FDA Starts Wrapping Up Position on Repackaging of Biologics and Human Drugs

The FDA announced the availability of two draft guidances related to the repackaging of biologic and human drug products. The draft guidances are titled ‘‘Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application” and ‘‘Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities.” Within the draft guidances, the FDA indicates the circumstances under which the FDA plans to refrain from taking action against a state-licensed pharmacy, a federal facility, or an outsourcing facility that mixes, dilutes, or repackages biologic and human drug products.


In the first draft guidance, the FDA recognizes that some patient needs may require the mixing, diluting, or repackaging of biological products (80 FR 8882, February 19, 2015). However, if a facility engages in such repackaging outside of an approved biologics license application (BLA), under the Public Health Service (PHS) Act (21 U.S.C. § 262), the action would render the product an unlicensed biological product. The guidance sets out the circumstances under which the FDA will not take action against a facility that engages in such mixing, diluting, or repackaging without first obtaining an approved BLA. The draft guidance sets out specific information that the label of a mixed, diluted, or repackaged biological product must display, including: (1) information as to the facility where the repackaging occurred; (2) dosage form and strength information; (3) the date of repackaging; (4) a beyond-use-date; (5) the National Drug Code (NDC) number of the repackaged biological product; (6) a statement indicating the product is not for resale; (7) storage and handling instructions; and (8) a list of active and inactive ingredients.

Human Drug Products

The second draft guidance sets out when the FDA plans to not take action against certain facilities for violations of new drug application (NDA) requirements and current good manufacturing practice (CGMP) requirements when a facility repackages a prescription human drug product (80 FR 8884, February 19, 2015). The labeling requirements set out in the draft guidance for a repackaged human drug are comparable to those described above for the biological product repackaging guidance.

Related Guidances

In tandem, the two draft guidances are meant to address the FDA’s position “regarding hospital pharmacies repackaging and safely transferring repackaged drugs to other hospitals within the same health system during a drug shortage.” Although the FDA is accepting comments on the guidance at any time, to ensure that a comment is considered, the FDA recommends that comments be submitted in an electronic or written format by May 20, 2015.