Md. Code Regs. 10.34.03.09

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

Section 10.34.03.09 - Medication Packaging - Record Keeping

A. A licensed pharmacist shall verify the selection of medication to be packaged and verify the completed packaging of medication performed by a registered pharmacy technician for the following:

(1) Accuracy;

(2) Completeness:

(3) Appropriateness; and

(4) Compliance with the U.S. Food and Drug Administration and current United States Pharmacopeia approved packaging.

B. Packaging from the Manufacturer's Original Container. The pharmacy shall use a master log with respect to drugs that are packaged within the pharmacy facility from the original manufacturer's container which includes the:

(1) Lot number assigned by the distributor or manufacturer;

(2) Manufacturer's expiration date;

(3) Manufacturer;

(4) Lot number assigned by the pharmacy;

(5) Quantity packaged;

(6) Expiration date as defined in §C of this regulations;

(7) Generic name of the drug;

(8) Strength;

(9) Date of packaging;

(10) Name of person packaging; and

(11) Initials of verifying licensed pharmacist.

C. Unless the licensed pharmacist has reason to reduce the time period, the expiration date of the medication is the lesser of:

(1) Twelve months from the date of packaging;

(2) The manufacturer's or distributor's listed expiration date; or

(3) The maximum time period allowed for the specific packaging used for the medication.

D. The licensed pharmacist shall ensure that labeling of the medication container includes the:

(1) Generic name of the medication;

(2) Brand name of the medication, if appropriate

(3) Strength of the medication, if appropriate;

(4)Lot number of the distributor or manufacturer;

(5) Expiration date of the medication; and

(6) Beyond use date of the medication, if appropriate.

Md. Code Regs. 10.34.03.09