controlled substances regulation for veterinary practices

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