What are "grandfathered" drugs?

The term "grandfathered" drugs refers to medications that were already on the market before new safety regulations were enacted. These drugs were allowed to continue being sold without undergoing the same approval processes that newer medications must satisfy. This is significant because it acknowledges the historical presence of certain drugs within the healthcare system prior to the implementation of more rigorous safety standards, allowing them to bypass the extensive pre-market testing and approval that newer drugs need to go through.

Understanding this concept helps clarify the complexities of drug regulation and ensures that healthcare professionals are aware of the differences in oversight between older and newer medications, especially when considering prescribing practices and patient safety. The notion does not typically apply to newly introduced medications, nor to drugs that might not require approval solely on the basis of their history or status in regulatory frameworks. The Orange Book pertains to drug approvals and therapeutics equivalence, but is not directly relevant to the "grandfathered" status itself.