2. Controlled Substances Regulation for Veterinary Practices Douglas T. Kemp, PharmD, DICVP College of Veterinary Medicine University of Georgia Athens, GA 30602-7391

3. 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

4. C.Y.A.

5. GOALS Avoid Enforcement Action Discourage Abuse

6. Non-Controlled Drugs? DetomidineXylazineOthers??

7. Moving Target

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

9. Controlled Substances Laws & Regulations Title 21 USC §801-971 Title 21 CFR §1300 et seq Federal Register

10. Web Access USC, CFR and FR are searchable on the WWW table of contents of FR

11. 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)

12. 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

13. Florida Laws and Rules Florida Comprehensive Drug Prevention and Control Act Rules, Department of Professional Regulation, Board of Veterinary Medicine

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

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

16. Pharmacists Pharmacists have a corresponding responsibility for controlled substances prescriptions

17. Expectations You are expected to create and maintain a system that prevents theft and/or diversion

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

19. You are being watched!

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

21. Scheduling Potential for abuse International treaties Approved medical use (in the US)

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

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

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

25. Butorphanol, Ketamine Butorphanol C-IV 10/97 Ketamine C-III 8/99

26. Anabolic Steroids Any drug or hormonal substance, chemically or pharmacologically related to testosterone (other than estrogens, progestins, and corticosteroids) C-III September 1991 Veterinary implants exempt

27. Anabolic Steroids HCG ACTH

28. 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

29. 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

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

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

32. Ephedrine C-V in Ohio (except exempt drug products) Category III terminal distributor license required to dispense ORC 3917.41

33. Registration Every veterinarian who administers, prescribes, distributes or dispenses controlled substances must register with DEA (old)

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

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

36. 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)

37. Practitioner in Charge (PIC) Individual who holds DEA license for common stock All registrants shall provide effective controls…..

38. Pharmacop

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

40. 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

41. shall not employ as an agent or employee who has access to controlled substances any person who: Criminal Background Check “employ” means “use” DEA Advisement background check requirement applies to volunteers

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

43. Local law enforcement Criminal Background Check DEA 21CFR1301.93

44. overspray Concerns cost turn around time confidentiality liability

45. Don’t Trust

46. System Components Audit Trails Vapor Trails

47. C.Y.A.

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

49. Date of receipt, name and address of source, kind and quantity of drugs received Kentucky records Date of sale, administration, dispensing, disposal, name and address of recipient or client, species, kind and quantity of drug KRS 218A.200

50. 222 Form

51. “Prescription” means a written, electronic, or oral order for drugs or combinations or mixtures of drugs to be used by a particular individual or for treatment of a particular animal, issued by a licensed health care professional authorized to prescribe drugs Prescription OCR 4729.01

52. 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

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

54. C II Invoices

55. C III, IV & V Invoices

56. shall provide effective controls and procedures to guard against theft and diversion Security 21CFR 1301.71 shall be stored in a securely locked, substantially constructed cabinet 21CFR 1301.75

57. carfentanil, etorphine and diprenorphine shall be stored in a Class V security container Security 21CFR 1301.75

58. consolidated audit trail Disposition Records clear readily retrievable 21CFR 1304.04

59. Disposition Records

63. Serial Number Record

64. Restocking Cycle New disposition sheet + full container Old disposition sheet + empty container

65. CDM

66. CDM

67. CDM KEYPAD

68. CDM

69. CDM - DRAWER

70. CDM - RETURNS

72. CDM - ELECTRONICS

73. CDM - PC

74. AUTOMATED CHARGING CDM PC HOSPITAL SYSTEM

75. DISPOSITION RECORD

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

77. PRESCRIPTIONS

78. PRESCRIPTIONS

79. PRESCRIPTIONS

80. Prescription Packaging Child Resistant Amber Tight

81. Packaging

82. Packaging

83. Packaging

84. Packaging

85. 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

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

87. Audit Records

88. All controlled substances records must be readily retrievable

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

90. Perpetual Inventory

91. Medical Records Document administration/dispensing Document medical need

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

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

94. 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

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

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

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

98. Distribution Records

101. 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

102. Filling Prescriptions Veterinarian/Client/Patient Relationship Federal Law State Law

103. 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

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

105. 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…..

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