FDA Laxity of Compounded Drugs a Matter of Life, Death

FDA Laxity of Compounded Drugs a Matter of Life, Death

People naturally assume that the medicines prescribed by doctors are tightly regulated and have been approved by the Food and Drug Administration, but that’s not true. Loopholes in the regulations that set the standards for a practice called “drug compounding” have enabled dangerous products to injure and kill untold numbers of unsuspecting patients.

For more than a quarter century, FDA has permitted “compounding pharmacies” to prepare and dispense medicines as long as “the drug product is compounded for an identified individual patient based on the receipt of a valid prescription.” These drugs were intended to be customized to the needs of patients who, for example, might be allergic to a component of the commercially available medication, or who can’t swallow a pill and need a liquid version of a medicine.

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