AHA Urges USP to Delay Effective Dates for New Guidelines

AHA today urged the United States Pharmacopeial Convention to delay by at least 18 months the effective dates for its general chapter <797> pharmaceutical compounding and general chapter <800> hazardous drug handling in health care settings, as well as proposed revisions to general chapter <797>. “USP guidelines play a critical role in keeping our hospital staffs and the patients they care for safe,” AHA wrote. “However, we reiterate concerns we have previously shared regarding the compliance challenges that these two sections create.” Specifically, the proposed changes to general chapter <797> may impact or modify efforts by hospitals and health systems to comply with chapter <800>; the guidelines involve large capital investments, in some cases the construction of entirely new buildings; and the timeline has resulted in high demand for contractors and supplies, making it very challenging for all facilities to comply by the effective date, AHA said. The association also commended USP for simplifying many provisions in its September redraft of general chapter <797>, but shared some concerns regarding the beyond-use dates, repackaging and temperature metrics.

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