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Appendix C

DEA INVESTIGATIONS: REQUIRED DOCUMENTATION

Documents and information that NTPs are required to provide during a DEA investigation include the following:

  1. List of all individuals having access to controlled substances (including full name, date of birth and Social Security number)
     
  2. Designation in writing of all individuals who are authorized to accept medication shipments (including full name, date of birth, and Social Security number)
     
  3. All licenses/permits issued to the program and practitioners, nurses, and pharmacists
     
  4. Contract with alarm company that includes address, telephone number, current contact point, and services provided
     
  5. Biennial inventory and any other inventories conducted by the program
     
  6. All DEA-222 order forms, including:
    1. Order forms documenting receipt from supplier*
    2. Order forms documenting transfer to other sites or programs*
    3. Unexecuted, voided and cancelled order forms
      *       In instances where there are discrepancies between the amount ordered and the amount received, copies of invoices related to the order forms should be available.
       
  7. Manufacturing records for those programs that convert bulk powder to liquid, including:
    1. Batch records for powder to liquid conversion
    2. Batch records for bottling liquid medication
    3. ARCOS reports (where required)
       
  8. Dispensing records for controlled substances, including:
    1. Computer summary for time period
    2. Any manual dispensing records
    3. Patient identification cross-index reference
       
  9. Incident reports for investigation period  
     
  10. Report of Theft or Loss of Controlled Substances (DEA Form-106)
     
  11. Registrants Inventory of Drugs Surrendered (DEA Form-41)
     
  12. Powers of Attorney

During an investigation, the NTP also must provide an area where the investigators can work, which does not impede the operation of the program and allows for privacy. In addition, employees having access to methadone or having knowledge of the operation of the program should be available for interview.

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