Drug Dispensing FAQs

General Information

  • Permits are valid for five (5) years from the date of issue. The fee for the five-year term is $1,050.00 and is non-refundable. As required by Health Occupations Article, § 12-102.2, the Board collects $1,000.00 for the MDH-Office of Controlled Substances Administration (OCSA) to cover the cost of conducting inspections. The remaining $50.00 is retained by the Board as a processing fee.
  • A permit may lapse or be revoked under certain conditions. For example, failure to notify the Board of a change of address may lead to a lapse of your permit. See COMAR 10.32.23.12.

Do I need a Permit?

Dispensing is the procedure that results in a patient receiving a prescription drug and includes:

  1. Interpretation of the prescription;
  2. Selection and labeling of the drug; and
  3. Measuring and packaging of the drug. A pharmacist most often performs these tasks.

Per COMAR 10.32.23.03, a physician does not need a permit if either of the following scenarios is true:

  1. A physician dispenses prescription drugs or devices at
    1. a health facility or center described in Health Occupations Article § 12-102(g)(1)-(3);
    2. At a medical facility or clinic that is operated on a nonprofit basis;
    3. At a health center that operates on a campus of an institution of higher education; or
    4. At a public health facility, a medical facility under contract with a State or local health department, or a facility funded with public funds.
  2. A physician dispenses to a patient free of charge :
    1. A drug sample;
    2. A sample unit; or
    3. A starter dosage of a prescription drug, not to exceed a 72-hour supply.

If you have additional questions, please email the Board: mdh.mbpdrugdispense@maryland.gov.

No, a physician cannot dispense a prescription drug without a dispensing permit unless an exception applies. For more information on this exception, please refer to the Physician's Permit to Dispense Prescription Drugs Application.

No. This activity is called "administering" a drug. You do not need a dispensing permit to do this.

A physician who directly applies therapies of any kind to the patient while the patient is in the office or clinic is "administering," and there is no need for a dispensing permit to apply therapies.

No. Prescribing is not dispensing. A physician does not need a dispensing permit to prescribe CDS.

Please Note: To prescribe CDS, a physician must obtain both the registration from OCSA and the federal Drug Enforcement Administration (DEA). The Board of Physicians does not manage either of these registrations. Contact these agencies directly to obtain these registrations:

Educational Requirements

Yes. Health Occupations, §12-102 Drug Dispensing Permit Law requires all individual licensees with dispensing permits to complete ten (10) 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 of the Maryland Department of Health.

To support an option to ACPE, the Secretary has approved the following Continuing Education Resources, which the Board will periodically review and update: Preparing and Dispensing Prescription Drug Courses.

Fees

The fee is $1,050 for a five-year permit. This fee is not refundable.

The Board is required by §12-102.2 of the Health Occupations Article to charge a fee that will approximate the costs of the inspections performed by OCSA. The Board pays $1,000 from each dispensing permit application to the General Fund of the State to cover the cost of OCSA's inspections and retains $50 as a processing fee.

Yes. A physician needs permits for each location in which they dispense drugs. They shall print and display a copy of the permit and display at each location. To inform the Board of additional addresses applicable to the dispensing permit, please contact the Board: mdh.mbpdrugdispense@maryland.gov.

Legal Authorization and Requirements

The laws and regulations that govern the dispensing of drugs include:

  1. Health Occupations Article §12-102, Annotated Code of Maryland, authorizes physicians to dispense and sets out the requirements a physician dispenser must meet. COMAR 10.13.01 and the Board's regulations at COMAR 10.32.23 further set out these specific dispensing requirements.
  2. COMAR 10.19.03, including state regulations for:
    1. Labeling and packaging for CDS (COMAR 10.19.03.04);
    2. Recording, reporting, and inventory requirements (COMAR 10.19.03.05); and
    3. Prescription and dispensing requirements (COMAR 10.19.03.07).
  3. Title 5 of Maryland's Criminal Law Article, as well as federal statutes and regulations, govern the dispensing of and recordkeeping for CDS.

Yes. The physician will be responsible for being familiar with the applicable pharmacy and dispensing laws and regulations and for complying with them in signing the application to dispense prescription drugs.

Dispensing for Others

Yes, in certain circumstances. A physician may dispense a drug based on a prescription written by:

  1. A physician assistant with whom a physician has a delegation agreement that permits prescribing that drug; and
  2. A certified registered nurse practitioner who works with a physician in the same office setting and who is authorized by the Board of Nursing to prescribe that drug.

Yes. Those restrictions are:

  1. A physician may not dispense a drug that they are not authorized to prescribe themself;
  2. The physician must at all times keep available for inspection at each location where the physician dispenses;
  3. The names of all certified registered nurse practitioners for whom the physician dispenses at that location; and
  4. The names and the delegation agreements of all physician assistants for whom the physician dispenses at that location.

As with any other dispensing, the physician is responsible for the dispensing process and must perform at least the final check before the drugs are dispensed.

Yes. The physician must ascertain that the patient was informed individually by the prescriber, or the physician informed the patient themself, that the patient has the choice of filling the prescription either at a pharmacy or at the physician's dispensary.

Yes. A physician may delegate the "mechanical acts" of the dispensing process to another person, including an unlicensed person.

A mechanical act is an act that does not require professional judgment or medical or pharmaceutical training or the use of discretion in the filling of prescriptions. Examples of mechanical acts are placing the completed, labeled prescription in a bag, handing the labeled and closed container to the patient, and collecting payment for the prescription.

Yes. The following cannot be delegated to an unlicensed person:

  1. Selecting the drug;
  2. Measuring a drug, or interpreting any prescription that requires calculating dosages;
  3. Labeling the container in which the drug is dispensed;
  4. Interpretation of a prescription in order to change the route of administration, for example, from tablet form to liquid form;
  5. Substitution of a drug, for example, from generic to name-brand or vice-versa;
  6. Patient counseling; and
  7. Performing the final check.

The final check means the verification of the accuracy and completeness of a filled prescription, including the verification of the appropriateness of the dose, the accuracy of the drug dispensed, the strength of the drug dispensed, the accuracy of the expiration date, the correct labeling, and the appropriateness of the container in which the drug is dispensed, including child-proof containers where applicable.

Special Reporting Requirements and Reinstatement

Yes. A physician must report each year on the anniversary date of their permit whether they have dispensed prescription drugs in the past year. The Board will send them an email reminder of this requirement.

The physician's permit will lapse if without good cause as to why they failed to submit the report within 15 days of their anniversary date.

This report is needed so that the OCSA can determine at which locations drugs are actually being dispensed.

A physician may start dispensing again only after they notify the Board at mdh.mbpdrugdispense@maryland.gov prior to resuming dispensing. Resuming dispensing without notifying the Board is grounds for revocation of the permit, pursuant to COMAR 10.32.23.14.

No. A lapsed permit may not be reinstated. If a physician wishes to resume dispensing, they must apply for a new permit, which requires payment of the fee.

No. The permit belongs to the permit holder, not the employer. If a physician has changed employment but still wishes to dispense at a different location, they must notify the Board of the change. A physician may change this location twice during the permit period without charge.