APC: 503B bulk: What’s in? What’s out? Who tells the story?

August 5, 2020

503B bulk: What’s in? What’s out? Who tells the story?

Finally! Guess what, 503B pharmacies? The FDA is — after half a decade — considering updating the bulk drug substances list, and it wants your input.

IN (proposed): DPCP, glycolic acid, SADBE, TCA — see https://www.federalregister.gov/d/2020-16649/p-58

OUT (proposed): 19 other substances — see https://www.federalregister.gov/d/2020-16649/p-78

Where to comment: https://beta.regulations.gov/comment/FDA-2018-N-3240-0054