FDA set­tles drug com­pound­ing suit, agrees to speed its re­view of bulk in­gre­di­ents

Back in 2014, the FDA made very clear to the grow­ing but un­der-reg­u­lat­ed phar­ma com­pound­ing world that it would be­gin im­ple­ment­ing a new law from Con­gress re­quir­ing the agency to de­vel­op a list of bulk drug sub­stances (or ac­tive in­gre­di­ents) that com­pa­nies may use to com­pound drugs.

But the nom­i­na­tion process for these bulk in­gre­di­ents ran in­to a wide va­ri­ety of sub­mis­sions, with the FDA not­ing at the time that many of the nom­i­na­tions were not even for bulk drug sub­stances used in com­pound­ing as ac­tive in­gre­di­ents, “and none in­clud­ed suf­fi­cient in­for­ma­tion to jus­ti­fy in­clu­sion.”

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