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Ask for the reason and the route

Why is a pharmacy making it to order?

Compounding is the name for preparing medicine, including mixing it, in response to an order. Before discussing a pharmacy-made preparation, ask why it is being proposed for you.

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Check the conditions for pharmacy compounding

In September 2026, United States law allowed certain patient-specific pharmacy compounding when all its conditions were met.

Note A

The raw ingredient must meet one of three requirements in law. It must meet a recognised written drug standard if one exists. Without such a standard, the ingredient has to belong to a drug with FDA approval or appear on the official list of allowed ingredients.

The pharmacy also needs a valid prescription for the named patient. A prescription alone does not make every ingredient allowed.

Ask the prescriber which conditions apply to the exact preparation, not to compounding in general.

What review does the product have?

Compounded drugs had neither FDA approval nor a premarketing FDA check of their quality, benefit and safety in September 2026.

Note B

The Food and Drug Administration reviews drugs at the federal level; FDA is its short name.

Ask which pharmacy will make it and what written information you will receive. Ask why a finished approved product would not meet the need being discussed.

Can a pharmacy make BPC-157 or TB-500?

BPC-157 and TB-500 appear in HHS’s October 30, 2026 draft: HHS would not move against state-licensed pharmacies and licensed doctors making either alone for a patient’s prescription if the draft’s conditions are met.

Note C

FDA’s July 2026 documents say neither ingredient has the required written drug standard or is part of an approved drug. Neither is on the official list of allowed ingredients.

That conclusion follows from the ingredient rules and FDA documents cited below. It is not a new FDA announcement.

Ask for the basis of any different claim. A medicine being offered does not supply the missing explanation.

Page notes

  1. FDA on ingredients used in pharmacy compounding

    A prescription is only one requirement. The ingredient must also meet the rules described above.

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  2. FDA on the review gap for compounded drugs

    Ask whether the ingredient is allowed as well as whether the finished medicine has approval.

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  3. FDA explanation of the ingredient rules

    The FDA documents describe which ingredient requirements BPC-157 and TB-500 fail. The people or groups asking FDA to allow these ingredients took back their requests. Withdrawing those requests left pharmacies without permission to use the ingredients.

    FDA ingredient review: BPC-157 FDA ingredient review: TB-500 Official list of allowed ingredients Back to the briefing