Code of Maryland Regulations
Title 10 - MARYLAND DEPARTMENT OF HEALTH
Part 4
Subtitle 34 - BOARD OF PHARMACY
Chapter 10.34.03 - Inpatient Institutional Pharmacy
Section 10.34.03.09 - Medication Packaging - Record Keeping

Universal Citation: MD Code Reg 10.34.03.09

Current through Register Vol. 51, No. 19, September 20, 2024

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.

Disclaimer: These regulations may not be the most recent version. Maryland may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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