Rules - 2001
[Federal Register: November 9, 2001 (Volume 66, Number 218)] [Rules and Regulations] [Page 56607-56608] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr09no01-7]
DEPARTMENT OF JUSTICE
Office of the Attorney General
21 CFR Part 1306
[AG Order No. 2534-2001]
Dispensing of Controlled Substances To Assist Suicide
AGENCY: Department of Justice.
ACTION: Interpretive rule.
SUMMARY: For the reasons provided in the memorandum set forth below, the Attorney General has determined that assisting suicide is not a "legitimate medical purpose" within the meaning of 21 CFR 1306.04 (2001), and that prescribing, dispensing, or administering federally controlled substances to assist suicide violates the Controlled Substances Act. Such conduct by a physician registered to dispense controlled substances may "render his registration . . . inconsistent with the public interest" and therefore subject to possible suspension or revocation under 21 U.S.C. 824(a)(4). The Attorney General's conclusion applies regardless of whether state law authorizes or permits such conduct by practitioners or others and regardless of the condition of the person whose suicide is assisted. The Attorney General recognizes, however, that pain management is a legitimate medical purpose justifying a physician's dispensing of controlled substances. Finally, the Attorney General's determination makes no change in the current standards and practices of the DEA in any State other than Oregon.
EFFECTIVE DATE: November 9, 2001.
FOR FURTHER INFORMATION CONTACT: Patricia Good, Chief, Liaison and Policy Section, Office of Diversion Control, Drug Enforcement Administration, Washington, D.C. 20537, telephone 202-307-7297.
SUPPLEMENTARY INFORMATION: The text of the Attorney General's memorandum follows:
Memorandum for Asa Hutchinson, Administrator, The Drug Enforcement Administration
From: John Ashcroft, Attorney General
Subject: Dispensing of Controlled Substances to Assist Suicide
As you are aware, the Supreme Court reaffirmed last term that the application of federal law regulating controlled substances is uniform throughout the United States and may not be nullified by the legislative decisions of individual States. See United States v. Oakland Cannabis Buyers' Coop., 532 U.S. 483 (2001). In light of this decision, questions have been raised about the validity of an Attorney General letter dated June 5, 1998, which overruled an earlier Drug Enforcement Administration (DEA) determination that narcotics and other dangerous drugs controlled by federal law may not be dispensed consistently with the Controlled Substances Act, 21 U.S.C. 801-971 (1994 & Supp. II 1996) (CSA), to assist suicide in the United States. Upon review of the Oakland Cannabis decision and other relevant authorities, I have concluded that the DEA's original reading of the CSA--that controlled substances may not be dispensed to assist suicide--was correct. I therefore advise you that the original DEA determination is reinstated and should be implemented as set forth in greater detail below.
The attached Office of Legal Counsel opinion, entitled "Whether Physician-Assisted Suicide Serves a "Legitimate Medical Purpose" Under The Drug Enforcement Administration's Regulations Implementing the Controlled Substances Act" (June 27, 2001) ("OLC Opinion") (attached) sets forth the legal basis for my decision.
- Determination on Use of Federally Controlled Substances to Assist Suicide. For the reasons set forth in the OLC Opinion, I hereby determine that assisting suicide is not a "legitimate medical purpose" within the meaning of 21 CFR § 1306.04 (2001), and that prescribing, dispensing, or administering federally controlled substances to assist suicide violates the CSA. Such conduct by a physician registered to dispense controlled substances may "render his registration * * * inconsistent with the public interest" and therefore subject to possible suspension or revocation under 21 U.S.C. 824(a)(4). This conclusion applies regardless of whether state law authorizes or permits such conduct by practitioners or others and regardless of the condition of the person whose suicide is assisted.
I hereby direct the DEA, effective upon publication of this memorandum in the Federal Register, to enforce and apply this determination, notwithstanding anything to the contrary in the June 5, 1998, Attorney General's letter.
- Use of Controlled Substances to Manage Pain Promoted. Pain management, rather than assisted suicide, has long been recognized as a legitimate medical purpose justifying physicians' dispensing of controlled substances. There are important medical, ethical, and legal distinctions between intentionally causing a patient's death and providing sufficient dosages of pain medication necessary to eliminate or alleviate pain.
- No Change in Current DEA Policies and Enforcement Practices Outside Oregon. The reinstated determination makes no change in the current standards and practices of the DEA in any State other than Oregon. Former Attorney General Janet Reno's June 5, 1998, letter relating to this matter emphasized that action to revoke the DEA registration of a physician who uses federally controlled substances to assist a suicide "may well be warranted * * * where a physician assists in a suicide in a state that has not authorized the practice under any conditions." The reinstated determination does not portend any increase in investigative activity or other change from the manner in which the DEA presently enforces this policy outside of Oregon.
- Enforcement in Oregon. Under 3 Oregon Revised Statutes (O.R.S.) § 127.855 (1999), an attending physician who writes a prescription for medication to end the life of a qualified patient must document the medication prescribed. Under 3 O.R.S. § 127.865(1)(b) (1999), the State of Oregon's Health Division must require any health care provider upon dispensing medication pursuant to the Death with Dignity Act to file a copy of the dispensing record with the Division. Those records should contain the information necessary to determine whether those holding DEA registrations who assist suicides in accordance with Oregon law are prescribing federally controlled substances for that purpose in violation of the CSA as construed by this Memorandum and the attached OLC Opinion.
The Department has the authority to take appropriate measures to obtain copies of any such reports or records sent to the Oregon State Registrar. See 21 U.S.C. 876. When inspection of these documents discloses prohibited prescription of controlled substances to assist suicide following the effective date of this memorandum, then appropriate administrative action may be taken in accordance with 21 CFR §§ 1316.41 to 1316.68 (2001).
Thus, it should be possible to identify the cases in which federally controlled substances are used to assist suicide in Oregon in compliance with Oregon law by obtaining reports from the Oregon State Registrar without having to review patient medical records or otherwise investigate doctors. Accordingly, implementation of this directive in Oregon should not change the DEA's current practices with regard to enforcing the CSA so as materially to increase monitoring or investigation of physicians or other health care providers or to increase review of physicians' prescribing patterns of controlled substances used for pain relief.
- Distribution. Please ensure that this Memorandum and the OLC opinion on which it is based are promptly distributed to appropriate DEA personnel, especially those with authority over the enforcement of the CSA in Oregon.
Note: The attachment containing the Office of Legal Counsel opinion dated June 27, 2001, does not appear in the Federal Register. It is available from the Drug Enforcement Administration at the address listed in FOR FURTHER INFORMATION CONTACT.
Dated: November 6, 2001.
[FR Doc. 01-28358 Filed 11-7-01; 12:43 pm]
BILLING CODE 4410-09-P
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