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 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 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.