'Objectionable Conditions' Persist at Drug Compounding Facilities
Among the GAO report's findings:
- The FDA's ability to oversee drug compounding is unclear, in part because two federal circuit court decisions have granted different and conflicting sets of authorities over the agency's ability to inspect and take enforcement action.
- Gaps in oversight of drug compounding result because although states generally regulate the practice of pharmacy, and the FDA oversees the practice of drug manufacturing, there is "no consensus on whether compounding drugs in large quantities —in anticipation of individual prescriptions or without prescriptions—and selling those drugs across state lines falls within the practice of pharmacy or is a type of drug manufacturing."
- Even with its limited oversight and ability to get timely and reliable information, the FDA this year looked at pharmacies it considers high-risk or which had had problems in the past and found continued problems in almost all of those.
- Some compounding pharmacies have "registered" with the FDA "to market themselves as 'FDA-registered,' which may lead some purchasers to assume that FDA has inspected or approved their compounded drugs" when "this is generally not the case."
- National pharmacy organizations and officials from state boards of pharmacy say "some states do not have the resources to inspect pharmacies on a regular basis" but do so "only in response to a complaint or a reported adverse drug event."
In addition, only 25 state pharmacy regulatory boards require compliance with the generally recognized USP (U.S. Pharmacopeia-National Formulary) 797 guidelines for proper sterility practices and equipment.
The GAO report also says that legally, "pharmacies are generally not required to report to FDA adverse events regarding compounded drugs they have produced, unlike drug manufacturers," and instead, such reports about compounded drugs causing patient harm are merely voluntary.
Cheryl Clark is senior quality editor and California correspondent for HealthLeaders Media. She is a member of the Association of Health Care Journalists.
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