What’s the Deal with Peptides?
Lately, there seems to be a lot of confusion and interest regarding Peptides. While the current administration has a different view of food, drugs, and the like, guidance is confusing and the potential risk of enforcement should cause you to proceed with education and caution.
Peptides are not blanket-banned by the FDA. But they’re not a typical candidate for FDA-approval/off-label use either.
Peptides that can be compounded are either: FDA-approved or are FDA GRAS (Generally Recognized as Safe) status, have a USP monograph, appear on the 503A Bulks List, or have been placed in Category I of the interim 503A Bulks List. After a determination of the regulatory status of whether a particular peptide can be compounded, it is equally important that peptides as active pharmaceutical ingredients be carefully sourced. Any supplier must be listed with the FDA as an API manufacturer and provide a Certificate of Analysis. Peptides that are ‘research use only’ (RUO) cannot be used in human or veterinary compounding. For human use, the API must be ‘pharmaceutical grade’, and not ‘food grade’ or ‘RUO.’
While there are a number of websites selling peptides over-the-counter (OTC) with multiple disclaimers that they are for RUO and not intended to diagnose, treat, cure, or prevent any disease, great risk still remains with the FDA enforcement. The FDA has commenced enforcement action where it can be shown that the products were actually intended for human use, where for example, therapeutic claims were made or where the products were sold together with diluent and syringes. FDA has stated such disclaimers were simply stated in an attempt to avoid FDA scrutiny for selling misbranded and adulterated products in violation of the FD&C Act.
There have also been some warning letters to compounding pharmacies pertaining to the compounding of peptides. The oversight on compounding peptides has mostly been issued if certain claims were made or if the facility has had other violations such as incorrect BUDs, insanitary conditions, product strength exceeding label claims, high doses with reported side effects, or sold OTC (without a prescription). This means you must also consider your source for peptides, as non-compliance could impact your platform as a reseller/distributor.
If you intend to compound or sell peptides, call the lawyers at Older Lundy Koch and Martino to ensure that you are compliant with state and federal law.
