Current through Register Vol. 49, No. 13, September 23, 2024
Subpart 1.
Prepackaging.
Pharmacies may prepackage and label drugs in convenient
quantities for subsequent complete labeling and dispensing. Prepackaging into
unit-dose containers shall be done according to United States Pharmacopeia,
chapter 1146. Such drugs shall be prepackaged by or under the direct
supervision of a pharmacist. The supervising pharmacist shall cause to be
prepared and kept a packaging control record containing the following
information:
A. date;
B. identification of drug: name, dosage form,
manufacturer or distributor, lot number assigned by manufacturer or
distributor, strength, and expiration date assigned by manufacturer or
distributor, if any;
C. container
specification;
D. copy of the
label;
E. unique identifier of the
packager;
F. unique identifier of
the supervising pharmacist;
G.
quantity per container; and
H.
internal control number or date.
Subp. 2.
Labeling.
Each prepackaged container shall bear a label containing the
following information:
A. name of
drug;
B. strength;
C. name of the manufacturer or distributor of
the finished dosage form of the drug;
D. a beyond-use date as provided in part
6800.3350, or any earlier date
which, in the pharmacist's professional judgment, is preferable;
E. internal control number or date;
F. after July 1, 2008, a physical
description, including any identification code that may appear on tablets and
capsules or a bar code based on the National Drug Code (NDC). Such a
description does not need to be placed on individual unit-doses, provided that
the pharmacy dispenses the unit-doses in outer packaging that contains a
physical description of the drug or the pharmacy dispenses less than a 72-hour
supply of the unit-doses; and
G.
radiopharmaceuticals must be labeled according to the requirements of part
6800.8550.
Statutory Authority: MS s
151.06;
152.02
