USA REGULATORY COMPLIANCE 

EXPORT OTC TO THE U.S.A

FDA and State Regulations

Over-the-counter (OTC) 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), mainly through monographs (recipes / guides) that set the guidelines to apply in our product.  

The registration of an OTC medicine is more complex than that of a cosmetic product and consists of the following parts:

​

1. REVIEW OF INGREDIENTS ACCORDING TO PRODUCT MONOGRAPH

We adapt your product to the existing monograph within its category, respecting restrictions, indicated concentrations, active substances, etc ...  

​

2. REVIEW OF OTC CLAIMS

Check that the claims of the effects of the active substances are correct and allowed by the FDA.  

​

3. CREATION OF LABELS AND INFORMATION ABOUT THE MEDICINAL PRODUCT

Designing a label that is compliant with the 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.

​

4. REGISTRATION OF THE PRODUCT WITH THE FDA: DRUG LISTING

Before an OTC can be marketed, it is mandatory that the product and all its variants (eg the different shades of makeup) be registered with the FDA. In this way, the agency can know at all times which OTCs are available in the market.

​

5. REGISTRATION OF THE MANUFACTURER WITH THE FDA: DRUG ESTABLISHMENT REGISTRATION

In the US, OTC manufacturers must comply with Good Manufacturing Practices (GMP). They must also register with the FDA's Drug Establishment Registration. This registration is mandatory for all manufacturers, including those that manufacture for third parties (eg manufacturers of "white label" products).

As manufacturers, they are responsible for the OTC they make, even if it is not marketed under their brand. Brands that commission the manufacture of their OTC to third parties must therefore ensure that manufacturers have this registration. If this is not the case, they should ask for it to be obtained, since without it the marketing of their OTC products will not be possible.

​

In order to register through the FDA electronic system, manufacturers must obtain DUNS identifiers and an NDC tag code.

​

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.

​

6. US AGENT SERVICE

​

The US agent is the representative of the foreign filer in the US and plays a critical role.

This agent is in charge of examining, disseminating, directing and responding to all communications with the FDA, including those of an urgent nature.

It is also responsible for responding to questions related to drugs imported or proposed for import into the United States.

Additionally, you can assist FDA in planning any necessary inspections.