Country of origin free#

NAFTA – the North American Free Trade Agreement – has special COO marking rules for products originating in its member countries (United States, Canada and Mexico). It requires each product, in the form it is shipped to the “ultimate purchaser,” to be marked with the proper COO.Ĥ. Customs doesn’t care about an importer’s logistics. In that case, the proper COO for the product could vary from week to week, or from batch to batch – with all the attendant legal consequences of getting it wrong. And God help you (or at least get legal help) if you buy the same API from multiple suppliers in different countries. If your new supplier is in a different country, and is supplying your active ingredient/API, the proper COO marking for the finished product probably changed too. The more things change, the more they change changing suppliers often changes the COO.įound a lower-cost supplier? One better able to ship to your location? Great, but remember to watch your COO. That’s about as much as we can say, since more detailed analysis is very fact-sensitive, and varies from product to product, so manufacturers need somebody who understands both the law and the specifics of the particular product’s manufacture.ģ. For processing to cause a “substantial transformation” means that the character of the active ingredient must actually change. That ingredient may be imported in raw form, and undergo all sorts of costly processing before being suitable for human consumption, but if it still does the same thing (has the same biological effect) then all that processing doesn’t amount to a hill of beans from the Customs standpoint. The “essence” of a drug (less clear with devices) for customs purposes is its API.

For Customs purposes the COO usually follows the source of clinical benefit/API. Mess it up, and the fines can be pretty big (although, again they vary). Finally, selling the product abroad can require a COO certificate based on still other standards imposed by foreign governments. “Made in the USA” claims involve yet another standard. There’s more, the COO for Customs purpose can differ from the COO for purposes of selling the product to the government. Over-reliance on processing that doesn’t “substantially transform” APIs is the single most significant source of pharmaceutical COO mistakes. So, a company might do a lot to a product, but if the aspect (for drugs, it’s called the “active pharmaceutical ingredient” or “API”) that creates the product’s medical benefit wasn’t changed, then the COO for Customs purposes remains the country from which that key aspect/API was imported. What does that mean? Basically, what comes out must have a different character and use from what went in. For Customs purposes, a product’s COO isn’t what the FDA considers its place of manufacturer, but rather the country where all the various components (which may be a lot or a little) are “substantially transformed” into a new product. Customs and Border Protection (which we’ll call “Customs” for short) requires COO designations (technically referred to as “markings”). Except for prescription medical products produced essentially entirely in the United States, U.S. What the FDA requires drug labels to state about where a drug/device is manufactured isn’t going to help much with other federal agencies. COO means different things to different federal agencies. So we thought we’d pass along to our readers ten things that you ought to know (but may well not) about COO in the pharmaceutical context:ġ. As we listened to the presentation and learned about all the nasty problems that could befall a manufacturer that didn’t get these complicated “country of origin” (which we’re abbreviating “COO” from now on) rules right in its product information, we couldn’t help harking back to a phrase from our (or at least Bexis’) misspent youth – COO sounds like a “ nexus of the crisis, and the origin of storms.” Still, when we heard Jeff give an oral presentation recently on his top ten list of “country of origin” issues for pharmaceutical products (a lot of which is also relevant to medical devices), we thought, first, “we didn’t know that,” and second, that if we didn’t, our readers might not know it either. DDL by contrast, is notoriously unbranded, since we have bloggers from different law firms. For one thing it’s more or less a rehash of a post by Jeff Orenstein, one of Reed Smith’s regulatory enforcement types, on one of the firm’s “branded” blogs.