06/09/2026
LOVE TO DO IT - BUT WE CAN'T
We receive requests almost daily asking whether we can compound retatrutide.
We understand the interest. Recent media coverage has highlighted why patients and prescribers are asking about it: retatrutide is being studied as a next-generation weight-loss medication, and early results have generated significant attention. But enthusiasm, demand, or even a prescription request does not create a lawful compounding pathway. CBS News has reported on the growing demand for this experimental drug despite the fact that it has not been approved by FDA.
As of today, retatrutide is investigational. Eli Lilly describes it as an investigational GIP, GLP-1, and glucagon triple hormone receptor agonist being evaluated in Phase 3 trials.
For a licensed compounding pharmacy, the issue is straightforward: retatrutide cannot be used in compounding under federal law. FDA has stated that retatrutide is not a component of an FDA-approved drug and has not been found safe and effective for any condition.
Under Section 503A, state-licensed pharmacies may compound with bulk drug substances only when the substance meets specific criteria, such as having an applicable USP/NF monograph, being a component of an FDA-approved drug, or appearing on FDA’s 503A bulks list. Retatrutide does not meet those criteria. FDA has also stated that compounded retatrutide products are not eligible for 503A exemptions because retatrutide is not the subject of an applicable USP or NF monograph, is not a component of an FDA-approved human drug, and does not appear on the 503A bulks list.
The same conclusion applies under Section 503B. Outsourcing facilities may compound using a bulk drug substance only if it appears on FDA’s 503B bulks list or the drug product appears on FDA’s drug shortage list at the time of compounding, distribution, and dispensing. FDA has specifically stated that retatrutide does not appear on the 503B bulks list and is not used to compound a drug that appears on the shortage list.
For those reasons, a licensed compounding pharmacy committed to compliance, quality, and patient safety cannot prepare, dispense, or facilitate compounded retatrutide.
We will continue to monitor FDA guidance, approved treatment options, and legitimate clinical-trial developments. Until a lawful pathway exists, our answer must remain: we cannot compound retatrutide.
Doctors are jumping the gun to prescribe a medication lacking FDA approval that has gone viral on social media. "Why are we waiting?" one physician asked.
