FDA to issue revised draft guidance on hospital pharmacy compounding

The Food and Drug Administration plans to revise its 2016 draft compounding guidance for hospital and health system pharmacies. “The agency recognizes that hospital and health system pharmacies are different than other pharmacies not owned by hospitals and from conventional manufacturers, and as such, have unique needs and challenges,” FDA Commissioner Scott Gottlieb, M.D., said this week. “To that end, we plan to issue a revised draft guidance regarding hospital or health system compounding to provide further clarification on how the FDA intends to apply section 503A of the FD&C Act to drugs compounded at these facilities. Our revised policies will also provide guidance for hospital or health system pharmacies that might be considering registering as an outsourcing facility under section 503B.”

In comments submitted in 2016, AHA urged the agency to revise the draft guidance to allow hospital and health system pharmacies to continue to distribute compounded drug products to other health care facilities in the same system. Specifically, AHA urged the agency to remove the “arbitrary” one-mile radius limitation and replace it with an alternative approach that would support the existing hospital and health system care delivery model.

Among other actions, FDA plans to issue another proposed rule to further amend the list of bulk drug substances that 503A compounders can use to compound drugs, and finalize its memorandum of understanding with states to address traditional compounders that distribute a certain percentage, known as inordinate amounts, of their compounded drugs across state lines. The agency also plans to hold a public meeting in May to discuss current good manufacturing practice for outsourcing facilities and receive public feedback on the potential impact of proposed policies related to current good manufacturing practice requirements on office stock access for health care providers.