Public Comment on Proposed Rule - DEA

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

21 CFR Part 1306 [Docket No. DEA-287N] RIN 1117-AB01

Issuance of Multiple Prescriptions for Schedule II Controlled Substances
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of proposed rulemaking.
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SUMMARY: DEA is hereby proposing to amend its regulations to allow practitioners to provide individual patients with multiple prescriptions, to be filled sequentially, for the same schedule II controlled substance, with such multiple prescriptions having the combined effect of allowing a patient to receive over time up to a 90- day supply of that controlled substance. DEA is requesting public comment on this proposed rule.

DATES: Written comments must be postmarked, and electronic comments must be sent, on or before November 6, 2006.

ADDRESSES: Please submit comments, identified by "Docket No. DEA- 287N,'' by one of the following methods:

1. Regular mail: Deputy Administrator, Drug Enforcement Administration, Washington, DC 20537, Attention: DEA Federal Register Representative/ODL.
2. Express mail: DEA Headquarters, Attention: DEA Federal Register Representative/ODL, 2401 Jefferson-Davis Highway, Alexandria, VA 22301.
3. E-mail comments directly to agency: dea.diversion.policy@usdoj.gov.
4. Federal eRulemaking portal: http://www.regulations.gov. Follow the on-line instructions for submitting comments.

Anyone planning to comment should be aware that all comments received before the close of the comment period will be made available in their entirety for public inspection, including any personal information submitted. For those submitting comments electronically, DEA will accept attachments only in the following formats: Microsoft Word; WordPerfect; Adobe PDF; or Excel.

FOR FURTHER INFORMATION CONTACT: Mark W. Caverly, Chief, Liaison and Policy Section, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537; Telephone: (202) 307-7297.

SUPPLEMENTARY INFORMATION:
I. Background
On August 26, 2005, DEA published in the Federal Register a "Clarification Of Existing Requirements Under The Controlled Substances Act For Prescribing Schedule II Controlled Substances.'' 70 FR 50408. That document addressed the situation of patients who have been receiving prescriptions for schedule II controlled substances for legitimate medical purposes (for example, for the treatment of severe pain or attention deficit hyperactivity disorder (ADHD)) and have settled into a routine of seeing their physician once every three months. The document was intended to address the concerns of many such patients who were under the mistaken impression that, because of DEA's November 16, 2004, Interim Policy Statement (69 FR 67170), they had to begin seeing their physicians every month to obtain their schedule II prescriptions. As the August 26, 2005, clarification document noted: "DEA wishes to make clear that the Interim Policy Statement did not state that such patients must visit their physician's office every month to pick up a new prescription.'' The clarification document further explained some of the possible ways in which, under appropriate circumstances, patients can continue to receive schedule II prescriptions without visiting their physicians' offices every month.\1\1\ The clarification document stated, among other things, that a lawfully issued prescription may be mailed by the physician to the patient or pharmacy.

Read more here: http://www.deadiversion.usdoj.gov/