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Cause and effect: Demystifying the Drug Quality and Security Act

In 2012, compounding made headlines when 64 people died as a result of fungal meningitis caused by contaminated compounded products.

History
In the fall of 2012, an outbreak of fungal meningitis was reported, and the Centers for Disease Control and Prevention tracked the outbreak to contaminated steroid injections, packaged and marketed by the New England Compounding Center in Framingham, Mass. The contaminated products had been distributed to 75 facilities in 23 states, and doses were given to approximately 14,000 patients. Of those, more than 750 fungal meningitis cases were reported, including 64 fatalities.

While pharmacists have long been mixing compounded products for patients with individual prescriptions, over the past several decades, mass compounding — with some pharmacies selling thousands of doses of regularly used compounded products for doctors to keep on hand for the future — had become increasingly popular.

The Drug Quality and Security Act
At the end of November 2013, President Barack Obama signed into law H.R. 3204, The Drug Quality and Security Act. The new law creates federal oversight for large volume compounding operations, but still allows pharmacists to provide traditional compounding services to individual patients. The idea was to give the Food and Drug Administration oversight for “outsourcing facilities,” a new class of compounding facility that is allowed to sell products in bulk to hospitals and physician practices without requiring individual prescriptions.

How much impact the new law will have is still largely unknown. The act allows traditional pharmacies to continue to be regulated by state boards of pharmacy; however, larger compounding facilities will be monitored via a system of voluntary registration. Once registered, these compounding facilities will be monitored by the FDA in much the same way as typical drug manufacturers are.

Who has registered so far?
As of the beginning of January 2014, only 11 compounding pharmacies had registered with the FDA. These pharmacies hope that registering with the FDA will give them a marketing advantage. Those who registered with the FDA are required to pay a fee, comply with good manufacturing standards, be subject to routine FDA inspections and report adverse events associated with their products.

The FDA hopes that healthcare organizations will prefer to purchase compounded medications from an FDA-regulated facility, and in early January, FDA commissioner Margaret Hamburg sent out hundreds of letters to hospitals urging them to buy compounded medications only from FDA-registered facilities.

“As a purchaser of compounded drugs, you can play an important role in improving the quality of compounded drugs by requiring compounding pharmacies that supply drugs to your facility to register as outsourcing facilities,” Hamburg wrote.

FDA draft guidance
Meanwhile, at the end of 2013, the FDA issued draft industry guidance about the new compounding law. The guidance suggests that compounding be done in accordance with U.S. Pharmacopeia chapters 795 and 797. While this would not be burdensome for non-sterile compounding, compliance with USP 797 could create implementation costs for compounding pharmacies. The second piece of guidance from the FDA would limit compounding pharmacies that do not have an agreement in place between the FDA and their state from shipping more than 5% of their compounded products outside of the state. Finally, the draft guidance also indicates that the FDA will regulate the bulk substances drug list. Comments to the guidance were due in early February.

Practically speaking
Will the new law affect most pharmacists?  No — particularly if the compounding is the typical mixing of a lotion in a mom-and-pop pharmacy. The new law really is targeting large operations compounding sterile — often injectable — medications, and selling them to hospitals, large physician practices and across state lines. As the year progresses and more compounding pharmacies register with the FDA, it will become clearer what the long-term effects of the new law will be.


Ann W. Latner, JD, a former criminal defense attorney, is a freelance medical writer in Port Washington, N.Y.

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