A new proposal for USP 797 was released in September of 2021 for stakeholder review and comment. Pharmacies wanting to apply extended BUDs to their CSPs will be particularly impacted. Stakeholders have argued that many of the additional requirements for extended BUDs closely resemble some GMP processes and controls that 503Bs have to abide by. Others have debated that the 250-unit cap is arbitrary, cost-prohibitive, and will decrease patient access.
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