Status of USP Chapter 800 Becomes More (and Less) Clear Following USP Appeals Panel Decision

On March 12, 2020, an Appeals Panel of the United States Pharmacopeial Convention (“USP”) granted appeals to revisions of two compounding standards—General Chapter <795> Pharmaceutical Compounding – Nonsterile Preparation (“Chapter 795”), and General Chapter <797> Pharmaceutical Compounding – Sterile Preparations (“Chapter 797”).  At the same time, the Appeals Panel denied an appeal to General Chapter <825> Radiopharmaceuticals – Preparation, Compounding, Dispensing, and Repackaging.  The challenges to the revisions of Chapters 795 and 797 are being remanded to USP’s Compounding Expert Committee with a recommendation for “further engagement” on the issues raised in the appeals.

As a result of the Appeals Panel decisions, the currently official versions of Chapter 795 (last revised in 2014) and Chapter 797 (last revised in 2008) remain in effect.  Both Chapters 795 and 797 underwent revisions that were published on June 1, 2019, resulting in the appeals.  The status of Chapters 795 and 797 is significant in terms of their effect on the applicability of USP General Chapter <800> (“Chapter 800”), which governs the safe handling of hazardous drugs (“HDs”).  Because the currently official versions of Chapters 795 and 797 will remain in effect until the status of the 2019 revisions is fully resolved, Chapter 800 will remain “informational and not compendially applicable.”

Under USP’s standards framework, a general chapter numbered below 1000 becomes compendially applicable and thus a required standard only when it is referenced in (a) a USP monograph, (b) another general chapter numbered below 1000, or (c) USP General Notices.  In the case of Chapter 800, it is referenced in the 2019 revisions of both Chapters 795 and 797, but not in the currently official versions of those chapters or in a monograph or General Notices.  Accordingly, until the updates to Chapters 795 and 797 are fully resolved, Chapter 800 will remain informational and not compendially applicable.

So what does this mean for health care providers?  While the informational status of Chapter 800 is clear for the immediate future, it is not clear how federal and state regulators will respond.  USP has made it clear that State agencies (e.g., State Boards of Pharmacy), other regulators (e.g., the Occupational Safety and Health Administration), and oversight organizations (e.g., The Joint Commission) may make their own determinations regarding the applicability and enforceability of Chapter 800 for organizations within their jurisdiction.  USP has also stated that it continues to engage and inform regulators, accreditation organizations, and stakeholders about the compendial status of Chapter 800.

With both federal and state governments presently scrambling to respond to the COVID-19 crisis, it can be assumed that regulators and oversight organizations will be delayed in their efforts to implement any enforcement of Chapter 800.  Any such delay affords health care providers the opportunity of time to assess how Chapter 800 affects their operations and to undertake any physical plant and operational changes dictated by that assessment.

About Chapter 800

Chapter 800 is not a rule, but rather a set of practice and quality standards that govern the handling of HDs from arrival at a health care facility until disposal (and beyond, when medical surveillance is factored in).  Chapter 800 became official on December 1, 2019; however, as noted above, it remains informational and not compendially applicable until the revisions to Chapters 795 and 797 are fully resolved.

The standards within Chapter 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 Chapter 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 to the same extent.  As a result, it will be critical for health care providers to become familiar with Chapter 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 in the facility.

Once the risk assessment has been completed, an analysis of the effectiveness of existing controls and containment methods 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.  Additionally, policies, procedures and training protocols will need to be developed with the goal of preventing or minimizing exposure to HDs.

USP Chapter 800 calls for designation of 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 individuals being served by the provider, minimize exposure to staff, and minimize environmental contamination from HDs.  Accordingly, Chapter 800 calls for extensive staff training prior to staff independently handling HDs, and staff competency must be demonstrated, documented and reassessed at least every 12 months.

A more detailed look at Chapter 800 geared toward long-term care is available here.