Gly­col­ic acid, TCA among FDA's pro­posed ad­di­tions to 503B bulk drugs list

Four new bulk sub­stances are up for in­clu­sion on the list of ac­tive phar­ma­ceu­ti­cal in­gre­di­ents that out­sourc­ing fa­cil­i­ties can use in drug com­pound­ing un­der sec­tion 503B of the Fed­er­al Food, Drug, and Cos­met­ic Act, ac­cord­ing to a pro­pos­al from the FDA.

The four sub­stances FDA is propos­ing to in­clude as bulk drug sub­stances are diphenyl­cy­clo­propenone, gly­col­ic acid, squar­ic acid dibutyl es­ter and trichloroacetic acid. An ad­di­tion­al 19 bulk drug sub­stances were con­sid­ered for in­clu­sion in the 503B bulk drug sub­stances list, but FDA is propos­ing not to in­clude these sub­stances, cit­ing a lack of clin­i­cal need for an out­sourc­ing fa­cil­i­ty to com­pound drugs from the 19 sub­stances. This lack of need, said the agency, meant the drugs did not meet the statu­to­ry cri­te­ria for ad­di­tion to the list.

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