Md. Code Regs. 10.34.36.09

Current through Register Vol. 51, No. 12, June 14, 2024

Section 10.34.36.09 - Drug Control and Accountability

A. Medications may be accepted for return if:

(1) The returned medication is properly labeled and properly sealed in the manufacturer's package or an individually labeled unit dose of a drug or a device;

(2) A licensed pharmacist determines that procedures are in place that the returned medication has 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; and

(3) The permit holder otherwise complies with COMAR 10.34.10.07.

B. Discontinued Medications " Controlled Dangerous Substances.

(1) Except as provided in §§B(2) and C(2) of this regulations, drugs classified as Schedule II, Schedule III, Schedule IV, and Schedule V may not be returned to the inventory of the pharmacy.

(2) Schedule III, Schedule IV, and Schedule V medications may be returned to inventory of a pharmacy when the pharmacy uses a distribution system that classifies medications as pharmacy inventory until the utilization of the medication by the resident.

C. A compounded sterile preparation may not be returned to the inventory of a pharmacy.

D. Drugs requiring refrigeration may not be returned to the inventory of a pharmacy.

E. Interim Box. An interim box may be provided to an assisted living program by a permit holder if:

(1) A licensed nurse is present on site 24 hours a day, 7 days a week;

(2) The assisted living program is compliant with the pharmacy's policies and procedures regarding usage of the interim box under Regulation .03 of this chapter; and

(3) The contents of the interim box are part of the pharmacy inventory until administered.

F. Prescriber Orders.

(1) A licensed pharmacist shall dispense medications from the pharmacy only upon receipt of a valid written prescription, chart order, or verbal order from an authorized prescriber.

(2) A chart order shall be considered a prescription drug order provided that the prescription drug order contains:

(a) The full name of the resident, patient, or consumer, as appropriate;

(b) The date of issuance;

(c) The name, strength, and dosage form of the drug prescribed;

(d) The name, type, and specifications of any device;

(e) The directions for use;

(f) If written, the authorized prescriber's signature or the signature of the authorized prescriber's agent (including the name of the authorized prescriber);

(g) If electronically transmitted, prescription requirements as described in COMAR 10.34.20; and

(h) If verbal, the name of the prescriber and the prescriber's agent, if applicable.

(3) A written order may be received by the pharmacy by facsimile, electronic transmission, or as the original physician order.

(4) The licensed pharmacist shall document immediately a verbal order in writing.

(5) A licensed pharmacist may receive a verbal order:

(a) By telephone with the licensed pharmacist reading back the prescription to the prescriber or the prescriber's agent; or

(b) By a voice messaging system.

G. Controlled Dangerous Substances.

(1) Drug Accountability. The permit holder shall ensure that personnel employed by the pharmacy abide by the laws and regulations as defined in:

(a) Health-General Article, Title 27, Annotated Code of Maryland; and

(b) COMAR 10.19.03.

(2) Storage and Security. The permit holder shall establish effective procedures for storage and security of Schedule II controlled dangerous substances including limitation of access to these drugs in the pharmacy to licensed pharmacists and registered pharmacy technicians.

H. Drug Recalls. The licensed pharmacist shall develop and implement a recall procedure that can be readily activated to ensure that drugs which have been recalled are:

(a) Returned to the pharmacy;

(b) Sequestered; and

(c) Handled as appropriate to the level of the recall.

I. Adverse Drug Reactions.

(1) The licensed pharmacist shall participate on the appropriate committee, if applicable of the assisted living program or group home, to establish procedures to report and record adverse drug reactions.

(2) The licensed pharmacist shall ensure the procedures established include, at a minimum:

(a) The reporting of significant adverse drug reactions to the attending prescriber or designee and other parties as specified by the appropriate committee of the assisted living program or group home; and

(b) The recording in writing of an adverse reaction on the resident's chart at the time it is reported.

J. Records and Reports. The licensed pharmacist shall maintain records and reports as may be required by law, this chapter, and the policies of the assisted living program or group home.

Md. Code Regs. 10.34.36.09

Regulation .09 amended effective 40:9 Md. R. 789, eff.6/15/2013