PAA’s policy positions are grounded in evidence, responsive to current regulatory developments, and always aligned with one principle: access should follow the science.
We do not advocate for every peptide equally. We advocate for evidence-based access — distinguishing between compounds with strong safety records and those with limited human data, and crafting positions accordingly.
Join our coalition →The FDA’s current framework for determining which substances may be used in compounding pharmacies has systematically excluded peptide compounds with established safety profiles — not through adverse clinical findings, but through bureaucratic inaction. This must change.
Under the Drug Quality and Security Act (DQSA) of 2013, the FDA regulates which bulk drug substances can be used in compounding via two lists: 503A (traditional pharmacies) and 503B (outsourcing facilities). Substances not on these lists cannot legally be compounded, regardless of their safety record.
In 2020, the FDA nominated BPC-157 for evaluation — an action that effectively triggered a restriction before any adverse finding was made. Dozens of additional peptides, including TB-500 and Selank, remain in regulatory limbo: not banned, not approved, and practically inaccessible to patients through legitimate channels.
The nomination-to-decision timeline frequently exceeds five years, leaving practitioners and patients in an untenable position. The cost of regulatory uncertainty falls entirely on the patient.
PAA supports a reformed bulk substance nomination process that is evidence-based, transparent, and time-bound. The threshold question — whether a compound may be compounded — should be answered by clinical evidence of risk and genuine therapeutic need, not by the absence of a completed FDA review cycle.
We support the interim use of peptide compounds with established human safety profiles while formal review is pending, subject to practitioner oversight and quality standards. The current default of restriction-pending-review is backwards: it punishes safety-conscious practitioners and drives patients toward the unregulated gray market.
PAA will submit formal comments to the FDA’s bulk substance docket, engage congressional offices on DQSA reform, and build the clinical coalition necessary to demonstrate genuine therapeutic demand.
The FDA’s 2025 resolution of the semaglutide shortage designation has effectively terminated legal access to compounded GLP-1 medications for millions of patients who cannot afford branded alternatives. This is a patient safety crisis masquerading as a regulatory success.
From 2022 through early 2025, the FDA’s shortage designation for semaglutide (Ozempic, Wegovy) permitted 503A and 503B compounding pharmacies to legally produce compounded versions at a fraction of the branded price — typically $150–$250/month versus $900–$1,400/month for branded products.
In early 2025, the FDA removed Ozempic and Wegovy from the shortage list, triggering enforcement guidance requiring compounding pharmacies to cease production. For hundreds of thousands of patients already established on compounded GLP-1 therapy, this created an immediate access cliff — not because the drug became unavailable, but because the price became prohibitive.
The FDA’s “essentially a copy” doctrine, intended to prevent compounders from competing with approved drugs for commercial reasons, was never designed to address a patient population with no realistic access to the branded alternative.
PAA supports the FDA’s interest in ensuring the quality and safety of compounded medications. We do not oppose shortage resolution as a principle. What we oppose is using shortage resolution as a mechanism to terminate access for patients who, in practice, cannot afford the branded alternative.
The right framework distinguishes between compounders acting for commercial advantage — a legitimate regulatory concern — and practitioners serving patients with genuine access barriers. These are not the same situation, and they should not be regulated identically.
PAA is engaging congressional offices on legislation that would create a patient-protection framework for transitions from shortage-period compounding, requiring proof of patient need rather than blanket prohibition. We also support policy interventions addressing pharmaceutical pricing as the structural root cause of this crisis.
FDA enforcement interpretations have created a chilling effect on legitimate scientific communication about peptide compounds. Citing peer-reviewed research is not a drug claim. Practitioners and researchers must be able to share evidence without fear of regulatory retaliation.
Under FDA’s current enforcement framework, the distribution of information about a compound’s health effects — including the distribution of peer-reviewed scientific literature — can constitute evidence of “intent to distribute as a drug” for unapproved substances. This interpretation has led to warning letters, enforcement actions, and the systematic suppression of scientific communication in the peptide space.
The practical effect is that practitioners who want to have informed conversations with patients about research compounds face genuine legal risk for doing so. Advocacy organizations like PAA must navigate extraordinary legal complexity simply to share published science.
This is not what the FDCA was designed to do. The statute’s intent was to prevent fraudulent health claims, not to suppress the dissemination of peer-reviewed research to informed adults.
The sharing of peer-reviewed, publicly available scientific research is protected expression. A practitioner who cites a published PubMed study in a clinical conversation is not making a drug claim — they are practicing evidence-based medicine. The FDA’s conflation of these activities is both legally questionable and practically harmful.
PAA supports a clear, bright-line distinction between legitimate scientific communication and commercial drug promotion. This distinction exists in case law (Washington Legal Foundation v. Henney; Whitaker v. Thompson) but has not been codified in FDA guidance in a way that provides practitioners and researchers with meaningful protection.
We are supporting litigation efforts that challenge overbroad FDA enforcement interpretations, engaging the FDA’s Office of Prescription Drug Promotion on updated guidance, and building a coalition of First Amendment attorneys, practitioners, and researchers to push for Congressional action.
Whether you’re a practitioner, researcher, or advocate — your voice matters. Join our coalition and receive policy briefings, comment letter drafts, and action alerts.