2. Drug Abuse … the prevalence of severe drug abuse problems and their consequences has increased since 1985…. The Economic Costs of Alcohol and Drug Abuse in the United States, 1992 National Institute on Drug Abuse National Institute on Alcohol Abuse and Alcoholism

3. GOALS Avoid Enforcement Action Discourage Abuse

4. Controlled Substances Laws Harrison Narcotic Act of 1914 Comprehensive Drug Abuse Prevention and Control Act of 1971

5. Georgia Laws and Rules Title 16, Chapter 13, Article 1-2 (CSA) Title 26, Chapter 4, Article 1 (PHR) Pharmacy Rules, Chapter 480-28 Vet Rules, Chapter 700-8-.01(c)

6. Veterinary Rules - GA Can not prescribe without examinationCan not prescribe without examination Can not dispense or prescribe more than 30 days of C-IICan not dispense or prescribe more than 30 days of C-II Approved doses, published references or documented clinical needApproved doses, published references or documented clinical need Must reexamine before each C-II prescriptionMust reexamine before each C-II prescription

7. State vs Federal Laws If state and federal laws conflict If state and federal laws conflict… the more stringent law holds

8. Basic Requirements Valid Veterinarian/Client/Patient (V/C/P) Relationship Good Faith

9. System Components Audit Trails Security/Accountability Valid Uses Common Sense

10. System Components DEA will inspect many aspects of your practice Policy and procedure manuals

11. Schedule I High potential for abuse No accepted medical use (in the US) (heroin, LSD)

12. Schedule II High potential for abuse Accepted medical use (in the US) (morphine, oxymorphone, fentanyl)

13. Schedule III-V Decreasing potential for abuse Accepted medical use (in the US)

14. Chemical Diversion and Trafficking Act of 1988 List I : chemicals that are methamphetamine precursors List II : Chemicals that are use in manufacture, encapsulating and tableting machines 21CFR1313

15. Chemical Diversion and Trafficking Act of 1988 Reduced access to chemicals exported for cocaine production Created a diversion market for finished drug products containing ephedrine and related products used in illicit methamphetamine manufacture

16. Domestic Chemical Diversion and Control Act of 1993 Added finished ephedrine drug products to List I Created a diversion market for pseudoephedrine

17. Comprehensive Methamphetamine Control Act of 1996 Added finished pseudoephedrine and phenylpropanolamine drug products to List I Defined record keeping for distributors 21CFR1300, 1309, 1310

18. Registration Agents may function as agents of the registrant Agents may administer or dispense Agents may not prescribe

19. Registration If a veterinarian dispenses or administers controlled substances at more than one location, then that veterinarian must register at each location (old)

20. Registration If a veterinarian dispenses or administers controlled substances at more than one location, then that veterinarian should contact DEA for registration advice (relief veterinarians, etc)

21. Non-practitioners: ordering, administering, inventory control…. Can not dispense but can measure quantities, produce labels, under direct supervision Use of Agents

22. shall not employ as an agent or employee who has access to controlled substances any person who: Criminal Background Check has a drug convictionhas a drug conviction has been considered for chargeshas been considered for charges DEA license has been revokedDEA license has been revoked DEA license has been refusedDEA license has been refused DEA license has been surrenderedDEA license has been surrendered 21CFR1301.76

23. Questions: Employee Screening Illegal use of drugs? 21CFR1301.90 Drug convictions?

24. blank 222 forms Records executed 222 forms C II invoices C III-V invoices dispensing records disposal records “biennial” inventory loss or theft records

25. A prescription shall not be issued for a practitioner to obtain a controlled substance for the purpose of general dispensing to patients Prescription KRS218A180, 21CFR 1306.04

26. C II invoices separate Receiving records 21CFR 1304.02, 1304.04 C III-V invoices separate -or- marked with red “C”

27. PRESCRIPTIONS C-IIC-IIC-II C-III, IV, V C C-III, IV, V OTHERSOTHERS C-III, IV, V C OTHERS

28. Prescription Packaging Child Resistant Amber Tight

29. Labeling Serial number and date of dispensing Name of patient Name of drug and quantity Name and address of dispenser Directions for use Precautionary information Expiration date Federal caution label

30. Audit Records Detect and correct errors WHILE THEY ARE FRESH!

31. Audit Records All controlled substances records must be readily retrievable

32. Biennial Inventory Every 2 years Separate from other inventory records Readily retrievable Perpetual Inventory?

33. Medical Records Document administration/dispensing Document medical need

34. Computerized Records Keep written records Continuity of records Complete information Backup system Keep printouts Continuity of system

35. Loss or theft Notify local law enforcement Notify your licensing board Notify DEA and complete form 106

36. Disposal of Drugs Store out of date or contaminated drugs in a secure place separate from other controlled substances Contact Pharmaceutical Disposer Registrant Complete DEA form 41

37. Retention of Records 2 years (state and federal law) Infinity (Kemp) 5 years (statute of limitations)

38. Inspections Must make records available Certain information exempt No warrants needed

39. Distribution to another Practitioner Not by prescription Subject to 5%limit

40. Practitioner Transfers (D) No licensed terminal distributor of dangerous drugs shall purchase for the purpose of resale dangerous drugs from any person other than a registered wholesale distributor of dangerous drugs, except as follows:.......occasional purchases of dangerous drugs for resale from a pharmacist......... licensed terminal distributor of dangerous drugs having more than one establishment or place may transfer or receive dangerous drugs from one establishment..... ORC 4729.51

41. Criminal Fine Enforcement Act of 1984 up to $100,000 for a misdemeanor by a corporation or individual not resulting in death up to $500,000 for a misdemeanor by a corporation or individual resulting in death or for a felony up to 1 year in prison for a misdemeanor up to $250,000 for a misdemeanor by an individual resulting in death or for a felony up to 10 years in prison for a felony

42. Other Penalties Forfeiture of property: Real Estate Cars, boats, airplanes Money, securities, items of value

43. Other Penalties Within 1000 ft of school, park, playground, youth center, public swimming pool, video arcade (including their parking lots)……. Double penalties……up to life imprisonment…..

44. Advisements Get important communications with regulatory agencies IN WRITING!