FDA Provides Guidance on Biologics Mixing, Diluting, and Repackaging

The US Food and Drug Administration (FDA) has finalized recommendations on repackaging drugs by pharmacies and registered outsourcing facilities and also issued a revised draft guideline detailing policies on mixing, diluting, and repackaging certain types of biological products outside of the scope of an approved biologics license application.

____________________________________________________________________________________________________________________________________
RELATED CONTENT
Patient Preference Varies Between Biosimilars or Biologics
Understanding the Challenges Facing Biosimilars
____________________________________________________________________________________________________________________________________

In the document, the FDA clarifies situations where it will enforce certain federal regulations with regard to repackaging drugs by state-licensed pharmacies, federal facilities, or registered outsourcing facilities. It also eliminates a proposed limitation on prepackaging which some claimed might put patients at risk and add significant compliance costs to long-term care pharmacies.

In addition, the FDA also provides a clear definition of repackaging, calling it the, “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 of the drug."

They add that, "If a drug is manipulated in any other way, including if the drug is reconstituted, diluted, mixed or combined with another ingredient, that act is not considered repackaging."

However, they also explain that while repackaged drugs are not exempt from standard provisions outlined in the Food, Drug, and Cosmetic Act, the agency does not intend to enforce such provisions against state-licensed pharmacies, federal facilities, or outsourcing facilities as long as they meet criteria outlined in the guideline.

In the draft guideline on mixing, diluting, or repackaging biologics, the FDA states that even minor manipulations of products could significantly impact safety and efficacy of most solutions.

Still, they recognize that there are clinical scenarios in which it is best to mix or dilute biological products in order to meet specific patient needs, such as when there is no licensed pediatric strength or dosage form for children.

While there are exemptions from certain federal regulations for compounded drugs under sections 503A and 503B of the Drug Quality and Security Act, these exemptions do not apply to biological products licensed under sections 351(a) or (k) of the Public Health Service (PHS) Act.

But again, the FDA says it has no intention of acting against violators so long as state-licensed pharmacies, federal facilities, and outsourcing facilities mix, dilute, and repackage biologic products in accordance with the guideline. They also note that the guidance does not apply to radioactive biological products or to investigational new drugs.—Sean McGuire

References

Mezher M. FDA Finalizes Repackaging Guidance, Revises Draft on Biologics Mixing, Diluting and Repackaging. RAPS Website. https://bit.ly/2jxW8If. Published January 16, 2017. Accessed January 18, 2017.

SCPC Praises Final FDA Repackaging Guidance Recognizing LTC Pharmacies' Unique Value in U.S. Health Care Continuum [press release]. Washington, DC: Senior Care Pharmacy Coalition; January 17, 2017. https://prn.to/2k4OZ2Z. Accessed January 18, 2017.

US Department of Health and Human Services. Repackaging of certain human drug products by pharmacies and outsourcing facilities: Guidance for industry. https://bit.ly/2k4QfTK. Published January 15, 2017. Accessed January 18, 2017.

US Department of Health and Human Services. Mixing, Diluting, or repackaging biological products outside the scope of an approved biologics license application: Guidance for industry. https://bit.ly/2jxUNkL. Published January 15, 2017. Accessed January 18, 2017.