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 marketing 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. Antidandruff shampoo, toothpaste with fluoride, Sunscreen products, etc... are regulated as over-the-counter drug (OTC) products. New FDA OTC Monograph Drug Facility Fees 2024

OTC Drug Establishment Registration with US FDA

Domestic and foreign establishments that manufacture, repack, or re-label OTC drug products or import or offer to 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 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 the 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 upload the product image. If a private label distributor lists the OTC drug with the 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 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 OTC Drug labeling like immediate container, outer package, package insert, etc.. . The required information includes Drug Facts labeling and Principal 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 the 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 assists in the preparation and submission of SPL files for

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

LMG also assists you to

• Review and modify your labeling to comply with US FDA requirements
• Review product ingredients to comply with US FDA requirements

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