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OTC Drug Establishment Registration and Listing Requirements

Over the counter (OTC) drug products are those drugs that are available to consumers without a prescription. There are more than 80 therapeutic categories of OTC drugs, ranging from acne drug products to weight control drug products. US FDA is not approving the OTC products but FDA is evaluating the ingredients and labeling of these products as part of the FDA OTC Drug Review Program.

FDA OTC Drug monograph

The OTC monographs represent regulatory standards for the marketing of non-prescription drug products not covered by new drug applications. These standards provide the marketing conditions for some OTC drug products including the active ingredients, labeling, and other general requirements. Marketing pre-clearance of OTC drug products by the US FDA is not required if the standards of the applicable monograph are met. An antidandruff shampoo, tooth paste with fluoride, Sunscreen products etc... are regulated as over the counter drug (OTC) product.

OTC Drug Establishment Registration with US FDA

Domestic and foreign establishments that manufacture, repack, or re-label OTC drug products or import or offer for import OTC drug products to the United States require FDA drug establishment registration, and renew the registration annually, FDA drug establishment registration information should be submitted electronically using SPL files with coded data fields. US FDA encourages electronic registration, even though you can submit registration in paper format if a waiver is granted. A Private Label Distributor (PLD) does not require US FDA drug registration. A contract sterilizer and Contract Testing Laboratory (dosage forms & active ingredient release) require US FDA registration but not listing. A foreign drug manufacturer also requires US FDA registration and listing, if drug from the manufacturer is marketing in the USA.

US FDA OTC Drug Listing Requirements

Registrants are required to submit initial listing information of all OTC drugs in commercial distribution at the time of FDA establishment registration. The listing information should submit in SPL format and should upload the product image also. If a private label distributor is listing the OTC drug with US FDA, the PLD may request their own NDC Labeler code, but PLD does not require FDA establishment registration. By submitting the drug listing information the PLD assumes the full responsibility for compliance with US FDA drug listing requirements. Owners and operators of all registered establishments shall update their drug listing information with US FDA every June and December.

US FDA OTC Drug Labeling Requirements

US FDA is not pre-approving OTC Drug Labels marketed under OTC Monograph, but US FDA regulates all of the OTC Drug labeling like immediate container, outer package, package insert etc.. . The required information's include Drug Facts labeling and Principle Display Panel labeling. The regulations help to standardize the content and format of OTC Drug labeling. The registrant may upload the OTC drug labeling at the time of drug listing in SPL file format.

FDA Drug Registration Certificate

US FDA does not issue a certificate of registration nor does US FDA recognizes a registration certificate issued by private businesses. You can verify the registration status of your establishment at fda website. FDA updates registration and listing status twice a month. If you require assistance in Drug registration and listing, Liberty Management Group Ltd. can help you.

Who is required to Register and List

LMG provide assistance in preparation and submission of SPL files for

  • US FDA Drug Establishment Registration
  • Drug Listing with US FDA
  • NDC Labeler code request to US FDA
Services and Fees

  FDA Registration and   U.S. Agent service

       USD 649        (Annually)

  Drug Listing

       USD 399 /        Drug

  Label Review

       USD 649 /        Drug

  DMF Submission and   U.S. Agent service

       USD 649/        (Annually)

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"Our sincere thanks for helping us in preparing the SPL file and completing drug listing with FDA."

Benedict, India

"Greetings from Los Angeles. Much thanks and regards to help us to finalize our electronic FDA submission"

Paul, Los Angeles

"Wonderful job, you did it so quickly."

Nervaliz, Israel