Regulatory

    Compliance

    Effective Date: January 1, 2026

    US Certified Peptides operates under a strict compliance framework covering research-use designation, regulatory alignment, analytical testing standards, and qualified-researcher verification. This page documents our compliance commitments, the regulatory frameworks our methods align with, and the responsibilities of both US Certified Peptides and the researchers we serve.

    Research Use Only Designation

    ALL products sold by US Certified Peptides are designated for laboratory research use only. They are not approved drugs, dietary supplements, food, cosmetic products, or veterinary medicines. They are not intended for any application involving human or animal subjects. Specifically, our products are NOT:

    • Approved by the FDA for any therapeutic, diagnostic, or human consumption use
    • Intended for self-administration by any individual
    • Intended for use in cosmetic, food, or supplement applications
    • Authorized for use in clinical trials without proper IRB and regulatory authorization
    • Sold for resale or redistribution to unqualified parties

    All product labels, packaging, certificates of analysis, and marketing materials clearly state 'Research Use Only.' Researchers acknowledge and agree to this designation as a condition of purchase.

    Regulatory Framework Alignment

    Our Elite Certification testing methods align with the following US regulatory frameworks. Method references appear on every Certificate of Analysis.

    FDA Guidance

    Analytical methods reference FDA Guidance for Industry standards including 21 CFR 211 (cGMP analytical methods), ICH Q2(R1) (analytical method validation), and FDA Guidance for peptide drug products. Note: alignment with FDA-recognized methodologies does not constitute FDA approval of our products.

    USDA Standards

    Where applicable to research chemical handling and contamination screening, testing aligns with USDA APHIS Biologics Regulations and 9 CFR Part 113 standard requirements.

    USP General Chapters

    Each of the seven Elite Certification tests references specific USP general chapters including USP <85> (Bacterial Endotoxins Test), USP <232>/<233> (Elemental Impurities), USP <621> (Chromatography), USP <736> (Mass Spectrometry), and USP <61>/<62> (Microbiological Examination).

    EPA Methods

    Heavy metal and trace contamination analysis applies EPA Method 200.8 (ICP-MS) and EPA Method 6020B (Metals Analysis) where appropriate.

    ISO/IEC 17025:2017 Accreditation

    All Elite Certification testing is performed by an independent ISO/IEC 17025:2017 accredited laboratory. ISO/IEC 17025:2017 is the international standard for the competence of testing and calibration laboratories. Accreditation requires:

    • Demonstrated methodological rigor and validation
    • Calibrated, traceable instrumentation
    • Documented procedures and quality systems
    • Reproducible results verified through inter-laboratory comparisons
    • Independent audit by recognized accreditation bodies

    The accreditation status of our testing partner is publicly verifiable through international accreditation registries.

    Qualified Researcher Verification

    Sales are limited to qualified research professionals. Before fulfilling first orders, we verify researcher eligibility through one or more of the following:

    • Institutional affiliation (university, hospital, contract research organization, biotech, pharmaceutical company)
    • Research credentials (advanced degree in life sciences, biochemistry, pharmacology, or related field)
    • Professional licensure (where applicable to the researcher's role)
    • Verifiable professional standing (publications, grant funding, professional society membership)

    We reserve the right to request additional documentation, to deny accounts that do not meet eligibility requirements, and to terminate accounts that misrepresent eligibility. Verification reduces but does not eliminate the risk of product diversion; primary responsibility for compliant use rests with the researcher.

    Researcher Responsibilities

    By purchasing from US Certified Peptides, researchers agree to the following responsibilities:

    • Use products solely for laboratory research consistent with their professional role
    • Maintain compliance with all applicable federal, state, local, and institutional regulations
    • Obtain any required IRB, IACUC, or regulatory authorizations before research involving human or animal subjects
    • Not administer products to any human or animal subject without proper authorization
    • Not resell, redistribute, transfer, or share products with unqualified parties
    • Store and handle products according to documented protocols
    • Document research use and disposal in accordance with applicable laws

    Controlled Substance Status

    The peptides in our catalog are not currently scheduled controlled substances under the federal Controlled Substances Act. Some peptides may be subject to additional regulation in specific states, jurisdictions, or international markets. Researchers are responsible for ensuring compliance with all applicable regulations in their jurisdiction. We may decline to ship to jurisdictions where products are restricted.

    Export and International Compliance

    Products may be subject to export control regulations under the Export Administration Regulations (EAR) and other US export laws. Researchers requesting international shipment are responsible for compliance with both US export regulations and the import regulations of the destination country. We may decline international orders that do not meet export compliance requirements.

    Reporting and Documentation

    We maintain documentation of all certifications, COAs, batch records, and shipping records consistent with regulatory requirements. Records are retained for periods required by applicable regulations. In the event of a regulatory inquiry, we cooperate fully with authorized federal, state, or international regulators.

    Adverse Event or Misuse Reporting

    If you become aware of an adverse event, product misuse, or suspected counterfeiting involving US Certified Peptides products, contact us immediately at compliance@uscertifiedpeptides.com. Reports are reviewed promptly and may be escalated to relevant regulatory authorities as appropriate.

    Anti-Diversion Commitment

    Product diversion to unqualified parties or unintended uses harms research integrity and undermines public safety. US Certified Peptides is committed to preventing diversion through:

    • Researcher verification before first orders
    • Lot-specific QR-coded labeling with third-party hosted COAs
    • Quantity limits on individual orders consistent with research-scale use
    • Refusal to ship to addresses or accounts inconsistent with stated research purpose
    • Cooperation with law enforcement in cases of suspected diversion

    Changes to This Compliance Statement

    Regulatory frameworks evolve. We may update this Compliance page as standards change or our processes improve. Material changes will be communicated by posting the updated statement on our website with a revised Effective Date.

    Contact

    For compliance-related inquiries, regulatory questions, or to report concerns, contact us at compliance@uscertifiedpeptides.com or through the contact form at /contact.

    Compliance Inquiries

    Talk to our compliance team.

    For regulatory questions, researcher verification inquiries, or to report concerns about product use or diversion, contact our compliance team.

    Contact Compliance