Approval and Monitoring of Narcotic Treatment Programs: A Guide on the Roles of Federal and State Agencies Technical Assistance Publication (TAP) Series 12
Exhibit J—Typical Problems That Can Lead to Adverse Action by FDA
Missing physician signatures on medication changes and
laboratory results
Missing toxicology reports for various patients
Missing required physical exams
Incomplete treatment plans
Inadequate documentation for take-home medication or
authorization given without FDA approval for take-home medications
in amounts greater than the limits required based on the amount of
time the patient has successfully been in treatment (e.g., 2 days
after 3 months, 3 days after 2 years, 6 days after 3 years).
Failure to reduce clinic attendance when indicated by urinalysis
test results.