Research-Use-Only Restrictions

Critical restriction

1. Product-specific scope

This policy applies only where a product, quote, accepted order, label, specification, or documentation expressly identifies the item as “Research Use Only,” “RUO,” “Not for Human Use,” or an equivalent restriction. It does not independently determine the legal classification of any item. Product-specific law, labeling, documentation, and accepted agreements control.

2. Authorized purchaser and environment

• A legally organized, verified institution or business conducting legitimate nonclinical laboratory research.
• Qualified personnel, suitable facilities, written procedures, appropriate storage, access control, material handling, incident response, and lawful waste disposal.
• Institutional, biosafety, chemical-safety, animal-research, import/export, or other approvals required for the actual project.
• An identified research objective, end user, destination, and responsible person that are consistent with the product’s documented restriction.

3. Prohibited uses

• Human or veterinary ingestion, injection, implantation, topical application, inhalation, administration, exposure, or dosing.
• Clinical care, diagnosis, screening, treatment, mitigation, cure, prevention, wellness, body composition, performance, cosmetic, or patient-specific use.
• Compounding, pharmacy dispensing, prescription fulfillment, clinical-trial use without the required lawful pathway, or incorporation into a product for human or animal use.
• Food, dietary-supplement, cosmetic, drug, biologic, device, or consumer-product manufacture unless separately and lawfully authorized under product-specific documentation.
• Providing dosage, administration, treatment, or patient-use instructions; soliciting patient outcomes; or using testimonials or disease claims to promote the product.
• Resale, transfer, brokering, drop-shipping, or delivery to an individual, residence, patient, unverified intermediary, or unapproved organization.
• Removal, concealment, alteration, contradiction, or defeat of research-use labeling, documentation, restrictions, or traceability.
• Representing or implying that Pharma Americas, a supplier, FDA, or another authority approved, cleared, endorsed, certified, or authorized a clinical or therapeutic use.

4. Intended use and conduct must align

A disclaimer does not cure conduct showing a different intended use. Client may not provide Pharma Americas with information suggesting a legitimate research purpose while marketing, instructing, distributing, or using the product for a clinical, therapeutic, diagnostic, personal, or other prohibited purpose. Pharma Americas may consider the organization, communications, website, marketing, destination, quantities, personnel, prior conduct, downstream parties, and other risk signals when evaluating eligibility.

5. Handling and records

• Maintain receipt, lot, quantity, custody, location, storage, use, transfer, incident, and disposition records appropriate to the material and project.
• Limit access to trained and authorized personnel and maintain security proportionate to diversion, exposure, and misuse risk.
• Follow the supplier’s current safety, storage, handling, and disposal documentation and applicable hazardous-material requirements.
• Promptly report loss, theft, diversion, suspected prohibited use, exposure, quality concern, or material inconsistency.
• Preserve labels and restrictions through authorized transfers and provide records reasonably requested for eligibility, quality, safety, trade, or legal review.

6. Transfer and resale

No transfer or resale is permitted without Pharma Americas’ prior written authorization under the accepted order. If authorized, Client must verify the downstream organization and end user; flow down restrictions at least as protective as this policy; preserve traceability; prohibit onward transfer except as authorized; and remain responsible for Client’s representations, selection, instructions, marketing, and failure to control the transfer.

7. Marketing and communications

Client must ensure that websites, catalogs, social media, sales scripts, labels, invoices, training, and communications are truthful, non-misleading, consistent with the documented research intended use, and not designed to attract or instruct prohibited use. Pharma Americas does not provide medical advice, dosing information, patient guidance, or substantiation for a prohibited claim.

8. Verification, suspension, and enforcement

Pharma Americas may request end-use statements, project descriptions, credentials, facility information, licenses, responsible-person confirmation, downstream records, websites, marketing, sanctions information, and other diligence; refuse or limit a transaction; require corrective action; suspend or terminate access; cancel an unaccepted request; preserve or disclose information; or report activity where required or appropriate by law.

False information, evasion, credential sharing, unexplained residential shipment, inconsistent marketing, prohibited-use communication, diversion, or refusal to provide reasonable diligence is grounds for immediate hold or termination. Client remains responsible for accepted financial obligations and for indemnity under the Terms.

9. FDA RUO context

FDA’s formal RUO guidance cited below directly addresses certain in vitro diagnostic products and explains that RUO labeling must remain consistent with the manufacturer’s intended use. Other products may be governed by different statutes, regulations, and facts. Pharma Americas applies the same core control principle—labeling, promotion, sale, and actual use must not contradict the documented restriction—without representing that every product is an IVD or that the cited guidance alone determines legal status.