New DEA guidance on Schedule II prescriptions

September 7, 2022

The Pharmacy Quality Assurance Commission (PQAC) issued a bulletin that contains the latest guidance from the Drug Enforcement Administration (DEA) regarding modifications to a Schedule II prescription. The DEA’s new guidance states, “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.”

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).” Click here to read PQAC’s full bulletin regarding DEA’s new guidance. (David Streeter)

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