Unregulated drug manufacturing in pharmacies raises concerns among consumer advocates

• 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.