lovepink
(Goddess)
03/26/03 02:53 PM
Re: FDA ALERT - Check it out!

I've had the Import Alert bookmarked for a while now...although the date of February 2003 is currently on top, scroll down the list and check when these OPs were added. MM and PharmaGroup were added in 2001, EuroCare in 1996, etc. InterPharm is just among the newwest to be added to this list.

REASON FOR
ALERT : FDA has observed an increase in the promotion and importation of unapproved prescription drugs of foreign origin. Unapproved prescription drugs present serious safety and effectiveness concerns. Moreover, approved U.S. versions of these drugs are available. Therefore, this import alert is being established to provide a listing of known distributors.


GUIDANCE: Districts may detain without physical examination all dosage forms and shipments, commercial and personal, of foreign manufactured unapproved prescription drugs from distributors listed in the attachment. Districts should determine whether the drugs are covered by a current approved NDA or IND. FDA has concluded that shipments of these foreign manufactured unapproved prescription drugs are inappropriate for release under the personal importation policy.




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