FDA rejects 2 drugs from 503B bulks list

Two medications, ephedrine sulfate and hydroxychloroquine sulfate, were denied inclusion on the FDA’s 503B bulks list, the agency said Aug. 21. 

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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.

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