FDA Says Some Drug Compounding Inspections Changing

An FDA statement says that the agency is changing its procedure for inspections of entities that are seeking to compound drugs under section 503A of the Federal Food, Drug, and Cosmetic Act (human drug compounders not registered with FDA as section 503B outsourcing facilities). As of 8/1, it says, FDA investigators will make a preliminary assessment of whether such entities are compounding their human drugs in accordance with certain conditions of section 503A before closing the inspection.

If the investigator issues an FDA-483, the notice says, it will not include observations that represent deviations solely from the agency’s current good manufacturing practice requirements unless it appears, based on the investigator’s preliminary assessment, that the firm compounds drugs that do not qualify for section 503A exemptions.

After the inspection, FDA says, the agency will conduct a thorough review of the evidence to evaluate whether the firm compounds all of its drugs in accordance with certain conditions of section 503A and other applicable provisions of federal law. “When FDA’s more thorough post-inspection review differs from the FDA investigators’ preliminary assessment and reveals that a facility fails to produce drugs in accordance with the conditions of section 503A,” the notice says, “FDA intends to consider citing CGMP violations in any regulatory action it decides to pursue.”