Dispensing Legend Drugs

Laws and Rules Governing 

Dispensing i Prescription 

Drugs During the Practice 

of Veterinary Medicine 

Edwin A. Bayó 

Grossman, Furlow, and Bayó, LLC 

1408 N. Piedmont Way 

Tallahassee, FL. 32308 

(850) 385-1314 

e.bayo@gfblawfirm.com 

Florida Association of Equine Practitioners

Section 1 

Veterinary Prescription Drugs

Veterinary Prescription Drugs 

Veterinary prescription drugs are labeled for use 

only by or on the order of a licensed 

veterinarian. 

Veterinary prescription drugs are used or 

prescribed only within the context of a valid 

veterinarian/client/patient relationship (VCPR). 

A veterinarian can be disciplined for “using the 

privilege of ordering, prescribing, or making 

available medicinal drugs” outside of a VCPR. 

§474.214(1)(y), F.S.

Veterinary Prescription Drugs 

 

 

Veterinary yprescription 

p 

drugs must be properly 

labeled before being 

dispensed. dspe sed 

Appropriate dispensing 

and treatment records 

must be maintained, and 

veterinary prescription 

drugs should be 

dispensed d only in 

quantities required for 

the treatment of the 

animal(s) for which the 

drugs are dispensed.

Veterinarian/Client/Patient 

Relationship 

A VCPR exists when all of the following 

conditions have been meet: 

1. The veterinarian has sufficient knowledge of the 

animal(s) to initiate at least a general or 

preliminary diagnosis of the medical condition of 

the animal(s), which h means that t the veterinarian 

i 

is personally acquainted with the keeping and 

caring of the animal(s) and has seen the 

animal(s) or has made medically appropriate 

and timely visits to the premises where the 

animal(s) are kept.

Veterinarian/Client/Patient 

Relationship (continued)… 

2 The veterinarian is available or provides for 

2. The veterinarian is available or provides for 

follow up care and treatment in case of an 

adverse reaction or failure of the regimen of 

therapy. 

3. Maintains records which document patient 

visits, diagnosis, treatment, and other relevant 

information.

Section 2 

Federal Laws

U.S. Drug Enforcement 

Agency

DEA Registration 

In order for Florida licensed veterinarians to be 

able to prescribe, administer or dispense 

controlled substances, they must be registered 

with the U.S. Drug Enforcement Agency (DEA). 

DEA Form-224 

Available online and can be submitted electronically: 

www.deadiversion.usdoj.gov/drugreg/process.htm 

Send by U.S. Mail: 

DEA Registration ti Unit 

Registration Section/ODR 

P.O. Box 2639 

Springfield, VA 22152-2639

Source: An Informational Outline of the Controlled Substances Act (2006 ed.)

DEA Registration 

Veterinarians who practice at multiple locations 

must be registered with the DEA at each location. 

The only exception is the practitioner who uses or 

dispenses controlled substances as an agency of 

a veterinarian who is registered at each location. 

You must furnish your DEA registration number to 

obtain Schedule III, IV, and V controlled 

substances from suppliers. Veterinarians must 

use DEA Triplicate Order Form-222 to obtain 

Schedule II substances.

DEA Registration: Mobile 

Clinics 

Veterinarians who 

operate mobile clinics 

would be registered at 

the location where the 

controlled substances 

are stored. 

Records should be 

maintained as if the 

mobile unit were part 

of the registrant’s 

permanent location.

DEA Registration Modification 

Practitioners who wish to modify their Drug 

Enforcement Administration Registration for a 

name change or change of address should let 

their local DEA office know ahead of time, so 

appropriate registration changes can be made. 

Information concerning the DEA registration 

process can also be obtained by contacting 

the Registration Call Center at (800) 882- 

9539.

DEA Registration Renewal 

The DEA Form 224a is currently available online. 

Renewal applications are mailed automatically to 

the registered location 60 days prior to the 

expiration date. 

Any changes of address must be reported in 

writing to the DEA at the time the change occurs 

so that the renewal application will be sent to the 

correct address. 

Renewal applications will not be forwarded by the 

Post Office. If you are moving to a new state, t the 

DEA asks that you submit a copy of the new state 

license and a copy of the state controlled 

substance bt registration. it ti

DEA Registration Renewal 

Certificates must renewed every three (3) 

years. 

Cost of the registration fee, background check, 

etc. are the responsibility of the requesting 

veterinarian.


DEA Inspections 

 

 

The DEA does not routinely 

investigate t veterinary clinics, i but if 

an inspection does take place, 

organization and accurate records 

are essential. The DEA’s descent 

on a clinic will not allow the 

owner(s) time to search for files- 

one must be able to immediately 

access critical information. 

Situations that may provoke an 

investigation include those 

involving unusual prescribing 

practices, reports of controlled 

substance abuse, diversion, or 

other illegal activity.

DEA Identification of 

Controlled Substances 

Controlled substances are labeled with a 

large “C” and contain a roman numeral in 

the center to identify the schedule of the 

substance. 

The drugs and drug products that come 

under the jurisdiction of the Controlled 

Substance Act are divided into 5 schedules. 

These schedules are:

Controlled Substances Act: 

Drug Scheduling 

Schedule Description: Examples: 

I. 

The drug or other substance has a high 

potential for abuse. The drug or other 

substance has no currently accepted 

medical use in treatment in the United 

States. 

GHB, Heroin, Cannabis, 

Ecstasy, LSD. 

II. 

The drug or other substance has a high 

potential for abuse. The drug or other 

substance has a currently accepted 

medical use in treatment in the United 

States or a currently accepted medical 

use with severe restrictions. Abuse of 

the drug or other substances may lead 

to severe psychological l or physical 

dependence 

Cocaine, Codeine, 

Opium, Oxycodone, 

Morphine, Dexedrine.


Drug Scheduling (continued) 


III. 

The drug or other substance has a 

potential for abuse less than the drugs 

or other substances in Schedules I and 

II. The drug or other substance has a 

currently accepted medical use in 

treatment in the United States. Abuse 

of the drug or other substance may 

lead to moderate or low physical 

dependence or high psychological 

dependence. 

Anabolic steroids; 

Intermediate-acting 

barbiturates, such as 

talbutal or butalbital; 

Buprenorphine; 

Ketamine; Xyrem; 

Hydrocodone / codeine, 

when compounded with 

an NSAID




IV. 

The drug or other substance has a low 

potential for abuse relative to the drugs 

or other substances in Schedule III. 



treatment in the United States. 

Abuse of the drug or other substance 

may lead to limited physical 

dependence or psychological 

dependence relative to the drugs or 

other substances in Schedule III. 

Xanax, Stadol, Librium, 

Klonopin, Ativan, Restoril, 

Ambien, Serax




V. 

The drug or other substance has a low 

potential for abuse relative to the drugs 

or other substances in Schedule IV. 



treatment in the United States. 

Abuse of the drug or other substance 

may lead to limited physical 

dependence or psychological 

dependence relative to the drugs or 

other substances in Schedule IV 

Cough suppressants 

containing small amounts 

of codeine (e.g., 

promethazine+codeine); 

Preparations containing 

small amounts of opium 

or diphenoxylate (used to 

treat diarrhea); 

Pyrovalerone.

Ordering Controlled 

Substances 

Due to their potential for addiction, Schedule II 

drugs get more attention during their 

manufacturing, distribution, and dispensing. 

To order Schedule II substances, a federal 

triplicate order form must be used. These 

forms can be obtained by requesting them on 

the initial application form (DEA-224) by 

checking block “3.” 

They may also be obtained from the DEA 

Registration Unit in Washington, D.C. or online 

at https://www.deadiversion.usdoj.gov. 

di i d


Substances 

When using the DEA Triplicate Order Form- 

222 to obtain Schedule II substances, be sure 

to: 

Fill out the correctly or it will be sent back to the 

supplier. 

Fill in the “number of packages” and the “date 

received” sections.



Substances 

All other controlled substances are ordered in the 

same manner as any other medication. The 

supplier will ask for a copy of your current DEA 

registration form. 

There are no special requirements for Schedule 

III, IV, and V purchases. 

Obtaining controlled substances from a local 

pharmacy for “in-house” or “re-sale” use is 

prohibited. 

Prescriptions for controlled substances to be filled 

by a local pharmacy should be written only for 

specific patients.

DEA Records and 

Prescriptions 

Veterinarians must keep records for all 

controlled substances used or dispensed. 

These must be kept for 3 years by Florida law. 

Records for Schedule III, IV, and V controlled 

substances can be maintained as part of 

patient t records, by must be readily retrievable. 

Schedule II records must be kept separately. 

You must maintain i records or invoices i of 

controlled substances received for a 2 year 

period after the last quantity of each controlled 

substance on the invoice has been depleted.


Prescriptions 

You might be required to keep a copy of each 

prescription issued. Although the DEA does 

not require registrants to keep records of 

prescriptions issued, approximately 40% of 

states require multiple copies of controlled 

substance prescriptions. 

Prescriptions for Schedule II drugs must be in 

writing and cannot be refilled. Prescriptions 

for Schedule III or IV may be issued orally or in 

writing and can be refilled only up to five times 

in 6 months.


Prescriptions 

In emergencies, a 

pharmacist may fill 

oral prescriptions for 

Schedule II drugs 

but must notify the 

DEA if a written 

prescription order is 

not received within 

72 hours.

DEA: Biennial Inventory 

In addition to an initial inventory, yyou must make a 

biennial inventory of all controlled substances on 

hand. The inventory must be made every 2 years 

from initial registration and opening inventory. 

The following information should be included: 

1. Name, address, and registration number of each 

registrant. 

2. Name, unit size, and total quantity of each controlled 

substance. 

3. Date and time of inventory. 

4. Signature of person(s) making the inventory 

5. Separate records for Schedule II drugs. 

6. And new controlled drugs introduced must be put on 

inventory list with quantity and date.

DEA: Transfers of 


You may transfer or receive a limited amount of 

controlled substances to or from another 

practitioner if you are both DEA registrants. Both 

registrants must maintain records of the 

transaction. 

Records of Schedule II controlled substance 

transfers must be kept on DEA Order Form-222. 

Records of Schedule III, IV, and V controlled 

substances bt may be in the form of finvoices. 

i 

The total amount transferred by a registrant must 

not be more that 5% of the total number of dosage 

units used, dispensed, or prescribed during the 

same calendar year.

DEA: Safety Requirements 

You must keep 

controlled 

substances in a 

securely locked, 

substantially 

constructed cabinet 

or safe.


If a moveable lock-box is used, it must be 

securely affixed to a wall, floor, or cabinet. 

Similarly, lightweight filling cabinets or fire 

safes are inappropriate since they can be 

easily picked up and removed. 

Mobile units should be stocked with only 

enough of each controlled drug necessary for 

basic operation. 

Excess supplies should remain in a fixed 

secure location.


There are no additional security requirements 

for vehicles other than a substantial container 

must be used if the vehicle is unsupervised 

(i.e.. parking lot or store). 

Keeping drugs in a bag is not adequate. If the 

vehicle is not equipped with locking bins or 

compartments, then a small lockable box 

should be affixed to the vehicle. 

It is not necessary to remove the drugs from 

the vehicle for storage if a strong, non- 

moveable safe box is available.

DEA: Safety Recommendations 

It is recommended that the controlled 

substance stocks be kept to a minimum. 

Should it be necessary to have a substantial 

quantity of controlled substances stored in the 

clinic, the DEA encourages having security, 

which exceeds the minimum requirements, 

such as a large safe and alarm system. 

Access to the controlled substance storage 

area should be restricted to the absolute 

minimum number of employees.

DEA: Accountability of 


Whenever a practice administers a controlled 

substance to a patient, it must be recorded 

both on the patient’s medical record AND a 

“readily retrievable” log or controlled 

substance record. 

See §893.07, F.S.- Records

DEA: Theft And Loss Reporting 

You must report thefts or other losses of 

controlled substances or records promptly to 

the DEA. 

Completing DEA Form-106 is required in such 

cases.

DEA Form-106 Report of Theft or 

Loss of Controlled Substances 


U.S. Food and Drug 

Administration

Food, Drug, & Cosmetic Act 

Under the FD&C section of Title 21 of the 

United States Code, the FDA’s Center for 

Veterinary Medicine has been given the 

authority to govern the manufacture, 

distribution, and use of veterinary drugs that 

are distributed between states. 

The Federal Code also gives the FDA the 

authority to write regulations on how it will 

enforce the FD&C Act. Those regulations are 

contained in the Code of Federal Regulations 

Title 21.

The Food and Drug 

Modernization Act of 1997 

Signed into law in November of 1997 and fully 

enacted in April of 1999, the Act (among many 

other things) called for: 

A reduction in the time for the approval of new 

pharmaceutical drugs. 

Relaxed medical device regulations. 

Restricted the advertising of compounded 

drugs, i.e. mixtures made up by pharmacists. 

This provision was overturned by the US 

Supreme Court in 2002 on grounds of freedom 

of speech.

Obtaining Approval: New 

Animal Drug Applications 

Section 512 of the FD&C Act outlines the rules 

that govern the safety and efficacy of new 

animal drugs. 

The Code of Federal Regulations (CFR) 

details the requirements of submissions 

demonstrating the safety and efficacy of a drug 

before approval can be granted. 

The new animal drug approval (NADA) 

process is extremely complicated and has so 

far proved a very effective safeguard.

Extra-Label Drug Use (ELDU) 

"Extra-label use" is defined as: 

"Actual use or intended use of a drug in an 

animal in a manner that is not in accordance 

with the approved labeling. This includes, but 

is not limited to, use in species not listed in the 

labeling, use for indications (disease and other 

conditions) not listed in the labeling, use at 

dosage levels, frequencies, or routes of 

administration other than those stated in the 

labeling, li and deviation from labeled l withdrawal 

time based on these different uses."

Extra-Label Drug Use 

Under the provisions of the Animal Medicinal 

Drug Use Clarification Act of 1994, the FDA 

recognizes the professional judgment of 

veterinarians, i and allows the extra-label l use of 

drugs by veterinarians under certain conditions 

(21 CFR 530). 

Any drug used in an extra-label manner is by 

definition a prescription p drug since the 

involvement of a veterinarian is required. 

Extra-label use of drugs may only take place 

within the scope of a valid veterinarian-client- 

i t 

patient relationship (VCPR)


In the absence of a 

valid VCPR, if an 

approved new animal 

drug is used for a use 

for which it is not 

labeled, such use has 

caused dthe drug to be 

deemed unsafe and 

therefore adulterated 

under the Act (21 

U.S.C. 351(a)(5)).


The FDA has taken legal action against 

veterinarians who were responsible for 

creating violative drug tissue residues in the 

human food supply, especially when these 

were the result of drugs used contrary to label 

instructions. 

Nevertheless, extra-label drugs used in 

treating food-producing animals may be 

considered by a veterinarian when the health 

of animals is immediately threatened and 

suffering or death would result from failure to 

treat the affected animals.

Labeling of drugs prescribed 

for extra-label use 

At a minimum, the following label information is recommended: 

1. The name and address of the prescribing veterinarian. 

2. The established name of the drug (active ingredient), or if 

formulated from more than one ingredient, the established 

name of each ingredient. 

3. Any directions for use specified by the practitioner (including 

class/species or identification of the animals; dosage, 

frequency, and route of administration; and, duration of 

therapy). 

4. Any cautionary statements specified by the veterinarian. 

5. The veterinarian's specified withdrawal/discard time(s) for 

meat, milk, eggs, or any food which h might be derived d from 

the treated animals.

Drugs Prohibited for Extra- 

Label Use in Food Animals: 

Chloramphenicol; Sulfonamide drugs in 

Clenbuterol; 

lactating dairy cattle 

(except approved use 

Diethylstilbestrol 

of sulfadimethoxine, 

(DES); 

sulfabromomethazine, 

Dimetridazole; 

and 

 

Ipronidazole; 

sulfaethoxypyridazine); 

i Other nitroimidazoles; Fluoroquinolones; 

 

Furazolidone; 

 

Phenylbutazone in 

Nitrofurazone; 

female dairy cattle 20 

months of age or older. 

 

Glycopeptides;

Compounding Under 

AMDUCA 

Animal Medicinal Drug Use Clarification Act 

The extra-label drug use regulation also 

provides for the legal compounding of animal 

drugs from approved animal drugs and 

approved human drugs. The compounding 

must be in compliance with the provisions of 

this regulation. The regulation provides 

additional requirements for extra-label 

compounding (21 CFR 530.13). 

The extra-label drug use regulation does not 

allow for legal l animal drug compounding from 

active pharmaceutical ingredients (bulk drugs).

Human-Label Drug Products 

Veterinarians, as licensed health professionals, 

must have the right to purchase or prescribe 

human-labeled prescription drugs and to use them 

according to their best medical judgment in 

compliance with relevant laws and regulations. 

The FDA has confirmed that manufacturers may 

legally sell human-labeled prescriptions drugs to 

veterinarians upon their order. 

Veterinarians have full responsibility when using 

human-labeled prescription products in the 

treatment of animals, and must recognize that 

manufacturers cannot promote the sale of those 

products to veterinarians.

Adulterated Drugs 

Under Section 301 of the FD&C Act, the 

introduction or delivery into interstate commerce 

of any food, drug, device, or cosmetic that is 

adulterated is prohibited. 

Section 501 of Title 21 defines what constitutes an 

adulterated drug. 

Simply stated, drugs that contain unsanitary 

components, lack adequate control in 

manufacture, differ in strength th from that 

t 

recognized in the official compendium, or that are 

mixed with another substance to reduce their 

quality or strength are considered to have been 

adulterated.

Compounding 

The Federal Food, Drug, and Cosmetic Act (the 

Act) does not distinguish compounding from 

manufacturing or other processing of drugs for 

use in animals. 

FDA acknowledges the use of compounding 

within certain areas of veterinary practice. 

The current state of veterinary medicine requires 

products to treat many conditions in a number of 

different species, some of which are known to 

have unique physiological characteristics. 

Furthermore, FDA regulations specifically permit 

the compounding of products from approved 

animal or human drugs under the conditions set 

forth in 21 CFR 530.13.

Compounding 

However, the FDA is 

greatly concerned 

about veterinarians and 

pharmacies that are 

engaged in 

manufacturing and 

distributing unapproved 

new animal drugs in a 

manner that is clearly 

outside the bounds of 

traditional pharmacy 

practice and that 

violates the Act

Compounding 

With regard to compounding from bulk drug 

substances, two Federal Appeals Court 

decisions, United States v. Algon Chemical 

Inc., 879 F.2d 1154 (3d Cir. 1989) and United 

States v. 9/1 Kg. Containers, 854 F.2d 173 (7th 

Cir. 1988), affirmed the FDA position that the 

Act does not permit veterinarians to compound 

unapproved finished drug products from bulk 

drug substances, unless the finished i drug is 

not a new animal drug. 

The principle established by the court applies 

The principle established by the court applies 

equally to compounding by pharmacists.

Compounding 

Neither the Act nor its implementing regulations 

exempt veterinarians or pharmacists from the 

approval requirements in the new animal drug 

provisions of the Act, 21 U.S.C. Section 360b. 

In the absence of an approved new animal drug 

application, the compounding of a new animal 

drug from any unapproved drug or from bulk drug 

substances results in an adulterated new animal 

drug in violation of section 21 U.S.C. Section 

351(a)(5). 

The compounding of a new animal drug from an 

approved human or animal drug also results in an 

adulterated new animal drug in violation of 21 

U.S.C. Section 351(a)(5), unless the conditions 

set forth in 21 CFR 530.13(b) are met.

Compounding 

 

 

Generally, FDA will defer to state authorities regarding g the day- 

to-day regulation of compounding by veterinarians and 

pharmacists of animal and human drugs that are intended for 

use in animals. FDA anticipates that, in such cases, cooperative 

efforts between the states and the Agency will result in 

coordinated investigations, referrals, and follow-up actions by 

the states. 

However, when the scope and nature of activities of 

veterinarians and pharmacists raise the kinds of concerns 

normally associated with a drug manufacturer and result in 

significant violations of the new animal drug, adulteration, or 

misbranding provisions of the Act, FDA has determined that it 

will seriously consider enforcement action.

Compounding 

 

 

The FDA chooses to enforce its “regulatory discretion” and 

“ordinarily” will not take regulatory action when: 

1. A legitimate need is identified. 

2. There is a need for an appropriate dosage regimen for the 

particular species, size, age, or medical condition, and 

3. There is no marketed approved animal drug which, when 

used in conformity with the regulations as set forth 

AMDUCA, may treat the condition diagnosed in the 

available dosage form, or there is some other rare 

extenuating circumstance. 

The FDA places its highest priority on compounding products for 

use in food animals.

Compounding in Florida 

 

Rule 64B16-27.700, F.A.C.- Definition of Compounding: 

“Compounding” is the professional act by a pharmacist or 

other practitioner authorized by law, employing the science 

or art of any branch of the profession of pharmacy, 

incorporating ingredients to create a finished product for 

dispensing to a patient or for administration by a 

practitioner or the practitioner’s agent; and shall specifically 

include the professional act of preparing a unique finished 

product containing any ingredient or device defined by 

Sections 465.003(7) and (8), F.S. 

(1) Compounding includes:

Compounding in Florida 

(a) The preparation of drugs or devices in anticipation of 

prescriptions based on routine, regularly observed prescribing 

patterns. 

(b) The preparation pursuant to a prescription of drugs or 

devices which are not commercially available. 

(c) The preparation of commercially available products from bulk 

when the prescribing practitioner has prescribed the 

compounded product on a per prescription basis and the patient 

has been made aware that the compounded product will be 

prepared by the pharmacist. The reconstitution of commercially 

available products pursuant to the manufacturer’s guidelines is 

permissible without notice to the practitioner. 

(2) The preparation of drugs or devices for sale or transfer to 

pharmacies, practitioners, ii or entities ii for purposes of fdispensing 

i 

or distribution is not compounding.

Section 3 

State t Laws

Chapter 465, F.S. 


Florida Pharmacy Act

§ 465.003, F.S.- Definitions: 

(8) "Medicinal drugs" or "drugs" means those 

substances or preparations commonly known as 

"prescription" or "legend" drugs which are 

required by federal or state law to be dispensed 

only on a prescription, but shall not include 

patents or proprietary preparations as hereafter 

defined. 

d 

(9) "Patent or proprietary preparation" means a 

medicine in its unbroken, original package which 

is sold to the public by, or under the authority of, 

the manufacturer or primary distributor thereof 

and which h is not misbranded d under the provisions 

i 

of the Florida Drug and Cosmetic Act.

§465.0255, F.S.- Expiration date of 

medicinal drugs; display; related use 

and storage instructions: 

ti 

(1) The manufacturer, repackager, or other distributor of 

any medicinal i drug shall display the expiration i date of 

each drug in a readable fashion on the container and on 

its packaging. The term "readable" means conspicuous 

and bold. 

(2) Each pharmacist for a community pharmacy 

dispensing medicinal drugs and each practitioner 

dispensing i medicinal i drugs on an outpatient ti t basis shall 

display on the outside of the container of each medicinal 

drug dispensed, or in other written form delivered to the 

purchaser: 

(a) The expiration date when provided by the manufacturer, 

repackager, or other distributor of the drug; or 

(b) An earlier beyond-use date for expiration, which may be up 

to 1 year after the date of dispensing.

§465.0255, F.S.- Expiration date of 

medicinal drugs; display; related use 

and storage instructions ti (continued): 

The dispensing pharmacist or practitioner must provide 

information i concerning the expiration i date to the purchaser 

upon request and must provide appropriate instructions 

regarding the proper use and storage of the drug. 

(3) This section does not impose liability on the dispensing 

pharmacist or practitioner for damages related to, or 

caused by, a medicinal drug that loses its effectiveness 

prior to the expiration date displayed d by the dispensing i 

pharmacist or practitioner. 

(4) The provisions of this section are intended to notify the 

patient t receiving i a medicinal i drug of the information 

required by this section, and the dispensing pharmacist 

or practitioner shall not be liable for the patient's failure 

to heed such notice or to follow the instructions for 

storage.

Other Pertinent Chap. 465 

Sections: 

§465.026, F.S.: Filling of certain prescriptions 

§465.0276, F.S.: Dispensing practitioner 

§465.035, F.S.: Dispensing of medicinal drugs 

pursuant tto facsimile il of prescription

Chapter 499, F.S.: Drugs, Devices, 


Cosmetics, and Household Products


Cosmetics, and Household Products. 

§499.003(52): "Veterinary yprescription p drug" 

means a prescription drug intended solely for 

veterinary use. The label of the drug must bear 

the statement, "Caution: Federal law restricts this 

drug to sale by or on the order of a licensed 

veterinarian." 

§ 499.006 Adulterated drug or device. --Adrug 

or device is adulterated: 

(11) If it is a prescription drug subject to, defined by, 

or described by s. 503(b) of the Federal Food, Drug, 

and Cosmetic Act which has been returned by a 

veterinarian to a limited prescription drug veterinary 

wholesale distributor.



499.005 Prohibited acts.--It is unlawful for a 

person to perform or cause the performance of 

any of the following acts in this state: 

(14) The purchase or receipt of a prescription 

drug from a person that is not authorized under 

this chapter to distribute prescription drugs to that 

purchaser or recipient. 

(15) The sale or transfer of a prescription drug to 

a person that is not authorized under the law of 

the jurisdiction in which the person receives the 

drug to purchase or possess prescription drugs 

from the person selling or transferring the 

prescription drug.



499.01 Permits: 

(j) A veterinary prescription drug retail 

establishment; 

(k) A veterinary prescription drug wholesale 

distributor; 

(l) A limited prescription drug veterinary 

wholesale distributor

Chapter 828, F.S.: Animals: Cruelty, 

Chapter 828, F.S.: Animals: Cruelty, 

Sales, Animal Enterprise Protection

Chapter 828, Florida Statutes 

Animals: Cruelty, Sales, Animal Enterprise 

Protection. 

§828.05: Killing an injured or diseased domestic 

animal. 

§828.055: Sodium pentobarbital; permits for 

use in euthanasia of domestic animals.

Chapter 828, Florida Statutes 

§828.058: Euthanasia of dogs and cats. 

§828.065: Euthanasia of animals offered for 

sale by pet shops. 

§828.29: Dogs and cats transported or offered 

for sale; health requirements; consumer 

guarantee.– Official certificates of veterinary 

inspection.


Florida Comprehensive Drug Abuse 

Prevention and Control Act.

§893.02 Definitions 

 

"Practitioner" means a physician licensed 

pursuant to chapter 458, a dentist licensed 

pursuant to chapter 466, a veterinarian 

licensed pursuant to chapter 474, an 

osteopathic physician licensed pursuant to 

chapter 459, a naturopath licensed pursuant to 

chapter 462, or a podiatric physician licensed 

pursuant to chapter 461, provided such 

practitioner holds a valid federal controlled 

substance registry number.


 

"Prescription" means and includes an order for drugs or 

medicinal i supplies written, signed, or transmitted by word of 

mouth, telephone, telegram, or other means of communication by 

a duly licensed practitioner licensed by the laws of the state to 

prescribe such drugs or medicinal supplies, issued in good faith 

and in the course of professional practice, intended to be filled, 

compounded, or dispensed by another person licensed by the 

laws of the state to do so, and meeting the requirements of s. 

893.04. The term also includes an order for drugs or medicinal 

supplies so transmitted or written by a physician, dentist, 

veterinarian, or other practitioner licensed to practice in a state 

other than Florida, but only if the pharmacist called upon to fill 

such an order determines, in the exercise of his or her 

professional judgment, that the order was issued pursuant to a 

valid patient-physician relationship, that it is authentic, and that the 

drugs or medicinal supplies so ordered ed are considered ed necessary 

for the continuation of treatment of a chronic or recurrent illness.


Continued… 

However, if the physician writing the prescription is not 

known to the pharmacist, the pharmacist shall obtain 

proof to a reasonable certainty of the validity of said 

prescription. A prescription order for a controlled 

substance shall not be issued on the same 

prescription blank with another prescription order for a 

controlled substance which is named or described in a 

different schedule, nor shall any prescription order for 

a controlled substance be issued on the same 

prescription blank as a prescription order for a 

medicinal drug, as defined in 1 s. 465.031(5), which 

does not fall within the definition of a controlled 

substance as defined in this act.

§893.07: Records 

(3) The record of all controlled substances sold, 

administered, dispensed, or otherwise disposed of 

shall show: 

(a) The date of selling, administering, or 

dispensing. 

(b) The correct name and address of the person 

to whom or for whose use, or the owner and 

species of animal for which, sold, 

administered, or dispensed. 

(c) The kind and quantity of controlled substances 

sold, administered, or dispensed.


(2) The record of controlled substances received 

shall in every case show: 

(a) The date of receipt. 

(b) The name and address of the person from 

whom received. 

(c) The kind and quantity of controlled substances 

received.


(4) Every inventory or record required by this chapter, including 

prescription records, shall be maintained: 

i (a) Separately from all other records of the registrant, or 

(b) Alternatively, in the case of Schedule III, IV, or V controlled 

substances, in such form that t information required by this 

chapter is readily retrievable from the ordinary business 

records of the registrant. 

In either case, records shall be kept and made available for a period 

of at least 2 years for inspection and copying by law enforcement 

officers whose duty it is to enforce the laws of this state relating to 

controlled substances. 

(5) Each person shall maintain a record which shall contain a 

detailed d list of controlled substances lost, destroyed, d or stolen, if 

any; the kind and quantity of such controlled substances; and the 

date of the discovering of such loss, destruction, or theft.

Other Chapter 893 Provisions 

§893.04: Pharmacist and practitioner. 

§893.05: Practitioners and persons 

administering controlled substances in their 

absence. 

§893 055: Prescription drug monitoring 

§893.055: Prescription drug monitoring 

program.

Other Chapter 893 Provisions 

§893.0551: Public records exemption for the 

prescription drug monitoring program. 

§893.06: Distribution of controlled substances; 

order forms; labeling and packaging 

requirements. 

§893.065: Counterfeit-resistant prescription 

blanks for controlled substances listed in 

Schedule II, Schedule III, or Schedule IV.

Rule 64F-12.006, F.A.C.: Drugs and 

Rule 64F 12.006, F.A.C.: Drugs and 

Devices; Labeling Requirements.

Rule 64F-12.006, F.A.C. 

 

(1) The department 

adopts and incorporates 

by reference the labeling 

requirements e e for 

prescription drugs and 

over-the-counter drugs 

as set forth in the 

federal act at 21 U.S.C. 

ss. 301 et seq. and in 

Title 21 Code of Federal 

Regulations Parts 1- 

1299 (as of 10/1/03).

Rule 64F-12.006, F.A.C. 

(a) The label on the immediate container of each 

unit dose repackaged drug product or multiple unit 

prepackaged drug product must contain the 

following: 

1. Brand or generic name, or both; 

2. Strength of drug; 

3. Dosage form; 

4. Manufacturer’s name and lot number or a 

control number if a log is maintained which cross 

references the control number with the 

manufacturer’s name and lot number; and 

5. Expiration date.

Rule 64F-12.006, F.A.C. 

(b) An authorized practitioner dispensing complimentary 

prescription i drugs to his own patients may dispense 

them in the manufacturer’s package which shall also 

include the practitioner’s name, the patient’s name 

and the date dispensed. If complimentary prescription 

drugs are not dispensed in the manufacturer’s labeled 

package, they shall be dispensed in a container which 

bears a label containing the following: 

1. Practitioner’s name and address; 

2. Patient’s name; 

3. Date dispensed; 

4. Name and strength of drug; 

5. Directions for use; and 

6. Expiration date.

Rule 64F-12.006, F.A.C. 

(c) A Veterinary Legend Drug Retail establishment shall 

attach a label l to the original, i sealed manufacturer’s 

container in a manner which leaves the manufacturer’s 

labeling intact and legible, upon the sale of a veterinary 

legend drug to a consumer. The label shall bear the 

following: 

1. Name, address and veterinary legend drug retail 

establishment number; 

2. Prescribing veterinarian’s name; 

3. Name of the animal or kennel name if so authorized; 

4. Date prescription filled or refilled; 

5. Prescription number or other prescription identification 

adequate to readily identify the prescription; p and 

6. Directions for use.

Rule 64F-12.006, F.A.C. 

(2) The department adopts and incorporates by 

reference the labeling requirements for medical 

devices as set forth in the federal act at 21 U.S.C. 

ss. 301 et seq. and in Title 21 Code of Federal 

Regulations Parts 800-895 (as of 10/1/03). 

Note: Title 21 Code of Federal Regulations Parts 

800-895 contain the specific regulations governing 

medical devices. The requirements include 

labeling, premarket approval, registration and 

listing, medical device reporting, in vitro diagnostic 

labeling, investigational devices exemptions, and 

device classifications.

Wrap Up 

Questions?

END OF PRESENTATION 



1408 N. Piedmont Way 

Tallahassee, FL. 32308 

(850) 385-1314 

e.bayo@gfblawfirm.com

The Laws and Rules 

Governing the Practice of 

Veterinary Medicine and 

Disciplinary Actions 



2022-2 2 Raymond Diehl Rd 

Tallahassee, FL 32308 

(850) 385-1314 


The Sources 

Chapter 474, Florida Statutes: Veterinary Medical 

Practice Act 

Grants the Board of Veterinary Medicine the authority 

to promulgate rules, including standards of practice, 

and provides the grounds for disciplinary action 

against a licensed veterinarian. 

i 

Rule 61G18, FL Administrative Code: 

Contains all the rules promulgated by the Board of 

Veterinary Medicine, including grounds for disciplinary 

proceedings and disciplinary guidelines.

The Sources 

Chapter 455, Florida Statutes: 

Establishes the authority and procedures to conduct 

an investigation and disciplinary action. Provides 

general grounds for disciplinary action against all 

DBPR licensees 

Chapter 828, Florida Statutes: 

Animals: Cruelty, Sales, Animal Enterprise Protection 

§828.29 Dogs and cats transported or offered for 

sale; health requirements; consumer guarantee.– 

Official certificates of veterinary inspection.

The Sources 



Chapter 465, F.S.: Florida Pharmacy Act. 

Chapter 893, F.S.: Florida Comprehensive 

Drug Abuse Prevention and Control lAct. 

Rule 64F-12.006, F.A.C.: Drugs and Devices; 

Labeling Requirements.

Common Causes for 

Disciplinary Action 

Found in Chp. 475, F.S., Chp. 455, F.S., and Rule 

61G18-30.001, F.A.C. 

Include: 

Inadequate Record Keeping 

Knowingly employing unlicensed persons in the 

practice of veterinary medicine. 

i 

Knowingly operating a veterinary establishment 

or premises without a valid premise permit. 

Having a license to practice veterinary medicine 

revoked, suspended, or otherwise acted against, 

including the denial of licensure, by the licensing 

authority of another state, territory, or country.



 

 

 

Being convicted or found guilty, regardless 

of an adjudication, of a crime in any 

jurisdiction which directly relates to the 

practice of veterinary medicine or the ability 

to practice veterinary medicine. 

Practicing with a revoked, suspended, or 

inactive license. 

Being unable to practice veterinary medicine 

with reasonable skill and safety to patients 

t 

by reason of illness, drunkenness, use of 

drugs, narcotics, chemicals, or any other 

material or substance or as a result of any 

mental or physical condition.



Knowingly gymaintaining a professional connection or 

association with any person who is in violation of the 

provisions of Chapter 474, F.S., or the rules of the 

Board. 

Paying or receiving kickbacks, rebates, bonuses, or 

other remuneration for receiving a patient or client or 

for referring a patient t or client to another provider of 

veterinary services or goods. In construing this 

section, the Board shall deem that a referral to an 

entity with which the veterinarian has a contractual 

relationship, for the sale of non-veterinary, non- 

medical pet food or pet supplies, does not constitute a 

kickback, so long as the client is aware of the 

relationship.



Engaging in fraud in the collection of fees from 

consumers or any person, agency, or 

organization paying fees to practitioners. 

Fraud, deceit, negligence, incompetency, or 

misconduct in the practice of veterinary 

medicine. 

Being convicted of a charge of cruelty to 

animals. 

Performing or prescribing unnecessary or 

unauthorized treatment.



Being guilty of incompetence or negligence by failing 

to practice veterinary medicine with that level of care, 

skill, and treatment which is recognized by a 

reasonably prudent veterinarian i as being acceptable 

under similar conditions and circumstances. 

Failing to keep the equipment and premises of the 

business establishment in a clean and sanitary 

condition or having a premise permit suspended or 

revoked pursuant to Section 474.215, F.S. 

Refusing to permit the Department to inspect the 

business premises of the licensee during regular 

business hours.



Using the privilege of ordering, prescribing, or making 

available medicinal drugs or drugs defined in Chapter 

465, F.S., or controlled substances as defined in Chapter 

893, F.S., for use other than for the specific treatment of 

animal patients for which there is a documented 

veterinarian/client/patient relationship. 

Violating any of the requirements of Chapter 499, F.S., 

the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301- 

392, the Federal Food, Drug, and Cosmetic Act; 21 

U.S.C. ss. 821 seq., the Comprehensive Drug Abuse 

Prevention and Control Act of 1970, more commonly 

known as the Federal Drug Abuse Act; or Chapter 893, 

F.S. 

The list goes on…

Disciplinary Process 

§455.225, F.S., Disciplinary proceedings: 

A complaint is legally sufficient if it contains ultimate 

facts that show that a violation of this chapter, of any of 

the practice acts relating to the professions regulated 

by the department, or of any rule adopted by the 

department or a regulatory board in the department 

has occurred. 

The department may investigate an anonymous 

complaint if the complaint is in writing and is legally 

sufficient, if the alleged violation of law or rules is 

substantial, and if the department has reason to 

believe, after preliminary inquiry, that the violations 

alleged in the complaint are true. 

Division of Regulation: enforcement authority for 

the professional boards and programs.

Important: 

When an investigation i i of any subject is 

undertaken, the department shall promptly furnish 

to the subject or the subject's attorney a copy of 

the complaint or document that resulted in the 

initiation of the investigation. 

The subject may submit a written response to 

the information contained in such complaint or 

document within 20 days after service to the 

subject of the complaint or document. The 

subject's written response shall be considered 

by the probable cause panel.

Important: 

Upon completion of the investigation i i and pursuant 

to a written request by the subject, the department 

shall provide the subject an opportunity to inspect 

the investigative file or, at the subject's expense, 

forward to the subject a copy of the investigative file. 

The subject may file a written response to the 

information contained in the investigative file. 

Such response must be filed within 20 days, 

p y , 

unless an extension of time has been granted by 

the department.

Important: 

When its investigation is complete and legally sufficient, the 

department shall prepare and submit to the probable cause 

panel of the appropriate regulatory board the investigative 

report of the department. The report shall contain the 

investigative findings and the recommendations of the 

department concerning the existence of probable cause. 

The determination as to whether probable cause exists shall 

be made by majority vote of a probable cause panel of the 

board, or by the department, as appropriate. 

All proceedings of the panel and all documents and 

information obtained during an investigation are confidential 

only until an investigation ceases to be active. An 

investigation ceases to be active when the case is dismissed 

without a finding of probable cause or 10 days after probable 

cause is found.

Important: 

 

In lieu of a finding of probable cause, the probable 

cause panel, or the department when there is no 

board, may issue a letter of guidance to the 

subject. 

If the probable bl cause panel finds that t probable 

bl 

cause exists, it shall direct the department to file a 

formal complaint against the licensee.

Final Agency Action 

§ 455.225(6), F.S.: : The appropriate board, with those 

members of the panel, if any, who reviewed the 

investigation pursuant to subsection (4) being 

excused, or the department when there is no board, 

shall determine and issue the final order in each 

disciplinary case. Such order shall constitute final 

agency action. Any consent order or agreed 

settlement t shall be subject to the approval of the 

department.

What can the Board do to 

you for a violation? 

Range of Penalties: 

Denial of an application for licensure. 

Revocation or suspension of a license. 

Imposition of an administrative fine not to exceed 

$5,000 for each count or separate offense. 

Issuance of a reprimand. 

Placement of the licensee on probation for a period 

of time and subject to such conditions as the board 

may specify. 

Restriction of the authorized scope of practice by the 

licensee. 

Also: Aggravating and Mitigating Circumstances

Emergency suspension, restriction, 

or limitation of a license: 

If the agency finds that immediate serious danger to 

the public health, safety, or welfare requires 

emergency suspension, restriction, or limitation of a 

license, the agency may take such action by any 

procedure that is fair under the circumstances 

Example of such a situation: Being arrested for a 

crime pertaining to substance abuse of diversion.

What is the best way to avoid 

legal and disciplinary problems? 

Become familiar 

with the laws and 

rules. 

Renew your license 

and keep up with 

your continuing 

education. 

Respond (timely) to 

any notice from the 

Board.

END OF PRESENTATION 



2022-2 Raymond Diehl Rd 

Tallahassee, FL 32308 

(850) 385-1314

Dispensing Legend Drugs

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