Md. Code Regs. 10.34.23.09

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

Section 10.34.23.09 - Drug Control and Accountability

A. The director of pharmacy or designee shall develop a process for the pharmacy to be notified of medications which have been discontinued.

B. 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) The licensed pharmacist determines 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.

C. 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 patient.

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

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

F. Emergency Drug Kit.

(1) The director of pharmacy or designee shall ensure that the emergency drug kit is secured with a tamper-evident seal or electronic security system which will indicate the opening of the kit.

(2) Labeling. The director of pharmacy or designee shall ensure that the emergency drug kit meets the following specifications:

(a) The exterior of the emergency drug kit is labeled to indicate clearly and unmistakably that it is an emergency drug kit and that it is for use in emergencies only;

(b) The exterior of the emergency drug kit is labeled to indicate the:

(i) Names of the drugs contained in the emergency drug kit;

(ii) Strengths of the drugs contained in the emergency drug kit;

(iii) List of contents with expiration dates, with the date of the first item to expire in bold print; and

(iv) The quantity of each drug contained in the emergency drug kit; and

(c) Medications contained in the emergency drug kit are labeled with the:

(i) Name of the drug;

(ii) Strength of the drug;

(iii) Expiration date of the drug;

(iv) Lot number of the drug; and

(v) Other information required by the medical staff.

(3) Replacement of Medications.

(a) A licensed pharmacist or licensed pharmacist's designee shall replace the emergency drug kit or replenish used or expired drugs contained in the emergency drug kit within 72 hours of notification of use or expiration.

(b) A licensed pharmacist shall perform the final check on the contents of the emergency drug kit.

G. Interim Box.

(1) An interim box may be provided by the pharmacy and kept at the comprehensive care facility if comprehensive care facility policies and procedures address an interim box and the pharmacy complies with these policies and procedures.

(2) A licensed pharmacist shall perform the final check on the contents of the interim box.

H. 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 patient;

(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.

I. 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 Health-General Article, Title 27, Annotated Code of Maryland, and 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.

J. Drug Recalls. The director of pharmacy or designee shall develop and implement a recall procedure that can be readily activated to ensure that drugs which have been recalled are returned to the pharmacy, sequestered, and handled as appropriate to the level of the recall.

K. Adverse Drug Reactions.

(1) The director of pharmacy or designee shall participate on the appropriate committee of the comprehensive care facility to establish procedures to report and record adverse drug reactions.

(2) The director of pharmacy or designee 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 committee of the comprehensive care facility; and

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

L. Records and Reports. The director of pharmacy or designee shall maintain records and reports as may be required by law, this chapter, and the policies of the comprehensive care facility.

Md. Code Regs. 10.34.23.09

Regulation .09G amended effective 40:18 Md. R. 1479, eff.9/16/2013