State-by-State Peptide Compounding Legality Guide
What Pharmacists, Prescribers & Clinics Must Know
Peptide compounding legality in the U.S. is not determined by your state. It is determined by three federal questions — and states add enforcement intensity above that floor, not permissions below it. Understanding that distinction is the single most important thing pharmacists, prescribers, and clinic operators can know before making any compliance decision.
Key takeaways
- Peptide compounding legality rests on three federal determinations: FDA-approved (legal with prescription), Category 1 bulk drug substance (compoundable under 503A/503B with valid Rx), or Category 2/unevaluated (cannot be legally compounded, regardless of state)
- States cannot override federal Category designations — they add enforcement requirements and documentation standards above the federal baseline, but no state can make a Category 2 peptide legal to compound
- As of March 2026, the 19 peptides placed on the FDA’s Category 2 list in 2023 remain Category 2; HHS Secretary Kennedy announced expected reclassification of approximately 14 on February 27, 2026, but no formal FDA regulatory action had been published at the time of writing
- The 2025–2026 enforcement wave is state-led: 38 attorneys general sent a formal letter to the FDA, Connecticut obtained a monetary judgment against a research peptide seller, and Alabama obtained a temporary restraining order against a GLP-1 distributor in November 2025
- “Research use only” labels do not provide legal protection when products are marketed with dosing guides, before/after photos, or syringes — the FDA has stated this explicitly in warning letters
Legal and compliance notice This guide is for general educational purposes only. It does not constitute legal advice and does not create an attorney-client relationship. Regulatory status changes frequently — verify all Category designations at FDA.gov before making compliance decisions. The February 2026 HHS announcement regarding reclassification has not been formalized in FDA regulatory documentation as of this writing. Consult a licensed healthcare attorney and your state pharmacy or medical board for current, jurisdiction-specific guidance.
The federal framework — what controls everything
The FDA’s three-question framework determines whether any peptide can be legally compounded, prescribed, or sold. These questions must be answered in order.
Question 1: Is this peptide FDA-approved? If yes — it can be prescribed with a valid Rx, filled at any licensed pharmacy, and used for its approved indication. Off-label prescribing of FDA-approved drugs is legal.
Question 2: Is this peptide on the Category 1 bulk drug substances list? If yes — a licensed 503A or 503B compounding pharmacy can prepare it with a valid prescription from a licensed prescriber.
Question 3: Is it Category 2 (safety concerns) or simply unevaluated with no USP monograph? If yes to either — it cannot be legally compounded under 503A or 503B, regardless of state.
The intent-based doctrine
The FDA’s authority over peptides flows from the Federal Food, Drug, and Cosmetic Act (FDCA), which treats any substance as a “drug” when it is intended — by label or by evident marketing purpose — to diagnose, cure, treat, or prevent a disease.
This is the intent-based doctrine. Selling BPC-157 with a “research use only” disclaimer does not change its legal classification if the seller’s website includes dosing protocols, before/after testimonials, or syringes. The marketing conduct determines the legal characterization, not the label.
Sections 503A and 503B
Sections 503A and 503B of the FDCA create narrowly defined exemptions from standard drug approval requirements for compounding pharmacies and outsourcing facilities, respectively. Both exemptions require that the compounded substance meet specific eligibility criteria. When a peptide does not meet those criteria — as Category 2 peptides do not — neither exemption applies.
DEA scheduling
Most peptides are not DEA-controlled substances. The DEA’s Controlled Substances Act schedules drugs based on abuse potential, dependency risk, and accepted medical use. Somatropin (human growth hormone itself) carries specific federal restrictions under 21 U.S.C. 333(e), which prohibits distribution except for FDA-approved uses. GH secretagogues and GHRH analogs do not currently hold DEA Schedule status. Anabolic steroids are Schedule III — peptides are structurally and mechanistically distinct and do not fall under that category.
The federal floor principle
States can layer additional requirements onto federal law, but they cannot reduce federal restrictions. A state cannot make BPC-157 compoundable. A state can add documentation requirements, inspection standards, or enforcement mechanisms above the federal baseline.
Learn more about are peptides legal in the US — the 2026 updated guide.
Three legal categories — the FDA classification system
The FDA’s Category system is the central compliance reference for every pharmacist, prescriber, and clinic operator.
The PCAC (Pharmacy Compounding Advisory Committee) reviews nominated bulk drug substances and recommends Category placements. A substance reaches Category 1 by demonstrating adequate safety information and a credible clinical rationale. Category 2 designations follow a finding of significant safety concerns — including insufficient human data, immunogenicity risk, or sterility concerns. Category 3 (insufficient data to evaluate) and Category 2 produce the same practical outcome: the substance cannot be compounded.
A January 2025 FDA guidance clarified that substances nominated on or after January 7, 2025 will no longer be placed in the Category 1/2/3 labeling system. Existing Category designations for previously nominated substances remain in effect.
| Category | Status | Named examples | Compoundable? | Legal access channel |
|---|---|---|---|---|
| FDA-Approved | Fully legal with Rx | Semaglutide (Wegovy/Ozempic), Tirzepatide (Zepbound), Tesamorelin (Egrifta), PT-141 (Vyleesi) | Yes — standard pharmacy | Rx from licensed prescriber; standard or compounding pharmacy |
| Category 1 | Compoundable under 503A/503B | Sermorelin, GHK-Cu (topical, with limitations), NAD+, VIP, Gonadorelin | Yes — licensed compounding pharmacy only | Valid Rx from licensed prescriber; 503A or 503B pharmacy |
| Category 2 | NOT compoundable | BPC-157, TB-500, CJC-1295, Ipamorelin, AOD-9604, Melanotan II | No | No legal compounding channel exists |
| Category 3/unevaluated | NOT compoundable | Substances with no USP monograph, no FDA approval, not on Category 1 list | No | No legal compounding channel exists |
Compounded GLP-1 status
Semaglutide and tirzepatide compounding was permitted during the FDA-declared drug shortage period. The FDA declared the semaglutide shortage resolved in February 2025. By September 2025, the FDA had issued more than 50 warning letters to GLP-1 compounders and confirmed DOJ involvement in several cases. Thirty telehealth companies received warnings for misleading advertising of compounded GLP-1 drugs. As of March 2026, compounding semaglutide or tirzepatide outside an FDA-declared shortage is not legally supported.
The February 2026 reclassification announcement
On February 27, 2026, HHS Secretary Kennedy announced that approximately 14 of the 19 Category 2 peptides are expected to move to Category 1. As of this writing, no formal FDA regulatory action has been published and those peptides remain Category 2.
Important: Pharmacies and prescribers should not change their practices based on this announcement alone. PeptideRx will update this section when formal FDA documentation is published. Verify current status at FDA.gov before making any compliance decisions.
Learn more about FDA peptide reclassification 2026: what the announcement means.
The research chemical channel — where RUO labels fail
“Research use only” is a legitimate product classification — for actual research. RUO labeling is legally valid when a peptide genuinely goes to laboratories for in vitro or animal research, not human administration. The legal shield dissolves the moment a seller’s conduct signals consumer-facing intent.
The FDA has identified four indicators that override an RUO label:
- Syringes or bacteriostatic water packaged with the product
- Human dosing guides on the product page or included literature
- Before/after photos suggesting human use
- Marketing language aimed at consumers rather than research institutions
When these indicators are present, the FDA treats the product as an unapproved drug and the seller as a drug manufacturer operating without FDA registration. Warning letters, product seizures, injunctions, and criminal referrals to the DOJ have all followed from this theory.
The DOJ confirmed involvement in peptide enforcement in 2025 alongside the FDA’s 50+ GLP-1 warning letter campaign. Peptide Sciences, one of the largest U.S. research peptide vendors, voluntarily shut down in March 2026 following sustained regulatory pressure — a meaningful marker of structural change in how the RUO channel operates.
Purchaser exposure: FDA enforcement has concentrated on sellers. Individual purchasers face theoretical FDCA exposure but prosecution of individual buyers remains rare. Physicians who direct patients to RUO sellers, however, expose themselves to medical board disciplinary action regardless of where enforcement pressure falls — the prescription is the prescriber’s professional act.
Learn more about gray market peptides: why unregulated sourcing is dangerous.
503A vs 503B — operational differences that determine compliance
503A and 503B are not interchangeable. The distinction determines who can compound what, for whom, and under what conditions.
| Attribute | Section 503A | Section 503B |
|---|---|---|
| Who it applies to | State-licensed traditional compounding pharmacies | FDA-registered outsourcing facilities |
| Prescription required at dispensing | Yes — patient-specific Rx required | No — can produce batch stock without individual Rx |
| Production type | Patient-specific preparations | Non-patient-specific batch production permitted |
| cGMP standard | Not required (USP <795>/<797> mandatory) | cGMP mandatory — same standard as commercial drug manufacturers |
| Interstate shipping | Limited — patient-specific orders in states where licensed | Broader — may ship interstate under specific FDA conditions |
| FDA oversight level | State pharmacy board primary; FDA secondary | FDA facility inspection; ongoing registration requirements |
503A in practice: A patient visits a physician, receives a prescription for compounded sermorelin, and the physician sends the Rx to a licensed 503A pharmacy. The pharmacy prepares the patient-specific vial under USP <797> sterile standards and dispenses it directly to the patient. The pharmacy cannot produce a batch of sermorelin vials in advance without individual prescriptions.
503B in practice: A telehealth platform or clinic chain signs a supply agreement with an FDA-registered 503B outsourcing facility. The 503B facility produces batch stock of compounded sermorelin under cGMP. The clinic dispenses to patients with valid prescriptions. Interstate distribution rights are broader — the 503B can supply multiple states, subject to FDA registration requirements and facility inspection.
USP <797> requirements for injectable peptide compounding (503A)
Non-compliance with USP <797> triggers FDA Form 483 observations during inspections and state pharmacy board sanctions. Several Ohio pharmacy license suspensions in 2024–2025 followed from peptide-related USP <797> violations documented in state board proceedings.
Key <797> requirements for sterile peptide compounding:
- Beyond-use dating (BUD): Sterile preparations have defined BUD limits based on environmental standards and aseptic technique. Refrigerated sterile preparations have shorter BUDs than those meeting ISO 5 environmental standards.
- Environmental monitoring: Primary engineering controls (ISO 5 laminar flow hoods) and cleanrooms (ISO 7 or ISO 8 depending on compounding activity) with documented monitoring logs required.
- Sterility testing: Required for preparations intended for multiple-dose vials or preparations that exceed standard BUD parameters.
- Personnel training: Documented aseptic technique training and media fill testing required for all personnel performing sterile compounding.
Learn more about what is a compounding pharmacy — and how it relates to peptide access.
State-by-state enforcement tiers
Federal law sets the floor. State enforcement intensity varies significantly above it. States are grouped into three tiers based on pharmacy board guidance, medical board activity, AG enforcement history, and state-specific telehealth requirements.
| State | Tier | Pharmacy board posture | Medical board activity | AG enforcement trend | Telehealth notes |
|---|---|---|---|---|---|
| Florida | Permissive | Follows federal framework; no additional peptide-specific rules | Low to moderate | Low peptide-specific activity | No state-specific telehealth restrictions beyond federal for non-controlled substances |
| Texas | Permissive | Follows federal; TSBP active on compounding quality | Moderate; TSBME standard-of-care expectations apply | Low peptide-specific activity | Telemedicine prescription permitted with established relationship |
| Nevada | Permissive | Follows federal | Low | Low | No additional restrictions |
| Arizona | Permissive | Follows federal; some naturopathic physician prescribing authority | Low | Low | Telehealth-friendly |
| Illinois | Moderate | Illinois Pharmacy Practice Act compliance; IDFPR oversight | Moderate | Moderate | Standard telemedicine requirements |
| Colorado | Moderate | Follows federal; CDPHE oversight | Moderate | Moderate | No additional restrictions |
| Ohio | Moderate | Summary suspension orders issued in 2024–2025 related to peptide distribution | Moderate to high | Moderate | Standard |
| Pennsylvania | Moderate | Follows federal with active inspection program | Moderate | Low to moderate | Standard |
| Georgia | Moderate | Follows federal | Moderate | Low | Standard |
| New York | Restrictive | Facility inspection and compliance documentation required for peptide production; additional QC requirements beyond federal | Very high — OPMC actively investigates off-label prescribing without adequate documentation | High — AG active on consumer protection | May 2025: DOH finalized rules adding documentation requirements for telemedicine Rx |
| California | Restrictive | Medical Board investigations for prescribing unapproved substances | Very high — Medical Board investigations active | High — aggressive consumer protection law | Telehealth standard-of-care documentation required; CURES PDMP closely monitored |
| Connecticut | Restrictive | Active; follows federal with state enforcement layering | High | Very high — most active AG state for peptide enforcement in 2025 | May 2025 AG notice to weight-loss clinics re: compounded GLP-1s |
| Massachusetts | Restrictive | NECC legacy sterile compounding restrictions add documentation burden beyond federal | High | High | Standard telemedicine requirements |
| Alabama | Restrictive | Follows federal | Moderate | High — November 2025 TRO against GLP-1 distributor | Standard |
| Louisiana | Restrictive | Additional inspection and documentation requirements | Moderate | Moderate to high | Standard |
State AG enforcement — the 2025–2026 wave
State attorneys general have become the primary enforcers of peptide distribution law, using consumer protection tools that operate independently of FDA proceedings.
February 2025 — 38-state AG coalition: The National Association of Attorneys General transmitted a formal letter to the FDA, signed by a bipartisan coalition of 38 state and territory AGs. The letter identified products containing unknown contaminants or incorrect dosages, online sales of GLP-1 active ingredients labeled “research use only” but marketed to consumers without prescriptions, and inadequate coordination against counterfeit peptides entering the U.S. market.
Connecticut (2025): AG William Tong filed suit against Triggered Brand and Made In China under the Connecticut Unfair Trade Practices Act (CUTPA) for selling research-grade GLP-1 drugs directly to consumers without prescriptions. Triggered Brand was required to cease operations in Connecticut and accepted a monetary judgment. On May 21, 2025, the AG issued a statewide notice to weight-loss clinics emphasizing that bulk compounding of semaglutide and tirzepatide is no longer permitted and that marketing terms like “generic Ozempic” may violate CUTPA.
Alabama (November 10, 2025): The Alabama AG obtained a temporary restraining order and asset freeze against Aurora IV & Wellness, LLC — representing the first state-level injunctive relief against a GLP-1 distributor (State of Alabama v. Aurora IV & Wellness, LLC, Circuit Court of Alabama, 2025).
Ohio (2024–2025): The Ohio Board of Pharmacy issued summary suspension orders and settlement agreements against pharmacies involved in peptide distribution, including documented USP <797> violations.
LegitScript as de facto enforcement: LegitScript classifies research-use-only peptides marketed for human use as “not eligible for certification.” Major payment processors — including Visa and Mastercard — rely on LegitScript certification for merchant account decisions. Loss of payment processing has functioned as enforcement against grey-market sellers independently of any FDA or AG action, forcing multiple vendors to cease operations before any formal legal proceeding began.
The legal theories Connecticut and Alabama deployed are portable across every state jurisdiction. State AGs do not need to prove FDCA violations — consumer protection and unfair trade practice statutes are sufficient.
Telemedicine and peptide prescribing — 2026 compliance framework
Most peptides are non-controlled substances. The DEA telemedicine rules do not govern most peptide prescribing. The DEA’s telemedicine extension, in effect through December 31, 2026, covers Schedule II–V controlled substances only. State medical practice acts govern prescribing standards for non-controlled peptides.
Every state that permits telemedicine prescribing requires an established patient-provider relationship — a documented clinical encounter (synchronous video or in-person) before the first prescription, a medical history review, and a clinical rationale for the prescribed treatment.
The FDA’s September 2025 enforcement initiative specifically targeted telehealth companies making “generic” or “clinically proven” claims about compounded GLP-1 drugs. Thirty companies received warnings for misleading advertising. The legal theory: marketing compounded GLP-1s as equivalent to FDA-approved branded products violates FDCA misbranding provisions.
Documentation checklist for prescribers
| Documentation element | Notes |
|---|---|
| Complete medical history | Including current medications, contraindications, and prior treatments |
| Clinical rationale | Documented reason for the specific compounded peptide selected |
| Patient-specific prescription | Compound, dose, route, frequency, quantity |
| Informed consent | Notes that the compound is not FDA-approved, evidence quality, known risks, and alternative treatments |
| Monitoring plan | Follow-up intervals documented at time of prescribing |
| State-specific requirements | New York requires additional quality documentation; California Medical Board expects evidence-based rationale for off-label prescribing |
The “peptide mill” enforcement signal: The FDA’s September 2025 campaign targeted platforms operating high-volume, low-oversight telehealth models where prescriptions were issued without adequate clinical evaluation. Prescribers using these platforms face the same medical board exposure as the platform operators — the prescription is the prescriber’s professional act regardless of the platform structure.
WADA, NCAA, and sports anti-doping rules
WADA prohibition applies regardless of U.S. legal status. A compound can be legally compounded and still banned for competitive athletes.
The 2026 WADA Prohibited List (in force January 1, 2026) covers the following peptide-relevant categories:
| WADA section | What is prohibited |
|---|---|
| S2.2.4 — GH releasing factors | All GHRH analogs (CJC-1295, sermorelin, tesamorelin) and all GH secretagogues (ipamorelin, GHRP-2, GHRP-6, hexarelin, MK-677/ibutamoren) — prohibited at all times |
| S2.3 — Growth factors | Thymosin Beta-4 and its derivatives, explicitly including TB-500 |
| S2.2.3 — GH fragments | AOD-9604 |
| S4.4.1 — Metabolic modulators | MOTS-c — prohibited at all times |
Semaglutide, tirzepatide, BPC-157, Thymosin Alpha-1, Selank, and Semax are not on the 2026 WADA Prohibited List. Athletes must verify status annually at wada-ama.org — the list updates every January 1.
NCAA rules and professional league policies add layers beyond WADA. BPC-157 is not on the WADA list, but individual sport federations may prohibit it. Athletes competing under sport-specific rules (IOC, IWF, FIFA, and other WADA Code signatories) must verify each compound against their specific federation’s prohibited substance list.
Therapeutic Use Exemptions (TUEs) exist for athletes who have a legitimate medical need for prohibited substances. Tesamorelin, for example, holds FDA approval for HIV-associated lipodystrophy — an athlete with this condition could apply for a TUE before using it.
DSHEA and the dietary supplement question
DSHEA does not protect synthetic peptides. The Dietary Supplement Health and Education Act of 1994 defines a dietary supplement as a product containing a “dietary ingredient” — a vitamin, mineral, amino acid, herb, botanical, or substance used to supplement the diet with a history of food use.
| Peptide type | DSHEA eligible? | Legal channel |
|---|---|---|
| Collagen peptides (hydrolyzed collagen from food sources) | Yes — food-derived, history of dietary use | OTC dietary supplement |
| Individual amino acids | Yes — dietary ingredients | OTC dietary supplement |
| BPC-157 (synthetic; no food history) | No — unapproved drug | No legal OTC channel |
| TB-500 (synthetic Thymosin Beta-4 fragment) | No — unapproved drug | No legal OTC channel |
| CJC-1295 / Ipamorelin (synthetic GH peptides) | No | No legal OTC channel |
Synthetic peptides fail DSHEA on three grounds: they are not dietary substances under the act’s definition, they have no food history, and the FDA treats them as unapproved drugs when sold with any therapeutic claim. A pill or cream format does not change the legal analysis — the underlying substance is what the FDA evaluates, not the dosage form.
FDA enforcement on oral BPC-157 “supplement” sellers has increased alongside the broader 2025 enforcement wave. Sellers of oral BPC-157 labeled as a supplement face the same misbranded/adulterated drug theory as injectable RUO sellers.
Learn more about types of peptides: a complete classification guide.
Business licensing requirements
Operating in the peptide market without proper federal and state licensing creates FDCA liability, state enforcement risk, and civil liability exposure.
Federal requirements:
- FDA drug establishment registration is mandatory for any entity that manufactures, repackages, or distributes drugs — including compounded medications. Unregistered manufacturers face seizure and injunction risk.
- API sourcing: All active pharmaceutical ingredients used in compounded human-use products must come from FDA-registered suppliers. RUO-labeled APIs from unregistered suppliers cannot be used in compounded drugs.
- DEA registration is required only if the business handles DEA-scheduled substances. Most peptides are not scheduled.
State requirements by function:
- Compounding pharmacy (503A): State pharmacy board license required in every state of operation. Interstate patient-specific shipments require licensure in the patient’s state.
- Outsourcing facility (503B): FDA registration mandatory. State drug manufacturer licenses may apply. Higher compliance bar than 503A.
- Drug distributor/wholesale: State wholesale drug distributor license required where applicable.
- Medspa/clinic: State health department licensing and medical director requirements apply. Not all states permit non-physician administration of compounded injectables.
LegitScript certification: LegitScript independently audits health and pharmacy merchants. A business handling peptide-related products should assess its LegitScript certification status before launch — loss of credit card processing is an existential business risk that operates independently of formal regulatory action.
Healthcare attorneys with peptide-specific experience — including Frier Levitt, Holt Law, and LumaLex Law — provide compliance review before business launch. The complexity of multi-state licensing, FDA registration, API sourcing requirements, and marketing compliance makes legal counsel a practical necessity, not a precaution.
Practical compliance checklists
Patients (3 steps)
Step 1: Verify that any peptide you are pursuing is either FDA-approved or on the Category 1 bulk drug substances list before pursuing it through any channel. Check FDA.gov for current status.
Step 2: Obtain your prescription from a licensed physician who has documented a clinical rationale and provided an informed consent discussion. Do not source peptides from online sellers — use a licensed compounding pharmacy.
Step 3: Ask your compounding pharmacy for its state license number and PCAB accreditation status (voluntary but a meaningful quality signal).
Prescribers and providers (4 steps)
Step 1: Prescribe only FDA-approved peptides or Category 1 compounded peptides. Do not direct patients to RUO sellers or grey-market sources — this creates medical board exposure regardless of patient consent.
Step 2: Document every prescription: medical history, clinical rationale, diagnosis codes where applicable, informed consent confirming unapproved drug status, and a monitoring plan with follow-up dates.
Step 3: Know your state board’s published guidance. New York’s OPMC, California’s Medical Board, and Connecticut’s DPH have published or enforced specific positions on off-label and compounded prescribing.
Step 4: Use thorough telehealth consultations. The September 2025 FDA enforcement wave specifically targeted prescribers issuing high-volume, low-documentation telehealth prescriptions — the same scrutiny applies to all compounded peptides, not only GLP-1s.
Businesses, pharmacies, and clinic operators (4 steps)
Step 1: Obtain FDA drug establishment registration before distributing any compounded medication. Ensure all APIs come from FDA-registered manufacturers with Certificates of Analysis.
Step 2: Secure state-by-state licensing: pharmacy license in every state where you ship patient-specific orders (503A); state drug manufacturer licenses where applicable (503B and distributors). Florida and Texas have relatively streamlined licensing; New York and California require additional documentation.
Step 3: Audit your marketing before launch. Remove any content that makes therapeutic claims, implies FDA approval, or combines your product with syringes, dosing guides, or before/after images if you are selling RUO compounds. Retain a healthcare attorney to review product pages and advertising copy before going live.
Step 4: Consult a healthcare attorney before expanding into new states, new product categories, or new distribution channels. The multi-state AG coordination means enforcement actions in Connecticut or Alabama directly signal risk for similar operations in other states.
The bottom line
The three-question compliance framework — FDA-approved, Category 1 compoundable, or not legally available — applies uniformly regardless of state. States add enforcement intensity and documentation requirements above the federal baseline, but no state can make a Category 2 peptide legal to compound. The enforcement direction through 2025–2026 is unambiguous: FDA warning letters, DOJ criminal referrals, a 38-state AG coalition, state-level injunctive relief, payment processor pressure through LegitScript, and the collapse of several major grey-market vendors have all moved in the same direction. Bookmark FDA.gov’s bulk drug substances page for Category status updates, which change as PCAC reviews continue and formal rulemaking follows announcements. Consult a healthcare attorney with peptide-specific experience before making operational changes. If you are a patient navigating this landscape, working with a licensed physician who uses a compliant 503A or 503B pharmacy is the single most important step you can take.
PeptideRx will update this guide when formal FDA documentation of the February 2026 reclassification announcement is published.
Considering legal peptide therapy? Consult a licensed physician to discuss your goals, confirm which compounds are currently available through compliant channels, and receive a prescription through a licensed compounding pharmacy.
References
- Federal Food, Drug, and Cosmetic Act (FDCA), Section 503A (21 U.S.C. 353a) and Section 503B (21 U.S.C. 353b)
- FDA. Bulk Drug Substances Used in Compounding Under Section 503A — Category 1 and Category 2 listings. FDA.gov (verify current listings before use in compliance decisions)
- FDA. Revised Guidance for Compounding Pharmacies. January 13, 2025 (eliminated Category 2/3 labeling for new nominations after January 7, 2025)
- Connecticut Attorney General. Consumer Alert: Compounded GLP-1 Weight Loss Drugs. May 21, 2025
- Connecticut v. Triggered Brand (CUTPA enforcement action, 2025). Monetary judgment
- State of Alabama v. Aurora IV & Wellness, LLC. Temporary Restraining Order and Asset Freeze. Circuit Court of Alabama, November 10, 2025
- National Association of Attorneys General. Multi-State Letter to FDA Commissioner Regarding Counterfeit, Compounded, and Research-Grade GLP-1 Receptor Agonists. February 2025 (38 state and territory AGs)
- FDA. September 2025 GLP-1 compounding warning letters — 50+ issued; DOJ involvement confirmed; 30 telehealth companies warned for misleading advertising
- FDA. PCAC Meeting Materials: Ipamorelin, Ibutamoren (MK-677), CJC-1295, AOD-9604. PCAC Proceedings, 2024
- WADA 2026 Prohibited List (in force January 1, 2026). Sections S2.2.3, S2.2.4, S2.3, S4.4.1. wada-ama.org
- Ohio Board of Pharmacy. Summary Suspension Orders and Settlement Agreements Involving Peptide Distribution. 2024–2025
- 21 U.S.C. 333(e) — prohibition on distribution of somatropin except for FDA-approved uses
- Frier Levitt. Regulatory Status of Peptide Compounding in 2025. FrierLevitt.com, April 2025
Compliance disclaimer: The information on this page is for general educational purposes only. We do not provide legal or medical advice. Nothing in this guide constitutes legal advice or creates an attorney-client relationship. Regulatory status changes frequently — verify all Category designations at FDA.gov before making compliance decisions. The February 2026 HHS announcement regarding reclassification has not been formalized in FDA regulatory documentation as of this writing. Consult a licensed healthcare attorney and your state pharmacy or medical board for current, jurisdiction-specific guidance. All compounded peptides require a valid physician prescription under 503A and 503B of the Federal Food, Drug, and Cosmetic Act.