As a result of legislation that took effect in March of last year, FDA stated that drugs transitioning to biologics would no longer be eligible for the exemptions for compounded drugs under the Food, Drug, and Cosmetic Act.
For compounders, that announcement seems inconsistent with existing law and with FDA’s own 2018 guidance (the Mixing/Repackaging Biologics GFI).
That guidance made clear that its provisions for biologics did not apply to drugs ‘for which a marketing application can be or has been submitted under section 505 of the FDCA.’ One good example: HCG. It has a USP monograph and is not on the demonstrably difficult list; it should be eligible for compounding.
All this in mind, APC submitted a comment letter to FDA this week asking for it to clarify these seemingly contradictory statements, and to “reconsider and rescind the March 23, 2020, notice until such time that FDA can work with stakeholders on a new GFI on this subject.”
Our letter follows a similar request of FDA from the Outsourcing Facilities Association. In addition, APC and OFA have jointly requested a meeting with FDA officials on this subject.