Guidance on Biologics: Restrictions on Beyond-Use Dates

As part of its enforcement authority for compounding of prescription medications under the 2013 Drug Quality & Security Act, the FDA clarified in 2015 that Avastin is not considered a compounded drug but a repackaged biologic, subject to repackaging guidelines. In issuing this clarification in its ‘Draft Guidance on Mixing, Diluting or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application,’ a new concern emerged. The FDA proposed excessively short beyond-use dates (BUDs) for traditional compounders and outsourcing facilities that essentially put bevacizumab out of reach entirely for retina specialists and their patients who rely on it for sight-saving treatment.

ASRS Launches Take Action to Preserve Avastin

In response ASRS launched ‘Take Action to Preserve Avastin,’ a grassroots campaign that generated 300 unique member letters urging the FDA to maintain availability of repackaged bevacizumab by setting aside arbitrary proposed BUDs and focusing on the science as extensive clinical research has shown that repackaged bevacizumab remains stable, sterile, and efficacious with BUDs longer than those proposed by the FDA when standardized aseptic procedures are followed.

In June 2015 ASRS, AAO and others urged members to support both congressional and senatorial sign-on letters to help increase the BUDS. In June 2016, ASRS and others testified to the FDA urging it to focus on science in setting BUDs.

As a result of these efforts, in 2017, the FDA issued a “Revised Draft Guidance” providing a pathway to longer BUDs but leaving ambiguity in the process. In March 2017 comments, the ASRS applauded the Agency for creating a pathway for outsourcing facilities to extend BUDs of finished biologics through stability testing, and asked for clarification on what would constitute passage of the product-related impurities provision in their proposed guidance. In June 2017, the ASRS again urged the FDA for clarification at its listening session on regulations affecting physician offices. ASRS spoke with several outsourcing facilities that repackage bevacizumab and all agree that further guidance is needed before they can comply with the new requirements that would extend the BUD.

In the final guidance published in January 2018, the FDA, at the urging of the ASRS, added references to Appendix A to clarify the tests required to extend the BUD.


Comment Letters


ASRS Testimony


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