# COMAR Title 10 — Maryland Department of Health

## Subtitle 34 — Board of Pharmacy

### Chapter 03 — Institutional Pharmacy

#### Regulation .09 Medication Packaging — Record Keeping.

*COMAR 10.34.03.09*

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.