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No Means No, US FDA Advises 503A Compounding Pharmacies

The Pharmacies Must Honor 503A Bulks List Denials, But Can Appeal Them

 
• By Joanne S. Eglovitch

The US FDA has issued question-and-answer guidance to help pharmacies better understand and comply with its final rule establishing its 503A bulks list. The guidance addresses how the agency developed the list of approved bulk drug substances and how to appeal decisions to get substances placed on the list.

Side view of titration in a compounding pharmacy

The US Food and Drug Administration meant what it said in a 19 February rule disallowing traditional pharmacies regulated under Section 503A of the Food, Drug and Cosmetic Act from compounding drugs from four bulk active substances – despite the small-business impact – the agency explained in a 24 May question-and-answer guidance document.

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