Pharmacy Practice & Compliance
1 Does Maryland maintain a formulary for generic substitution?
'Effective November 1, 2006, the Department eliminated the policy that prohibits substitution of certain drugs, thereby removing six drugs from the Maryland Drug Formulary of Equivalent Drug Products. The drugs are Carbamazepine Oral Tablets 200 mg; Phenytoin Sodium Extended Oral Capsules 100 mg; Valproic acid; Theophylline extended release; Warfarin sodium; and Primidone. The FDA has declared these drugs do have generic equivalents. Therefore, they no longer need to continue as nonsubstitutable narrow therapeutic index drugs in Maryland.'
2 May prescriptions be transmitted electronically?
The electronic transmission of prescriptions is governed by COMAR 10.34.20.
You may obtain the text of this regulation or any other Board of Pharmacy regulation by using the
link to COMAR On-Line that appears on our Legislation and Regulation page or by visiting
http://www.dsd.state.md.us/comar/
The Board of Pharmacy and the Board of Physicians have also posted a “Prescription Signature Options Chart” on their websites to inform pharmacists and physicians of the types of signatures that are acceptable in Maryland. It is located on the homepage of both Boards.
3. Are preprinted prescription pads legal in Maryland?
A prescription for a controlled dangerous substance within the meaning of Article 27 of the Code may not be written on a preprinted prescription form that states the name, quantity, or strength of the controlled dangerous substance. Annotated Code of Maryland, Health-General Article, Title 21-220.
Preprinted prescription pads for non-controlled dangerous substances are not prohibited by law.
4. Does the Board of Pharmacy have required pharmacist/technician ratios or workload limits?
No. However, the Pharmacy Act does require the permit holder to provide adequate personnel, automation, and technology as are necessary to allow the licensed pharmacist employee sufficient time to utilize the pharmacist=s knowledge and training to perform the functions of a licensed pharmacist as required by law. A permit holder 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. Annotated Code of Maryland, Health Occupations Article, Title 12-403(b) (7) and (15). Violation of these provisions may be grounds for disciplinary action against the permit holder.
5. Can blister packages prepared and dispensed by the pharmacy be returned to stock if returned to the pharmacy?
COMAR 10.34.10.07 permits a pharmacist to accept the return of a properly labeled and properly sealed manufacturer’s package or individual unit dose of a drug or a device that the pharmacist determines to have been handled in a manner which preserves the strength, quality, purity, and identity of the drug or device during an interim period between the sale of the drug or device and its return to the pharmacy.
In 2000, the Board of Pharmacy considered whether medications prepared and dispensed by a pharmacy in blister packaging could be returned to the pharmacy stock and used for subsequent dispensing. Such packages are neither sealed manufacturer’s packages nor individual unit doses.
A pharmacist may not return to stock for subsequent dispensing blister packages prepared by the pharmacy that intermingles different drugs in a single compartment.
A pharmacist may return to stock, for subsequent dispensing, blister packages prepared by the pharmacy if the packages contain a single drug entity in each compartment of the package and repackaging is not required for subsequent dispensing.
6. Who may legally enter the pharmacy prescription area when the pharmacy is closed?
Except in an emergency as defined by law, such as fire or flood, an individual may not be in the prescription area unless a pharmacist is immediately available on the premises to provide pharmacy services. COMAR 10.34.05. This applies to all pharmacy practice settings, including institutional and inpatient.
7. Can prescriptions from out of state be filled in Maryland?
Prescriptions may be filled if written by an authorized prescriber licensed in one of the 50 states or U.S. Territories. Additionally, a prescription may be filled if it is valid, based on professional judgment and the circumstances involved. A prescription is valid if, among other things, it is the result from a valid patient-prescriber relationship. If the prescription is valid when and where it originates, the prescription is valid and may be filled.
8. Are physician assistants and nurse practitioners permitted to prescribe controlled dangerous substances?
The prescriptive authority of nurse practitioners, physician assistants and other mid-level practitioners is governed by their respective licensing boards. Their authority to prescribe controlled dangerous substances is derived from their scope of practice and/or delegation agreements entered into with supervising physicians.
Questions regarding a particular practitioner should be directed to the Board of Nursing or the Board of Physicians. As a courtesy, a list of physician assistants authorized to prescribe provided by the Board of Physicians (BoP) can be accessed on this web site.
Mid-level practitioners authorized to prescribe controlled dangerous substance must have their own DEA number. They cannot use the DEA number of a supervising physician to issue prescriptions for controlled dangerous substances.