Md. Code Regs. 10.32.23.06

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

Section 10.32.23.06 - Requirements for Permit Holders

A. A permit holder shall comply with all federal and State statutes and regulations regarding prescription drugs, including all requirements for:

(1) Dispensing, including labeling;

(2) Storing and securing inventory;

(3) Allowing access only to authorized individuals;

(4) Managing inventory controls;

(5) Recordkeeping; and

(6) Submitting prescription monitoring data to the Maryland Prescription Drug Monitoring Program in accordance with Health-General Article, Title 21, Subtitle 2A, Annotated Code of Maryland.

B. A permit holder shall:

(1) Perform in person the final check of each drug dispensed;

(2) Sign or initial documentation in person that the final check was completed;

(3) Be present on the premises and available for consultation at the time the drug is dispensed;

(4) With regard to inspections by the OCSA:

(a) Personally sign at the time of the inspection the acknowledgement of receipt of the inspection report required by Health Occupations Article, §12-102(c)(2)(ii) 4D, Annotated Code of Maryland; or

(b) Assure that during all normal office hours a designee is available on the premises who will sign at the time of the inspection the acknowledgement of receipt of the inspection report;

(5) Assure that the lot number of a drug obtained from a stock bottle or other larger container:

(a) Is recorded in the office records;

(b) Can be correlated with any patient's prescription for that drug; and

(c) Is immediately available for inspection; and

(6) Except with regard to sample units, drug samples, and starter dosages in the possession and control of an authorized prescriber, assure that physical access to all prescription drugs is denied to all individuals at all times that a permit holder is not on the premises.

C. A permit holder may not dispense medications by:

(1) Mail order; or

(2) A refill.

D. For the purposes of this regulation, "refill" means an additional allotment of the same drug initially authorized by the original, written prescription. "Refill" does not prohibit a permit holder from dispensing the same or different drug through an additional or subsequent, written prescription.

Md. Code Regs. 10.32.23.06

Regulation .06 adopted effective 45:6 Md. R. 320, eff. 3/26/2018