Drug Repackaging

PURPOSE: This rule establishes requirements for drug repackaging. PUBLISHER’S NOTE: The secretary of state has determined that the publication of the entire text of the material which is incorporated by reference as a portion of this rule would be unduly cumbersome AND INSURANCE or expensive. Therefore, the material which is so incorporated is on file with the agency who filed this rule, and with the Office of the Secretary of State. Any interested person may view this material at either agency’s headquarters or the same will be made available at the Office of the Secretary of State at a cost not to exceed actual cost of copy reproduction. The entire text of the rule is printed here. This note refers only to the incorporated by reference material. (1) A pharmacist or pharmacy may prepackage drugs for other than immediate dispensing purposes provided that the following conditions are met: (A) Only products which will be directly provided to the patient may be prepackaged; (B) Containers utilized for prepackaging shall meet, as a minimum requirement, that of Class B container standards as referenced by the United States Pharmacopoeia (USP), which has been incorporated herein by reference. Where applicable, light sensitive containers shall be used; (C) The maximum expiration date allowed for prepacked drugs shall be the manufacturer’s expiration date or twelve (12) months, whichever is less; and (D) Any prepacked drug must have a label affixed to it which contains, at a minimum, the name and strength of the drug, the name of the manufacturer or distributor, an expiration date as defined in subsection (1)(C) and lot number. Pharmacies that store drugs within an automated counting device may, in place of the required label, maintain records for lot numbers and expiration dates that are required on the label as long as it is fully traceable and is readily retrievable during an inspection. (2) The term prepacked as used in this rule is defined as any drug which has been removed from the original manufacturer’s container and is placed in a dispensing container for other than immediate dispensing to a patient. AUTHORITY: sections 338.140 and 338.280, RSMo 2000.* This rule originally filed as 4 CSR 220-2.130. Original rule filed Dec. 10, 1986, effective May 28, 1987. Amended: Filed Nov. 15, 1988, effective March 11, 1989. Emergency amendment filed July 1, 1991, effective July 26, 1991, expired Nov. 22, 1991. Amended: Filed July 1, 1991, effective Jan. 13, 1992. Amended: Filed July 28, 2000, effective Jan. 30, 2001. Amended: Filed Jan. 31, 2003, effective Aug. 30, 2003. Moved to 20 CSR 2220-2.130, effective Aug. 28, 2006. *Original authority: 338.140, RSMo 1939, amended 1981, 1989, 1997 and 338.280, RSMo 1951, amended 1971, 1981.