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 or biological product in Drugs @ FDA.
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 biological products for people, such as immunomodulators and cytokines, have a Biologics License Application (BLA) number. NDA, ANDA, and BLA numbers all have six digits.
Most FDA-approved human drugs and therapeutic biological 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.
- Look up the drug in the Orange Book or the biological product in the Purple 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 (also known as trade name or brand name), active ingredient, and application (NDA or ANDA) number.
More information about the Orange Book.
All FDA-approved human biological products licensed under a BLA are listed in the searchable, online Database of Licensed Biological Products, called the Purple Book for short. You can search the Purple Book using either the product’s proprietary name (also known as the trade name or brand name) or the nonproprietary name (also known as the proper name or active ingredient).
More information about the Purple Book.