An FDA draft guidance limiting the bulk drug substances that 503B facilities can use in compounding may trigger several unintended consequences, including a worsening of drug shortages affecting critical medications, some stakeholders contend.
Interested parties have until May 25 to provide comment on the guidance document.
As part of the implementation of the Drug Quality and Security Act (DQSA), approved in 2013, the FDA was directed to develop a list of bulk drug substances