Controlled Substances Regulation Controlled Substances Regulation for Veterinary Practices for Veterinary Practices Douglas T. Kemp, PharmD, Douglas T. Kemp, PharmD, DICVP DICVP College of Veterinary College of Veterinary Medicine Medicine University of Georgia University of Georgia Athens, GA 30602-7391 Athens, GA 30602-7391 www.vet.uga.edu/pharmacy/pharmacy.html www.vet.uga.edu/pharmacy/pharmacy.html
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Controlled Substances Regulation for Veterinary Practices Douglas T. Kemp, PharmD, DICVP College of Veterinary Medicine University of Georgia Athens,
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Douglas T. Kemp, PharmD, Douglas T. Kemp, PharmD, DICVPDICVP
College of Veterinary College of Veterinary MedicineMedicine
University of GeorgiaUniversity of GeorgiaAthens, GA 30602-7391Athens, GA 30602-7391www.vet.uga.edu/pharmacy/pharmacy.htmlwww.vet.uga.edu/pharmacy/pharmacy.html
DrugDrug AbuseAbuse
… … the prevalence of severe the prevalence of severe drug abuse problems and drug abuse problems and their consequences has their consequences has increased since 1985….increased since 1985….
The Economic Costs of Alcohol and Drug Abuse in the United States, 1992
National Institute on Drug AbuseNational Institute on Alcohol Abuse and Alcoholism
Vet Rules, Chapter 700-Vet Rules, Chapter 700-8-.01(c)8-.01(c)
Veterinary Rules - GAVeterinary Rules - GA
•Can not prescribe without Can not prescribe without examinationexamination•Can not dispense or prescribe Can not dispense or prescribe more than 30 days of C-IImore than 30 days of C-II
•Approved doses, published Approved doses, published references or documented clinical references or documented clinical needneed
•Must reexamine before each Must reexamine before each C-II prescriptionC-II prescription
Florida Laws and RulesFlorida Laws and Rules
Florida Comprehensive Drug Florida Comprehensive Drug Prevention and Control ActPrevention and Control Act
Rules, Department of Rules, Department of Professional Regulation, Professional Regulation, Board of Veterinary MedicineBoard of Veterinary Medicine
State vs Federal LawsState vs Federal Laws
If state and federal laws If state and federal laws conflictconflict…
the more stringent law the more stringent law holdsholds
Decreasing potential for abuseDecreasing potential for abuse
Accepted medical use (in the US)Accepted medical use (in the US)
Butorphanol, KetamineButorphanol, Ketamine
Butorphanol C-IV 10/97Butorphanol C-IV 10/97
Ketamine C-III 8/99Ketamine C-III 8/99
Anabolic SteroidsAnabolic Steroids
Any drug or hormonal substance, chemicallyAny drug or hormonal substance, chemicallyor pharmacologically related to testosterone or pharmacologically related to testosterone
(other than estrogens, progestins, and (other than estrogens, progestins, and corticosteroids) corticosteroids)
Chemical Diversion and Trafficking Chemical Diversion and Trafficking Act of 1988Act of 1988
List I : chemicals that are methamphetamineList I : chemicals that are methamphetamineprecursorsprecursors
List II : Chemicals that are use in manufacture,List II : Chemicals that are use in manufacture,encapsulating and tableting machinesencapsulating and tableting machines
21CFR131321CFR1313
Chemical Diversion and Trafficking Chemical Diversion and Trafficking Act of 1988Act of 1988
Reduced access to chemicals exported Reduced access to chemicals exported for cocaine production for cocaine production
Created a diversion market for finished Created a diversion market for finished drug products containing ephedrine and drug products containing ephedrine and related products used in illicitrelated products used in illicitmethamphetamine manufacturemethamphetamine manufacture
Domestic Chemical Diversion and Domestic Chemical Diversion and Control Act of 1993Control Act of 1993
Added finished ephedrine drug Added finished ephedrine drug products to List Iproducts to List I
Created a diversion market for Created a diversion market for pseudoephedrinepseudoephedrine
Comprehensive Methamphetamine Comprehensive Methamphetamine Control Act of 1996Control Act of 1996
Added finished pseudoephedrine and Added finished pseudoephedrine and phenylpropanolamine drug products phenylpropanolamine drug products to List Ito List I
Defined record keeping for Defined record keeping for distributorsdistributors
21CFR1300, 1309, 131021CFR1300, 1309, 1310
EphedrineEphedrine
C-V in OhioC-V in Ohio
(except exempt drug products)(except exempt drug products)
Category III terminal distributor licenseCategory III terminal distributor licenserequired to dispenserequired to dispense
ORC 3917.41ORC 3917.41
RegistrationRegistration
Every veterinarian who administers, Every veterinarian who administers, prescribes, distributes or dispenses prescribes, distributes or dispenses
controlled substancescontrolled substancesmust register with DEAmust register with DEA
(old)(old)
RegistrationRegistration
DVMs may function as agents of the registrantDVMs may function as agents of the registrant
Agents may administer or dispenseAgents may administer or dispense
Agents may not prescribeAgents may not prescribe
RegistrationRegistration
If a veterinarian dispenses or administers If a veterinarian dispenses or administers controlled substances at more than one controlled substances at more than one
location, then that veterinarian location, then that veterinarian must registermust registerat each locationat each location
(old)(old)
RegistrationRegistration
If a veterinarian dispenses or administers If a veterinarian dispenses or administers controlled substances at more than one controlled substances at more than one location, then that veterinarian should location, then that veterinarian should
contact DEA for registration advicecontact DEA for registration advice
Can not dispense but can measure Can not dispense but can measure quantities, produce labels, under quantities, produce labels, under direct supervisiondirect supervision
Use of AgentsUse of Agents
shall not employ as an agent or employee shall not employ as an agent or employee who has access to controlled substances who has access to controlled substances any person who:any person who:
•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 surrendered21CFR1301.7621CFR1301.76
shall not employ as an agent or employee shall not employ as an agent or employee who has access to controlled substances who has access to controlled substances any person who:any person who:
Date of receipt, name and Date of receipt, name and address of source, kind and address of source, kind and quantity of drugs receivedquantity of drugs received
Kentucky recordsKentucky records
Date of sale, administration, Date of sale, administration, dispensing, disposal, name and dispensing, disposal, name and address of recipient or client, address of recipient or client,
species, kind and quantity of drugspecies, kind and quantity of drugKRS 218A.200
222 Form222 Form
““Prescription” means a written, Prescription” means a written, electronic, or oral order for drugs electronic, or oral order for drugs
or combinations or mixtures of or combinations or mixtures of drugs to be used by a particular drugs to be used by a particular individual or for treatment of a individual or for treatment of a particular animal, issued by a particular animal, issued by a
licensed health care professional licensed health care professional authorized to prescribe drugsauthorized to prescribe drugs
PrescriptionPrescription
OCR 4729.01
A prescription shall not be issued A prescription shall not be issued for a practitioner to obtain a for a practitioner to obtain a controlled substance for the controlled substance for the
purpose of general dispensing to purpose of general dispensing to patientspatients
PrescriptionPrescription
KRS218A180, 21CFR 1306.04
C II invoices C II invoices separateseparate
Receiving recordsReceiving records
21CFR 1304.02, 1304.04
C III-V invoices separateC III-V invoices separate-or--or-
marked with red “C”marked with red “C”
C II InvoicesC II Invoices
C III, IV & V InvoicesC III, IV & V Invoices
shall provide effective shall provide effective controls and procedures to controls and procedures to
guard against theft and guard against theft and diversiondiversion
SecuritySecurity
21CFR 1301.71
shall be stored in a securely shall be stored in a securely locked, substantially locked, substantially constructed cabinetconstructed cabinet21CFR 1301.75
SecuritySecurity
SecuritySecurity
carfentanil, etorphine and carfentanil, etorphine and diprenorphine shall be diprenorphine shall be
stored in a Class V security stored in a Class V security containercontainer
SecuritySecurity
21CFR 1301.75
consolidated audit consolidated audit trailtrail
Disposition RecordsDisposition Records
cleaclearr
readily retrievablereadily retrievable
21CFR 1304.04
Disposition RecordsDisposition Records
Disposition RecordsDisposition Records
Disposition RecordsDisposition Records
Disposition RecordsDisposition Records
Serial Number RecordSerial Number Record
Restocking CycleRestocking Cycle
New disposition sheet + full New disposition sheet + full containercontainer
2 years (state and federal law)2 years (state and federal law)
Infinity (Kemp)Infinity (Kemp)
5 years (statute of limitations)5 years (statute of limitations)
InspectionsInspections
Must make records availableMust make records available
Certain information exemptCertain information exempt
No warrants neededNo warrants needed
Distribution to another Distribution to another PractitionerPractitioner
Not by Not by prescriptionprescription
Subject to 5% limitSubject to 5% limit
Distribution Records Distribution Records
Distribution RecordsDistribution Records
Distribution RecordsDistribution Records
Practitioner TransfersPractitioner Transfers
(D) No licensed terminal distributor of (D) No licensed terminal distributor of dangerous drugs shall purchase for the purpose dangerous drugs shall purchase for the purpose of resale dangerous drugs from any person of resale dangerous drugs from any person other than a registered wholesale distributor of other than a registered wholesale distributor of dangerous drugs, except as follows:dangerous drugs, except as follows:
.......occasional purchases of dangerous drugs .......occasional purchases of dangerous drugs for resale from a pharmacist.....for resale from a pharmacist.....
.... licensed terminal distributor of dangerous .... licensed terminal distributor of dangerous drugs having more than one establishment or drugs having more than one establishment or place may transfer or receive dangerous drugs place may transfer or receive dangerous drugs from one establishment.....from one establishment.....
Criminal Fine EnforcementCriminal Fine EnforcementAct of 1984Act of 1984
up to $100,000 for a misdemeanor by a corporation or up to $100,000 for a misdemeanor by a corporation or individual not resulting in deathindividual not resulting in death
up to $500,000 for a misdemeanor by a corporation or up to $500,000 for a misdemeanor by a corporation or individual resulting in death or for a felonyindividual resulting in death or for a felony
up to 1 year in prison for a misdemeanorup to 1 year in prison for a misdemeanor
up to $250,000 for a misdemeanor by an individual up to $250,000 for a misdemeanor by an individual resulting in death or for a felonyresulting in death or for a felony
up to 10 years in prison for a felonyup to 10 years in prison for a felony
Other PenaltiesOther Penalties
Forfeiture of Forfeiture of property:property:
Real Real EstateEstate
Cars, boats, Cars, boats, airplanesairplanes
Money, securities, items of Money, securities, items of valuevalue
Other PenaltiesOther Penalties
Within 1000 ft of school, park, Within 1000 ft of school, park, playground, youth center, public playground, youth center, public swimming pool, video arcade swimming pool, video arcade (including their parking lots)…….(including their parking lots)…….
Double penalties……up to life Double penalties……up to life imprisonment…..imprisonment…..
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