FDA Begins Restricting Bulk Compounding With First DQSA Determinations
FDA has taken its first action on the 503B bulks list since DQSA was enacted five years ago by banning two bulk drug substances – vasopressin and nicardipine hydrochloride – from the list of bulk drug substances that outsourcing facilities can use to compound drugs. The agency also issued final guidance addressing its polices for developing the 503B bulks list. Legal observers say that these actions should prompt outsourcing facilities to be wary of using bulk drug substances not approved by FDA.
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The US FDA has proposed allowing outsourcing facilities to compound from four drug substances, but not from 19 others that it says already are available in FDA-approved drug products. Compounding pharmacies also would be allowed to compound from two of the four drug substances.
FDA proposal would allow traditional compounding from five drug substances based on medical need, but not from another 26.
Expected flurry of FDA proposals against 503B compounding from bulk drug substances follows vasopressin court ruling.