FDA Drug Requirements for Brand-Name & Generic Drugs

The FDA requirements for brand-name and generic drugs are the same.

 

Brand Name Drug

 Generic Drug

For reformulations of a brand-name drug or generic versions of a drug, FDA reviews data showing the drug is bioequivalent to the one used in the original safety and efficacy testing.

    x      x

FDA evaluates the manufacturer's adherence to good manufacturing practices before the drug is marketed.

    x      x

FDA reviews the active and inactive ingredients used in the formulation before the drug is marketed.

    x      x

FDA reviews the actual drug product.
   x      x

FDA reviews the drug's labeling.
   x      x

Manufacturer must seek FDA approval before making major manufacturing changes or reformulating the drug.
   x      x

Manufacturer must report adverse reactions and serious adverse health effects to the FDA.
   x      x

FDA periodically inspects manufacturing plants.
   x      x

FDA monitors drug quality after approval.
   x      x

Source: FDA