Current through Register Vol. 49, No. 17, October 21, 2024
Part 6800.3200 - PREPACKAGING AND LABELINGSubpart 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:
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;E. unique identifier of the packager;F. unique identifier of the supervising pharmacist;G. quantity per container; andH. internal control number or date.Subp. 2.Labeling.Each prepackaged container shall bear a label containing the following information:
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; andG. radiopharmaceuticals must be labeled according to the requirements of part 6800.8550.Minn. R. agency 164, ch. 6800, OPERATION OF PHARMACIES, pt. 6800.3200
18 SR 1145; 31 SR 1673; 36 SR 237Statutory Authority: MS s 151.06; 152.02