USP 797 and 800 Pharmaceutical Packaging for Federal Hazardous Drug Distribution

What hazardous drugs are covered under USP 800?

USP 800 references the NIOSH List of Hazardous Drugs (updated periodically) covering antineoplastics (chemotherapy agents), non-antineoplastic hazardous drugs (immunosuppressants, hormones, antivirals with hazardous profiles), and drugs with reproductive or developmental hazards. The NIOSH list is the authoritative source; USP 800 imposes handling requirements on whatever appears on the current list.

What packaging requirements apply to hazardous drug transport?

Hazardous drug transport packaging must contain the drug, prevent contamination of handlers and the environment if a container fails, and segregate hazardous drugs from non-hazardous in shared transport. Standard requirements include a tested chemo-resistant containment bag or liner (ASTM D6978 tested), an outer secondary container, hazardous-drug-specific labeling, and segregation from food or general supplies in shared shipments.

• Inner container — manufacturer-supplied unit-dose or vial packaging, intact and verified
• Containment liner — ASTM D6978-tested chemo bag, sealed around the inner container
• Outer container — rigid secondary, leak-resistant, with cushioning sufficient to prevent crushing
• Labeling — hazardous drug label per institutional policy, NIOSH classification reference, recipient warning
• Segregation — separate tote, separate vehicle compartment, or separate trip from non-hazardous drugs

How does USP 797 sterile compounding intersect with packaging?

USP 797 (Pharmaceutical Compounding — Sterile Preparations) governs sterile compounding facilities and the immediate-handling environment for compounded sterile preparations. For a federal packaging or reseller contractor, USP 797 typically does not apply directly (the contractor is not compounding) but the contractor must preserve the compounded preparation's sterility during transport and avoid breaking the unit-dose or final-container seal.

Does federal pharmacy procurement specify USP 800 in the contract?

VA Pharmacy Services and DoD pharmacy procurements typically reference USP 800 in performance work statements where the procurement involves hazardous drug handling. NAICS 561910 packaging contracts and NAICS 423450 medical-supplies reseller contracts for hazardous-drug-adjacent product categories include the standard by reference. The contractor's QMS or operating procedure must demonstrate USP 800 compliance for the activities scoped.