Drug Use Guidance

General Information

The following resources contain a variety of information, all of which should assist you in making sound decisions as to what drugs may legally be used in the United States and the conditions under which they may be used. These resources do not include those drugs yet to be approved for which the U.S. Fish & Wildlife Service holds Investigational New Animal Drug (INAD) exemptions.

The “Drug-use Guidance” sections do include direct links to various guidance documents, at this time primarily from the FDA. Guidance documents are often intended to assist prospective sponsors of drugs, animal health practitioners, animal owners and caretakers, and other interested parties in making informed decisions about the use of drugs and the generation of information pertinent to applications for new animal drug approvals.

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Drugs Approved for Use in Aquaculture

All drugs used to treat and control diseases, induce spawning, change gender, or in any other way change the structure or function of aquatic species (and all animals for that matter) must be approved by the U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM). At production aquaculture facilities, it is illegal to use any drug that is not approved unless it is being used under the strict conditions of an INAD exemption or an extra-label prescription issued by a licensed veterinarian. Even those drugs listed as LRP drugs are technically illegal to use. CVM has indicated that they will probably not take legal action against anyone using LRP drugs, but such a stance does not mean that LRP drugs are legal, approved drugs.

Below is a link to a table that lists those drugs currently approved by CVM for use on/in aquatic species. The aforementioned table has been developed from the website belonging to the U.S. Food and Drug Administration’s Center for Veterinary Medicine, and has been modified for clarity. Please refer to CVM’s list of approved aquaculture drugs as the definitive source of information.

Bear in mind that any use of an approved drug in a manner not specifically noted on the drug’s label is illegal, unless used where permitted, under an extra-label prescription by a licensed veterinarian.

 

Extra Label Drug Use

Certain drugs approved by FDA’s Center for Veterinary Medicine (CVM) for other animals or other conditions of use (i.e., treatment claims) may, under very specific circumstances, be legally used on aquatic species for which the drugs are not approved. Any such use is referred to as “extra-label” or “off-label” drug use.

All of the following general conditions must be true before extra-label drug use (ELDU) is permissible.

A pivotal law was passed in 1994, the Animal Medicinal Drug Use Clarification Act, which essentially legalized extra-label drug use.

The Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA): FDA’s Center for Veterinary Medicine states that “…[AMDUCA] allows veterinarians to prescribe extra-label uses of certain approved animal drugs and approved human drugs for animals under certain conditions. Extra-label use refers to the use of an approved drug in a manner that is not in accordance with the approved label directions. The key constraints of AMDUCA are that any extra-label use must be by or on the order of a veterinarian within the context of a veterinarian client patient relationship, must not result in violative residues in food-producing animals, and the use must be in conformance with the implementing regulations published at 21 CFR Part 530.”

The table below summarizes several key sources of information, from CVM and the American Veterinary Medical Association (AVMA) documents, that provide information about AMDUCA and should be consulted for details. In essence, AMDUCA converts (or codifies) what was once a case of regulatory discretion (i.e., it was illegal, but something that CVM would normally choose not to take regulatory action against) into a law, which now means that extra-labeling by veterinarians is legal if conducted per the conditions of the Act.

Additional Information:

Animal Medicinal Drug Use Clarification Act of 1994

Code of Federal Regulations covering Extra Label Drug Use in Animals

Extra Label Use of Medicated Feeds for Minor Species

Extra Label Use of approved drugs in aquaculture

 

Low Regulatory Priority Drugs

The following list of drugs has been determined by CVM to be of low regulatory priority (LRP). CVM is unlikely to object to the use of LRP substances if 1.) the substances are used for the listed indications, 2.) the substances are used at the prescribed levels, 3.) the substances are used according to good management practices, 4.) the product is of an appropriate grade for use in food animals, 5.) there is not likely to be an adverse effect on the environment.

The List of LRP Drugs includes:

 

A complete and detailed listing of the LRP drugs can be found on CVM’s website.

 

Substances Generally Recognized as Safe

The FDA has published in the Code of Federal Regulations a list of substances that are generally recognized as safe (GRAS) for their specific uses. For example: FDA regards such common food ingredients as salt, pepper, sugar, vinegar, baking powder, and monosodium glutamate as safe for their intended use. As additional conditions for use of such substances, the FDA considers these to be GRAS substances only if they are made and used in accordance with good manufacturing or feeding practice, respectively.

Although this specific section (of the Code of Federal Regulations) refers to “substances” as opposed to “drugs,” any one of these listed GRAS substances could be defined (by CVM) as a drug based on the intended use of the substance. If the intended use of the substance is other than that listed in 21 CFR 182 or 21 CFR 582, it is no longer GRAS, and if it were to be used in a manner consistent with FDA’s definition of a drug, it would then be considered an unapproved drug and illegal to use. For example: eugenol, the primary ingredient of clove oil, is considered to be GRAS when used as a flavoring substance and adjuvant. However, clove oil, when used as an aesthetic on fish, is an unapproved drug and illegal to use.

Additional Information:

A complete listing of all substances defined as GRAS by FDA

The Code of Federal Regulations

 

Forbidden drugs

Drugs which are forbidden for use in aquatic animals and/or drugs FDA considers to be of high enforcement priority.The FDA has forbidden the use of certain drugs in all animals or in specific groups of animals. The basis for such decisions are primarily a function of safety to the target animal, the environment or humans who may come in contact with the drug either directly (during the administration of the drug) or indirectly (e.g., via consumption of an animal with drug residues or exposure to effluent water containing the drug).

The following drug is prohibited for use in animal food or feed:

 

Deferred Drugs

Currently, CVM has deferred a decision on the status of two drugs, copper sulfate and potassium permanganate. Both of these drugs were/are either currently EPA registered pesticides with approved uses in aquaculture settings. Both also have other industrial and agricultural approved, registered or recognized uses. Both are available in bulk quantities from chemical and agricultural supply sources. Both are being studied by the Service under a valid INAD exemption. Both have pharmaceutical sponsors, pursuing approvals.

Additional Information:

 

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