Benefits of a Closed System of Drugs Distribution

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Under the FD&C Act, the interstate shipment of any prescription drug that lacks required FDA approval is illegal. Interstate shipment includes importation--bringing drugs from a foreign country into the United States.

Drugs sold in the United States also must have proper labeling that conforms with the FDA's requirements, and must be made in accordance with good manufacturing practices.

As part of the FDA's high standards, drugs can only be manufactured at plants registered with the agency, whether those facilities are domestic or foreign. If a foreign firm is listed as a manufacturer or supplier of a drug's ingredient on a new drug application, the FDA generally travels to that site to inspect it.

After the FDA approves a drug, manufacturers still are subject to FDA inspections and must continue to comply with good manufacturing practices. "With an unapproved drug, you can't be sure that it has been shipped, handled, and stored under conditions that meet U.S. requirements," McCallion says.

Along with legal requirements on manufacturing, U.S. pharmacists and wholesalers must be licensed or authorized in the states where they operate, and limits on how drugs can be distributed lessen the likelihood that counterfeit or poor quality drugs will turn up. It's because of such safeguards that the process of getting drugs onto U.S. pharmacy shelves is commonly referred to as a "closed" distribution system.

Counterfeit drugs--phony replicas of pharmaceuticals--can surface anywhere. Historically, they have been more common in foreign countries than in the United States. And while the Internet has given customers the convenience of buying drugs from the privacy of their own homes, it's also opened up windows for crooks to crawl through.

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In an investigation that ended in the indictment of seven people and five companies in the spring of 2002, undercover agents in the Manhattan District Attorney's Office in New York bought more than 25,000 counterfeit Viagra pills. They pretended to sell the impotence pills and uncovered four supply streams from China and India.

Some of the little blue pills arrived in the mail stuffed inside a teddy bear and stereo speakers. The exporters used a machine to punch the pills with Pfizer's logo, and intermediaries sold the pills over the Internet to brokers and consumers.

In this case, all the counterfeit pills tested had some of Viagra's active ingredient (sildenafil citrate) with varying potency, according to Barbara Thompson, a spokeswoman for the Manhattan District Attorney's Office. With fake drugs, "you could be getting some of an active ingredient or you could be getting nothing at all," she says.

That's what happened with a batch of Viagra worth $150,000 that HALT recently seized from Los Angeles gift shops. "It looked perfect," says Hancz. "But there was nothing there--just lactose, dye, and other filling agents."

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By Michelle Meadows www.fda.gov

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