Legal Requirements of Using Pharmaceuticals in Florida

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Legal Requirements of Using Pharmaceuticals in Florida

Postby malernee » Fri Oct 13, 2006 7:03 am

Legal Requirements of Using Pharmaceuticals (VET-638, VET-639)
Western Veterinary Conference 2004
Alistair I. Webb
College of Veterinary Medicine, University of Florida
Gainesville, FL, USA


To provide information of handling of controlled and legend drugs so as to comply with federal requirements mandated by FDA and DEA.

To provide material that meets the State of Florida's Pharmacy CE requirements.

Key Points

Purchasing, prescribing and dispensing of controlled drugs are overseen by the Drug Enforcement Administration [DEA] who divide drugs into 5 schedules based on potential for abuse and current use in medical practice.

DEA requires records of all dealing involving controlled drugs be kept for possible inspection for a minimum of 2 years.

The Food and Drug Administration [FDA] through its Center for Veterinary Medicine controls the registration of drugs as well as their manufacture and distribution.

The Animal Medical Drug Clarification Act [AMDUCA] legalized the extralabel use of drugs by veterinarians within a valid veterinarian-client-patient relationship. In companion animals the prime criteria is animal safety and becomes the veterinarian's responsibility.

Extra-label use of drugs in food producing animals is more restricted requiring more structured criteria of when it can occur and what drugs can be used. Records regarding the extra-label use have to be maintained for 2 years and be available for possible inspection by FDA.

There are drugs prohibited from used in food producing animal and they include chloramphenicol, clenbuterol, diethylstilbestrol, nitroimidazoles, nitrofurans, sulfonamides, and glycopeptides. Also the extralabel use of fluoroquinolones is prohibited [they are currently only labeled for treatment of respiratory disease in adult beef cattle and for control of mortality from E. coli in chickens and turkeys].


A "valid veterinarian-client-patient relationship" is the core of legal and ethical use of drugs-both legend and controlled. When dispensing or prescribing any drug, a veterinarian should ensure he/she is acting within the elements of a valid relationship. This was initially defined by the AVMA but has more lately been codified in the Federal Regulations. A valid veterinarian-client-patient relationship exists when:

The Veterinarian is responsible for medical judgments on the health and treatment of the animal(s) and the client (owner/agent) agrees to follow the veterinarian's instructions.

Through physical examination of the animal(s) and/or medically appropriate and timely visits to the premises where the animals(s) are kept, the Veterinarian is sufficiently knowledgeable of the animal(s) to make a general or preliminary diagnosis of the medical problem.

The veterinarian is readily available for follow-up in case of adverse reactions or failure of the regimen of therapy.

Such a relationship can exist only when the veterinarian has recently seen and is personally acquainted with the keeping and care of the animal(s) by virtue of examination of the animal(s), and/or by medically appropriate and timely visits to the premises where the animal(s) are kept.

There are a number of laws that control how veterinarians use drugs in the practice of their profession. These originate from both Federal and State legislatures with the state laws often mirroring the federal laws. However, where there are differences, you must follow the law with the higher standard. The laws encompass (a) Drug abuse prevention and control, (b) Regulation of food, drugs and cosmetics, and (c) Conduct of veterinary practice. The latter is a State of Florida law only.

Controlled Substances

Although supported by almost identical Florida laws, the Drug Enforcement Administration (DEA) is the primary federal law enforcement agency charged with the responsibility of supervising the Controlled Substances Act through a system of classification and licensing.


Drugs and chemicals with abuse potential are classified into five schedules based on potential for abuse and their use in medical practice in the USA.

Schedule I--these have a high potential for abuse1 and no currently accepted medical use in treatment in the United States. Examples include opium derivatives such as heroin and codeine methylbromide, as well as hallucinogenic substances (marijuana, LSD, THC, peyote, mescaline), and stimulants/depressants such as methaqualone and methylamphetamine. These drugs are not available to clinicians.

Schedule II--thisincludes drugs available for medical use in the United States but which have a high potential for abuse which may lead to severe psychological or physical dependence. Included in this category are opium itself, morphine, codeine, fentanyl, hydromorphone, methadone, meperidine, oxycodone, and oxymorphone. Etorphine hydrochloride and carfentanil are included but are in a subclass restricted to use in the restraint of wild and zoo animals. Also included are stimulants such as cocaine, phencyclidine, amphetamine, methamphetamine as well as methylphenidate. The short acting barbiturates, amobarbital, pentobarbital, and secobarbital are included here also.

Schedule III--thesehave less abuse potential than the drugs in Schedules I and II. They are accepted in medical practice in the United States but their abuse can still lead to moderate to low physical dependence or high psychological dependence. Drugs included in this schedule are the ultrashort-acting barbiturates [thiopental]. Also included are stimulants such as phenmetrazine, ketamine and Telazol®. Additional preparations are those containing limited quantities of narcotic drugs along with nonnarcotic drugs. [acetaminophen with hydrocodone (Hycodan®), with codeine (Tylenol #3®), and with oxycodone (Tylox® and Percocet®)]. Anabolic steroids are also included in this schedule. Buprenorphine, a partial mu opioid agonist, was added here last year.

Schedule IV--drugs in this schedule IV have still lower potential for abuse. Included are products such as phenobarbital, chloral hydrate, meprobamate, and the benzodiazepines (chlordiazepoxide, diazepam, and midazolam), and opioid agonist/antagonists such as butorphanol and pentazocine.

Schedule V--drugs in schedule V have the lowest potential for abuse of those scheduled as controlled drugs. Include are mixtures containing small concentrations of narcotic drugs diluted by nonnarcotic active ingredients. These are antitussive and antidiarrheal medications. Diphenoxylate hydrochloride with atropine sulfate (Lomotil®), Robitussin A-C® syrup, and Actifed-C® expectorant are examples.


The prime requirement of the controlled drug laws is that anyone who manufactures, distributes, or dispenses a controlled substance must register with the DEA. Although the DEA's clinically relevant regulations have been written primarily to cover physicians, pharmacists, and human hospitals, veterinarians are treated no differently than professionals from other medical fields.2 Registration is for three years at a time with a current fee of $210. The certificate of registration is issued for that particular place of business and must be kept at that site. Any additional places of business where controlled drugs are stored require separate registration.

Practitioners must be licensed in the states where they are practicing and have a valid DEA registration to order controlled substances from distributors. No special form is needed for orders of drugs in Schedules III, IV, and V, however in Schedule II, drugs must be ordered with the DEA's own form (Form DEA-222) which is pre-printed with the registrant's name and address. Suppliers of any controlled drugs will require proof of your State and DEA registration.

Record Keeping

Schedule II Drugs: All records for Schedule II drugs must be kept separate from all other data. These records, required to be kept for two years, consist of records of receipt of all shipments and details of the disposition of those drugs. MINIMALLY - annotated as received carbons of the DEA's order form (DEA-222A), and the details of individual dispensings (client's name, date, species, dose administered). It is important that the administration of ALL scheduled drugs is included in the medical record as it may act as proof of administration in the event of an inquiry.

Schedules III-V: A log must be kept of all deliveries (best to keep packing slip endorsed to show verified receipt and date). Individual details of drug disposition must be kept separately as for Schedule II or be "readily retrievable from ordinary business records." These data must be kept two years as well. The basic difference through schedules III through V is of decreasing penalties for criminal offenses with no difference in record keeping or storage requirements.

Biennial Inventory: Starting on the date DEA registration is received, a complete and accurate inventory of all controlled drugs on hand must be taken and repeated at least every two years. The inventory should have Schedule II items listed separately from other controlled drugs. These lists must include your name. DEA number, the address where the inventory was performed and be signed & dated. It should be kept for at least two years and must be produced to a DEA officer on demand.

Dispensing: When dispensing for clients to administer at home, you must ensure that the drug is adequately labeled with your name, address & phone #; name of the owner & species of patient; dispensing & expiry dates; directions for use; and a warning drug must not be transferred to another patient. You should also use a childproof container unless specifically requested otherwise. Finally, when the drug is dispensed, do not forget to subtract it from inventory/records. The transfer of any controlled substance requires formal record keeping--an individual practitioner can deliver or transfer a controlled drug to another registrant as long as records are kept of the transaction. Since most veterinary practitioners do not administer or dispense large quantities of controlled substances, their activities generally are under less close governmental scrutiny although in recent years they have become a target beak-ins. If a theft or break-in occurs, it must be reported to both the police and the DEA. One rule in Florida that many practitioners seem unaware about is that once drugs are dispensed and leave your premises that cannot be returned and re-dispensed. This applies even if the packaging seems unopened.

Disposal: Despite the Act, the regulations are not clear here but do give individual DEA Offices power to establish local practices. To dispose of controlled substances you need DEA permission--Form DEA-41 in triplicate is prescribed for occasional disposals. Several years ago the DEA contracted with a number of companies to act as it's agent in controlled drug collection and disposal--to find you nearest/economic reverse distributor contact your local DEA diversion office. Today it seems that the DEA's position has softened somewhat and they regard drugs that have been dispensed/withdrawn to be of low interest to them and can be destroyed under controlled and witnessed conditions. You must keep records of such disposals.

Prescriptions: Requirements for writing prescriptions for controlled drugs do not vary from standard prescription format. It is mandated by Federal regulations that prescriptions for controlled drugs have the same basic elements as when you are labeling dispensed drugs. The script must be signed, dated and have the prescriber's DEA number. It is recommended that the DEA number be written and not pre-printed. Pharmacists who fill your prescriptions must retain them for two years. Controlled drug prescriptions only have a life of six months and repeats are not allowed for Schedule II drugs but up to five repeats are allowed for Schedules III-V.

Security: Veterinary practitioners who store controlled drugs and substances within their offices, hospitals, or clinics must keep these drugs in securely locked, substantially constructed cabinets or safes. Drug stocks should be kept to a minimum. Access to the storage area should be restricted to an absolute minimum number of authorized employees.

Florida's Veterinary Medicine Practice Act

Florida's practice act has some specific restrictions on veterinarians administering, dispensing or prescribing drugs that can result in disciplinary action if not followed. These include:

failing to keep contemporaneous written medical records

prescribing or dispensing legend drugs inappropriately or in excessive quantities

presigning blank prescription forms

failing to give owners of a patient an option of a written prescription rather than dispensing the drug,

failing to obtain an owner's informed consent when prescribing or dispensing drugs extra-labelly where the intend use is novel, unproven or experimental

Food, Drug & Cosmetics Act

The Food and Drug Administration's Center for Veterinary Medicine [FDA CVM] has been given the authority to govern the manufacture, distribution, and use of veterinary drugs. The Federal Regulations set requirements for drugs to be approved which include demonstrating both efficacy and safety of the drug [to both the patient and humans who come in contact with the drug directly or by eating treated animals]. Once a new animal drug clears this process, the FDA approval identifies the specific conditions for which the drug has been shown to be safe and effective as well as any restrictions for use. This information is part of the label or insert provided with each drug container. Although the same drug may be effective and safe for other uses or perhaps other species, the economics of a limited marketplace often prohibit a pharmaceutical company from performing sufficient additional research to seek wider approval. This fact and others often result in "extra-label" uses of drugs. This is when the drug is administered in a manor not covered by the conditions of the FDA approval--this can mean different doses, routes of administration, indications and species. Such use used to be illegal but is now permitted for treatment of disease and/or pain but only to veterinarians acting within the confines of a valid veterinarian-client-patient relationship. Such use by laypersons or in mediated feed is prohibited. When companion animals are treated the only restrictions are that the drug must be approved by the FDA in man or animals and that the veterinarian is using good clinical judgment. In food producing animals there are a series of requirement that must be met as well as correct record keeping of the decision and the identity of the animals involved. Of course all drug use, label or off-label in any species can be curtailed by FDA if that use is "against the public interest."

Extra-Label Drug Use in Food Producing Animals

Veterinarians are now given considerable latitude in the therapeutic use of animal drugs off-label as long as they inform livestock producers of the appropriate drug withdrawal times for food-producing animals and follow the following steps in deciding what drug and dose to use:.

1. a careful medical diagnosis is made by an attending veterinarian within the context of a valid veterinarian-client-patient relationship;

2. a determination is made that there is no marketed drug (a) specifically labeled to treat the condition diagnosed, or (b) clinically ineffective in the animals to be treated

3. procedures are instituted to assure that identity of the treated animals is carefully maintained;

4. a significantly extended time period, supported by appropriate scientific information, is assigned for drug withdrawal prior to marketing meat, mild, or eggs and steps are taken to assure that the assigned time frames are met, and no illegal residues occur;

5. a drug approved for animals should always be used where possible before considering use of a human-labeled drug;

6. records are to be maintained by the veterinarian for a minimum of two years documenting that the above steps were observed.

Despite this ability to use drugs off label there are drugs where extra-label use in food producing animals is prohibited. The FDA considers this area to be of major regulatory priority and has demonstrated both the will and desire to prosecute offenders. The drugs currently in that list are: chloramphenicol, clenbuterol, diethylstilbestrol, nitroimidazoles, nitrofurans, sulfonamides, fluoroquinolones, and glycopeptides. The FDA has reserved the power to add to that list and has recently done so in the addition of the last two antibiotic groups.

There is a lot of concern at the extent of antibiotic use by both the medical and veterinary professions as well as the use of antibiotics as growth promotants. Veterinarians need to be aware of the latest guidelines about prudent usage and exercise restraint in using newer drugs that have potential of significant application in humans.


All aspects of using drugs of abuse potential in veterinary practice is controlled by the Diversion Service of the DEA. The DEA determines scheduling, storage and record keeping requirements of these drugs. Veterinarians need a DEA registration to have access to drugs like opioid analgesics, barbiturates, and benzodiazepine tranquilizers. Both OTC and legend drugs have to be approved by the FDA and their manufacturing, labeling and distribution are regulated by that agency. Condition for and record keeping for extralabel use of drugs in food producing animals is set by federal law [AMDUCA]. Records required by both agencies have to be kept for 2 years.


1. potential for abuse is defined in the regulations as having properties of CNS stimulation, depression, or hallucination that creates a substantial likelihood of its being:

a. used in amounts that create a hazard in the user's health or the safety of the community

b. diverted from legal channels and distributed through illegal channels

c. taken on the user's own initiative rather than on the basis of professional advice

2. The Florida statutes specifically enable veterinarians to dispense controlled drugs and to supervise their administration by un-licensed personnel (term = direct supervision, which equates with responsible supervision rather than "immediate supervision" where the veterinarian's physical presence is mandated)


1. DEA's diversion page

2. FDA Center for Veterinary Medicine

3. AVMA's NOAH web site

4. Veterinary PDA Programs

5. FARAD home page

6. Florida law On-Line

7. Verified Internet Pharmacy Practice Sites

Speaker Information
(click the speaker's name to view other papers and abstracts submitted by this speaker)
Alistair I. Webb, BVSc
Professor, Clinical Pharmacology
University of Florida
Gainesville, FL
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Posts: 462
Joined: Wed Aug 13, 2003 5:56 pm

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