Legal & Regulatory

Compliance & RUO Policy

Reserve Research operates in strict accordance with FDA Research Use Only (RUO) regulations. This page outlines our compliance framework and your obligations as a buyer.

What is Research Use Only (RUO)?

Research Use Only (RUO) is a designation applied to products intended for in-vitro research, laboratory studies, and non-clinical scientific investigation. Under U.S. FDA regulations (21 CFR Part 864), RUO products:

  • Are not approved for diagnostic or therapeutic use in humans or animals
  • Are not subject to the same pre-market approval requirements as clinical products
  • Must be clearly labeled "For Research Use Only" or "RUO"
  • Cannot be sold with medical claims or recommendations for human use
  • Must be sold to qualified research professionals or institutions
Important: The RUO designation is a regulatory classification, not a statement about a compound's inherent danger. Many pharmaceutical compounds in early development phases are sold RUO. The designation protects both suppliers and buyers by clearly defining the intended use context.

Buyer Obligations

By purchasing from Reserve Research, you confirm and agree to the following:

  1. Age Requirement: You confirm that you are 18 years of age or older. Reserve Research does not sell to minors under any circumstances.
  2. Qualified Researcher: You are a researcher, scientist, or qualified professional purchasing for legitimate research purposes. Products are not for general consumer use.
  3. Research Purpose Only: Products will be used solely for in-vitro research, laboratory analysis, or other legitimate scientific purposes. They will not be used in humans or animals in any form.
  4. Legal Compliance: You are responsible for ensuring your purchase, possession, and use of these compounds complies with all applicable federal, state, local, and international laws and regulations.
  5. Not for Resale: Products will not be resold, reformulated, or otherwise distributed to third parties for purposes outside your stated research use, without prior written consent.
  6. Storage & Handling: Compounds will be stored, handled, and disposed of in accordance with applicable safety regulations and good laboratory practices (GLP).
  7. No Medical Use: Products will not be administered to any human or animal, or used to prepare products for such administration, under any circumstances.

Labeling Standards

All Reserve Research products are labeled in full compliance with FDA RUO guidelines. Every product label includes:

  • Compound name (generic and common name where applicable)
  • Batch/lot number for full traceability
  • Net weight and/or quantity
  • "For Research Use Only — Not for Use in Diagnostic Procedures"
  • Storage conditions and temperature requirements
  • Supplier name and contact information
  • Hazard information where applicable (GHS-compliant)
Note on HIPAA: HIPAA (Health Insurance Portability and Accountability Act) governs the handling of protected health information (PHI) by healthcare providers and related entities. It does not apply to the sale of RUO research compounds. Reserve Research's compliance framework is governed by FDA regulations, not HIPAA. No medical or health information about our customers is collected or required in connection with product purchases.

COA Documentation

Every Reserve Research compound comes with a batch-specific Certificate of Analysis (COA) generated from independent third-party laboratory testing. Our COAs include:

HPLC-UV Purity Analysis

Exact percentage purity by high-performance liquid chromatography

LCMS Identity Confirmation

Liquid chromatography-mass spectrometry confirms correct molecular mass

LAL Endotoxin Level

Limulus amebocyte lysate assay for bacterial endotoxin contamination

K-F Moisture Content

Karl Fischer titration for residual moisture percentage

COAs are linked directly to product pages and updated when a new batch is released. You may also request a COA for any past order by contacting us with your order number and batch number.

FDA RUO Framework

The legal basis for Research Use Only product sales in the United States is primarily established under:

  • 21 CFR Part 864 — Hematology and pathology devices (establishes the RUO classification)
  • FDA Guidance Document: "Distribution of In Vitro Diagnostic Products Labeled for Research Use Only" — Clarifies that RUO products may not be marketed for clinical use
  • Federal Food, Drug, and Cosmetic Act (FD&C Act) § 301 — Prohibits misbranding or adulteration of regulated products

Reserve Research maintains its RUO compliance by: making no clinical or therapeutic claims, refusing to advise on human administration protocols, requiring research-purpose purchase agreement at checkout, and maintaining complete sales records.

Your Data & Privacy

Reserve Research collects only the information necessary to process your order and communicate with you. We do not sell, rent, or share your personal information with third parties for marketing or advertising purposes.

  • Order information is used solely to fulfill your purchase and maintain required records.
  • Your email may be used to send order confirmations and shipping updates. You will not be added to marketing lists without your consent.
  • We do not store payment card details — all transactions are processed through secure third-party payment processors.
  • We do not collect or require any health or medical information.
We do not sell your data. Your information is used only to fulfill your order and communicate with you about it.

Frequently Asked Questions