U.S. Food & Drug Administration

Notice to all parties distributing FDA-regulated research compounds

This notice establishes the obligations of every authorized distributor and reseller handling FDA-regulated research compounds. It identifies the federal provisions applicable to research-grade peptides in the United States and outlines the standards expected of all parties in the supply chain. Each distributor is directed to read this notice in its entirety and maintain a copy for their records.

1. Intended Use and Labeling Requirements

Research-grade peptides supplied through regulated channels are intended exclusively for laboratory and research purposes. These compounds are not approved by the FDA for human or veterinary therapeutic use. Distributors shall not market, label, represent, or imply that any research compound is intended to diagnose, treat, cure, or prevent any disease, or is suitable for human consumption. Any labeling or promotional material that suggests a therapeutic application constitutes a misbranding violation under the Federal Food, Drug, and Cosmetic Act.

2. Registration and Licensing: Obtained Directly Through Federal Agencies

Any establishment registration, drug listing, or controlled-substance registration applicable to your operations must be filed directly through the designated federal systems. The Compliance Information Service does not process, accept, or intermediate registration applications. The following are the sole official channels for such filings:

• FDA establishment registration and drug listing: access.fda.gov
• DEA registration (where applicable): deadiversion.usdoj.gov

3. Recordkeeping and Chain of Custody

Distributors shall maintain comprehensive records of receipt, storage, and onward distribution sufficient to establish the chain of custody for each lot. Certificates of analysis shall be retained and produced upon request. Records must be preserved for a minimum period consistent with applicable federal retention requirements.

4. Downstream Accountability

Authorized distributors bear responsibility for the conduct of any sub-distributor or reseller to whom they supply regulated compounds. Each distributor shall ensure that all downstream parties receive, acknowledge, and comply with this notice.

5. Acknowledgment of Receipt

Distributors whose agreements require formal acknowledgment shall confirm receipt of this notice through their designated account representative. Such acknowledgment records receipt of this compliance notice and confirms the distributor's awareness of the obligations set forth herein.

Contact the Compliance Desk