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Controlled Substances Regulation for Veterinary Practices

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. Drug Abuse.

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Controlled Substances Regulation for Veterinary Practices

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  1. 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

  2. DrugAbuse … 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. C.Y.A.

  4. GOALS Avoid Enforcement Action Discourage Abuse

  5. Non-Controlled Drugs? Tramadol Detomidine Xylazine Others??

  6. Moving Target

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

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

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

  10. 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)

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

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

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

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

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

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

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

  18. You are being watched!

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

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

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

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

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

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

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

  26. Anabolic Steroids HCG ACTH

  27. 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

  28. 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

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

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

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

  32. 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

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

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

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

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

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

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

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

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

  44. Criminal Background Check Concerns cost turn around time overspray confidentiality liability

  45. Trust Don’t

  46. System Components Audit Trails Vapor Trails

  47. C.Y.A.

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

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

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