By Law, Generic Medicines Are the Same Medicines as Brands

To receive FDA approval, generic prescription medicines must be the SAME medicines as the brands and deliver the same results. All generic medicines must have the same amount of active ingredient; safety and effectiveness; strength and dosage; and labeling and use.  And generics must follow the same high quality manufacturing standards as the brands.

While generics may be a different color, size or shape due to U.S. trademark laws, FDA has clearly stated that these cosmetic differences have no impact on safety or effectiveness, and all must be approved by FDA.

The FDA has a strict approval process, and generics are required to meet stringent standards for every product, batch-to-batch. These specific quality standards as outlined by FDA include: 

•    The generic must have the same active ingredient(s) and the same labeled strength (e.g., 50 mg) as the brand product. The generic must have the same dosage form—tablets and liquids are examples of dosage forms. It must be administered to a patient in the same way, for example, swallowed as a pill or given as an injection.

•    The manufacturer must show the generic drug is "bioequivalent" to the brand-name drug.

•    The generic drug's labeling must be the same as that of the approved drug; yet, the generic may not be permitted by FDA to be labeled for a particular use because that use is still protected by the brand patent.

•    The manufacturer must fully document the generic drug's chemistry, manufacturing steps, and quality control measures. Each step of the process must be detailed for FDA review.

•    The manufacturer must assure the FDA that the raw materials and the finished product meet USP specifications. The USP, or U.S. Pharmacopoeia, is the non-profit, scientific body chartered by Congress to set standards for drug purity in the United States.

•    The manufacturer must show that its generic drug remains safe and effective for its intended use over a period of time before it can be sold. Once on the market, the firm must continue to monitor the drug's stability. Manufacturers making sterile drugs must submit sterility assurance data showing microbiologic integrity of these products.

•    The manufacturer must provide a full description of the facilities it uses to manufacture, process, test, package, label, and control the drug. It must certify that it follows federal regulations about current good manufacturing practices and undergoes FDA inspection of the manufacturing facility to assure compliance, whether the product is made in the United States or overseas.