Growth Hormone & Lean Body Composition
Sermorelin, CJC-1295, Somatropin, Tesamorelin and Ipamorelin FDA Status
Five substances, four materially different regulatory situations
The category splits four ways.
Somatropin & Tesamorelin were deemed to be licensed biological products on 23 March 2020. FDA’s notice to compounders states that from that date “these transitioning biological products will not be eligible for the exemptions for compounded drugs under sections 503A and 503B of the FD&C Act.”
Sermorelin is not on that transition list; it remains a drug, and it sits in Category 1 of FDA’s 503B nominations document marked as a component of an FDA-approved drug.
Ipamorelin Acetate sits in Category 2 of that same document — the category FDA titles “Bulk Drug Substances that Raise Significant Safety Risks.”
CJC-1295 appears in the nominated-but-withdrawn table on FDA’s safety-risks page.
None of the above peptides appears on the 503A Bulks List at 21 CFR 216.23 (current as of 1 September 2026) or on the 503B Bulk Drug Substances List — those are the lists a substance must be on to qualify by that route. Separately, none appears on 21 CFR 216.24 (current as of 2 September 2026), which is the list of products withdrawn or removed for safety or effectiveness reasons; absence there means a substance is not caught by that bar, and settles nothing else. None of this is a complete legal analysis on its own. Whether a product may lawfully be supplied turns further on the formulation, the facility, the route, whether supply is against a prescription for a named individual or for office use, and on state law. Those questions are not answered here. This page is meant for regulatory tracking only. Not medical or legal advice.
HOW WE SUPPORT CLINICS
Phoenix Meds Regulatory Support Model
Our support in this category is built around one fact: these five substances sit next to each other on every growth-hormone menu in the country, and no two of them stand in the same place under federal law.
Drug or Biologic, Established First
Whether a substance is a drug or a licensed biological product decides whether the compounding exemptions are available at all. We check FDA’s transition list before anything else.
Withdrawal Reasons Distinguished
A product withdrawn from sale is not the same as a product withdrawn for safety or effectiveness reasons. The difference decides whether a route stays open, and FDA publishes the determination.
Category 2 Surfaced
One substance here sits in the category FDA titles as raising significant safety risks. We quote the agency’s entry in full, with the qualifications FDA attached to it.
Both Documents Checked
FDA maintains separate nomination materials for 503A and 503B, and a substance’s status in one framework does not automatically establish its status under the other. We check both and record each result.
Four Positions, Four Files
Where a clinic stocks more than one of these, we document each substance separately rather than issuing a view on the category. Nothing is inherited from the substance next to it on the shelf.
Transition List Checked
FDA publishes which approved products became licensed biologics in 2020. The list is short, public, and directly relevant to the analysis here, and we check it against every product a supplier names.
Whether a particular product may lawfully be compounded, prescribed, dispensed or administered depends on the substance, the formulation, the route, the prescription, and applicable federal and state law. That determination rests with the clinic, the pharmacy and their own counsel.
Regulatory Support Delivered
Clinic Benefits
This is the one category on this site where the answer differs by substance. Knowing which is which is the whole exercise.
✓ The Biologics Line Drawn
Which of these are licensed biological products, and what FDA has said that means for the compounding exemptions. Quoted from the agency’s own notice.
✓ Sermorelin’s Position Documented
The application numbers, the withdrawal date, and FDA’s published determination on why it was withdrawn. That determination is the whole question.
✓ Category 2 Language Quoted
FDA’s recorded findings for ipamorelin acetate, in full, including what the agency says the literature reported and the route it concerned.
✓ Advisory History Traced
Which substances went before the committee, when, and for what use — which is narrower than how any of them are marketed.
✓ Blend Component Seperated
A combination product carries every component’s position. Where two substances are sold together, we set out each one’s status on its own.
✓ Approval Read Precisely
An approved product is approved for what its label says and nothing wider. We set out the application number and leave the indication where FDA put it.Growth Hormone and Body Composition in Clinical Practice
Growth hormone deficiency is a defined endocrine diagnosis with approved treatments and established diagnostic criteria. Body composition, by contrast, is a broad clinical interest that has drawn a range of substances toward it, some approved for narrow indications and some not approved at all. The two get discussed together, and that is where the trouble starts.
A prescriber treating diagnosed growth hormone deficiency with an approved product is on entirely different ground from a practice offering a growth-hormone-adjacent peptide for body composition. That is a clinical distinction, and this page does not address it. How the two sections differ, and what each requires, is set out on our legal and regulatory status page. What this page addresses is narrower: what the federal record says about each substance, and what that does and does not settle about obtaining it.
Nothing here suggests that any substance on this page addresses body composition, ageing, recovery or any other condition. An approved indication is stated as FDA approved it and not extended by a word; where there is none, the page says so.
The Five Substances in This Category
Grouped by regulatory position rather than by how they are marketed, because that is the grouping that decides anything.
Somatropin & Tesamorelin: Licensed Biological Products
Both hold FDA approval, and both changed legal character on the same day. FDA’s List of Approved NDAs for Biological Products That Were Deemed to be BLAs on March 23, 2020 includes thirteen somatropin products — among them Genotropin (NDA 020280), Humatrope (019640), Norditropin (021148), Nutropin AQ (020522), Omnitrope (021426), Saizen (019764), Serostim (020604) and Zomacton (019774) — and tesamorelin acetate, marketed as EGRIFTA and EGRIFTA SV, application 022505, approved 10 November 2010 to Theratechnologies.
What the transition changed. FDA’s notice to compounders states that from 23 March 2020 “these transitioning biological products will not be eligible for the exemptions for compounded drugs under sections 503A and 503B of the FD&C Act,” and that “biological products subject to licensure under section 351 of the PHS Act are not eligible for the exemptions for compounded drugs under sections 503A and 503B.”
That is a different kind of finding from the ones elsewhere on this site. For most substances we report that we did not identify a satisfied condition. Here FDA has stated that the exemptions themselves are unavailable for this class of product. A clinic being offered compounded somatropin or compounded tesamorelin should read that sentence before anything else, and should ask the supplier to address it directly.
Our finding. For these two the lists are beside the point. FDA has stated the exemptions are unavailable to licensed biological products. For completeness: neither appears on the 503A Bulks List, the 503B Bulk Drug Substances List or either nominations document, and neither is caught by the separate bar at 21 CFR 216.24. On the sources reviewed in September 2026 we did not identify a 503A or 503B basis for compounding either from bulk.
Sermorelin: An Approved Drug, Withdrawn but not for safety or effectiveness
Sermorelin acetate was formerly approved as GEREF; it is not an approved product today. Two applications: NDA 020443, for the 0.5 mg and 1.0 mg presentations, and NDA 019863 for the 0.05 mg ampoule. The sponsor, EMD Serono, discontinued them in December 2008 and July 2008 respectively, and approval was withdrawn effective 18 June 2009.
The determination that matters. In a Federal Register notice dated 4 March 2013, FDA determined that the GEREF products “were not withdrawn for reasons of safety or effectiveness,” and stated that “ANDAs that refer to GEREF (Sermorelin Acetate) injection … may be approved by the Agency as long as they meet all other legal and regulatory requirements.”
Sermorelin is not on FDA’s list of products deemed to be BLAs, so it did not transition; it remains a drug. And in FDA’s 503B nominations document, updated 21 March 2025, it appears in Category 1 as “Sermorelin Acetate**”. FDA’s footnote to that marker is about the essentially-a-copy condition in section 503B, and it carries a sentence that bears directly on sermorelin: FDA “does not intend to take action against an outsourcing facility for failing to compound in accordance with section 503B(a)(5) if it fills orders for a compounded drug that is essentially a copy of an approved drug that has been discontinued and is no longer marketed.” GEREF was discontinued and is no longer marketed. That is a stated enforcement intention, not a grant of authority, and it speaks to one condition out of several.
Our finding. Sermorelin stands differently from every other substance on this page. Category 1 placement carries FDA’s stated interim enforcement position for outsourcing facilities, subject to the conditions the guidance sets out; it does not, by itself, establish that a particular compounded preparation satisfies every applicable requirement. Alongside it, the 2013 withdrawal determination means the approved-drug-component condition under section 503A is a live question for sermorelin in a way it is not for CJC-1295 or ipamorelin. Both are questions for the compounding pharmacy and its counsel to answer for a specific preparation. This page does not resolve them, and does not need to.
CJC-1295: Withdrawn nomination, recorded adverse events
FDA considered five CJC-1295-related bulk drug substances — free base, acetate, DAC free base, DAC acetate and DAC trifluoroacetate — at its Pharmacy Compounding Advisory Committee meeting of 4 December 2024, in connection with potential inclusion on the 503A Bulks List. The use FDA identified for the meeting was growth hormone deficiency. A committee’s consideration of a substance does not itself establish any status for it.
A limitation worth stating. FDA published a briefing document for the CJC-1295 substances. We could not retrieve it on 4 September 2026, so this page does not state FDA’s conclusions from it. Read it directly from the meeting page linked below before relying on any account of what it says.
What FDA has recorded. CJC-1295 appears in the nominated-but-withdrawn table on FDA’s safety-risks page. The entry reads in full: “Compounded drugs containing CJC-1295 may pose risk for immunogenicity for certain routes of administration and may have complexities with regard to for peptide-related impurities and API characterization. FDA has identified serious adverse events associated with CJC-1295 including increased heart rate and systemic vasodilatory reaction. Available clinical data are limited.”
Our finding. On the sources reviewed in September 2026 we did not identify a condition under section 503A or section 503B satisfied by CJC-1295 in any of its forms.
Ipamorelin acetate: Category 2
Ipamorelin acetate is the only substance in this category placed in Category 2 of FDA’s 503B nominations document — the category the agency titles “Bulk Drug Substances that Raise Significant Safety Risks.” It also appears in the nominated-but-withdrawn table on the safety-risks page.
What FDA has recorded. The entry reads in full: “Compounded drugs containing Ipamorelin acetate may pose risk for immunogenicity for certain routes of administration due to the potential for aggregation or peptide-related impurities. Ipamorelin acetate also contains unnatural amino acids, which add to the complexity of peptide characterization. A study published in literature identified serious adverse events including death when ipamorelin was administered intravenously for improving gastric motility. FDA has not identified safety-related information regarding ipamorelin acetate via certain other injectable routes of administration. Therefore, the agency lacks sufficient information to know whether the drug would cause harm if administered to humans via those routes.”
Two qualifications belong with that quotation wherever it is repeated: FDA attributes the finding to a study published in the literature, and the events described concerned intravenous administration for gastric motility rather than the routes these products are sold for. Quote it whole or not at all.
Our finding. On the sources reviewed in September 2026 we did not identify a condition under section 503A or section 503B satisfied by ipamorelin acetate.
The Evidence and What FDA Recorded
Two substances here have approved labelling built on trial programmes that FDA reviewed. Somatropin products carry indications established for each application. Tesamorelin was approved on 10 November 2010 for a specific population; the approved indication is what it is, and it is not general body composition. Where a clinic wants to know what an approved product is approved for, the label is the source, not this page and not a supplier.
The other three are in a different position, and FDA has said what it found:
- For CJC-1295, FDA identified serious adverse events including increased heart rate and systemic vasodilatory reaction, and recorded that available clinical data are limited.
- For ipamorelin acetate, FDA cited a published study identifying serious adverse events including death on intravenous administration for gastric motility, and stated it lacks sufficient information about other injectable routes.
- Sermorelin sits apart from both: its position is regulatory rather than evidentiary. An approved product existed, its approval was withdrawn in 2009, and FDA determined in 2013 that the withdrawal was not for safety or effectiveness reasons.
The FDA materials reviewed here do not establish an approved clinical protocol for any of these substances in body composition. Any clinical decision, and the responsibility for it, rests with the prescriber. None of the above is a recommendation to use these compounds.
Why Clinics Have Explored These Peptides
Approved growth hormone therapy is expensive, tightly indicated and closely reviewed by payers. That has created steady interest in substances presented as achieving something similar through a different mechanism, and the market has answered energetically — frequently by selling two of them together and describing the pair as a protocol.
Describing that demand is not endorsing what has been built to meet it. A price list is not a regulatory position, and the fact that two substances are sold in one vial tells a clinic nothing about where either one stands. Nothing in this section should be read as a suggestion that a clinic add any of these to its offering.
CATEGORY-SPECIFIC RISK
Two Questions Specific to This Category
An approved product can be the harder position, not the easier one
Suppliers cite somatropin’s and tesamorelin’s approval as though approval helped. It does the opposite twice over. First, FDA has stated that licensed biological products are not eligible for the section 503A and 503B compounding exemptions at all. Second, where an approved version of a drug exists, compounding engages the restrictions on preparations that are essentially copies of a commercially available product — a harder analysis, not a shortcut.
If a supplier offers a compounded version of an approved product, ask it to address FDA’s March 2020 notice by name. The answer, in writing, tells you what you are dealing with.
A blend does not get its own status
CJC-1295 and ipamorelin are commonly sold as one item. FDA does not evaluate a combination under a trade name; it evaluates bulk substances one at a time, and it has reached different places on these two. Ipamorelin acetate sits in Category 2 for significant safety risks. CJC-1295 sits in the withdrawn-nominations table with its own adverse-event finding, alongside the substances covered on our weight loss and metabolic page.
A single price and a single vial do not merge two regulatory positions into one. Ask for each component’s status separately, and expect the answers to differ.
What to Verify Before Any Sourcing Decision
Start by establishing whether the thing being offered is a drug or a licensed biological product, because that decides whether the compounding exemptions are available before any other question is reached. FDA publishes the transition list; somatropin and tesamorelin are on it and sermorelin is not.
Only once that is settled does the ordinary question arise: which statutory condition does the supplier say is met, under which section, and can it produce the document rather than a description of it. Ask whether the supply is a 503A prescription for a named individual or 503B office stock, because the conditions differ and a registration number speaks to neither.
Three questions are specific to this category. If a supplier relies on sermorelin’s history, ask it to identify the approved product, the application number, and how the component condition is satisfied for the particular preparation being supplied. If a supplier offers a CJC-1295 and ipamorelin combination, ask for each component’s position separately. And ask what the supplier does with FDA’s Category 2 language on ipamorelin acetate — the agency has published it, and a supplier that has not raised it has left out the most material thing the federal record says.
Research Use Only labelling settles nothing about how a product is treated. 21 CFR 201.128 provides that intended use may be shown by expressions, by the design or composition of the article, and by the circumstances surrounding its distribution. In practice that means the marketing sits alongside the label rather than behind it: FDA reached exactly that conclusion in a warning letter of 17 June 2026 to a Brooksville, Florida distributor, finding two products to be unapproved new drugs on the evidence of the firm’s own promotion. That letter bound that firm and those products.
State Law Sits On Top of This
Availability Through Phoenix Meds
Sourcing position, September 2026
The answer differs by substance here, and we set it out that way. For CJC-1295 and ipamorelin acetate we did not identify a satisfied statutory condition under section 503A or section 503B. Somatropin and tesamorelin are licensed biological products, and FDA has stated those exemptions are not available to them. Sermorelin is the exception: the approved-drug-component question is live, and it belongs to the compounding pharmacy and its counsel rather than to us.
Phoenix Meds does not determine whether a preparation is lawful. We document what the FDA record shows so the clinic and its counsel can.
What we do here is unglamorous and specific. We establish drug-versus-biologic status before anything else, we read the withdrawal determination rather than the withdrawal date, we quote FDA’s Category 2 language in full and with its qualifications intact, and we separate a blend into its components. Where an applicable federal and state-law basis can be independently established for a particular transaction, we may coordinate sourcing through appropriately licensed pharmacy partners. We do not treat a supplier’s representation as establishing that basis.
If a supplier has offered you a compounded version of an approved biological product, or a two-peptide blend described as having one regulatory status, that is worth knowing before you order rather than after.
If FDA opens a rulemaking, amends either Bulks List, alters either nominations document, or changes the transition list in a way that affects these substances, we update this page and re-date it.
Verify This Yourself
FDA — List of Approved NDAs for Biological Products That Were Deemed to be BLAs on March 23, 2020 — the thirteen somatropin products and tesamorelin acetate (022505). Sermorelin does not appear.
FDA — notice to compounders on the 23 March 2020 changes — carries the statement that transitioning biological products are not eligible for the section 503A and 503B exemptions.
Federal Register, 4 March 2013 — GEREF determination — the withdrawal dates, the finding that it was not for safety or effectiveness reasons, and the ANDA statement.
21 CFR 216.23 — the 503A Bulks List. None of the five appears. Current as of 1 September 2026.
21 CFR 216.24 — the separate bar on withdrawn or removed products. None of the five is caught by it. Current as of 2 September 2026.
FDA Drug Shortages database — the second 503B route. None of the five identified; somatropin injection listed under discontinuations. Checked September 2026.
FDA — 503B Bulk Drug Substances List — five substances; none of ours. Shows “Updated August 21, 2023”, content current 16 May 2024.
FDA — substances nominated under section 503A — a separate document from the 503B one. None of the five appears. Updated 14 May 2026.
Drugs@FDA — application 022505 — tesamorelin acetate, EGRIFTA and EGRIFTA SV, approved 10 November 2010, Theratechnologies.
FDA warning letter, 17 June 2026 — Wholesale Peptide, Brooksville FL — Prostamax and Gonadorelin found to be unapproved new drugs; intended use established from the firm’s own website despite “research use only” labelling.
21 CFR 201.128 — how intended use is established from the circumstances surrounding distribution.
Related Clinic Resources
Legal & Regulatory Status Overview
How 503A and 503B differ, what the bulks lists are, and how we report a finding rather than a legal conclusion.
Weight Loss & Metabolic
AOD-9604 and MOTS-c, a category where the answer does not split — and why that matters here.
Cellular Energy, NAD+ & IV
The other category where substances sit in different places, and a worked example of an identified basis.
GH Secretagogue Peptides: Clinic Guide
Background on this class of substances, separate from the regulatory question addressed here.
Choosing a Reliable Injectable Supplier
What to ask a supplier in writing, and which answers should end the conversation.
Disclaimer and regulatory scope:
This page is regulatory information for licensed clinics, compiled from public FDA materials. It is not medical or legal advice, and not a determination that any product or preparation is lawful.
On the federal sources reviewed in September 2026 we did not identify a 503A or 503B basis permitting CJC-1295 or ipamorelin acetate to be compounded from bulk. Somatropin and tesamorelin are licensed biological products, which FDA has stated are not eligible for those exemptions; for sermorelin the approved-drug-component question under section 503A is live. That is our finding on those sources at that time, not a legal conclusion.
State pharmacy law and medical practice acts apply on top. For how 503A and 503B differ and what the bulks lists are, see our Legal & Regulatory Status Overview. Work with counsel in your state.
Phoenix Meds Inc. is not a pharmacy, clinic, prescriber or medical provider, and we do not dispense. We coordinate sourcing between licensed clinics and licensed pharmacies. The pharmacy or outsourcing facility prepares, dispenses and ships; any clinical decision rests with the prescriber. Last reviewed: September 2026.