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CONTROLLED SUBSTANCES

CONTROLLED SUBSTANCES. You Are In Charge Now. Your Responsibilities. Ordering Receiving Inventory Access Control Reporting. Ordering. Controlled Substances can only be ordered if you have a DEA license on file with the supplier. Ordering.

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CONTROLLED SUBSTANCES

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  1. CONTROLLED SUBSTANCES You Are In Charge Now

  2. Your Responsibilities • Ordering • Receiving • Inventory • Access Control • Reporting

  3. Ordering • Controlled Substances can only be ordered if you have a DEA license on file with the supplier

  4. Ordering • Schedule I and some Schedule II controlled substances require a DEA Form 222 for ordering • Only the DEA license holder is issued DEA Forms 222

  5. Ordering • Request longest dating on the Controlled Substances ordered

  6. Receiving • CS must be secured immediately upon receipt

  7. Receiving • CS must be logged into the inventory immediately upon receipt • All invoices must be kept in a separate file in case of DEA inspection

  8. Inventory • A physical inventory is only required every 6 months based on the date the license is issued. • The DEA license holder must sign the physical inventory every 6 months

  9. Inventory • Monthly/Semi-annual Inventory Forms are available on the FLSC web page under FORMS as a .pdf file or word document www.nd.edu/~ndflsc/formpage.html

  10. Inventory • The Monthly/Semi-annual inventory is not kept with the drugs. • It must be readily available during a DEA inspection

  11. Inventory • All use of CS must be recorded in a running log • The minimum information required for each use is: Date Animal or Experiment Quantity Used Name or Initials of User

  12. Inventory • The running log forms are available on the FLSC web page under FORMS as a .pdf file or word document www.nd.edu/~ndflsc/formpage.html

  13. Inventory • The running log is matched to the Monthly/Semi-annual physical inventory

  14. Inventory • The running log must be kept with the controlled substances

  15. Access Control • Drugs must be secured to prevent theft • CS storage boxes at FLSC are available

  16. Access Control • Only one key is issued per lab • Key must be kept secured at all times

  17. Access Control • Maintain a list of all individuals with access • Update access list at least annually

  18. Reporting • The DEA license holder must arrange for disposal of expired or contaminated CS according to DEA regulations

  19. Reporting • Cost for destruction or disposal is the license holder’s responsibility

  20. Reporting • DEA Form 41 must be filled out for any CS surrendered for destruction or disposal • DEA form 41 requires an accurate inventory of surrendered CS • http://www.deadiversion.usdoj.gov/21cfr_reports/surrend/41/41_instruct.htm

  21. Reporting • The DEA license holder is responsible for reporting any theft or loss of CS to both the DEA and local police

  22. Reporting • DEA Form 106 is required for the Report of Theft or Loss of Controlled Substances • http://www.deadiversion.usdoj.gov/21cfr_reports/theft/index.html

  23. Penalties • The DEA can impose monetary fines at their discretion.

  24. Penalties • The DEA can give jail/prison terms for violations.

  25. Penalties • The DEA license holder is responsible for all controlled substances ordered on their license.

  26. You are in charge now!

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