US FDA outlines expectations for human drug compounders

Yesterday, the US Food and Drug Administration issued several policy documents regarding compounded drug products for human use, as part of the agency’s continuing effort to implement the compounding provisions of the Drug Quality and Security Act (DQSA), enacted in November 2013.

The policy documents consist of a draft interim guidance, a proposed rule, a final guidance, and two revised requests for nominations for the bulk drug substances lists.

“Providing clarity to the compounding industry on the agency’s expectations for these unapproved drug products is a priority for the agency,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “These actions are essential next steps in providing the compounding industry with the appropriate tools to comply with the law and advancing the FDA’s efforts to continue protecting patients,” she noted