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What Is Pseudoephedrine?

Craig Mitchelldyer, Getty Images

More and more cases of abuse of pseudoephedrine are being reported.  But what is pseudoephedrine?

Pseudoephedrine is a decongestant.  It is used mainly to treat stuffy noses and the symptoms of colds.  It works by narrowing the blood vessels, decreasing swelling.

Products containing pseudoephedrine often contain multiple warnings and precautionary notices, and, like all medication, should only be used as directed by a medical professional.  When used properly most people agree that it is safe.  The problem is that not everyone does that.

It is sold over the counter under many brands including Sudafed, Afrinol (Afrin, Dimetapp, Drixoral**), and Novafed.  **Note that, as of this writing, Drixoral is no longer available in the United States.**

In the early 1970′s the drug was “Generally Recognized as Safe and Effective,” or “GRASE,” by the Food and Drug Administration.  However, it soon gained popularity in the process of manufacturing methamphetamine, or “meth.” On April 13, 2010 Dr. Charles J. Ganley, Director of the Office of Drug Evaluation IV of the FDA, gave testimony before the Senate Caucus on International Narcotics Control explaining why pseudoephedrine earned special restrictions from the FDA:

On March 9, 2006, The Combat Methamphetamine Epidemic Act of 2005 (Title VII of the USA PATRIOT Improvement and Reauthorization Act of 2005, P.L. 109-177), was signed into law. Congress passed this law in an effort to reduce the illicit manufacture of methamphetamine.  The law requires, among other things, that all sellers of pseudoephedrine self certify, confirming that:  (1) employees have been trained; (2) records of the training are being maintained; (3) sales limits are being enforced; (4) products are being stored appropriately; and (5) a written or electronic logbook is being maintained.  Specifically, the law requires that these retailers must place pseudoephedrine products where customers do not have direct access to such products before a sale is made.  Although the law uses the term “behind the counter” to describe product placement by the retailer, FDA defines pseudoephedrine as an OTC drug in accordance with the monograph and FDA regulations.  An OTC drug is a drug whose use does not require oversight by a health care professional.”

Its sale is now controlled to the extent that retailers must require appropriate identification from consumers and careful inventories or logging of its distribution.

Craig Mitchelldyer, Getty Images

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