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.
You may also be interested in...
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.
By siding with the FDA against bulk compounding of vasopressin, is court encouraging more limits to Section 503B outsourcing facilities?