Compounders Get Guidance on Fixing Insanitary Conditions

Drug compounders have new FDA guidance on identifying insanitary conditions at their facilities.

The Food and Drug Administration issued a draft guidance Aug. 3 to help compounding facilities identify insanitary conditions so that they can correct them. The guidance also will help state regulatory agencies understand what the FDA considers to be insanitary conditions.

The agency said drug products “compounded under insanitary conditions could become contaminated and cause serious adverse events in patients, including death.”

Comments on the draft guidance, identified by Docket No. FDA-2016-D-2268, are due Oct. 3. A notice announcing the draft guidance was published in the Aug. 4 Federal Register (81 Fed. Reg. 51,449).

John Voliva, executive vice president of the International Academy of Compounding Pharmacists (IACP), told me in an Aug. 3 e-mail that IACP “is appreciative of the FDA's efforts to further define and clarify what the Agency feels are insanitary conditions.”

“We do have concerns around some items which could be related to cGMP [current good manufacturing practice] and will fully identify these issues in our comments,” Voliva said. “However, overall, this draft guidance, along with the FDA’s recent notice regarding inspections, gives the industry a clearer picture as to the agency’s process when it comes to investigations of pharmacies who comply with Section 503A of the Federal Food, Drug, and Cosmetic Act.” Section 503A describes the requirements for traditional compounding pharmacies.

In July, the FDA said it was changing its inspection process to clarify that traditional drug compounders are exempt from cGMP requirements.

Stay on top of new developments in health law and regulation with a free trial to the Health Law Resource Center. Learn more about Bloomberg Law and sign up for a free trial.