Posted 04 March 2014
By Alexander Gaffney, RAC
The US Food and Drug Administration (FDA) may be in the process of moving on from a scandal involving deficient practices by pharmaceutical compounding pharmacies, but as evidenced by three Warning Letters released today, it's not done scrutinizing the industry.
Unlike more traditional pharmaceutical manufacturers-think Pfizer, for example-compounding pharmacies make custom versions of already-approved pharmaceuticals with the stated purpose of meeting unique patient needs. A compounding pharmacy might make a smaller dose of a drug than is commercially available, for example.
But as a massive outbreak of fungal meningitis in late 2012 illustrated, not all was well in the compounding sector. FDA investigators would later determine that deficient quality practices at a compounding pharmacy had resulted in patients being exposed to contaminated products, leaving dozens dead and hundreds seriously injured.
A subsequent surge of FDA inspections discovered scores of similar violations at other compounding pharmacies, leading to a wave of recalls and enforcement actions.
In response to the crisis, legislators ultimately passed the Drug Quality and Security Act, which created a new system in which some compounding pharmacies will be incentivized to register with FDA as "outsourcing pharmacies" (Section 503B of the Federal Food, Drug and Cosmetic Act) and consent to inspections. The hope, legislators said, is that this category of pharmacy will be sought after by consumers because of the quality assurances they offer relative to smaller pharmacies.
Other compounding pharmacies will continue to be regulated by state pharmacy boards (per Section 503A).
But while FDA continues to set up that outsourcing pharmacy system, it has continued to send out Warning Letters to companies based on the outcomes of deficient site inspections.
The first letter to be sent out after the passage of the DQSA went to North Carolina-based Triangle Pharmacy, and reflected some of FDA's new authorities under the law. Specifically, it cited three new compounding guidance documents that FDA had published, and made the case that the pharmacy had violated both Section 503A and an agency Compliance Policy Guide (460.200) that were in effect at the time of the inspection.
Two of the three Warning Letters sent by FDA this week are similar to that Triangle Pharmacy letter. Like the Triangle letter, FDA cites both companies-Nora Apothecary and Alternative Therapies; and Wedgewood Village Pharmacy-for compounding without having received valid prescriptions for individually identifiable patients.
Those actions caused both companies to be in violation of the FD&C Act, FDA wrote.
The highly similar letters also went on to note other violations of the FD&C Act, such as issues related to sterile compounding, current good manufacturing practices (cGMPs) and general misbranding.
A third letter to Pallimed Solutions, whose products were recalled in March 2013, was alleged to have manufactured adulterated products under unsanitary conditions. FDA inspectors had found "filamentous and brown floating particles" in several lots of sterile drug products, as well as chipped paint on the ceiling of the compounding room, yellow/brownish discoloration in a laminar flow hood, and residue on a plastic curtain used to divide the gowning area from the rest of the compounding room.
The Pallimed letter was the only one not to cite FDA's new authority under the DQSA.