Code of Federal Regulations (Last Updated: November 8, 2024) |
Title 21 - Food and Drugs |
Chapter II - Drug Enforcement Administration, Department of Justice |
Part 1306 - Prescriptions |
Controlled Substances Listed in Schedule Ii |
§ 1306.12 - Refilling prescriptions; issuance of multiple prescriptions.
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§ 1306.12 Refilling prescriptions; issuance of multiple prescriptions.
(a) The refilling of a prescription for a controlled substance listed in Schedule II is prohibited.
(b)
(1) An individual practitioner may issue multiple prescriptions authorizing the patient to receive a total of up to a 90-day supply of a Schedule II controlled substance provided the following conditions are met:
(i) Each separate prescription is issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice;
(ii) The individual practitioner provides written instructions on each prescription (other than the first prescription, if the prescribing practitioner intends for that prescription to be filled immediately) indicating the earliest date on which a pharmacy may fill each prescription;
(iii) The individual practitioner concludes that providing the patient with multiple prescriptions in this manner does not create an undue risk of diversion or abuse;
(iv) The issuance of multiple prescriptions as described in this section is permissible under the applicable state laws; and
(v) The individual practitioner complies fully with all other applicable requirements under the Act and these regulations as well as any additional requirements under state law.
(2) Nothing in this paragraph (b) shall be construed as mandating or encouraging individual practitioners to issue multiple prescriptions or to see their patients only once every 90 days when prescribing Schedule II controlled substances. Rather, individual practitioners must determine on their own, based on sound medical judgment, and in accordance with established medical standards, whether it is appropriate to issue multiple prescriptions and how often to see their patients when doing so.
[72 FR 64929, Nov. 19, 2007]