In the Know

USP 800 to Present Significant Compliance Challenges for Long-Term Care Providers
November 20, 2019
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Arnall Golden Gregory LLP

When many long-term care providers first hear about USP General Chapter <800> Hazardous Drugs--Handling in Healthcare Settings (“USP 800”), they naturally confuse it with the final EPA hazardous pharmaceuticals rule (“EPA Rule”), which became effective in August, 2019. While there certainly are areas in which the two overlap, the provisions of the EPA Rule concern hazardous pharmaceuticals once they are no longer used for their intended purpose and thus become waste. USP 800, however, concerns hazardous drugs (“HDs”) throughout their entire post-manufacturing lifecycle—from receiving and storage at a pharmacy or health care facility through disposal. As such, USP 800 is likely to have a profound effect on pharmacy and health care facility operations.

USP 800 is not a rule, but rather a set of practice and quality standards for handling HDs developed by The United States Pharmacopeial Convention (“USP”). It is part of USP’s compendium of standards related to compounding of drugs. USP was to have become an official part of the compendium on December 1, 2019; however, revisions to other chapters in the compendium of compounding standards are being appealed, and USP has stated that until such time as those appeals are resolved, USP 800 will be “informational and not compendially applicable.”

USP 800 will be enforced at the federal level primarily by the Occupational Safety and Health Administration (“OSHA”), and at the state level by state boards of pharmacy.

The standards within USP 800 address the following matters:

  • Identification of HDs
  • Types of Exposure
  • Responsibilities of Staff Handling HDs
  • Facilities and Engineering Controls
  • Environmental Quality and Control
  • Personal Protective Equipment
  • Hazard Communication Program
  • Staff Training
  • Receiving
  • Labeling, Packaging, Transport, and Disposal
  • Dispensing Final Dosage Forms
  • Compounding
  • Administering HDs
  • Deactivating, Decontaminating, Cleaning, and Disinfecting
  • Spill control
  • Policies and Procedures
  • Medical Surveillance

Because USP 800 applies in a variety of health care settings and thus is very comprehensive, not all of the standards will be applicable in all settings. As a result, it will be critical for long-term care providers to become familiar with USP 800, then undertake a risk assessment that considers the HDs administered in the facility, the movement of HDs throughout the facility, staff members that may come into contact with HDs, and quantifying the risk for exposure to HDs for each activity undertaken with respect to HDs.

Once the risk assessment has been completed, an analysis of the effectiveness of existing controls and containment methods, as well as policies and procedures, for preventing or minimizing exposure to HDs in light of the USP 800 requirements should be undertaken to determine if additional measures will need to be implemented. Depending on the nature of the activities being undertaken in a facility, special engineering controls for compounding may be required.

USP calls for each facility to designate a qualified and trained person responsible for developing and implementing appropriate procedures, overseeing compliance, ensuring the competency of personnel, and ensuring environmental control of storage and compounding areas (as applicable). USP stresses that the designated person must “thoroughly understand” the risks associated with HDs, both from a safety and compliance standpoint. Additionally, the designated person must oversee testing and sampling at the facility.

Facility staff that handle HDs are responsible for understanding the fundamental practices and precautions, and for continually evaluating them, to prevent harm to residents, minimize exposure to other staff, and minimize contamination from HDs. Accordingly, USP 800 calls for extensive staff training prior to employees independently handling HDs. Additionally, staff competency must be demonstrated, documented, and reassessed at least every 12 months.

A more detailed summary of USP 800 and its implications for long-term care providers will be available shortly.

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