FDA Warns against Compounding Drugs; Pharmacies Seek to Bypass Approval Process
Byline: Gregory Lopes, THE WASHINGTON TIMES
The Bush administration is cracking down on pharmacies that mass manufacture their own versions of commercial drugs, fearing that the practice poses a serious health risk to consumers.
The Food and Drug Administration (FDA) recently issued warning letters to three large medical equipment companies - RoTech Healthcare Inc., CCS Medical and Reliant Pharmacy Services - to stop manufacturing and distributing thousands of doses of compounded inhalation drugs nationwide.
FDA inspectors found that the companies were producing commercially available drugs illegally, sometimes with higher dosage levels.
The pharmaceutical practice known as compounding has evolved from crushing tablets into liquid for children to mass manufacturing heart and blood pressure medications.
Though the FDA has not attributed any fatalities to a compounded medication, the government says compounded drugs pose unnecessary health risks and is attempting to slow the practice by requiring that compounded drugs, which are not recognized as safe and effective, be approved by the FDA.
"Products are being compounded that we never thought would be," said Carmen Catizone, executive director of the National Association of Boards of Pharmacy.
For example, companies are investing in natural hormone replacement treatments as an alternative to commercially available hormone replacement treatments, which use artificial ingredients. Compounded hormone replacement treatments use bio-identical hormones that mimic the body's natural hormones such as estrogen. Critics of bio-identical hormone replacement treatments say women are taking an experimental, unproven treatment.
Profit margins for compounded drugs can reach hundreds of millions of dollars. Last year, Health Sciences Group Inc., a provider of nutritional products, announced that it expanded its pharmaceutical operations to offer compounding services to independent pharmacies. At the time, John Park, vice president of the company said gross margins for compounding can range from 50 percent to 80 percent.
Legitimate pharmacy compounding is an age-old practice, and occurs when a patient needs a medication that is not commercially available. Pharmacists modify a drug to fit the patient's specific needs such as converting tablets to liquids or individualizing dosage levels. …