FDA LISTING INC: EXPERIENCED ADVISORS FOR FULL-SERVICE FDA REGISTRATION & COMPLIANCE
+1 212 444 8202
U.S. FDA Registration
& Labeling Compliance Assistance
Drugs
Navigating FDA registration can be challenging. Our dedicated team is here to make it seamless for you. Whether you’re introducing a new product to the U.S. market, renewing existing registrations, or maintaining compliance with FDA standards, we’re ready to assist every step of the way.
Why Choose Us?
With extensive expertise in FDA regulatory compliance, we understand the drug industry’s unique requirements and challenges. Our team ensures your products meet all FDA standards, from establishment registration, drug listings, and Drug Master File submissions to labeling compliance. We manage every aspect of the process, including document preparation, submission, and ongoing communication with FDA officials as needed.
Drugs
Navigating FDA registration can be challenging. Our dedicated team is here to make it seamless for you. Whether you’re introducing a new product to the U.S. market, renewing existing registrations, or maintaining compliance with FDA standards, we’re ready to assist every step of the way.
Why Choose Us?
With extensive expertise in FDA regulatory compliance, we understand the drug industry’s unique requirements and challenges. Our team ensures your products meet all FDA standards, from establishment registration, drug listings, and Drug Master File submissions to labeling compliance. We manage every aspect of the process, including document preparation, submission, and ongoing communication with FDA officials as needed.
OTC Drug Establishment
Registration & Drug Listing
Over-the-counter (OTC) drugs are products considered safe and effective by the FDA, yet can be purchased without a prescription.
OTC Drug
Labeling Requirements
All drugs sold in the U.S., regardless of where they are manufactured, must comply with the labeling requirements set by the FDA (FD&C Act).
FDA NDC
Labeler Code
The United States Drug Listing Act of 1972 requires registered drug establishments to provide the FDA with a current list of all drugs manufactured.
FDA Drug
Master File (DMF)
A Drug Master File (DMF) is a secure submission to the FDA that contains confidential and detailed information about facilities, processes.
FDA Registration
Certificate & US Agent
Companies registered with the FDA often seek a certificate to use as proof of registration when dealing with trade or industry partners.
FDA Import Alert
& Detention Assistance
FDA Import Alerts protect US consumers from products produced at facilities with a known history of violations. After identifying a violation.
OTC Drug Establishment
Registration & Drug Listing
Over-the-counter (OTC) drugs are products considered safe and effective by the FDA, yet can be purchased without a prescription.
OTC Drug Labeling
Requirements
All drugs sold in the U.S., regardless of where they are manufactured, must comply with the labeling requirements set by the FDA (FD&C Act).
FDA NDC
Labeler Code
The United States Drug Listing Act of 1972 requires registered drug establishments to provide the FDA with a current list of all drugs manufactured.
FDA Drug
Master File (DMF)
A Drug Master File (DMF) is a secure submission to the FDA that contains confidential and detailed information about facilities, processes.
FDA Registration
Certificate & US Agent
Companies registered with the FDA often seek a certificate to use as proof of registration when dealing with trade or industry partners.
FDA Import Alert
& Detention Assistance
FDA Import Alerts protect US consumers from products produced at facilities with a known history of violations. After identifying a violation.
Frequently Asked Questions (FAQ)
Who must register a drug establishment and list products with the FDA?
Any domestic or foreign facility that manufactures, repacks, relabels, or salvages human drug products for U.S. commercial distribution must complete FDA establishment registration. Additionally, every unique drug formulation and packaging style must be listed with its assigned National Drug Code (NDC).
What is an FDA Labeler Code, and how do you obtain one?
An NDC Labeler Code is a unique 4- or 5-digit identifier assigned by the FDA to the company marketing the drug product. Companies must request a labeler code electronically via Structured Product Labeling (SPL) XML submission prior to listing their drugs.
What are the labeling requirements for Over-the-Counter (OTC) drugs?
OTC drugs sold in the U.S. must feature a standardized Drug Facts panel displaying active ingredients, purposes, uses, warnings, directions, and inactive ingredients in a uniform, FDA-mandated format.
What is a Drug Master File (DMF), and who needs to submit one?
A DMF is a confidential technical submission provided to the FDA by raw material suppliers, active pharmaceutical ingredient (API) manufacturers, or packaging providers. It allows drug applicants to reference proprietary manufacturing processes without disclosing trade secrets to third parties.
How does the FDA regulate Over-the-Counter (OTC) drugs under the Monograph system?
OTC drugs that comply with an established FDA OTC Monograph Order (governing permitted ingredients, dosages, and claims) can be marketed without pre-market FDA approval, provided the facility is registered and the product is properly listed.
How do you resolve an FDA import detention for a pharmaceutical shipment?
If a drug shipment is detained at the U.S. border for issues such as unlisted NDCs, non-compliant labeling, or facility registration mismatches, the importer must present official testimony, laboratory test results, or corrected regulatory data to the FDA Division of Import Operations within the required response window.