Your Practice May Not Be Subject to USP <797> and <800> Standards; Check with Your Relevant Regulatory Body

July 23, 2019

The American Society of Clinical Oncology (ASCO) recently received clarification from the United States Pharmacopeia (USP) around the newly revised USP General Chapter <797> Pharmaceutical Compounding Standards – Sterile Preparations and USP General Chapter <800> Hazardous Drugs – Handling in Healthcare Settings, which become official December 1, 2019 and may not apply to most U.S. oncology practices that administer and prepare oncological agents. However, as rules and regulations vary across states, practices should contact their respective state pharmacy board, medical board, regulatory agency, and/or accrediting organization to determine how the standards may apply to their specific situation.

In comments on the draft standards, ASCO urged USP to harmonize the standards with the Food and Drug Administration’s (FDA) definition of compounding. Reflecting ASCO’s recommended changes, the final standards are more closely aligned with the FDA definition of compounding and make clear that the following activities are not subject to compounding standards in <797>:

  • Administration of a sterile medication, including injections and infusions. (Section 1.2)
  • Preparation of drugs – mixing, reconstituting, and other acts – in accordance with the medication label and other manufacturer directions. (Section 1.4)

Chapter <800> may not be applicable to a practice, so long as the practice’s activities fall into the exceptions listed above. USP has provided informational resources to clarify the compendial applicability of <800> (links below). 

ASCO Safe Handling of Hazardous Drugs Standards

ASCO has long been committed to promoting and supporting research, guidance, and educational materials to help promote the safety of professionals in the oncology workforce who may handle or otherwise come into contact with hazardous drugs. Earlier this year, ASCO published in the Journal of Clinical Oncology new standards for the safe handling of hazardous drugs. The ASCO safe handling standards stress the need for evidence-based safety measures that are supported by high-quality, unbiased studies on health outcomes, while stating that an entity’s health and safety management system must include, at a minimum:

  • a list of hazardous drugs
  • facility and engineering controls
  • competent personnel
  • safe work practices
  • proper use of appropriate personal protective equipment
  • policies for hazardous drug waste segregation and disposal

Further, ASCO and the Oncology Nursing Society published a 2016 update to the Chemotherapy Administration Safety Standards, which included standards for pediatric oncology.

What Oncology Practices Need to Know

While USP <797> and <800> do not apply to the mixing and reconstitution activities typically performed by oncology care providers in preparation for administration to patients, the rules and regulations governing these activities vary from state to state. ASCO encourages practices to contact their respective state pharmacy board, medical board, regulatory agency, and/or accrediting organization to determine what standards or rules may apply to their specific situation.

USP is an independent scientific organization that collaborates with the world’s top experts in health and science to develop quality standards for medicines, dietary supplements, and foods. USP has no role in enforcement and ensuring compliance with the requirements of the standards, which is the responsibility of regulators, such as the FDA, states, and other government authorities.

To learn more about USP <797> and USP <800>: