Are peptides FDA Approved?
There are many peptides that have been FDA Approved and still more that are currently in clinical trials. However, the FDA has stated that once a product is compounded, it cannot retain its FDA Approval. It is safest to assume that there is no FDA Approval for any product on this website, as these are intended for research use only (with several exceptions). If there were FDA Approval, this would be accompanied by an on-label indication, and the product would be classified as a drug.[1]
Am I allowed to use something that does not have FDA Approval?
Disclaimer: The items sold on this website are for research use only. FDA Approval and pre-market approval are synonymous, and as such, the lack of FDA Approval prevents marketing for specific conditions, uses, safety, and outcomes. PYB does not have any ability to speak to the potential uses of any research chemical outside of research-based conversations.[2]
A state medical license defines one’s scope of practice. FDA Approval is synonymous with pre-market approval and does not govern how licensed medical providers practice medicine. Always consult your healthcare attorney for additional details.[3]
Can I submit prescriptions to your company for patient delivery?
No. PYB does not operate as a pharmacy and does not provide products directly to patients. Products are supplied only to licensed medical professionals, and our manufacturing partners are labs that do not function on a per-patient basis.
Are prescriptions required for me to use/administer peptides?
Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), products that are not classified as drugs or controlled substances can generally be sold without a prescription. Dried and powder form products typically fall into the category of dietary supplements, biologics, or food products, which are subject to different regulatory standards than prescription medications. According to the FDA’s guidelines, these products do not require prescriptions as long as they do not make drug claims and comply with labeling requirements.[4] You may see disclaimers consistent with these labeling standards.
Are there state-specific considerations that hold relevance over federal compliance regulations?
While federal law permits the sale of these products without a prescription, state laws may vary. Some states, including New York and California, have stricter regulations regarding the sale of certain supplements and health products.
- California Laws:
- Proposition 65 (Prop 65): Requires warnings about significant exposures to chemicals known to cause cancer, birth defects, or other reproductive harm. Please review all product lines to ensure compliance.[5]
- AB 82 and AB 1341: Target dietary supplements for weight loss and over-the-counter diet pills. They prohibit the sale of these products to minors under 18 without a prescription and require retailers to post notices about potential health risks.[6]
What is a Statement of Use, and why is it required at checkout?
This is a common practice for chemical suppliers, who must provide an explanation of intended use when acquiring various excipients and chemicals. Based on the manufacturer’s intent of research use, we require a brief explanation of the use or research hypothesis related to the products ordered.
Example: Lyophilized GLP-1/GIP is being purchased to study the potential of microdoses with varied frequency in comparison to standard clinical trial dosing strategies.
What is Research Use Only (RUO), and why am I seeing this all over the internet?
The terminology “Research Use Only” (RUO) is part of FDA governance under in-vitro diagnostic (IVD) definitions. RUO indicates that there can be no insinuation of intended uses in clinical diagnostics, based on the manufacturer’s labeled intent.[7]
RUO labeling is prevalent in the supplement industry, as some companies misunderstand that the “Research Use Only” label does not permit them to promote clinical uses. PYB, as a research chemical manufacturing company, will not make clinical insinuations or suggestions. For more information, refer to the FDA’s non-binding recommendations.
I heard there is a potential problem with peptides being combined in the same vial or same syringe due to potential aggregation, or “cross-linking.”
This is a valid concern; however, our products are made with a proprietary inclusion complex that prevents this issue. This inclusion complex is a non-glycemic, sugar-based technology that is non-reactive and has demonstrated safety for the intended research uses.