Generic Substitution
Dispensing a generic drug product for a prescription written for
the brand name medication is known as a therapeutic equivalent.
Generic products must show the same clinical effects and safety
profile of the original drug product. These therapeutic equivalents
must follow the criteria:
- Approved by the FDA as safe and effective
- Contain identical amounts of the same active ingredients
- Are the same dosage form
- The same route of administration
- Meets standards of strength, quality, purity, and identity
- The same rate and extent to which the active drug product is
available at the site of action
- They are adequately labeled
- They are manufactured in accordance with Current Good
Manufacturing Practice regulations
Source: Orange Book - www.accessdata.fda.gov/scripts/cder/ob/default.cfm