{"id":5724,"date":"2022-11-04T09:53:44","date_gmt":"2022-11-04T13:53:44","guid":{"rendered":"https:\/\/a4pc.org\/?p=5724"},"modified":"2022-11-04T09:53:44","modified_gmt":"2022-11-04T13:53:44","slug":"chapter-includes-bud-batch-size-restrictions","status":"publish","type":"post","link":"https:\/\/whizkid.com\/a4pc\/2022-11\/chapter-includes-bud-batch-size-restrictions\/","title":{"rendered":"Chapter <797> includes BUD, batch size restrictions"},"content":{"rendered":"

The revised USP Chapter <797> related to sterile compounding, released on Tuesday<\/a>, includes restrictions on beyond-use dates and batch size for CSPs that APC and others had argued<\/a> were not supported by scientific evidence. USP also released a revised Chapter <795>, related to non-sterile compounding.<\/p>\n

\u201cWe\u2019re disappointed but not surprised at the restrictions in <797>,\u201d said APC President Dave Miller. \u201cIt was clear throughout the process that USP\u2019s Compounding Expert Committee was pursuing arbitrary restrictions on BUDs and batches. What no one has been able to demonstrate, though, is how patients are made safer by these restrictions.\u201d<\/p>\n

In written comments and public presentations earlier this year, APC had urged CEC \u201cto withstand pressures to implement arbitrary restrictions on batch size and Category 3 BUDs until it can clearly demonstrate the scientific basis for those restrictions and enunciate how patients are objectively better served by them. Not only will patients be harmed if [USP] proceeds in finalizing Chapter <797> with those restrictions, but so too will USP\u2019s high reputation.\u201d<\/p>\n

That stance was echoed in comment letters to USP from APhA and NCPA.<\/p>\n

\u201cWhat they\u2019ve done in effect is apply BUDs for the most unstable CSPs to all CSPs,\u201d said pharmacist and APC Vice President Tenille Davis, who led APC\u2019s Beyond-Use Date Task Force, which crafted APC\u2019s comments on the proposed <797> revisions. \u201cReason would dictate that BUDs should be rooted in the properties of a particular CSP, rather than applying the most extreme case to all CSPs. If a stability study can support a BUD for a product, the pharmacy should be able to use that data instead of a one-size-fits-all BUD.\u201d<\/p>\n

Davis also notes that the arbitrary batch size limitation of 250 units in the new chapter will require more frequent entry into the clean room, increasing the potential for contamination. \u201cIf USP felt that a stronger system was needed for sterility assurance for larger batches and longer BUDs, then why didn\u2019t they build it?\u201d she asked.<\/p>\n

\u201cUltimately, it\u2019s our patients who are going to be disadvantaged by these restrictions,\u201d said Miller. \u201cThey\u2019re going to see decreased access, increased costs, and the need for more frequent refills on their medications. It\u2019s beyond frustrating, because there were more effective approaches USP could have taken to address these issues.\u201d<\/p>\n

APC\u2019s BUD Task Force will meet soon to review the new chapters in detail and develop guidance to assist our members in complying.<\/p>\n

The chapters are available on USP\u2019s website only to those who subscribe to the USP Compendium.<\/p>\n","protected":false},"excerpt":{"rendered":"

The revised USP Chapter <797> related to sterile compounding, released on Tuesday, includes restrictions on beyond-use dates and batch size for CSPs that APC and others had argued were not supported by scientific evidence.
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