Drugdu.com expert's response:

OTC stands for "Over-the-Counter," referring to medications that can be purchased without a prescription from a healthcare professional. These medications are typically used to treat common health issues such as headaches, colds, fevers, and mild pains. In the United States, the Food and Drug Administration (FDA) regulates OTC drugs, and certain products require an application for OTC status before they can be sold on the market.

Products that need to apply for OTC status according to the FDA include:

1.New Drugs: Drugs that have not been previously marketed require FDA approval before being sold as OTC products, regardless of their composition or effects.

2.Prescription Drugs: Some prescription drugs can apply for OTC status after undergoing clinical studies and safety assessments to demonstrate their safety and effectiveness.

3.Previously OTC Products with Safety Concerns: Certain OTC products may be required by the FDA to halt sales or undergo further research and evaluation due to safety concerns. In such cases, manufacturers may need to reapply for OTC status to comply with FDA requirements.

Overall, FDA oversight of OTC medications focuses on safety, effectiveness, and proper usage. Manufacturers must adhere to FDA regulations, submit necessary application materials, and undergo rigorous review and evaluation to obtain OTC status and sell their products on the market.