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U.S. Department of Health and Human Services

Drugs

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Counterfeit Drug Task Force Report October 2003 - REQUEST FOR COMMENTS

FDA seeks comment on issues related to the potential options presented here, as well as the specific questions posed above. Interested persons may submit to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, Maryland, 20852, written or electric comments by November 3, 2003. Groups should submit two copies. Individuals may submit one copy. You should annotate and organize your comments to identify the specific options or questions to which they refer. To ensure timely handling, the outer envelope should clearly state the docket number, 2003N-0361.

Footnote:

 1 The Food Drug and Cosmetic Act (the Act) defines a counterfeit drug as “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. 201(g)(2))

 

 REFERENCES

1. Profile of the Prescription Drug Wholesaling Industry. ERG. February 12, 2001

2. Florida Statewide Grand Jury Report, February 2003

3. The Prescription Drug Marketing Act Report to Congress, FDA, June 2001

4. NABP Model Rules