A name isn’t permission
Can this medicine be offered legally?
Get the exact medicine’s name. Does the Food and Drug Administration (FDA) approve that product, is it made to order, or does it carry a research label? Check the rules below.
Find out which kind of product is offered.
An approved medicine
The approved-product record at the Food and Drug Administration (FDA) names semaglutide as Ozempic and Wegovy, and tirzepatide as Mounjaro and Zepbound in September 2026. Read semaglutide’s FDA labelRead tirzepatide’s FDA label
In September 2026, FDA approval means the agency accepted a particular product for a specified use after weighing evidence about benefit and harm.
Get the medicine’s full name and ask how you would take it: tablets or shots?
In September 2026, both Ozempic and Wegovy names covered tablets as well as shots.
Medicine made to order
Compounded describes medicine prepared for an order; the person making it is a pharmacist or doctor.
U.S. rules allow some medicines to be made to order, but the exact product must meet the compounding rules, as of September 2026. FDA compounding guidance
The September 2026 approval status is clear: FDA has not approved the compounded preparation itself.
For a regular pharmacy making a medicine to order, September 2026 rules require a named patient’s prescription, a licensed pharmacist and a licensed pharmacy.
Under September 2026 rules, an existing official quality standard must be met by the raw ingredients. Without such a standard, the ingredients must appear in an approved drug or on FDA’s allowed list.
Have the prescriber, the person writing your prescription, identify the rule that permits your particular preparation. Request a written answer.
Difficulty swallowing tablets or an allergic reaction to a dye are examples FDA gives of needs that may call for compounding.
These examples do not settle whether your product is allowed. Ask how its ingredients and the pharmacy meet the rules.
A research-labelled product
FDA says federal rules bar retatrutide and cagrilintide from compounding, as of September 2026. FDA statement on these products
FDA letters reviewed in September 2026 challenged human-use sales despite research-only labels.
In September 2026, those letters set out FDA’s claims against firms rather than rulings by a court.
A research label does not supply a care plan. Do not let it end the conversation.
Ask what justifies a compounded copy.
The September 2026 FDA check found no national shortage listing for semaglutide injection or tirzepatide. FDA update on supply and copies
September 2026 rules limit making copies of a medicine already sold. For one patient, a prescriber can decide that a change makes a significant difference. FDA account of the rules
Have the prescriber explain the change to the product and its importance to your health. This is a rule about making the medicine, not a medical test.
Under September 2026 rules, saving money by itself cannot establish a significant difference for an individual patient.
- What change is needed in my case?
- Under which rule can you prepare this particular medicine?
- Is there an approved option that meets the same need?