3. Controlled Substances Regulation for Veterinary Practices Doug Kemp, PharmD, DICVP College of Veterinary Medicine University of Georgia Athens, GA 30602-7391 www.vet.uga.edu/pharmacy

4. 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

5. C.Y.A.

6. GOALS Avoid Enforcement Action Discourage Abuse

7. Non-Controlled Drugs? TramadolDetomidineXylazineOthers??

8. Moving Target

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

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

11. Web Access USC, CFR and FR are searchable on the WWW table of contents of FR via email www.vet.uga.edu/pharmacy

12. 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)

13. 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

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

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

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

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

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

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

20. You are being watched!

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

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

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

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

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

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

27. 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

28. Anabolic Steroids HCG ACTH

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

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

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

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

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

34. Pesudoephedrine Georgia (except exempt or pediatric drug products) Effective Jan 2006 Behind the Counter Blister packaging 3 packages/9grams maximum sale Purchased from licensed wholesaler or manufacturer OCGA16-13-30.3

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

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

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

38. 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)

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

40. Pharmacop

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

42. 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

43. 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

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

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

46. overspray Concerns cost turn around time confidentiality liability

47. Don’t Trust

48. System Components Audit Trails Vapor Trails

49. C.Y.A.

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

51. 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

52. 222 Form

53. CSOS www.deaecom.gov/csosmain.html Controlled Substances Ordering System

54. CSOS

55. CSOS

56. CSOS

57. CSOS

58. CSOS

59. CSOS

60. CSOS

61. CSOS

62. “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

63. 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

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

65. C II Invoices

66. C III, IV & V Invoices

67. 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

68. Security

69. Security

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

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

72. Disposition Records

76. Serial Number Record

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

78. CDM

79. CDM

80. CDM KEYPAD

81. CDM

82. CDM - DRAWER

83. CDM - RETURNS

85. CDM - ELECTRONICS

86. CDM - PC

87. AUTOMATED CHARGING CDM PC HOSPITAL SYSTEM

88. DISPOSITION RECORD

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

90. PRESCRIPTIONS

91. PRESCRIPTIONS

92. PRESCRIPTIONS

93. Prescription Packaging Child Resistant Amber Tight

94. Packaging

95. Packaging

96. Packaging

97. Packaging

98. 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

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

100. Audit Records

101. All controlled substances records must be readily retrievable

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

103. Perpetual Inventory

104. Medical Records Document administration/dispensing Document medical need

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

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

107. Disposal of Drugs Store out of date or contaminated drugs in a secure place separate from other controlled substances Contact Reverse Distributor Complete DEA form 41

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

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

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

111. Distribution Records

115. 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

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

117. 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

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

119. 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…..

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

121. www.vet.uga.edu/pharmacy