503A pharmacy compounders must abide by all federal, state and local requirements. Recently, states have undertaken to enact a series of restrictive compounding laws and regulations ranging from licensure requirements, to beyond use date updates, to prohibitions on compounding using certain ingredients. This is creating a patchwork of state compounding requirements that differ from the federal requirements.
On November 1, 2023, the long-awaited revisions to USP <797> for sterile compounding and <795> for non-sterile compounding became official. Some states have simply stated that USP <797> and <795> are minimum standards only. While states have previously used legislation and rulemaking to fill regulatory gaps (e.g., several states require 503A compounders to report Adverse Drug Events from compounded products), over the last year there have been increased state level laws and regulations for 503A compounding. In many cases, these rules are stricter than federal requirements without any clear or verifiable rationale why the more stringent regulation is necessary. Additionally, several state rules have poorly defined wording, leading to unclear requirements. Recently, the State Board of California has proposed a definition of “essentially a copy” to include the phrase “comparable in active ingredients” where the word “comparable” is open to wide interpretation as it does not have a succinct definition.
Likewise, Mississippi’s Board of Pharmacy requires an annual statistical report of all compounds and restricts advertising by explicitly prohibiting pharmacies from soliciting business by promoting the compounding of specific drug products (e.g., like a manufacturer). The Ohio Board of Pharmacy requires that most compounded products be prepared in a “clean room” unless used within six hours.[1] In several other states, including Idaho and Ohio, the Board of Pharmacy is responsible for oversight of physician compounding. The Boards of Pharmacy in New Jersey, Louisiana, Mississippi, North Carolina, Alabama and West Virginia have issued warnings on compounding of semaglutide, with several states prohibiting out of state compounding pharmacies from shipping semaglutide to patients in their states. New York has added a one-hour compounding credit continuing education requirement for pharmacists licensed in that state. California and Alabama are restricting orders for bulk office use compounded products shipped to clinics within their states and are further requiring that only patient-specific compounded prescriptions be permitted into those states.
Not all state actions are more stringent, however. For example, Mississippi has proposed to permit IV hydration solutions to be compounded outside of a 503A pharmacy, permitting their compounding by nurses and nurse practitioners in a clinic.[2]
Additionally, we are seeing an uptick in the volume of state Board of Pharmacy inspections of 503A pharmacies with a strong emphasis on USP <797> compliance and sterile compounding. Triggers for state Board of Pharmacy inspection of 503A compounders often come from patient complaints, MedWatch ADR reports to FDA (who then notifies the state board), 503A compounding for “office use” or other inappropriate distribution, advertising a compound for a specific indication, PBM complaints, and inappropriate delegation/supervision of compounding.
In 2024, we expect additional states to enact different regulations than those permitted federally and ramp up oversight and enforcement activities.
How Frier Levitt Can Help
We provide regular counseling on Section 503A and state-specific compounding requirements. We can assess your compounding practices for state and federal regulatory compliance, including medical necessity documentation, reimbursement issues, infrastructure and preparing compounding policies and procedures that provide clear guidelines, standards and training for staff.
[1] Id. § 4729.541.
[2] HB 648.
