I have been asked by several of our readers to explain exactly what a compounding pharmacy is. Traditionally, compounding has been a pharmacy practice in which a pharmacist alters, mixes or recombines ingredients to make a drug that meets the special needs of a patient with a physician’s prescription. But in recent decades, a number of compounding operations have grown to resemble full-scale manufacturing firms without meeting FDA standards. That was never the intended purpose of compounding by pharmacists.
I have also been asked why the government hasn’t done a better job of regulation of this industry. The U.S. Food and Drug Administration’s power to regulate compounded drugs is legally nonbinding and lacks the authority of stringent standards imposed on drug manufacturers. That was the conclusion of a Congressional report compiled by the staff of Rep. Edward Markey (D-Mass.). It’s now quite obvious that very little control has been in place of this growing industry.
The release of the report drew an immediate response from FDA Commissioner Margaret Hamburg, who said the agency is committed to working with Congress and others to garner “the authority we need to help prevent tragedies like this from happening again.” The Commissioner said in a statement:
Over the years, there has been substantial debate within Congress about the appropriate amount of FDA oversight and regulation of compounding pharmacies. But unfortunately, there has been a lack of consensus and many challenges from industry. As pointed out in the report from Congressman Markey, FDA’s authority over compounding pharmacies is more limited by statute than with drug manufacturers.
Congress should give the FDA new powers to oversee compounding pharmacies. Public Citizen has called on the Department of Health and Human Services to investigate the FDA on grounds that the agency failed to exercise its existing authority to prevent the very serious meningitis outbreak involving the New England Compounding Center. The FDA had issued a warning letter to NECC in 2006 describing potential health risks including microbial contamination. But there has been little evidence of a follow-up. Congressional investigators also say there is evidence that the FDA and state regulators knew of potential problems at NECC in 2002.
State governments, which are now the chief regulators of pharmacy compounding, cannot perform the kind of safety oversight necessary to prevent more drug-related outbreaks from occurring. The FDA has issued dozens of warning letters against compounding pharmacies since 2001. But the report said the agency has based its enforcement actions on relatively weak, nonbinding guidance documents since a 1997 law granting it oversight of “new drugs” was struck down in U.S. courts more than a decade ago in cases brought by compounders.
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