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.
The 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, if appropriate;
(3)
Name of the pharmacy;
(4)
Expiration date of the medication.
C. Unless the licensed 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. The
licensed pharmacist may package patient specific medication received from
another pharmacy licensed in Maryland or operated by the government of the
United States provided that:
(1) The 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) The 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) The 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 for 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 patient.
