drugs to:</text> <level label="1"> <text>The original wholesale distributor;</text> </level> <level label="2"> <text>The original manufacturer; or</text> </level> <level label="3"> <text>A third party returns processor.</text> </level> </level> </level> </level> <level label="v"> <level label="1"> <text>“Wholesale distributor” means a person that is engaged in the wholesale distribution of prescription drugs or prescription devices.</text> </level> <level label="2"> <text>“Wholesale distributor” includes:</text> <level label="i"> <text>A manufacturer;</text> </level> <level label="ii"> <text>A repackager;</text> </level> <level label="iii"> <text>An own–label distributor;</text> </level> <level label="iv"> <text>A private–label distributor;</text> </level> <level label="v"> <text>A jobber;</text> </level> <level label="vi"> <text>A broker;</text> </level> <level label="vii"> <text>A warehouse, including a manufacturer’s or distributor’s warehouse;</text> </level> <level label="viii"> <text>A manufacturer’s exclusive distributor or an authorized distributor of record;</text> </level> <level label="ix"> <text>A drug wholesaler or distributor;</text> </level> <level label="x"> <text>An independent wholesale drug trader;</text> </level> <level label="xi"> <text>A third party logistics provider;</text> </level> <level label="xii"> <text>A pharmacy that conducts wholesale distribution, if the wholesale distribution business accounts for more than 5% of the pharmacy’s annual sales; and</text> </level> <level label="xiii"> <text>A pharmacy warehouse that conducts wholesale distribution.</text> </level> </level> </level> <level label="w"> <text>“Wholesale distributor permit” means a permit issued by the Board under this subtitle to distribute prescription drugs or prescription devices into, out of, or within the State as a wholesale distributor.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-6C-02" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6C" subtitle_name="Wholesale Distributor Permitting and Prescription Drug Integrity Act"> <text>This subtitle does not affect any person while distributing:</text> <level label="1"> <text>Feed for livestock or poultry;</text> </level> <level label="2"> <text>Fertilizers;</text> </level> <level label="3"> <text>Fungicides;</text> </level> <level label="4"> <text>Insecticide;</text> </level> <level label="5"> <text>Land plaster;</text> </level> <level label="6"> <text>Lime;</text> </level> <level label="7"> <text>Seeds;</text> </level> <level label="8"> <text>Devices, drugs, or supplies of any kind for the treatment, care, or cure of farm animals; or</text> </level> <level label="9"> <text>Compounded nonsterile preparations or compounded sterile preparations provided in accordance with § 12–510 of this title to a licensed veterinarian who intends to dispense the compounded nonsterile preparations or compounded sterile preparations in accordance with § 2–313(c) of the Agriculture Article.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-6C-03" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6C" subtitle_name="Wholesale Distributor Permitting and Prescription Drug Integrity Act"> <level label="a"> <text>A wholesale distributor shall hold a permit issued by the Board before the wholesale distributor engages in wholesale distribution in the State.</text> </level> <level label="b"> <level label="1"> <text>A manufacturer engaged in wholesale distribution shall hold a wholesale distributor permit issued under this subtitle.</text> </level> <level label="2"> <text>Notwithstanding paragraph (1) of this subsection, the information and qualification requirements for obtaining a permit under this subtitle, beyond that required by federal law, do not apply to:</text> <level label="i"> <text>A manufacturer that distributes its own prescription drugs that are approved by the U.S. Food and Drug Administration; or</text> </level> <level label="ii"> <text>A manufacturer that distributes its own prescription devices that are approved or authorized by the U.S. Food and Drug Administration.</text> </level> </level> </level> <level label="c"> <text>A manufacturer’s exclusive distributor and a third–party logistics provider shall hold a wholesale distributor permit issued under this subtitle.</text> </level> <level label="d"> <text>A wholesale distributor permit shall be displayed conspicuously in the place of business for which the permit is issued.</text> </level> <level label="e"> <text>A wholesale distributor permit is not transferable.</text> </level> <level label="f"> <text>Subject to any other restriction provided by law, a person may not purchase or obtain a prescription drug or prescription device unless the prescription drug or prescription device is purchased or obtained from a person who holds a wholesale distributor permit, a licensed pharmacist, or an authorized prescriber.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-6C-03.1" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6C" subtitle_name="Wholesale Distributor Permitting and Prescription Drug Integrity Act"> <level label="a"> <text>The Department may purchase and distribute prescription drugs and prescription devices for public health purposes.</text> </level> <level label="b"> <text>The Department shall adopt regulations, in consultation with the Board, to implement this section.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-6C-03.2" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6C" subtitle_name="Wholesale Distributor Permitting and Prescription Drug Integrity Act"> <level label="a"> <text>Notwithstanding any other provision of this subtitle, a wholesale distributor applicant or permit holder that prepares sterile drug products shall submit to the Board a report of an inspection conducted by the U.S. Food and Drug Administration or a Board designee:</text> <level label="1"> <text>At the time of application; and</text> </level> <level label="2"> <text>On renewal.</text> </level> </level> <level label="b"> <text>The inspection report required under subsection (a) of this section shall:</text> <level label="1"> <text>Be conducted within 1 year before the date of application or renewal; and</text> </level> <level label="2"> <text>Demonstrate compliance with applicable federal good manufacturing practice standards.</text> </level> </level> <level label="c"> <text>An applicant or permit holder is responsible for obtaining an inspection to meet the requirements of this section.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-6C-04" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6C" subtitle_name="Wholesale Distributor Permitting and Prescription Drug Integrity Act"> <level label="a"> <level label="1"> <text>In this section the following words have the meanings indicated.</text> </level> <level label="2"> <text>“Accreditation organization” means a private entity that:</text> <level label="i"> <text>Is recognized by the Board; and</text> </level> <level label="ii"> <text>Conducts inspections and surveys of wholesale distributors based on nationally recognized and developed standards.</text> </level> </level> <level label="3"> <text>“Deemed status” means a status under which a wholesale distributor may be exempt from initial and routine inspection requirements under this subtitle.</text> </level> </level> <level label="b"> <text>The Board may only grant deemed status to a wholesale distributor that is:</text> <level label="1"> <text>Currently accredited by an accreditation organization, wherever the wholesale distributor is located; or</text> </level> <level label="2"> <text>Located in a state that has requirements that:</text> <level label="i"> <text>Are substantially equivalent to the requirements of this State; and</text> </level> <level label="ii"> <text>Include pedigrees, routine inspections of wholesale distributors, operation of wholesale distributors in a commercial nonresidential facility, and security measures.</text> </level> </level> </level> <level label="c"> <level label="1"> <text>The Board may issue a wholesale distributor permit by reciprocity to a wholesale distributor who holds a license or permit under the laws of another state if the Board determines that the requirements of that state are substantially equivalent to the requirements of this State.</text> </level> <level label="2"> <text>A wholesale distributor that receives a permit by reciprocity shall comply with the requirements of § 12–6C–05(e) and (f) of this subtitle.</text> </level> <level label="3"> <text>In addition to meeting the requirements under this subtitle, a wholesale distributor located out–of–state that is not eligible for reciprocity shall be accredited by an accreditation organization.</text> </level> <level label="4"> <text>The Board shall grant deemed status to a wholesale distributor that:</text> <level label="i"> <text>Is currently accredited by an accreditation organization; or</text> </level> <level label="ii"> <text>Has been granted reciprocity by the Board.</text> </level> </level> </level> <level label="d"> <text>The Board or its designee may inspect a wholesale distributor who is accredited or has been issued a permit by reciprocity to:</text> <level label="1"> <text>Determine compliance with any permit requirement under this subtitle; or</text> </level> <level label="2"> <text>Investigate a complaint.</text> </level> </level> </section> <section article="gho" article_name="Health Occupations" number="12-6C-05" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6C" subtitle_name="Wholesale Distributor Permitting and Prescription Drug Integrity Act"> <level label="a"> <text>To apply for a wholesale distributor permit, an applicant shall:</text> <level label="1"> <text>Pay to the Board an application fee set by the Board; and</text> </level> <level label="2"> <text>Submit an application to the Board on the form that the Board requires.</text> </level> </level> <level label="b"> <text>The application shall include the following:</text> <level label="1"> <text>The name, full business address, and telephone number of the applicant;</text> </level> <level label="2"> <text>All trade or business names used by the applicant;</text> </level> <level label="3"> <text>Addresses, telephone numbers, and the names of contact persons for the facility used by the applicant for the storage, handling, and distribution of prescription drugs;</text> </level> <level label="4"> <text>The type of business form under which the applicant operates, such as partnership, corporation, or sole proprietorship;</text> </level> <level label="5"> <text>The name of each owner and operator of the applicant, including:</text> <level label="i"> <text>If an individual, the name of the individual;</text> </level> <level label="ii"> <text>If a partnership, the name of the partnership and of each partner;</text> </level> <level label="iii"> <text>If a corporation, the name of the corporation, the name and title of each corporate officer and director, and the state of incorporation; and</text> </level> <level label="iv"> <text>If a sole proprietorship, the full name of the sole proprietor and the name of the sole proprietor’s business entity;</text> </level> </level> <level label="6"> <text>A list of all licenses and permits issued to the applicant by any other state that authorizes the applicant to purchase or possess prescription drugs;</text> </level> <level label="7"> <text>For the designated representative and the immediate supervisor of the designated representative at the applicant’s place of business, the following:</text> <level label="i"> <text>Name;</text> </level> <level label="ii"> <text>Places of residence for the past 7 years;</text> </level> <level label="iii"> <text>Date and place of birth;</text> </level> <level label="iv"> <text>The name and address of each business where the individual was employed during the past 7 years, and the individual’s job title or office held at each business;</text> </level> <level label="v"> <text>A statement of whether, during the past 7 years, the individual has been the subject of any proceeding for the revocation of any professional or business license or any criminal violation and, if so, the nature and disposition of the proceeding;</text> </level> <level label="vi"> <text>A statement of whether, during the past 7 years, the individual has been enjoined, either temporarily or permanently, by a court of competent jurisdiction from violating any federal or state law regulating the possession, control, or distribution of prescription drugs, together with details concerning the event;</text> </level> <level label="vii"> <text>A description of any involvement, including any investments other than the ownership of stock in a publicly traded company or mutual fund, by the individual during the past 7 years with any business that manufactures, administers, prescribes, distributes, or stores prescription drugs, and any lawsuits in which the business was named as a party;</text> </level> <level label="viii"> <level label="1"> <text>A description of any misdemeanor or felony offense of which the individual, as an adult, was found guilty, regardless of whether adjudication of guilt was withheld or whether the individual pled guilty or nolo contendere; and</text> </level> <level label="2"> <text>If the individual indicates that a criminal conviction is under appeal and submits a copy of the notice of appeal, within 15 days after the disposition of the appeal, a copy of the final written order of disposition; and</text> </level> </level> <level label="ix"> <text>A photograph of the individual taken in the previous 180 days.</text> </level> </level> </level> <level label="c"> <text>The information required under subsection (b) of this section shall be provided under oath.</text> </level> <level label="d"> <text>The Board may not issue a wholesale distributor permit to an applicant unless the Board or its designee:</text> <level label="1"> <text>If the applicant holds prescription drugs or devices, conducts a physical inspection of the applicant’s place of business, including any facility of the applicant;</text> </level> <level label="2"> <text>Finds that the place of business and facility, if any, meets the Board’s requirements;</text> </level> <level label="3"> <text>Determines that the designated representative of the applicant meets the following qualifications:</text> <level label="i"> <text>Is at least 21 years of age;</text> </level> <level label="ii"> <text>Has been employed full time for at least 3 years in a pharmacy or with a wholesale distributor in a capacity related to the dispensing and distribution of, and record keeping relating to, prescription drugs;</text> </level> <level label="iii"> <text>Is employed by the applicant full time in a managerial level position;</text> </level> <level label="iv"> <text>Is actively involved in and aware of the daily operation of the wholesale distributor;</text> </level> <level label="v"> <text>Is physically present, except for an authorized absence such as sick leave or vacation leave, at the facility of the applicant during regular business hours;</text> </level> <level label="vi"> <text>Is serving as a designated representative for only one applicant at a time, or for two or more wholesale distributors who are located in the same facility and are members of an affiliated group, as defined in § 1504 of the Internal Revenue Code;</text> </level> <level label="vii"> <text>Does not have any convictions for a violation of any federal, state, or local laws relating to wholesale or retail prescription drug distribution or distribution of controlled substances; and</text> </level> <level label="viii"> <text>Does not have any convictions for a felony under federal, state, or local laws; and</text> </level> </level> <level label="4"> <text>Determines that the immediate supervisor of the designated representative of the applicant meets the following qualifications:</text> <level label="i"> <text>Is at least 21 years of age;</text> </level> <level label="ii"> <text>Has been employed full time for at least 3 years in a pharmacy or with a wholesale distributor in a capacity related to the dispensing and distribution of, and record keeping relating to, prescription drugs;</text> </level> <level label="iii"> <text>Is employed by the applicant full time in a managerial level position;</text> </level> <level label="iv"> <text>Is actively involved in and aware of the daily operation of the wholesale distributor;</text> </level> <level label="v"> <text>Does not have any convictions for a violation of any federal, state, or local laws relating to wholesale or retail prescription drug distribution or distribution of controlled substances; and</text> </level> <level label="vi"> <text>Does not have any convictions for a felony under federal, state, or local laws.</text> </level> </level> </level> <level label="e"> <text>The designated representative and the immediate supervisor of the designated representative of an applicant shall submit to a criminal history records check in accordance with § 12–6C–05.1 of this subtitle.</text> </level> <level label="f"> <level label="1"> <text>In this subsection, “gross receipts” means gross receipts from sales of prescription drugs and devices in the State.</text> </level> <level label="2"> <text>This subsection does not apply to a pharmacy warehouse that is not engaged in wholesale distribution.</text> </level> <level label="3"> <level label="i"> <text>An applicant for a wholesale distributor permit shall submit a surety bond or other equivalent means of security acceptable to the State, such as an irrevocable letter of credit or a deposit in a trust account or financial institution, payable to the State Board of Pharmacy to be deposited into an account established by the State under paragraph (7) of this subsection.</text> </level> <level label="ii"> <text>The surety bond or other security shall be in the amount of:</text> <level label="1"> <text>$100,000, if the annual gross receipts of the applicant for the previous tax year are $10,000,000 or more; or</text> </level> <level label="2"> <text>$50,000, if the annual gross receipts of the applicant for the previous tax year are less than $10,000,000.</text> </level> </level> <level label="iii"> <text>The Board may require by regulation documentation for the gross receipts of the wholesale distributor to qualify for a surety bond or other security in the amount of $50,000.</text> </level> </level> <level label="4"> <text>The purpose of the surety bond is to secure payment of any fines or penalties imposed by the Board and any fees and costs incurred by the State relating to the permit that:</text> <level label="i"> <text>Are authorized under State law; and</text> </level> <level label="ii"> <text>Are not paid by the permit holder within 30 days after the fines, penalties, fees, or costs become final.</text> </level> </level> <level label="5"> <text>The State may make a claim against the surety bond or other security until 2 years after the permit holder’s permit ceases to be valid.</text> </level> <level label="6"> <text>A single surety bond shall cover all facilities operated by the applicant in the State.</text> </level> <level label="7"> <text>The Board shall establish an account, separate from its other accounts, in which to deposit the applicant’s surety bond or other security.</text> </level> </level> <level label="g"> <text>If a wholesale distributor distributes prescription drugs or prescription devices from more than one facility, the wholesale distributor shall obtain a permit for each facility.</text> </level> <level label="h"> <text>Within 30 days after the date the Board receives a completed application, including the results of all required criminal history records checks, the Board shall notify the applicant of the Board’s acceptance or rejection of the application.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-6C-05.1" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6C" subtitle_name="Wholesale Distributor Permitting and Prescription Drug Integrity Act"> <level label="a"> <level label="1"> <text>In this subsection, “Central Repository” means the Criminal Justice Information System Central Repository of the Department of Public Safety and Correctional Services.</text> </level> <level label="2"> <text>This subsection applies to applicants located in the State.</text> </level> <level label="3"> <text>As part of an application to the Central Repository for a State and national criminal history records check, the designated representative and the immediate supervisor of the designated representative of an applicant shall submit to the Central Repository:</text> <level label="i"> <text>A complete set of legible fingerprints taken in a format approved by the Director of the Central Repository and the Director of the Federal Bureau of Investigation;</text> </level> <level label="ii"> <text>The fee authorized under § 10–221(b)(7) of the Criminal Procedure Article for access to Maryland criminal history records; and</text> </level> <level label="iii"> <text>The mandatory processing fee required by the Federal Bureau of Investigation for a national criminal history records check.</text> </level> </level> <level label="4"> <text>In accordance with §§ 10–201 through 10–229 of the Criminal Procedure Article, the Central Repository shall forward the criminal history records information of the designated representative and the immediate supervisor of the designated representative of an applicant to the Board and the applicant.</text> </level> <level label="5"> <text>Information obtained from the Central Repository under this subsection:</text> <level label="i"> <text>Is confidential;</text> </level> <level label="ii"> <text>May not be redisseminated; and</text> </level> <level label="iii"> <text>May be used only for the permitting purpose authorized by this subtitle.</text> </level> </level> <level label="6"> <text>The subject of a criminal history records check under this subsection may contest the contents of the criminal history records information issued by the Central Repository as provided in § 10–223 of the Criminal Procedure Article.</text> </level> <level label="7"> <text>If criminal history record information is reported to the Central Repository after the date of the initial criminal history records check, the Central Repository shall provide to the Board and the individual revised criminal history record information for the individual.</text> </level> </level> <level label="b"> <level label="1"> <text>This subsection applies to applicants located outside the State.</text> </level> <level label="2"> <text>The designated representative and the immediate supervisor of the designated representative of an applicant shall submit to a criminal history records check by the applicant’s state of residence, in accordance with the laws of the applicant’s state of residence.</text> </level> <level label="3"> <text>The criminal history records check shall consist of:</text> <level label="i"> <text>A state criminal history records check for the applicant’s state of residence; and</text> </level> <level label="ii"> <text>A national criminal history records check.</text> </level> </level> <level label="4"> <text>The designated representative and the immediate supervisor of the designated representative of an applicant shall request the appropriate entity in the applicant’s state of residence to forward the results of the criminal history records check to the Board and the applicant.</text> </level> <level label="5"> <text>The Board shall ensure that information obtained under this subsection:</text> <level label="i"> <text>Is kept confidential;</text> </level> <level label="ii"> <text>Is not redisseminated; and</text> </level> <level label="iii"> <text>Is used only for the permitting purpose authorized by this subtitle.</text> </level> </level> </level> </section> <section article="gho" article_name="Health Occupations" number="12-6C-06" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6C" subtitle_name="Wholesale Distributor Permitting and Prescription Drug Integrity Act"> <level label="a"> <text>A wholesale distributor permit expires on May 31 after its effective date, unless the wholesale distributor permit is renewed for an additional 2–year term as provided in this section.</text> </level> <level label="b"> <level label="1"> <text>Except as provided in paragraph (2) of this subsection, at least 1 month before a wholesale distributor permit expires, the Board shall send to the wholesale distributor permit holder a renewal notice by electronic means to the last known e–mail address of the permit holder.</text> </level> <level label="2"> <text>If requested by a wholesale distributor permit holder, the Board shall send to the permit holder a renewal notice by first–class mail to the last known address of the permit holder.</text> </level> <level label="3"> <text>If a renewal notice sent by electronic means under paragraph (1) of this subsection is returned to the Board as undeliverable, the Board shall send to the wholesale distributor permit holder a renewal notice by first–class mail to the last known address of the permit holder.</text> </level> <level label="4"> <text>A renewal notice sent under this subsection shall state:</text> <level label="i"> <text>The date on which the current wholesale distributor permit expires;</text> </level> <level label="ii"> <text>The date by which the renewal application must be received by the Board for the renewal to be issued and mailed before the current wholesale distributor permit expires; and</text> </level> <level label="iii"> <text>The amount of the renewal fee.</text> </level> </level> <level label="5"> <text>Before a wholesale distributor permit expires, a wholesale distributor permit holder periodically may renew it for an additional 2–year term, if the wholesale distributor permit holder:</text> <level label="i"> <text>Otherwise is entitled to a wholesale distributor permit;</text> </level> <level label="ii"> <text>Pays to the Board a renewal fee set by the Board; and</text> </level> <level label="iii"> <text>Submits to the Board a renewal application on the form that the Board requires.</text> </level> </level> <level label="6"> <level label="i"> <text>The renewal application form shall set forth the information that the wholesale distributor provided under § 12–6C–05 of this subtitle.</text> </level> <level label="ii"> <text>Within 30 days after receiving the form, the wholesale distributor shall identify and state under oath to the Board all changes or corrections to the information that was provided under § 12–6C–05 of this subtitle.</text> </level> </level> <level label="7"> <text>The Board shall renew the wholesale distributor permit of a wholesale distributor permit holder who meets the requirements of this subtitle and any regulations adopted under this subtitle.</text> </level> <level label="8"> <text>If a wholesale distributor is located outside the State, the designated representative and immediate supervisor of the designated representative of the permit holder shall submit to a criminal history records check in accordance with § 12–6C–05.1 of this subtitle before the permit may be renewed.</text> </level> <level label="9"> <text>The Board may deny, suspend, or revoke the permit of a wholesale distributor if the Board determines that the wholesale distributor no longer qualifies for a permit.</text> </level> </level> </section> <section article="gho" article_name="Health Occupations" number="12-6C-07" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6C" subtitle_name="Wholesale Distributor Permitting and Prescription Drug Integrity Act"> <text>The Board:</text> <level label="1"> <text>Shall adopt regulations that require routine inspections of wholesale distributor facilities; and</text> </level> <level label="2"> <text>May adopt regulations establishing:</text> <level label="i"> <text>Minimum requirements for the receipt, storage, and handling of prescription drugs or prescription devices, security precautions, quality control, record keeping, and procedures, policy, and responsibilities of personnel; and</text> </level> <level label="ii"> <text>Education and experience requirements for personnel employed in positions responsible for carrying out the duties:</text> <level label="1"> <text>Referenced in item (i) of this item; or</text> </level> <level label="2"> <text>Related to State permit requirements under this subtitle.</text> </level> </level> </level> </section> <section article="gho" article_name="Health Occupations" number="12-6C-08" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6C" subtitle_name="Wholesale Distributor Permitting and Prescription Drug Integrity Act"> <text>Information provided by a wholesale distributor or an applicant for a wholesale distributor permit under this subtitle may not be disclosed to any person or entity except a State licensing or permitting authority, State board, or government agency that needs the information for licensing, permitting, monitoring, or law enforcement purposes.</text> </section> <section article="gho" article_name="Health Occupations" number="12-6C-09" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6C" subtitle_name="Wholesale Distributor Permitting and Prescription Drug Integrity Act"> <level label="a"> <level label="1"> <text>A wholesale distributor shall receive prescription drug returns or exchanges from a pharmacy or pharmacy warehouse according to the terms and conditions of the agreement between the wholesale distributor and the pharmacy or pharmacy warehouse.</text> </level> <level label="2"> <text>Returns of expired, damaged, recalled, or otherwise nonsaleable prescription drugs shall be distributed by the receiving wholesale distributor only to either the original manufacturer or a third party returns processor.</text> </level> <level label="3"> <text>Returns or exchanges of prescription drugs, saleable or otherwise, including any redistribution by a receiving wholesaler, are not subject to the pedigree requirements of § 12–6C–10 of this subtitle if they are exempt from the pedigree requirement of the U.S. Food and Drug Administration’s currently applicable Prescription Drug Marketing Act guidelines.</text> </level> <level label="4"> <text>Wholesale distributors and pharmacies shall be accountable for:</text> <level label="i"> <text>Administering their returns process; and</text> </level> <level label="ii"> <text>Ensuring that the returns process is secure and does not permit the entry of adulterated and counterfeit product.</text> </level> </level> </level> <level label="b"> <text>A wholesale distributor may supply prescription drugs only to a person authorized by law to dispense or receive prescription drugs.</text> </level> <level label="c"> <level label="1"> <text>Except as provided in paragraph (2) of this subsection, a wholesale distributor may deliver prescription drugs only to:</text> <level label="i"> <text>The premises listed on the recipient’s license or permit; or</text> </level> <level label="ii"> <text>An authorized person or an agent of an authorized person at the premises of the wholesale distributor if:</text> <level label="1"> <text>The identity and authorization of the person or agent is properly established; and</text> </level> <level label="2"> <text>This method of delivery is employed only to meet the immediate needs of a particular patient of the authorized person.</text> </level> </level> </level> <level label="2"> <level label="i"> <text>Prescription drugs may be supplied to a hospital pharmacy receiving area if a pharmacist or authorized receiving personnel of the hospital pharmacy signs, at the time of delivery, a receipt showing the type and quantity of the prescription drug received.</text> </level> <level label="ii"> <text>Any discrepancy between the type and quantity of the prescription drug indicated on the receipt and the type and quantity of the prescription drug received:</text> <level label="1"> <text>Shall be reported to the delivering wholesale distributor by the next business day after the delivery to the hospital pharmacy receiving area; and</text> </level> <level label="2"> <text>May be reported to the Board for investigation.</text> </level> </level> </level> </level> <level label="d"> <level label="1"> <text>A wholesale distributor may not accept payment or allow the use of a person’s credit to establish an account for the purchase of prescription drugs from any person other than the owner of record, the chief executive officer, or the chief financial officer listed on the license or permit of a person legally authorized to receive prescription drugs.</text> </level> <level label="2"> <text>Any account established for the purchase of prescription drugs shall bear the name of the license or permit holder.</text> </level> </level> <level label="e"> <text>A wholesale distributor may not operate out of a residence.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-6C-09.1" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6C" subtitle_name="Wholesale Distributor Permitting and Prescription Drug Integrity Act"> <level label="a"> <level label="1"> <text>In this section the following words have the meanings indicated.</text> </level> <level label="2"> <text>“Covered entity” has the meaning stated in 42 U.S.C. § 256b(a)(4).</text> </level> <level label="3"> <text>“Package” has the meaning stated in 21 U.S.C. § 360eee(11).</text> </level> <level label="4"> <level label="i"> <text>“340B drug” means a drug that:</text> <level label="1"> <text>Is a covered outpatient drug under 42 U.S.C. § 256b;</text> </level> <level label="2"> <text>Has been subject to an offer for reduced prices by a 340B manufacturer under 42 U.S.C. § 256b(a)(1); and</text> </level> <level label="3"> <text>Is purchased by a covered entity.</text> </level> </level> <level label="ii"> <text>“340B drug” includes a drug that would have been purchased but for the limitation under subsection (c) of this section.</text> </level> </level> <level label="5"> <text>“340B manufacturer” means a manufacturer, as defined in 42 U.S.C. § 1396r–8(k)(5), of covered outpatient drugs that has signed a pharmaceutical pricing agreement under 42 U.S.C. § 256b(a)(1).</text> </level> </level> <level label="b"> <text>This section may not be construed to be:</text> <level label="1"> <text>Less restrictive than any federal law that is applicable to a person regulated by this section; or</text> </level> <level label="2"> <text>In conflict with applicable federal and State laws and regulations.</text> </level> </level> <level label="c"> <level label="1"> <text>Except as provided in paragraph (2) of this subsection, a 340B manufacturer may not directly or indirectly deny, restrict, prohibit, discriminate against, or otherwise limit the acquisition of a 340B drug by, or delivery of a 340B drug to, a pharmacy that is under contract with or otherwise authorized by a covered entity to receive 340B drugs on behalf of the covered entity unless the receipt of 340B drugs is prohibited by the U.S. Department of Health and Human Services.</text> </level> <level label="2"> <text>A 340B manufacturer may limit the distribution of a 340B drug if the limitation is required under 21 U.S.C. § 355–1.</text> </level> </level> <level label="d"> <level label="1"> <level label="i"> <text>A violation of subsection (c) of this section:</text> <level label="1"> <text>Subject to paragraph (2) of this subsection, is an unfair, abusive, or deceptive trade practice within the meaning of Title 13 of the Commercial Law Article and is subject to the enforcement and penalty provisions contained in Title 13 of the Commercial Law Article; and</text> </level> <level label="2"> <level label="A"> <text>If the alleged violation was committed by a person that is licensed or permitted by the Board, shall be investigated by the Board or the Consumer Protection Division of the Office of the Attorney General; or</text> </level> </level> <level label="B"> <text>If the alleged violation was committed by a person that is not licensed or permitted by the Board, shall be investigated by the Consumer Protection Division of the Office of the Attorney General.</text> </level> </level> <level label="ii"> <text>As part of an investigation conducted under subparagraph (1)(i)2 of this paragraph, the Board or the Consumer Protection Division of the Office of the Attorney General may investigate an affiliate or a contractor of the 340B manufacturer, including a wholesaler or third–party logistics provider.</text> </level> </level> <level label="2"> <level label="i"> <text>In addition to the penalties under Title 13 of the Commercial Law Article, a civil fine may be assessed in the amount of $5,000 per violation of subsection (c) of this section.</text> </level> <level label="ii"> <text>A violation of this section does not create a private right of action under § 13–408 of the Commercial Law Article.</text> </level> </level> <level label="3"> <text>If a violation of subsection (c) of this section is committed by a person licensed or permitted by the Board, the Board may impose discipline, suspension, or revocation of the person’s license or permit.</text> </level> <level label="4"> <text>Each package of 340B drugs subject to a violation of subsection (c) of this section shall constitute a separate violation.</text> </level> </level> </section> <section article="gho" article_name="Health Occupations" number="12-6C-10" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6C" subtitle_name="Wholesale Distributor Permitting and Prescription Drug Integrity Act"> <level label="a"> <text>A person who is engaged in the wholesale distribution of a prescription drug that leaves, or has ever left, the normal distribution channel shall provide, before each wholesale distribution of the prescription drug, a pedigree to the person who receives the prescription drug.</text> </level> <level label="b"> <text>A retail pharmacy or pharmacy warehouse shall comply with the requirements of this section only if the pharmacy or pharmacy warehouse engages in the wholesale distribution of a prescription drug in the State.</text> </level> <level label="c"> <level label="1"> <text>To be considered part of the normal distribution channel, a wholesale distributor, a manufacturer’s exclusive distributor, and a manufacturer’s third party logistics provider also must be an authorized distributor of record.</text> </level> <level label="2"> <text>Notwithstanding paragraph (1) of this subsection, a pharmacy warehouse that is not an authorized distributor of record shall be considered part of the normal distribution channel.</text> </level> </level> <level label="d"> <text>Each person who engages in the wholesale distribution of a prescription drug, including repackagers but excluding the original manufacturer of the finished form of the prescription drug, who is provided a pedigree for the prescription drug and attempts to further distribute the prescription drug, shall authenticate, before any distribution of the prescription drug occurs, that each transaction listed on the pedigree has occurred.</text> </level> <level label="e"> <text>The pedigree shall include:</text> <level label="1"> <text>All necessary identifying information relating to each sale in the chain of distribution of the prescription drug from the manufacturer or the manufacturer’s third party logistics provider, co–licensed partner, or manufacturer’s exclusive distributor, through acquisition and sale by any wholesale distributor or repackager, until final sale to a pharmacy or other person dispensing or administering the prescription drug, including:</text> <level label="i"> <text>The name, address, telephone number, and if available, electronic mail address, of each owner and each wholesale distributor of the prescription drug;</text> </level> <level label="ii"> <text>The name and address of each location from which the prescription drug was shipped, if different from the owner’s;</text> </level> <level label="iii"> <text>Transaction dates; and</text> </level> <level label="iv"> <text>Certification that each recipient has authenticated the pedigree;</text> </level> </level> <level label="2"> <text>The name of the prescription drug;</text> </level> <level label="3"> <text>The dosage form and strength of the prescription drug;</text> </level> <level label="4"> <text>The size of the container;</text> </level> <level label="5"> <text>The number of containers;</text> </level> <level label="6"> <text>The lot number and National Drug Code of the prescription drug; and</text> </level> <level label="7"> <text>The name of the manufacturer of the finished dosage form.</text> </level> </level> <level label="f"> <text>Each pedigree for a prescription drug shall be:</text> <level label="1"> <text>Maintained by the purchaser and the wholesale distributor for 3 years from the date of sale or transfer; and</text> </level> <level label="2"> <text>Available for inspection or use within 5 business days on request of the Board, the Board’s designee, or an authorized law enforcement officer.</text> </level> </level> </section> <section article="gho" article_name="Health Occupations" number="12-6C-11" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6C" subtitle_name="Wholesale Distributor Permitting and Prescription Drug Integrity Act"> <level label="a"> <level label="1"> <text>If a person knowingly violates any provision of this subtitle or any regulation adopted under this subtitle, the Board may impose a fine not to exceed $500,000.</text> </level> <level label="2"> <text>Before the Board imposes a fine, the Board shall consider the appropriateness of the fine in relation to:</text> <level label="i"> <text>The size of the wholesale distributor;</text> </level> <level label="ii"> <text>The gravity of the violation for which the fine is to be imposed;</text> </level> <level label="iii"> <text>The good faith of the wholesale distributor; and</text> </level> <level label="iv"> <text>Any previous violations by the wholesale distributor.</text> </level> </level> </level> <level label="b"> <text>In addition to the penalty provided in subsection (a) of this section, the Board also may take disciplinary action against a permit holder who is convicted of or pleads guilty or nolo contendere to a violation of State, federal, or local drug laws.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-6C-12" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6C" subtitle_name="Wholesale Distributor Permitting and Prescription Drug Integrity Act"> <text>On or before January 1, 2008, the Board shall adopt regulations to implement this subtitle.</text> </section> <section article="gho" article_name="Health Occupations" number="12-6C-13" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6C" subtitle_name="Wholesale Distributor Permitting and Prescription Drug Integrity Act"> <text>On or before January 1, 2008, and on or before January 1 of each subsequent year, the Board shall report to the Governor and, in accordance with § 2–1257 of the State Government Article, to the General Assembly on the implementation of this subtitle.</text> </section> <section article="gho" article_name="Health Occupations" number="12-6D-01" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6D" subtitle_name="Registered Pharmacy Interns"> <text>In this subtitle, “ACPE” means the Accreditation Council for Pharmacy Education.</text> </section> <section article="gho" article_name="Health Occupations" number="12-6D-02" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6D" subtitle_name="Registered Pharmacy Interns"> <text>Except as otherwise provided in this title or §§ 10–14A–03 and 10–14B–03 of the State Government Article, an individual shall be registered and approved by the Board as a registered pharmacy intern before the individual may practice pharmacy under the direct supervision of a licensed pharmacist in accordance with this subtitle.</text> </section> <section article="gho" article_name="Health Occupations" number="12-6D-03" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6D" subtitle_name="Registered Pharmacy Interns"> <level label="a"> <text>To qualify for registration an applicant shall be an individual who:</text> <level label="1"> <text>Is currently enrolled and has completed 1 year of professional pharmacy education in a doctor of pharmacy program accredited by the ACPE;</text> </level> <level label="2"> <text>Is currently enrolled and has completed 1 year of professional pharmacy education in a doctor of pharmacy program under accreditation review by the ACPE;</text> </level> <level label="3"> <text>Has graduated from a doctor of pharmacy program accredited by the ACPE and has applied for licensure with the Board; or</text> </level> <level label="4"> <text>Is a graduate of a foreign school of pharmacy who:</text> <level label="i"> <text>Has established educational equivalency as determined by the Board; and</text> </level> <level label="ii"> <text>Has passed an examination of oral English approved by the Board.</text> </level> </level> </level> <level label="b"> <text>An applicant shall submit a request for a State and national criminal history records check in accordance with § 12–6D–04 of this subtitle.</text> </level> <level label="c"> <text>The Board may not approve an application until the State and national criminal history records check is completed.</text> </level> <level label="d"> <text>The applicant shall be of good moral character.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-6D-04" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6D" subtitle_name="Registered Pharmacy Interns"> <level label="a"> <text>In this section, “Central Repository” means the Criminal Justice Information System Central Repository of the Department of Public Safety and Correctional Services.</text> </level> <level label="b"> <text>As part of an application to the Central Repository for a State and national criminal history records check, the applicant shall submit to the Central Repository:</text> <level label="1"> <text>A complete set of legible fingerprints taken in a format approved by the Director of the Central Repository and the Director of the Federal Bureau of Investigation;</text> </level> <level label="2"> <text>The fee authorized under § 10–221(b)(7) of the Criminal Procedure Article for access to Maryland criminal history records; and</text> </level> <level label="3"> <text>The mandatory processing fee required by the Federal Bureau of Investigation for a national criminal history records check.</text> </level> </level> <level label="c"> <text>In accordance with §§ 10–201 through 10–229 of the Criminal Procedure Article, the Central Repository shall forward to the Board and the individual the individual’s criminal history record information.</text> </level> <level label="d"> <text>Information obtained from the Central Repository under this section:</text> <level label="1"> <text>Is confidential;</text> </level> <level label="2"> <text>May not be redisseminated; and</text> </level> <level label="3"> <text>May be used only for the registration purpose authorized by this subtitle.</text> </level> </level> <level label="e"> <text>The subject of a criminal history records check under this subsection may contest the contents of the printed statement issued by the Central Repository as provided in § 10–223 of the Criminal Procedure Article.</text> </level> <level label="f"> <text>If criminal history record information is reported to the Central Repository after the date of the initial criminal history records check, the Central Repository shall provide to the Board and the individual revised criminal history record information for the individual.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-6D-05" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6D" subtitle_name="Registered Pharmacy Interns"> <level label="a"> <text>An applicant for registration shall:</text> <level label="1"> <text>Submit an application to the Board on the form that the Board requires;</text> </level> <level label="2"> <text>Provide documentation of:</text> <level label="i"> <text>Enrollment in a doctor of pharmacy program;</text> </level> <level label="ii"> <text>Graduation from an approved college of pharmacy; or</text> </level> <level label="iii"> <text>For an applicant who satisfies the requirements under § 12–6D–03(a)(4) of this subtitle, proof of:</text> <level label="1"> <text>Educational equivalency; and</text> </level> <level label="2"> <text>Oral English competency;</text> </level> </level> </level> <level label="3"> <text>Submit to a request for a State criminal history records check; and</text> </level> <level label="4"> <text>Pay the application fees set by the Board.</text> </level> </level> <level label="b"> <text>The application shall be signed by the applicant.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-6D-06" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6D" subtitle_name="Registered Pharmacy Interns"> <level label="a"> <text>The Board shall register as a pharmacy intern any applicant who meets the requirements of this subtitle.</text> </level> <level label="b"> <level label="1"> <text>The Board may set reasonable fees for the issuance and renewal of registrations and other services.</text> </level> <level label="2"> <text>The fees charged shall be set so as to approximate the cost of registering pharmacy interns.</text> </level> </level> <level label="c"> <text>A licensed pharmacist may not directly supervise more than two registered pharmacy interns at one time.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-6D-07" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6D" subtitle_name="Registered Pharmacy Interns"> <level label="a"> <text>A registered pharmacy intern shall notify the Board of each plea of guilty for, conviction of, or entry of a plea of nolo contendere for a felony or a crime involving moral turpitude, regardless of whether:</text> <level label="1"> <text>An adjudication of guilt or sentencing or imposition of sentence is withheld; or</text> </level> <level label="2"> <text>Any appeal or other proceeding is pending regarding the matter.</text> </level> </level> <level label="b"> <text>The registered pharmacy intern shall notify the Board within 7 days of the conviction or entry of the plea.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-6D-08" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6D" subtitle_name="Registered Pharmacy Interns"> <level label="a"> <text>Registration authorizes a registered pharmacy intern to practice pharmacy under the direct supervision of a licensed pharmacist while the registration is effective.</text> </level> <level label="b"> <text>A registered pharmacy intern may administer vaccinations in accordance with regulations adopted by the Board.</text> </level> <level label="c"> <text>A registered pharmacy intern may not:</text> <level label="1"> <text>Delegate a pharmacy act;</text> </level> <level label="2"> <text>Perform a final verification of a prescription drug or device before dispensing; or</text> </level> <level label="3"> <text>Perform other duties prohibited by regulations adopted by the Board.</text> </level> </level> </section> <section article="gho" article_name="Health Occupations" number="12-6D-09" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6D" subtitle_name="Registered Pharmacy Interns"> <level label="a"> <level label="1"> <text>Registration expires on the date set by the Board.</text> </level> <level label="2"> <text>Registration is valid for up to 2 years from the date of issue.</text> </level> </level> <level label="b"> <level label="1"> <text>A registered pharmacy intern who qualified for registration under § 12–6D–03(a)(1) and (2) of this subtitle may renew the registration one time if the registered pharmacy intern:</text> <level label="i"> <text>Otherwise is entitled to be registered as a pharmacy intern;</text> </level> <level label="ii"> <text>Submits to the Board a renewal application on the form that the Board requires; and</text> </level> <level label="iii"> <text>Pays to the Board a renewal fee set by the Board.</text> </level> </level> <level label="2"> <text>A registered pharmacy intern who qualified for registration under § 12–6D–03(a)(3) and (4) of this subtitle may not renew the registration.</text> </level> </level> <level label="c"> <text>The registration of a pharmacy intern registered under this subtitle expires and may not be renewed on the date that the registered pharmacy intern becomes a licensed pharmacist.</text> </level> <level label="d"> <level label="1"> <text>Except as provided in paragraph (2) of this subsection, the Board shall send to each registered pharmacy intern, at least 1 month before a registration expires, a renewal notice by electronic means to the last known e–mail address of the registered pharmacy intern.</text> </level> <level label="2"> <text>If requested by a registered pharmacy intern, the Board shall send to the registered pharmacy intern a renewal notice by first–class mail to the last known address of the registered pharmacy intern.</text> </level> <level label="3"> <text>If a renewal notice sent by electronic means under paragraph (1) of this subsection is returned to the Board as undeliverable, the Board shall send the registered pharmacy intern a renewal notice by first–class mail to the last known address of the registered pharmacy intern.</text> </level> <level label="4"> <text>A renewal notice sent under this subsection shall state:</text> <level label="i"> <text>The date on which the current registration expires;</text> </level> <level label="ii"> <text>The date by which the renewal application shall be received by the Board for the renewal to be issued and mailed before the registration expires; and</text> </level> <level label="iii"> <text>The amount of the renewal fee.</text> </level> </level> </level> <level label="e"> <text>The Board shall renew the registration of each pharmacy intern who meets the requirements of this section.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-6D-10" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6D" subtitle_name="Registered Pharmacy Interns"> <level label="a"> <text>Each registered pharmacy intern shall:</text> <level label="1"> <text>Display the pharmacy intern’s registration in the office or place of business in which the pharmacy intern is practicing pharmacy under the direct supervision of a licensed pharmacist; or</text> </level> <level label="2"> <text>Have the registration on the pharmacy intern’s person available for viewing.</text> </level> </level> <level label="b"> <text>When practicing pharmacy under the direct supervision of a licensed pharmacist, the registered pharmacy intern shall wear identification that conspicuously identifies the registered pharmacy intern as a registered pharmacy intern.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-6D-11" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6D" subtitle_name="Registered Pharmacy Interns"> <text>Subject to the hearing provision of § 12–315 of this title, the Board may deny a pharmacy intern’s registration to any applicant, reprimand a registered pharmacy intern, place any pharmacy intern’s registration on probation, or suspend or revoke a pharmacy intern’s registration if the applicant or pharmacy intern registrant:</text> <level label="1"> <text>Performs an act that is restricted to a licensed pharmacist;</text> </level> <level label="2"> <text>Practices pharmacy without the direct supervision of a licensed pharmacist;</text> </level> <level label="3"> <text>Fraudulently or deceptively obtains or attempts to obtain a pharmacy intern’s registration for the applicant or assists or attempts to assist another in fraudulently or deceptively obtaining a pharmacy intern’s registration;</text> </level> <level label="4"> <text>Fraudulently uses a pharmacy intern’s registration;</text> </level> <level label="5"> <text>Knowingly aids an unauthorized individual to practice pharmacy or to represent that the individual is a licensed pharmacist or registered pharmacy intern;</text> </level> <level label="6"> <text>Practices pharmacy while:</text> <level label="i"> <text>Under the influence of alcohol; or</text> </level> <level label="ii"> <text>Using any narcotic or controlled dangerous substance, as defined in § 5–101 of the Criminal Law Article, or other drug that is in excess of therapeutic amounts or without valid medical indication;</text> </level> </level> <level label="7"> <text>Willfully makes or files a false report or record as part of the registered pharmacy intern’s duties or employment;</text> </level> <level label="8"> <text>Willfully fails to file or record any report that is required by law;</text> </level> <level label="9"> <text>Willfully impedes or obstructs the filing or recording of any report that is required by law;</text> </level> <level label="10"> <text>Willfully induces another to fail to file or record any report that is required by law;</text> </level> <level label="11"> <text>Provides or causes to be provided to any authorized prescriber prescription forms that bear the name, address, or other means of identification of a licensed pharmacist or pharmacy;</text> </level> <level label="12"> <text>Knowingly aids a licensed pharmacist in dispensing any drug, device, or diagnostic for which a prescription is required without a written, oral, or electronically transmitted prescription from an authorized prescriber;</text> </level> <level label="13"> <text>Unless an authorized prescriber authorizes the refill, refills a prescription for any drug, device, or diagnostic for which a prescription is required;</text> </level> <level label="14"> <text>Is physically or mentally incompetent;</text> </level> <level label="15"> <text>Pleaded guilty or nolo contendere to, or has been found guilty of, a felony or a crime involving moral turpitude, regardless of whether:</text> <level label="i"> <text>An adjudication of guilt or sentencing or imposition of sentence is withheld; or</text> </level> <level label="ii"> <text>Any appeal or other proceeding is pending regarding the matter;</text> </level> </level> <level label="16"> <text>Violates any provision of this title;</text> </level> <level label="17"> <text>Is disciplined by a licensing, registering, or disciplinary authority of any state or country or convicted or disciplined by a court of any state or country for an act that would be grounds for disciplinary action under the Board’s disciplinary statutes;</text> </level> <level label="18"> <text>Violates any regulation adopted by the Board;</text> </level> <level label="19"> <text>Refuses, withholds from, denies, or discriminates against an individual with regard to the provision of professional services for which the registered pharmacy intern is registered and qualified to render because the individual is HIV positive;</text> </level> <level label="20"> <text>Participates in any activity that is grounds for Board action under § 12–313, § 12–409, or §12–6B–09 of this title;</text> </level> <level label="21"> <text>Provides or causes to be provided confidential patient information to any person without first having obtained the patient’s consent, as required by § 12–403(b)(13) of this title and by Title 4, Subtitle 3 of the Health – General Article; or</text> </level> <level label="22"> <text>Fails to cooperate with a lawful investigation conducted by the Board or the Office of Controlled Substances Administration.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-6D-12" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6D" subtitle_name="Registered Pharmacy Interns"> <level label="a"> <text>If after a hearing under § 12–315 of this title, the Board finds that there is a ground under § 12–6D–11 of this subtitle to reprimand a registered pharmacy intern, place a pharmacy intern’s registration on probation, or suspend or revoke a pharmacy intern’s registration, the Board may impose a penalty not exceeding $2,500:</text> <level label="1"> <text>Instead of reprimanding the registered pharmacy intern, placing the registered pharmacy intern on probation, or suspending or revoking the pharmacy intern’s registration; or</text> </level> <level label="2"> <text>In addition to reprimanding the registered pharmacy intern, placing the registered pharmacy intern on probation, or suspending or revoking the pharmacy intern’s registration.</text> </level> </level> <level label="b"> <text>The Board shall adopt regulations to set standards for the imposition of penalties under this section.</text> </level> <level label="c"> <text>The Board shall pay any penalty collected under this section into the General Fund of the State.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-6D-13" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6D" subtitle_name="Registered Pharmacy Interns"> <level label="a"> <text>Unless the Board agrees to accept the surrender of a pharmacy intern’s registration, a registered pharmacy intern may not surrender the pharmacy intern’s registration nor may the pharmacy intern’s registration lapse by operation of law while the registered pharmacy intern is under investigation or while charges are pending against the registered pharmacy intern.</text> </level> <level label="b"> <text>The Board may set conditions on the Board’s agreement with the registered pharmacy intern under investigation or against whom charges are pending to accept the surrender of the pharmacy intern’s registration.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-6D-14" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6D" subtitle_name="Registered Pharmacy Interns"> <text>Except as otherwise provided in this title, an individual may not practice, attempt to practice, or offer to practice as a registered pharmacy intern in the State unless registered with the Board.</text> </section> <section article="gho" article_name="Health Occupations" number="12-6D-15" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6D" subtitle_name="Registered Pharmacy Interns"> <level label="a"> <text>Except as otherwise provided in this subtitle, an individual may not represent to the public by title, by description of services, methods, or procedures, or otherwise, that the individual is registered to practice as a registered pharmacy intern unless registered in accordance with this subtitle.</text> </level> <level label="b"> <text>Except as otherwise provided in this subtitle, an individual may not use the terms “registered pharmacy intern” or “pharmacy intern” with the intent to represent that the individual is authorized to practice as a registered pharmacy intern unless registered as a pharmacy intern under this subtitle.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-701" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="7" subtitle_name="Prohibited Acts; Penalties"> <text>Except as otherwise provided in this title, a person may not practice, attempt to practice, or offer to practice pharmacy in this State unless licensed by the Board.</text> </section> <section article="gho" article_name="Health Occupations" number="12-702" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="7" subtitle_name="Prohibited Acts; Penalties"> <level label="a"> <text>A person may not obtain a license by making any false representation.</text> </level> <level label="b"> <text>On conviction of a person for obtaining a license by false representation, the license held by that person is void.</text> </level> </section> <section article="gho" article_name="Health Occupations" number="12-703" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="7" subtitle_name="Prohibited Acts; Penalties"> <text>A person may not establish or operate a pharmacy in this State or a nonresident pharmacy unless the person holds a pharmacy permit issued by the Board.</text> </section> <section article="gho" article_name="Health Occupations" number="12-704" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="7" subtitle_name="Prohibited Acts; Penalties"> <level label="a"> <level label="1"> <text>Unless authorized to practice pharmacy under this title, a person may not represent to the public by title, by description of services, methods, or procedures, or otherwise, that the person is authorized to practice pharmacy in this State.</text> </level> <level label="2"> <text>Unless authorized to practice pharmacy under this title, a person may not use the terms “pharmacist” or “druggist” with the intent to represent that the person practices pharmacy.</text> </level> </level> <level label="b"> <level label="1"> <text>Unless an establishment has a pharmacy permit, a person may not represent to the public by title, by description of services, methods, or procedures, or otherwise, that the establishment is a pharmacy.</text> </level> <level label="2"> <text>The acts prohibited by this subsection include using, with the intent to misrepresent that an establishment is a pharmacy, the terms “pharmacy” or “drugstore”, the characteristic show bottles or globes filled with colored water, or any other term or symbol traditionally associated with practicing pharmacy.</text> </level> </level> </section> <section article="gho" article_name="Health Occupations" number="12-707" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="7" subtitle_name="Prohibited Acts; Penalties"> <level label="a"> <text>A person who violates any provision of the following subtitles or sections of this title is guilty of a misdemeanor and on conviction is subject to a fine not exceeding $1,000:</text> <level label="1"> <text>§ 12–311 (“Display of licenses”);</text> </level> <level label="2"> <text>Subtitle 4 (“Pharmacy permits”);</text> </level> <level label="3"> <text>§ 12–502(b) (“Pharmaceutical information”);</text> </level> <level label="4"> <text>§ 12–505 (“Labeling requirements for prescription medicines”); and</text> </level> <level label="5"> <text>§ 12–604 (“General power to inspect drugs, devices, and other products”).</text> </level> </level> <level label="b"> <text>A person who violates any provision of the following sections of this title is guilty of a misdemeanor and on conviction is subject to a fine not exceeding $1,000 or imprisonment not exceeding 1 year or both:</text> <level label="1"> <text>§ 12–701 (“Practicing pharmacy without license”);</text> </level> <level label="2"> <text>§ 12–702 (“License obtained by false representation”);</text> </level> <level label="3"> <text>§ 12–703 (“Operating a pharmacy without permit”);</text> </level> <level label="4"> <text>§ 12–704 (“Misrepresentations”);</text> </level> <level label="5"> <text>§ 12–6B–12 (“Working as an unregistered pharmacy technician”); and</text> </level> <level label="6"> <text>§ 12–6D–15 (“Practicing as an unregistered pharmacy intern”).</text> </level> </level> <level label="c"> <text>Each day that a violation of any section of Subtitle 4 of this title continues constitutes a separate offense.</text> </level> <level label="d"> <text>Within 10 days after a court renders the conviction, the court shall report to the Board each conviction of a pharmacist or registered pharmacy technician for:</text> <level label="1"> <text>Any crime regarding the pharmacy or drug laws that involves professional misconduct; or</text> </level> <level label="2"> <text>Any crime that involves the State law regarding controlled dangerous substances or the federal narcotic laws.</text> </level> </level> <level label="e"> <level label="1"> <text>Any person who violates § 12–701 (“Practicing pharmacy without a license”), § 12–703 (“Operating a pharmacy without a permit”), § 12–6B–12 (“Working as an unregistered pharmacy technician”), or § 12–6D–15 (“Practicing as an unregistered pharmacy intern”) of this title is subject to a civil fine of not more than $50,000 to be assessed by the Board.</text> </level> <level label="2"> <text>The Board shall pay any penalty collected under this subsection into the State Board of Pharmacy Fund.</text> </level> </level> </section> <section article="gho" article_name="Health Occupations" number="12-801" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="8" subtitle_name="Short Title; Termination of Title"> <text>This title may be cited as the “Maryland Pharmacy Act”.</text> </section> <section article="gho" article_name="Health Occupations" number="12-802" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="8" subtitle_name="Short Title; Termination of Title"> <text>Subject to the evaluation and reestablishment provisions of the Maryland Program Evaluation Act, this title and all rules and regulations adopted under this title shall terminate and be of no effect after July 1, 2030.</text> </section>