QUESTION: I was told by our customs broker that new Regulations are in effect by the FDA on 2/2 impacting items classified under HTS: 8541.20.2000. I was told that this HTS will require FDA filing? Has anyone heard/read anything about it? I can’t validate this information to implement such changes. ========== Answers: I am having […]
QUESTION: If we import a research and development pharmaceutical compound into the US and transmit information to the FDA, can we automatically issue a TSCA negative certification or do we still need to analyze TSCA rules ========== Answers: My opinion is that these are 2 different government agencies that do not share information —- so […]
QUESTION: I am interested to import food product which is subject to FDA oversight. What CBP issues do I need to understand? What FDA and/or other government agency regs do I need to be aware of and comply with? Can you suggest any good reading material to get up to speed on regulatory matters regarding […]
QUESTION: We are a pharma company in development of a new investigational drug. We manufacture the API outside the U.S. and turn it into finished product inside the U.S. We would like to import an entire batch of API for finishing, use part of the finished drug product in pursuance of an IND (testing, evaluation, […]
QUESTION: My company is importing components and assemblies for medical goods. We are providing the following information: Program Code: DEV Intended Usage Code: 081.007 We’ve been able to work out the Affirmations of Compliance, however, the Gov’t Agency Processing Code for RED / NED determination has been a challenge for the analyst. Is the FDA […]
QUESTION: Does ACE allow for corrections to be made to FDA filing? Two situations have been caught in an audit and I am wondering what recourse exists: 1) FDA Claim – wrong FDA product code or other Mandatory elements filed. Can a correction be made to input the correct mandatory elements? 2) FDA Disclaim […]
Question: Can someone find a reg and cite it defining the FDA country of origin? The question being, does packaging contribute to the automated country of origin declaration upon import? It isn’t black or white on their website. ========== Answer: Assuming you mean the outside packaging to support it for sale on retail shelves (bottles, […]
Question: It appears on October 10, 2003, FDA issued an interim final rule to implement amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) made by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act), which requires domestic and foreign facilities that manufacture, process, pack, or hold food […]
Question: What is the best way to import items that are being used for the sole purpose of testing? What information should we provide FDA at time of import? ************** Answers: A foreign-trade zone provides enormous flexibility, especially if you will destroy or re-export the material. **************** Depending on the country of export I would […]
Question: I would like to ask the membership how they handle imports that are marked as “import for export” and are subject to FDA. We traditionally have long clearance times on this type of import. Is there any type of paperwork we could provide ahead of time or at time of clearance? Or, are […]
Question: I would like to ask members who in your company keeps and files the FDA notices for hold , detention and exams regarding imports. Is this Customs compliance area or Regulatory Affairs Dept. who is responsible of keeping the records. ========== Answers: Customs compliance ========== We at Global Trade Compliance keep these notices as […]
Question: Are US produced goods returning to the US subject to FDA regulations (FDA accession number)? ANSWER: Yes… however there are some exceptions that are available. Personal goods Repair and export samples etc %%%%%%%%%%% Yes, absolutely. You need to make a declaration to FDA with US goods returned. FDA will be interested in why the […]
