This chapter provides information to any person who removes drugs from their original manufacturer's container and repacks them into a different containerclosure system for resale or for distribution to hospitals or other pharmacies. It does not apply to repackaging of any radioactive drug products, including oral solids.
A repackager referred to here may also be a contract packager or a contract repackager. The words repackager and repacker are the same in this text and may be used interchangeably. These functions are beyond the regular practice of a pharmacist. A repackager is required to register with the FDA and comply with current Good Manufacturing Practices (cGMPs) regulations in 21 CFR 210 and 211.
A repackager is expected to meet the requirements of packaging practice under 21 CFR 210 through 226. Because the packaging practice relates to packaging, processing, or holding a drug product intended for administration to humans or animals, the repackager is expected to comply with regulations such as those relating to the sections pertaining to quality control, personnel qualifications, building and facilities, equipment, production and process controls, packaging and labeling controls, laboratory controls, master production record, batch records and reprints, distribution records, storage control records, and complaint files.