Minnesota Administrative Rules

6800.3200 PREPACKAGING AND LABELING.

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

History:

18 SR 1145; 31 SR 1673; 36 SR 237

Published Electronically:

September 21, 2011