http://blog.pharmtech.com/2008/10/10/will-we-see-country-of-origin-labeling-for-pharma-ingredients/ The blog of Pharmaceutical Technology magazine Tue, 07 Feb 2012 17:25:13 -0500 http://wordpress.org/?v=2.8.4 hourly 1 http://blog.pharmtech.com/2008/10/10/will-we-see-country-of-origin-labeling-for-pharma-ingredients/comment-page-1/#comment-11812 Anthony Beran Sat, 17 Jan 2009 08:07:37 +0000 http://blog.pharmtech.com/?p=425#comment-11812 What is the position of the FDA on the country of origin requirements for medical devices? Do the requirements of the USA customs and border protections (CBP) for the country of origin labelling apply to medical devices? What is the position of the FDA on the country of origin requirements for medical devices? Do the requirements of the USA customs and border protections (CBP) for the country of origin labelling apply to medical devices?

]]> http://blog.pharmtech.com/2008/10/10/will-we-see-country-of-origin-labeling-for-pharma-ingredients/comment-page-1/#comment-10244 Jance Sun, 16 Nov 2008 11:11:36 +0000 http://blog.pharmtech.com/?p=425#comment-10244 All the reports of this issue miss the fact that currently manufacturers are prohibited from including country of origin information on the label by the FDA. This may be an unintentional effect, merely a consequence of the FDA allowing absolutely no deviation from their approved label. It does not seem that difficult to fix. Hopefully all makers know where their products or made, if not, maybe it is a good thing that they figure it out. We are told where our stationary is made, where our notebooks, pens, etc. are made. I want to know, where any drugs I buy are made, and be able to judge for myself the chances they were made using good manufacturing practices or not. I would think this would help manufacturers who are trying to put a good safe product on the shelf. All the reports of this issue miss the fact that currently manufacturers are prohibited from including country of origin information on the label by the FDA. This may be an unintentional effect, merely a consequence of the FDA allowing absolutely no deviation from their approved label. It does not seem that difficult to fix. Hopefully all makers know where their products or made, if not, maybe it is a good thing that they figure it out.
We are told where our stationary is made, where our notebooks, pens, etc. are made. I want to know, where any drugs I buy are made, and be able to judge for myself the chances they were made using good manufacturing practices or not. I would think this would help manufacturers who are trying to put a good safe product on the shelf.

]]> http://blog.pharmtech.com/2008/10/10/will-we-see-country-of-origin-labeling-for-pharma-ingredients/comment-page-1/#comment-9043 Susan Van Arnum Tue, 21 Oct 2008 18:30:35 +0000 http://blog.pharmtech.com/?p=425#comment-9043 Country of origin labeling should parallel the description of the location of the manufacturer or supplier as listed in the Chemistry, Manufacturing and Controls section (CMC) of a NDA. Country of origin labeling should parallel the description of the location of the manufacturer or supplier as listed in the Chemistry, Manufacturing and Controls section (CMC) of a NDA.

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