Retatrutide (and other things that you shouldn’t be compounding)

Important: In case it’s not obvious, APC is not offering legal advice here; we’re simply sharing this information as best we understand the law and regulations. If you have any questions, we strongly urge you to consult your attorney.

We’ve received inquiries lately regarding what active pharmaceutical ingredients are permitted for use in compounded medications. As a reminder, under federal law a bulk drug substance that is not classified by the FDA as a biologic may be used in a drug compounded by a so-called 503A pharmacy only if it meets at least one of the following four criteria: 

1. It has a USP or NF monograph; 
2. It is a component of an FDA-approved drug product; 
3. It appears on the FDA’s published final or interim list of bulk drug substances for compounding (also known as the 503A Bulks List); or
4. It is not on the list of drug products published in the Federal Register that have been withdrawn or removed from the market because such drug products have been found to be unsafe or not effective.

Additionally, the bulk substance must be manufactured by an FDA-registered manufacturer with a license to manufacture or distribute issued by the state in which your pharmacy is located. The bulk substance must also be sent with a certificate of analysis. 

If a substance does not meet any of these criteria, or is on the list of withdrawn or removed products, it is not eligible for use in 503A compounding. 

We know there is increasing prescriber interest in certain peptide therapies that are still in clinical development but are not yet FDA approved or USP monographed — for example, retatrutide. Despite that interest, these substances are not eligible for use in compounding unless and until they meet the criteria above. 

We’ve seen advertising by med spas and other entities for compounded drugs that do not meet criteria above — and that advertising may be what is sparking prescriber interest in sending you prescriptions for compounded substances that don’t meet the criteria. But FDA’s stance on retatrutide compounding in particular is clear: Read the agency’s warning here, and share it with prescribers. 

Similarly, we’ve received questions about APIs with orphan drug designation but without orphan FDA approval, such as tesofensine. It is our understanding that unless an orphan drug is FDA approved, it is not appropriate for use in compounding. Orphan drugs go through a two-step process: A manufacturer of an orphan drug in development may apply for an orphan drug designation. (There are FDA application-fee discounts and certain tax benefits for the research and development costs associated with a drug that is designated an “Orphan Drug.”) The designation does not mean the medication is FDA approved, and until it is approved, a pharmacy may not compound derivatives. Tesofensine is not FDA-approved. 

As always, APC recommends that pharmacies and prescribers work closely with their attorneys and compliance teams to ensure they are following all applicable laws and regulations. 

If you have questions or need clarification, don’t hesitate to reach out. We’ll continue to monitor developments from FDA and provide updates as needed.