ASCO Urges Amended Language in Pharmaceutical Compounding

December 6, 2018

ASCO submitted comments to the United States Pharmacopeia Convention (USP) concerning a proposed chapter on pharmaceutical compounding. The society’s comments urge USP to make clarifications to the proposal’s language and harmonize it with the U.S. Food and Drug Administration’s (FDA) definition of compounding. ASCO is concerned that proposed chapter, General Chapter <797> Pharmaceutical Compounding– Sterile Preparations (USP <797>), as it is currently written, could create unnecessary confusion for providers, interfere with patient access to potentially life-saving drugs, and undermine FDA drug approval requirements.

In its comments, ASCO urges USP to update USP <797> with language that aligns the proposal’s definition of drug “compounding” for conventionally manufactured sterile products, with the FDA’s definition of the term. The society also asserts that the concept of immediacy, as it is presented in the proposal, should be eliminated from its definition of administration.

ASCO’s comments state that the reference to “immediate” drug administration in the proposed chapter is arbitrary, not well-grounded in science, and in non-emergency situations, immediate administration is not necessary. The society also notes that drug administration should fall outside the scope of USP <797> and that differences in the setting of care and other factors may influence the timing that the preparation and administration of a drug calls for.

A significantly revised version of USP <797> was released in September 2015, and ASCO was among the many stakeholder groups that submitted feedback during the open comment period. USP plans to finalize General Chapter <797> in June 2019, with implemented slated for December 2019.

ASCO remains committed to ensuring patient and workplace safety through the proper and accurate preparation, handling, and administration of anticancer drug regimens. ASCO has convened a Task Force on Safe Handling of Chemotherapy in order develop recommendations for updated safety standards.

Read the full comment letter.

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