Animal & Veterinary
How can I tell if a drug is FDA-approved for people?
Under the Animal Medicinal Drug Use Clarification Act (AMDUCA) of 1994, veterinarians can legally use FDA-approved human drugs in animals under certain conditions. But, it’s not always easy to tell if a drug is approved for people. Here are some tips to help you identify an FDA-approved human drug:
- Look up the drug in Drugs @ FDA.
Most prescription and over-the-counter FDA-approved human drugs and therapeutic biologic products are listed in Drugs @ FDA, a searchable database. The database allows you to search by drug name, active ingredient, or application (NDA, ANDA, or BLA) number.
All FDA-approved human drugs have a New Drug Application (NDA) number, or for generic human drugs, an Abbreviated New Drug Application (ANDA) number. FDA-approved therapeutic biologic products for people, such as immunomodulators and cytokines, have a Biologics License Application (BLA) number. NDA, ANDA, and BLA numbers all have six digits.
- Look up the drug in the Orange Book.
Most prescription and over-the-counter FDA-approved human drugs are included in the online publication, Approved Drug Products with Therapeutic Equivalence Evaluations, called the Orange Book for short. You can search the Orange Book using several parameters, such as proprietary name (trade name), active ingredient, and application (NDA or ANDA) number. Within each parameter, you have to search by drug category – prescription, over-the-counter, or discontinued drugs.
- Look up the drug in the National Drug Code Directory.
The National Drug Code (NDC) Directory is an online list of human drugs. You can search the NDC Directory using several parameters, including proprietary name (trade name), active ingredient, and application (NDA, ANDA, or BLA) number.
The NDC number is a unique ten-digit product identifier indicating the drug is in commercial distribution. The drug’s NDC number is usually found on its label, but that does not mean the drug is FDA-approved.
When the results of your online NDC Directory search come up, you can tell if the drug is approved by looking in the "Market Category Name" and "Application Number" columns. The "Market Category Name" column will have "NDA" for approved drugs, "ANDA" for approved generic drugs, or "BLA" for approved therapeutic biologic products. The "Application Number" column will list the six-digit NDA, ANDA, or BLA number. If the drug is not FDA-approved for people, the "Market Category Name" column will state "unapproved" and the "Application Number" column will be blank.
Animal drugs also have NDC numbers, but the NDC Directory only lists human drugs. As with a human drug, an NDC number on an animal drug’s label does not mean the drug is FDA-approved. Tips on how to determine if a drug is FDA-approved for animals.