HHS Overrules FDA Scientists, Approves Six Peptides for Compounding

In a significant move that has sparked debate within the medical community, the Department of Health and Human Services (HHS) has approved six experimental peptides for compounding by licensed pharmacies and physicians, a decision that reportedly came despite objections from FDA career scientists ¹²³⁴⁵.

This development marks a notable shift in the regulatory landscape, as it is typically the FDA that makes decisions regarding compounding under normal circumstances ³. However, the HHS’s recent policy change now directs the FDA not to take action against pharmacies selling these peptides, which are used for wellness purposes ³⁴.

The six peptides in question include BPC-157 and TB-500, and they are now covered under a new policy that includes safety measures such as requiring their ingredients to come from FDA-registered factories ³⁴⁵. This is particularly noteworthy because, under standard FDA rules, these peptides would be classified as illegal drugs ³⁴.

The decision by HHS to allow the compounding of these peptides comes at a time when the FDA had recently added several peptides to its list of substances that should not be compounded due to safety risks ³⁵. This move by the FDA in 2023 highlights the ongoing tension between the two agencies over the regulation of these compounds.

Kennedy, a notable figure in the field, described using BPC-157 to treat a muscle injury, illustrating one potential application of these peptides ³. The approval by HHS opens up new possibilities for patients seeking alternative treatments, while also raising questions about the future of peptide compounding regulations.

What we know

• HHS allowed six experimental peptides to be compounded by licensed pharmacies and physicians. ¹³⁴
• This decision was made despite objections from FDA career scientists. ¹²³⁴⁵
• The six peptides include BPC-157 and TB-500. ¹³⁴
• The policy covers six specific peptides used for wellness purposes. ³⁴
• The policy directs the FDA not to take action against pharmacies selling these peptides. ³⁴
• Under normal FDA rules, these peptides would be considered illegal drugs. ³⁴
• The policy includes safety measures such as requiring peptide ingredients from FDA-registered factories. ³⁴⁵
• Decisions about compounding have traditionally been made by the FDA, not HHS. ³
• In 2023, the FDA added several peptides to its list of substances that should not be compounded due to safety risks. ³⁵
• Kennedy described using BPC-157 to treat a muscle injury. ³