Vasopressin Ruling May Greenlight More FDA Limits On Bulk Drug Compounding
Executive Summary
By siding with the FDA against bulk compounding of vasopressin, is court encouraging more limits to Section 503B outsourcing facilities?
You may also be interested in...
Nine More FDA Bulk Compounding Denials Proposed Post-Vasopressin
Expected flurry of FDA proposals against 503B compounding from bulk drug substances follows vasopressin court ruling.
Athenex Sues FDA To Get Vasopressin On List Of Drugs That Can Be Compounded
Company argues there is a clinical need for its ready-to-use, preservative-free compounded formulation of vasopressin but agency says Vasostrict is available in a dose without the preservative.
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.