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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

Executive Summary

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.

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