What the word means
Compounding is preparing a medicine to order, rather than providing a factory-made finished product.
It can serve a need that an approved medicine cannot address.
The US drug agency (FDA) does not approve compounded products or check their quality, benefit and safety before marketing, as of September 26, 2026.
The ingredient has to qualify
Under federal rules as of September 26, 2026, a regular pharmacy must first check for an official written quality standard for the ingredient. If one exists, the ingredient must meet it.
If that standard does not exist, the ingredient must be in an approved drug. If neither of those applies, it must be on FDA’s allowed-ingredient list. It does not have to meet all of these tests.
FDA’s MOTS-c review found no written quality standard for it and no approved drug containing it. MOTS-c was also missing from the allowed-ingredient list as of September 30, 2026.
What that means for raw MOTS-c
Reading FDA’s ingredient rules together, raw MOTS-c cannot be lawfully compounded by a regular pharmacy, as of September 26, 2026.
A doctor’s prescription does not let a pharmacy skip these ingredient rules.
Taking back the request did not allow its use
The people who asked FDA to add MOTS-c to the allowed-ingredient list took back their request. FDA’s page still listed concerns about possible harm to people as of September 30, 2026.
Withdrawing the request did not give MOTS-c approval. It also did not put MOTS-c in the group where FDA temporarily holds off on enforcing the ingredient-list rule, as of September 26, 2026.
Keep this in mind
As of September 26, 2026, the ingredient rules still block regular pharmacies from compounding raw MOTS-c.
A question to take
Which raw-ingredient rule allows this exact preparation to be made?
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