Summary
Some drugs sold in America are not manufactured by the regulated pharmaceutical industry, consumer advocates warn. Instead some products -- ranging from asthma drugs to hair loss treatments to painkillers -- are mixed by companies that are, technically, pharmacies. These companies produce drugs for an estimated 30 million prescriptions each year. "When you can know more about a box of Cheerios than you can about what some of these pharmacies are making, that's wrong," an asthma patient advocate says.
Original source:
http://www.usatoday.com/news/health/2005-03-23-cover-compounding_x.htm?POE=NEWISVA
Details
Like millions of Americans, Margaret Copeland's 5-year-old son, Will, relies on prescription medications for his asthma and inhales the drugs daily with the help of a small, tabletop machine.
And, like Copeland, tens of thousands of those patients --- and their doctors --- may not know that they are using respiratory drugs that are mixed together in pharmacies from bulk-purchased ingredients: Those drugs are not approved by the Food and Drug Administration, and they are made with far less oversight than drugs produced by pharmaceutical companies.
At their best, such pharmacies produce a variety of medications for individual patients who can't get what they need from products made by brand-name or generic drug companies, such as flavored syrups for those who can't take pills and dye-free products for patients allergic to colorings.
But at worst, critics and regulators say, some pharmacies are skirting federal law by mass-producing drugs without FDA oversight, sometimes making contaminated, ineffective or too-potent products.
While compounding technically violates federal drug law because pharmacies produce drugs without FDA approval, regulators have long allowed it because "the vast majority of pharmacies ...
Tracking problems associated with compounded medications is difficult because the overwhelming majority of states don't require compounding pharmacies to report adverse events associated with their products, according to the National Association of Boards of Pharmacy.
Several states are tightening their rules overseeing firms that compound
drugs, even as it remains unclear where state authority ends and FDA oversight begins.
At the least, they say, patients and doctors need to be specifically informed that they are getting pharmacy-made drugs so they can weigh the drugs' risks against their benefits.
"Americans expect that if they're taking a prescribed medication that it's FDA approved," says Sander of the allergy mothers group.
About the author: Mike Adams is a consumer health advocate and award-winning journalist with a passion for sharing empowering information to help improve personal and planetary health He has authored more than 1,800 articles and dozens of reports, guides and interviews on natural health topics, and he has authored and published several downloadable personal preparedness courses including a downloadable course focused on safety and self defense. Adams is an honest, independent journalist and accepts no money or commissions on the third-party products he writes about or the companies he promotes. In 2010, Adams launched TV.NaturalNews.com, a natural health video site featuring videos on holistic health and green living. He also launched an online retailer of environmentally-friendly products (BetterLifeGoods.com) and uses a portion of its profits to help fund non-profit endeavors. He's also a veteran of the software technology industry, having founded a personalized mass email software product used to deliver email newsletters to subscribers. Adams volunteers his time to serve as the executive director of the Consumer Wellness Center, a 501(c)3 non-profit organization, and practices nature photography, Capoeira, martial arts and organic gardening. Known by his callsign, the 'Health Ranger,' Adams posts his missions statements, health statistics and health photos at www.HealthRanger.org
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Thursday, March 31, 2005
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