Controlled Substances RegulationControlled Substances Regulationfor Veterinary Practicesfor Veterinary Practices
Doug Kemp, PharmD, DICVPDoug Kemp, PharmD, DICVP
College of Veterinary MedicineCollege of Veterinary MedicineUniversity of GeorgiaUniversity of Georgia
Athens, GA 30602-7391Athens, GA 30602-7391
www.vet.uga.edu/pharmacywww.vet.uga.edu/pharmacy
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
C.Y.AC.Y.A..
GOALSGOALS
Avoid Enforcement ActionAvoid Enforcement Action
Discourage AbuseDiscourage Abuse
Non-Controlled Drugs?Non-Controlled Drugs?
TramadolTramadol
DetomidineDetomidine
XylazineXylazine
Others??Others??
Moving TargetMoving Target
Controlled Substances LawsControlled Substances Laws
Harrison Narcotic Act of 1914Harrison Narcotic Act of 1914
Comprehensive Drug Abuse Comprehensive Drug Abuse Prevention and Control Act of Prevention and Control Act of 19711971
Controlled Substances LawsControlled Substances Laws& Regulations& Regulations
Title 21 USC §801-971Title 21 USC §801-971
Title 21 CFR §1300 et seqTitle 21 CFR §1300 et seq
Federal RegisterFederal Register
Web AccessWeb Access
USC, CFR and FR are USC, CFR and FR are searchable on the WWWsearchable on the WWW
table of contents of FR via table of contents of FR via emailemail
www.vet.uga.edu/pharmacywww.vet.uga.edu/pharmacy
Georgia Laws and RulesGeorgia Laws and Rules
Title 16, Chapter 13, Article Title 16, Chapter 13, Article 1-2 1-2 (CSA)(CSA)
Title 26, Chapter 4, Article 1 Title 26, Chapter 4, Article 1 (PHR)(PHR)
Pharmacy Rules, Chapter Pharmacy Rules, Chapter 480-28480-28
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
Basic RequirementsBasic Requirements
Valid Valid Veterinarian/Client/Patient Veterinarian/Client/Patient
(V/C/P) Relationship(V/C/P) Relationship
Good FaithGood Faith
PharmacistsPharmacists
Pharmacists have a Pharmacists have a corresponding responsibility corresponding responsibility
for controlled substances for controlled substances prescriptionsprescriptions
ExpectationsExpectations
You are expected to create You are expected to create and maintain a system that and maintain a system that
prevents theft and/or prevents theft and/or diversiondiversion
System ComponentsSystem Components
Audit TrailsAudit Trails
Security/AccountabilitySecurity/Accountability
Valid UsesValid Uses
Common SenseCommon Sense
You are being You are being
watched!watched!
System ComponentsSystem Components
DEA will inspect many DEA will inspect many aspects of your aspects of your
practicepractice
Policy and procedure Policy and procedure manualsmanuals
SchedulingScheduling
Potential for abusePotential for abuse
International treatiesInternational treaties
Approved medical use (in the US)Approved medical use (in the US)
Schedule ISchedule I
High potential for abuseHigh potential for abuse
No accepted medical use (in the US)No accepted medical use (in the US)
(heroin, LSD)(heroin, LSD)
Schedule IISchedule II
High potential for abuseHigh potential for abuse
Accepted medical use (in the US)Accepted medical use (in the US)
(morphine, oxymorphone, fentanyl)(morphine, oxymorphone, fentanyl)
Schedule III-VSchedule III-V
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)
C-III September 1991C-III September 1991
Veterinary implants exemptVeterinary implants exempt
Anabolic SteroidsAnabolic Steroids
HCGHCG
ACTHACTH
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 used in manufacture,List II : Chemicals that are used 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 methamphetamine production for methamphetamine 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
PesudoephedrinePesudoephedrine
GeorgiaGeorgia(except exempt or pediatric drug products)(except exempt or pediatric drug products)
Effective Jan 2006Effective Jan 2006
Behind the CounterBehind the CounterBlister packagingBlister packaging
3 packages/9grams maximum sale3 packages/9grams maximum salePurchased from licensed wholesaler or manufacturerPurchased from licensed wholesaler or manufacturer
OCGA16-13-30.3OCGA16-13-30.3
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
(relief veterinarians, etc)(relief veterinarians, etc)
Practitioner in ChargePractitioner in Charge(PIC)(PIC)
Individual who holds DEA license Individual who holds DEA license for common stockfor common stock
All registrants shall provide All registrants shall provide effective controls…..effective controls…..
PharmacopPharmacop
Non-practitioners: ordering, Non-practitioners: ordering, administering, inventory control….administering, inventory control….
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:
Criminal Background CheckCriminal 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 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:
Criminal Background CheckCriminal Background Check
““employ” means “use”employ” means “use”
DEA AdvisementDEA Advisement
background check requirement appliesbackground check requirement appliesto volunteersto volunteers
Questions:Questions:
Employee ScreeningEmployee Screening
Illegal use of drugs?Illegal use of drugs?
21CFR1301.9021CFR1301.90
Drug convictions?Drug convictions?
Local law enforcementLocal law enforcement
Criminal Background CheckCriminal Background Check
DEADEA
21CFR1301.9321CFR1301.93
oversprayoverspray
Criminal Background CheckCriminal Background CheckConcernsConcerns
costcost
turn around timeturn around time
confidentialityconfidentiality
liabilityliability
Don’tDon’t
TrustTrust
System ComponentsSystem Components
Audit Audit TrailsTrails
Vapor TrailsVapor Trails
C.Y.AC.Y.A..
blank 222 formsblank 222 forms
RecordsRecords
executed 222 formsexecuted 222 forms
C II invoicesC II invoices
C III-V invoicesC III-V invoices
dispensing recordsdispensing records
disposal recordsdisposal records““biennial” inventorybiennial” inventory
loss or theft recordsloss or theft records
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
CSOSCSOS
www.deaecom.gov/csosmain.htmlwww.deaecom.gov/csosmain.html
Controlled Substances Controlled Substances Ordering SystemOrdering System
CSOSCSOS
CSOSCSOS
CSOSCSOS
CSOSCSOS
CSOSCSOS
CSOSCSOS
CSOSCSOS
CSOSCSOS
““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
Old disposition sheet + empty containerOld disposition sheet + empty container
CDMCDM
CDMCDM
CDM KEYPADCDM KEYPAD
CDMCDM
CDM - DRAWERCDM - DRAWER
CDM - RETURNSCDM - RETURNS
CDM - RETURNSCDM - RETURNS
CDM - ELECTRONICSCDM - ELECTRONICS
CDM - PCCDM - PC
AUTOMATED CHARGINGAUTOMATED CHARGING
CDMCDM
PCPC
HOSPITAL SYSTEMHOSPITAL SYSTEM
DISPOSITION RECORDDISPOSITION RECORD
PRESCRIPTIONSPRESCRIPTIONS
C-IIC-II C-IIC-II C-IIC-IIC-III, IV, V C-III, IV, V CC
C-III, IV, C-III, IV, VV
OTHERSOTHERS OTHERSOTHERS
C-III, IV, V C-III, IV, V CCOTHERSOTHERS
PRESCRIPTIONSPRESCRIPTIONS
PRESCRIPTIONSPRESCRIPTIONS
PRESCRIPTIONSPRESCRIPTIONS
Prescription PackagingPrescription Packaging
Child ResistantChild Resistant
AmberAmber
TightTight
PackagingPackaging
PackagingPackaging
PackagingPackaging
PackagingPackaging
LabelingLabeling
Serial number and date of dispensingSerial number and date of dispensing
Name of patientName of patient
Name of drug and quantityName of drug and quantity
Name and address of dispenserName and address of dispenser
Directions for useDirections for use
Precautionary informationPrecautionary information
Expiration dateExpiration date
Federal caution labelFederal caution label
Audit RecordsAudit Records
Detect and correct errorsDetect and correct errors
WHILE THEY ARE FRESH!WHILE THEY ARE FRESH!
Audit RecordsAudit RecordsAudit RecordsAudit Records
Audit RecordsAudit Records
All controlled substancesAll controlled substancesrecords must be records must be readily retrievablereadily retrievable
Biennial InventoryBiennial Inventory
Every 2 yearsEvery 2 years
Separate from other inventory Separate from other inventory recordsrecords
Readily retrievableReadily retrievable
Perpetual Inventory?Perpetual Inventory?
Perpetual InventoryPerpetual Inventory
Medical RecordsMedical Records
Document administration/dispensingDocument administration/dispensing
Document medical needDocument medical need
Computerized RecordsComputerized Records
Keep written recordsKeep written records
Continuity of recordsContinuity of records
Complete informationComplete information
Backup systemBackup system
Keep printoutsKeep printouts
Continuity of systemContinuity of system
Loss or theftLoss or theft
Notify local law enforcementNotify local law enforcement
Notify your licensing boardNotify your licensing board
Notify DEA and complete form 106Notify DEA and complete form 106
Disposal of DrugsDisposal of Drugs
Store out of date or Store out of date or contaminated drugs in a secure contaminated drugs in a secure
place separate from other place separate from other controlled substancescontrolled substances
Contact Reverse DistributorContact Reverse Distributor
Complete DEA form 41Complete DEA form 41
Retention of RecordsRetention of Records
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
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.....
ORC 4729.51ORC 4729.51
Filling PrescriptionsFilling Prescriptions
Veterinarian/Client/Patient Veterinarian/Client/Patient RelationshipRelationship
Federal LawFederal Law
State LawState Law
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…..
AdvisementsAdvisements
Get important communications Get important communications with regulatory agencies with regulatory agencies IN IN WRITING!WRITING!
www.vet.uga.edu/pharmacywww.vet.uga.edu/pharmacy