Approval and Monitoring of Narcotic Treatment Programs: A Guide on the Roles of Federal and State Agencies
Technical Assistance Publication (TAP) Series 12

Appendix A—FDA Forms and Information

Many of the forms included in ths Appendix are not available electronically. Please contact the FDA for current copies of the forms listed below.

Food and Drug Administration
Division of Scientific Investigations
Regulatory Management Branch
7520 Standish Place, Room 115
Rockville, MD 20855
(301) 594-1029

FDA Forms:

a. Form FDA 2632 (4/93) Application for Approval for Use of Narcotic Drugs in a Narcotic Addiction Treatment Program
b. Form FDA 2633 (6/93) Medical Responsibility Statement for Use of Narcotic Drugs in a Treatment Program
c. Form FDA 2635 (7/93) Consent to Treatment with an Approved Narcotic Drug*
d. Form FDA 2636 (8/92) Hospital Request for Methadone Detoxification Treatment
e. Form FDA 482 (5/85) Notice of Inspection (sample)
f. Form FDA 2438b (5/84) Routine Notice to Observe Patient Identifying Information
g. Form FDA 483 (5/85) Inspectional Observations
i. Checklist Guide for Completing Form FDA-2632, Application for Approval of Use of Narcotic Drugs in a Narcotic Addiction Treatment Program
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