Two medications, ephedrine sulfate and hydroxychloroquine sulfate, were denied inclusion on the FDA's 503B bulks list, the agency said Aug. 21.
Outsourcing facilities are only allowed to compound drugs with five bulk substances — diphenylcyclopropenone, glycolic acid, quinacrine hydrochloride, squaric acid dibutyl ester and trichloroacetic acid — for specific uses, such as topical or oral use.
The FDA has evaluated and blocked 20 other solutions from joining the list, according to documents.