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The purpose of this rule is to modify 21 CFR 1306.05(a) to stipulate when pharmacists and/or pharmacist technicians can make changes and/or additions to schedule II-V written controlled substance prescriptions once a prescription has been signed by a DEA registered practitioner. Currently, 21 CFR 1306.05(a) does not state when or if any changes and/or additions can be made to a controlled substance prescription once a prescription has been signed by a DEA registered practitioner. This uncertainty can result in delays for patients receiving prescriptions of controlled substances.

In determining what regulation changes needed to occur, DEA reviewed questions, issues, and concerns that have been raised by patients, caretakers, underserved communities, medical and pharmacy professionals during various industry meetings, local outreach efforts, webinars, conferences, or via correspondence.

DEA will publish an NPRM, continue to engage with stakeholders, patients in underserved communities, and take into consideration accepted and recommended industry standards, while ensuring patient’s public health and safety, prior to the publication of the rule.