Some Reasons Why The FDA should Not Regulate Drug Compounding Pharmacies Like Drugmakers

With confirmed cases of fungal meningitis caused by compounded epidural steroid injections at 119 and deaths at 11, members of the U.S. House of Representatives are promising to introduce legislation to "require certain pharmacies that engage in interstate commerce to register with the FDA and comply with basic minimum safety standards."

That quote comes from Massachusetts Rep. Edward Markey, a Democrat who represents the district where the New England Compounding Center is located. NECC prepared and shipped the contaminated methylprednisolone dosages at the heart of the deadly disease outbreak. The company subsequently recalled all of its compounded products.

Markey is teaming with Connecticut Democrat Rep. Rosa DeLauro to draft the legislation, which most likely could not be officially presented to federal lawmakers until the new Congress convenes in January 2013.

The representatives have a lot of company in calling for giving the U.S. Food and Drug Administration authority to regulate compounding pharmacies like pharmaceutical manufacturers. Such calls seem to miss three important realities, though.

First, FDA already has mandated oversight of drug compounding. The federal rules, explained here, differ from those applied to drugmakers, but they are not nonexistent or especially permissive.

Second, both in conjunction with and addition to, federal regulations, compounding pharmacies, pharmacists and pharmacy technicians must operate in compliance professional standards that carry the force of law and with rules set by the state in which they are located. The primacy of state-based regulation of compounding accords with how all health care practices are regulated in the United States.

Last, more FDA regulation would mean more FDA regulators. The agency would have to expand its staffs of investigators and investigation support personnel significant to keep stricter tabs on compounding pharmacies. While some would argue that committing additional funds and people would be good investments in Americans' health, costs would have to be considered.

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