Yes. All foreign drug establishments exporting pharmaceutical products to the U.S. must be registered with the FDA under 21 CFR Part 207 and must designate a U.S. Agent. Without registration, drug shipments will be refused entry and may trigger an import alert.

Annually. FDA drug establishment registration must be renewed every year during the official renewal window, which runs from October 1 through December 31. Failure to renew on time results in cancellation of the registration.

Your products are treated as misbranded under FD&C Act §502(o). The FDA can block shipments at the U.S. border, issue refusal notices, place products on Import Alert, and initiate enforcement actions including Warning Letters, seizures, and injunctions.

A Labeler Code is a unique FDA-assigned identifier required for all companies that label or co-label drug products in the U.S. It is the foundation for NDC (National Drug Code) numbers. Without a Labeler Code you cannot legally assign NDC numbers to your drug products or submit drug listings to the FDA.

An NDC (National Drug Code) is a unique 3-segment identifier assigned to every drug product marketed in the U.S. The format is Labeler Code – Product Code – Package Code. To obtain an NDC you must first have an FDA Labeler Code, then assign product and package codes based on your product formulation and packaging.

Yes. The FDA requires every foreign drug establishment to designate a U.S. Agent under 21 CFR 207.69. The U.S. Agent acts as the FDA's official domestic contact and must be available to respond to FDA inquiries, inspection scheduling, and emergency communications.

Yes, it is required. Drug listing is the process of submitting information about each drug product you manufacture or distribute to the FDA in SPL (Structured Product Labeling) format under 21 CFR Part 207. Drug listings must be updated whenever product information changes and recertified twice per year in June and December.

No. Drug establishment registration is a mandatory administrative requirement and does not constitute FDA product approval. Prescription drugs require a separate NDA or ANDA approval process. OTC drugs must comply with an FDA monograph or obtain their own approval.

A DUNS (Data Universal Numbering System) number is a 9-digit unique business identifier required by the FDA as part of the drug establishment registration process. It helps the FDA verify business identity. We assist companies in obtaining their DUNS number quickly to avoid registration delays.

24–48 hours in most cases. When all information is correct and complete, drug establishment registration is typically confirmed by the FDA within 24 to 48 hours. Errors in facility information, missing DUNS numbers, or incorrect establishment roles can cause significant delays.

All finished drug products intended for human or animal use in the U.S. require drug establishment registration. This includes prescription drugs, OTC drugs, biologics classified as drugs, compounded drugs for commercial distribution, APIs, homeopathic drugs, and veterinary pharmaceuticals.

Current Good Manufacturing Practice (cGMP) regulations under 21 CFR Parts 210 and 211 establish minimum requirements for methods, facilities, and controls used in drug manufacturing. All registered drug establishments must comply with cGMP.

Yes. FDA Registration Assistance provides full U.S. Agent services for foreign drug establishments — included in the $449/year fee. We serve as the official FDA point of contact, receive inspection notices and regulatory correspondence, and respond to FDA communications on your behalf.

FDA drug establishment inspections may review cGMP compliance, manufacturing records, laboratory controls, equipment maintenance, personnel training, labeling procedures, and complaint handling. Inspectors may issue Form 483 observations that must be addressed promptly.

Yes. If you are the labeler of an OTC drug product — even if you outsource manufacturing — your establishment must be registered with the FDA and you must obtain a Labeler Code and NDC numbers for your products.

Yes. We assist pharmaceutical companies in resolving FDA drug import alerts and Detention Without Physical Examination (DWPE) listings. Our regulatory team prepares corrective action plans, gathers documentation, and works through the FDA process.

No, not for standard registration. The FDA does not charge a government fee for drug establishment registration under 21 CFR Part 207. Certain establishments subject to GDUFA or PDUFA may have separate user fee obligations. Our professional service fee is $449/year.

If your company manufactures, repacks, relabels, or commercially distributes any drug product in or to the United States — including OTC, prescription, APIs, homeopathic, or veterinary drugs — you almost certainly require FDA drug establishment registration.

Yes. We track annual renewal deadlines, update establishment information, manage drug listing submissions, handle labeler code and NDC changes, and provide continuous regulatory support so your drug establishment remains fully compliant year after year.

Depending on your operation, this may include drug establishment registration confirmation, U.S. Agent designation, DUNS number documentation, Labeler Code assignment, NDC numbers, SPL drug listing files, cGMP compliance records, and label compliance documentation.

Drug registration errors — incorrect establishment roles, missing DUNS numbers, improper SPL submissions, or NDC formatting mistakes — can cause registration rejection, import alerts, and enforcement actions. Our regulatory experts ensure every filing is accurate and compliant.

$449/year covers the full establishment registration package. Included: FDA drug establishment registration under 21 CFR Part 207, U.S. Agent designation for foreign establishments, DUNS verification, SPL drug listing setup for one product, and annual renewal filing during the Oct 1 – Dec 31 window. The FDA itself charges no government fee for standard registration. Typical add-ons billed separately: Labeler Code Registration $349 one-time (required before any NDC can be assigned), NDC Code Assignment $199 per product, additional SPL drug listings beyond the first, Drug Label & Ingredient Review, and DMF support.

Technically yes, but strongly discouraged. The FDA only requires that the U.S. Agent be a U.S. resident or U.S. business with a verifiable physical street address (no P.O. boxes) who is reachable during business hours. There is no FDA license, exam, or registration for U.S. Agents. The risk is that a friend or relative who does not understand FDA correspondence — Form 483 timelines, inspection scheduling, import-entry inquiries — can cause your registration to be deemed invalid the moment they fail to respond.

Your registration can be cancelled and your shipments refused at the border. Under 21 CFR 207.69 the U.S. Agent must be reachable and respond to FDA communications. If the FDA cannot reach the agent — or the agent fails to acknowledge an inspection notice, Form 483, or import inquiry — the agency can treat the registration as invalid, place the establishment on Import Alert (DWPE), and refuse entry of all incoming drug shipments.

You must update your registration within 30 days of the change. Under 21 CFR 207.57(b), any change to the establishment name, address, U.S. Agent, owner/operator, or contact information must be reported to the FDA within 30 days. The update is filed electronically through the same FURLS / CDER Direct system used for the original registration, in SPL format.

Yes, if you label drug products. Drug Establishment Registration ($449/year) registers your facility; a Labeler Code ($349 one-time) identifies your company on every drug product label. The Labeler Code is the 4- or 5-digit first segment of every NDC. Without it you cannot assign NDC numbers ($199 per product) or submit a valid SPL drug listing.

They are completely separate. Drug Establishment Registration (21 CFR Part 207) is an administrative listing of your facility — it does not approve any product. An NDA or ANDA under 21 CFR Part 314 is a scientific review process that approves a specific drug for U.S. marketing.

Yes, technically. The FDA charges no government fee for standard registration, and self-filing is possible through CDER Direct or FDA ESG. However, the SPL format is XML-based, the establishment-role classification is technical, and DUNS verification, U.S. Agent designation, and drug listing must all be completed correctly. Errors cause rejection, registration cancellation, or import alerts.

FEI stands for Facility Establishment Identifier. It is the unique numeric identifier the FDA assigns to every registered drug establishment. The FEI is used by the FDA to track inspections, compliance history, and import entries — and it is the number U.S. Customs cross-references at the border.

Yes. Under 21 CFR 207.17, each physical drug establishment must be registered separately, and each receives its own FEI number. A company operating three manufacturing sites needs three registrations — even if they share ownership. Each site must also independently comply with cGMP under 21 CFR Parts 210 and 211.

Yes. Amazon, Walmart Marketplace, Shopify Payments, and most major U.S. e-commerce platforms require sellers of OTC drugs to provide proof of FDA drug establishment registration, a valid NDC, and an SPL drug listing before listings are activated. Missing or expired registration is a top cause of OTC drug listings being suspended or de-listed.

October 1 to December 31. Annual renewal must be filed during this 90-day window under 21 CFR 207.29. Missing the deadline results in automatic cancellation on January 1, after which the FDA treats the establishment as unregistered for import and enforcement purposes.

Your products become misbranded under FD&C Act §502(o). They cannot enter U.S. commerce. The FDA can refuse all incoming shipments, place the facility on Import Alert (DWPE), and issue a Warning Letter. Reinstating a cancelled registration requires a full new filing, fresh SPL submissions, and often a written explanation.

No — only a U.S. Agent. Foreign drug establishments must designate a U.S. Agent with a verifiable U.S. street address (P.O. boxes are not accepted). You do not need to incorporate a U.S. entity, lease a U.S. office, or have any U.S. employees.

No, they are entirely separate. Food facility registration is governed by 21 CFR Part 1, Subpart H (under FSMA) and renews every even-numbered year. Drug establishment registration is governed by 21 CFR Part 207 and renews every year between Oct 1 – Dec 31. A company that manufactures both food and drugs needs both registrations.