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Copies and shortages

# Weight-care copies need a closer look

An old shortage claim can leave out a major change.

Fact file: September 26, 2026.

In brief

In the United States, the Food and Drug Administration (FDA) handles the review of medicines.

Neither semaglutide nor tirzepatide appeared on the national shortage list maintained by FDA as of September 26, 2026.

Making copies because of a national shortage was therefore no longer allowed. A separate rule could still allow a change that the person writing the prescription judged to make a significant difference for a named patient, subject to the other compounding rules.

A compounded medicine is made for a particular order instead of being supplied as the manufacturer’s finished drug.

## What the shortage changed

Federal compounding rules can permit copies through an exception for medicines listed by FDA as nationally in shortage.

A pharmacy’s local stock gap is different from a medicine’s entry on the national shortage list.

If an offer mentions a shortage, ask which official listing it relies on and when that listing was checked.

## “Different” needs an explanation

FDA’s position reviewed on September 26, 2026 was that a semaglutide preparation with added vitamin B12 could still be essentially a copy.

For that separate patient-specific rule, the prescriber had to document the change and explain its significant difference for the individual patient.

In FDA’s general examples, a patient might need a preparation without an allergy-causing dye, or a different form because swallowing a tablet is not possible.

Those examples do not automatically make a vitamin blend allowed.

Ask which medical need the change meets for you and how the copy rule applies.

Ask: “What change do I need, and why does it matter for my care compared with the approved medicine?” Ask for that reason in writing. A vitamin in the name does not explain the medical need.

## Compounded and generic are different words

A generic is a medicine approved as a copy of a brand-name drug.

As of September 26, 2026, no approved, marketable generic version of semaglutide or tirzepatide existed in the United States.

FDA identifies advertising a compounded drug as a generic or as equivalent to an approved drug as false or misleading.

The records behind this briefing [Open the source file →](/source-file/#copies)

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