MOU 225-76-3009
Memorandum of Understanding
Between The Drug Enforcement Administration
and The Food and Drug Administration
I. Purpose
This Memorandum of Understanding outlines the working arrangements between the Drug Enforcement Administration (DEA) and the Food and Drug Administration (FDA) regarding the approval or denial procedures for narcotic treatment programs (hereinafter referred to as treatment programs) and the cooperative efforts of both agencies in any denial or revocation of approval by FDA, or denial or revocation of registration by DEA initiated against these treatment programs. Treatment programs under this agreement include all programs that use any narcotic drug for the treatment of narcotic addiction.
II. Background.
The methadone regulation in Section 310.505 (21 CFR 291.505)* requires that prior approval by FDA be obtained before a treatment program may receive shipments of methadone. Before FDA may give such approval, it must consult with DEA to determine if the applicant is in compliance with the Controlled Substances Act of 1970 (CSA) and the Narcotic Addict Treatment Act (NATA) of 1974. Prior approval of the State authority is also required, except programs wholly operated by an agency of the U.S. Government.
* Recodified to 21 CFR 310.505.
The NATA of 1974 amended the CSA by requiring that all treatment programs appropriately register with DEA. DEA may not register an applicant without consulting FDA in order to determine if the program meets the medical standards established by the Secretary of Health, Education, and Welfare.
Both agencies have the authority to deny or revoke approval of a treatment program independently of each other, or at the recommendation of the other agency or a State authority, for violation of laws or regulations governing the operations of such programs.
DEA and FDA will continue to work in close cooperation to prevent treatment programs from beginning operations without the required approvals of both agencies, to coordinate any denial or revocation proceedings, and to provide for the disposition of the narcotics if a program's approval or registration is revoked.
III. Substance of Agreement.
a. Each agency shall obtain prior approval of the other before a new application for a treatment program is approved by FDA or registered by DEA. Before FDA may give approval, prior approval by the appropriate State authority is necessary, except in the case of a program wholly operated by the U.S. Government.
b. The agencies shall notify each other of any denial or revocation of approval or registration of treatment programs when such action is initiated and shall keep each other informed of the outcome of such action.
c. Investigations of treatment programs by either agency that reveal suspected violations of the regulations promulgated by the other agency shall be promptly report to that agency.
d. When one agency recommends denial or revocation of approval or registration to the other, the recommending agency shall provide the other agency with all necessary reports, documents, and testimony for successful completion of the action.
e. Both agencies shall cooperate with each other in terminating illegally operating programs and in seizing or accepting surrender of the program's drug supply, as well as the supplies of other programs terminated for any reason.
f. FDA shall obtain DEA approval prior to approving treatment program requests for:
1. Alternate dispensing sites;
2. Alternate methods of distribution;
3. Exceptions that involve storage of methadone at locations not approved for that purpose by either FDA or DEA, e.g., jail facilities or wholesalers who only store methadone for a program;
4. Establishment of medication units.
g. FDA shall consult with DEA before approving program-wide, as opposed to individual patient, requests for additional take-home medication not provided for by the regulation.
h. The agencies shall hold periodic meetings to discuss resolution of procedural problems related to mutual endforcement activities.
i. In the forum of the Federal Methadone Treatment Policy Review Board (composed of designated representatives from the Drug Enforcement Administration, Food and Drug Administration, National Institute on Drug Abuse, and the Veterans Administration) DEA and FDA will discuss with each other, and other members of the Board, any proposed new regulations, regulation changes, or any significant interpretative modification with regard to treatment programs that will impact on the other agency.
IV. Liaison Officers.
For DEA:
Mr. Ronald W. Buzzeo
Chief
Regulatory Investigations Section
Compliance Investigation Division
1405 "I" St. N.W.
Washington, DC 20537
(202) 382-4217.
For FDA:
Mr. Buddy F. Stonecipher
Director
Div. of Methadone Monitoring (HFD-340) Bureau of Drugs
5600 Fishers Lane
Rockville, Md. 20857
(301) 443-3414.
V. Period of Agreement.
When accepted by both agencies, the agreement will have an effective period of performance from the date of signature with no expiration date. It may be modified by mutual consent of both parties or may be terminated by either party upon thirty (30) days advance written notice to the other.
At such time as the Secretary delegates authority and responsibility pursuant to the Narcotic Addict Treatment Act of 1974, this agreement will be amended to reflect any changes which may be appropriate.
Effective date. This Memorandum of Understanding became effective on
May 27, 1976.
Approved and Accepted
for the Drug Enforcement Administration
Signed by: Peter B. Bensinger
Administrator
Drug Enforcement Administration
Date: May 27, 1976
Approved and Accepted
for the Food and Drug Administration
Signed by: A.M. Schmidt
Commissioner
Date: May 20, 1976
Approved and Accepted
for the Food and Drug Administration
Signed by: Sam D. Fine
Associate Commissioner for Compliance
Date: July 2, 1976