Final answer:
Pharmacists cannot substitute a brand-name drug with a generic that hasn't been FDA-approved for bioequivalence. The FDA mandates a strict approval process to ensure generics are therapeutically equivalent to brand-name drugs. The 1989 generic drug scandal underscored the necessity of such regulations.
Step-by-step explanation:
Pharmacists are not allowed to substitute a brand name drug with a generic drug that has not been evaluated and rated for bioequivalence by the U.S. Food and Drug Administration (FDA). For a generic drug to be considered interchangeable with its brand name counterpart, it must go through a rigorous approval process, which includes submitting an Abbreviated New Drug Application (ANDA) proving its therapeutic equivalence. This means that the generic drug is expected to have the same clinical effect and safety profile as the branded drug when administered to patients under the conditions specified in the labeling.
During the 1989 generic drug scandal, it was uncovered that some manufacturers had submitted false data to the FDA in order to get approval for their generics, leading to recalls and legal action. This highlighted the importance of FDA's stringent approval process. Therefore, it would be both illegal and unethical for a pharmacist to provide a patient with a generic drug without FDA's approval for bioequivalence and therapeutic equivalence to the branded drug.