USP-800 Labeling, Packing, and Transport Requirements Summary


USP800 Proposed Labeling, Packing, and Transport Requirements for Hazardous Drugs — Handling in Healthcare SettingsUSP-800 Labeling, Packing, and Transport Requirements Summery

  • The entity must establish standard operating procedures for the labeling, handling, packaging, and transport of HDs.
  • The SOPs must address prevention of accidental exposures or spills, personnel training on response to exposure, and use of a spill kit.
  • Examples of special exposure- reducing strategies include small-bore connectors (such as Luer Lock) and syringes, syringe caps, CSTDs, the capping of container ports, sealed impervious plastic bags, impact-resistant and/or water-tight containers, and cautionary labeling.

11.1 Labeling

  • Hazardous drugs identified by the entity as requiring special hazardous drugs handling precautions must be clearly labeled at all times during their transport.

11.2 Packaging

  • Compounding personnel must select and use packaging containers and materials that will maintain physical integrity, stability, and sterility (if needed) of the HDs during transport.
  • Packaging materials must protect the HD from damage, leakage, contamination, and degradation, while protecting healthcare workers who transport HDs.
  • The entity must have written SOPs to describe appropriate shipping containers and insulating materials, based on information from product specifications, vendors, mode of transport, and experience of the compounding personnel.

11.3 Transport

  • HDs that need to be transported must be labeled, stored, and handled in accordance with applicable federal, state, and local regulations.
  • HDs must be transported in containers that minimize the risk of breakage or leakage.
  • Pneumatic tubes must not be used to transport any liquid or antineoplastic HDs because of the potential for breakage and contamination.
  • When shipping HDs to locations outside the entity, the entity must consult the Transport Information on the SDS. The entity must ensure that labels and accessory labeling for the HDs include storage instructions, disposal instructions, and HD category information in a format that is consistent with the courier’s policies.

View Proposed Chapter USP-800 Here >