Tag: Grandfathered drugs

While unapproved drugs make up only about 2% of prescriptions, they account for an estimated 72 million prescriptions each year in the United States [1.8.4]. The question of 'What drug is not FDA approved?' reveals a complex landscape of medications available to patients outside the standard regulatory process.

Hundreds of drug products are currently marketed in the United States without having received the required approval from the U.S. Food and Drug Administration (FDA). This raises serious safety and efficacy questions for anyone wondering **what drugs are not FDA approved** and why they are still available.

Many common prescription drugs in the US, including phenobarbital for seizures and sublingual nitroglycerin for chest pain, were grandfathered onto the market decades ago and have never undergone modern FDA scrutiny. This raises the critical question for many patients and healthcare professionals: **What common drugs are not FDA approved?** Understanding the types of unapproved medications, from legacy drugs to personalized compounded formulas, is crucial for patient safety and informed healthcare decisions.