The PEW Charitable Trusts Releases Report on the State of Human Drug Compounding by Traditional Pharmacies and Outsourcing Facilities
Posted: 26 Feb 2018 04:41 PM PST
detailed report on the general state of pharmacy compounding of human drug products in the United States. The Report focuses on compounding pharmacies, but addresses both sterile and non-sterile compounding regulation by states. The Report also touches on states’ regulation of Outsourcing Facilities, which Congress created when it enacted Title I of the Drug Quality and Security Act (The Compounding Quality Act). The detailed Report provides a helpful roadmap of where states stand concerning their widening role in the regulation of human drug compounders in a post-NECC world. Given the morass of inconsistent state laws covering both traditional pharmacy compounding and Outsourcing Facilities (for both sterile and non-sterile human drugs) the roadmap is a welcome tool for industry, and those curious about what states are doing to address these important issues. The press release accompanying the Report notes the following points:Today the PEW Charitable Trusts released a
The Report contains recommendations for states on best practices for compounders to ensure a safe supply of compounded formulations. Those recommendations include a focus on quality assurance and emphasis on adherence to at least USP guidelines, alignment with federal law regarding office stock compounding (which law remains controversial among the pharmacy compounding community and some members of Congress about the appropriate parameters of office use compounding pursuant to FDCA Section 503A).
Although the content of the Report itself addresses in detail each of these and other points, even more interesting components of the Report appear in its Appendices. As anyone who works in the compounding world knows, understanding positions of various states on issues such as sterile and non-sterile compounding, inspections, state licensing fees, permissibility of office stock compounding, and Outsourcing Facility licensing requirements — to name a few — can induce both hand-wringing and hair pulling experiences for those that grapple with compliance with the myriad state requirements.
The Appendices set forth the questionnaire that PEW provided to states, and include several tables and charts specifically describing where states stand on these and other important issues (below). With respect to the Appendices, PEW sought states’ verification of data collected. Forty-three states and D.C. responded, but seven did not respond.