Question: What changes can be made to a schedule II paper prescription?
Answer: In the past few months, DEA has received an increasing number of questions concerning pharmacists’ ability to add or modify information—like a patient’s address—on paper prescriptions. To address these questions, DEA has been reviewing the relevant regulations and working to draft new regulations to address this issue. In the interim, pharmacists should 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. EO-DEA257, DEA-DC-063, October 18, 2022
Question: Does the CSA or DEA regulations prohibit DEA-registered practitioners or mid-level practitioners from issuing controlled substance prescriptions for personal use of the prescriber, friends, or family members?
Answer: No. However, practitioners and mid-level practitioners should be aware when prescribing controlled substances for personal use of the prescriber, friends, and family members, that the CSA and DEA regulations require that a prescription for a controlled substance be issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. The practitioner is responsible for the proper prescribing and dispensing of controlled substances, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription that is not issued for a legitimate medical purpose in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of 21 U.S.C. 829. The person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances. 21 U.S.C. 841(a)(1) and 21 CFR 1306.04(a). Further, a prescription may not be issued in order for an individual practitioner to obtain controlled substances for supplying the individual practitioner for the purposes of general dispensing to patients. 21 CFR 1306.04(b). In addition, prescribing practitioners and mid-level practitioners must comply with applicable State, Federal, and local laws which may prohibit such activity. 21 U.S.C. 823(f)(4). The contents of this document do not have the force and effect of law and are not meant to bind the public in any way. This document is intended only to provide clarity to the public regarding existing requirements under the law or Department of Justice policies. EO-DEA099, October 4, 2022
Question: Can I send electronic controlled substance prescriptions to a pharmacy via e-mail?
Answer: No. "An electronic prescription"—that is, "a prescription that is generated on an electronic application and transmitted as an electronic data file"—must "be created and signed using an application that meets the requirements of part 1311 of this chapter." 21 CFR 1300.03, 1306.05(e). These requirements include, among other things, an audit or certification to ensure that the application "records, stores, and transmits" the necessary information "accurately and consistently," the capability to "[l]ink each registrant, by name to at least one DEA registration number," logical access controls "set by individual user name or role" that limit permissions for "signing controlled substance prescriptions," the ability to "accept two-factor authentication," and digital signature functionality that satisfies the relevant Federal Information Processing Standards (FIPS) developed by the National Institute of Standards and Technology. 21 CFR 1300.03, 1311.120(b). E-mail does not satisfy these requirements. EO-DEA094, DEA-DC-049, November 20, 2020
Question: May a prescription be issued in order for a practitioner to obtain controlled substances for dispensing to patients?
Answer: No. See 21 CFR 1306.04(b), "A prescription may not be issued in order for an individual practitioner to obtain controlled substances for supplying the individual practitioner for the purpose of general dispensing to patients." EO-DEA098, October 19, 2020
Question: I write controlled substance prescriptions to my patient. Does Federal law require that I see the patient every 30 days?
Answer: No. Neither the CSA nor DEA regulations require a practitioner to see a patient every 30 days. Nonetheless, the CSA and DEA regulations do require that a prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. See 21 CFR 1306.04(a). As DEA has previously stated, "practitioners who prescribe controlled substances must see their patients in an appropriate time and manner so as to meet their obligation to prescribe only for a legitimate medical purpose in the usual course of professional practice and to thereby minimize the likelihood that patients will abuse, or become addicted to, the controlled substances." Issuance of Multiple Prescriptions for Schedule II Controlled Substances, 72 FR 64921, 64928 (2007). EO-DEA093, June 23, 2020
Disclaimer: Guidance documents, like this document, are not binding and lack the force and effect of law, unless expressly authorized by statute or expressly incorporated into a contract, grant, or cooperative agreement. Consistent with Executive Order 13891 and the Office of Management and Budget implementing memoranda, the Department will not cite, use, or rely on any guidance document that is not accessible through the Department's guidance portal, or similar guidance portals for other Executive Branch departments and agencies, except to establish historical facts. To the extent any guidance document sets out voluntary standards (e.g., recommended practices), compliance with those standards is voluntary, and noncompliance will not result in enforcement action. Guidance documents may be rescinded or modified in the Department's complete discretion, consistent with applicable laws.