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 .