FDA Hails Court Compounding Decision

FDA says it is pleased that a DC federal court upheld the agency’s interpretation regarding the bulk substances that may be used by outsourcing facilities in drug compounding. An agency statement says FDA previously announced that vasopressin is not a bulk drug substance for which there is a clinical need because there is already an FDA-approved product on the market to meet patients’ medical needs. It therefore decided not to include the bulk drug substance vasopressin on a list of bulk drug substances that can be used in compounding by outsourcing facilities.

The court ruled that the agency’s method of determining clinical need for a bulk drug substance is consistent with the law.

“We will continue to evaluate bulk drug substances nominated for use in compounding by outsourcing facilities in accordance with our interpretation of clinical need,” the statement says.