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DEA Guidance Regarding Information Pharmacists May Provide on CS II Prescriptions

Topics: Controlled substances

Recognizing that pharmacists are sometimes presented with prescriptions for Schedule II controlled substances (CS) that are missing information required by law, Drug Enforcement Administration (DEA) provides guidance (PDF) for pharmacists regarding allowed changes or additions to such prescriptions. First, DEA reminds pharmacists of the corresponding responsibility to ensure that CS prescriptions are in compliance with federal law and regulations, and specifically that they must be dated as of and signed on the day when issued and must include the full name and address of the patient, the drug name, strength, dosage form, quantity prescribed, directions for use, and the name, address, and registration number of the practitioner.

DEA advises that whether a pharmacist may make changes to a CS II prescription – such as adding the practitioner’s DEA number, or correcting the patient’s name or address – varies case by case based on the facts present. Thus, “DEA expects that when information is missing from or needs to be changed on a schedule II controlled substance prescription, pharmacists use their professional judgment and knowledge of state and federal laws and policies to decide whether it is appropriate to make changes to that prescription."

DEA also reminds pharmacists and other health care providers to be mindful of dispensing-related activities that violate the Controlled Substances Act (CSA). For example, DEA notes, the following activities are unlawful:

  • Intentionally furnishing false or fraudulent material information, or omitting material information from documents required under CSA
  • Dispensing a CS prescription in violation of requirements for CS schedule II prescriptions (21 USC 829)
  • Knowingly or intentionally using a registration number that is fictitious, revoked, suspended, expired, or issued to another person

The NABP Task Force to Review and Recommend Revisions to the Controlled Substances Act made recommendations related to CSA required prescription elements and allowable changes. The report of the task force is available in the Members section of the NABP Web site.