FDA will not include vasopressin on 503B bulks list

The US Food and Drug Administration determined that there is no clinical need to compound vasopressin under Section 503B of the Drug Quality and Security Act.

As a result, it will be unlawful for outsourcing facilities to sell compounded vasopressin products unless they manufacture those products using an FDA-approved vasopressin product, rather than bulk vasopressin, or if vasopressin were to be added to the FDA's drug shortage list.

Par Sterile Products, a subsidiary of Endo International (Nasdaq: ENDP), is the manufacturer of Vasostrict, the only vasopressin product approved by the FDA. Par and another Endo subsidiary are plaintiffs in a lawsuit against the FDA challenging a previously issued "interim policy" that authorized bulk compounding of vasopressin in violation of the applicable statute.