Over the last 18 months, injectable peptides have moved from the fringes of the wellness and anti-aging market into the broader commercial healthcare market. At the same time, regulatory oversight and inconsistent enforcement of these products (such as BPC-157, AOD-9604, CJC-1295, MK-677 (ibutamoren), and ipamorelin) have continued to create confusion within the industry. While federal law remains explicit in limiting the sale of peptides for human use to only select peptides, enforcement has been sparse, and the government’s intentions with regard to greater enforcement remain unclear. At the same time, state regulation and enforcement have been equally inconsistent, ranging from certain agencies aggressively seeking discipline of providers and suppliers, to others taking a “hands off” approach.
Against this backdrop, prognosticators abound, seeking to predict what action, enhanced enforcement or regulatory clarification, will happen next. While there has been no formal shift “approving” peptides for routine compounding, recent activity by the FDA and several state agencies provides important insight into how regulators are approaching this space and what stakeholders should expect going forward.
FDA Enforcement: A Consistent and Expanding Posture
At the federal level, the FDA has continued to emphasize that many peptides being marketed for injection are unapproved new drugs that do not qualify for the statutory exemptions available to traditional pharmacy compounding.
In late 2024, the FDA issued a series of Warning Letters to entities marketing peptides online for human use, notwithstanding attempts to characterize the products as for “research use only.” These letters alleged violations of the Federal Food, Drug, and Cosmetic Act (FDCA), specifically the marketing and sale of misbranded and unapproved new drugs and warned of escalation to seizures or injunctions if these violations were not promptly corrected. Although these actions were directed primarily at peptide vendors rather than licensed compounding pharmacies, they underscore the FDA’s willingness to act where peptide products are visible, commercialized, and intended for human administration.
Separately, FDA inspection and enforcement activity directed at large sterile compounders serving wellness and longevity markets, while not always peptide-specific, has reinforced a broader theme that the FDA is closely examining high-volume sterile compounding operations that appear to function more like manufacturers than traditional pharmacies.
PCAC Proceedings: FDA’s Policy Rationale in Plain View
Beyond enforcement, the FDA has used formal Pharmacy Compounding Advisory Committee (PCAC) proceedings to articulate its concerns with specific peptides. During multiple PCAC meetings in 2024, the FDA presented detailed briefing materials addressing nominations for substances including ipamorelin, ibutamoren (MK-677), CJC-1295, and AOD-9604. In those materials, the Agency highlighted recurring issues: limited or inadequate safety data, concerns about characterization and impurities, lack of evidence of historical use in compounding, and potential immunogenicity risks. While PCAC recommendations are advisory, these proceedings function as a clear public statement of the FDA’s thinking.
That said, the FDA is in the process of evaluating candidates to fill open seats on the PCAC. While the nomination and vetting process is still in its early stages, it is possible that the newly constituted PCAC, especially under direction from the current Administration, might reach different conclusions related to these products.
State Enforcement: Ohio as a Case Study
At the state level, enforcement activity has been more episodic but, in some jurisdictions, notably direct.
Ohio has emerged as one of the most visible examples. Over the past year, the Ohio Board of Pharmacy has issued and published summary suspension orders and settlement agreements involving clinics and distributors where peptide products (specifically including AOD-9604, BPC-157, and ipamorelin) were identified. In these actions, the Board repeatedly characterized the peptides as unapproved drugs or substances not permitted to be compounded and used their presence as a basis for immediate licensure action or discipline.
Importantly, several of these matters did not involve pharmacies at all, but rather clinics or terminal distributors of dangerous drugs. This reflects a broader enforcement trend: states need not rely solely on pharmacy-specific authorities to act when injectable peptides are identified. Instead, boards are leveraging drug distribution, storage, and supply-chain authorities to address what they view as unlawful products.
Other states have taken a quieter approach, communicating the FDA’s peptide posture through board minutes, agenda materials, or licensee advisories rather than headline enforcement actions. These communications nonetheless serve as public signals to licensees that peptides are on regulators’ radar.
No “Condoning” Actions, But Selective Enforcement
Notably absent in the last 18 months is any formal action by the FDA or states affirmatively condoning or approving peptide compounding. There have been no additions of these peptides to the 503A bulk list, no guidance suggesting enforcement discretion, and no public statements signaling tolerance for routine injectable use of these unapproved drugs.
That said, enforcement has not been uniform nor systematic. Many pharmacies and clinics report ongoing peptide activity without direct regulatory contact. This uneven enforcement should not be mistaken for regulatory acceptance or the exercise of enforcement discretion. Historically, FDA action in compounding spaces often lags market behavior, then accelerates rapidly once priorities are set and factual records are developed.
What This Means for Stakeholders
Taken together, recent enforcement actions and public pronouncements point to a consistent message: injectable peptides are viewed by regulators as high-risk, unapproved drugs that fall outside the traditional bounds of pharmacy compounding. The absence of universal enforcement does not equate to safety from scrutiny, particularly as volume increases, distribution expands, or marketing becomes more visible.
For pharmacies, clinics, and investors evaluating peptide activity, the key risk is not merely theoretical legality but practical exposure – inspection risk, forced cessation, reputational harm, and collateral scrutiny of broader operations. Regulators have shown they are willing to proceed incrementally, product by product, while reserving the ability to escalate to systemic action where warranted.
How Frier Levitt Can Help
As demand for peptides continues to grow, stakeholders should assume that regulatory scrutiny will also increase and should plan accordingly.
Frier Levitt attorneys with experience in both pharmacy and FDA law are available to assist clients with strategic advisory, regulatory compliance, and enforcement defense services in the pharmacy and peptide space as regulations and enforcement in this sector continues to evolve.
Senior Associate