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OTC PRODUCTS
Regulatory Compliance for Over-the-Counter Drugs in the United States
OTC (Over-the-Counter) products in the United States are over-the-counter medications that do not require a prescription and must comply with FDA regulations to be considered safe and effective. Common examples include sunscreens and acne products. At Belab Services, we handle the FDA registration and compliance process, ensuring that your OTC product meets all regulations for sale in the US market.
WHAT IS AN OTC PRODUCT?
An OTC (Over-the-Counter) medication is a medication that the FDA (U.S. Food and Drug Administration) considers safe and effective for use without a prescription. These products can be purchased directly from pharmacies or retail stores. Common examples of OTC medications include sunscreens, acne creams, eye drops, and hand sanitizers, among others.
Currently, there are more than 300,000 over-the-counter medications on the U.S. market, classified into various therapeutic categories. To be marketed, OTC products must comply with FDA monographs , which are pre-approved guidelines on formulation, ingredients, and labeling.
STEPS TO REGISTER AN OTC IN THE UNITED STATES
To launch an OTC product in the U.S. market, several steps must be followed, ensuring that the product complies with regulations established by the FDA:
01
Establishment registration
Facilities that manufacture, process, package, or distribute OTC products must register with the FDA through a US Agent. This registration applies to both US-based companies and foreign companies wishing to sell their products in the country. This registration must be renewed annually.
02
Obtaining the labeling code
Companies must obtain a National Drug Code (NDC) labeling code, a unique 10-digit identification number assigned by the FDA. This code is required to list the OTC product and is used for billing and tracking purposes. Foreign companies must designate a U.S. agent to manage this process.
03
Labeling compliance :
Although the FDA does not review or pre-approve OTC product labels, it is the manufacturer's or distributor's responsibility to ensure that the labeling complies with current regulations. Labeling must follow a standardized format that includes clear information about ingredients, dosages, and warnings on a Drug Facts Panel.
04
OTC Product Listing :
Once the establishment has registered and the labeling code and NDC have been obtained, the manufacturer must list the product with the FDA. This listing must include details such as the active and inactive ingredients, packaging, container type, and any references to the applicable FDA monograph. Once approved, the product will appear in the public NDC directory.
WHAT IS AN FDA OTC MONOGRAPH?
An OTC monograph is a set of rules established by the FDA for different therapeutic categories. These guidelines detail the approved active ingredients, permitted dosages, and labeling requirements that products must meet to be considered safe and effective without a prescription.
Companies that follow these monographs can launch their products without prior FDA approval, as long as they meet established guidelines.
FDA REGISTRATION CERTIFICATE
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Once registration is complete, the FDA will assign a registration number to the corresponding pharmacy establishment. Although the FDA does not issue registration certificates, FDA Listing Inc., Belab Services, as a third-party agent, can provide you with an FDA OTC drug registration certificate.
This certificate can be used as evidence before U.S. customs authorities and with trading partners.
To market an OTC product in the United States, a process regulated by the FDA must be followed, including facility registration, obtaining an NDC code, and product listing. These steps ensure that OTC medications meet FDA-established safety and efficacy standards, thereby protecting consumers.
With over 10 years of experience in cosmetic safety assessments and USA regulation, BELAB SERVCES offers a comprehensive and reliable solution to effectively verify and register cosmetic products.
Our solution, based on a deep knowledge of the legislation, has a team of scientific consultants and advanced IT tools, making it the fastest and most reliable way to access the European market.
OTC FAQs