This week, FDA published a new draft guidance on the Prohibition on Wholesaling Under Section 503B...
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