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Open a Peptide Therapy Clinic Built on What Is Lawful to Compound Today.
BPC-157, TB-500, ipamorelin and many of the compounds patients search for are not on the 503A Bulks List, and a temporary enforcement policy is not a listing or an approval. ACG helps you build the version of this clinic designed to still be open in three years.
Book a Strategy CallPeptide Demand Is Real.
Most of the Menu Is Not Legal.
Monthly U.S. searches run 100,000 to 1 million for sermorelin and 10,000 to 100,000 for peptide therapy (Google Keyword Planner).
That is the opportunity. Here is the trap: many of the peptides patients ask about, BPC-157 above all, are not on the 503A Bulks List or FDA-approved. Operators open clinics around them anyway, because a supplier said it was fine, or an advisory vote or a temporary enforcement policy was read as approval.
ACG helps you open a wellness clinic built around peptides, without the lifetime royalties of a peptide clinic franchise.
A clinic that has already built protocols, pricing, and marketing around a compound that never gets listed has not just wasted the work. It has created a written record of intent.
Google Keyword Planner, U.S., Sep 2025 to Aug 2026, in the ranges Google reports. Local demand varies by market.
Stop Asking If a Peptide Is Category 2.
Many operators, and a surprising number of consultants, still use Category 2 as their legality test. That model is now wrong, and wrong in a way that produces confident bad advice.
In April 2026 the FDA removed twelve peptides from Category 2 because their nominations were withdrawn, the same reason five others left in September 2024. Removal from Category 2 is not approval. The twelve now sit in no category, and none can be compounded under 503A.
Neither event created permission to compound anything.
A 503A pharmacy may compound from a bulk substance only if it is on the 503A Bulks List, is a component of an FDA-approved drug, or has a USP or NF monograph. That is the test. For most research peptides, the answer today is still no.
"Is it still Category 2?" This tells you almost nothing about whether a pharmacy can lawfully make it.
"Is it on the 503A Bulks List yet?" A yes is permission. Anything else is not.
In July 2026 an FDA advisory committee recommended six of seven reviewed peptides for the Bulks List, against FDA staff recommendation. The votes are non-binding, and as of October 2026 the FDA has proposed no rule.
Is there an FDA-approved product. May a pharmacy compound it. Is it sold Research Use Only. Operators collapse these into one question and reach the wrong answer.
Where Each Peptide Actually Stands
The table operators ask for and few publish: ACG's reading of the current federal position. Not legal advice, and it has a short shelf life.
| Agent | Status | Basis and conditions |
|---|---|---|
| Semaglutide (Ozempic, Wegovy) | FDA Approved | Prescribe the approved product. Off-label use is permitted with documentation. |
| Tirzepatide (Mounjaro, Zepbound) | FDA Approved | Prescribe the approved product. See our metabolic and weight loss clinic model for the full GLP-1 build. |
| Liraglutide (Saxenda, Victoza) | FDA Approved | Approved product. Its compounding position differs from the other two, see the conditional rows below. |
| Tesamorelin (Egrifta) | FDA Approved | Approved for HIV-associated lipodystrophy. Metabolic and NAFLD use is off-label and requires a signed off-label consent. |
| Bremelanotide, PT-141 (Vyleesi) | FDA Approved | Approved finished product. Pairs with a sexual wellness service line. |
| Endocrine and diagnostic peptides | FDA Approved | Human insulin, oxytocin, vasopressin, desmopressin, octreotide, teriparatide (Forteo), leuprolide (Lupron), cosyntropin. |
| Sermorelin | Conditional | Compoundable as a component of a previously approved drug (Geref, withdrawn in 2009 for reasons other than safety or effectiveness). Not an FDA-approved finished product today. |
| Oxytocin, glutathione | Conditional | Oxytocin is a component of an approved drug (Pitocin). Glutathione is in Category 1, compoundable under FDA's interim policy while it is evaluated. Confirm the pharmacy holds current certificates of analysis. |
| GHK-Cu (copper peptide) | Conditional | Non-injectable routes, topical included, are in Category 1 and compoundable under FDA's interim policy. Injectable GHK-Cu is not compoundable. The route is the entire question. |
| Compounded semaglutide or tirzepatide | Conditional | Both shortages have ended. What remains is narrow: 503A compounding for a prescriber-documented patient need, or an FDA-regulated clinical study under an IRB-approved protocol and an IND, which ACG helps prepare. Not a program offering. In April 2026 the FDA also proposed excluding both from the 503B bulks list. See our metabolic and weight loss page. |
| Compounded liraglutide | Conditional | Liraglutide is still on FDA's drug shortage list (reverified September 22, 2026), which keeps a compounding pathway open for now. In April 2026 the FDA proposed excluding it from the 503B bulks list, so treat the pathway as closing when the shortage ends, and verify the shortage status before relying on it. |
| BPC-157, TB-500 | Not on the List | Left Category 2 in April 2026. An advisory committee recommended both in July 2026, against FDA staff recommendation. Neither is on the Bulks List. Since October 30, 2026, an HHS enforcement discretion policy covers 503A compounding of both under strict conditions; it is temporary, not a listing or an approval. Note that the FDA reviewed BPC-157 for ulcerative colitis, not musculoskeletal repair. |
| KPV, MOTS-c, Semax, Epitalon | Not on the List | Same July 2026 advisory recommendation, same status, same October 2026 enforcement policy. Recommended is not listed. |
| Emideltide (DSIP) | Not on the List | The one compound of the seven that the committee declined to recommend. |
| CJC-1295, ipamorelin, AOD-9604, thymosin alpha-1, Selank | Not on the List | Left Category 2 in September 2024 when the nominators withdrew their nominations. Never added to Category 1, and an advisory committee voted against listing four of them in late 2024. No Bulks List entry means no lawful 503A compounding. |
| Melanotan II, injectable GHK-Cu, PEG-MGF, ibutamoren, kisspeptin-10, dihexa, LL-37 | Not on the List | Remain restricted. Not compoundable. |
| Anything sold Research Use Only | Not on the List | RUO product is never lawful to administer to a patient, regardless of any category status, and exposes the prescriber to board discipline and FDA action. |
Current as of October 2026. FDA has changed peptide categories three times since September 2024, so treat each line as the last-known position, not settled law. Verify with the FDA bulk drug substances pages, your pharmacy of record and your state board before any decision. ACG is a business consulting firm; this is not legal, medical, or regulatory advice.
What a Compliant Peptide Clinic Actually Offers
Narrower than many competitors advertise, and a menu built to survive an inspection.
FDA-approved GLP-1 agents prescribed as the approved products, with the cleanest regulatory footing in this category. See our Metabolic and Weight Loss model.
Sermorelin, prescriber-directed, with documented clinical need over an approved alternative. The defensible core of a growth hormone program, and a natural pair with hormone optimization.
PT-141 as the approved finished product (approved for women), alongside other sexual wellness services. See Sexual Wellness.
PRP and bone marrow concentrate returned to the same patient in a single procedure. The usual redirect when a patient asks for a compound you cannot lawfully offer. See Joint and Musculoskeletal.
Topical GHK-Cu within its limitations, glutathione, and compounded agents your pharmacy can document. Route and documentation decide compliance here, not the compound name.
BPC-157, TB-500, ipamorelin, CJC-1295 and the rest stay on a tracked watch list, not the menu, while HHS's temporary policy settles. If rulemaking ever lists them, ACG clients can add them in weeks.
Peptide Clinic Consulting, From Market to Opening Day
The 503A compounding framework, the bulk drug substances lists, state-by-state prescribing variation, and the Medical Director relationship all have to be settled before the first patient.
Paid advertising is restricted for this category on every major platform, so ACG plans the organic search strategy as part of setup. Marketing execution is a separate engagement.
We would rather hand you a shorter menu you can defend than a longer one you cannot. Many consultants in this category will tell you what is possible. Ask them what is listed.
Every proposed service line is checked against the Bulks List before it reaches a pro forma. Nothing gets priced that cannot be made.
A compliant 503A or 503B partner will tell you plainly what it can make. ACG connects you to pre-vetted pharmacies and joins that conversation.
Prescribing authority and scope of practice vary by state. ACG introduces vetted physicians in all 50 states and maps the rules for yours.
Copy that promises what a compound does for a condition can change how that compound is treated. Your website is part of your compliance posture, which is why ACG's marketing audit reviews it.
FDA has changed peptide categories three times since September 2024. ACG clients get the current position before a number or a claim goes into a client document.
Why Peptide Patients Can Become Long-Term Clients
Protocols run over months under the Medical Director's direction, so the relationship matters more than any single visit. The clinic that earns trust here competes on relationship, not price.
One consulting fee. No royalties and no franchise dependency. You own the business, the brand and the equity.
Multi-Month
Protocols run over months, set by your Medical Director, rather than one-off visits.
Independent MD
No medical background is required to own the business. An independent, state-licensed Medical Director directs all clinical care.
Launched
By our team, with 30+ years of combined experience. We help founders open in all 50 states.
Launch Window
From keys received, market and regulatory conditions permitting.
Questions About Opening
a Peptide Therapy Clinic
Straight answers on what is lawful, what is not, and how to build a peptide clinic that holds up, including the answers that cost us business. Anything else, ask on the strategy call.
View All FAQsIs BPC-157 legal to prescribe right now?
What is the 503A Bulks List and why does it decide everything?
Which peptides can a pharmacy actually make today?
Can I still build a real business on the compliant list?
Should I buy a peptide clinic franchise or open my own?
Do I need to be a physician to open a peptide therapy clinic?
Do I need a consultant to open a peptide clinic?
Open Your Peptide Therapy Clinic With the Team Behind Hundreds of Launches
Build the clinic that survives the rulemaking. Talk with Grayson Miller about peptide demand in your market, which service lines are defensible today and what opening takes. No pitch. No obligation.
- Local demand review
- A defensible menu
- An honest read on fit
ACG is a consulting and advisory firm, not a medical practice; an independent, state-licensed Medical Director directs all clinical care. Results are not guarantees of income. Individual outcomes vary. The 60-day target begins from clinic keys received, market and regulatory conditions permitting.
Structured to keep you on the right side of the line.
Knowing the rules is the foundation of every clinic we help launch.
Your Medical Director Directs Care
You own and run the business. An independent, state-licensed Medical Director makes every clinical, prescribing and treatment decision, structured for your state's Corporate Practice of Medicine laws. We connect you to a vetted network; you retain your own provider.
We Know the Regulatory Lines
PRP, peptides, GLP-1 medications and cellular products each carry federal and state rules, and not every product or use is FDA-approved. Exosomes for therapeutic use are not FDA-approved at all, and we steer you away from them. Your menu and marketing are built to hold up to FDA, FTC and state medical board scrutiny.
No Hype. No Guarantees.
We show real ranges and never promise an income or a clinical outcome. What you earn depends on your market, your capital and your execution.
Altos Consulting Group is a business consulting and advisory firm, not a medical practice, and does not provide, prescribe or sell any drug, biologic, device or therapy. The FDA has stated there are currently no FDA-approved exosome products for the treatment of any disease; clinic owners are responsible for the compliance of every product, therapy and claim. See the full regulatory notice below.