May a drug repackager provide a direct purchase pedigree?
This will depend on the repackagers operation. YES, if a drug repackager purchases finished and fully labeled prescription drugs directly from the prescription drug manufacturer for placement in a convenience kit, provided that the drug repackager does not change the immediate container or label of the specific unit of the finished and fully labeled prescription drug received from the manufacturer. The department treats as a drug repackager the maker of a combination medical device containing any prescription drug component, as long as the FDA requires that such component comply with federal prescription drug regulations. NO, if a drug repackager changes the specific unit of a prescription drug purchased directly from the manufacturer must.
