Md. Code Regs. 10.34.03.13

Current through Register Vol. 51, No. 22, November 1, 2024

Section 10.34.03.13 - Controlled Dangerous Substances

A. Drug Accountability.

(1) The director of pharmacy is responsible for establishing procedures and maintaining adequate written or electronic records regarding dispensing and accountability of controlled dangerous substances which specify at least the following:

(a) Name and strength of the drug;

(b) Dose;

(c) Dosage form;

(d) Prescriber;

(e) Patient name with second identifier;

(f) Date and time of administration; and

(g) Individual administering the drug;

(2) The director of pharmacy shall be responsible for establishing and maintaining adequate procedures for documentation of:

(a) Recording of receipt of delivery to the pharmacy;

(b) Entering into pharmacy inventory;

(c) Receiving into Schedule II inventory; and

(d) Dispensing of controlled dangerous substances, Schedule II - Schedule V.

(3) The director of pharmacy or designee shall be responsible for establishing and maintaining adequate procedures for documenting partially administered controlled dangerous substances:

(a) For disposal by hospital policy; and

(b) Return of unused drugs to the pharmacy.

(4) The director of pharmacy or designee shall establish procedures to ensure that controlled dangerous substance records include the handwritten or electronic signature of the individual authorized:

(a) By the institution to dispose of drugs or to return them to the pharmacy; and

(b) To witness the disposal, as defined by the institution's policies and procedures.

B. Storage and Security in the Institutional pharmacy.

(1) On at least a monthly basis, a pharmacist or registered pharmacy technician shall perform a physical count of each Schedule II controlled dangerous substance in the pharmacy and shall then compare that count with the perpetual inventory maintained by the pharmacy with reference to each drug;

(2) On at least a monthly basis, the director of pharmacy or designee shall:

(a) Investigate discrepancies within the pharmacy;

(b) Report losses as required by law; and

(c) Take appropriate action; and

(3) The director of pharmacy or designee shall establish a procedure by which previously dispensed controlled dangerous substances that are no longer necessary for medical reasons are returned to the pharmacy.

C. Storage and Security in the Institution. The director of pharmacy shall develop policies that only permit the dispensing of controlled dangerous substances when the following security precautions exist in the institution and the pharmacy:

(1) Access to controlled dangerous substances outside the pharmacy is restricted to authorized personnel approved by institutional policy;

(2) Controlled dangerous substances stored outside the pharmacy are accounted for at least at the change of each shift by licensed personnel authorized by the institution, unless a controlled access automated dispensing system provides an on-demand report of a perpetual inventory; and

(3) A pharmacist reviews the discrepancies in counts of controlled dangerous substances previously reported by other professional personnel.

Md. Code Regs. 10.34.03.13