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FDA Issues Final Guidance on Repackaging and Revised Draft Guidance on Mixing, Diluting, and Repackaging Biological Products

[1/12/2017] Today, FDA issued a final guidance that describes policies concerning repackaging of certain drug products by state-licensed pharmacies, federal facilities, and outsourcing facilities. FDA also issued a revised draft guidance that describes policies concerning mixing, diluting, and repackaging licensed biological products.

The policies described in the final and revised draft guidances are intended to minimize public health risks that repackaging drug products and mixing, diluting, or repackaging biological products can present, while preserving health care practitioner and patient access to these drugs, when appropriate.

Final Guidance: Repackaging of Certain Human Drug Products by State-Licensed Pharmacies and Outsourcing Facilities (PDF - 646KB)

This guidance explains that FDA regards repackaging generally as the act of taking a finished drug product from the container in which it was distributed by the original manufacturer and placing it into a different container, without further manipulation. Repackaging is performed by a range of entities, including facilities that specialize in repackaging drug products and pharmacies. FDA is aware that repackaging is done for a variety of reasons including:

  • to meet the needs of specific groups of patients;
  • to reduce medication errors associated with drawing up a dose from a vial at the point of patient care;
  • to reduce the availability of drug products that could be abused when controlled substances are left over in a vial after a dose is drawn out;
  • to provide a particular sized container to fit into a particular device to administer the drug (such as a particular pain medication pump);
  • for convenience for the practitioner administering an injection to a patient;
  • to reduce waste and conserve drug supplies; and
  • to reduce cost in some cases.

Repackaged drug products are generally not exempt from any of the provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) related to drug production, and sections 503A and 503B of the FD&C Act, related to compounding, do not address repackaging.

Therefore, FDA is issuing guidance to describe the conditions under which the Agency does not intend to take action for certain violations of the FD&C Act when a state-licensed pharmacy, federal facility, or outsourcing facility repackages certain drug products. 

Revised Draft Guidance: Mixing, Diluting, and Repackaging Biological Products Outside the Scope of an Approved Biologics License Application (PDF - 969KB)

Under the Public Health Service Act, a biological product that is mixed, diluted, or repackaged outside the scope of an approved biologics license application (BLA) is an unlicensed biological product and may not be legally marketed.

FDA recognizes that biological products are sometimes mixed, diluted, or repackaged in ways not addressed in prescribing information or other approved labeling. However, biological products cannot qualify for the exemptions in sections 503A and 503B of the FD&C Act. FDA has developed draft guidance describing the conditions under which FDA does not intend to take action when certain biological products are mixed, diluted, or repackaged in a manner not described in their approved labeling.

This revised draft guidance takes the place of previous draft guidance on this subject. Examples of changes in the revised draft guidance include longer beyond-use-dates (BUDs) and a mechanism for outsourcing facilities to assign BUDs for repackaged biological products based on data.

Comments on the revised draft guidance should be submitted within 60 days. For information on how to submit comments to the public docket, see the notice in the Federal Register.