DRUG REPACKAGING OUTSIDE NDA/ANDA SPECS MAY BRING FDA REGULATORY ACTION

DRUG REPACKAGING OUTSIDE NDA/ANDA SPECS MAY BRING FDA REGULATORY ACTION, the agency warned in a compliance policy guide, notice of which was announced in the Jan. 28 Federal Register. The guide "describes the circumstances that may result in FDA regulatory action regarding the marketing of approved new drug and antibiotic drug products that have been subject to additional processing or other manipulations not covered by an approved application," the notice states. FDA explained that the enforcement policy was made necessary by the increased repacking of products "outside the terms" of their approved marketing applications to meet demand for "varied product package sizes." Such repacking "has become much more common due to the increased demand for varied product package sizes, including products for 'multi-dose' dispensing by doctors, pharmacists and institutions," the document states. "Custom repackers have responded to this increased demand by performing manipulations that are well beyond the intended uses approved in the labeling for pharmacists and physicians," the agency said. "Such manipulations result in new products whose safety and effectiveness have not been established" in that repacking "may result in an unanticipated interaction between the pharmaceutical entity and the new packaging, such as absorption and degradation, which may affect the quality of the product," FDA explained. Repacking may compromise specifications for active ingredients, such as identity, stability, sterility assurance and closure integrity. Issuance of the guide appears to have been prompted, at least in part, by FDA's experience with Baxter. Last summer the Seventh Circuit upheld a 1989 Illinois federal court preliminary injunction against Baxter's sale of eight antibiotics the firm had repackaged ("The Pink Sheet" June 4, T&G-13). The agency first brought the complaint in 1988. FDA said the guide does not apply to the standard practice of pharmacy, that is, preparing products for patients; however, it is meant to prohibit repacking of drugs, even by pharmacists, for sale to hospitals, other pharmacies or other entities except patients. "The agency regards mixing, packaging and other manipulations of approved drugs by licensed pharmacists, consistent with the approved labeling of the product, as an approved use of the product if conducted within the practice of pharmacy, i.e., filling prescriptions for identified patients," the notice states. However, "processing and repacking (including repackaging) of approved drugs by pharmacists for resale to hospitals, other pharmacies, etc., are beyond the practice of pharmacy and are thus subject to the requirements of premarket approval."