Resolve the offer · Myth and fact
Someone may say a request was taken back and suggest that means the drug is now allowed. Start by asking what the request was for and what the FDA actually decided.
The myth to test
Thinking a request taken back means FDA approved the drug.
Ipamorelin acetate is a different chemical version of plain ipamorelin.
The US medicines agency (FDA) page carries the date April 22, 2026 and lists ipamorelin acetate in two places. One records requests that were taken back. The other names ingredients that raise safety concerns for large facilities preparing batches of medicines.
The groups asked FDA to allow ipamorelin acetate as an ingredient for ordinary pharmacies making medicines for named patients under section 503A. They later took those requests back.
As of October 1, 2026, FDA recorded the requests as taken back. That did not mean FDA had approved ipamorelin or settled its safety concerns.
Larger facilities make batches under a separate law section, called 503B. As of October 1, 2026, ipamorelin acetate remained in FDA’s category 2 for those facilities. Category 2 means the ingredient raises safety concerns.
FDA’s page does not give a date for the withdrawal.
At the October 29, 2024 meeting, the FDA advisory panel voted against adding each ipamorelin form to the ordinary-pharmacy ingredient list. The approved meeting minutes record those votes.
As of September 26, 2026, a panel vote was advice to FDA. Changing the allowed-ingredient list required a formal process.
As of October 1, 2026, no proposed or final FDA rule on compounding with ipamorelin had been found. Ipamorelin was absent from both the ordinary-pharmacy and larger-facility allowed lists.
A prescription offer still leaves a question: what allows this pharmacy to use the ingredient? Ask for the written rule and its date.