Legal

B2B Distribution Notice

Regulatory and compliance information for professional distribution of Primara products.

Last updated · July 20, 2026

Professional distribution only

Primara Health Sciences products are intended for authorized B2B professional distribution only. They are not for retail sale and are Rx Only. Primara does not sell direct to consumers.

Manufacturing and quality

  • Products are GMP-manufactured in the United States under documented process controls.
  • Each lot ships with a Certificate of Analysis covering identity, HPLC purity, and endotoxin results where applicable.
  • Lot-level traceability is maintained via PHS-LOT and PHS-COA references on every vial.
  • Cold-chain handling and storage conditions are documented from manufacture through delivery.

Partner responsibilities

Distributors, clinics, pharmacies, and other partners are solely responsible for compliance with all applicable federal, state, and local laws in their jurisdiction, including licensing, import authorization, prescribing, dispensing, storage, and record-keeping requirements. Primara provides documentation to support lawful distribution but does not provide medical or legal advice.

International markets

Distribution to Latin America and the Caribbean may require additional import permits, bilingual labeling, and market-specific regulatory filings. Partners must confirm local requirements before ordering. Primara supports compliant documentation packages but cannot guarantee clearance in every jurisdiction without partner-provided authorization.

Disclaimer

Information on this website and in product documentation is provided for B2B distribution purposes only. It does not constitute medical advice, diagnosis, or treatment guidance. Product availability, labeling, and regulatory status may vary by market and are subject to change without notice.

Contact

For compliance or documentation inquiries, contact techsupport@primarahealthsciences.com or info@primarahealthsciences.com.

Primara Assistant

Typically replies instantly

Talk to an agent