Research use only science infographic

RUO Statement

Learn about our Research Use Only product guidelines and usage terms.

BOSS Peptides Research Use Only Statement and Compliance Terms

Preamble BOSS Peptides issues this Research Use Only (“RUO”) Statement and Compliance Terms to define the permitted uses, handling requirements, regulatory alignment, and legal limitations that apply to all products sold, supplied, or distributed by BOSS Peptides that are labeled, marketed, or otherwise designated as Research Use Only, RUO, or equivalent.

RUO Declaration of Intended Use

All BOSS Peptides products bearing an RUO designation are intended exclusively  For Research Use Only. They are not intended, labeled, or authorized for:

  • Human consumption;
  • Medical, therapeutic, or clinical use;
  • Diagnostic procedures or clinical laboratory testing;
  • Veterinary administration;
  • In vivo studies involving human subjects or animals intended for clinical treatment.

Marketing materials, technical data sheets, and invoices shall contain the same statement and shall not include claims or imagery that reasonably suggest clinical, diagnostic, or therapeutic use.

Permitted and Prohibited Uses

Declaration of Intended Use BOSS Peptides hereby declares that all products sold, supplied, or distributed by BOSS Peptides that are labeled “Research Use Only,” “RUO,” or equivalent, are intended exclusively for laboratory research purposes and not for use in human or veterinary diagnosis, treatment, or administration. This designation excludes any representation of safety, efficacy, or suitability for clinical, diagnostic, therapeutic, or commercial human use.

Permitted Uses

  • Controlled laboratory research, in vitro experimentation, method development, and basic science investigations consistent with institutional policies and applicable law.

Prohibited Uses

  • Any use that involves administration to humans or animals for therapeutic, diagnostic, or prophylactic purposes;
  • Use in clinical decision making, patient care, or any activity that would require regulatory approval for clinical or diagnostic devices or drugs;
  • Transfer, resale, or distribution for clinical, veterinary, or in vivo applications without prior written authorization and appropriate regulatory reclassification.

Regulatory Alignment This RUO classification is intended to align with applicable RUO labeling expectations and regulatory frameworks, including but not limited to FDA RUO guidance (e.g., 21 CFR 809.10(c)) and standard U.S. RUO labeling practices.

Buyer Responsibilities By purchasing RUO products, the buyer acknowledges and agrees that they must:

  • Ensure personnel are trained in laboratory chemical and biosafety handling;
  • Use products only in controlled research environments and follow institutional safety protocols;
  • Maintain required documentation, approvals, and records demonstrating research‑only use;
  • Comply with all applicable federal, state, and local laws and regulations;
  • Disclose in writing to BOSS Peptides any intended use outside research so that reclassification, validation, or regulatory support can be evaluated.

Storage Handling and Safety Requirements

Customers must follow product‑specific storage and handling instructions and general laboratory best practices, including:

  • Storage conditions as specified per product (e.g., 2–8°C or ambient‑stable where indicated);
  • Avoiding freeze–thaw cycles and maintaining cold‑chain integrity when required;
  • Using sterile technique for reconstitution and procedures that require aseptic handling;
  • Preventing cross‑contamination and disposing of waste in accordance with institutional and regulatory laboratory waste rules.

Warranty, Liability, and Limitations of Use

No Warranties RUO products are provided as is for research purposes only. BOSS Peptides makes no warranties (express or implied) regarding experimental outcomes, biological activity, fitness for clinical, diagnostic, therapeutic, veterinary or human use.

Limitation of Liability To the fullest extent permitted by law, BOSS Peptides’ liability for claims arising from RUO product use is limited to, at BOSS Peptides’ option, replacement of the product or refund of the purchase price. BOSS Peptides is not liable for indirect, incidental, special, consequential, punitive damages, or for claims arising from misuse, improper storage, unauthorized applications, research failures, or adverse events resulting from non‑compliant use.

Key Considerations for Users

  • Regulatory Risk: Using RUO products in diagnostic or clinical settings can trigger regulatory obligations and potential liability.
  • Documentation: Maintain institutional approvals, SOPs, and records demonstrating research‑only use.
  • Reclassification: If you intend clinical or diagnostic use, contact BOSS Peptides to discuss reclassification, validation, and regulatory pathways.

Recommended Actions

  • Affix RUO labeling to all containers and documentation. Do not advertise or imply clinical utility.
  • Institute internal controls to prevent diversion to human or veterinary use.
  • Seek legal/regulatory counsel before any use that could be construed as clinical or diagnostic.

Compliance Acknowledgment and Enforcement

Regulatory Compliance and Buyer Responsibilities Buyers and end users are responsible for ensuring compliance with applicable laws and regulations in their jurisdiction. Use of RUO products in a clinical laboratory context may render the user a manufacturer under certain regulatory regimes and carry associated obligations and liabilities. BOSS Peptides disclaims responsibility for any regulatory noncompliance arising from misuse or off‑label use by the purchaser.

By ordering, accepting delivery of, or using RUO products, the purchaser and end user acknowledge and agree that they:

  • Understand and accept the RUO designation and the restrictions herein;
  • Are responsible for safe handling, storage, and disposal;
  • Will not use or transfer products for clinical, diagnostic, therapeutic, or veterinary administration without prior written authorization and any required regulatory approvals;
  • Will indemnify and hold BOSS Peptides harmless for regulatory noncompliance or damages arising from prohibited uses.