FDA Category 1 peptides are bulk drug substances that were nominated for the FDA’s 503A bulks list with enough supporting information and are still under evaluation. While FDA evaluates them, it does not intend to take action against a licensed 503A compounding pharmacy that prepares them with a valid, patient-specific prescription. As of FDA’s list updated May 14, 2026, Category 1 includes GHK-Cu (non-injectable routes only), glutathione, NAD+, and Vasoactive Intestinal Peptide. BPC-157, TB-500, and Sermorelin are not on it.
A lot of information online gets this wrong, because the lists changed twice in 2026. This guide covers what each category means in FDA’s own terms, which peptides are where today, what the April 2026 Category 2 removals did and did not change, and what compliance requires.
Important: This article is for informational purposes only and does not constitute legal or medical advice. Classifications are subject to change. Confirm current status with your pharmacy partner and legal counsel before launching any program.
What the FDA Category System Actually Means
A 503A pharmacy may compound from a bulk drug substance (the active ingredient in raw form) only if the substance has a USP monograph, is a component of an FDA-approved drug, or is on the FDA’s 503A bulks list. While FDA works through substances nominated for that list, it sorts them into three interim categories.
Category 1: Under Evaluation
Category 1 substances were nominated with sufficient supporting information and appear on no other list. While FDA evaluates them, it does not intend to take action against a 503A pharmacy that compounds with them, provided the other conditions of its interim policy are met. In practice:
- A licensed 503A compounding pharmacy can prepare them with a valid, patient-specific prescription
- Licensed prescribers can write prescriptions for those compounded formulations
- The permission is interim: it lasts until FDA decides whether to add the substance to the 503A bulks list
Category 1 does not mean the substance has cleared FDA drug approval, which requires clinical trials and a New Drug Application.
Category 2: Significant Safety Risks
Category 2 substances were nominated with sufficient information, but FDA has identified significant safety risks, so the Category 1 permission does not apply.
Category 3: Nominated Without Adequate Support
Category 3 substances were nominated without enough supporting information for FDA to evaluate them, so the Category 1 permission does not apply either.
The Summary
| Category | FDA’s description | Interim permission to compound? |
|---|---|---|
| Category 1 | Under evaluation | Yes, with a valid patient-specific prescription |
| Category 2 | Raises significant safety risks | No |
| Category 3 | Nominated without adequate support | No |
| No category | Never nominated, or nomination withdrawn | No, unless the substance qualifies another way |
Source: FDA, Bulk Drug Substances Used in Compounding Under Section 503A, category list updated May 14, 2026.
Which Peptides Are in Category 1 Today
FDA’s Category 1 list is mostly vitamins, amino acids, and botanicals. The peptides and peptide-like substances on it as of May 14, 2026:
- GHK-Cu, for non-injectable routes only. FDA removed GHK-Cu from Category 1 on April 22, 2026, after its nominations were withdrawn, then restored the non-injectable routes after one nominator clarified it meant to withdraw only the injectable route. Injectable GHK-Cu is not in Category 1.
- Glutathione
- NAD+ (nicotinamide adenine dinucleotide)
- Vasoactive Intestinal Peptide
What Changed in Category 2 in 2026
In February 2026, HHS announced plans to move about 14 Category 2 peptides, including BPC-157 and Thymosin Alpha-1, back to Category 1. What actually happened was narrower:
- April 2026: FDA removed 12 peptides from Category 2 because their nominators withdrew the nominations. Removal did not put them in Category 1 or on the 503A bulks list, so they still cannot be compounded.
- May 14, 2026: FDA’s updated list keeps one peptide in Category 2, Kisspeptin-10.
- Advisory review: FDA scheduled its Pharmacy Compounding Advisory Committee to discuss peptides for the 503A bulks list in July 2026 and again before the end of February 2027. An advisory meeting is not a rule; only a final rule adds a substance to the list.
So BPC-157, TB-500 / Thymosin Beta-4, and CJC-1295/Ipamorelin sit in no category today, and they are not eligible for compounding. Karpa does not offer them.
Popular Peptides That Are Not on the Category Lists
Sermorelin, gonadorelin, and PT-141 are three of the most requested peptides in cash-pay medicine, and none of them appears in Category 1, 2, or 3. The categories only sort substances that need a place on the 503A bulks list. Section 503A lets a pharmacy compound from a bulk substance that has a USP monograph, or that is a component of an FDA-approved drug, without any listing. FDA’s interim policy says such substances can be compounded “without being included on the 503A bulks list,” and points to the USP-NF and the Orange Book to check.
| Peptide | Basis for 503A compounding | How settled |
|---|---|---|
| Gonadorelin | Official USP monographs for gonadorelin acetate and gonadorelin hydrochloride | Clear |
| PT-141 (bremelanotide) | Active ingredient of Vyleesi, an FDA-approved drug still on the market | Clear, with the copies limit below |
| Sermorelin | Active ingredient of Geref, an FDA-approved drug that was discontinued, not withdrawn for safety or effectiveness | Relied on by pharmacies; FDA has not issued a sermorelin-specific statement |
Sources: FDA Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A (January 2025), USP gonadorelin monographs, Drugs@FDA for Vyleesi (NDA 210557) and Geref (NDAs 019863 and 020443), and FDA’s Geref determination (78 FR, March 4, 2013).
Two limits apply to all three. A 503A pharmacy cannot regularly compound essentially copies of a commercially available drug, so compounded PT-141 should not duplicate Vyleesi’s strength and route unless the prescriber documents a clinical difference for the patient. And none of these compounded products is itself FDA-approved, so marketing cannot claim they treat or cure a disease.
Sermorelin
Sermorelin is a synthetic peptide that signals the pituitary gland to produce and release growth hormone naturally rather than introducing exogenous growth hormone directly. The FDA originally approved it in 1997 for growth hormone deficiency in children. The manufacturer voluntarily discontinued commercial production in 2008, and in a March 2013 Federal Register notice the FDA determined that Geref was not withdrawn for reasons of safety or effectiveness. Sermorelin has no USP monograph, so that approval history is the basis pharmacies rely on to compound it.
Common program applications:
- Hormone optimization and men’s health
- Body composition and metabolic support
- Sleep quality and recovery
- Longevity and healthy aging
Gonadorelin
Gonadorelin is a synthetic hormone that supports the body’s natural hormonal production cycle. In men’s health programs it is most commonly paired with testosterone replacement therapy to help maintain the body’s own hormonal function during treatment, addressing one of the most common patient concerns about TRT. It was initially approved for diagnostic testing and fertility applications in the 1980s (as Factrel and Lutrepulse), and both products were later discontinued. Gonadorelin’s 503A basis does not depend on that history: USP publishes official monographs for gonadorelin acetate and gonadorelin hydrochloride.
Common program applications:
- TRT companion therapy for preserving natural hormonal function
- Men’s health and hormone optimization
- Women’s reproductive health protocols
A Note on GLP-1 Receptor Agonists
GLP-1 medications like semaglutide and tirzepatide are frequently grouped with peptide therapy in patient conversations, and many operators offer them alongside peptide programs. However, GLP-1 compounding operates under a separate FDA framework rather than the Category 1 system. Semaglutide and tirzepatide are active ingredients in FDA-approved drugs, and since the FDA ended both shortages (tirzepatide in December 2024, semaglutide in February 2025), compounded versions are limited to patient-specific prescriptions that differ significantly from the brand-name product. See the GLP-1 compounding regulations guide.
If you are building a GLP-1 program, confirm current compounding eligibility with your pharmacy partner before launching. Karpa monitors this on an ongoing basis for all platform partners.
Is It Legal? What Compliance Actually Requires
Eligibility to compound opens the legal door. What happens inside that door depends on how the program is built.
The Federal Requirements
A compliant compounded peptide program requires:
- A valid, patient-specific prescription from a licensed provider in the patient’s state
- A licensed 503A compounding pharmacy meeting USP 797 standards for sterility, potency, and quality
- Human-grade API sourced from FDA-registered manufacturers (not research-grade)
- Documented medical necessity in the patient record
- Informed consent covering the compounded and off-label nature of the therapy
These are federal minimums. State rules add another layer.
State-Level Complexity
Federal eligibility to compound does not automatically satisfy every state’s requirements. A few examples of where this matters:
- Some states require synchronous (live video) provider consultations for initial prescriptions rather than asynchronous intake
- Compounding pharmacies must hold licenses in each state where they ship patient-specific medications, meaning not every pharmacy can serve every state
- Prescribing scope varies by provider type and state, so what a nurse practitioner can independently prescribe in one state may require physician oversight in another
For operators building multi-state programs, this is an operational reality that requires a pharmacy partner with broad state licensing and a provider network credentialed appropriately for each state.
Research-Grade vs. Human-Grade API
This distinction matters more than most operators initially realize, and it is where some programs create significant liability.
Research-grade peptide API is not the same as human-grade API. Peptides labeled “for research use only” typically lack the cGMP certification required for human therapeutic use. Using research-grade API in peptide compounding introduces clinical risk to patients and regulatory and legal exposure to the operator and any prescribers involved.
Human-grade API used in compounding must come from FDA-registered facilities following strict current Good Manufacturing Practice guidelines: purity verification, endotoxin testing, detailed certificates of analysis, full material traceability, and rigorous quality control.
When vetting compounding pharmacy partners, one of the most important questions is sourcing. Any legitimate compounding pharmacy should be able to provide documentation of API sourcing from FDA-registered manufacturers.
What This Means for Operators Building Programs
Peptides that are eligible for compounding today represent a clear, compliant opportunity for cash-pay programs. The patient demand is real, and the regulatory pathway is established for the right set of substances.
The friction is operational. Building a compliant program from scratch requires:
- Identifying a compounding pharmacy partner with multi-state licensing and verified API sourcing
- Establishing a provider network with credentials appropriate across your patient states
- Creating intake, triage, and informed consent workflows that meet both federal and state requirements
- Monitoring regulatory status ongoing, because classifications and state rules change
Operators who try to piece this together independently spend months on infrastructure before their first patient. Operators who use a platform like Karpa launch in about 30 days when Karpa builds the website, or in about 7 days with their own website and LegitScript certification, with the infrastructure already built.
Karpa’s platform provides:
- A 50-state licensed provider network for all prescribing
- Integrations with vetted 503A compounding pharmacies with verified API sourcing
- HIPAA-compliant intake and automated eligibility screening
- Pre-built clinical protocols for the peptide programs it offers
- Ongoing regulatory monitoring so your program stays compliant as the landscape shifts
You build the brand and the patient audience. Karpa supplies the operational infrastructure behind it, and independent licensed providers in its network handle the clinical side.
