Regulation .09 Medication Packaging — Record Keeping.
Regulation .09 Medication Packaging — Record Keeping.LinkCopy Citation
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.