CVM MEMO
CVMM-10
VETERINARY RX DRUGS-THEIR ILLEGAL SALE
FOOD AND DRUG ADMINISTRATION,
CENTER FOR VETERINARY MEDICINE
COMMUNICATIONS AND EDUCATION BRANCH,
HFV-12,
301/594-1755
DHHS Pub. No. (FDA) 95-6012
Revised January 1995
U.S. Department of Health and Human Services
Public Health Service
Food and Drug Administration
7500 Standish Place, HFV-12, Rockville, Maryland 20855
What's the Difference Between Veterinary "OTC" and "Rx" Drugs?
Animal over-the-counter (OTC) drugs may be obtained by the layman from a large number of distributing outlets and may be sold and purchased without a prescription or other order from a licensed veterinarian. OTC drugs must be labeled clearly with "adequate directions for use," which means the directions enable the layman to use the drug "safely and for the purposes for which it is intended." Adequate directions include:
Statements of all conditions, purposes, uses for which the drug is intended (but may not refer to conditions, uses, or purposes for which the drug can be used safely only under the supervision of a veterinarian).
Quantity (dosage) of drug to be used.
Frequency and duration of administration or application, including appropriate withdrawal period if indicated for food-producing animals.
Time of administration or application.
Route or method of administration or application.
Preparation for use.
As with all drug products, users must READ THE LABEL and follow directions carefully.
Veterinary Rx (prescription or other order) drugs, on the other hand. may be used only by or on the order of a licensed veterinarian, since adequate directions for their use by a layman cannot be written. One of the common reasons for assigning an Rx status to a drug is the difficulty of diagnosing the disease to be treated by it. In some cases, using these drugs properly is so complex that the layman would not have the necessary expertise to use them without help or supervision from a veterinarian. Generally, Rx drugs are quite potent and may be hazardous because of a narrow safety margin or because they possess a potential for misuse and harmful side effects. They often bear serious warnings on the labeling. Because of these characteristics, Rx drugs may be sold to the animal owner for animal use only after a veterinarian has diagnosed the health problem and prescribed or ordered the drug and has given his client appropriate instructions.
What Regulations Deal with "Rx" Drugs?
Section 502(f)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) requires that drug labeling contain adequate directions for use. However, since not all animal drugs can be labeled with adequate directions for lay use, regulations have been promulgated in section 201.105 of the Code of Federal Regulations (by authority of section 502(f)(1) of the Act) which establish a category of animal drugs--Rx drugs--that are exempt from the adequate-directions-for-use requirement. The regulation stipulates that such drugs must: (a) be in the possession of a person lawfully engaged in the manufacture, transportation, storage, or distribution of veterinary drugs; (b) be sold only to or on the prescription or other order of a licensed veterinarian for use in his practice; and (c) bear the statement "Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian," thus providing safeguards against misuse of potentially dangerous products.
Selling animal Rx drugs directly to a layman for treating animals without a prescription or other order from a licensed veterinarian is a violation of the Act, and thus a Federal offense. Those individuals distributing such drugs must be licensed or registered as required by State laws.
Is There a Problem with Illegal Sale of Animal Rx Drugs?
The Food and Drug Administration (FDA) continues to receive reports from veterinarians, industry, consumers, and others of illegal animal prescription drug sales. Due to the public health hazards that could occur as a result of such illegal sales, FDA has an active investigative program to deal with violators. FDA investigations have resulted in seizures of illegal drugs and Federal court injunctions. Violators are also subject to prosecution. The first offense usually constitutes a misdemeanor; conviction carries a penalty of a $1,000 fine and/or 1 year in prison on each count. The second offense may constitute a felony with penalties up to $10,000 in fines and/or up to 3 years in prison on each count. However, under the Criminal Fine Enforcement Act of 1984, fines for crimes under federal laws are increased up to $250,000 for individuals and $500,000 for corporations for each offense.
What Harm Can Come from Misuse of the Rx Drugs?
Indiscriminate use or improper administration of animal Rx drugs by laymen may result in injury to farm animals or pets.
Human health may be endangered when the drugs are used improperly and result in illegal residues in animal derived foods (meat, milk, and eggs). Under the Act, illegal drug residues in these foods cause them to be adulterated. At times, illegally distributed and potentially dangerous animal drugs may have been used by humans on themselves and others.
How is FDA Handling the Problem?
FDA conducts surveillance programs to uncover illegal distributors and investigates reports of illegal sales of animal Rx drugs from veterinarians, veterinary medical associations, drug firms, consumers, and others to determine the extent and nature of the violations. Followup investigations of some tissue residue violations have uncovered illegal Rx drug distribution. Detention Notices may be issued when Rx drugs are offered for import into the United States to laymen.
What Can Drug Distributors Do to Alleviate the Problem?
Wholesalers and retailers of animal drug products should be extremely careful that animal Rx drugs are distributed only to authorized persons. Distributors should be appropriately licensed as State or local laws require. Animal Rx drug sales to lay individuals may be made only on the bona-fide prescription or other order of a licensed veterinarian. When selling by catalog to practitioners, evidence of proper State licensing of the practitioner should be required. Firms distributing drugs by mail order should advertise which products are Rx and require purchasers to submit a veterinarian's prescription or order with their Rx purchase orders.
What Can Veterinarians Do about the Problem?
To protect themselves and their clients, veterinarians should take steps to assure their instructions will be followed, especially when they prescribe or recommend drugs for food-producing animals that require a preslaughter withdrawal period. Directions and cautionary statements, including withdrawal statements, in the drug labeling should be included on the prescription or order.
While these are not FDA requirements, some precautionary measures veterinarians may take are:
Warn clients to read and follow withdrawal information on labels when recommending use of an over-the-counter drug.
Require a signed statement from clients indicating they were given proper drug withdrawal time instructions.
Refuse to prescribe or dispense any drug unless they have first hand knowledge of the animal's condition.
Refuse permission for repeated refills of a prescription if they feel the drug may be misused.
As a matter of professional policy and ethics, veterinarians may refuse services to anyone who fails to follow their instructions.
Because the illegal sale and use of animal Rx drugs reflects badly on their profession, practitioners should report incidents involving such sale and use of animal Rx drugs to FDA, State, or local authorities.
How and Where May Complaints Be Filed?
Concerned citizens who wish to protect themselves and their neighbors from public health hazards resulting from the illegal distribution, sale, and use of animal Rx drugs should report such activities to the nearest FDA office. FDA offices are listed under "United States Government" in the telephone directories of the cities where they are located. If there is no FDA office in your city, call or write the Center for Veterinary Medicine, Division of Compliance, Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, (301) 594-1726.
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