Biologics and Compounding Rules Change

On March 5, 2020, FDA issued a notice to drug compounders that on March 23, 2020 biologic products that were approved under the Federal Food, Drug, and Cosmetic (FD&C) Act will transition to licensure under the Public Health Service (PHS) Act. After this change in the law, biological products will not be eligible for exemptions for compounded drugs under sections 503A and 503B of the FD&C Act.

This change comes as part of the Biologics Price Competition and Innovation Act of 2009, which requires that an approved marketing application for a biologic product under section 505 of the FD&C Act be deemed to be a license under section 351 of the PHS Act as of March 23, 2020. FDA has issued guidance detailing the conditions under which the agency does not intend to take action in the mixing, dilution, or repackaging of biological products not described in their approved labeling.

According to FDA, four bulk substances-human chorionic gonadotropin, hyaluronidase, follicle stimulating hormone (FSH or urofollitropin) and menotropins-have been identified by outsourcing facilities as being affected by this transition. Hyaluronidase, which was on category 1 of the 503B bulks interim policy, will be removed from category 1 as of March 23.