What is OTC Drug Product?
Over-the-counter or OTC drugs are drug products that are considered safe and effective by the FDA and yet can be purchased without a prescription. Currently, over 300,000 OTC drugs exist within 100 different therapeutic categories in the US market. Some examples of OTC drug products are acne creams, dry eye drops, sunscreen, sanitizers, etc. To enter US market, all OTC products must follow and comply with specific FDA pre-approved formulation rules, known as FDA monographs.
What is FDA OTC Monograph?
The FDA’s OTC monograph is a "rule book" for each therapeutic category containing information such as approved active ingredients, doses, and labeling requirements under which an OTC drug is approved to be safe and effective. Currently, the FDA lists hundreds of FDA monographs within nearly 100 therapeutic areas. See the list of all FDA proposed monographs
OTC Drug Registration Steps:
- OTC Drug Establishment Registration ......... (1-2 days)
- Obtaining Labeler Code ................................. (3-5 days)
- OTC Drug Label Compliance ........................ (5-7 days)
- OTC Drug Listing ........................................... (3-5 days)
OTC Drug Establishment Registration
According to the FDA, all OTC drug establishments that formulate, process or pack, manufacture, and distribute OTC drugs in the US must register and/or list all their OTC products with FDA. This rule applies to domestic and foreign manufacturers, processors, packers, and labelers for OTC, API, generic, homeopathic, and “unapproved drugs”. Applicants must submit an electronic request using the Structured Product Labeling SPL format (a valid DUNS number is required). Companies based outside the US must have a US agent assigned that will be the FDA's primary point of contact. All OTC drug establishment registration must be renewed annually between October 1- December 31.
A complete guide about who must register and list can be accessed here.
Obtaining Labeler code
Labeler code, also known as NDC labeler code, is a 5-digit company identification number assigned by the FDA to the manufacturer or distributor of OTC drugs. A labeler code is required to submit an OTC drug listing and obtain an NDC code. NDC code is a 10-digit identification number for all OTC drugs sold in the US that is also used for billing and insurance purposes. The drug manufacturers must submit an electronic request in SPL format containing the primary location, operation, contact information of the company to obtain the labeler code. Foreign entities must have a US agent to be able to submit a labeler code application. For more info, see what an NDC is and how is can be created.
OTC Drug Labeling Requirement
FDA neither reviews nor does pre-approve the label of the OTC drug products. Instead, it is the responsibility of the OTC drug manufacturer or distributor to comply with FDA OTC drug labeling requirements published by the FDA. The OTC drug label must comply with a specific standardized format and content requirements for the OTC drug fact panel and principal display panel sections of the OTC drug label.
OTC Drug Listing
As a final step, the OTC drug manufacturer and distributors must list the OTC drug, submit the product's label to the FDA, and obtain a 10-digit NDC code. An OTC listing submission shall contain all important OTC drug info, such as active and inactive ingredients, inner and outer packaging, container type, FDA monograph citation, marketing start and end dates, drug facts panel info, etc. The OTC drug listing form must be submitted electronically using SPL format.
Once an OTC drug listing is complete, the registrant will receive the NDC number for the drug (see more about what an NDC is). The drug registration record will be published in the NDC directory within a few days. All OTC drug listings must be renewed, or certified, annually, between October 1 and December 31.
If you need assistance with establishment registration, labeler code, drug label review, and listing of OTC drug products feel free to reach us via phone at +1 646-902-1448 or email us at [email protected], and we will assist you.
Important Questions:
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What if the brand owner of the drug is not the same as the manufacturer?
If the drug manufacturer is different than the brand owner, as in most Private Label Distributor PLD and contract manufacturer relationships, the brand owner or PLD must repeat steps 2-4 from the above steps. In other words, if the manufacturer does not own the brand of the drug product, then the brand owner firm must also obtain the labeler code and list the OTC drug, aside from the manufacturer.
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Are there any FDA fees involved with OTC registration?
Aside from the registration service fees, there is no FDA fee to be paid at the time of OTC drug registration. However, under FDA’s OTC Monograph Drug User Fee Program (OMUFA), all facilities involved in OTC manufacturing, either own-brand MDF or contract manufacturer CMO, must pay an annual user fee in the subsequent fiscal year. There are no FDA annual user fees for the distributor of OTC products. For more information about the current year’s FDA user fees, Please visit the FDA OMUFA website.
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What is the DUNS number, and how to get it for an overseas firm?
The DUNS number is a unique nine-digit identifier for businesses, which is required for the FDA registration process. The DUNS number is issued by Dun & Bradstreet, a US-based company. Most US-based and Canadian companies can have a DUNS number issued without any fees. To obtain the DUNS number overseas, you can either create an account and submit a DUNS application on DUNS Import Safety Portal or contact the local DUNS office in the foreign country.
FDA Registration Certificate
After your registration is complete, the registered drug establishment will be assigned a registration number by the FDA. The FDA does not issue any registration certificate; however, as a third-party agent, FDA Listing Inc. will provide you with a certificate of FDA OTC drug registration which can be used as proof before US customs and with industry partners.
