From the American Academy of Ophthalmology

Following strong advocacy efforts by the Academy, the Food and Drug and Administration today released draft guidance that includes clarification on the use of repackaged drugs from compounding facilities. An initial review of the draft guidance specifies that the FDA will allow ophthalmologists to access repacked Bevacizumab− commercially known as Avastin − from compounding facilities.

The draft guidance specifically recognizes a need for the “ophthalmic use” of repackaged biologics. The Academy is in the process of reviewing the entire draft guidance, including recommendations on seemingly problematic and restrictive beyond-use-date requirements. The FDA is seeking public comments.

The Academy has asked the FDA on several occasions to specify use of repackaged biologics. We will continue to work with the FDA to ensure that final guidance on this issue works for ophthalmology and its patients.

If you have any further questions, email the Governmental Affairs advocacy communications manager at cmoye@aaodc.org.