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 anti-acne products. At Belab Services, we take care of the FDA registration and compliance process, ensuring that your OTC product complies with all regulations for marketing in the US market.
What is an OTC in the United States?
An OTC (Over-The-Counter) 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 OTCs include sunscreens, acne creams, eye drops, and hand sanitizers, among others.
There are currently more than 300,000 over-the-counter drugs on the U.S. market, classified into a variety of therapeutic categories. To be marketed, OTC products must comply with FDA monographs , which are pre-approved guidelines on formulation, ingredients, and labeling.
Classification and evaluation of the record
Evaluation and obtaining the DUNS
Reg. Establishment and obtaining of the NDC
OTC Drug Review List and Compliance
Final approval by the FDA
Steps to Register an OTC Product in
USA
To launch an OTC product in the US market, several steps must be followed, ensuring that the product complies with the regulations established by the FDA:
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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 companies within the US and foreign companies wishing to sell their products in the country. This registration must be renewed annually.
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Obtaining the labeling code : Companies must obtain a National Drug Code (NDC), 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.
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Labeling Compliance : Although the FDA does not review or pre-approve OTC product labels, it is the manufacturer or distributor's responsibility to ensure that labeling complies with applicable regulations. Labeling must follow a standardized format that includes clear information about ingredients, dosage, and warnings on a drug facts panel.
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OTC Product Listing : Once the establishment has registered and obtained the labeling code and NDC, 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 reference 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, allowable 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 needing prior FDA approval, as long as they comply with the established guidelines.
FDA Registration Certificate
Once registration is complete, the FDA will assign a registration number to the relevant pharmaceutical 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 with U.S. customs authorities and trading partners.
To market an OTC product in the United States, it is necessary to follow an FDA-regulated process that includes registering the facility, obtaining the NDC code, and listing the product. These steps ensure that over-the-counter medications meet the safety and efficacy standards set by the FDA, 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.
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EU Responsible Person and UK Responsible PersonAnother important aspect of regulation is that of the responsible person. In Europe, the responsible person is someone who has legal responsibility for ensuring that a product meets legal requirements. The same goes for the UK responsible person in the UK. Experts in cosmetics and healthcare product regulation can help companies understand the roles and responsibilities involved in this process.
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CPNP and SCPN and PIF registrationCPNP Registration (Cosmetic Product Notification Portal) is a legal requirement for cosmetic products in Europe. SCPN is the UK equivalent. In order to register on these portals, detailed information about the product is required, including ingredients and formulations. Experts in cosmetics and healthcare product regulation can help companies complete these registrations and ensure they are complying with legal requirements.
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Technical dossier for product authorization in EuropeA technical dossier is a document that describes the technical and safety aspects of a product. It is a legal requirement for most cosmetic and health products in Europe. Experts in cosmetics and medical device regulation can help companies complete a technical dossier for product authorization in Europe.
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Who is responsible for the regulation of cosmetic products in Europe?In Europe, the regulation of cosmetic products is the responsibility of the European Commission, which establishes regulations and requirements to guarantee the safety and quality of the products that are marketed
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What are the requirements that a cosmetic product must meet in order to be marketed in Europe?A cosmetic product must comply with a series of requirements established in European Regulation 1223/2009. These requirements include aspects related to safety, labeling, permitted ingredients, animal testing and prior notification before marketing.
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What products are not considered cosmetics according to European Regulation 1223/2009?According to European Regulation 1223/2009, products that have a medical purpose, such as medicines, medical devices or health products, are not considered cosmetics. These products are regulated by other specific regulations.