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Drug Enforcement Administration (DEA), in Title 21 CFR §1306.05(a), states what information is required for a practitioner to include on any controlled substance prescription prepared for a patient.
In the past, DEA issued a guidance document regarding when a licensed pharmacist could add to or edit a Schedule II controlled substance prescription. That document has since been rescinded, and recently, the following guidance was provided by the DEA:
Schedule II controlled substance prescriptions must contain all the information required in 21 CFR § 1306.05(a), and licensed pharmacists may add or modify Schedule II prescription information if consistent with state regulations or policy after oral consultation with a prescriber.
The Pharmacy Quality Assurance Commission (commission / PQAC) interprets its laws and rules, and DEA’s laws, rules, and guidance, to permit a pharmacist to adapt a prescription for a controlled substance in Schedule II in accordance with WAC 246-945-335 after oral consultation with the prescriber. WAC 246-945-335 permits a pharmacist to: change the quantity (WAC 246-945-335(1)), change the dosage form (WAC 246-945-335(2)), or complete missing information (WAC 246-945-335(3)) if certain criteria are met. DEA guidance requires that any adaptation of a prescription for a controlled substance in Schedule II be in compliance with the commission’s laws and rules and after the pharmacist has had an oral consultation with the prescriber. If a pharmacist wants to adapt a prescription for a controlled substance in Schedule II in a manner that does not meet the criteria in WAC 246-945-335, then the pharmacist is required to obtain a new prescription from the prescriber that complies with WAC 246-945-010, WAC 246-945-011 and 21 C.F.R. § 1306.05(a).
This announcement seeks to provide needed clarification to pharmacy professionals and other interested parties, as the PQAC recognizes that there has been considerable confusion surrounding this topic.
The DEA encourages practitioners to monitor the website www.regulations.gov for any new Notices of Proposed Rulemaking related to this topic. Please see also the Office of Management and Budget, Unified Agenda of Regulatory and Deregulatory Actions at www.reginfo.gov for status updates on any pending regulations.
More information can be found by accessing the Question and Answer (Q&A) section of the DEA Diversion website. The Q&As offer information on DEA requirements in a plain language format. Further guidance information may be found by accessing the DEA Guidance Portal. Please contact the DEA Policy Section by email at ODLP@dea.gov if additional assistance is required.
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