Please note this notice is clarification to an earlier email distributed on May 16, 2011 from the Board of Pharmacy to its interested parties list.
The earlier email was titled: DEA Registration Numbers on CII Prescriptions
Also, the telephone number for Cathy Williams, Pharmacist Consultant has been corrected below.
Making Changes to Controlled Substance Prescriptions
At the June 8, 2011, meeting the board clarified the recent confusion around Schedule II (CII) controlled substance prescriptions and prescribers’ federal Drug Enforcement Administration (DEA) registration numbers.
The DEA published in November 2007 a Final Rule titled Issuance of Multiple Prescriptions for Schedule II Controlled Substances. In the preamble to that rule, the DEA stated that ‘the essential elements of a Schedule II prescription written by the practitioner such as the name of the controlled substance (CS), strength, dosage form, and quantity prescribed may not be modified orally.’
The instructions in the rule’s preamble are in opposition to the DEA’s previous policy, which allows a pharmacist to make the same changes to schedule II controlled prescriptions as to schedules III-V controlled substance prescriptions after oral consultation with the prescriber.
A policy letter, written in October 2008 by Joe Rannazzisi, DEA Deputy Chief of Operations, Office of Diversion Control states, “The DEA recognizes the resultant confusion regarding this conflict and plans to resolve this matter through future rulemaking. Until that time, pharmacists are instructed to adhere to state regulations or policy regarding those changes that a pharmacist may make to a schedule II prescription after oral consultation with the prescriber.”
The October 2008 policy letter remains in effect. Nothing has changed since the issuance of that letter regarding the DEA registration numbers and other required information on CS prescriptions. These instructions apply until the rule is updated and a notice is issued by the DEA.
Washington State Board of Pharmacy reaffirms its long held guidance and interpretation regarding changes to a CII prescription.
A pharmacist in consultation with the prescriber may change all elements of Schedule II prescriptions except the patient’s name, the drug, or the prescriber’s signature. The pharmacist shall note the consultation on the prescription. A pharmacist may add the patient’s address or the prescriber’s DEA registration number to the prescription without consulting the prescriber.
Question: What changes may a pharmacist make to a prescription written for a controlled substance in schedules III-V?
Answer: The pharmacist may add or change the dosage form, drug strength, drug quantity, directions for use, or issue date only after consultation with and agreement of the prescribing practitioner. A pharmacist may add or change the patient’s address and may add the prescriber’s DEA registration number to the prescription without consulting the prescriber. The pharmacist should note all consultations and corresponding changes on the prescription. Pharmacists and practitioners must comply with any state/local laws, regulations, or policies prohibiting any of these changes to controlled substance prescriptions.
If you have additional question, please contact Tim Fuller or Cathy Williams, Pharmacist Consultants for the Washington State Board of Pharmacy.
Tim Fuller – 360.236.4827 [log in to unmask]
Cathy Williams 360.236.4875 [log in to unmask]
Doreen E. Beebe
Washington State Board of Pharmacy
PO Box 47863
Olympia WA 98504-7863
Public Health – Always Working for a Safer and Healthier Washington.