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Chapter one · Name the medicine

# What kind of medicine are we talking about?

A peptide is a small chain of the pieces that make proteins. Insulin is a familiar example.

The exact product matters more than a broad promise of peptide therapy.

Medicine status here reflects September 26, 2026.

## An approved product has a named use

FDA approval

A review by the Food and Drug Administration of a particular medicine for a named use.

On September 26, 2026, FDA-approved semaglutide products include Ozempic and Wegovy, with approval limited to particular uses.

Tirzepatide (Mounjaro, Zepbound) also has approved products as of that date.

Approval covers one specific product for a stated use. It does not mean every peptide, or every use, has been cleared.

Ask which product is being offered and what condition the clinician is trying to treat.

## Made to order is a different route

Compounded

A pharmacist or doctor prepares the medicine to order.

The patient’s medicine is prepared through compounding rather than supplied as a ready-made drug product.

For someone whose needs an approved product cannot meet, compounding may help, for example by leaving out a dye they are allergic to.

Compounded medicines have no FDA approval on September 26, 2026; their safety, quality and effectiveness receive no agency review before marketing.

## A research label does not make treatment legitimate

Research use

A label for laboratory work; it is not approval to treat a person.

In warning letters to sellers, the FDA said products labelled for research were being promoted for use in people as drugs without approval.

These letters state the FDA’s claims against particular sellers. They are not court decisions.

No US drug product containing BPC-157, ipamorelin or retatrutide has approval as of September 26, 2026.

A listing in a government drug directory does not establish FDA approval, as of the same date.

Ask it this way

Can you show me this medicine’s FDA approval? If it is made to order, which rules allow it to be made for me?

Source information checked: September 26, 2026.

### Read the FDA distinction

The agency separates approved medicines from made-to-order preparations. Keep that distinction when comparing claims.

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

[Return to the introduction](/) [Next: Colorado care rules](/state-rules-chapter/)

A little clarity for your next care conversation: these pages offer guidance; we neither operate a clinic nor sell any medicines.

[Official source guide](/source-guide/) [Read this chapter as text](/chapter-one/index.md)