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GAO advises Congress to clarify FDA authority; tells FDA to do better at documenting inspections and tracking compounding pharmacies
Inconsistent decisions by two federal courts have compromised the FDA’s ability to regulate compounding pharmacies that produce drugs on a large scale and ship them across state lines. These decisions have required the agency to regulate drug compounding differently in different parts of the country, stretched the agency’s resources, and added time to the inspection process. In July, the Government Accountability Office (GAO) published a report, Drug Compounding: Clear Authority and More Reliable Data Needed to Strengthen FDA Oversight, confirming the need for Congress to clarify the FDA’s authority to regulate these compounders. Congress is currently debating several bills that address this regulation.
The FDA’s uncertain regulatory authority assumed prominence in 2012 because of the NECC meningitis scandal, in which allegedly contaminated sterile injectables resulted in (at latest count) hundreds of cases and 63 deaths. Currently, states regulate pharmacies, and compounding pharmacies claim that compounding is not manufacturing, and therefore, does not fall under the FDA’s authority. After discussions with authorities in a sample of states—California, Connecticut, Florida, and Iowa, GAO found that the current environment could create gaps in oversight, leading to inadequate protection of the public health.
GAO’s report discusses a second issue, the fact that the FDA’s inspections database doesn’t identify all inspections of compounding pharmacies and doesn’t always provide the final classification of inspection results, making oversight difficult. In addition, no requirements currently exist for large-scale drug compounders to register with the FDA, making identification of such compounders challenging. Some compounders, however, register voluntarily, possibly creating the impression among purchasers that the FDA has inspected or approved their compounded drugs. The FDA has agreed to make sure that its databases collect reliable and timely data on inspections of these drugs and that the data differentiates drug compounders from manufacturers.
The GAO report also cites data from the International Academy of Compounding Pharmacists that roughly 26,000 community pharmacies do some level of compounding, and about 7,500 “specialize” in the practice. In addition, there are 8,200 hospital pharmacies performing compounding. IACP, a trace group, is one of eight pharmacy associations that have formed the Pharmacy Compounding Accreditation Board for voluntary, national standards of performance. So far, 176 pharmacies have been granted accreditation, and 124 have applied.