Compounders Complain They Can’t Make These Four Drugs Once They’re Deemed Biologics
Executive Summary
After 23 March, the US FDA won’t allow any more bulk compounding of four oft-compounded drug substances, disrupting patient care, compounders say.
Major disruptions in patient access to compounded versions of four bulk drug substances may result from the US Food and Drug Administration’s decision, announced 5 March, to regulate them beginning 23 March as biologics licensed under the Public Health Service Act, drug compounding industry groups say.
The announcement said outsourcing facilities complained four substances on the FDA’s preliminary list would be affected by the transition when they are deemed as biologics: human chorionic gonadotropin (HCG), hyaluronidase, follicle simulating hormones (FSH or urofollitropin) and menotropins.
Compounding is allowed under sections 503A and 503B of the FD&C Act, which exempt it from certain FD&C Act requirements. The problem is the Public Health Service Act lacks such exemptions.
Industry groups said that the US Food and Drug Administration’s 5 March announcement that four drugs will lose their compounding exemption on 23 March when they are deemed biologics has “huge implications” for traditional 503A pharmacies and 503B outsourcing pharmacies and have asked to meet with the agency.
The FDA’s 5 March announcement followed a guidance document issued on March 4 on the implementation of the transition provisions under the Biologics Price Competition and Innovation Act’s “deemed to be a license” provision. (Also see "'Authorized Biosimilars' Can't Use 351(k) Pathway, US FDA Concludes" - Pink Sheet, 4 Mar, 2020.)
In the announcement, the FDA referenced a preliminary list, updated through 31 December 2019, of 95 new drug applications that will transition to the PHS Act on 23 March.
When the BPCI Act was written, Congress did not address the issue of how this transition would affect compounding of bulk drug substances, and this ambiguity is causing some confusion, a compounding industry representative explained.
The Outsourcing Facilities Association argued in its 18 February comments that Section 503B of the FD&C Act allows compounding from a bulk drug substance if the drug appears on the FDA’s drug shortage list.
The US FDA attempted to clarify this confusion by announcing it would not take enforcement action against compounding, but only if the final product is made from FDA-approved finished products. The agency will not permit such compounding if the final product is produced from bulk drug ingredients not approved by FDA. This pronouncement was made in the agency’s 2018 guidance “Mixing, Diluting, or Repacking Biological Products Outside the Scope of an Approved Biologics License Application.”
FDA’s Move Would Result In Disruptions
David Pore, the legislative and regulatory counsel for the Alliance for Pharmacy Compounding, asserted in a 6 March statement that the FDA’s action may have major implications for patients who depend on these drugs.
“Obviously, this communication from FDA is concerning and this has huge implications for 503A and 503B pharmacies, physicians and the patients they serve. 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 disruptions in patient access and care.”
The OFA raised similar concerns in its 18 February comments to the FDA. The group asserted that the FDA’s “administrative conversion should not deprive patients of access to effective and affordable medications such as insulin, human chorionic gonadotropin and hyaluronidase. … Compounders have been compounding these drugs and increasing patient access to these medications for nearly 50 years.”
The OFA added that “patients should not suffer due to access issues as a result of a purely regulatory change. If FDA does not clarify that deemed BLAs will be regulated as ‘drugs’ for purposes of Section 503A and Section 503B of the FD&C Act, significant disruptions to patient access and patient care may arise.”
[Editor's Note: In an earlier version of the story, it was incorrectly reported that the preliminary list of drugs that will be transitioning to biologics was first published on 31 December 2019. In fact the list has been published multiple times, with the latest version updated through 31 December 2019]