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# Check the medicine behind the claim

Keep a written note of the medicine, the goal of care and the document offered as support. Compare those details with what a service tells you.

[Approved medicines](#approved) [Compounding](#compounding) [Research products](#unapproved) [Questions left open](#next-steps)

## Match the claim to a named product

Ask what record establishes approval for the actual product. The federal agency that reviews drugs uses the name Food and Drug Administration (FDA). Ask which use the doctor is proposing and where that use appears in the supporting record.

FDA’s approval records, checked September 26, 2026, include tirzepatide products (Mounjaro, Zepbound) and semaglutide products (Ozempic, Wegovy).

Their approved uses differ by product, so a drug name alone is not a complete description of a treatment plan.

Request the exact brand or generic name and the form being offered.

An approved copy of a brand-name drug is called a generic. A compounded preparation is different.

As of November 3, 2026, neither semaglutide nor tirzepatide had an approved generic that could be marketed in the U.S. At that check, liraglutide injections did have approved generics, including some labeled for weight management.

Approval belongs to the product

A business calling itself FDA registered has not established approval of its products. The federal rule on registration, checked September 26, 2026, gives no approval through that process.

[Read the registration and listing rule](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-207/subpart-F/section-207.77)

Keep the source and the product name together. Ask the clinician to point to the part that supports the proposed use, and to explain what it does and does not establish.

## Separate compounding from approval

Compounding describes the pharmacist’s or doctor’s work of making a medicine for an individual need.

For example, a dye allergy or difficulty with the available form may leave an approved product unable to meet the need.

Compounded preparations lack FDA approval under U.S. rules as checked September 26, 2026. Before sale, FDA does not review how they are made, their effects or their safety.

Ask why the proposed change is needed for you, which pharmacy would make it, and what approved options have been considered. A clear answer names the preparation and the reason for it.

An ordinary compounding pharmacy generally cannot copy an available medicine as a regular service or in unusually large amounts. That is the U.S. rule reviewed September 26, 2026. The exception depends on the prescriber’s judgment that a particular change matters significantly for that person.

By the September 26, 2026 check, FDA no longer listed semaglutide or tirzepatide injections as being in national shortage.

An empty shelf at a nearby pharmacy does not, on its own, mean a drug is in national shortage.

What to ask about an added ingredient

An added vitamin does not, by itself, get a preparation around the rule against regular copies. FDA gives this example in its April 2026 update. The example concerns semaglutide. The prescriber’s documentation needs to show why a change makes a significant difference for that person.

[Read FDA’s compounding policy updates](https://www.fda.gov/drugs/drug-alerts-and-statements/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize)

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

## Pause at a claim that cannot be checked

Ask for the record behind a claim. If a service points to the word “research” or “registered,” ask what that word tells you about the exact product.

No U.S. product containing BPC-157 or MOTS-c had approval at the September 26, 2026 record check.

Lack of approval does not settle whether a pharmacy may prepare a drug. Before paying, ask the pharmacist to identify the active ingredient, meaning the part meant to make the medicine work. Ask which rule permits that ingredient in your preparation.

An ordinary compounding pharmacy must use these tests in order, under U.S. rules reviewed September 26, 2026:

- An ingredient with an applicable official drug-quality standard has to meet it.
- If there is no such standard, the ingredient must be found in a drug with FDA approval.
- If neither route applies, use is limited to ingredients named on FDA’s allowed list of raw substances.

The pharmacy must also follow official compounding standards, obtain a valid report of the ingredient’s test results, and use an ingredient from a maker registered with FDA.

FDA states, as checked September 26, 2026, that retatrutide and cagrilintide cannot be compounded under federal law.

Some people or groups asked FDA to add ingredients to its list for compounding, then took those requests back. FDA lists those withdrawn requests separately. That list includes BPC-157 and MOTS-c, with FDA’s safety concerns still beside them. The page does not say when each request was withdrawn. FDA gives April 22, 2026 as the date its ingredient page was current. That page date does not grant permission to use an ingredient.

FDA’s concerns for peptide ingredients include the body reacting to an injected peptide as an invader, unwanted substances mixed with the ingredient, and too little human safety information.

Withdrawing a request gives no FDA approval or permission to compound the ingredient. The U.S. Department of Health and Human Services (HHS) addressed compounding separately in a draft published October 30, 2026. It describes conditions under which HHS plans to hold off on enforcement against state-licensed pharmacies and physicians. The policy covers MOTS-c, KPV, TB-500, semax, BPC-157 and epitalon, each prepared for a prescription for one person.

Only preparations with one peptide ingredient are covered; blends are excluded. The policy also excludes the larger batch compounders known as 503B outsourcing facilities. Its conditions include limits on the ingredient’s identity and how it is given. This draft is nonbinding and gives no ingredient FDA approval. FDA’s 503A list of raw ingredients allowed for ordinary compounding still contained none of the six when checked November 3, 2026.

[Read the HHS draft and its conditions](https://www.hhs.gov/sites/default/files/hhs-503a-peptide-enforcement-discretion-policy-appendix-b.pdf)

Withdrawal also does not place the ingredient in “Category 1,” FDA’s temporary group for certain ingredients still under review.

For ingredients in that group, FDA temporarily plans not to act against compounders if they meet its policy’s conditions. This policy of holding off on action is not legal permission to make a drug.

Read past the research label

In warning letters issued in 2026, FDA described products labeled for research but advertised to treat people. FDA alleged that these were unapproved drugs despite the research wording.

A warning letter tells a company what FDA believes it is doing unlawfully. It is an official warning about that company, rather than a court ruling or a new rule.

[Read FDA’s product concerns](https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss)

Use the named source to check what the claim actually says. If the answer changes subject from a specific product to peptides in general, bring it back to the product being proposed.

## Keep unanswered questions visible

A missing answer is something to take back to the clinician. Write it down beside the proposed medicine and the health concern, rather than trying to fill the gap from an advertisement.

### Take these questions back

- Which finding supports the choice for my concern?
- What is known about this exact preparation?
- What important questions remain unanswered?
- Which pharmacy would supply it, and can I check its record?
- Who will explain the next steps if a problem occurs?

On its online-pharmacy checklist, FDA looks for a pharmacist who can answer questions, a state license and a valid prescription.

A low advertised amount, viewed alone, cannot establish that an offer is legitimate; lawful cash-pay prices can also be below a list price.

The pharmacy’s license and the specific medicine deserve their own checks. Read the quote and the care plan together before deciding whether the answers are complete.

Reports describe problems, not a measured likelihood

A report alone does not prove a drug caused a problem. FDA says reports of problems after people use a medical product cannot show how often those problems occur.

An “adverse event” means something unwanted happening in connection with a medical product, such as feeling ill after taking a medicine.

[Read the limits of FDA’s event reports](https://www.fda.gov/drugs/fda-adverse-event-monitoring-system-aems/fda-adverse-event-monitoring-system-aems-public-dashboard)

If a clinician recommends a medicine, ask about its risks and what response they expect if a problem develops. Those personal treatment questions belong in a conversation with a qualified health professional.

[Find the state pharmacy license search](https://www.fda.gov/drugs/besaferx-your-source-online-pharmacy-information/locate-state-licensed-online-pharmacy) [Return to the visit questions](/primer-questions)

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