Can hCG be compounded? hCG, tesamorelin and the biologics rule

Updated September 2026. Federal sources checked as of September 23, 2026.

Short answer: Can hCG be compounded? No. Since March 23, 2020, hCG has been regulated as a licensed biologic, and FDA says biologics licensed under section 351 of the Public Health Service Act are not eligible for the 503A or 503B compounding exemptions. The same applies to tesamorelin, somatropin, hyaluronidase, menotropins and follitropins. Clinics can order the FDA-licensed products. Sermorelin sits in a different, unsettled category.

The March 2020 hCG biologic transition

For years, hCG and several other protein products were approved as drugs under new drug applications. The Biologics Price Competition and Innovation Act of 2009 changed that on a fixed date: on March 23, 2020, approved NDAs for biological products were "deemed to be" biologics licenses (FDA transition list).

• What counts as a protein. FDA's final rule (February 21, 2020; effective March 23, 2020) interprets "protein" as any alpha amino acid polymer with a specific, defined sequence greater than 40 amino acids.
• What moved. FDA's transition list includes chorionic gonadotropin (Pregnyl, Novarel, Fresenius Kabi's chorionic gonadotropin and Ovidrel), menotropins, follitropins, hyaluronidase, somatropin and tesamorelin acetate (Egrifta).
• What it meant for compounders. FDA's notice to compounders said that from March 23, 2020, these transitioning biological products "will not be eligible for the exemptions for compounded drugs under sections 503A and 503B." It named hCG, hyaluronidase, FSH (urofollitropin) and menotropins as bulk substances outsourcing facilities had been using.

The general rule comes from FDA's 2018 biologics guidance: for purposes of sections 503A and 503B, a "drug" does not include a biological product subject to licensure under section 351, so the FD&C Act provides no legal pathway for marketing a biologic prepared outside an approved license.

Can hCG be compounded? What the rule means for sourcing

hCG product statuses are from Drugs@FDA as of September 22, 2026. An offer of "compounded hCG" made after March 2020 is outside 503A and 503B.

The narrow exception: mixing, diluting or repackaging a licensed product

FDA's 2018 guidance describes conditions under which it does not intend to act when a state-licensed pharmacy, a federal facility or an outsourcing facility mixes, dilutes or repackages a licensed biological product outside its labeling. A state-licensed pharmacy may distribute such a product only after receiving a prescription for an identified patient. The policy does not extend to anyone who starts from other material: mixing a licensed biologic with a bulk drug substance, for example, requires a license. So the practical question for any pharmacy offering hCG is simple: what is the starting material? If the answer is bulk hCG powder, it is not the licensed product.

Compounded tesamorelin and "research use only" tesamorelin

Tesamorelin acetate (Egrifta) was on FDA's March 2020 transition list, so compounded tesamorelin falls outside 503A and 503B for the same reasons as hCG. It also turns up in the research-chemical market. FDA's August 24, 2026 warning letter to Royal Peptides listed tesamorelin among products sold as "for research use only" and "not for human or animal consumption," alongside bacteriostatic water and a "peptide calculator." FDA treated the products as unapproved new drugs.

Sermorelin compounding in 2026: an unsettled case

Sermorelin is often grouped with tesamorelin, but its legal position is different:

• No approved product. The GEREF (sermorelin acetate) approvals were withdrawn effective June 18, 2009 at the maker's request. In 2013, FDA determined the products were not withdrawn for reasons of safety or effectiveness. Because those approvals were withdrawn years earlier, sermorelin was not among the approved products deemed to be biologics licenses in March 2020.
• No FDA category. Sermorelin does not appear in any of FDA's 503A bulk-substance categories (May 14, 2026 list).
• An unconfirmed basis. Many 503A pharmacies compound it, relying on its history as the active ingredient of an approved drug. We found no FDA statement specific to sermorelin compounding, and whether a withdrawn approval satisfies the "component of an FDA-approved drug" condition in section 503A is not confirmed.

State boards can also move first. Mississippi's Boards of Nursing, Pharmacy and Medical Licensure said in an August 19, 2026 joint statement that providers may not compound, administer or dispense a non-FDA-approved or research-grade peptide to a patient. Mississippi clinicians using sermorelin should ask the boards how that applies. Other growth hormone secretagogues, such as CJC-1295 and ipamorelin, have their own statuses on the growth hormone secretagogue page.

hCG for weight loss: what FDA says

FDA's consumer update (July 13, 2020) says hCG is approved as a prescription drug for conditions such as female infertility, not for weight loss. It notes that the prescription label says there is "no substantial evidence" that hCG increases weight loss beyond what caloric restriction produces, and it warns that very-low-calorie diets marketed with hCG carry risks such as gallstones, electrolyte imbalance and irregular heartbeat.

Unverified: we could not confirm an FTC action, or a joint FDA and FTC action, specific to hCG diet products from primary sources for this article, so we don't describe one here.

Before you order hCG, tesamorelin or another biologic

• Confirm the product is FDA-licensed by finding it in Drugs@FDA or the Purple Book. See the hCG and fertility regulations page.
• For pharmacy-prepared versions, ask for the starting material and whether the preparation follows FDA's mixing, diluting and repackaging conditions.
• Confirm the pharmacy is licensed for the patient's state (nonresident pharmacy map), and check your state's physician dispensing rules if you dispense from the office.
• Read how MedGrid classifies products by regulatory lane, including biologics and research-use labels, on the regulatory lanes page.

Sources

• FDA, Notice to compounders: changes that affect compounding as of March 23, 2020 (2020-03-05)
• FDA, List of Approved NDAs for Biological Products That Were Deemed to be BLAs on March 23, 2020 (2020-03-23)
• FDA, Federal Register, Definition of the Term "Biological Product", final rule, 85 FR 10057 (2020-02-21)
• FDA (CDER/CBER), Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application, Guidance for Industry (2018-01-01)
• FDA (openFDA), Drugs@FDA records for chorionic gonadotropin products (2026-09-22)
• FDA, Federal Register, Determination That GEREF (Sermorelin Acetate) Injection Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness (FR Doc. 2013-04827) (2013-03-04)
• FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503A (Categories 1-3) (2026-05-14)
• FDA, Warning Letter: Royal Peptides LLC (MARCS-CMS 734884) (2026-08-24)
• Mississippi Board of Nursing, Board of Pharmacy and State Board of Medical Licensure, Joint Statement Concerning the Prescribing of Non-FDA Approved (Research-Grade) Peptides (2026-08-19)
• FDA, Avoid Dangerous HCG Diet Products (Consumer Update) (2020-07-13)

Frequently asked questions

Can hCG be compounded?

No. Since March 23, 2020, hCG has been regulated as a licensed biologic, and FDA says biological products licensed under section 351 of the PHS Act are not eligible for the 503A or 503B compounding exemptions. FDA's notice to compounders named hCG specifically. Clinics can order FDA-licensed hCG products.

Why is hCG considered a biologic now?

Under the Biologics Price Competition and Innovation Act, approved drug applications for biological products, including proteins, were deemed to be biologics licenses on March 23, 2020. FDA's final rule treats a protein as an amino acid polymer with a specific, defined sequence greater than 40 amino acids, and chorionic gonadotropin was on FDA's transition list.

Is compounded tesamorelin legal?

Tesamorelin acetate (Egrifta) was on FDA's March 2020 transition list, so it is a licensed biologic and falls outside the 503A and 503B compounding exemptions. FDA's August 2026 warning letter to Royal Peptides also listed tesamorelin among products sold as 'research use only'.

Can sermorelin still be compounded in 2026?

Its status is unsettled. Sermorelin's only approved products (GEREF) were withdrawn in 2009 at the maker's request, and it is not in any of FDA's 503A bulk-substance categories. Many 503A pharmacies compound it, but we found no FDA statement confirming the basis, so ask the pharmacy which section 503A condition it relies on.

Is hCG approved for weight loss?

No. FDA says hCG is approved as a prescription drug for conditions such as female infertility, not for weight loss, and that the prescription label states there is no substantial evidence it increases weight loss beyond caloric restriction. We could not verify an FTC action specific to hCG diet products for this article.

This article is general information, not legal advice. Confirm current FDA status and your state's rules with your counsel and boards before ordering, prescribing or dispensing.

Check the rules, then see what verified vendors list. Look up hCG and peptide rules for your state in the MedGrid regulations tool, and verify your NPI to see licensed products from diligence-cleared vendors. Sign-up is free.