FAQs

Find answers to common questions, and about our

Are peptides FDA-approved?

Many peptides have been FDA-approved, and still more 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, an on-label indication would accompany this, 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 the 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. BioTiva 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.
What is Research Use Only (RUO), and why am I seeing this all over?

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. BioTiva, as a research chemical manufacturing company, will not make clinical insinuations or suggestions. For more information, refer to the FDA’s non-binding recommendations

References:

  1. 1. FDA compounding regulations and enforcement actions
  2. 2. What are Biologics? – FDA
  3. 3. FDA Regulatory Standards for Non-Drug Products
  4. 4. FDA guidelines on dietary supplements and labeling
  5. 5. California Proposition 65 FAQ – AHPA
  6. 6. California AB 82 and AB 1341 Regulations
  7. 7. FDA guidance on RUO labeling
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