For Non-GLP-1 Peptide Treatments
Peptides are short chains of amino acids that serve as signaling molecules in the body. Peptide therapy involves the administration of specific peptides to support various physiological functions. Only peptides with a lawful compounding pathway may be prescribed at this practice.
The FDA has significantly restricted peptide compounding. Many formerly available peptides have been removed from the FDA’s interim bulks list or rejected by the Pharmacy Compounding Advisory Committee (PCAC). BPC-157, TB-500 (thymosin beta-4), and several other popular peptides are now classified as Category 2 (identified safety concerns) and CANNOT be legally compounded. Only peptides that remain on the FDA’s 503A bulks list or are components of FDA-approved drugs may be compounded pursuant to a valid prescription. This practice only prescribes peptides that have a current legal compounding pathway.
Category 1 or component of approved drug
Your prescriber will confirm the current regulatory status of any peptide recommended for your treatment, as the FDA bulks list is subject to change.
Category 2 / Prohibited
Products labeled “For Research Use Only – Not for Human Consumption” (RUO) are NOT prescribed at this practice. The FDA has stated that RUO labels are a “ruse to avoid FDA scrutiny.” Use of RUO products on patients constitutes distribution of unapproved new drugs. APIs used in compounding must be pharmaceutical grade from licensed sources. If you are obtaining peptides from non-pharmacy sources, inform your prescriber immediately.
Individual results vary. No specific outcomes are guaranteed. Many peptides lack long-term clinical trial data in humans.
Alternatives may include conventional pharmaceutical treatments, lifestyle modifications, surgical interventions, physical therapy, or no treatment. Your prescriber will discuss appropriate alternatives.
