METHADONE SUMMARY
METHADONE HYDROCHLORIDE TABLETS, USP
5 mg, 10 mg
CONDITIONS FOR DISTRIBUTION AND USE OF METHADONE PRODUCTS:
Code of Federal Regulations, Title 21, Sec. 291.505
METHADONE PRODUCTS, WHEN USED FOR TREATMENT OF NARCOTIC ADDICTION IN DETOXIFICATION OR MAINTENANCE PROGRAMS, SHALL BE DISPENSED ONLY BY APPROVED HOSPITAL PHARMACIES, APPROVED COMMUNITY PHARMACIES, AND MAINTENANCE PROGRAMS APPROVED BY THE FOOD AND DRUG ADMINISTRATION AND THE DESIGNATED STATE AUTHORITY.
APPROVED MAINTENANCE PROGRAMS SHALL DISPENSE AND USE METHADONE IN ORAL FORM ONLY AND ACCORDING TO THE TREATMENT REQUIREMENTS STIPULATED IN THE FEDERAL METHADONE REGULATIONS (21 CFR 291.505).
FAILURE TO ABIDE BY THE REQUIREMENTS IN THESE REGULATIONS MAY RESULT IN CRIMINAL PROSECUTION, SEIZURE OF THE DRUG SUPPLY, REVOCATION OF THE PROGRAM APPROVAL, AND INJUNCTION PRECLUDING OPERATION OF THE PROGRAM.
A METHADONE PRODUCT, WHEN USED AS AN ANALGESIC, MAY BE DISPENSED IN ANY LICENSED PHARMACY.
Each 5 mL of solution for oral administration contains:
Methadone Hydrochloride.............. 5 mg or 10 mg
Alcohol 8%
Methadone hydrochloride acts as a narcotic analgesic.
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