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Alerts and Updates

Physicians May Now Write Multiple Prescriptions for Schedule II Controlled Substances

December 4, 2007

The Drug Enforcement Administration ("DEA") of the Department of Justice issued new regulations on November 19, 2007, which allow physicians to prescribe up to a 90-day supply of a Schedule II controlled substance during a single prescribing event for a patient through the use of up to three separate prescriptions. Prior to the new rule, physicians could only prescribe up to a 30-day supply on a single prescription. The regulations allow physicians more flexibility in treating patients with conditions requiring long-term use of Schedule II medications.

The rule change is permissive, not mandatory. Physicians are permitted, but not required, to issue up to three prescriptions for a 30-day supply each. If the circumstances do not warrant multiple prescriptions, they should not be given. The rule also does not allow refilling of Schedule II medications. Federal law prohibits refills and this regulation does not change the law. See 21 U.S.C. § 829(a). Rather, up to three prescriptions can be given to a patient during the same prescribing event with directions to the pharmacist that at least two of the prescriptions cannot be filled before a certain date. Because pharmacists cannot fill such a prescription prior to the date stated, physicians should take into account the number of days in the month when writing multiple prescriptions so their patients are not left short in a 31-day month.

A physician may issue multiple prescriptions if each of the following conditions are met:

  1. Each separate prescription is issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice;
  2. 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;
  3. The individual practitioner concludes that providing the patient with multiple prescriptions in this manner does not create an undue risk of diversion or abuse of the medication;
  4. The issuance of multiple prescriptions is permitted under applicable state laws; and
  5. The individual practitioner complies fully with all other applicable state and federal laws.

The new regulations can be found at 21 C.F.R. Part 1306.12 and 1306.14.

For Further Information

If you have any questions about this Alert or would like more information, please contact Frederick R. Ball, one of the other members of the Health Law Practice Group or the attorney in the firm with whom you are regularly in contact.

Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. For more information, please see the firm's full disclaimer.

 

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