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article imageFDA proposes rule to destroy illegal imports

By Tim Sandle     Jul 5, 2014 in Health
The U.S. FDA is proposing that it be given powers to to destroy any drug valued at $2,500 or less that has been refused admission into the United States under the Federal Food, Drug, and Cosmetic Act.
The legislation that the U.S. Food and Drug Administration (FDA) is seeking is designed to protect consumers by preventing the drug falling into the "wrong hands." The FDA would gain this power through the Federal Food, Drug, and Cosmetic Act (FDASIA).
On July 9, 2012, President Barack Obama signed FDASIA into law. Title VII of FDASIA provides FDA with important new authorities to help the Agency better protect the integrity of the drug supply chain. Based on this, FDA is issuing a proposed rule to implement section 708 of FDASIA. This provision directs FDA to issue regulations that provide the owner or consignee of a drug valued at $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation) that has been refused admission into the U.S.
A drug that is imported or offered for import can be subject to refusal of admission if it is or appears to be adulterated, misbranded, or unapproved. The majority of refused drug products come into the U.S. via an International Mail Facility (IMF) or an express courier hub. It is estimated that the number of such parcels which contain drugs that enter the United States each year through the IMFs is between 20 million and 100 million.
The FDA works with other agencies to prevent the import of ineffective or illegal drugs through Operation Safeguard. Operation Safeguard is an initiative designed to target illicit imports of prescription drugs. In total, from fiscal years 2010 through 2012, FDA examined nearly 45,000 shipments and seized more than 14,000 illicit shipments of prescription drugs. Here international mail shipments constituted the majority of the shipments that were seized. Despite these efforts, the high volume of inbound international mail shipments has strained limited Federal resources at the IMFs making it extremely difficult to interdict all incoming shipments of violative drugs.
Violative drugs pose a serious public health threat to consumers in the United States because they might not contain the active ingredient that patients need for the treatment of their disease; they might have too much or too little of an active ingredient; they might contain the wrong active ingredient; and/or they might contain toxic ingredients. In light of this, the FDA considers that new powers will help it to further protect consumers.
More about Fda, Drugs, Illegal drugs, Imports
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