Md. Code Regs. 10.34.36.07

Current through Register Vol. 51, No. 24, December 2, 2024

Section 10.34.36.07 - Medication Packaging

A. A licensed pharmacist shall verify the:

(1) Selection of medication to be packaged; and

(2) Completed packaging of medication performed by registered pharmacy technicians for the following:

(a) Accuracy;

(b) Completeness;

(c) Appropriateness; and

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

B. A licensed pharmacist shall ensure that labeling of the medication container includes the:

(1) Brand or generic name of the medication;

(2) Strength of the medication;

(3) Name of the pharmacy; and

(4) Expiration date of the medication.

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

(1) 12 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. Packaged from the Manufacturer's Original Container. The pharmacy may use a lot number and expiration date assigned by the pharmacy instead of the distributor or manufacturer information in a master log if kept with respect to drugs that are packaged within the pharmacy facility from the original manufacturer's container which includes the:

(1) Name of the drug;

(2) Strength;

(3) Manufacturer;

(4) Lot number assigned by the pharmacy;

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

(6) Quantity packaged;

(7) Expiration date as defined in §C of this regulation;

(8) Manufacturer's expiration date;

(9) Date of packaging;

(10) Name of pharmacy technician packaging; and

(11) Name and initials of verifying licensed pharmacist.

E. Packaged from Another Pharmacy. A licensed pharmacist may package medication received directly from another pharmacy licensed in Maryland or operated by the government of the United States provided that:

(1) A licensed pharmacist determines that the 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 time it was dispensed by the original pharmacy and received by the packaging pharmacy;

(2) A licensed pharmacist packages and dispenses all at one time the entire quantity of the prescription medications received from another pharmacy for packaging;

(3) The manufacturer's name is present on the container received from the other pharmacy; and

(4) A licensed pharmacist maintains a master log that includes the following information:

(a) Name of the drug;

(b) Lot number assigned by the packaging pharmacy;

(c) Strength;

(d) Manufacturer;

(e) Name, address, and telephone number of the original dispensing pharmacy;

(f) Prescription number from the original dispensing pharmacy;

(g) Quantity packaged;

(h) Expiration date as assigned by the original dispensing pharmacy;

(i) Date of packaging;

(j) Name of pharmacy technician packaging;

(k) Name and initials of verifying licensed pharmacist; and

(l) Name of the resident.

Md. Code Regs. 10.34.36.07

Regulation .07 amended effective 40:9 Md. R. 789, eff.6/15/2013