Pharmacy compounding plays a vital and time-honored role in American healthcare, offering customized medication solutions when FDA-approved drugs are in shortage or a prescriber judges a custom formulation is needed for an individual patient’s needs. Compounded medications are prepared in licensed pharmacies by trained professionals under rigorous oversight from state pharmacy boards and in general accordance with compounding standards established by the U.S. Pharmacopeia.
Under President Trump’s 10:1 Executive Order requiring the elimination of unnecessary federal rules, we believe pharmacy compounding presents a clear opportunity for reform.
This document highlights key federal policies or proposals that are redundant, unauthorized by statute, or unproven in their benefit to public health. It offers constructive recommendations to support smarter, more effective regulatory approaches—ones that preserve safety without undermining access or innovation.
A strong regulatory framework for pharmacy compounding is essential. But unnecessary regulation—especially when it fails to deliver a measurable safety benefit—is more than a nuisance; it’s a threat to patient access and a burden on the small businesses that serve those patients.
FDA continues to enforce a 1997 Memorandum of Understanding that no longer aligns with today’s legal landscape—thanks to the Drug Quality and Security Act (DQSA). The MOU is burdensome, legally obsolete, and limits patient access, especially across state lines.
Action Needed: Congress must repeal the outdated MOU provision and align federal law with modern compounding practices.
FDA is trying to apply rules intended for 503B outsourcing facilities to 503A pharmacies—going beyond its legal authority to ban entire drug categories, not just individual formulations.
Action Needed: FDA must follow congressional intent and limit prohibitions under 503A to specific drug products only.
FDA refuses to recognize dietary supplement monographs as applicable for compounding—even though they meet USP scientific standards.
Action Needed: Recognize all USP monographs, including those for supplements, as valid under Section 503A.
From GLP-1 warnings to compounded ketamine alerts, FDA public messaging lacks evidence and nuance—undermining trust and misleading the public.
Action Needed: FDA must use balanced, evidence-based communications that clearly distinguish legitimate compounding from counterfeit products.
Pharma companies are lobbying to add GLP-1 APIs to DDC lists—not because they’re difficult to compound, but to eliminate competition.
Action Needed: FDA must ground decisions in science, not corporate interest.
Millions rely on compounded bioidentical hormone therapy (cBHT), but FDA is using a flawed 2020 report to justify restricting it.
Action Needed: Disqualify the biased NASEM report from influencing any rulemaking. Preserve patient access to tailored hormone care.
FDA relies on drugmakers to declare shortages—ignoring on-the-ground realities from providers and pharmacists.
Action Needed: Support legislation requiring FDA to consider real-world data when determining drug shortages.
FDA’s Pharmacy Compounding Advisory Committee (PCAC) excludes real-world voices and favors agency narratives.
Action Needed: Ensure balanced PCAC membership with practicing compounders and equal opportunity for public comment.
FDA still hasn’t finalized the 503B bulks list, a critical tool intended to define which bulk drug substances outsourcing facilities can use to prepare compounded medications. This delay—more than a decade since the creation of the 503B pathway—has left hundreds of safe and essential substances in regulatory limbo. Without this list, 503B facilities face uncertainty, risk, and restricted ability to serve hospitals, clinics, and patients in need. The absence of a finalized list hampers patient access to medications, stalls investment, and invites unnecessary enforcement risk.
Action Needed: Finish the 503B review and deliver a science-based, comprehensive bulks list now.
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