Approval and Monitoring of Narcotic Treatment Programs: A Guide on the Roles of Federal and State Agencies Technical Assistance Publication (TAP) Series 12
Checklist Guide for Completing Form FDA-2632
Application for Approval of Use of Narcotic Drugs in a Narcotic Addiction Treatment Program
Form FDA-2632 completed and signed by the program sponsor. The sponsor is the individual, or agent of an organization, who bears responsibility for assuring compliance with the requirements of the Methadone Regulation (21 CFR 291.505).
Form FDA-2633, Medical Responsibility Statement, completed and signed by each physician licensed by law to administer or dispense narcotic drugs at the primary dispensing location of this program. The physician must indicate whether he/she will be the medical director of the program. The medical director is the physician ultimately responsible for the policies and practices of the program related to ordering, prescribing, and dispensing of drugs at the primary dispensing location. Sponsors, medical directors, and physicians may be one-and-the same, or different individuals.
If the medical director of this facility is also the medical director for another treatment program, enclose a written justification for the feasibility of such an arrangement. This feasibility statement shall address the portion of the medical director's time spent in the treatment of unrelated medical patients, memberships on boards and committees that compete for time allocated to the treatment program.
List the names and State license numbers of individuals (other than physicians) licensed by law to dispense narcotic drugs even if they are not at present responsible for administering or dispensing methadone. These would include pharmacists, registered nurses, and licensed practical nurses.
Enclose a tentative schedule which shows (1) dispensing hours, (2) counseling hours, and (3) hours to be worked by physicians, nurses, and counselors. Any work to be performed away from the primary dispensing site, should also be stated. The program must be open for dispensing at least six days per week.
A description of the organizational structure of the program. A chart indicating the position and title of key personnel.
A list of the sources of funding, including the name and address of each governmental agency providing funds.
A diagram and description of the facilities to be used by this program. Demonstrate how the facilities are adequate for drug dispensing and for individual and group counseling.
Describe the number of patients who will be treated by the program when it is operating at capacity.
Specify the name of the individual who will be responsible for providing rehabilitative guidance and employment placement to the patients. If any of these services are provided off site, describe the percentage contracted. The use of State or local employment agencies will not substitute for services required to be provided by the treatment program.
Provide the name and address of the hospital or hospitals providing medical services to the patients.
Provide a list containing the name, address, and a description of each public and private agency, organization, or institution that will be used as part of the treatment program's plan to provide access to counseling, rehabilitative and other social services (e.g., vocational and educational guidance, employment placement). The program sponsor must be able to document that medical and rehabilitative services are fully available to patients.
Provide the name and address of the laboratory providing the required drug testing or analyses. The laboratory must affirm its compliance with all applicable Federal and State proficiency testing and licensing standards.
Provide the name and address of any facility other than the primary dispensing site where methadone will be dispensed either on a regular basis or on weekends, and a service to the treatment program.
Provide an affirmative statement that the treatment program will use containers having safety closures for all take-home medication dispensed to outpatients.
Describe clearly and concisely the manner in which methadone will be received, stored, prepared and dispensed at the primary dispensing location.