FDA announces changes that will soon affect compounders

The US Food and Drug Administration (FDA) has announced that a change to the law will impact compounding of certain products beginning on 23 March 2020. On that date, biological products that were approved under the Federal Food, Drug, and Cosmetic (FD&C) Act will transition to being licensed under the Public Health Service (PHS) Act. It’s said that from that date, these transitioning biological products will not be eligible for the exemptions for compounded drugs.  

The Biologics Price Competition and Innovation (BPCI) Act of 2009 created an abbreviated licensure pathway under the PHS Act for biological products that are demonstrated to be biosimilar to, or interchangeable with, an FDA-approved biological product. This pathway was established as a way to provide more treatment options, increase access to lifesaving medications, and potentially lower health care costs through competition, the agency said.

To aid in this change the FDA has posted a preliminary list of approved biological products that will transition. Outsourcing facilities have recently reported using four bulk drug substances that are affected by the transition: human chorionic gonadotropin, hyaluronidase, follicle stimulating hormone (FSH or urofollitropin) and menotropins, said the agency.

Although these transitioning biological products will not be eligible for the exemptions in certain sections, the agency has said its guidance, ‘Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application’, explains the conditions under which it does not intend to take action when certain biological products are mixed, diluted, or repackaged in a manner not described in their approved labeling.   

More information can be found here or at the FDA’s Human Drug Compounding website.