Controlled substances regulation for veterinary practices
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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

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


Controlled substances regulation for veterinary practices

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


Controlled substances regulation for veterinary practices

C.Y.A.


Controlled substances regulation for veterinary practices

GOALS

Avoid Enforcement Action

Discourage Abuse


Controlled substances regulation for veterinary practices

Non-Controlled Drugs?

Tramadol

Detomidine

Xylazine

Others??


Controlled substances regulation for veterinary practices

Moving Target


Controlled substances regulation for veterinary practices

Controlled Substances Laws

Harrison Narcotic Act of 1914

Comprehensive Drug Abuse Prevention and Control Act of 1971


Controlled substances regulation for veterinary practices

Controlled Substances Laws

& Regulations

Title 21 USC §801-971

Title 21 CFR §1300 et seq

Federal Register


Controlled substances regulation for veterinary practices

Web Access

USC, CFR and FR are searchable on the WWW

table of contents of FR via email

www.vet.uga.edu/pharmacy


Controlled substances regulation for veterinary practices

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)


Controlled substances regulation for veterinary practices

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


Controlled substances regulation for veterinary practices

Florida Laws and Rules

Florida Comprehensive Drug Prevention and Control Act

Rules, Department of Professional Regulation, Board of Veterinary Medicine


Controlled substances regulation for veterinary practices

State vs Federal Laws

If state and federal laws conflict…

the more stringent law holds


Controlled substances regulation for veterinary practices

Basic Requirements

Valid Veterinarian/Client/Patient (V/C/P) Relationship

Good Faith


Controlled substances regulation for veterinary practices

Pharmacists

Pharmacists have a corresponding responsibility for controlled substances prescriptions


Controlled substances regulation for veterinary practices

Expectations

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


Controlled substances regulation for veterinary practices

System Components

Audit Trails

Security/Accountability

Valid Uses

Common Sense


Controlled substances regulation for veterinary practices

You are being

watched!


Controlled substances regulation for veterinary practices

System Components

DEA will inspect many aspects of your practice

Policy and procedure manuals


Controlled substances regulation for veterinary practices

Scheduling

Potential for abuse

Approved medical use (in the US)

International treaties


Controlled substances regulation for veterinary practices

Schedule I

High potential for abuse

No accepted medical use (in the US)

(heroin, LSD)


Controlled substances regulation for veterinary practices

Schedule II

High potential for abuse

Accepted medical use (in the US)

(morphine, oxymorphone, fentanyl)


Controlled substances regulation for veterinary practices

Schedule III-V

Decreasing potential for abuse

Accepted medical use (in the US)


Controlled substances regulation for veterinary practices

Butorphanol, Ketamine

Butorphanol C-IV 10/97

Ketamine C-III 8/99


Controlled substances regulation for veterinary practices

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


Controlled substances regulation for veterinary practices

Anabolic Steroids

HCG

ACTH


Controlled substances regulation for veterinary practices

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


Controlled substances regulation for veterinary practices

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


Controlled substances regulation for veterinary practices

Domestic Chemical Diversion and

Control Act of 1993

Added finished ephedrine drug

products to List I

Created a diversion market for

pseudoephedrine


Controlled substances regulation for veterinary practices

Comprehensive Methamphetamine

Control Act of 1996

Added finished pseudoephedrine and

phenylpropanolamine drug products

to List I

Defined record keeping for distributors

21CFR1300, 1309, 1310


Controlled substances regulation for veterinary practices

Ephedrine

C-V in Ohio

(except exempt drug products)

Category III terminal distributor license

required to dispense

ORC 3917.41


Controlled substances regulation for veterinary practices

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


Controlled substances regulation for veterinary practices

Registration

(old)

Every veterinarian who administers,

prescribes, distributes or dispenses

controlled substances

must register with DEA


Controlled substances regulation for veterinary practices

Registration

DVMs may function as agents of the registrant

Agents may administer or dispense

Agents may not prescribe


Controlled substances regulation for veterinary practices

Registration

(old)

If a veterinarian dispenses or administers

controlled substances at more than one

location, then that veterinarian must register

at each location


Controlled substances regulation for veterinary practices

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)


Controlled substances regulation for veterinary practices

Practitioner in Charge

(PIC)

Individual who holds DEA license

for common stock

All registrants shall provide

effective controls…..


Controlled substances regulation for veterinary practices

Pharmacop


Controlled substances regulation for veterinary practices

Use of Agents

Non-practitioners: ordering,

administering, inventory control….

Can not dispense but can measure

quantities, produce labels, under

direct supervision


Controlled substances regulation for veterinary practices

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


Controlled substances regulation for veterinary practices

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


Controlled substances regulation for veterinary practices

Employee Screening

Questions:

Illegal use of drugs?

Drug convictions?

21CFR1301.90


Controlled substances regulation for veterinary practices

Criminal Background Check

Local law enforcement

DEA

21CFR1301.93


Controlled substances regulation for veterinary practices

Criminal Background Check

Concerns

cost

turn around time

overspray

confidentiality

liability


Controlled substances regulation for veterinary practices

Trust

Don’t


Controlled substances regulation for veterinary practices

System Components

Audit Trails

Vapor Trails


Controlled substances regulation for veterinary practices

C.Y.A.


Controlled substances regulation for veterinary practices

Records

blank 222 forms

executed 222 forms

C II invoices

C III-V invoices

dispensing records

“biennial” inventory

disposal records

loss or theft records


Controlled substances regulation for veterinary practices

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


Controlled substances regulation for veterinary practices

222 Form


Controlled substances regulation for veterinary practices

CSOS

Controlled Substances

Ordering System

www.deaecom.gov/csosmain.html


Controlled substances regulation for veterinary practices

CSOS


Controlled substances regulation for veterinary practices

CSOS


Controlled substances regulation for veterinary practices

CSOS


Controlled substances regulation for veterinary practices

CSOS


Controlled substances regulation for veterinary practices

CSOS


Controlled substances regulation for veterinary practices

CSOS


Controlled substances regulation for veterinary practices

CSOS


Controlled substances regulation for veterinary practices

CSOS


Controlled substances regulation for veterinary practices

Prescription

“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

OCR 4729.01


Controlled substances regulation for veterinary practices

Prescription

A prescription shall not be issued for a practitioner to obtain a controlled substance for the purpose of general dispensing to patients

KRS218A180, 21CFR 1306.04


Controlled substances regulation for veterinary practices

Receiving records

C II invoices separate

C III-V invoices separate

-or-

marked with red “C”

21CFR 1304.02, 1304.04


Controlled substances regulation for veterinary practices

C II Invoices


Controlled substances regulation for veterinary practices

C III, IV & V Invoices


Controlled substances regulation for veterinary practices

Security

shall provide effective controls and procedures to guard against theft and diversion

21CFR 1301.71

shall be stored in a securely locked, substantially constructed cabinet

21CFR 1301.75


Controlled substances regulation for veterinary practices

Security


Controlled substances regulation for veterinary practices

Security


Controlled substances regulation for veterinary practices

Security

carfentanil, etorphine and diprenorphine shall be stored in a Class V security container

21CFR 1301.75


Controlled substances regulation for veterinary practices

Disposition Records

consolidated audit trail

clear

readily retrievable

21CFR 1304.04


Controlled substances regulation for veterinary practices

Disposition Records


Controlled substances regulation for veterinary practices

Disposition Records


Controlled substances regulation for veterinary practices

Disposition Records


Controlled substances regulation for veterinary practices

Disposition Records


Controlled substances regulation for veterinary practices

Serial Number Record


Controlled substances regulation for veterinary practices

Restocking Cycle

Old disposition sheet + empty container

New disposition sheet + full container


Controlled substances regulation for veterinary practices

CDM


Controlled substances regulation for veterinary practices

CDM


Controlled substances regulation for veterinary practices

CDM KEYPAD


Controlled substances regulation for veterinary practices

CDM


Controlled substances regulation for veterinary practices

CDM - DRAWER


Controlled substances regulation for veterinary practices

CDM - RETURNS


Controlled substances regulation for veterinary practices

CDM - RETURNS


Controlled substances regulation for veterinary practices

CDM - ELECTRONICS


Controlled substances regulation for veterinary practices

CDM - PC


Controlled substances regulation for veterinary practices

AUTOMATED CHARGING

CDM

PC

HOSPITAL SYSTEM


Controlled substances regulation for veterinary practices

DISPOSITION RECORD


Controlled substances regulation for veterinary practices

PRESCRIPTIONS

C-II

C-II

C-II

C-III, IV, V C

C-III, IV, V

C-III, IV, V C

OTHERS

OTHERS

OTHERS


Controlled substances regulation for veterinary practices

PRESCRIPTIONS


Controlled substances regulation for veterinary practices

PRESCRIPTIONS


Controlled substances regulation for veterinary practices

PRESCRIPTIONS


Controlled substances regulation for veterinary practices

Prescription Packaging

Child Resistant

Amber

Tight


Controlled substances regulation for veterinary practices

Packaging


Controlled substances regulation for veterinary practices

Packaging


Controlled substances regulation for veterinary practices

Packaging


Controlled substances regulation for veterinary practices

Packaging


Controlled substances regulation for veterinary practices

Labeling

Name and address of dispenser

Serial number and date of dispensing

Name of patient

Name of drug and quantity

Directions for use

Expiration date

Precautionary information

Federal caution label


Controlled substances regulation for veterinary practices

Audit Records

Detect and correct errors

WHILE THEY ARE FRESH!


Controlled substances regulation for veterinary practices

Audit Records

Audit Records


Controlled substances regulation for veterinary practices

Audit Records

All controlled substances

records must be readily retrievable


Controlled substances regulation for veterinary practices

Biennial Inventory

Every 2 years

Separate from other inventory records

Readily retrievable

Perpetual Inventory?


Controlled substances regulation for veterinary practices

Perpetual Inventory


Controlled substances regulation for veterinary practices

Medical Records

Document administration/dispensing

Document medical need


Controlled substances regulation for veterinary practices

Computerized Records

Keep written records

Keep printouts

Complete information

Backup system

Continuity of records

Continuity of system


Controlled substances regulation for veterinary practices

Loss or theft

Notify local law enforcement

Notify DEA and complete form 106

Notify your licensing board


Controlled substances regulation for veterinary practices

Disposal of Drugs

Store out of date or contaminated drugs in a secure place separate from other controlled substances

Complete DEA form 41

Contact Reverse Distributor


Controlled substances regulation for veterinary practices

Retention of Records

2 years (state and federal law)

5 years (statute of limitations)

Infinity (Kemp)


Controlled substances regulation for veterinary practices

Inspections

Must make records available

No warrants needed

Certain information exempt


Controlled substances regulation for veterinary practices

Distribution to another Practitioner

Not by prescription

Subject to 5% limit


Controlled substances regulation for veterinary practices

Distribution Records


Controlled substances regulation for veterinary practices

Distribution Records


Controlled substances regulation for veterinary practices

Distribution Records


Controlled substances regulation for veterinary practices

Distribution Records


Controlled substances regulation for veterinary practices

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


Controlled substances regulation for veterinary practices

Filling Prescriptions

Veterinarian/Client/Patient Relationship

Federal Law

State Law


Controlled substances regulation for veterinary practices

Criminal Fine Enforcement

Act of 1984

up to $100,000 for a misdemeanor by a corporation or individual not resulting in death

up to $250,000 for a misdemeanor by an individual resulting in death or for a felony

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 10 years in prison for a felony


Controlled substances regulation for veterinary practices

Other Penalties

Forfeiture of property:

Real Estate

Cars, boats, airplanes

Money, securities, items of value


Controlled substances regulation for veterinary practices

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…..


Controlled substances regulation for veterinary practices

Advisements

Get important communications with regulatory agencies IN WRITING!


Controlled substances regulation for veterinary practices

www.vet.uga.edu/pharmacy


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