OTC Products
OTC Drug Regulatory Compliance for the United States
OTC medications are over-the-counter medications that can be purchased without a prescription. They belong to a narrower range of adverse effects. Most OTC remedies do not have the same potential as those obtained with a prescription. This does not mean, however, that they are risk-free.
Registration of OTC products to the United States
What is an OTC under FDA Regulation?
OTC (Over the Counter) medications are those that the consumer can buy without a prescription at the pharmacy or parapharmacy section. Some products, such as sun creams, antiperspirant deodorants, mouthwashes or anti-dandruff shampoos, are considered OTC in the United States and have been regulated under the regulations of the Federal and Drug Administration (FDA), which set the guidelines to be applied in our product.
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Steps to Register an OTC medication
1. REVIEW OF INGREDIENTS ACCORDING TO THE PRODUCT MONOGRAPH
We adapt your product to the existing monograph within its category, respecting restrictions, indicated concentrations, active substances, etc...
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2. REVIEW OF OTC CLAIMS
Check that the claims of the effects of the active substances are correct and permitted by the FDA.
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3. CREATION OF LABELS AND INFORMATION ABOUT THE MEDICINAL PRODUCT
Designing a label compliant with FDA and monographs is a task that requires experience and skill. With this we will be able to rigorously describe the function of the product, the active ingredients, the side effects, etc.
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4. PRODUCT REGISTRATION WITH THE FDA: DRUG LISTING
Before an OTC can be marketed, it is mandatory that the product and all its variants (e.g. different shades of makeup) be registered with the FDA. In this way, the agency can know at all times which OTCs are available on the market.
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5. MANUFACTURER REGISTRATION WITH THE FDA: DRUG ESTABLISHMENT REGISTRATION
In the US, OTC manufacturers must comply with Good Manufacturing Practices (GMP). Likewise, they must register in the FDA's Drug Establishment Registration. This registration is mandatory for all manufacturers, including those that manufacture for third parties (e.g. manufacturers of “white label” products).
As manufacturers, they are responsible for the OTC they make, even if they are not marketed under their brand. Brands that commission the manufacturing of their OTC to third parties must therefore ensure that the manufacturers have this registration. If this is not the case, they must be asked to obtain it, since without it the marketing of their OTC products will not be possible.
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In order to register through the FDA electronic system, manufacturers must obtain DUNS identifiers and an NDC label code.
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At the end of this registration, the manufacturer receives a registration certificate, the duration of which is one year and must be renewed annually between October 1 and December 31.bre.
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6. US AGENT SERVICE
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The U.S. agent is the foreign filer's representative in the U.S. and plays a critical role.
This agent is responsible for reviewing, disseminating, directing and responding to all communications with the FDA, including urgent communications.
It is also responsible for responding to questions regarding medications imported or proposed for importation into the United States.
Additionally, it can assist the FDA in planning any necessary inspections.
FDA Registration Certificate
​Once the registration process is complete, the FDA will assign a registration number to the registered pharmaceutical establishment. It is important to mention that the FDA does not issue a registration certificate itself. However, as an external entity, FDA Listing Inc. will provide an FDA over-the-counter drug registration certificate, which can be used as evidence before United States customs authorities and also with industry partners.
