FDA and the Veterinarian

To the Veterinarian:

The Center for Veterinary Medicine (CVM) within the Food and Drug Administration (FDA) helps to ensure the safety of the food supply and assists in providing for the health care needs of animals through the approval and post-approval monitoring of safe and effective animal drugs, medical devices for animals, and oversight of animal feeds. Veterinarians also help to ensure food safety and provide for the health care needs of animals through appropriate and responsible use of FDA-regulated products. Because of the similarities of mission between FDA and veterinarians, this booklet was written to provide a source of information on CVM activities which may be of interest to veterinarians. Our success at CVM depends on the knowledge, abilities and ethics of veterinarians to use FDA-regulated products responsibly within their practice. We hope this booklet will serve as a catalyst for greater communication between CVM and the veterinary profession.

Bernadette M. Dunham, D.V.M., Ph.D.
Director, Center for Veterinary Medicine

The purpose of this publication is to provide information on the laws and regulations enforced by the Food and Drug Administration (FDA) as they relate to veterinary medicine. Under the Federal Food, Drug, and Cosmetic Act (the Act), FDA has the broad mandate to assure safety and effectiveness of drugs (including animal drugs), devices (including veterinary devices), and the safety of the food supply.

Two amendments to the Act expanded the veterinarian’s authority in the area of drug use:

Animal drugs must be safe and effective for their intended use. Section 512 of the Act, the basic statutory provision governing new animal drugs, provides that a new animal drug is unsafe unless it is the subject of an approved new animal drug application and the use of a drug and its labeling conform to the approved application or unless that drug is used for a legal extra-label use by or on the order of a veterinarian (see section 512(a)(4)(A) and 21 CFR Part 530). An unsafe new animal drug is adulterated and subject to the enforcement provisions of the Act. All FDA regulations are codified in Title 21 of the CODE OF FEDERAL REGULATIONS [1]. Parts 500-599 of the CFR specifically address animal drugs and feeds and how to ensure that animal drugs are safe and effective for their intended uses and do not result in unsafe residues in foods from treated animals.

The Food and Drug Administration is responsible for regulating animal drugs, feeds/foods, devices, and most animal health products; however some classes of animal products come under the jurisdiction of other Federal or State government agencies. This is a quick guide to clarify which agency has responsibility for these products.

Germicidal preparations for use on inanimate objects, as well as rodenticides, and most insecticides are subject to the Federal Insecticide, Fungicide, and Rodenticide Act, administered by the Environmental Protection Agency (EPA), Washington, D.C. 20460. However, some products used to control external pests are intended to act systemically and, therefore, are regulated as drugs by the FDA and not as pesticides by the EPA. For example:

FDA is also responsible for enforcing regulations that set the limits of pesticides that are allowed in animal-derived products.

The term “veterinary biologics” includes all viruses, serums, toxins, or analogous products of natural or synthetic origin which are intended for use in the treatment of animals and which act primarily through the direct stimulation, supplementation, enhancement, or modulation of the immune system or immune response. Such products include but are not limited to vaccines, bacterins, allergens, antibodies, diagnostics, antitoxins, toxoids, immunostimulants, antigenic or immunizing components of microorganisms intended for use in the prevention, diagnosis, management or cure of disease in animals. The Veterinary Biologics Staff, Animal and Plant Health Inspection Service, U.S. Department of Agriculture, is responsible for regulating veterinary biologics for purity, safety, potency and effectiveness. Additional information can be found at http://www.aphis.usda.gov/animal_health/vet_biologics/.

FDA regulations which apply to pet foods are published in Title 21, Parts 501, 573, 582, 584, and 589 of the CODE OF FEDERAL REGULATIONS. These regulations are available on the Internet at http://www.gpoaccess.gov/cfr/index.html.

As with human food, pet foods may not be adulterated or misbranded. Pet foods may not contain any poisonous or deleterious substances or residues of pesticides in excess of established tolerances. They may not be stored in any containers which may render the contents injurious to health because of any poisonous or deleterious substance and may not contain any color additives or food additives which are unsafe. To ensure safety, canned pet food must be manufactured and registered in accordance with the FDA regulations for low-acid canned foods. Pet food labeling may not be false or misleading in any particular. Damage or inferiority may not be concealed in any manner. Pet food may not be sold under the name of any other food and may not have any valuable constituents omitted or extracted.

Although pet food products do not need to have premarket approval by FDA, these products are subject to the requirements of the Act and pet food manufacturers are subject to individual annual product registration in most States.

State laws may require that pet food labels bear, in addition to the mandatory information required by Federal law, a label statement of "guaranteed analysis" for minimum protein and fat content, and maximum fiber and moisture content, a nutritional adequacy statement, and feeding directions. Additional information concerning State registration and labeling requirements may be obtained from the individual states where the products will be distributed or from the Official Publication of the Association of American Feed Control Officials, Inc. c/o Sharon Krebs, Assistant Secretary, AAFCO, P.O. Box 478, 104 East McConnell Street, Oxford, Indiana, 47971. AAFCO’s website is http://www.aafco.org/.

Pet foods are also subject to the labeling requirements of the Fair Packaging and Labeling Act, which governs certain aspects of consumer product labeling. AAFCO has developed definitions for certain nutrient content claims, such as "lite" or “light.”

There are currently no requirements for FDA pre-market approval of medical devices intended for animal use. Animal medical devices and diagnostic aids are, however, subject to the general provisions of the Act that relate to misbranding and adulteration. For example, an animal medical device is misbranded if the labeling is false or misleading (21 U.S.C. 352(b)). An animal medical device may be considered misbranded if the labeling fails to bear adequate directions for use by the layperson (21 U.S.C. 352(f)(1)). An animal device is misbranded if it is dangerous to animal or human health when used in the manner prescribed, recommended, or suggested in labeling (21 U.S.C. 352(j)). The FDA relies on veterinarians and other users to report unsafe animal medical devices.

Articles such as screening test kits for drug residues are regulated as animal medical devices. One example of screening tests is the test used to screen milk for the presence of drug residues. As with other animal medical devices, screening tests must bear adequate directions for use, the labeling may not be false or misleading, and the manufacturer should have data adequate to demonstrate that use of the screening kit in accord with label directions will yield consistent and reliable results.

If adequate directions cannot be written for lay use, the animal medical device is deemed unsafe for use except under the supervision of a licensed veterinarian. The FDA, therefore, requires that the label bear the statement: "Caution: Federal law restricts this device to sale by or on the order of a licensed veterinarian" (21 CFR 801.109). Examples of animal medical devices which are required to bear the prescription legend include transcutaneous electronic nerve stimulators, pulse magnetic field devices, and lasers.

The animal counterpart of a cosmetic is commonly referred to as a "grooming aid." The Act defines a cosmetic as pertaining only to human use (21 U.S.C. 321(i)). Therefore, products intended for cleansing or promoting attractiveness of animals are not subject to FDA control. However, if such products are intended for any therapeutic purpose or if they are intended to affect the structure or function of the animal, they are subject to regulation as new animal drugs under the Act.

Under the Act, the term "drug" means articles recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary; articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and articles other than food intended to affect the structure or any function of the body of man or other animals. It also includes articles intended for use as a component of a drug.

Once a product is determined to be a drug for animal use, the next step is to determine whether or not it is a new animal drug. The Act defines a new animal drug (in part) as any drug intended for use for animals other than man, the composition of which is not generally recognized, among experts qualified by scientific training and experience, as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling. By virtue of Supreme Court interpretations of the necessary basis for general recognition, there are, for all practical purposes, no animal drugs which are not also new animal drugs. The Green Book, accessible from the CVM Home Page (http://www.fda.gov/cvm/Green_Book/greenbook.html) contains a searchable database of all FDA-approved animal drugs.

An unapproved new animal drug may be distributed in accordance with 21 CFR Part 511 if the drug will be used for research, i.e., for the collection of data intended to be submitted in support of an NADA approval. Investigational New Animal Drug (INAD) regulations provide that such drugs may be distributed for use only by experts, qualified by scientific training and expertise, to investigate the safety and effectiveness of animal drugs.

Before a new animal drug may receive FDA approval, the sponsor must establish that the new animal drug is safe and effective.

Drug sponsors submit a New Animal Drug Application (NADA) along with supporting data, including all adverse effects associated with the drug's use. The NADA must also include information on the drug's chemistry; composition and component ingredients; manufacturing methods, facilities, and controls; proposed labeling; analytical methods for residue detection and analysis if applicable; an environmental assessment; and other information. The sponsor of a new animal drug is responsible for submitting all appropriate data to establish effectiveness and safety. If the drug product is intended for use in a food-producing animal, residues in food products must also be established as safe for human consumption.

FDA review of the NADA submitted by drug sponsors is very detailed and comprehensive. FDA scientists will determine whether the data have been developed in accordance with either Good Laboratory Practice Regulations or clinical trial guidance. If the studies were conducted properly, the data are evaluated with respect to drug safety and effectiveness. The animal safety data for a drug product must relate to the dosage levels and routes of administration proposed in the labeling. The primary objective is to determine the safety of the product relative to labeled usage.

At the conclusion of the animal safety review, a summary is prepared which explains why the product is safe or not shown to be safe. If the product has been shown to be safe but some restrictions or constraints on use are needed, all warning and precaution statements to be placed on the label must be enumerated and included in the summary, as well as any expected side effects.

All effectiveness data submitted must relate either directly or indirectly to the specific label and labeling claims made for the product. The sponsor must demonstrate that the product produces the claimed effect.

With respect to human food safety, it is the responsibility of the producer or sponsor of the animal drug to furnish FDA with the scientific information and experimental data that demonstrate that the presence of residues of the animal drug in the edible food products of the animal are safe for the consumer of the food product. The term "residues" applies to the parent drug and/or its metabolites. Detailed guidance on the studies required for animal drug approval is available from the Center for Veterinary Medicine (CVM). To assure that human food of animal origin can be monitored for the presence of drug residues, FDA requires sponsors of drugs for food animal use to provide acceptable analytical methods capable of determining and confirming the animal drug or its metabolites in the animal tissue.

FDA is responsible for determining the marketing status (prescription, over-the-counter, or VFD[3]) of animal drug products based on whether or not it is possible to prepare "adequate directions for use" under which a layperson can use the drugs safely and effectively. Prescription (Rx) products can be dispensed only by or upon the lawful written order of a licensed veterinarian. Safe use includes safety to the animal, safety of food products derived from the animal, safety to the persons associated with the animal, and safety in terms of the drug's impact on the environment.

Effective use of a drug product assumes that an accurate diagnosis can be made with a reasonable degree of certainty, that the drug can be properly administered, and that the course of the disease can be followed so that the success or lack of success of the product can be observed.

The same drug substances can be marketed in a number of different dosage forms, intended for use by different routes of administration, and in different species of animals. Thus, these drug products may be appropriately labeled Rx in some cases and OTC in others. Rx products must bear the legend:

"Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian."

Since adequate directions for safe and effective lay use cannot be written for animal prescription drug products, such products can only be sold on the prescription or other order of a licensed veterinarian (Section 503(f)). Prior to being sold or dispensed, they must remain in the possession of a person or firm regularly and lawfully engaged in the manufacture, transportation, storage, or wholesale or retail distribution of animal prescription drug products. The drug products may be distributed only by persons or firms authorized by State and local laws.

Sale (dispensing, shipping, or otherwise making available for use in animals) of an animal prescription drug product to the layperson may be made only by or on the bona fide prescription or other order of a licensed veterinarian. Sale of a animal prescription drug product to a layperson, except on a prescription or on order of a licensed practitioner, causes the product to be misbranded and subjects the seller to civil and/or criminal provisions of the Act.

A licensed veterinarian may legally use or dispense an animal prescription drug product only within the course of his/her professional practice where a valid veterinarian-client-patient relationship [4] exists. Veterinarians employed by drug manufacturers or distributors may not legally dispense prescription drug products to laypersons unless they meet the above criteria. Similarly, practicing veterinarians or their employees may not legally sell animal prescription drug products to walk-in customers unless the same criteria are met. Federal regulations require that drug manufacturers provide at least the following information on the label of the finished package form of animal prescription drug products:

What needs to be included in the veterinarian’s prescription and included on the label of the dispensed product?

Any additional requirements of State or local laws for dispensed animal drug products must also be followed.

To protect themselves and their clients, veterinarians should make efforts to ensure their instructions are followed, especially when they prescribe or recommend drugs for food-producing animals that require a withdrawal period.

Anyone who adds drugs to feed is subject to the Act. Just as each label claim for a new animal drug must be approved, a drug must be specifically approved for administration in animal feed. When the new animal drug application for use of the compound in animal feed is approved, a notice is published in the FEDERAL REGISTER [2]. The medicated feed must be labeled in accordance with the approved labeling.

A drug may only be mixed into feed for uses and at potency levels specifically permitted in the regulations (21 CFR Part 558.) The person or firm mixing a medicated feed containing a category II, Type A medicated article (21 CFR Part 558.4) must be registered with the FDA as a drug manufacturer and hold an approved medicated feed mill license.

It is a violation of the Act for drugs to be added for uses or at levels not specified in the regulations. Any individual authorizing the violation, as well as the individual illegally mixing the feed may be subject to regulatory action. Additionally, the feed itself may be subject to seizure. The agency will ordinarily allow off-label use of drugs in the feed of minor species provided certain conditions are met, including the involvement of a licensed veterinarian. Compliance Policy Guide 615.115 see (http://www.fda.gov/ora/compliance_ref/cpg/cpgvet/cpg615-115.html).

The Animal Drug Availability Act of 1996 (ADAA) amended the Act to establish a new category of drugs, veterinary feed directive (VFD) drugs. A drug intended for use in or on feed, which is limited by an approved application to use under the professional supervision of a licensed veterinarian is a VFD drug. Final regulations covering the use and distribution of VFD feeds (medicated feeds containing VFD drugs) were published in the FEDERAL REGISTER on December 8, 2000.

The VFD process is straightforward in practice. A veterinarian, operating within the confines of a valid veterinarian-client-patient relationship, examines and diagnoses animal conditions and determines whether a condition warrants use of a VFD drug. If it does, the veterinarian will issue a signed VFD containing information specified by regulation. Extra-label use of a VFD drug is not permitted by anyone, including the veterinarian. The veterinarian keeps a copy of the VFD and provides the completed and signed original and a copy to the client. The client keeps the copy and gives the original VFD to the feed manufacturer. The VFD authorizes the VFD feed to be shipped to the client’s animal feeding operation.

Anyone intending to distribute VFD feeds must notify CVM prior to beginning distribution. Distributor includes the VFD feed manufacturer or anyone in the distribution chain who ultimately supplies VFD feed to an animal producer. This could include the veterinarian if he/she is the source of VFD feed. A VFD feed may not be distributed to a client without a signed VFD. However, VFD feed may be sent down the distribution chain if the consignee provides the distributor with a signed acknowledgment letter affirming that it will only ship the VFD feed to a VFD holder or to another distributor who supplies a similar acknowledgment letter.

FDA is responsible for programs and regulatory actions aimed at preventing illegal drug residues in human food products derived from treated animals. (For regulatory purposes, live animals are considered unprocessed food.) Illegal drug residues in edible products can constitute a hazard to the health of persons consuming such food. Failure to observe label withdrawal periods before slaughter or processing, or failure to withhold milk is the principal cause of illegal drug residues. Other causes may include failure to follow other label directions, poor feed manufacturing practices, and human negligence.

FDA is also responsible for ensuring that contaminants of feed origin do not result in unsafe contamination in human food of animal origin. Regardless of the cause, it is FDA's policy to hold responsible any individual in the production and marketing chain who can be shown to have caused (by an act of commission or omission) illegal residues or other contaminants in edible animal products [5]. If a veterinarian prescribes, dispenses, or treats an animal(s) with a drug which results in the occurrence of an illegal drug residue in edible products from the treated animal, the veterinarian may be held responsible for having caused a violation of law.

Additional information on residue avoidance and withdrawal times can be found in the Food Animal Residue Avoidance Databank (FARAD; http://www.farad.org/).

In general, compounding an animal drug from an active pharmaceutical ingredient (bulk drug) is not permitted by the Act unless covered by an approved new animal drug application. This is true even if the compounder is a veterinarian or a pharmacist. However, CVM acknowledges the medical need for compounding may exist within certain areas of veterinary practice. The contemporary practice of veterinary medicine requires products to treat hundreds of conditions and diseases in dozens of species. Business and market realities in the animal health industry can only provide a fraction of products necessary for these indications. Consequently, veterinarians continue to require products to treat diseases or conditions in animals for which no FDA-approved product is available. Veterinarians must by necessity on occasion utilize products that are compounded to meet a specific patient’s medical need. Thus, the agency may exercise its enforcement discretion in not objecting to compounding from bulk drugs under certain conditions. Additional information on the FDA policy regarding animal drug compounding can be found in Compliance Policy Guide, Section 608.400, “Compounding of Drugs for Use in Animals,”
(http://www.fda.gov/ora/compliance_ref/cpg/cpgvet/cpg608-400.html).

Animal drugs may be legally compounded from FDA-approved animal drugs and FDA-approved human drugs if the compounding practices are in conformance with the provisions of the regulation on the Extra-label Use of FDA-approved drugs (See Next Section).

Under the provisions of the Animal Medicinal Drug Use Clarification Act of 1994, the FDA recognizes the professional judgment of veterinarians, and allows the extra-label use of drugs by veterinarians under certain conditions (21 CFR 530). Any drug used in an extra-label manner is by definition a prescription 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-patient relationship (VCPR) [4]. 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 the drug to be deemed unsafe and therefore adulterated under the Act (21 U.S.C. 351(a)(5)).

An approved new animal drug or human drug intended to be used for an extra-label purpose in an animal is not unsafe under the Act (21 U.S.C. 360b) and is exempt from the labeling requirements the Act (21 U.S.C. 502(f)), if such use is by or on the lawful written or oral order of a licensed veterinarian within the context of a valid veterinarian-client-patient relationship and such use complies with the extra-label use regulation (21 CFR Part 530). Extra-label use is limited to circumstances when the health of an animal is threatened, or suffering or death may result from failure to treat. This means that extra-label use to enhance production is prohibited. Extra-label use of drugs may be considered by food animal veterinarians only when:

The following additional conditions must be met for a permitted extra-label use, in food producing animals, of an approved human drug, or of an animal drug approved only for use in animals not intended for human consumption:

Extra-label use of an approved human drug in a food producing animal is not permitted if an animal drug approved for use in food producing animals can be used in an extra-label manner for the particular use.

The prescribed or dispensed extra-label drug (prescription legend or over-the-counter) must bear labeling information which is adequate to assure the safe and proper use of the product.

Because extra-label use of animal and human drugs in nonfood-producing animals (companion, sporting, exotic, etc) does not ordinarily pose a threat to the public health, extra-label use of animal and human drugs is permitted in nonfood-producing animals except where the public health is threatened.

Extra-label use of drugs in treating animals is allowable only by licensed veterinarians within the context of a valid veterinarian-client-patient relationship, and does not include drug use in treating animals by the layman (except under the supervision of a licensed veterinarian).

Lay persons cannot be expected to have sufficient knowledge and understanding concerning animal diseases, pharmacology, toxicology, drug interactions, and other scientific parameters to use drugs in any way other than as labeled.

In addition to uses which do not comply with the provision set forth in Sec. 530.10, the following specific extra-label uses are not permitted and result in the drug being deemed unsafe within the meaning of section 512 of the Act:

FDA may prohibit the extra-label use of an approved new animal or human drug or class of drugs in animals if FDA determines that:

A prohibition may be a general ban on the extra-label use of the drug or class of drugs or may be limited to a specific species, indication, dosage form, route of administration, or combination of factors.

The following drugs are prohibited for extra-label animal and human drug uses in food-producing animals:

The following drugs, or classes of drugs, that are approved for treating or preventing influenza A, are prohibited from extralabel use in chickens, turkeys, and ducks:

Extra-label use of drugs in treating food-producing animals for improving rate of weight gain, feed efficiency, or other production purposes is prohibited under AMDUCA. A drug (including a bulk drug) may not be mixed into feed for any use or at a potency level not specifically permitted by the regulations in 21 CFR Part 558, even if prescribed by a veterinarian.

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 the regulation as presented above. The regulation provides additional requirements for extra-label compounding (21 CFR 530.13).

The extra-label drug use regulation does not allow for legal animal drug compounding from active pharmaceutical ingredients (bulk drugs). This type of compounding is addressed in the previous Section on COMPOUNDING OF ANIMAL DRUGS.

Users of new animal drug products are encouraged to notify the product's sponsor of any unexpected or adverse reactions resulting from the use of that product. Among the data which must be submitted by the sponsor to FDA are reports of injury, toxicity, sensitivity reaction, unexpected incidence or severity of side-effects associated with use, or failure of the drug to exhibit expected pharmacological action. FDA scientists analyze these data to determine if any modifications are needed in the drug's labeling, dosage level, etc., to mitigate future adverse reactions. In extreme instances, the adverse reactions may be so severe as to request withdrawal of approval of the drug.

FDA also encourages veterinarians to report adverse drug reactions directly to the Agency. The reports should be submitted on Form FDA 1932a, Veterinary Adverse Reaction, Lack of Effectiveness, or Product Defect Report. This is a pre-addressed, postage-paid form which is filled out and dropped in the mail by the veterinarian. This form is available at http://www.fda.gov/cvm/adereporting.htm. Copies of the form are also usually available from State veterinary medical associations, clinics of colleges of veterinary medicine, USDA Extension Service veterinarians, and FDA offices. FDA may occasionally need more detailed information about an incident, and the veterinarian may be called by an FDA staff veterinarian.

Adverse reactions may be reported by telephone during normal working hours (7:00 a.m. to 4:00 p.m. Eastern Standard/Daylight Time) by calling 888-FDA-VETS (888-332-8387) or after hours by dialing 888-FDA-VETS (888-332-8387) and leaving a message. In the second case, a message is recorded and the call is returned by a veterinarian the following working day.

Types of FDA Regulatory Actions

The objective of FDA regulatory programs is to assure compliance with the Federal Food, Drug, and Cosmetic Act (the Act). Specific enforcement activities include actions to correct and prevent violations, remove violative products or goods from the market, and punish offenders. The type of enforcement activity FDA uses will depend on the nature of the violation. The range of enforcement activities include issuing a letter notifying the individual or firm of a violation and requesting correction, to criminal prosecution of the individual or firm. Adulteration or misbranding is usually the result of an individual failing to take steps to assure compliance with the law. Such an individual may be liable for a violation of the Act and, if found guilty, be subject to the penalties specified by the law.

Warning Letters - are sent to the individuals or firms, advising them of specific noted violations. These letters request a written response as to the steps which will be taken to correct the violation. These letters constitute one form of warning that can be issued under current Agency policy.

Seizure - An action brought against an FDA-regulated product because it is adulterated and/or misbranded within the meaning of the Act. The purpose of such an action is to remove specific violative goods from commerce.

Injunction - An order by a court that requires an individual or corporation to do or refrain from doing a specific act. FDA may seek injunctions against individuals and/or corporations to prevent them from violating or causing violations of the Act.

Criminal prosecution - may be recommended in appropriate cases for violation of Section 301 of the Act. Misdemeanor convictions, which do not require proof of intent to violate the Act, can result in fines and/or imprisonment up to one year. Felony convictions, which apply in the case of a second violation or intent to defraud or mislead, can result in fines and/or imprisonment up to three years.

The FDA field offices have primary responsibility for conducting inspections or investigations and collecting samples which may lead to recommendations for enforcement/regulatory action. The type of action recommended will depend upon the nature of the violation and the public health concern, Agency policy, previous history of violations by the firm, and other factors.

Criminal Fines for Food Drug and Cosmetic Act Violations

Misdemeanor fines under the Act may reach $500,000 under some circumstances. The Criminal Fine Enforcement Act of 1994 (Public Law 98-596) provides for fines for violations of Federal law. Although it is not part of the Act, the Criminal Fine Enforcement Act of 1994 applies to all fines levied under the Act, as well as other statutes that contain provisions enforced by FDA.

Up to $100,000 for a misdemeanor by an individual that does not result in death.
Up to $200,000 for a misdemeanor by a corporation that does not result in death.
Up to $250,000 for a misdemeanor by an individual that results in death, or a felony.
Up to $500,000 for a misdemeanor by a corporation that results in death, or a felony.

The maximum imprisonment for a misdemeanor under the Act remains a year for each offense.

The Food and Drug Administration is most effective in carrying out its mission under a policy of openness and free communication. Everyone is best served when there is clear understanding of the FDA's regulations and policies and how they are administered. FDA seeks to create confidence in, and support for, programs that are intended to promote and protect the health and well-being of all.

FDA encourages anyone to contact the Agency for assistance, to supply information, or to report a problem with a product. To help direct requests to the proper location for a rapid response, we offer the following guidance:

Information on approved drugs, regulations, policies, copies of guidelines, or CVM publications can be found on the CVM website at: http://www.fda.gov/cvm.

If you wish to request information by mail, or to submit suggestions or comments, address your letter to:

Food and Drug Administration
Center for Veterinary Medicine, HFV-12
7519 Standish Place
Rockville, MD 20855

Food and Drug Administration
Freedom of Information Staff (HFI-35)
5600 Fishers Lane
Rockville, MD 20857

Call 1-888-FDA-VETS between 7:00 a.m. - 4:00 p.m. Eastern Standard (or Daylight) Time, Monday-Friday. After hours leave a message and your call will be returned by a veterinarian the next working day.

To report a violation of the Federal Food, Drug, and Cosmetic Act, contact your nearest FDA office or

Office of Surveillance and Compliance (HFV-200)
Center for Veterinary Medicine
Food and Drug Administration
7519 Standish Place
Rockville, MD 20855
Telephone: (240) 453-6830

LOCATION		JURISDICTION
NEW ENGLAND DISTRICT One Montvale Avenue 4^th Floor Stoneham, MA 02180 (781) 596-7700		Connecticut Maine Massachusetts New Hampshire Rhode Island Vermont
NEW YORK DISTRICT 158-15 Liberty Avenue Jamaica, NY 11433 (718) 340-7000		New York City Downstate New York Long Island
BUFFALO DISTRICT 300 Pearl Street, Suite 100 Buffalo, NY 14202 (716) 551-4461		Upstate New York
NEW JERSEY DISTRICT Waterview Corp. Center 10 Waterview Blvd., 3^rd Floor Parsippany, NJ 07054 (973) 331-4900		New Jersey
SAN JUAN DISTRICT 466 Fernandez Juncos Avenue San Juan, PR 00901-3223 (787) 474-9500		Puerto Rico
PHILADELPHIA DISTRICT 200 Chestnut Street Room 900, U.S. Customhouse Philadelphia, PA 19106 (215) 597-4390		Delaware Pennsylvania
BALTIMORE DISTRICT 6000 Metro Drive, Suite 101 Baltimore, MD 21215 (410) 779-5454		District of Columbia Maryland Virginia West Virginia
ATLANTA DISTRICT 60 Eighth Street, N.E. Atlanta, GA 30309 (404) 253-1169		Georgia North Carolina South Carolina
FLORIDA DISTRICT 555 Winderley Place Suite 200 Maitland, FL 32751 (407) 475-4700		Florida
CHICAGO DISTRICT 550 West Jackson Blvd Suite 1500-South Chicago, IL 60661 (312) 353-5863		Illinois
CINCINNATI DISTRICT 6751 Steger Drive Cincinnati, OH 45237-3097 (513) 679-2700		Kentucky Ohio
DETROIT DISTRICT 300 River Place, Suite 5900 Detroit, MI 48207 (313) 393-8100		Indiana Michigan
MINNEAPOLIS DISTRICT 212 3^rd Avenue, South Minneapolis, MN 55401 (612) 334-4100		North Dakota Minnesota South Dakota Wisconsin
DALLAS DISTRICT 4040 North Central Expressway Suite 300 Dallas, TX 75204 (214) 253-5200		Arkansas Oklahoma Texas
NEW ORLEANS DISTRICT 404 BNA Drive Building 200, Suite 500 Nashville, TN 37217-2565 (615) 366-7801		Alabama Louisiana Mississippi Tennessee
KANSAS CITY DISTRICT 11630 West 80^th Street Lenexa, KS 66214-3340 (913) 752-2100		Iowa Kansas Missouri Nebraska
DENVER DISTRICT Denver Federal Center Bldg. 20 6^th & Kipling Street P.O. Box 25087 Denver, CO 80225-0087 (303) 236-3017		Colorado New Mexico Utah Wyoming
SAN FRANCISCO 1431 Harbor Bay Parkway Alameda, CA 94502-7070 (510) 337-6700		California (Northern) Hawaii Nevada
LOS ANGELES DISTRICT 19701 Fairchild Irvine, CA 92612-2506 (949) 608-2900		Arizona California (Southern)
SEATTLE DISTRICT 22201 23^rd Drive, S.E. Bothell, WA 98021-4421 (425) 483-8788		Alaska Idaho Oregon Washington Montana

A comprehensive ORA Field Directory is located on the FDA Home Page at http://www.fda.gov/ora/inspect_ref/iom/iomoradir.html.

Adulteration: A violation of the Federal Food, Drug, and Cosmetic Act which includes products that are defective, unsafe, not shown to be safe, filthy, or produced under insanitary conditions. It also includes products which are manufactured under procedures and controls which do not comply with Current Good Manufacturing Practice regulations as well as new animal drug products which are not the subject of an NADA approval. Detailed definitions of adulteration are in the Act itself, and have been developed in regulations and by the courts.

Adverse Drug Experience: An unexpected side effect, injury, toxicity, sensitivity reaction, or unexpected incidence or severity of side effects associated with use of a new animal drug product. The failure of a new animal drug product to exhibit expected pharmacological action also is an adverse drug reaction.

Animal Feed: An article which is intended for use for food for animals other than man and which is intended for use as a substantial source of nutrients in the diet of the animal. It is not limited to a mixture intended to be the sole ration of the animal.

Device: An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its principal intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its principal intended purposes.

Drug: means (A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C). A food or dietary supplement for which a claim, subject to sections 343(r)(1)(B) and 343(r)(3) of this title or sections 343(r)(1)(B) and 343(r)(5)(D) of this title, is made in accordance with the requirements of section 343(r) of this title is not a drug solely because the label or the labeling contains such a claim. A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance with section 343(r)(6) of this title is not a drug under clause (C) solely because the label or the labeling contains such a statement.

Electronic Animal Identification Products: Implantable transponders which contain unique information for use in animal identification. A reader compatible with the transponder is used to make the final identification. These transponders are implanted into inedible portions of the animal (e.g., ear) and if the implant is rendered for animal feed, the Center is regulating the transponder as a food additive.

Extra-Label Use: Refers to the actual or intended use of an approved new animal drug in a manner that is not in accordance with the approved label directions.

Food Additive: Any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing, manufacturing, processing, preparing, treating, packaging, transporting, or holding food; and including source of radiation intended for any such use), if such substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures...to be safe under the conditions of its intended use... (see 21 U.S.C. 321 (s) for complete definition).

Labeling: All labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers or (2) accompanying such article.

Medicated Animal Feed: An article intended for use as food for animals, other than man, bearing, containing, or purporting to bear or contain any kind of animal drug/drug combination.

Misbranding: A drug or device shall be deemed to be misbranded (a) if its labeling is false or misleading in any particular; (b) if in package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer, or distributor; and (2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count; (c) If any word, statement, or other information required by or under authority of the Act to appear on the label is not prominently placed thereon with such conspicuousness and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use... The complete definition of misbranding can be found in the Act (21 U.S.C. 502).

New Animal Drug: Any drug intended for use for animals other than man which, among other things, is not generally recognized by qualified experts as safe and effective for use under the condition prescribed, recommended, or suggested in the labeling thereof.

Veterinary Biologics: Vaccines, bacterins, diagnostics, etc, which are used to prevent, treat, or diagnose animal diseases. These products generally work through some immunological method or process.

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