Hostname: page-component-8448b6f56d-dnltx Total loading time: 0 Render date: 2024-04-24T04:07:29.326Z Has data issue: false hasContentIssue false
  • English
  • Français

Federal Regulation of Clinical Practice in Narcotic Addiction Treatment: Purpose, Status, and Alternatives

Published online by Cambridge University Press:  01 January 2021

Stephen P. Molinari ,
James R. Cooper  and
Dorynne J. Czechowicz
Get access Rights & Permissions [Opens in a new window]

Extract

The regulation of narcotic medications used in narcotic addiction treatment is unique in medical therapeutics. Physicians who want to use narcotics for this indication must obtain a separate annual registration from the Drug Enforcement Administration (DEA). Annual registration is contingent on compliance with both the DEA's security regulations (inventory, record-keeping, and physical security) as well as treatment regulations jointly promulgated by the Food and Drug Administration (FDA) and the National Institute on Drug Abuse (NIDA).

During the last decade, a number of events have occurred that persuaded NIDA that it is time to reevaluate the current method by which the Department of Health and Human Services (HHS) regulates methadone treatment. As a result of research during the past twenty years, we have learned about the effective components of methadone treatment. In comparison to other available treatment modalities for opioid addiction, methadone treatment is uniquely effective when administered by well-trained medical staffs.

Type
Article
Information
Journal of Law, Medicine & Ethics , Volume 22 , Issue 3 , Fall 1994 , pp. 231 - 239
Copyright
Copyright © American Society of Law, Medicine and Ethics 1994

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Institute of Medicine, Treating Drug Problems (Washington, D.C.: National Academy Press, 1990); and Simpson, D.D., “Treatment for Drug Abuse. Follow-up Outcomes and Length of Time Spent,” Archives of General Psychiatry, 38 (1981): 875-80.Google Scholar
Cooper, J.R., “Methadone Treatment and Acquired Immunodeficiency Syndrome,” JAMA, 262 (1989): 1664–68.CrossRefGoogle Scholar
Dole, V.P., “Hazards of Process Regulations; The Example of Methadone Maintenance,” JAMA, 267 (1992): 2234–35.CrossRefGoogle Scholar
Federal Register, 54 (Mar. 2, 1989): 8976–79.Google Scholar
U.S. General Accounting Office, Methadone Maintenance: Some Treatment Programs Are Not Effective; Greater Federal Oversight Needed (Washington, D.C.: U.S. General Accounting Office, GAO/HRD-90-104, 1990).Google Scholar
Dole, V.P. Nyswander, M.E. Desjarlais, D., “Performance-Based Rating of Methadone Maintenance Programs,” JAMA, 306 (1982): 169–71.Google Scholar
Cooper, J.R., “Establishing a Methadone Quality Assurance System: Rationale and Objectives,” in Pickens, R.W. Leukefeld, C.G. Schuster, C.R., eds., Improving Drug Abuse Treatment. National Institute on Drug Abuse Research Monograph 106 (Washington, D.C.: U.S. Government Printing Office, DHHS Pub. No. (DAM) 91-1754, 1991).Google Scholar
Institute of Medicine, Development of Anti-Addiction Medications: Issues for the Government and Private Sector (Washington, D.C.: National Academy Press, 1994).Google Scholar
Pub. L. No. 91–513 (1970).Google Scholar
Pub. L. No. 93–281 (1974).Google Scholar
Pub. L. No. 98–473 (1984).Google Scholar
21 U.S.C. § 822(a) (1970).CrossRefGoogle Scholar
21 U.S.C. § 823 (1970).CrossRefGoogle Scholar
21 U.S.C. § 824 (1970).CrossRefGoogle Scholar
U.S. House of Representatives Report No. 93–884, U.S. Code Congressional and Administrative News, 93rd Congress (1974), pp. 3029–39.Google Scholar
Pub. L. No. 93–281 (1974).Google Scholar
21 U.S.C. § 823(g) (1974).Google Scholar
21 U.S.C. § 824(a) (1974).Google Scholar
21 U.S.C. § 822(a) (1974); 21 U.S.C. § 823 (1974); and 21 U.S.C. § 824 (1974).Google Scholar
U.S. House of Representatives Report No. 91-1444 (Part 1), U.S. Code Congressional and Administrative News, 91st Congress (1970), p. 4589.Google Scholar
See op. cit., note 17.Google Scholar
Ibid.Google Scholar
See op. cit., note 9.Google Scholar
Federal Register, 35 (June 11, 1970): 9014–15.Google Scholar
Federal Register, 37 (Dec. 15, 1972): 26790–807.Google Scholar
American Pharmaceutical Association v. Mathews, 530 F.2d 1054 (D.C. Cir. 1976).Google Scholar
Federal Register, 41 (July 6, 1976): 28262–65.Google Scholar
Personal communication with Vodra, William W., dated November 1993.Google Scholar
See op. cit., note 11.Google Scholar
See op. cit., note 15.Google Scholar
21 U.S.C. § 823(f) (1984).Google Scholar
See op. cit., note 11.Google Scholar
U.S. House of Representatives Report No. 98-835 (Part 1), U.S. Code Congressional and Administrative News, 98th Congress (1984), p. 3448.Google Scholar
Ibid. See also op. cit., note 15.Google Scholar
See op. cit., note 15.Google Scholar
See op. cit., note 33.Google Scholar
Orders to Show Cause, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, March 20, 1990.Google Scholar
Order to Show Cause, Administrator, Drug Enforcement Administration, March 16, 1992.Google Scholar
Order to Show Cause, Administrator, Drug Enforcement Administration, April 23, 1992.Google Scholar
21 U.S.C. § 824(d) (1984).Google Scholar
Federal Register, 58 (July 12, 1993): 37505–06.Google Scholar
See op. cit., notes 13 and 18.Google Scholar
See op. cit., note 11.Google Scholar
Ibid.Google Scholar
See op. cit., note 9.Google Scholar
See op. cit., note 10.Google Scholar
Federal Register, 53 (April 11, 1988): 11970–89.Google Scholar
21 C.F.R. § 10.90 (1979).CrossRefGoogle Scholar
Federal Register, 55 (Dec. 10, 1990): 50776–77; and Federal Register, 58 (Dec. 27, 1993): 68416-18.Google Scholar
Ibid.; and see also Federal Register, 59 (April 25, 1994): 19723–25.Google Scholar
Ibid.Google Scholar
Federal Register, 57 (July 31, 1992): 33992–34021.Google Scholar
Federal Register, 58 (June 30, 1993): 35007–20.Google Scholar
21 U.S.C. § 351(b) (1974).Google Scholar