Grand Fathered Drugs

 

Grand Fathered Drugs

 Drugs that entered the market before the passage of the 1938 act or the 1962 amendments to the act are often referred to as grandfathered drugs.

• Under the 1962 grandfather clause, the FFDCA exempts a drug from the effectiveness requirements if its composition and labeling have not changed since 1962 and if, on the day before the 1962 amendments became effective, it was

1.   Used or sold commercially in the United States

2. Not a new drug as defined by the act at that time

3. Not covered by an effective application

• Many older drugs without FDA approval claim to be grandfathered; however, FDA believes that very few drugs are on the market that are actually entitled to grandfather status because the drugs currently on the market likely differ from the previous versions in some respect, such as formulation, dosage or strength, dosage form, route of administration, indications, labelling, or intended patient population.