FDA Begins Restricting Bulk Compounding With First DQSA Determinations

06 Mar 2019

• By Joanne S. Eglovitch

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.

In two actions with widespread implications for the compounding industry and healthcare providers, FDA has decided to ban two bulk drug substances – vasopressin and nicardipine hydrochloride – from the list of bulk drug substances that outsourcing facilities may use in compounding drugs in its first such decision in the five years since the Drug Quality and Security Act required the agency to establish the list. FDA has also issued final guidance establishing its criteria for evaluating these substances for placement on the 503B bulks list.

Legal observers say that these two actions are significant in that it puts outsourcing facilities on notice that the agency...