Peptide Considerations
As of 2024, the FDA has approved several peptides for use as therapeutic agents, each with specific indications. The regulatory landscape for peptides is nuanced, especially regarding their compounding and classification under FDA guidelines.
The FDA categorizes bulk drug substances used for compounding into different categories based on their safety and approval status. For instance, substances like GHK-Cu and L-Theanine are in Category 1, indicating they are permissible as active ingredients in compounding under section 503A of the FD&C Act. In contrast, some peptides have been placed in Category 2 due to identified safety risks, which restricts their use in compoundingg (Alliance for Pharmacy Compounding)..
Moreover, the FDA’s Center for Drug Evaluation and Research (CDER) regularly approves new drugs, including peptides, each year. These approvals are based on a rigorous evaluation of the peptides’ safety, efficacy, and quality (FDA). For a detailed database of FDA-approved peptide and protein therapeutics, resources like the THPdb provide comprehensive information, including pharmacological data, indications, and regulatory statuses(PLOS)..
For the most current and detailed information on FDA-approved peptides and their regulatory statuses, including any recent changes, the FDA's official website and resources like the Federal Register are recommended for the latest updates and comprehensive guidelines (FDA).
The FDA categorizes bulk drug substances used for compounding into different categories based on their safety and approval status. For instance, substances like GHK-Cu and L-Theanine are in Category 1, indicating they are permissible as active ingredients in compounding under section 503A of the FD&C Act. In contrast, some peptides have been placed in Category 2 due to identified safety risks, which restricts their use in compoundingg (Alliance for Pharmacy Compounding)..
Moreover, the FDA’s Center for Drug Evaluation and Research (CDER) regularly approves new drugs, including peptides, each year. These approvals are based on a rigorous evaluation of the peptides’ safety, efficacy, and quality (FDA). For a detailed database of FDA-approved peptide and protein therapeutics, resources like the THPdb provide comprehensive information, including pharmacological data, indications, and regulatory statuses(PLOS)..
For the most current and detailed information on FDA-approved peptides and their regulatory statuses, including any recent changes, the FDA's official website and resources like the Federal Register are recommended for the latest updates and comprehensive guidelines (FDA).