October 29, 2021

FDA takes aim at medical office compounding

The FDA is effectively giving notice to compounders in medical offices and clinics: It’s concerned, it says, over reports of pharmaceutical compounding being done under insanitary conditions.

The published article, “FDA highlights concerns with compounding of drug products by medical offices and clinics under insanitary conditions,” does not specify any new or changed guidance — it simply expresses the agency’s concerns while listing a number of examples of insanitary conditions that were observed.

FDA has become increasingly aware of drug products compounded at medical offices and clinics that were prepared under insanitary conditions. FDA has also become aware of business models, such as intravenous (IV) hydration clinics, medical spas, and mobile IV infusion services, that are compounding drugs that may not meet the conditions of section 503A of the FD&C Act or comply with state regulations.