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Regulatory Updates on Certain Peptide Therapies

Impacts from recent FDA regulation changes to the availability of certain peptides.

On September 29, 2023 the FDA made changes to its regulations concerning the production and availability of certain peptides. This unexpected change will effect the availability of the following peptides:

  • BPC-157
  • CJC/Ipamorelin
  • Dihexa
  • Epithalon
  • GHK-Cu Injection
  • Ibutamoren
  • Kisspeptin
  • KPV
  • Melanotan
  • MOTS-C
  • Selank
  • Sermorelin/Ipamorelin

Pharmacies will continue to dispense these peptide therapies until supply runs out, then they will no longer be available. 

A note from TeleWellnessMD® founder and CEO, Brent Agin, MD:

Over the years, we have witnessed significant advancements in our understanding of peptides and their therapeutic applications. Peptides are short chains of amino acids that are found naturally in our bodies and play crucial roles in numerous physiological processes. The therapeutic potential of peptides has garnered increasing attention, leading to their incorporation into various treatments for a multitude of conditions.
The decision to halt the production of many peptide agents DOES NOT reflect on their proven efficacy and safety, but rather by placing them under the biologics umbrella, the government can then regulate, control, and restrict their manufacturing and distribution.
With that said, this is not the first or the last time that we will have to navigate around new regulations. We will continue to work diligently to keep everyone on their road to health and happiness with any and all tools available. This will include making necessary changes to your current therapies as well as finding new cutting-edge opportunities. 

Caution with Non Pharmacy Vendors: We urge you to exercise caution when considering online "peptide sites" to purchase. Many of these vendors are not based in the USA or may not be FDA regulated pharmacies. This means they may not adhere to the strict regulatory standards that ensure product safety and quality, leading to potential health risks.

Your Health is Our Priority:
I understand that this shift may raise concerns or questions, especially if you are currently receiving or considering peptide therapy. Please rest assured that our primary commitment remains your health and well-being. Should you have any questions or require further information, please do not hesitate to reach out to your Wellness Advisor.
-Brent Agin, MD
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