Drug Establishment Registration Guide

What Is FDA Drug Establishment Registration?

Drug establishment registration is a mandatory FDA requirement under Section 510 of the Federal Food, Drug, and Cosmetic Act. It applies to facilities engaged in the manufacture, preparation, propagation, compounding, or processing of drugs for commercial distribution in the United States.

Registration provides FDA with vital information about who is manufacturing drugs and where. This information supports FDA inspection planning, product recalls, and surveillance of the drug supply chain. For a broader industry overview, see our pharmaceutical FDA compliance page.

Who Must Register a Drug Establishment?

The following types of drug establishments must register with FDA:

Domestic Establishments

• Manufacturers: Facilities that make drugs from raw materials
• Repackers: Facilities that repackage drugs into different containers
• Relabelers: Facilities that change drug labeling
• Drug salvagers: Facilities that return distressed drugs to market
• Private label distributors: Companies that market drugs under their own label

Foreign Establishments

Foreign establishments that manufacture, prepare, propagate, compound, or process drugs for export to the United States must also register. This includes:

• API (Active Pharmaceutical Ingredient) manufacturers
• Finished dosage form manufacturers
• Contract manufacturers making drugs for US markets
• Repackers and relabelers serving the US market

Foreign establishments must designate a US Agent as part of registration.

Exemptions

Certain establishments are exempt from registration:

• Pharmacies: Licensed pharmacies dispensing prescriptions (but pharmacies engaging in manufacturing must register)
• Licensed practitioners: Physicians and other practitioners who compound drugs in their practice
• Teaching hospitals: For drugs used only within the hospital
• Analytical laboratories: Labs that only analyze drugs (don't manufacture)

How Do I Register a Drug Establishment with the FDA?

Drug establishment registration is completed electronically through FDA's Drug Registration and Listing System (DRLS).

Step 1: Obtain Required Numbers

• DUNS number: Obtain from Dun & Bradstreet (required)
• FDA Establishment Identifier (FEI):Assigned by FDA upon first registration

Step 2: Create FDA Account

Access FDA Industry Systems and create an account if you don't have one. This account will be used for all FDA electronic submissions.

Step 3: Complete Registration

Through DRLS, provide:

• Establishment name and physical address
• Contact information
• DUNS number
• Type of operations conducted
• US Agent information (foreign establishments)
• Business operation dates

Step 4: List Drug Products

After registration, list all drug products manufactured at the facility:

• NDC numbers
• Product names (proprietary and nonproprietary)
• Dosage form and route of administration
• Active ingredients
• Package information
• Labeling (SPL format)

Step 5: Pay User Fees (if applicable)

Most drug establishments must pay annual user fees. Fee requirements depend on the type of products manufactured.

When Is Drug Establishment Registration Renewed?

Drug establishment registration must be renewed annually between October 1 and December 31. This is not automatic -- you must actively renew.

Renewal Process

1. Log in to DRLS during the renewal period
2. Review and update establishment information
3. Review and update drug listings
4. Confirm or update US Agent (foreign establishments)
5. Submit renewal

Consequences of Non-Renewal

• Registration lapses and establishment is listed as "inactive"
• Products may be subject to FDA enforcement action
• Import alerts may be issued for foreign establishments
• Re-registration may require additional scrutiny

What Are the FDA Drug Listing Requirements?

Drug listing is a companion requirement to establishment registration. Every drug manufactured, repacked, or relabeled must be listed in DRLS. Each product needs a National Drug Code; see our complete NDC number guide for details on obtaining and using NDC numbers.

Initial Listing Timeline

• Before distribution: Products should be listed before commercial distribution begins
• New products: List within 5 days of beginning distribution

Listing Updates

Update listings when:

• New products are introduced
• Products are discontinued
• Labeling changes
• Formulation changes
• Package size changes

SPL (Structured Product Labeling)

Drug listing requires submission of labeling in SPL format, an XML-based standard for drug labeling. SPL submissions include:

• Drug label content
• Product data elements
• Indexing terms for searchability

What User Fees Must Drug Establishments Pay?

Drug user fees fund FDA's drug review process. Most drug establishments must pay annual fees.

GDUFA (Generic Drug User Fee Act)

Applies to generic drug and API manufacturing establishments:

• Domestic and foreign finished dosage form (FDF) manufacturers
• Domestic and foreign API manufacturers
• Contract manufacturing organizations (CMOs)

PDUFA (Prescription Drug User Fee Act)

Applies to brand-name drug establishments. Includes application fees and establishment fees.

Fee Amounts

User fees are adjusted annually. Check FDA's website for current fee amounts. As of recent years:

• GDUFA FDF facility fee: Approximately $600,000+ annually
• GDUFA API facility fee: Approximately $50,000-$100,000+ annually
• PDUFA fees vary based on application type and establishment

Fee Exemptions

Some establishments may qualify for fee exemptions:

• Small businesses meeting specific revenue thresholds
• First-time generics manufacturers (reduced fees)
• Orphan drug manufacturers (certain exemptions)

Do Foreign Drug Establishments Need a US Agent?

Foreign drug establishments must designate a US Agent during registration. The US Agent serves as FDA's point of contact for the foreign facility. Learn more about this requirement in our drug establishment registration service page.

US Agent Responsibilities

• Receive FDA communications
• Respond to FDA inquiries
• Forward FDA messages to foreign establishment
• Assist with regulatory matters

See our complete US Agent Requirements Guide for detailed information.

How Do I Maintain Drug Registration Compliance?

Registration is just the beginning. Maintaining compliance requires ongoing attention:

What Are the Most Common Drug Registration Mistakes?

What Steps Are Needed for Drug Establishment Registration?