Today the PEW Charitable Trusts released a 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:
- Thirty-two state pharmacy boards require pharmacies that engage in sterile human drug compounding to be in “full compliance” with the quality standards for sterile compounding set forth in USP<797>.
- An additional ten states have requirements that are “’equivalent to or stricter than’” USP<797>, while an additional four states have pending policy changes that, if they are passed, would require USP<797> compliance or additional, more stringent requirements. The Report notes that, in 2015, 26 states required compliance with USP <797> or an equivalent quality standard.
- Thirty-nine states and the District of Columbia prohibit pharmacies from human drug compounding of sterile office stock formulations. This contrasts with responses to a PEW survey back in 2015 from two-thirds of the responding state boards that permitted office use compounding “to at least some extent.”
The Report does note, however, that only 22 states and D.C. report that they routinely inspect their in-state sterile compounders at least annually, which is down from 26 states in 2015. The Report states that “interviews with state officials underscore the need for more financial resources and inspection capacity.”
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.
- Quality Standards for Section 503A Pharmacies that Compound Sterile Drugs for Humans (App. C, Table C1): Addressing which states require compliance with USP <797> or an equivalent or stricter quality standard; whether a regulatory change will be needed to require compliance with revised <797> (not yet released); whether the state requires compliance with other quality standards; whether there is pending state legislation, and its effect if passed.
- State Policies on Section 503A Pharmacies Drugs for Humans in the Absence of Patient-Specific Prescriptions (App. C, Table C2): Addressing which states permit office use compounding and any restrictions on the same for sterile and non-sterile products; whether state legislation is pending.
- State Licensure and Registration of Outsourcing Facilities (App. C, Table C3): Addressing whether states license or register Outsourcing Facilities; the type of license required; the fees required for Outsourcing Facility state licenses; whether there is pending legislation affecting Outsourcing Facilities. Note that Table clarifies the confusing morass of state registration/licensing requirements for Outsourcing Facilities, which are both complex and at times inconsistent among states (and with the federal Compounding Quality Act).
- Inspections of In-State 503A Pharmacies that Perform Sterile Compounding for Humans (App. C, Table 4): Addressing the frequency of routine inspections; specific circumstances that trigger inspections.
- State Oversight of Out-of-State 503A Pharmacies that Perform Sterile Compounding for Humans (App. C, Table 5): Addressing applicable quality standards; whether inspections are required; frequency of inspections; who performs the inspections; whether there is pending legislation or regulations and what would happen if they passed.