January 11, 2017

FDA puts compounding pharmacies under scrutiny, GAO survey shows

The FDA is stepping up its inspections of drug compounders, including those in Georgia. From May 2012 through April 2016, 265 traditional compounding pharmacies operating under Section 503A of the federal Food, Drug and Cosmetic Act were inspected across the nation, according to a November 2016 report from the U.S. Government Accountability Office.

The FDA inspects compounding pharmacies for cause, follow-up and surveillance. Drug compounders operating under Section 503A are not required to register with the FDA, and the agency uses a risk-based model to determine which facilities to inspect. Adverse event history, prior regulatory actions, recall history, the frequency of complaints and prior inspections are all factors in that decision.

For-cause inspections are usually the result of a complaint. From May 2012 through April 2016, 46 percent of 503A inspections were for cause. Surveillance inspections were the second-most common type of inspection at 39 percent. The surveillance inspections are meant to check on known drug compounders, such as those that have been previously inspected. The remaining FDA inspections – 15 percent – are for follow-up. Follow-up inspections are made after a warning letter has been issued to check on corrective actions. The 265 inspections by the FDA resulted in 228 FDA inspection observation reports, which are presented to pharmacy management when possible violations are present. Known as Form 483, the observation reports cited various environmental issues including dead insects in ceilings.

When violations do occur, the FDA usually submits a warning letter. Eighty-one pharmacies received a warning letter during the time period examined by the GAO. A voluntary recall request is the second-most common action taken by the FDA. It requested 72 voluntary recalls to 503A pharmacies that were fulfilled and two that were ignored. The FDA shared its inspection findings with state regulatory agencies for follow-up in 31 cases. Only once did it request a regulatory meeting with pharmacy management to discuss illegal production.

The GAO report notes that the FDA sought and obtained two warrants to inspect pharmacies that denied inspectors access. The FDA also took criminal enforcement actions against three drug compounders that were not outsourcing facilities.

The FDA also inspected 75 outsourcing facilities, which require federal inspection on a risk-based schedule. Agency officials aim to inspect an outsourcing facility within two months of its initial registration. After that, an outsourcing facility should be inspected every 12 to 18 months.

Only six of the 75 inspections of outsourcing facilities were for cause during from May 2012 to April 2016. Most inspections – 72 percent – were for surveillance. A warning letter was the most common action when violations were found. Twenty-four outsourcing facilities received warning letters during the time period covered by the GAO report. A voluntary recall was requested 15 times and one pharmacy received an untitled letter, which notifies an outsourcing facility of violations that do not merit a formal warning letter.

The Hasson Law Group has specific recommendations for compounding pharmacies facing an FDA inspection. Even if an inspection is not imminent, all compounding pharmacies should conduct periodic audits to measure compliance in preparation for possible inspections. Any pharmacy that discovers potentially unsanitary conditions should seek immediate advice from qualified legal counsel.

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