NAICS 561910informational·8 MIN READ

USP 797 and 800 Pharmaceutical Packaging for Federal Hazardous Drug Distribution

Hazardous drug containment, segregation, and outer-package requirements for federal pharmacy and reseller distribution under USP General Chapters 797 and 800.

  • USP <800>
  • USP <797>
  • NIOSH List of Hazardous Drugs
  • ASTM D6978
a pile of pills sitting next to each other on top of a table
Photo: Roberto Sorin / Unsplash
USP General Chapter 800 (Hazardous Drugs. Handling in Healthcare Settings) governs containment, transport, and disposal of hazardous drugs across the healthcare supply chain, including the federal pharmacy distribution lane. USP 797 governs sterile compounding packaging requirements. For federal procurement, the standards apply when a contractor handles hazardous-drug shipments, transport, or compounding-grade packaging, including drop-ship preparation by SDVOSB resellers.

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.

FAQ

Frequently asked questions

Can a small business perform hazardous drug packaging at a standard packaging facility?+
USP 800-compliant hazardous-drug handling requires a controlled containment area and trained personnel. A standard packaging facility is not USP 800-certified by default. For federal opportunities requiring USP 800-grade containment, the standard pattern is teaming with a USP 800-certified subcontractor (compounding pharmacy or specialty pharmaceutical packager) while the small business retains prime contract responsibility.
What is ASTM D6978?+
ASTM D6978 is the standard test method for resistance of medical gloves and barrier materials to permeation by chemotherapy drugs. A 'chemo-tested' bag or liner passes ASTM D6978 against a panel of common chemotherapy agents. The standard is the practical materials qualification for USP 800-compliant containment.
Does USP 800 apply to non-antineoplastic hazardous drugs?+
Yes. USP 800 covers the full NIOSH List of Hazardous Drugs including antineoplastics, non-antineoplastic hazardous drugs, and drugs with reproductive or developmental hazards. The handling and containment requirements apply across the list, with some tier-specific variations based on dosage form and exposure risk.
How does USP 800 packaging interact with hazmat 49 CFR?+
USP 800 governs healthcare-setting handling and containment; 49 CFR governs hazardous-materials transport. For chemotherapy or other hazardous drugs that also meet 49 CFR hazardous-material definitions, both standards apply simultaneously. USP 800 for containment and contamination control, 49 CFR for vehicle, labeling, and driver-training requirements.
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