Section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) requires companies that manufacture, process, reproduce, compound, handle, or import drugs into the US to register with FDA and FDA number renewal. Just like food or cosmetics, you will also need a US Agent for your facility.
Import alert are a way for the FDA and the public to authorize detention without physical inspection (DWPE) of products that may violate FDA regulations. These violations may be related to the product, manufacturer, shipper and/or other information. If you are having problems related to import alert, let us help you.
Call our office today for a re-check on your submission. We provides drug registration, listing services with FDA and U.S Agent services.
Domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States are required to register with the FDA. This information helps FDA maintain a catalog of all drugs in commercial distribution in the United States.
Registration for drugs shall be renewed between October 1 and December 31 each year.
Exporters submit updated drug listing information to FDA twice each year, in June and December, notifying FDA if this information has changed (at any time in the calendar year).
If you are outside U.S, you need to have a representative who is American.
Along with FDA registration, FDA regulates that exporters from outside the U.S must appoint a representative in the U.S (U.S Agent) to register with FDA. U.S Agent is both regular and emergency communication channel between FDA and the facility.
In short, you need a real address and a real person representing your facility in the U.S.
All retail items containing any kind of drugs (both prescription and OTC (over-the-counter) drugs) must firstly contains essential scientific info at least for the safe and effective use of the drug. Second, the label should include the Prescribing Information, FDA-approved patient labeling (for certain drugs) and/or carton and container labeling.
Of course, FDA controls ingredients in the drugs product, especially Active Pharmaceutical Ingredient (or API) which has the intended therapeutic effect. The other type, or the inactive ingredients, has less scrutiny but still remains under FDA regulations.
Drugs that are not in compliance with all FDA regulations or are from unregistered drug facilities will be subject to detention, import alerts, and refusal of admission.
We will help you register for the drugs and check your ingredients before boarding in the U.S
Import alerts are like red flags to prevent unsafe or illegal products from entering the US:
Keeps bad stuff out: They prevent products that might break the law from reaching stores and homes.
Saves time for inspectors: Inspectors can focus on checking other shipments.
Fairness across the country: No matter where the drugs come from, the rules are the same.
Responsibility on importers: Importers must make sure they follow the rules or their products might get stopped.
Before importing into the United States, importers should know if their products are subject to DWPE. DWPE allows FDA to detain a product without physically examining it at the time of entry, so you should know further about this if you expect the drugs to go straight to the shelves of U.S stores.
We will be your go-to team of experts, ready to help you with any issue.
We will contact you for consultation as soon as possible.