FDA Issues Guidances Outlining Exemptions for Repackaging Products

The FDA issued a draft and a separate final guidance dealing with when the agency would exercise enforcement discretion for certain violations covering repackaging products. The draft addresses biologics, while the final guidance deals with drugs.

Biologic products must be mixed, diluted or repackaged in a state-licensed pharmacy, federal facility, or outsourcing facility and under the direct supervision of a licensed pharmacist, according to the revised draft.

The product cannot be combined with a bulk drug substance or a product licensed only for manufacturing use, which also lists a similar set of circumstances for allergenic extracts for subcutaneous immunotherapy.