New U.S. FDA Requirements for US Agents



you all remember the bio terrorism act the bio terrorism act kak in 2002 amended the food drug and cosmetic act just like physical amended the Food Drug and Cosmetic Act it's all part of the same statute that gives FDA's authorization and it created registration of food facilities for the first time and part of registration of food facilities and this was something new you'll see down the last one we don't have to read the whole thing but it provides that when foreign facilities register this is the actual statute that the foreign facility must designate the name of the United States agent for the facility and it's not on there but the statute goes are not to say that the United States agent is I'm sorry yeah is not it the company's business agent but it's just somebody that FDA will communicate with in the event of America emergency there's us agent is defined in the Code of Federal Regulations and you see it can't be a mailbox but it's just a person whom the foreign facility designates who is a communications link or FDA and that's what happened in 2002 and a lot of you probably remember this because a lot of you or your company's probably decided to become us ages you may have been doing an entry in foreign Casilla didn't have u.s. agent and salute agreed to be the meditation or your customer the import agreed to meet us agent in fact some of you might have even charging a little bit of money for that and full disclosure here registrar court we r us agent or thousands of foreign facilities farm facility designates its u.s. agent in section 7 of the facility registration form you're all probably familiar with that form is done electronically through the FDB fdsaf frm system and it's kind of small there but section 7 is where they designate they need the United States agent the information is not supposed to be a post office box it's supposed to be a person in the united states that fda we get in touch me so since 2003 that's been the way it is and a lot of companies registered in 2003 and may be listed you and if you got that email that says that they designated you as a u.s. agent is that ok with you and you might have said yes at the time or maybe did nothing at the time I think we all familiar with the fact that the default is that if you do nothing you are the u.s. age so a lot of you may not be not remember being the US agent that you want to go back to your records if you have your emails from FDA and check them to see if you are then along comes FISMA and again this is you know you're going to get out his fears / Dominic but this was not FDA this was your Congressman our elected representatives had to find a way to pay for food safe and fda decided that when there's a reinspection of foreign facility that the reinspection fee should be built to the foreign facility Z and the United States agent in each facility so bhisma now makes the United States agent responsible if the foreign facility is reinspect so the circumstance we do but say you have company that you've agreed to the US agent for let's say they're in Pakistan and they are inspected by FDA and they flunk their inspection they get a 383 it's horrible there's a million points on it and FDA decides that they need to go back and make sure they're only promised cures have been implemented so FDA goes back and they have to send a team over to Pakistan and that bill will go to vote the facility and to the United States agent now if ismat required FDA to calculate the amount of fees through a formula again this was you know FDA of course has some discretion in how they interpret FISMA but there was a formula that what principles FDA was supposed to use to determine the fee based on the costs to the agency in implementing these activities and the hourly rate that was announced in august that fda came up with is 224 dollars an hour where activities in the united states and 325 dollars per hour if foreign travel is required i just want to clarify because some of you may see another number in there probably not most women would need but just for those of you who do notice details FDA when an original one came out the original Federal Register notice had calculated the foreign travel at three hundred thirty-five dollars an hour when in fact that it was an arithmetic error and they issued a subsequent federal register notice correcting them so the number would be 325 so the thing is based on the number of direct outages and if you read the Federal Register notice and again mrs. you know going to the principles that Congress set for it it includes time spent conducting physical surveillance of your facility whatever components of the inspection of necessary preparations for travel etcetera you know if you're going to go to let's go back towards the Apple empty is that a 17 to Pakistan to invest to investigate they're going to need hotels they're going to need travel this is all going to take time and it's going to be built to both the facility adds to the ush it also includes like I'm sorry traveling preparing the reports because it's all that well and good that the team goes out there that that doesn't to FDA any good unless they put all that together in a report so somebody's got to spend the time to put together a report samples have to be analyzed the company could claim that their product is free but we really want to live to take a look at that in these days examining any labels all of you are familiar you've seen there issues and both the statute makes clear that this is authorized and FDA has put in the federal register any other activities until the facility is in compliance you

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