USFDA OTC Drug Registration Guidelines for Certified Manufacturers and Approved Plants

What is OTC Drug Product in USFDA?

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. Now, there are more than 300,000 OTC products in 100 different therapeutic categories. Some examples of OTC drug products, such as acne creams, dry eye drops and, sunscreens & disinfectants. To enter in to US market as a US FDA approved manufacturer for OTC product, all OTC products must follow and comply with specific FDA pre-approved formulation rules, known as FDA monographs.

What is US FDA OTC Monograph?

The US FDA 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. Recently, the FDA lists hundreds of FDA monographs within nearly 100 therapeutic areas.

OTC drug registration in USA

FDA classifies OTC drugs into two categories, OTC monograph drugs and new OTC drugs. OTC monograph drugs do not require FDA pre-approval before being marketed in USA. However, new OTC drugs require FDA pre-approval, either through NDA (New Drug Application) or ANDA (Abbreviated New Drug Application) before being listed in US FDA registered products.

To be US FDA registered products owner, both OTC monograph drugs and new OTC drugs are required to do first establishment registration and drug listing in US FDA approved OTC drug list, additionally they need to comply with the applicable Labeling and GMP requirements, and report the adverse events to FDA after being marketed in USA. 

US FDA OTC Drug Registration Steps

Step 1: US FDA OTC Drug Establishment Registration (1 – 2 days)

Step 2: Obtaining Labeler code (3 – 5 days)

Step 3: OTC Drug Label Compliance (5 – 7 days)

Step 4: OTC Drug Listing FDA (3 – 5 days)

US FDA OTC Drug Establishment Registration and OTC Drug Listing Steps

US FDA OTC Registration Process using Monograph Pathway

Step 1: FDA OTC Drug Establishment Registration

All OTC drug establishments that manufacture, distribute, formulate, process, or pack OTC drugs in the United States are required by the FDA to register and/or list all of their OTC products. To be a US FDA approved OTC drug Manufacturer, both domestic and international producers, processors, packers, and labelers of over-the-counter, API, generic, homeopathic, and “unapproved drugs” are subject to this regulation.

Using the Structured Product Labeling (SPL) format, applicants must electronically submit their product information, and a valid DUNS number is required. A US agent who will serve as the FDA’s main point of contact must be assigned to companies with headquarters outside of the US. Registration for all US OTC Approved Manufacturers must be renewed annually between October 1 and December 31.

Step 2: Obtaining Labeler code

The Labeler code, also known as the NDC labeler code, is a 5-digit identification number assigned by the FDA to the US FDA certified Manufacturer for OTC product, responsible for manufacturing or distributing over-the-counter (OTC) drugs. This code is required to submit an OTC drug listing and obtain a National Drug Code (NDC), a 10-digit identifier used for all OTC drugs sold in the US and for billing and insurance purposes. To be a US OTC Approved Plant, drug manufacturers must submit an electronic request in SPL format with company details to obtain the labeler code. Foreign companies must designate a US agent to apply for the code.

FDA National Drug Code NDC

The United States’ Drug Listing Act of 1972 mandates that drug establishments register with the FDA and submit a list of all drugs they manufacture, prepare, or process for commercial distribution. Each drug is assigned a unique 10-digit number, known as the National Drug Code (NDC), which acts as a universal identifier. The FDA publishes these NDC numbers along with other listing information in a public directory. To be a US OTC Approved Manufacturer, drug establishments must comply with this registration and listing requirement.

The 10-character National Drug Code (NDC) is divided into three segments: the first 5 digits, known as the Labeler Code, identify the manufacturer or distributor and are assigned by the FDA. The last 5 digits consist of the Product Code, which identifies the drug formulation, and the Package Code, which identifies the trade package size and type. Drug manufacturers assign the Product and Package Codes before listing the drug.

To obtain an NDC Labeler Code, manufacturers must submit a request in Structured Product Labeling (SPL) format via the FDA’s Electronic Submission Gateway (ESG). Foreign US OTC Exporters must have a US agent to submit the request. FDA Listing Inc. can serve as a U.S. agent and assist in preparing and submitting the SPL file to obtain the NDC Labeler Code.

Step 3: OTC Drug Label Compliance

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 labelling 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. US OTC Approved Manufacturers must ensure their labels meet these guidelines to ensure compliance with FDA regulations.

FDA Drug Labeling and Ingredient Requirement

Regardless of the manufacturing origin, all of the drugs that are in the U.S. market must comply with the Federal Food Drug and Cosmetic Act (FDCA). The US OTC Certified Manufacturer must ensure that their products comply with the applicable FDA regulations based on the drug’s “intended use.” This intended use is the primary factor in determining which FDA rules apply to the drug label.

The information that can appear on the drug label is largely determined by the FDA drug classification (e.g., prescription (Rx), API, etc.). The term “labeling,” as defined by the FDCA, includes not only the printed label on the drug package but also any inner packaging information, pamphlets, marketing materials, and the seller’s website. Any claims that go beyond what is approved by the FDA or fall outside the applicable regulations could lead to the drug being categorized as “unapproved.”

Labeling issues are often a primary cause of delays in FDA approvals, import alerts, and product detentions. To be a US OTC Approved Manufacturer, it’s crucial to ensure the label is compliant. FDA Listing Inc.’s drug labeling experts will first analyze your label by cross-checking it against applicable U.S. federal regulatory databases and FDA labeling guidelines. Then, we will provide you with a comprehensive FDA-compliant labeling review in an all-inclusive report, suggesting the proper format and ensuring it is ready for use on the drug packaging.

Step 4: OTC Drug Listing FDA

As a final step, the US OTC Certified Manufacturer must list the OTC drug, submit the product’s label to the FDA, and obtain a 10-digit NDC code. An OTC listing submission must contain all essential OTC drug information, such as active and inactive ingredients, inner and outer packaging, container type, FDA monograph citation, marketing start and end dates, drug facts panel information, and more. 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. 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.

US OTC Products Registration Fees

OTC Monograph Drug User Fee Rates

USFDA Registration Certificate

After your registration is complete, the US OTC Certified Manufacturer 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. This certificate can be used as proof before US customs and with industry partners.

Conclusion

The process for registering an OTC drug in the US largely depends on whether the product falls under an existing FDA OTC monograph or if it requires a New Drug Application (NDA). If the drug complies with a monograph, it may be marketed without pre-approval, but manufacturers must still ensure they meet all labeling, manufacturing, and safety requirements. If the product does not comply with a monograph, it will require more extensive review through the NDA process.

Key steps include establishment registration, obtaining a Labeler Code, ensuring FDA-compliant Labeling, and completing the OTC drug listing. US OTC Approved Manufacturers must also adhere to annual renewals, comply with Good Manufacturing Practices (GMP), and report any adverse events. By carefully following these steps and staying compliant with FDA guidelines, companies can successfully bring their OTC products to market and maintain their regulatory standing.

This article was crafted under the expert guidance of Ms. Ritika Patel, showcasing her invaluable contribution to its preparation and quality. – Team Conical Pharmaceuticals