About DNDLC

The Division of New Drugs and Labeling Compliance is responsible for compliance and enforcement issues related to approval and labeling requirements for OTC and prescription drugs, including Internet and Health Fraud, compounding, and imports/exports. The division's main responsibilities include enforcing the misbranding and new drugs provisions of the Federal Food, Drug, and Cosmetic Act for over-the-counter drug products. The program areas are Over-the-Counter Drug Monograph Compliance program, the Health Fraud and Internet program, the Import/Export program, the Pharmacy Compounding program, and the Rx Drug program. The main responsibilities of the Division are as follows:

• Ensuring that all marked over-the-counter (OTC) drugs and alternative medicines are safe and effective for their intended uses and are properly and legally labeled.
• Assuring the integrity of imported and exported drugs by monitoring investigational and unapproved new drugs.
• Identifying and addressing fraudulent or hazardous drug products that present a direct or indirect health hazard to the public.
• Giving enforcement strategy guidance for scientific and legal support of criminal prosecutions involving diverted and counterfeit drugs.
• Developing policies and compliance strategies to ensure marketed prescription drug products are safe and effective for their intended uses and are properly and legally labeled.
• Preventing the diversion of counterfeit, sub potent, adulterated, and misbranded prescription drug products by administering the Prescription Drug Marketing Act.