A common assumption
Does a prescription make every product approved?
Under federal law, a prescription medicine can be dispensed only with a valid prescription. A
Dispensing means handing over the medicine.
Compounding is preparing a medicine to order.
A made-to-order medicine lacks FDA approval even with a clinician’s prescription; FDA means Food and Drug Administration. B
A common assumption
Is compounding always against the law?
An approved product may leave a medical need unmet; compounding can fill that gap if the relevant rules are followed. B
Federal law limits repeatedly making products that are nearly the same as an approved medicine already sold.
The limits cover making these copies regularly or in very large amounts.
An exception may apply if the prescriber records a change that makes a medically important difference for one named patient. Paying less, on its own, does not show that medical difference. C
Semaglutide and tirzepatide are medicines with approved products used for type 2 diabetes or weight loss.
Adding vitamin B12 to a similar semaglutide injection can still count as making a copy.
Ask how the medicine would be changed and why that would matter for your health. Ask the prescriber to put that reason in writing.
A common assumption
Does a pharmacy being out of stock allow copies?
FDA’s shortage list tracks shortages across the country; it is different from one pharmacy running out.
When a drug is on that list, federal limits on making compounded copies do not apply in the same way.
Other compounding rules still apply.
The FDA shortage-list check on September 26, 2026, showed no listing for injections of either semaglutide or tirzepatide. C
Ask what specific patient need the proposed custom product would meet. Ask for the answer in writing.
A common assumption
What about these weight-loss offers?
Retatrutide and cagrilintide are names in FDA’s warning about unapproved weight-loss drugs.
FDA’s position at the September 26, 2026 check was that federal law bars compounding medicines with either retatrutide or cagrilintide.
Neither was part of an FDA-approved drug or found safe and effective for treating any health problem. D
An offer on a website does not answer the status question. Keep the exact product name when you ask about it.