ARTICLE
5 December 2007

Physicians May Now Write Multiple Prescriptions for Schedule II Controlled Substances

DM
Duane Morris LLP

Contributor

Duane Morris LLP, a law firm with more than 900 attorneys in offices across the United States and internationally, is asked by a broad array of clients to provide innovative solutions to today's legal and business challenges.
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
United States Food, Drugs, Healthcare, Life Sciences

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.

This article is for general information and does not include full legal analysis of the matters presented. It should not be construed or relied upon as legal advice or legal opinion on any specific facts or circumstances. The description of the results of any specific case or transaction contained herein does not mean or suggest that similar results can or could be obtained in any other matter. Each legal matter should be considered to be unique and subject to varying results. The invitation to contact the authors or attorneys in our firm is not a solicitation to provide professional services and should not be construed as a statement as to any availability to perform legal services in any jurisdiction in which such attorney is not permitted to practice.

Duane Morris LLP, one of the 100 largest law firms in the world, is a full-service firm of more than 600 lawyers. In addition to legal services, Duane Morris has independent affiliates employing approximately 100 professionals engaged in other disciplines. With offices in major markets in the United States and internationally, Duane Morris represents clients across the U.S. and around the world.

Mondaq uses cookies on this website. By using our website you agree to our use of cookies as set out in our Privacy Policy.

Learn More