Are Animal Drugs Subject to Less Regulation than Human Drugs?

November 19, 2021
3 min read

Article Highlights

  • Both human and animal drugs are regulated by the U.S. Food and Drug Administration (FDA) under the Federal, Food, Drug and Cosmetic Act.

  • Veterinary drugs are subject to similar regulations as human drugs.

  • Animal drugs are subject to the same purity and potency standards as human drugs.

We’ve all had experiences with drugs: over the counter pills for a headache, allergy medicine when flowers start to bloom, or antibiotics from a doctor. Most of us don’t worry about whether what we’re taking is safe or how it was regulated. But do you have the same faith in the drugs you give your pets? This is a reasonable concern, but it should ease your mind to know that the drugs you give your pets are just as safe as the drugs you take yourself.

Are human and animal drugs equally regulated?

In general—yes. Both human and animal drugs are regulated by the U.S. Food and Drug Administration (FDA) under provisions of the Federal Food, Drug and Cosmetic Act. To get approved by the FDA, both types of drugs must meet the FDA standards of safety and efficacy. Additionally, both types of drugs must meet the same strict FDA manufacturing standards. To demonstrate that new drugs meet these standards, companies must submit to FDA a New Drug Application (NDA) for human drugs, or a New Animal Drug Application (NADA) for animal drugs.

The NDAs and NADAs include information on the drug’s chemistry, composition, intended label description, intended effects, and all potential side effects. In addition to this information, the company submitting the application must include comprehensive data sets to demonstrate the drug’s safety and effectiveness profile.

Are there any differences between how human and animal drugs are regulated?

One difference between animal and human drug applications is the number of participants in a drug’s field safety and effectiveness trial. This information is part of the data set that evaluates a drug's safety and effectiveness under conditions of use. Human drug trials require thousands of participants, whereas veterinary drug trials require much fewer patients since the population of animal species (I.e., dogs, cats) is relatively small. Even though the data set is smaller for veterinary drugs, the drugs must still adhere to strict study standards set by the FDA in accordance with the Code of Federal Regulations (CFR). It takes companies 5-7 years and millions of dollars to gather enough data to fulfill FDA requirements for a NADA.

All drugs are subject to oversight in their method of manufacture, and new animal drugs must meet the same quality standards for purity, potency and stability as human drugs. In other words, the drugs prescribed to your pets meet the same quality standards and are just as safe as the drugs prescribed to you.

The bottom line is, yes, veterinary drugs are subject to very similar regulation as human drugs. You can rest easy knowing that your pet is getting safe, effective treatment.

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