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 Health-Care Settings, which become official December 1, 2019, and may not apply to most U.S. oncology practices that administer and prepare oncologic 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 U.S. 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>.
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.
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.
Resources for USP <797> and USP <800>
- Summary of New and Revised Standards
- USP Webinar on <800> Applicability and "Decision Tree" on Applicability
- USP <800> FAQs
- USP <797> FAQs ■
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