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[The Treatment Papers Hormones · Medicines · Care](/)

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Medicine note

Medicine status as of 26 September 2026.

# The name changes the answer.

Request a written medicine name, its intended use and how it is taken: by injection, as a tablet or some other way. Ask what approval covers that exact product.

A page lists “hormone support” but leaves out the medicine. Ask for the name in writing before treating the offer as a care plan.

Jump within this note ↓

- [Some peptide medicines have approval](#approved-products)

- [Compounding changes what has been reviewed](#prepared-products)

- [Hormone-related names have different histories](#hormone-names)

- [A research label does not establish treatment status](#research-labels)

## Some peptide medicines have approval

Product approval goes through a US agency. It is the Food and Drug Administration (FDA). The review concerns a specific product and proposed use.

Semaglutide (Ozempic, Wegovy) has approved uses in diabetes or weight care, depending on the product.

Somatropin is human growth hormone. Somatropin and tesamorelin (Egrifta) both have US approval.

These names are examples of medicines with approval. Ask which condition the exact product is approved to treat and why it is being proposed for you.

[FDA · medicine application records](https://api.fda.gov/drug/drugsfda.json)

Approval belongs to the product; it does not cover everything called peptide treatment.

Ask to see the FDA approval for the exact medicine and use being discussed. A broad promise about “hormones” leaves both questions open.

## Compounding changes what has been reviewed

Compounding means making a drug to order. A pharmacist or doctor prepares it to meet a patient’s needs.

Making a drug to order by compounding does not give it FDA approval. Before it is marketed, FDA does not check the finished drug’s safety, benefit or quality.

Some patient needs call for compounding because an approved drug cannot meet them. It can be lawful, with conditions; FDA approval is a different question.

[FDA · compounding and patient needs](https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers)

An example in FDA’s explanation is a patient who cannot use an ingredient in an approved product.

Ask why the drug needs to be made to order and why an approved medicine cannot meet that need.

### Hormone-related names have different histories

Sermorelin’s old brand was Geref. FDA withdrew its approvals in 2009.

In a later finding, FDA said safety or lack of benefit had not been the reasons for leaving the market.

This finding did not approve any sermorelin drug made to order today.

[Federal Register · the Geref finding](https://www.federalregister.gov/documents/2013/03/04/2013-04827/determination-that-geref-sermorelin-acetate-injection-05-milligrams-basevial-and-10-milligrams)

Geref’s old approval does not make a sermorelin drug made to order today FDA-approved.

Biologics are medicines made using living cells; some are protein medicines. Tesamorelin and somatropin belong to this legal group.

For this group, FDA product approval is called a biologics licence. Federal law provides no way to market a version prepared outside that approval.

[FDA · biologics and compounding](https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers)

A pharmacy cannot use the compounding rules to make its own version of a biologic, even with a prescription.

## A research label does not establish treatment status

A “research use only” label does not settle whether a product is being offered as a medicine. FDA pointed to website claims about treating people, such as claims about weight or hormones, in letters accusing sellers of marketing drugs.

These were allegations in letters sent to specific firms, rather than court findings.

[FDA · claims about treating people](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peak-performance-peptides-735127-08242026)

Read FDA’s letter for the company named in it. Ask the prescriber to identify the medicine’s FDA approval, or explain which compounding rules permit it to be made to order.

An NDC is a drug’s code in a government directory. The code identifies an entry; it gives no proof of product approval.

[FDA · what a product code means](https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory)

Check approval as its own question.

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The Treatment Papers is a reading guide to care decisions; this journal runs no clinic and sells no treatment.

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