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