FDA Issues Statement on Compounding Decision

August 6, 2019

A US District Court in Washington, DC upheld FDA’s interpretation of clinical need when choosing which substances are approved to use for drug compounding.

FDA is calling a US District Court’s decision regarding the agency’s interpretation of clinical need in bulk substances used in drug compounding a “victory for public health.” According to the agency, a US District Court judge in Washington, DC upheld the FDA’s definition of “clinical need” in its determination that vasopressin is not a bulk substance that should be included in its approved bulk substances list for drug compounding.

In March 2019, the agency decided that because an FDA-approved product was already on the market that would meet patients’ needs it would not put vasopressin on the list of bulk drug substances (the “503B Bulks List”) that may be used in compounding by outsourcing facilities. On August 1, a US District Court judge sided with FDA and found that the agency’s method for determining “clinical need” was consistent with the law.

“Our compounding work remains a top priority at the agency. We’ve long recognized that compounded drugs can serve an important role for patients whose medical needs cannot be met by an FDA-approved drug product. But compounded drugs are not approved by the FDA and, therefore, have not been evaluated for safety, efficacy or quality. We’ve seen first-hand the harm they can cause patients when they’re not appropriately compounded,” the agency stated in a press release. “Since the enactment of the DQSA [Drug Quality and Security Act], we’ve taken significant new steps to modernize and clarify our policies related to the quality of compounding in an effort to ensure continued access to compounded drugs for patients who need them, while also protecting patients from the risks of contaminated or otherwise harmful products.”

Source: FDA