Community Health

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