In this title the following words have the meanings indicated. “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. “Biological product” has the meaning stated in 42 U.S.C. § 262. “Board” means the State Board of Pharmacy. “Clinical research pharmacy” means a pharmacy that meets the requirements for a clinical research pharmacy permit under § 12–401.1(c) of this title. “Clinical research pharmacy permit” means a permit issued by the Board to establish and operate a clinical research pharmacy. “Compounded nonsterile preparations” means products compounded in accordance with USP 795. “Compounded sterile preparations” means biologics, diagnostics, drugs, nutrients, and radiopharmaceuticals that, under USP 797, must be compounded using aseptic techniques. “Compounding” means the preparation, mixing, assembling, packaging, or labeling of a drug or device: 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 For the purpose of, or incident to, research, teaching, or chemical analysis and not for the sale or dispensing of the drug or device. “Compounding” includes the preparation of drugs or devices in anticipation of a prescription drug order based on routine, regularly observed prescribing patterns. “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. “Delegated pharmacy act” does not include: An act within the parameters of a therapy management contract as provided under Subtitle 6A of this title; Except as provided in § 12–6B–06 of this title, the administration of a vaccination in accordance with § 12–508 of this title; The delegation of a pharmacy act by a registered pharmacy technician, pharmacy student, or pharmacy technician trainee; A pharmacy activity performed by a pharmacy student in accordance with § 12–301(b) of this title; A pharmacy activity performed by an applicant for a license to practice pharmacy in accordance with regulations adopted by the Board; A decision–making task that requires the professional judgment of a pharmacist; and The performance of other functions prohibited in regulations adopted by the Board. “Device” means a device used in the diagnosis, treatment, or prevention of disease. “Device” does not include any: Surgical or dental instrument; Physical therapy equipment; X–ray apparatus; or Component part or accessory of any of these items. “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. “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: Interpretation of an authorized prescriber’s prescription for a drug or device; Selection and labeling of the drug or device prescribed pursuant to that prescription; and Measuring and packaging of the prescribed drug or device in accordance with State and federal laws. “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. “Distribute” does not include the operations of a person who holds a permit issued under § 12–6C–03 of this title. “Drug” has the meaning stated in § 21–101 of the Health – General Article. “Injectable medication for treatment of a sexually transmitted infection” means a medication that: Is administered by injection other than intravenously; Treats a sexually transmitted infection; and Is not a vaccine. “Interchangeable biological product” means a biological product that is: 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 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”). “License” means, unless the context requires otherwise, a license issued to a pharmacist by the Board to practice pharmacy. “Licensed pharmacist” means, unless the context requires otherwise, a pharmacist who is licensed by the Board to practice pharmacy. “Maintenance injectable medication” means a medication that: Is administered by injection other than intravenously; and Treats a chronic need, condition, or disorder. “Maintenance injectable medication” includes a medication for the treatment of a psychiatric disorder or substance use disorder, contraception, and vitamins. “Nicotine replacement therapy medication” means a drug or product, regardless of whether it is available over the counter, that: Delivers nicotine to an individual; and Is approved by the federal Food and Drug Administration for the sole purpose of aiding in tobacco cessation or smoking cessation. “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. “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. “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. “Pharmacist” means an individual who practices pharmacy regardless of the location where the activities of practice are performed. “Pharmacy” means an establishment in which prescription or nonprescription drugs or devices are compounded, dispensed, or distributed. “Pharmacy permit” means a permit issued by the Board to establish and operate a pharmacy. “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. “Pharmacy technician trainee” means an individual engaged in a Board approved pharmacy technician training program. “Practice pharmacy” means to engage in any of the following activities: Providing pharmaceutical care; Compounding, dispensing, or distributing prescription drugs or devices; Compounding or dispensing nonprescription drugs or devices; Monitoring prescriptions for prescription and nonprescription drugs or devices; Providing information, explanation, or recommendations to patients and health care practitioners about the safe and effective use of prescription or nonprescription drugs or devices; Identifying and appraising problems concerning the use or monitoring of therapy with drugs or devices; Acting within the parameters of a therapy management contract, as provided under Subtitle 6A of this title; 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; Delegating a pharmacy act to a registered pharmacy technician, pharmacy student, or an individual engaged in a Board approved pharmacy technician training program; 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; Providing drug therapy management in accordance with § 19–713.6 of the Health – General Article; Prescribing and dispensing contraceptive medications and self–administered contraceptive devices approved by the U.S. Food and Drug Administration; Prescribing and dispensing nicotine replacement therapy medications; or 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. “Practice pharmacy” does not include the operations of a person who holds a permit issued under § 12–6C–03 of this title. “Registered pharmacy intern” means an individual who is registered with the Board to practice pharmacy under the direct supervision of a pharmacist. “Registered pharmacy technician” means an individual who is registered with the Board to perform delegated pharmacy acts. “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. “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. “Self–administered drug” includes: Eyedrops; and A drug that is administered by an intramuscular injection or a subcutaneous injection. “Supervision” means reviewing the work, guiding and directing the activities, and monitoring the performance of an individual. “USP–NF” means the United States Pharmacopeia and the National Formulary. “USP 795” means the standards set forth in the United States Pharmacopeia, General Chapter 795, “Pharmaceutical Compounding – Nonsterile Preparations”. “USP 797” means the standards set forth in the United States Pharmacopeia, General Chapter 797, “Pharmaceutical Compounding – Sterile Preparations”.

In this section the following terms have the meanings indicated. “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. “Nurse or midwife” means an individual licensed or certified by the Board of Nursing under Title 8 of this article. 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: Is physically present on the premises where the prescription is filled; and Performs a final check of the prescription before it is provided to the patient. 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. 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. This title does not prohibit: A licensed veterinarian from: Personally preparing and dispensing the veterinarian’s prescriptions; or Dispensing, in accordance with § 2–313(c) of the Agriculture Article, compounded nonsterile preparations or compounded sterile preparations provided by a pharmacy; A licensed dentist, physician, or podiatrist from personally preparing and dispensing the dentist’s, physician’s, or podiatrist’s prescriptions when: The dentist, physician, or podiatrist: Has applied to the board of licensure in this State which licensed the dentist, physician, or podiatrist; 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; 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 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; The person for whom the drugs or devices are prescribed is a patient of the prescribing dentist, physician, or podiatrist; The dentist, physician, or podiatrist does not have a substantial financial interest in a pharmacy; and The dentist, physician, or podiatrist: Complies with the dispensing and labeling requirements of this title; Records the dispensing of the prescription drug or device on the patient’s chart; 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; 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; 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; Does not direct patients to a single pharmacist or pharmacy in accordance with § 12–403(c)(8) of this title; Does not receive remuneration for referring patients to a pharmacist or pharmacy; Complies with the child resistant packaging requirements regarding prescription drugs under Title 22, Subtitle 3 of the Health – General Article; Complies with drug recalls; Maintains biennial inventories and complies with any other federal and State record–keeping requirements relating to controlled dangerous substances; 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; 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 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; 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: Otherwise complies with item (ii) of this paragraph; and Has obtained a special written permit under § 14–509 of this article; A licensed physician who complies with the requirements of item (ii) of this paragraph from personally preparing and dispensing a prescription written by: A physician assistant who complies with Title 15, Subtitle 3 of this article; or 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; A hospital–based clinic from dispensing prescriptions to its patients; 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 A health care provider licensed under this article from having an ownership interest in a clinical research pharmacy if: The operations of the clinical research pharmacy are limited to the requirements for a clinical research pharmacy permit in § 12–101 of this subtitle; A pharmacist licensed under this subtitle: Is present on–site during all hours of operation of the clinical research pharmacy; and Is responsible for all compounding, dispensing, and oversight of pharmacy services; and Any health care provider with a substantial ownership interest in the clinical research pharmacy does not: Direct patients to a single pharmacist or pharmacy in accordance with § 12–403(c)(8) of this title; or Receive remuneration for referring patients to a pharmacist or pharmacy. This title does not prohibit: A licensed veterinarian from personally dispensing a drug or device sample to a patient of the veterinarian; or 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: The sample complies with the labeling requirements of § 12–505 of this title; No charge is made for the sample; and The authorized prescriber enters an appropriate record in the patient’s chart. This title does not prohibit: A dentist, physician, nurse or midwife, or podiatrist from administering a prescription drug or device in the course of treating a patient; A licensed dental hygienist from administering medication under § 4–206.4 of this article; or A nurse anesthetist from administering medication under § 8–513 of this article. 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. 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: The starter dosage complies with the labeling requirements of § 12–505 of this title; No charge is made for the starter dosage; and The dentist, physician, nurse or midwife, or podiatrist enters an appropriate record on the patient’s chart. For the purposes of paragraph (1) of this subsection, “starter dosage” means an amount of drug or device sufficient to begin therapy: Of short duration of 72 hours or less; or Prior to obtaining a larger quantity of the drug or device to complete the therapy. 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: At a medical facility or clinic that is operated on a nonprofit basis; At a health center that operates on a campus of an institution of higher education; or At a public health facility, a medical facility under contract with a State or local health department, or a facility funded with public funds. 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: The product or rinse is dispensed to a patient of the licensed dentist; The licensed dentist enters an appropriate record in the patient’s chart that the product or rinse was dispensed to the patient; and The licensed dentist affixes a label on the product or rinse container that includes: The name of the patient; and Unless already printed on the container: The expiration date of the product or rinse; and The instructions for using the product or rinse. This title does not apply to a person who only dispenses: Prescription devices that do not contain a prescription drug; Prescription devices within which the only prescription drug is medical oxygen; Durable medical equipment, as defined by the Centers for Medicare and Medicaid Services; or Prosthetics, orthotics, and related supplies. This title does not prohibit a licensed dentist from dispensing a full course of antibiotics to a patient for infection control if: The patient is receiving pro bono dental care; There is no charge for the antibiotics; The licensed dentist enters an appropriate record of the treatment in the patient’s chart; and The licensed dentist affixes a label on the antibiotic container that includes: The name of the patient; and Unless already printed on the container: The expiration date of the antibiotic; and The instructions for taking the antibiotic. This title does not limit the right of a general merchant to sell: Any nonprescription drug or device; Any commonly used household or domestic remedy; or Any farm remedy or ingredient for a spraying solution, in bulk or otherwise. 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: The names and addresses of its licensees who are authorized to personally prepare and dispense prescription drugs; and 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. A dentist, physician, or podiatrist who fails to comply with the provisions of this section governing the dispensing of prescription drugs or devices shall: Have the dispensing permit revoked; and Be subject to disciplinary actions by the appropriate licensing board.

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. The Office of Controlled Substances Administration shall enter and inspect the office of a dentist, physician, or podiatrist who holds: An initial dispensing permit: Within 6 months after receiving the report required under § 12–102(l)(1) of this subtitle; and At least one more time during the duration of the permit; and A renewed dispensing permit at least two times during the duration of the permit. 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.

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. 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. 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.