Be Drug Smart

Choose Generic Drugs

Generics are Safe and Effective

Generics provide significant cost savings without sacrificing quality and safety.

To be approved, a generic and its brand name counterpart must have the same:

• Active ingredients
• Dosage form
• Standards for purity and quality
• Standards for manufacturing
• Amount of drug absorbed over the same time
• Clinical effect

Brand name and generic drugs have to meet the same requirements set by the Food and Drug Administration (FDA).

	FDA Requirements		Brand Name Drug		Generic 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 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

For more generic drug information:

• Generics cost less
• Generic research and development
• Ask about generics downloadable fact sheet (PDF)
• FDA Web site
• Drug Information & Drug Interaction Checker