Compounding pharmacy provides different view of FDA inspections

AnazaoHealth discusses difference between USP and cGMP standards

“All pharmacies—and especially pharmacies that do compounding like we do and like most of those other pharmacies that have been investigated—do not follow cGMP regulations; they follow state regulations, which for the most part are driven by USP <795> and USP <797>, which we follow rigorously,” David Joseph, BSPharm, AnazaoHealth’s Director of Pharmacy and Regulatory Compliance and Quality, said in an interview with pharmacist.com.When FDA inspectors made a surprise visit to AnazaoHealth Corporation in Tampa, FL, in February and announced they would be conducting a cGMP (current Good Manufacturing Practices) audit, AnazaoHealth employees were puzzled.

AnazaoHealth is one of the compounding pharmacies FDA inspected in February through April after the deadly October 2012 fungal meningitis outbreak was traced to tainted steroid injections distributed by the New England Compounding Center (NECC) in Framingham, MA. In response to the media furor and public outcry that followed, FDA conducted surprise inspections and made “observations” related to cGMP requirements at AnazaoHealth and 47 other compounding pharmacies. In April, Rep. Ed Markey (D-MA) released the report “State of Disarray: How States’ Inability to Oversee Compounding Pharmacies Puts Public Health at Risk,” and proposed legislation giving FDA greater authority over compounding pharmacies is currently wending its way through Congress.

Manufacturing standards versusUSP <797> guidelines

All compounding pharmacies, which are regulated by state boards of pharmacy, are required to adhere to the guidelines laid out in the U.S. Pharmacopeia (USP), whereas cGMP standards apply to large-scale drug manufacturers. “One standard is not more rigorous than the other; they’re just different standards,” said Natarsha D. Nesbitt, JD, AnazaoHealth’s Corporate Counsel. On the same inspection visit, noted Samantha Dangler, AnazaoHealth’s Marketing and Public RelationsManager, state authorities accompanying the FDA inspectors did not find any safety deficiencies or issue any warnings.

To AnazaoHealth, the cGMP-based inspections revealed a lack of understanding about the crucial role of compounding pharmacies, which make one prescription at a time for individual patients with special needs—for example, a patient who is allergic to a drug ingredient or an infant who can’t be given the full strength of a drug. “Where are they supposed to get that care if it’s not from us?” asked Dangler.