DEA Instructs Pharmacists to Adhere to State Regulations Regarding Schedule II Prescription Changes

Topics: Controlled substances

Drug Enforcement Administration (DEA) advises that pharmacists should adhere to state regulations or policy regarding changes that a pharmacist may make to a Schedule II prescription after oral consultation with the prescriber. DEA recognizes that there may be confusion regarding federal regulations on this matter, as DEA published in the Federal Register on November 19, 2007 the Final Rule titled Issuance of Multiple Prescriptions for Schedule II Controlled Substances, which contained instructions that conflict with prior DEA policy. Specifically, the more recent Final Rule states in its preamble that “the essential elements of the [Schedule II] prescription written by the practitioner (such as the name of the controlled substance, strength, dosage form, and quantity prescribed)…may not be modified orally,” while prior DEA policy permitted the same changes a pharmacist may make to Schedules III-V controlled substance prescriptions after oral consultation with the prescriber. DEA plans to resolve the issue through future rulemaking.

The topic of Schedule II prescription changes was addressed at the NABP 106th Annual Meeting CPE session, “The Controlled Substances Act – A New Frontier.”