By Marie Rosenthal
The FDA released a draft guidance document that will limit the bulk drug substances that 503B facilities can use in compounding, giving preference to the use of branded products over compounding from bulk components.
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 “for which there is a clinical need.” The new guidance attempts to address that requirement,