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Term / Compounding

Compounding: a different product, with different rules.

With compounding, a medicine is made to order. It is not supplied as the drug maker’s finished product.

Ask what makes this product different

  • Is this the finished medicine Zepbound or Mounjaro, or tirzepatide made to order by a pharmacy?
  • Who makes it, and where can I check the pharmacy licence?
  • What medical need does the changed product meet for me?
  • Why does the person writing my prescription propose this product?

Approval and compounding are separate

The product has not had the same review

As of September 26, 2026, medicines made to order are not approved by the Food and Drug Administration (FDA). This US agency checks medicines.

Before these medicines are sold, the FDA does not assess how safe they are, their quality or how well they work.

When approved medicines cannot meet a patient’s needs, compounding can provide a medicine for that person.

The shortage no longer allows pharmacy-made copies

An old shortage claim is not enough

As of September 26, 2026, the FDA’s last tirzepatide shortage decision was its December 19, 2024 finding that the national shortage had ended.

While tirzepatide was on the national shortage list, pharmacies could make copies under the shortage rules; that reason for making copies ended in 2025.

The deadlines were initially February 18, 2025, for ordinary compounding pharmacies and March 19, 2025, for larger facilities that make medicines for other care services. The FDA extended its pause on enforcing shortage rules for ordinary pharmacies through the court’s March 5, 2025 decision.

An empty shelf at one local pharmacy does not add a medicine to the FDA’s national shortage list.

A change must meet a named patient’s medical need

As of September 26, 2026, US law restricts pharmacies from regularly making copies of medicines already sold, or making those copies in large amounts.

The health professional writing a prescription is called a prescriber.

This rule allows an ordinary compounding pharmacy an exception when it changes a medicine for a single patient identified by name.

The prescription writer must judge the change to be an important difference for this patient when compared with the medicine already on sale.

A lower price by itself is not the kind of difference this rule requires.

The word generic does not fit

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