# COMAR Title 10 — Maryland Department of Health

## Subtitle 13 — Drugs

### Chapter 01 — Dispensing of Prescription Drugs by a Licensee

**Authority:** Health Occupations Article, §§12-102 and 12-102.1, Annotated Code of Maryland

**Administrative History:** Effective date: September 19, 1935

**Administrative History:** Chapter, Permits for Sale of Poisons by General Merchants, repealed effective July 10, 1989  (16:13 Md. R. 1421)

**Administrative History:** Chapter, Dispensing of Prescription Drugs by a Licensee, adopted effective May 11, 1992 (19:9 Md. R. 879)

**Administrative History:** Regulation .03A amended effective March 6, 2000 (27:4 Md. R. 453)

**Administrative History:** Chapter revised effective June 22, 2015 (42:12 Md. R. 762)

**Administrative History:** Regulation .02B amended effective March 26, 2018 (45:6 Md. R. 320)

**Administrative History:** Regulation .03A amended effective March 26, 2018 (45:6 Md. R. 320)

**Administrative History:** Regulation .04D, N amended effective March 26, 2018 (45:6 Md. R. 320)

**Administrative History:** Regulation .04S adopted effective March 26, 2018 (45:6 Md. R. 320)

**Administrative History:** Regulation .05 amended effective March 26, 2018 (45:6 Md. R. 320)

#### Regulation .01 Scope.

*COMAR 10.13.01.01*

This chapter defines the parameters under which a licensee may dispense prescription drugs in accordance with Health Occupations Article, §12-102, Annotated Code of Maryland.

#### Regulation .02 Definitions.

*COMAR 10.13.01.02*

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

  (1) “Board” means the Board of Dental Examiners, the Board of Physicians, or the Board of Podiatric Medical Examiners.

  (2) Final Check.

    (a) “Final check” means the verification of the accuracy and completeness of a filled prescription order by the permit holder before the drug is dispensed to the patient.

    (b) “Final check” includes the assumption of responsibility for the filled prescription, including verifying the:

      (i) Appropriateness of the dose;

      (ii) Accurate expiration date;

      (iii) Accuracy of the drug dispensed;

      (iv) Strength of the drug dispensed;

      (v) Labeling that complies with Health Occupations Article, §12-505, Annotated Code of Maryland; and

      (vi) Appropriateness of the container in which the drug is dispensed, including child-proof containers where applicable.

  (3) “Licensee” means the dentist, physician, or podiatrist who is licensed by the appropriate Board to practice in Maryland.

  (4) “Personally preparing and dispensing” means the licensed dentist, physician, or podiatrist:

    (a) Is physically present on the premises where the prescription is filled; and

    (b) Performs a final check of the prescription before it is dispensed to the patient.

  (5) “Public interest” means the dispensing of prescription drugs by a licensee to a patient when a pharmacy is not conveniently available to the patient.

#### Regulation .03 Application for Dispensing Permit.

*COMAR 10.13.01.03*

A. The licensee shall complete an application on a form approved by the appropriate Board and pay a fee in accordance with the fee schedule for:

  (1) Physicians at COMAR 10.32.01.12;

  (2) Podiatrists at COMAR 10.40.03; or

  (3) Dentists at COMAR 10.44.20.

B. The application shall require the following information to indicate that the applicant is personally preparing and dispensing prescription drugs in the public interest:

  (1) The name, address, and license number of the applicant;

  (2) An attestation by the applicant that the applicant shall comply with the:

    (a) Dispensing requirements set forth in Regulation .04 of this chapter;

    (b) Inspection requirements set forth in Regulation .05 of this chapter; and

    (c) Statutes and regulations governing dispensing of prescription drugs set forth in Health Occupations Article, Title 12, Annotated Code of Maryland, COMAR 10.19.03, and COMAR 10.34; and

  (3) The address of each practice location where the applicant dispenses prescription drugs.

C. Each permit issued to a licensee expires 5 years after its date of issuance and is renewable upon timely submission of a renewal application in accordance with the requirements set forth in this regulation. The fee schedule set forth in §A of this regulation applies to all renewal applications.

D. Continuing Education Requirement.

  (1) A permit holder shall complete 10 continuing education credits over a 5-year period relating to the preparing and dispensing of prescription drugs as a condition of permit renewal.

  (2) The continuing education credit requirement shall be implemented in accordance with Ch. 267, §2, Acts of 2012.

E. A permit issued to a licensee shall be nontransferable.

#### Regulation .04 Dispensing Requirements.

*COMAR 10.13.01.04*

A. A licensee shall submit an application to the appropriate Board on the form that the Board requires.

B. A licensee may not dispense prescription drugs until a written permit is received from the appropriate Board, except that a written permit is not required in order to dispense starter dosages or samples provided without charge.

C. A licensee shall personally prepare and dispense prescription drugs.

D. Except as provided in Health Occupations Article, §12-102(c)(2)(iii), Annotated Code of Maryland, and §S of this regulation, a licensee shall dispense prescription drugs only to the patients of the licensee.

E. A licensee shall comply with the labeling requirements set forth in Health Occupations Article, §12-505, Annotated Code of Maryland.

F. A licensee shall comply with the child resistant packaging requirements set forth in Health-General Article, Title 22, Subtitle 3, Annotated Code of Maryland.

G. A licensee shall comply with drug recalls.

H. A licensee shall record the dispensing of the prescription drug on the patient's chart.

I. A licensee may not have a substantial financial interest in a pharmacy.

J. A licensee shall, except for starter dosages or samples provided without charge, provide the patient with a written prescription.

K. A licensee shall maintain for at least 5 years:

  (1) A separate file for Schedule II prescriptions; and

  (2) Another file for other prescriptions.

L. A licensee shall maintain biennial inventories of all stocks of controlled substances.

M. A licensee shall dispense prescription drugs to a patient only when the patient determines that a pharmacy is not conveniently available to the patient.

N. In each patient’s chart for each patient to whom prescription drugs are dispensed or in a format readily retrievable, a licensee shall maintain a single form which:

  (1) Indicates that a pharmacy is not conveniently available to the patient;

  (2) States that the determination that a pharmacy is not conveniently available was made solely by the patient; and

  (3) Is signed and dated by the patient before dispensing prescription drugs to the patient for the first time.

O. A licensee shall display prominently a sign which informs the patient that prescription drugs can be purchased from the permit holder if the patient determines that a pharmacy is not conveniently available to the patient.

P. A licensee may not make any agreement that denies a patient a free choice of pharmacist or pharmacy services.

Q. A licensee shall post 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.

R. A licensee shall maintain at all times the minimum professional and technical equipment and sanitary appliances that are necessary to prepare and dispense prescriptions properly.

S. To the extent permitted by COMAR 10.32.23, a licensed physician may personally prepare and dispense a prescription written by:

  (1) A physician assistant with whom the physician has a delegation agreement that:

    (a) Complies with Health Occupations Article, Title 15, Subtitle 3, Annotated Code of Maryland; and

    (b) Permits the physician assistant to prescribe the drug; and

  (2) A certified registered nurse practitioner who is:

    (a) Authorized to practice under Health Occupations Article, Title 8, Subtitle 3, Annotated Code of Maryland; and

    (b) Working with the physician in the same practice.

#### Regulation .05 Inspection Requirements.

*COMAR 10.13.01.05*

A. The Board of Dental Examiners, the Board of Physicians, and the Board of Podiatric Medical Examiners shall report annually to the Office of Controlled Substances Administration the names and addresses of its licensees who:

  (1) Are authorized to personally prepare and dispense prescription drugs; and

  (2) Have reported to the appropriate Board that they have personally prepared and dispensed prescription drugs within the previous year.

B. A licensee shall allow the Office of Controlled Substances Administration to enter and inspect the licensee’s practice locations at all reasonable hours.

C. The Office of Controlled Substances Administration shall:

  (1) Enter and inspect the practice locations of a licensee who holds an initial dispensing permit:

    (a) Within 6 months after receiving the annual report set forth in §A(1) of this regulation; and

    (b) At least one more time during the duration of the permit;

  (2) If a licensee who holds an initial dispensing permit has more than one practice location:

    (a) Enter and inspect a practice location of the licensee within 6 months after receiving the annual report set forth in §A(1) of this regulation; and

    (b) Enter and inspect a different practice location at least one time during the duration of the permit;

  (3) If a licensee who holds a dispensing permit is seeking renewal:

    (a) Enter and inspect a practice location of a licensee at least two times during the duration of the permit; and

    (b) If licensee has more than one practice location, enter and inspect two different practice locations during the duration of the permit;

  (4) If the Office of Controlled Substances Administration finds a deficiency at one practice location of a licensee with multiple practice locations, require the licensee to prepare, sign, and submit an affidavit attesting that all practice locations are in or will be in compliance as a result of the inspection;

  (5) Report to the Board of Pharmacy a wholesale distributor not licensed in Maryland; and

  (6) Report the results of the inspections required under §C(1) and (2) of this regulation to the respective board of licensure.

D. A licensee shall sign and date an inspection form provided by the Office of Controlled Substances Administration relating to the requirements set forth in Health Occupations Article, §12-102, Annotated Code of Maryland.

E. A licensee shall pay a fee in an amount that will produce funds to approximate, but not exceed, the documented costs to the Office of Controlled Substances Administration for inspections, as required by the appropriate Board.

F. The Office of Controlled Substances Administration:

  (1) May suspend inspections of any physician who reports pursuant to Health Occupations Article, §12-102(c)(2)(ii)4L, Annotated Code of Maryland, that the physician has not personally dispensed any prescription medications during the preceding year; and

  (2) To the extent otherwise required by this regulation, shall resume inspections if that physician later reports that the physician has resumed dispensing activities.

#### Regulation .06 Failure to Comply with Dispensing Requirements.

*COMAR 10.13.01.06*

A licensee who fails to comply with the requirements governing dispensing of prescription drugs shall have the dispensing permit revoked and be subject to disciplinary action by the appropriate licensing board.

### Chapter 02 — Purchase and Distribution of Prescription Drugs and Devices

**Authority:** Health-General Article, §21-234; Health Occupations Article, §§12-6C-01(u) and 12-6C-03.1; Annotated Code of Maryland

**Administrative History:** Effective date: August 22, 2011 (38:17 Md. R. 1012)

#### Regulation .01 Scope.

*COMAR 10.13.02.01*

This chapter applies to the purchasing and distribution of prescription drugs and devices by the Department for public health purposes.

#### Regulation .02 Definitions.

*COMAR 10.13.02.02*

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

  (1) “Adulterated” means a drug or device where:

    (a) Any part of the drug or device is filthy, putrid, or a decomposed substance; or

    (b) The drug or device was produced, prepared, packed, or held under unsanitary conditions that reasonably would be expected to have:

      (i) Contaminated the drug or device with filth; or

      (ii) Caused the drug or device to be injurious to health.

  (2) “Board” means the State Board of Pharmacy.

  (3) “Department” means the Maryland Department of Health.

  (4) “Misbranded” means a drug or device where:

    (a) The drug’s or device’s:

      (i) Labeling is false or misleading in any way; or

      (ii) Labeling or packaging does not conform with Health-General Article, §21-248, Annotated Code of Maryland;

    (b) The drug or device is in package form and does not bear a label that contains the name and place of business of the manufacturer, packer, or distributor;

    (c) Any word, statement, or other information required under Health-General Article, Title 21, Subtitle 2, Annotated Code of Maryland, to appear on the drug’s or device’s labeling is not placed prominently on the labeling in a manner that is:

      (i) Conspicuous as compared with other words, statements, designs, or symbols on the labeling; and

      (ii) In terms likely to be read and understood by the ordinary individual under customary conditions of purchase and use;

    (d) The drug’s or device’s labeling does not include, in whatever manner and form that may be necessary to protect the user of the drug or device, adequate directions for the use of the drug or device;

    (e) The drug’s or device’s labeling does not include, in whatever manner and form that may be necessary to protect the user of the drug or device, adequate warnings against:

      (i) The use of the drug or device by anyone suffering from a pathological condition that may cause the drug’s or device’s use to be dangerous to health;

      (ii) The use of the drug or device by a child if the use by a child may be dangerous; and

      (iii) Unsafe dosages, methods of administration, or duration of administration of the drug or device;

    (f) The drug or device is dangerous to health when used in the dosage, with the frequency, or for the duration specified, recommended, or suggested in the labeling of the drug or device; or

    (g) The trademark, trade name, imprint, symbol, or other identifying mark of another drug or any likeness of any of these markings of another drug or device is placed on the drug or device or its container with the intent to defraud.

  (5) “Pedigree” means a record of the tracking of a drug or device through the supply chain, with each trading partner authenticating the drug or device upon receipt and transfer.

  (6) “Prescription device” means a device required by federal law or regulation to be dispensed only by a prescription.

  (7) Prescription Drug.

    (a) “Prescription drug” means a drug required by federal law or regulation to be dispensed only by a prescription.

    (b) “Prescription drug” includes:

      (i) A biological product; and

      (ii) Finished dosage forms and bulk drug substances subject to §503(b) of the Federal Food, Drug, and Cosmetic Act.

    (c) “Prescription drug” does not include:

      (i) Blood and blood components intended for transfusion; or

      (ii) Biological products that are also medical devices.

  (8) “Public health purposes” includes the purpose of controlling communicable diseases or environmental health hazards.

  (9) “Secretary” means the Secretary of Health.

#### Regulation .03 Personnel.

*COMAR 10.13.02.03*

A. The Secretary shall designate one or more Department employee representatives to be responsible for the purchase and distribution of prescription drugs and devices for public health purposes.

B. A designated Department representative shall:

  (1) Be a merit or contractual employee of the Department employed full time in a managerial level position;

  (2) Be aware of and knowledgeable about the policies and procedures pertaining to the purchase and distribution of prescription drugs and devices for public health purposes, including applicable State and federal laws;

  (3) Be actively involved in, and aware of, the daily operation of the Department’s purchasing and distribution of prescription drugs and prescription devices;

  (4) Be responsible for:

    (a) Storage and handling as set forth in Regulation .04 of this chapter;

    (b) Record-keeping requirements as set forth in Regulation .06 of this chapter; and

    (c) Making records available for inspection; and

  (5) Meet the following qualifications:

    (a) Is 21 years old or older;

    (b) Except for an authorized absence such as sick leave or vacation leave, is physically present at the Department during regular business hours;

    (c) 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

    (d) Does not have any convictions for a felony under federal, State, or local laws.

#### Regulation .04 Storage and Handling.

*COMAR 10.13.02.04*

A. Storage Facility. A designated Department representative shall store, hold, or handle prescription drugs and devices in a facility that:

  (1) Is constructed to facilitate:

    (a) Cleaning; and

    (b) Maintenance;

  (2) Has storage areas designed to provide adequate:

    (a) Equipment;

    (b) Humidity control;

    (c) Lighting;

    (d) Sanitation;

    (e) Security conditions;

    (f) Space;

    (g) Temperature; and

    (h) Ventilation;

  (3) Has a secured separate quarantine area for storage of prescription drugs or devices that are:

    (a) Adulterated;

    (b) Damaged;

    (c) Deteriorated;

    (d) In immediate or sealed secondary containers that have been opened;

    (e) Misbranded; or

    (f) Outdated;

  (4) Is maintained in a clean and orderly condition; and

  (5) Is free from insects, rodents, birds, or vermin.

B. Storage.

  (1) A designated Department representative shall store a prescription drug or device at appropriate temperatures and under appropriate conditions in accordance with requirements:

    (a) If any, on the labeling of the prescription drug or device; or

    (b) Set forth in the current edition of an official compendium, such as the United States Pharmacopeia/National Formulary (USP/NF).

  (2) If no storage requirements are established for a prescription drug or device, a designated Department representative shall hold the prescription drug or device at a controlled room temperature, as defined in an official compendium as set forth in §B(1)(b) of this regulation to help assure that its identity, strength, quality, and purity are not adversely affected.

  (3) A designated Department representative shall document proper storage of prescription drugs and devices in accordance with the:

    (a) Use of manual, electromechanical, or electronic temperature and humidity recording equipment, devices, and logs; and

    (b) Record-keeping requirements in Regulation .06 of this chapter for stored prescription drugs and devices.

C. Examination of Materials.

  (1) Upon receipt of a prescription drug or device, a designated Department representative shall visually examine each outside shipping container to prevent the acceptance of:

    (a) An adulterated prescription drug or device; or

    (b) A prescription drug or device that is otherwise unfit for distribution.

  (2) A designated Department representative shall examine each prescription drug or device container, as required under §C(1) of this regulation, to ascertain whether there is any damage to the container that would suggest possible contamination or other damage to the contents.

  (3) A designated Department representative shall carefully inspect each outgoing shipment:

    (a) For identity of the prescription drug or device being shipped; and

    (b) To ensure that there is no delivery of a prescription drug or device that has been damaged in storage or held under improper conditions.

  (4) Each unit of the Department, such as a local health department, that receives delivery of the prescription drug or device shall meet the requirements of this regulation for storage, security, and record keeping.

  (5) A designated Department representative shall follow the record-keeping requirements in Regulation .06 of this chapter for an incoming and an outgoing prescription drug or device.

D. Security of the Storage Area. A designated Department representative shall ensure that the area where prescription drugs and devices are stored is secure from unauthorized entry as follows:

  (1) Access from outside the premises is:

    (a) Kept to a minimum; and

    (b) Limited to authorized personnel as determined by the designated Department representative; and

  (2) The storage area is equipped with:

    (a) A security system that provides protection against theft and diversion;

    (b) An inventory management and control system that protects against, detects, and documents any instances of theft, diversion, or counterfeiting; and

    (c) A security system that protects the integrity and confidentiality of data and documents.

E. Authorized Access of Storage Area. A designated Department representative shall ensure that the area where prescription drugs and devices are stored:

  (1) Has a means in place to make the data and documentation required under this chapter readily available to the Board, an agent of the Board, or federal or State law enforcement officials; and

  (2) Allows for inspection by a Board representative.

#### Regulation .05 Quarantine, Destruction, and Return of Prescription Drugs and Devices.

*COMAR 10.13.02.05*

A. A designated Department representative shall quarantine and physically separate prescription drugs and devices that are outdated, damaged, deteriorated, misbranded, or adulterated from other prescription drugs and devices until the quarantined and separated prescription drugs and devices are destroyed or returned to their supplier for disposal.

B. A designated Department representative shall identify, mark, quarantine, and physically separate from other prescription drugs and devices those prescription drugs and devices whose immediate or sealed outer or sealed secondary containers have been opened or used, until the prescription drugs and devices are either destroyed or returned to their supplier for disposal.

C. Prescription Drugs.

  (1) If the conditions under which a prescription drug has been returned by a local health department or a health care provider cast doubt on the prescription drug's safety, identity, strength, quality, or purity, then a designated Department representative shall destroy the prescription drug or return the prescription drug to the supplier, unless examination, testing, or other investigation proves that the prescription drug meets appropriate standards of safety, identity, strength, quality, and purity.

  (2) In determining whether the conditions under which a prescription drug has been returned by a local health department or a health care provider cast doubt on the prescription drug's safety, identity, strength, quality, or purity, a designated Department representative shall consider, at a minimum, the:

    (a) Conditions under which the prescription drug has been held, stored, or shipped before or during the return of the prescription drug; and

    (b) Condition of the prescription drug and its container, carton, or labeling, as a result of storage or shipping.

D. Prescription Devices.

  (1) If the conditions under which a prescription device has been returned cast doubt on the prescription device's safety, identity, or quality, then a designated Department representative shall destroy or return the prescription device to the supplier, unless examination, testing, or other investigation proves that the prescription device meets appropriate standards of safety, identity, strength, and quality.

  (2) In determining whether the conditions under which a prescription device has been returned by a local health department or a health care provider cast doubt on the prescription device's safety, identity, or quality, a designated Department representative shall consider, at a minimum, the:

    (a) Conditions under which the prescription device has been held, stored, or shipped before or during return of the prescription device; and

    (b) Condition of the prescription device and the device’s container, carton, or labeling, as a result of storage or shipping.

E. A designated Department representative shall follow the record-keeping requirements in Regulation .06 of this chapter for outdated, damaged, deteriorated, misbranded, or adulterated prescription drugs and devices.

#### Regulation .06 Record Keeping.

*COMAR 10.13.02.06*

A designated Department representative shall:

A. Establish and maintain inventories and records of transactions regarding the receipt and distribution or other disposition of prescription drugs and devices;

B. Include the following information in the records required under §A of this regulation:

  (1) The source of a prescription drug or device, including the:

    (a) Name and principal address of the seller or transferor; and

    (b) Address of the location from which a prescription drug or device was shipped;

  (2) The identity and quantity of the prescription drugs and devices received and distributed or disposed of;

  (3) The dates of receipt and distribution or other disposition of the prescription drugs and devices; and

  (4) If required by Health Occupations Article, §12-6C-10, Annotated Code of Maryland, the pedigrees for prescription drugs that are wholesale distributed outside the normal distribution channel;

C. Establish, maintain, and adhere to written policies and procedures addressing the:

  (1) Receipt, security, storage, inventory, and distribution of prescription drugs and devices;

  (2) Identifying, recording, and reporting of losses or thefts; and

  (3) Correcting of errors and inaccuracies in inventories;

D. Include in the written policies and procedures established according to §C of this regulation the following:

  (1) A procedure by which the oldest approved and unexpired stock of a prescription drug or device is distributed first;

  (2) Procedures to be followed for handling a recall and withdrawal of a prescription drug or device due to:

    (a) An action initiated at the request of the United States Food and Drug Administration (FDA) or other federal, State, or local law enforcement or other government agency, including the Maryland Division of Drug Control;

    (b) A voluntary action by the manufacturer to remove a defective or potentially defective prescription drug or device from the market; and

    (c) An action undertaken to promote public health and safety by replacing existing merchandise with an improved product or new package design;

  (3) A procedure to ensure that the Department is prepared for, protected against, and able to handle a crisis that affects security or operation of a facility if any of the following situations occur:

    (a) Strike;

    (b) Fire;

    (c) Flood;

    (d) Catastrophic health emergency as defined in Public Safety Article, §14-3A-01, Annotated Code of Maryland;

    (e) Terrorist activities;

    (f) Natural disaster; or

    (g) Other situations of local, State, or national emergency;

  (4) A procedure to ensure that outdated prescription drugs and devices are segregated from other prescription drugs and devices and either returned to the manufacturer or destroyed;

  (5) A procedure for:

    (a) The disposing and destruction of containers, labels, and packaging to ensure that the containers, labels, and packaging cannot be used in counterfeiting activities; and

    (b) Appropriate witnessing of the destruction of any labels, packaging, immediate containers, or containers in accordance with applicable federal and State requirements; and

  (6) A procedure for:

    (a) Identifying, investigating, and reporting prescription drug inventory discrepancies involving counterfeiting, suspicion of counterfeiting, contraband, or suspicion of contraband; and

    (b) Upon discovery, the reporting of a discrepancy within 5 business days to the Board;

E. Make available inventories and records for inspection and copying by authorized federal or State law enforcement agency officials for a period of 3 years after the date of creation of the inventories and records;

F. Keep the records described in this regulation readily available for inspection by authorized federal, State, or local law enforcement agency officials during the retention period, either:

  (1) At the inspection site; or

  (2) So as to be immediately retrievable by computer or other electronic means;

G. Within 5 working days of a request by an authorized official of a federal, State, or local law enforcement agency, make available for inspection records kept at a central location apart from the inspection site and not electronically retrievable;

H. Establish and maintain procedures for reporting counterfeit and contraband or suspected counterfeit and contraband drugs or devices or counterfeiting and contraband or suspected counterfeiting and contraband activities to the Board and the FDA;

I. Maintain a system for the mandatory reporting of significant inventory losses of prescription drugs and devices where it is known or suspected that diversion is occurring to:

  (1) The Board;

  (2) The FDA; and

  (3) Where applicable, the U.S. Drug Enforcement Administration; and

J. Consider the following factors when determining if there has been a significant inventory loss:

  (1) The schedule of the missing items;

  (2) The abuse or misuse potential of the missing items;

  (3) The abuse or misuse potential in the Department’s area of the missing substance;

  (4) The quantity missing in relation to the total quantity purchased, for example, one tablet per

  (5) Whether this is the first time a potentially significant inventory loss has occurred;

  (6) Whether this loss was reported to local law enforcement authorities; and

  (7) Whether there is a significant resale value of the missing items.

### Chapter 03 — Guidelines for Co-Prescribing Opioid Overdose Reversal Drugs

**Authority:** Health-General Article, §§2-104(b), 13-3501, and 13-3502, Annotated Code of Maryland

**Administrative History:** Effective date: June 17, 2019 (46:12 Md. R. 544)

#### Regulation .01 Scope.

*COMAR 10.13.03.01*

This chapter applies to all licensed health care practitioners who may prescribe an opioid overdose reversal drug to an individual who:

A. May be at an elevated risk of experiencing an opioid overdose including, but not limited to, an individual who:

  (1) Is receiving an opioid for chronic pain;

  (2) Is receiving an opioid and a prescription for a benzodiazepine; or

  (3) Has an opioid use disorder; or

B. Resides or spends time with an individual who:

  (1) Is prescribed opioids;

  (2) Misuses opioids; or

  (3) Has an opioid use disorder.

#### Regulation .02 Definitions.

*COMAR 10.13.03.02*

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

  (1) “Co–prescribed” means, with respect to an opioid overdose reversal drug, the practice of prescribing the drug in conjunction with an opioid prescription for a patient at an elevated risk of overdose.

  (2) “Department” means the Maryland Department of Health.

  (3) “Monitored prescription drug” means a prescription drug that contains a Schedule II, Schedule III, Schedule IV, or Schedule V controlled dangerous substance designated under Criminal Law Article, Title 5, Subtitle 4, Annotated Code of Maryland.

  (4) “Opioid overdose reversal drug” means a drug that:

    (a) Rapidly reverses the respiratory depressant effects of an opioid medication; and

    (b) Is approved by the federal Food and Drug Administration for the treatment of a known or suspected opioid overdose.

  (5) “Prescribing licensed health care provider” means an individual who is authorized by law to prescribe a monitored prescription drug.

  (6) “Risk factor” means a characteristic, condition, behavior, or any variable that increases the likelihood of developing a disease or injury.

  (7) “Secretary” means the Secretary of the Maryland Department of Health.

  (8) Targeted Patient Population.

    (a) “Targeted patient population” means an individual likely to experience or witness an opioid overdose.

    (b) “Targeted patient population” includes, but is not limited to, an individual who:

      (i) Is being prescribed opioids for acute, if appropriate, or chronic pain;

      (ii) Is being treated for an opioid use disorder;

      (iii) Is receiving a prescription for an opioid and a benzodiazepine; or

      (iv) Resides or spends time with an individual who is prescribed opioids, misuses opioids, or has an opioid use disorder.

#### Regulation .03 General Provisions.

*COMAR 10.13.03.03*

A. When determined appropriate by the prescribing licensed health care provider, targeted patient populations may be co-prescribed an opioid overdose reversal drug, if the individual is at an elevated risk of experiencing an opioid overdose by virtue of belonging to one or more categories of the targeted patient population.

B. Responsibilities of the Prescribing Licensed Health Care Provider.

  (1) Risk Monitoring.

    (a) It is suggested that the licensed health care provider routinely assess patients for their risk of being likely to experience or witness an opioid overdose.

    (b) The prescriber may utilize additional sources of information for determining a patient’s opioid overdose risk including, but not limited to:

      (i) Checking the Maryland Prescription Drug Monitoring Program;

      (ii) Reviewing medical records; and

      (iii) Soliciting family input, if appropriate.

  (2) Education. If a patient is assessed to be at risk of an opioid overdose, the prescriber may educate the patient about, including but not limited to, the following areas:

    (a) The risks of an opioid overdose; and

    (b) How to identify and respond to an opioid overdose.

  (3) Documentation. Licensed health care providers should document education and clinical services related to the provision of an opioid overdose reversal drug in their patients’ medical records in accordance with the standard of care.

#### Regulation .04 Additional Guidelines.

*COMAR 10.13.03.04*

The Secretary may make the following additional clinical guidance available on the Department’s website:

A. Any available opioid overdose reversal drug formulations, corresponding prescribing templates, and any standing order for these drugs; and

B. Any other applicable information deemed necessary by the Secretary.

### Chapter 04 — Emergency Use Epinephrine Program

**Authority:** Health-General Article, §§2-104 and 13-7A-03, Annotated Code of Maryland

**Administrative History:** Effective date: May 20, 2019 (46:10 Md. R. 487)

**Administrative History:** Regulation .01 amended effective July 12, 2021 (48:14 Md. R. 538)

**Administrative History:** Regulation .02B amended effective July 12, 2021 (48:14 Md. R. 538); February 16, 2026 (53:3 Md. R. 122)

**Administrative History:** Regulation .03 amended effective July 12, 2021 (48:14 Md. R. 538); February 16, 2026 (53:3 Md. R. 122)

#### Regulation .01 Scope.

*COMAR 10.13.04.01*

This chapter applies to employees of food service, recreation, or wellness facilities on the premises of an institution of higher education as defined in Education Article, §10-101, Annotated Code of Maryland, and employees of food service facilities, as defined in COMAR 10.15.03, who voluntarily participate in the Program.

#### Regulation .02 Definitions.

*COMAR 10.13.04.02*

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

  (1) “Affiliated individual” means an individual who is 18 years old or older who has been designated in writing by a participating facility to serve either as a health supervisor or as a certificate holder.

  (2) “Agent” means an individual who:

    (a) Is 18 years old or older;

    (b) Has successfully completed, at the expense of the participating facility, an emergency epinephrine educational training program approved by the Department; and

    (c) Is designated in writing by a certificate holder to administer emergency use epinephrine in an emergency situation.

  (3) “Anaphylaxis” means a sudden, severe, and potentially life-threatening allergic reaction that occurs when an individual is exposed to an allergen.

  (4) “Applicant” means an individual applying for a Certificate for Emergency Epinephrine.

  (5) “Certificate for emergency epinephrine” means a certificate issued by the Maryland Department of Health to an individual employed or designated by a participating facility to obtain, store, and administer emergency use epinephrine.

  (6) “Certificate holder” means an individual who is authorized by the Maryland Department of Health to obtain, store, and administer emergency use epinephrine to be used in an emergency situation.

  (7) “Department” means the Maryland Department of Health.

  (8) “Eligible institution” means an institution of higher education that has a food service facility or a recreation and wellness facility on the premises and that otherwise meets the requirements of this chapter.

  (9) “Emergency use epinephrine” means a portable, disposable drug delivery device or product approved by the federal Food and Drug Administration that contains a premeasured single dose of epinephrine that is used to treat anaphylaxis in an emergency situation.

  (10) “Food service facility” has the meaning stated in COMAR 10.15.03.

  (11) “Health supervisor” means an individual who:

    (a) Provides health services for a participating facility; and

    (b) Is licensed by the State as a:

      (i) Physician;

      (ii) Certified nurse practitioner; or

      (iii) Registered nurse.

  (12) “Participating facility” means a recreation or wellness facility at an eligible institution or a food service facility, including a food service facility at an eligible institution, in the State that voluntarily participates in the Program.

  (13) “Successfully completed” means to pass a written examination with a grade of 75 percent or higher.

#### Regulation .03 Emergency Epinephrine.

*COMAR 10.13.04.03*

A. An individual may apply, on a form prescribed by the Department, for a certificate for emergency epinephrine, which shall be valid for up to 1 year if the applicant:

  (1) Is employed by a participating facility;

  (2) Is 18 years old or older; and

  (3) Has successfully completed, at the expense of the participating facility, an emergency epinephrine educational training program approved by the Department.

B. The applicant shall submit to the Department with the form required in §A of this regulation a written policy that includes:

  (1) Designation of agents and affiliated individuals;

  (2) The name of the approved emergency epinephrine educational training program; and

  (3) Procedures to:

    (a) Store emergency use epinephrine;

    (b) Maintain the emergency use epinephrine in a secure manner;

    (c) Report use of emergency use epinephrine according to §L of this regulation;

    (d) Train an emergency epinephrine certificate holder and agent annually; and

    (e) Maintain documentation of an emergency epinephrine certificate holder and agent training for 3 years.

C. A provider of an emergency epinephrine educational training program shall meet the requirements of COMAR 10.16.07.15C and D.

D. An individual teaching an emergency epinephrine educational training program shall be licensed as a physician, a registered nurse, or a certified nurse practitioner.

E. The Department shall:

  (1) Issue a certificate for emergency epinephrine to an applicant who meets the requirements in §§A and B of this regulation;

  (2) Deny the issuance of a certificate for emergency epinephrine to an applicant who does not meet the requirements in §§A and B of this regulation;

  (3) Revoke or suspend the certificate for emergency epinephrine of an individual who does not meet the requirements in §§A and B of this regulation;

  (4) Approve an emergency epinephrine educational training program if the training program meets the requirements of §C of this regulation;

  (5) Disapprove an emergency epinephrine educational training program if the training program does not meet the requirement of §C of this regulation; and

  (6) On or before January 31 of each year, publish a report summarizing the information obtained from the reported uses of emergency use epinephrine at participating facilities according to §L of this regulation.

F. A physician licensed to practice medicine in the State may prescribe emergency use epinephrine in the name of a certificate holder.

G. A pharmacist licensed to practice pharmacy in the State, or a physician, may dispense emergency use epinephrine under a prescription issued to a certificate holder.

H. A certificate holder may:

  (1) On presentment of a certificate for emergency epinephrine, receive from any physician licensed to practice medicine in the State a prescription for emergency use epinephrine; and

  (2) Possess and store prescribed emergency use epinephrine.

I. A participating facility:

  (1) Shall ensure that there is a written plan for the emergency epinephrine program that:

    (a) Is approved annually, in writing, by a health supervisor;

    (b) Is on file at the participating facility and is available for inspection; and

    (c) Includes at a minimum:

      (i) The name, title, and license number of the health supervisor;

      (ii) Information on the emergency epinephrine educational training program used;

      (iii) Procedures for disseminating information to staff on the emergency epinephrine program;

      (iv) Procedures for the proper storage and handling of medication;

      (v) Procedures for the use of emergency services and 911 services; and

      (vi) Procedures for documenting incidents involving the administration of emergency use epinephrine by a certificate holder in accordance with §L of this regulation;

  (2) Shall ensure that a certificate holder who is employed by, or a designated affiliated individual of, the participating facility complies with all provisions of this chapter;

  (3) Shall provide the Department with access to records and documents required under this chapter;

  (4) Shall designate in writing the certificate holders who will be responsible for the storage, maintenance, and control of the supply of emergency use epinephrine;

  (5) May not obtain or store emergency use epinephrine unless the participating facility has at least two certificate holders; and

  (6) Shall maintain a copy of the certificate issued to a certificate holder under §E of this regulation for at least 3 years.

J. Certificate Holders.

  (1) Subject to §I(4) of this regulation, a certificate holder may obtain:

    (a) A prescription for a supply of emergency use epinephrine from a licensed physician as provided in §F of this regulation; and

    (b) A supply of emergency use epinephrine from a licensed pharmacist or a licensed physician as provided in §G of this regulation.

  (2) A certificate holder shall store a supply of emergency use epinephrine obtained under §J(1) of this regulation:

    (a) In accordance with the manufacturer’s instructions; and

    (b) In a location that is readily accessible to certificate holders and agents in an emergency situation.

K. In an emergency situation when physician or emergency medical services are not immediately available, a certificate holder or agent may administer emergency use epinephrine to an individual who is experiencing or believed in good faith by the certificate holder or agent to be experiencing anaphylaxis.

L. A participating facility shall ensure that an incident that occurred on the premises of the facility that involved the administration of emergency use epinephrine by a certificate holder or agent is reported:

  (1) Immediately to the health supervisor and, in the case of a minor, to the minor’s parent or guardian; and

  (2) To the Department within 5 business days of the incident on a form prescribed by the Department.

### Chapter 05 — AIDS Education Program for Persons Convicted of Drug/Sex-Related Crimes

*Repealed*

**Administrative History:** Effective date: June 17, 1955

**Administrative History:** Chapter “Purchase of Exempt Narcotic Preparations” repealed effective August 25, 1978 (5:17 Md. R. 1329)

**Administrative History:** Regulations .01—.06 “AIDS Education Program for Persons Convicted of Drug/Sex-Related Crimes” adopted effective October 12, 1992 (19:20 Md. R. 1815)

**Administrative History:** Regulation .02B amended effective January 12, 2001 (28:1 Md. R. 26)

**Administrative History:** Chapter repealed effective March 26, 2018 (45:6 Md. R. 320)

### Chapter 06 — Acceptance of Oral Prescriptions for Certain Narcotic Drugs

*Repealed*

**Administrative History:** Effective date: November 10, 1955

**Administrative History:** Chapter repealed effective August 25, 1978 (5:17 Md. R. 1330)

### Chapter 07 — Sale of Dihydrocodeinone or any of its Salts

*Repealed*

**Administrative History:** Effective date: April 1, 1960

**Administrative History:** Chapter repealed effective August 25, 1978 (5:17 Md. R. 1330)

### Chapter 08 — Sale of Needles and Syringes or Other Paraphernalia

**Authority:** Health-General Article, §2-104(b), Annotated Code of Maryland

**Administrative History:** Effective date: December 21, 1970

**Administrative History:** Regulation .01 amended effective March 6, 2000 (27:4 Md. R. 454)

#### Regulation .01 Identification of Purchaser, and Record of Sale.

*COMAR 10.13.08.01*

The sale of needles and syringes or other paraphernalia shall be made by the pharmacist only in good faith to patients showing proper identification and indication of need.

### Chapter 09 — Sale of Nitrous Oxide

*Repealed*

**Administrative History:** Effective date: September 21, 1971

**Administrative History:** Regulations .01—.03 repealed effective January 21, 1991 (18:1 Md. R. 29)

### Chapter 10 — Prescribing, Administering, and Dispensing of Amphetamines and Methamphetamines

*Repealed*

**Administrative History:** Effective date: August 7, 1973

**Administrative History:** Chapter revised effective July 13, 1979 (6:14 Md. R. 1207)

**Administrative History:** Chapter revised effective January 21, 1991 (18:1 Md. R. 29)

**Administrative History:** Chapter repealed effective December 18, 1995 (22:25 Md. R. 1962)

### Chapter 11 — Sale of Drugs by Vending Machine

**Authority:** Health-General Article, §21-1111(c), Annotated Code of Maryland

**Administrative History:** Effective date: October 10, 1994 (21:20 Md. R. 1732)

#### Regulation .01 Exemption to Allow Sale of Drugs in Vending Machine.

*COMAR 10.13.11.01*

A. A person may sell by vending machine or other similar device, nonprescription drugs that alleviate pain in the quantities and form specified in §B of this regulation, and which are exempted from the prohibition of Health-General Article, §21-1111, Annotated Code of Maryland.

B. Nonprescription drugs that alleviate pain may be sold by vending machine or other similar devices in:

  (1) Solid oral dosage form only; and

  (2) Single dose quantities of not more than three tablets or capsules per dose.

### Chapter 12 — Impoundment and Disposal of Drugs and Prescription Records

**Authority:** Health-General Article, §21-1113, Annotated Code of Maryland

**Administrative History:** Effective date: June 24, 2002  (29:12 Md. R. 927)

#### Regulation .01 Definitions.

*COMAR 10.13.12.01*

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

  (1) “Authorized prescriber” means:

    (a) A licensed dentist, licensed physician, licensed podiatrist, licensed veterinarian, or to the extent permitted under Health Occupations Article, §8-601, Annotated Code of Maryland, certified nurse midwife;

    (b) A certified nurse practitioner to the extent permitted under Health Occupations Article, §8-508, Annotated Code of Maryland; or

    (c) Another individual authorized by law to prescribe prescription or nonprescription drugs or devices.

  (2) “Board” means a health occupation licensing board:

    (a) Authorized to issue a permit, license, or certificate under Health Occupations Article, Annotated Code of Maryland; and

    (b) That has regulatory authority over the permit holder or authorized prescriber who is responsible for the drugs or prescription records subject to impoundment.

  (3) “Department” means the Maryland Department of Health, or its authorized agent.

  (4) “Drug” means a prescription drug or device or a nonprescription drug, as defined in Health-General Article, §21-1113(a), Annotated Code of Maryland.

  (5) “Impoundment order” means an order issued by the Department to impound drugs or prescription records in accordance with Health-General Article, §21-1113, Annotated Code of Maryland, and this chapter.

  (6) “Permit holder” means a holder of, or applicant for:

    (a) A pharmacy permit, manufacturer's permit, or distributor's permit issued by the State Board of Pharmacy under Health Occupations Article, Title 12, Annotated Code of Maryland; or

    (b) A dispensing permit issued by the board under the authority of Health Occupations Article, §12-102(c)(2), Annotated Code of Maryland.

  (7) “Prescription records” means records maintained by a permit holder or authorized prescriber which identify a patient and any medical information relating to that patient.

  (8) “Transfer” means the release of impounded drugs or prescription records by the department to a transferee.

  (9) “Transferee” means a permit holder or authorized prescriber to whom impounded drugs or prescription records are transferred in accordance with this chapter.

#### Regulation .02 Requirements for an Impoundment Order.

*COMAR 10.13.12.02*

A. The Department may issue an impoundment order if:

  (1) A permit holder's permit or authorized prescriber's license has expired or has been revoked or suspended;

  (2) An application for a permit or license has been denied;

  (3) A board has:

    (a) Determined that the permit holder or authorized prescriber failed to comply with a board order, letter of surrender, or law regarding the disposition of drugs or prescription records; and

    (b) Requested that the Department impound the drugs or prescription records;

  (4) The drugs pose an imminent threat to the public health, safety, or welfare; or

  (5) The confidentiality of the prescription records is in imminent danger of being compromised.

B. The Department may issue an impoundment order based on:

  (1) On-site observation by a law enforcement official, the Department, or other regulatory official of drugs that pose imminent danger to the public health, safety, or welfare;

  (2) On-site observation by a law enforcement official, the Department, or other regulatory official that the confidentiality of prescription records is in imminent danger of being compromised;

  (3) Investigation by the Department or law enforcement authority sufficient to prove that drugs are posing an imminent danger to the public health, safety, or welfare, or that the confidentiality of prescription records is in imminent danger of being compromised; or

  (4) Review of the board's licensing records that indicate the permit holder or authorized prescriber does not have the licensing or permit authority to possess drugs or prescription records.

C. Before execution of an impoundment order issued in accordance with Health-General Article, §21-1113(c)(1), Annotated Code of Maryland, the Department shall:

  (1) Attempt to serve written notice of the impoundment on the permit holder or authorized prescriber by certified mail at the last known address in the board's licensing files; and

  (2) Provide the permit holder or authorized prescriber with an opportunity to:

    (a) Avoid impoundment by allowing the permit holder or authorized prescriber to dispose of the drugs or prescription records in a manner acceptable to the Department;

    (b) Review the nature, type, and amount of information upon which the Department issued the impoundment order; and

    (c) Avoid impoundment by providing the Department with information upon which the Department could reasonably conclude that the impoundment is not warranted.

D. Notice of Order of Impoundment.

  (1) If the Department issues an impoundment order in accordance with Health-General Article, §21-1113(c)(2), Annotated Code of Maryland, the Department shall attempt to contact the permit holder or authorized prescriber at the last known address or telephone number contained in the board's licensing files before executing the impoundment order.

  (2) Posting.

    (a) If the Department is unsuccessful in contacting the permit holder or authorized prescriber before the execution of the impoundment order, the Department shall post the impoundment order in a conspicuous place at the site of the drugs or prescription records.

    (b) The posted impoundment order shall contain information regarding:

      (i) The location of the impounded drugs or prescription records; and

      (ii) An individual to contact for further information.

#### Regulation .03 Disposition of Impounded Drugs or Prescription Records.

*COMAR 10.13.12.03*

A. If the Department executes an impoundment order against a permit holder or authorized prescriber, the Department shall:

  (1) Arrange for the drugs or prescription records to be kept in a secure location;

  (2) Ensure that any location which stores impounded drugs provides the necessary temperature controls and equipment to properly maintain the drugs; and

  (3) Provide the permit holder or authorized prescriber with a list of all drugs and prescription records impounded.

B. Reclamation or Transfer.

  (1) The permit holder or authorized prescriber may petition the Department to reclaim or transfer the impounded drugs or prescription records within 30 days of the date of the impoundment order.

  (2) In order to reclaim or receive a transfer of impounded drugs or prescription records, the permit holder, authorized prescriber, or transferee shall demonstrate:

    (a) Capability to maintain the impounded drugs or prescription records in compliance with all relevant State and federal laws;

    (b) Applicable licensing or permit authority to obtain possession of the impounded drugs or prescription records; and

    (c) If the impounded drugs or prescription records are to be transferred to a transferee, the existence of an express written agreement between the permit holder or authorized prescriber and the transferee, permitting the Department to release the impounded drugs or prescription records to the transferee.

  (3) If the Department grants a petition to reclaim or transfer impounded drugs or prescription records, the petitioner shall arrange for the removal and transport of the impounded drugs or prescription records.

  (4) Notice of Denial.

    (a) If the Department denies a petition to reclaim or transfer impounded drugs or prescription records, the Department may destroy or transfer the impounded drugs or prescription records in accordance with §C(2) of this regulation at least 15 days after the Department has attempted to serve notice by certified mail at the last known address of the permit holder or authorized prescriber.

    (b) The notice shall indicate that the Department:

      (i) Has denied the petition; and

      (ii) Intends to destroy or transfer the impounded drugs or prescription records.

C. Disposition of Drugs or Prescription Records if No Petition is Filed.

  (1) If the permit holder or authorized prescriber has not petitioned the Department within 30 days as provided in §B of this regulation, the Department may destroy or transfer the impounded drugs or prescription records.

  (2) The Department shall destroy or transfer:

    (a) Impounded drugs in accordance with all relevant State and federal laws, including Health-General Article, §21-1113(i), Annotated Code of Maryland; and

    (b) Prescription records in accordance with Health-General Article, §§4-403 and 21-1113(i), Annotated Code of Maryland.

D. Reimbursement.

  (1) The permit holder or authorized prescriber shall reimburse the Department for the reasonable expenses relating to the collection, storage, and disposition of impounded drugs or prescription records.

  (2) The Department may require that the permit holder or authorized prescriber provide advance reimbursement to the Department as a precondition to granting a petition to reclaim or transfer impounded drugs or prescription records.