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A guide to care questions / Made to order

Does “compounded” change the answer?

Made to order describes a process. It does not answer whether the ingredient can be used or whether the product has been reviewed.

Made-to-order medicine still has to meet the rules

A doctor or pharmacist may prepare medicine for a patient’s particular needs; making it to order this way is called compounding.

As checked on 26 September 2026, compounded drugs did not have FDA approval or a pre-sale FDA review of quality, benefit or harm.

Read an offer for a compounded product with that distinction in mind.

The ingredient still has to qualify

The September 2026 U.S. rules give regular pharmacies three ways for a raw ingredient to qualify.

  • If an official written standard describes what the ingredient is and how to check its quality, the ingredient must meet it.
  • Where no official written standard exists, the ingredient has to be a component of an approved medicine.
  • When neither of those routes applies, the ingredient has to appear on the official list allowing extra ingredients for pharmacies.

FDA found no such written standard for TB-500 and no approved medicine containing TB-500.

TB-500 was also absent from the allowed-ingredient list at the September 2026 check.

Taking back the request to add TB-500 to that list did not make the ingredient qualify.

Read the dated U.S. position

A registration or code is not approval

Federal rules checked in September 2026 give no approval to a facility or its drugs merely because it has FDA registration.

In a product directory, an NDC (National Drug Code) serves as an identifier, without showing whether FDA has approved the product.

Ask who made the product and which exact rule permits the ingredient. Keep the answers separate.

Check a licence and its limits

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