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Compounding notes / check the reason

Ask why it needs to be made this way.

Compounding means making a medicine for a particular need. Ask why the proposed product needs that change.

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Words used in this note
FDA
The US agency that checks medicines for approval is called the Food and Drug Administration.
Compounding
Preparing a medicine to meet a particular need.
Copies
Made-to-order versions of medicines already sold ready-made. The rules below explain when a patient’s medical need can make a difference.
Outsourcing facility
A business registered with FDA to make batches of medicines free of living germs.

Compounding can meet a specific patient need

These federal rules describe when medicines may be made to order. For a peptide offered in Alabama, also ask how it meets the Alabama board’s notice.

As of September 26, 2026, FDA says compounding may help if approved products cannot meet a patient’s medical need or are unavailable ready-made.

  • What need does the proposed change meet?
  • Why does the ready-made option not meet it?
  • What is the exact ingredient, and will I take it as a tablet, shot or something else?
  • Who writes down the reason?

A compounded product has no FDA approval

A pharmacy licence and a product approval answer different questions.

FDA distinction

Know which review is missing

As of September 26, 2026, FDA has not approved compounded medicines. It does not review how well they work, or their safety and quality, before sale.

Ask: “What studies support this medicine for my problem? Who makes it, and how do they check that it is properly made?” Use the pharmacy note to check Alabama’s permit, sterile-medicine approval and pharmacist training.

Read FDA’s compounding explanation

Alabama’s board notice also prohibits doctors from prescribing “non-FDA-approved or research grade” peptides, as of October 1, 2026.

  • Do not assume that meeting federal compounding rules means this peptide is allowed in Alabama.
  • Ask the prescriber for a written explanation of how this exact medicine meets the board’s notice.
Check pharmacy permissions and training Read Alabama’s peptide notice

Copies of available medicines have limits

Before paying, ask whether this medicine can be made under federal rules and prescribed in Alabama. A lower price does not answer either question.

Federal law restricts pharmacies and doctors from routinely preparing copies of ready-made medicines, as of September 26, 2026. It also limits very large amounts of those copies.

For one named patient, the prescriber can document a change that makes a meaningful medical difference for that person. Under the federal pharmacy rule, that can keep the changed medicine from being treated as a copy.

A price difference is not a meaningful medical difference under that rule.

Businesses that make batches under outsourcing rules also face federal limits on copies of approved medicines.

As of September 26, 2026, semaglutide and tirzepatide injection products were absent from FDA’s shortage list.

One pharmacy having no stock does not, on its own, put a medicine on FDA’s national shortage list.

  • Ask: “What medical need requires this change, and which federal rule allows you to make it?”
  • Ask what is different and why that difference matters for you.
  • Ask how the medicine also meets Alabama’s notice; a doctor’s note alone does not answer that.
  • If someone cites a shortage, ask whether the exact medicine is on FDA’s current national shortage list.
Read FDA’s supply and compounding update

Registration and approval answer different questions

An outsourcing facility registers with FDA as a business making batches of sterile medicines, which have no living germs. It can make batches without a prescription naming each patient.

As of September 26, 2026, registration as an FDA outsourcing facility does not approve the facility’s products or endorse the business.

As of September 26, 2026, FDA’s position is that federal law bars compounding either retatrutide or cagrilintide.

  • A badge saying the business is “FDA registered” does not answer whether your medicine is approved.
  • Get the precise product name, then ask if both federal rules and Alabama rules allow that medicine.
Read the FDA product concerns

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