There’s a new certification process for compounding pharmacies

Third-party certifications continue to be a lively area of activity in the pharmacy business, in part to qualify for certain reimbursable services, and in part to present a competitive advantage over non-certified entities. Thus, the specialty pharmacy arena has witnessed a near-explosion of certified providers, and the number of accreditation providers has also grown, with the Center for Pharmacy Practice Accreditation joining the Accreditation Commission for Health Care, the Joint Commission, and URAC as accreditation providers.

Now, a similar dynamic is showing up for compounding pharmacies. A longstanding program, Pharmacy Compounding Accreditation Board (PCAB) will have competition from HFAP, which has announced a new certification program. “With a focus on accuracy and consistency, the HFAP Compounding Pharmacies Certification Standards provide guidance on how best to assess and reduce risk,” said Marci Ramahi, CAE, director of Accreditation/Certification Operations. “While a certification is not required, the HFAP program aims to instill best practices into everyday activities, ensuring pharmacies and specialized pharma products meet the highest standards of quality.”

HFAP (originally, the Health Facilities Accreditation Program) is a Chicago-based organization that has been accredited hospitals since 1945, and has expanded into facilities for ambulatory care, mental health and physical rehabilitation, among others. It is a “deeming authority” under CMS guidelines, meaning that it certifies facilities that are reimbursed by Medicare or Medicaid. “A significant number of the hospitals we accredit operate their own compounding pharmacies, so it makes sense for us to provide this additional service,” says Ramahi, while noting that freestanding compounding pharmacies are also candidates. Certification consists of a review of documentation, interviews and site visits by surveyors.

PCAB originated a decade ago as an industry effort, and in 2014 became a service provided by ACHC; it now has three distinct types of compounding certification. Like PCAB, HFAP will follow the standards of US Pharmacopeia guidance, such as USP <795> and <797>.

The 70 or so compounding pharmacies that have been registered as 503(b) facilities at FDA (under the 2013 Drug Quality Safety Act) had revenues of around $2.5 billion in 2017, according to a recent market study by Global Market Insights, Inc. The much larger number of non-registered compounding pharmacies add billions more. Notwithstanding the industry and governmental regulation of compounding pharmacies (much improved since the meningitis scandal of NECC in 2012), the field still has its problems: numerous compounding pharmacies have been indicted in false-claims cases for Medicare and Tricare, and numerous pharmacies received warning letters from FDA as the 503(b) cranked up since 2013. Pharmedium, a major provider now owned by AmerisourceBergen, has failed numerous FDA inspections in the past 12 months and is still struggling to return to normal operations.