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Capitol Connections Article FDA Week Interview 1.24.14
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IACP's David Miller Interviewed by FDA Week

Excerpt from interview -

"David Miller, executive vice president and CEO of the International Academy of Compounding Pharmacists, expects the drug compounding marketplace will evolve as a result of the new law and that legal challenges similar to those that stalled FDA enforcement in the 1990s will re-emerge.

The FDA Modernization Act of 1997 created manufacturing exemptions for compounding pharmacists that met certain requirements, including not advertising, but the law was challenged in the courts. The Supreme Court eventually struck down an advertising prohibition for violating the First Amendment, but the high court did not rule on the severability of that provision, thus hindering FDA's implementation of the entire law. Last year's Drug Quality and Security Act (DQSA) reinstates provisions for traditional compounding pharmacists in the 1997 law without the advertising ban and adds a new section outlining requirements for a category of outsourcing facilities -- large scale compounders under federal oversight.
The law, however, does not address questions about the original law and how the drug compounding industry has changed during the intervening decade, Miller said. There were legal challenges to other aspects of the law that likely will re-emerge as FDA moves forward with the new law. 'We have literally turned the clock back 17 years,' Miller said.

One lingering question has been office-use compounding, which is allowed by some state laws. But industry has been reading early FDA indications as requiring patient prescriptions for any type of anticipatory compounding, which sets up a potential conflict with state laws that let physicians obtain compounded drugs for use in their practice. Miller said this could tee up a legal case of federal versus state oversight.

FDA is developing a memorandum of understanding that interested states can sign to limit interstate shipments of compounded drugs. This document will give insight into FDA's thinking about relationships with states, said Allan Coukell, senior director of drugs and medical devices at Pew Charitable Trusts. Further, it could indicate how the agency would like to see traditional pharmacy compounding requirements enforced and go into office use compounding, he said.

The agency must work with the National Association of Boards of Pharmacy to develop the MOU, but Miller argues that there are other drug compounders such as veterinarians and podiatrists that are not covered by boards of pharmacy on the state level that will not be included. Further, under the new law, outsourcing facilities do not have to be a pharmacy, opening up the possibility that other firms will shift into this new category, he said."

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