Are OTC-only wholesalers that do not carry prescription products required to be licensed or registered?

• A. Yes, they must be licensed in all states
• B. They must be licensed wholesale distributors
• C. No, they may not be required to be licensed or registered
• D. They must have a federal license

Answer: (C)

Licensing rules for wholesale distributors mainly target handling prescription drugs. If a wholesaler only distributes over-the-counter products and never carries prescription medications, they generally fall outside the licensing framework that governs drug wholesalers. The federal and state requirements under the DSCSA apply to wholesale distributors of prescription drugs, so OTC-only operations typically do not need a drug wholesale license or federal license. They may still need standard business registrations and to comply with general consumer-protection or business regulations, but not a specific drug-wholesale license. This is why OTC-only wholesalers aren’t universally required to be licensed or registered as drug distributors.