How to Verify an FDA Wholesale Distributor License

In the pharmaceutical and healthcare industry, ensuring that you're sourcing medicines or medical devices from a licensed distributor is not just a best practice—it's a legal requirement. An FDA Wholesale Distributor License acts as proof that the company you're dealing with meets the regulatory standards for safety, storage, and distribution.

What is an FDA Wholesale Distributor License?

An FDA Wholesale Distributor License is an authorization issued to businesses involved in the wholesale distribution of drugs or medical devices. This license ensures that the distributor adheres to standards laid out by the U.S. Food and Drug Administration (FDA) to prevent counterfeit or substandard products from entering the supply chain.

The Significance of Verifying Licenses

Ensures the legitimacy of the supplierPrevents the purchase of counterfeit or substandard productsMaintains legal compliance in the import/export processBuilds trust with end consumers and regulators

How an FDA Wholesale Distributor License Can Be Verified

The steps you can take are as follows:

1. Visit the FDA’s Database

The FDA offers a searchable online directory of importers and dealers of regulated pharmaceuticals.Go to the FDA’s Drug Establishment Registration Site (DRLS)

https://www.accessdata.fda.gov

2. Search by Establishment Name or FEI Number

You can use:

Company NameFacility Establishment Identifier (FEI)Country/State

3. Check for Active Status

Ensure the establishment’s license is:

Currently activeMatches the product category (drugs, devices, biologics, etc.)Has not been flagged for violations or warning letters

FDA License Requirements (For Distributors)

The applicant must fulfill several regulatory requirements to receive an FDA wholesale distributor license:

Valid business registration in the home country

GMP-compliant storage facilitiesProof of qualified personnel (like pharmacists or quality assurance officers)Standard operating procedures (SOPs)Track-and-trace systems (for drug supply chain integrity)Regular audits and recordkeeping

FDA License Cost & FDA Certificate Cost in India

Compliance setup, documentation, agent fees, and facility inspections are the costs associated with licensing, even though the FDA does not charge for licensing itself.

Estimated Costs for Indian Applicants:

ServiceApproximate CostU.S. FDA Agent Fees ₹1,00,000 – ₹2,50,000/yearFacility Inspection/Compliance Setup ₹50,000 – ₹1,50,000Documentation & Legal Fees ₹30,000 – ₹80,000

So, the FDA certificate cost in India can range from ₹1.5 Lakhs to ₹4 Lakhs, depending on the complexity of the business and product.

How to Apply for an FDA Wholesale License (From India)

Hire a U.S.-based FDA Agent

Submit Establishment Registration (FURLS system)Complete Drug/Device ListingEnsure Facility ReadinessMaintain Ongoing Compliance

FDA wholesale distributor database

 1. FDA’s “Check Licensure” Tool

The FDA mandates that wholesale drug distributors and third-party logistics providers (3PLs) submit annual licensure reports under the Drug Supply Chain Security Act (DSCSA) You can verify a firm’s licensure status by consulting:The state-level licensing authority (e.g., the state Board of Pharmacy)FDA’s Annual Reporting Database for wholesalers/3PLs 

2. Standalone “Verify Your Wholesale Drug Distributor” Page

The FDA also provides a portal with a U.S. map linking to state licensure lists so you can confirm if a distributor is licensed within their operating state

3. Drug Establishments Current Registration Site (DECRS)

While focused on manufacturers, repackers, and labelers, DECRS also lists establishments registered under Section 510—useful if the wholesaler handles manufacturing or repacking operations DECRS is updated daily and can be accessed directly on FDA.gov You can download the entire database as a ZIP file from data.gov 

4. How to Perform a License Check

State Level – Visit the state Board of Pharmacy (e.g., California, Texas, etc.) to confirm the firm’s license.FDA Annual Reporting – Search FDA’s DSCSA reporting database to check current status and any disciplinary flags Supplement – If the wholesaler does manufacturing/repacking, cross-check with DECRS.

5. Why It's Critical

The DSCSA prohibits transactions with unlicensed distributors to prevent counterfeit or diverted drugsUpdates to licensure can be made even overnight, so regular verification is necessary.

Final Thought

For companies engaged in the import/export or distribution of pharmaceutical items, confirming an FDA wholesale distributor license is an essential step. To prevent regulatory setbacks, it is essential to comprehend the FDA licensing requirements, predicted FDA license cost, and FDA certificate cost in India, whether you are a customer attempting to verify the legitimacy of a supplier or a business seeking the license yourself.