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FDA Regulation of Animal Drugs

A Brief Overview of FDA's Legal Marketing Statuses for Animal Drugs
Classifying Rx and OTC Drugs
Dispensing Veterinary Prescription Drugs
Requirements for Labeling On Manufactured Prescription Animal Drugs
Unapproved Animal Drugs
   Compounding Animal Drugs
Extra-Label Use of FDA Approved Drugs In Animals
Information about Extra-Label Use of Specific Drug Products
How to Report Animal Drug and Device Side Effects and Product Problems
Animal Drug Shortage Information


A Brief Overview of FDA's Legal Marketing Statuses for Animal Drugs

Under the Federal Food, Drug, and Cosmetic Act (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.

Under the Act, a new animal drug may not be legally introduced into interstate commerce unless it is the subject of either: 

  • an approved new animal drug application (NADA) or abbreviated new animal drug application (ANADA) under section 512 of the Act; 
  • a conditional approval under section 571 of the Act;
  • a listing on the Legally Marketed Unapproved New Animal Drug Index for Minor Species (the Index) under section 572 of the Act;
  • an emergency use authorization (EUA) under section 564 of the Act (an EUA may only be issued under very limited circumstances, more information regarding EUAs is available at this webpage: Emergency Use Authorization) ; or
  • an investigational exemption under section 512(j) of the Act. 

Three Pathways to Legal Marketing Status

Approval

An approved animal drug has gone through the New Animal Drug Application (NADA) process, or for an approved generic animal drug, the Abbreviated New Animal Drug Application (ANADA) process. If the information in the application meets the requirements for approval, FDA approves the animal drug. FDA’s approval means the drug is safe and effective when it is used according to the label. FDA’s approval also ensures that the drug’s strength, quality, and purity are consistent from batch to batch, and that the drug’s labeling is truthful, complete, and not misleading.

Learn more about the NADA and ANADA approval processes as well as the requirements for an investigational exemption by visiting the following webpage:

Conditional Approval

Conditional approval is only available for some animal drugs for use in a minor species or in a major species under special circumstances. A conditionally approved animal drug has gone through FDA's drug approval process except the drug has not yet met the effectiveness standard for full approval. FDA’s conditional approval means that when used according to the label, the drug is safe and has a “reasonable expectation of effectiveness.” FDA's conditional approval also means that the drug is properly manufactured.

The conditional approval is valid for one year. The drug company can ask FDA to renew the conditional approval annually for up to four more years, for a total of five years of conditional approval. During the 5-year period, the drug company can legally sell the animal drug while collecting the remaining effectiveness data. After collecting the remaining effectiveness data, the company submits an application to FDA for full approval. The agency reviews the application and, if appropriate, fully approves the drug.

Learn more about the conditional drug approval process by visiting the following webpage:

Indexing

An indexed animal drug is a drug on FDA’s Index of Legally Marketed Unapproved New Animal Drugs for Minor Species, referred to simply as “the Index.” As the name says, a drug listed on the Index is unapproved but has legal marketing status. It can be legally sold for a specific use in certain minor species. Indexing is allowed for drugs for:

  • Non-food-producing minor species, such as pet birds, hamsters, and ornamental fish. These animals are typically not eaten by people or by other animals that produce food for people to eat; and
  • An early non-food life stage of a food-producing minor species, such as oyster spat (immature oysters). Because people do not generally eat oyster spat, a drug to treat a disease in spat can be indexed, but a drug to treat a disease in adult oysters, which people commonly eat, cannot be indexed.

Indexing a drug is quite different from the drug approval process. Indexing relies heavily on a panel of qualified experts outside FDA. The experts review the drug’s safety in the specific minor species and the drug’s effectiveness for the intended use. All experts on the panel must agree that, when used according to the label, the drug’s benefits outweigh the risks to the treated animal. If FDA agrees with the panel, the agency adds the drug to the Index.

Learn more about indexing by visiting the following webpage:

More Information

Approved Animal Drug Products (Green Book)
Animal Drugs @ FDA Explained

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Classifying RX and OTC Animal Drugs

During the drug approval or indexing process, FDA is responsible for determining the marketing status (prescription, over-the-counter, or VFD) of animal drug products. To be sold over-the-counter (OTC), it must be possible to prepare "adequate directions for use" under which a layperson can use the drugs safely and effectively. Safe use includes safety to the animal, safety of food products derived from the animal, and safety to the persons associated with the animal.

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. Prescription (Rx) products can be dispensed only by or upon the lawful written order of a licensed veterinarian.

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." 

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Dispensing Prescription Animal Drugs

Since adequate directions for safe and effective lay use cannot be written for prescription animal drugs, such products can only be sold on the prescription or other order of a licensed veterinarian. 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 drugs may be distributed only by persons or firms authorized by State law.

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

A licensed veterinarian may legally use or dispense a prescription animal drug only within the course of her/his professional practice where a valid veterinarian-client-patient relationship exists. Veterinarians employed by drug manufacturers or distributors may not legally dispense prescription drugs to laypersons unless they meet the above criteria. Similarly, practicing veterinarians or their employees may not legally sell prescription animal drugs to walk-in customers unless the same criteria are met.

The following information must be included on the label of the dispensed prescription animal drug:

  • name and address of the dispenser;
  • serial number and date of the order or its filling;
  • name and address of the veterinarian who prescribed or ordered the drug product;
  • directions for use; and
  • any necessary warning and precautionary statements including withdrawal times.

Veterinarians must include the appropriate applicable information (above) in their prescription to allow it to be dispensed.  Veterinarians must also follow State laws for dispensing animal drugs.

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.

Requirements for Labeling On Manufactured Prescription Animal Drugs

In addition to the labeling requirements generally applicable to animal drugs, federal regulations require that drug manufacturers provide at least the following information on the label of the finished package form of prescription animal drugs:

  • the statement, "Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian;"
  • recommended or usual dosage;
  • route of administration, if it is not for oral use;
  • quantity or proportion of each active ingredient as well as the information required by section 502(e) of the Act;
  • names of inactive ingredients if it is for other than oral use;
  • an identifying lot or control number from which it is possible to determine the complete manufacturing history of the drug.

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Unapproved Animal Drugs

Unapproved animal drugs are new animal drugs that don’t have legal marketing status. They have not been approved, conditionally approved, or indexed by FDA. It’s illegal to market unapproved new animal drugs because they haven’t gone through the FDA pre-market review and obtained legal marketing status under the FD&C Act. Unapproved animal drugs may not meet the agency’s strict standards for safety and effectiveness and may not be properly manufactured or properly labeled and packaged. Unapproved animal drugs include animal drugs compounded from bulk drug substances.

More information:

Unapproved Animal Drugs

Compounding of Animal Drugs

Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), new animal drugs must be approved, conditionally approved, or included on the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species to be legally marketed. The FD&C Act does not generally distinguish between compounding and other methods of animal drug manufacturing.  New animal drugs that are not approved, conditionally approved, or indexed, which includes drugs compounded from bulk drug substances, are considered "unsafe" and “adulterated” under the FD&C Act.

FDA recognizes that in some situations a drug compounded from bulk drug substances may be the only appropriate treatment option for a particular animal. On April 22, 2022, FDA finalized Guidance for Industry #256, “Compounding Animal Drugs from Bulk Drug Substances,” which addresses situations in which the FDA does not intend to take action for certain violations of the Food, Drug, & Cosmetic Act when pharmacists and veterinarians compound or oversee the compounding of animal drugs from bulk drug substances:

  • to fill patient-specific prescriptions for nonfood-producing animals
  • to compound “office stock” (certain drugs kept in veterinarians’ supply) for nonfood-producing animals and
  • to compound antidotes for food-producing animals.

Animal drugs compounded from bulk drug substances do not undergo review by FDA, meaning that the FDA has not determined that these unapproved products are safe and effective for their intended use. Because of the safety benefits and protections of the pre-market review process and post-market monitoring of FDA-approved, conditionally approved, and indexed drugs, veterinarians should only use drugs compounded from bulk drug substances if FDA-approved, conditionally approved, or indexed drugs are not available to treat the animal.

More information:

Animal Drug Compounding

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