An offer is not permission.

KPV has no approved medical use

Records checked September 28, 2026 showed no KPV medicine approved by FDA, the US medicine regulator. [a]

Ask about FDA approval even if the offer comes with a prescription, a product code or a website listing.

Withdrawing the request did not grant permission

A pharmacy group asked FDA to consider allowing KPV in medicines made to order, then took back its request. [b]

FDA’s page dated April 22, 2026 lists KPV under withdrawn requests for pharmacy use, rather than in its safety-risk group. [b]

FDA gives no date for when KPV moved to that table and still warns that information about human use is missing. [b]

Taking back that request did not mean FDA approved KPV or cleared it for use. [b]

The pharmacy ingredient rules still matter

Compounding fills an order with medicine prepared for that order, rather than with a drug maker’s finished product. [e]

For a pharmacy preparing a named patient’s medicine, KPV did not meet the legal ingredient requirements as of September 26, 2026. [c]

KPV had no entry in the official drug-quality reference books, was not in an approved medicine, and was not on FDA’s extra-ingredient list. [c]

This guide concludes from the law and FDA’s findings that taking back the request does not give these pharmacies permission to use KPV. [c]

Compounded medicines lack FDA approval; their safety, quality and benefit are not reviewed by FDA before sale. [e]

An advisory meeting is not a rule change

In July 2026, FDA staff recommended excluding KPV from the extra-ingredient list for pharmacies that make medicine for a named patient. [a]

No official account of the advisory committee’s votes had been published by FDA as of September 28, 2026. [d]

Under the process checked September 26, 2026, a committee vote only advises FDA; it does not change the pharmacy ingredient list. [c]

To change that list, FDA must publish a proposed rule, invite public comments and then issue a final rule. [c]

Ask the clinician and pharmacy to show the current law or final FDA rule they rely on. Ask them to explain how it allows the exact ingredient in the offer.