OTC PRODUCTS (USA)
Launch your OTC products in the United States with FDA compliance
We assess your product’s regulatory classification and manage the requirements necessary for its commercialisation in the United States, from compliance with the applicable OTC monograph to establishment registration, product listing and labelling review.
What is an OTC product?
An OTC product —Over-the-Counter drug— is a non-prescription medicine that can be purchased in the United States without a prescription.
This category may include products such as sunscreens, acne treatments, antiperspirants, anti-dandruff shampoos, antiseptics, skin protectants and other products intended to treat, prevent or relieve certain conditions.
The classification depends mainly on the product’s intended use, its active ingredients, its claims and the way it is presented to consumers. Therefore, a product marketed as a cosmetic in other countries may be regulated as an OTC drug in the United States.
01. WHAT IS AN OTC PRODUCT?
Belab Services assesses the product’s classification and determines the applicable regulatory pathway before it is placed on the market.
Examples of OTC categories
Sunscreens
Anti-dandruff shampoos
Acne treatments
Skin protectants
Antiperspirants
Antiseptics and other products
Is your product an OTC, a cosmetic, or both?
In the United States, classification depends on the product’s intended use. Products intended solely to cleanse, beautify or alter appearance are generally considered cosmetics. Products intended to treat or prevent a disease, or to affect the structure or any function of the body, are considered drugs.
Some products may be subject to both cosmetic and OTC drug requirements.
02. OTC, COSMETIC OR BOTH?
Examples of OTC categories
Possible classification
"Moisturizes and softens the skin"
Cosmetic Product
"Helps treat acné"
OTC Drug
"Mousturizing acné treatment"
Cosmetic +
OTC Drug
Incorrect classification may result in enforcement action or removal of the product from the market.
03. HOW CAN YOU MARKET YOUR OTC PRODUCT?
Two regulatory pathways for marketing OTC products
Pathway 1: OTC Monograph
An OTC drug may be marketed without individual pre-approval when the product fully complies with all the conditions established in the applicable OTC monograph.
Conditions:
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Permitted active ingredients
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Authorised concentrations
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Established indications and claims
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Dosage form and route of administration
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Labeling requirements
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Testing and other applicable conditions
The monograph does not regulate only ingredients, concentrations, claims and Drug Facts. It may also establish permitted uses, dosage, routes of administration, labelling and testing requirements.
This is the standard pathway when the product complies with all the conditions of an applicable OTC monograph.
Pathway 2: NDA / Drug Application
This pathway may be required when the product does not comply with an applicable OTC monograph, introduces a new condition of use or must be marketed through a drug application approved by the FDA.
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Uses new active ingredients
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Includes new indications or claims
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Does not comply with an existing monograph
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Requires a comprehensive FDA evaluation
In certain cases, changes to the conditions of an OTC monograph may require an OTC Monograph Order Request —OMOR—.
04. OUR REGULATORY SERVICES
Everything you need to market your OTC product in the United States
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Establishment Registration
NDC Code
Drug Facts Labelling
Facilities that manufacture, prepare, propagate, compound or process OTC drug products must be registered with the FDA.
Preparation and management of the information necessary for NDC identification and drug listing.
The label must follow the FDA’s required Drug Facts format.
Drug Listing
The OTC drug product must be listed with the FDA before being marketed.
Ongoing
Compliance
Regulatory obligations, updates and maintenance after market launch.
A clear, reliable and efficient process
05. OUR WORKING PROCESS
1. We assess your product
We review its composition, active ingredients, claims, labelling and intended use.
2. We define the strategy
We identify the applicable OTC monograph or the appropriate alternative regulatory pathway.
3. We prepare the compliance requirements
We manage the required documentation, labelling, establishment registration, product listing and other applicable requirements.
4. We support your product launch
We verify that the product is ready for commercialisation and ongoing regulatory maintenance.
