There is probably no class of imports more complex than pharmaceuticals. WB Skinner has decades of experience in handling the importation of “over-the-counter” pharmaceutical compounds and biologics. We know just the right questions to ask to help you anticipate and avoid FDA problems and surprises. We’ll proactively ask for critical, related documents to ensure that your paperwork is in order, and can refer you to the right third parties when needed.
With Skinner, we make sure you get just the right information…never too little, never confusingly more than you need.
The Federal Food, Drug, and Cosmetic Act (Act) prohibits the interstate shipment (which includes importation and exportation) of unapproved new drugs. Imported pharmaceuticals regulated by the FDA are subject to inspection at the time of entry by the U.S. Bureau of Customs & Border Protection (Customs). Shipments not found to comply with the law are subject to detention. They must be brought into compliance, destroyed, or re-exported. Under the Act, FDA may refuse admission to any drug that “appears” to be unapproved, misbranded, or adulterated, placing the burden on the importer to prove that specific drugs sought to be imported are not in violation of the Act.
To ensure that FDA is notified of all regulated products imported into the United States, the importer, or his/her representative, must file an entry notice and an entry bond with Customs pending a decision regarding the admissibility of the product. FDA inspection and enforcement procedures for imports rely on coordination with Customs. FDA is notified by Customs of the product’s entry and makes a decision as to its admissibility.
WB Skinner is here to help
Needless to say, the process can become complex and bewildering to importers. Trust WB Skinner to provide the services and guidance you need to keep abreast of changes, and successfully navigate your imports through the pharmaceutical imports clearance process.