[Ip-health] The FDA's 2005 definition of counterfeit drugs

Charles Clift charlesclift at tiscali.co.uk
Mon Sep 6 01:49:46 PDT 2010


This a bit of an interpretation in fact.  What the law actually says is:

"The term "counterfeit drug" means a drug which, or the container or labeling of which, without authorization, bears the trademark, trade name, or other identifying mark, imprint, or device, or any likeness thereof, of a drug manufacturer, processor, packer, or distributor other than the person or persons who in fact manufactured, processed, packed, or distributed such drug and which thereby falsely purports or is represented to be the product of, or to have been packed or distributed by, such other drug manufacturer, processor, packer, or distributor." 21 U.S.C. 321 Section 201 (g) (2).  

That's all it says. 

What this FDA representative said in 2005 therefore seems to go far beyond what the law actually says. 


-----Original Message-----
From: ip-health-bounces at lists.keionline.org [mailto:ip-health-bounces at lists.keionline.org] On Behalf Of James Love
Sent: 03 September 2010 23:07
To: Ip-health
Subject: [Ip-health] The FDA's 2005 definition of counterfeit drugs

The FDA's 2005 definition of counterfeit drugs


U.S. law defines counterfeit drugs as those sold under a product name
without proper authorization, where the identity of the source of the
drug is knowingly and intentionally mislabeled in a way that suggests
that it is the authentic approved product. This definition can apply to
brand name, generic products, or the bulk ingredients used to make the
product. Counterfeit drugs under this definition may include products
without the active ingredient, with an insufficient quantity of the
active ingredient, with the wrong active ingredient, or with packaging
that falsely suggests the drug was manufactured by the FDA-approved
manufacturer. This definition depicts fraud toward the consumer
believing they are receiving the genuine FDA-approved product and does
not include products that are marketed as being similar to or a foreign
version of an approved drug. Those types of products are illegal and
referred to as “unapproved new drugs,” not counterfeit.

James Love, Director, Knowledge Ecology International
http://www.keionline.org | http://www.twitter.com/jamie_love
Wk: +1.202.332.2670 | US Mobile +1.202.361.3040 | Geneva Mobile +41.76.413.6584

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