FDA addresses implications of biologics reclass on compounding
On Wednesday, FDA released a final guidance for industry,
Deemed to be a License Provision of the BPCI Act: Questions and Answers
" that it says provides answers to common questions about FDA's implementation of the "transition" provision of the BPCI Act. One big question unanswered in that final GFI is how the reclassification will apply to compounding.
The BPCI Act requires that a marketing application for a "biological product" (that previously could have been submitted under section 505 of the Federal Food, Drug, and Cosmetic Act) must be submitted as a biologics license application (BLA) under section 351 of the Public Health Service Act (PHS Act).
Thursday's communication from FDA states that items on the transition list - along with all other biologics - are not eligible for compounding exemptions under 503A or 503B, but that FDA's Mixing/Diluting/Repackaging of Biologics GFI provides some parameters under which FDA may exercise enforcement discretion. The communication explicitly addresses HCG and hyaluronidase and asserts that compounders can work with the approved biologic outside of the scope of the BLA as long as the conditions of the Mixing/Diluting/Repackaging of Biologics GFI are followed.
"FDA is asserting that compounding from bulk API is not allowed for any biologic," said APC's Legislative & Regulatory Counsel David Pore. "That means that if a 503A or 503B facility expects enforcement discretion related to a biologic, it must start with an FDA-approved finished biologic product and mix/dilute/repackage it according to the GFI, which explicitly prohibits the use of any bulk API."
Importantly, FDA's communication also clarifies what a biologics license application (BLA) is.
"Obviously, this communication from FDA is concerning and has huge implications for 503A and 503B pharmacies, physicians, and the patients they serve," said APC chief executive officer Scott Brunner, CAE. "We've joined forces with the Outsourcing Facilities Association to request a face-to-face meeting with FDA officials as quickly as possible to discuss the matter. Our aim is to avoid big disruptions in patient access and care."