Understanding the offer
What can a pharmacy make?
A prescription is not enough. Ask which part of the law allows the pharmacy to use the ingredient in your medicine.
An ingredient has to fit the rules
This page looks at pharmacies filling a prescription by making medicine for a single patient named in the order.
As of September 2026, federal law sets rules for the raw ingredients those pharmacies may use.
A quality standard describes what the ingredient must be like and how its quality is checked.
The law uses the quality standards in two official books, called USP and NF.
If the ingredient has an official written quality standard, it must meet that standard.
If there is no such standard, the ingredient must be used in an FDA-approved drug.
If neither applies, the ingredient must be on the FDA’s official list of extra ingredients allowed for this kind of compounding.
Read the basisFood and Drug Administration (FDA) ingredient rules
These are checks against the law, not just a test in a laboratory.
Ask which rule covers the pharmacy’s work and which requirement the ingredient meets.
The FDA adds an ingredient to that list through a formal process of making a rule and asking for public comments.
For BPC-157 and TB-500, the gap remains
As of September 2026, BPC-157 and TB-500 have no written ingredient quality standard in USP or NF, and neither is used in an FDA-approved drug.
Read the basisFDA briefing on the reviewed ingredients
Neither BPC-157 nor TB-500 is on the FDA’s extra-ingredient list for pharmacies making medicine for a named patient, as of September 2026.
Read the basisThe official federal ingredient list
Under these rules, a pharmacy cannot use BPC-157 or TB-500 as raw ingredients to make medicine for a named patient, as of September 2026. This answers the ingredient question for that kind of pharmacy; it does not check every detail of a seller’s offer.
Groups had asked the FDA to add BPC-157 and TB-500 to the ingredient list, then took back those requests.
Withdrawing a request for an ingredient’s addition to the list grants neither permission for compounding nor FDA approval, as of September 2026.
Read the basisFDA’s ingredient-list framework