Look at the care
Compounding: medicines made to order
A medicine made to order has its own rules. The word does not settle the status of TB-500.
In the US, medicines are reviewed by the Food and Drug Administration, known as the FDA.
What is being made to order?
Compounding prepares a medicine for a particular need by making or mixing it, instead of using a drug maker's finished product.
- Licensed pharmacists and doctors can make medicines to order within the rules for compounding.
- As of September 2026, a compounded medicine has no FDA approval, and the FDA does not assess its safety, effect, or quality before it is marketed.
- FDA guidance says compounding may provide a medicine for a need that an approved product cannot address.
Apply the rules to the proposed ingredient
May an ordinary pharmacy use TB-500?
As of September 2026, TB-500 does not qualify as a raw ingredient for ordinary pharmacy compounding. Under these rules, a pharmacy may not use raw TB-500 to make medicine.
- The law sets rules about which raw ingredients an ordinary pharmacy may use. As of September 2026, an ingredient must meet its official written quality standard if one exists. If none exists, it must be in an FDA-approved medicine or on the FDA's list of allowed extra ingredients.
- TB-500 has no such official quality standard, as of September 2026. No FDA-approved medicine contains it, and it is absent from that extra-ingredient list.
- Taking back the request for TB-500 did not change those ingredient rules, as of September 2026.
Notes for this chapter
Ask for the specific explanation
- What exact substance is proposed?
- Which current FDA record or law allows a pharmacy to make this medicine for me?
- What other options could meet the same need?
- Can the explanation be put in writing?
Keep the discussion about this ingredient and this proposal.