During the health pandemic in 2020, the FDA provided guidance for compounded drugs made by outsourcing facilities for hospitalized patients. If the hospitals were unable to obtain FDA-approved medications, compounded drugs were sought after consultation with the outsourcing facilities. A product report reference was utilized to determine which facilities compounded drugs for hospitalized patients with COVID-19.
The agency drafted new guidance in October 2021 and released it for public comment, but it has yet to be implemented. The FDA clarified various points regarding limitations and specifics with drug shortages within the policies developed. The Hospital and Health System Compounding Draft Guidance under Section 503A of the Federal Food, Drug, and Cosmetic (FD&C) Act was intended to apply to provisions related to compounded products made in pharmacies that are not associated with outsourcing facilities and distributed to hospitals or health systems.
The draft also takes into account compounded drug products that are essentially copies of commercially available drug products falling under Section 503A of the FD&C Act. It was noted that this guidance does not apply to outsourcing facilities that fall under section 503B of the FD&C Act. For reference, Section 503A applies to human drug compounding by a licensed professional within a state-licensed pharmacy or federal facility. Meanwhile, Section 503B applies to human drug compounding within an outsourcing facility.
The 1-mile radius provision was one of the draft's standout features. The FDA intends to remove this restriction to help preserve access to compounded drugs. Furthermore, the FDA stated that drugs on the FDA shortage list, as well as those that have been discontinued or are no longer on the market, are not considered commercially available. In the case of drugs on the shortage list, the agency will not consider a compounded product produced by an outsourcing facility to be a "copy" if it is identical or nearly identical to an approved drug on the list. It was stated that the agency will not take action if a facility fills an order for a compounded drug that is a mirror copy of an approved drug that is no longer marketed or discontinued.
Specific compounded drug concerns related to the COVID pandemic were also elaborated on in the press release. Concerns were raised by the FDA about the use of specific medications prepared by compounding to treat patients during the pandemic. There were two standouts: the use of remdesivir and the inclusion of thymosin-alpha 1 during medication preparation. Patients receiving COVID-19 treatment have been offered thymosin-containing medications. However, thymosin-alpha 1, a peptide hormone, is not an approved drug and does not meet the conditions for compounding under the FD&C Act's two sections. Veklury (remdesivir) has been approved by the FDA to treat COVID-19. The issue arises when remdesivir is used as an active pharmaceutical ingredient (API) in compounding. This API's quality and sourcing can result in patient harm, and, therefore, the recommendation continues that patients prescribed remdesivir should be treated with Veklury.
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