
Biologics and Compounding Rules Change
FDA issued a notice to drug compounders regarding the transition of licensure of biologics to the Public Health Service Act.
On March 5, 2020, FDA
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.
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