IACP Member Alert
December 19, 2012
Your Academy has been involved in significant meetings, hearings and media interviews over the last 10 days. So much so that we determined that a Member Alert was in order to keep you up-to-date on all of the latest information.
IACP Meets with FDA Regarding Pharmacy Compounding
IACP is again participating in a intergovernmental workshop today on Wednesday, December 19, 2012, with the Food & Drug Administration (FDA). This marks the third meeting IACP has had with the agency in the past 10 days as both compounders and regulators discuss changes to the federal and state regulatory framework under which compounding pharmacies (and others engaged in compounding) should be regulated. Today’s meeting at 3:00-5:00 PM EST is entitled, “Framework for Pharmacy Compounding: State and Federal Roles” and immediately follows a meeting of the agency with representatives from the state Boards of Pharmacy. That earlier session provides State officials with an opportunity to discuss a variety of issues regarding their views on the role of the FDA and the States in the oversight of compounding.
“These meetings are an essential part of a collaborative process through which impacted stakeholders are trying to establish reasonable and workable solutions for the compounding sector to mitigate future scenarios similar to what occurred with the New England Compounding Center (NECC)," says, Sarah Dodge, IACP’s Vice President of Government Affairs. “We expect that IACP and the FDA will continue a constructive dialogue which clearly delineates the agency’s role in regulating manufacturing while continuing the tradition of state-based regulation of pharmacy practice.”
IACP members may listen in on the public meeting. Click here for more information.
IACP’s David Miller Testifies at Massachusetts State Legislative Hearing
On Monday, December 17, 2012, IACP’s Executive Vice President & CEO David G. Miller, RPh, testified before the Senate Post Audit and Oversight Committee in Boston, Mass., in response to the NECC meningitis outbreak tragedy.
“Although contentious at times, we believe yesterday’s hearing was another crucial step in IACP’s ability to create a dialogue at the state level around changes that would ensure more uniformity in state pharmacy compounding regulation,” says David Miller.
Click here for a Boston Globe hearing report with statements from David Miller.
Click here for a State House News Service report.
IACP’s David Miller Appears before House Energy & Commerce Subcommittee
Last Thursday, December 13, 2012, IACP’s David Miller met with the House Energy and Commerce Subcommittee on Oversight and Investigations in an effort to continue working collaboratively, as well as to answer any questions the Subcommittee had regarding about IACP and its representation of compounding pharmacists.
Last week’s meeting was in response to a formal letter from the House Energy & Commerce Committee requesting documents regarding an October 22, 2012, New York Times article which alleged that the Academy, in some manner, instructed pharmacists not to comply with legitimate requests for information from the FDA. This surrounded suspicious activities of individuals, purporting to be with the FDA, in October 2011 who called IACP members asking for "samples" of compounded 17-P. Click here to view previous IACP Capitol Connections article on this matter.
“I think there is clear evidence of IACP’s commitment to identify gaps in the law that allowed NECC to masquerade as a compounding pharmacy while engaged in clear and illegal manufacturing. We believe that the FDA already has sufficient legal authority to govern manufacturers of all types – including those hiding behind the good name of pharmacy and compounding,” David Miller told the Committee representatives. “Even so, we still have yet to hear clear and concise explanations from the agency as to why they are ‘confused’ about their authority and, more importantly, why their internal administrative system permitted extensive inaction on an identified and known problem pharmacy. Taking 684 days to follow-up on an inspection report is unacceptable… to everyone involved.”
IACP will continue to work closely with legislators from both the House and the Senate in an effort to establish reasonable and warranted changes, if needed, to federal law.
IACP ‘s David G. Miller, RPh, Interviews with CBS Evening News with Scott Pelley’s Anchor Jim Axelrod – Air Date Still to be Confirmed
On Wednesday, December 5, 2012, David G. Miller, RPh, sat down with CBS News anchor Jim Axelrod to discuss compounding pharmacy regulation and oversight of the practice. The interview took place at a compounding pharmacy located within miles of New England Compounding Center; Johnson Compounding & Wellness, owned by IACP Member Stephen Bernardi, MS, RPh, in Waltham, Mass.
The potential broadcast date for this interview still has not been confirmed. IACP will alert its members as soon as a definitive date is available.
IACP Members Continue to use Compounding Op-Ed Piece
Thank you to the several IACP Members who have taken the time to issue the op-ed your Academy provided to their local papers. Below is a sampling of recent placements. Click here to access this op-ed to place with your own local newspapers.
I am a Compounding Pharmacist - The Journal News Kentucky
In the Spotlight: Compounding pharmacists must work to safeguard process - Peoria Journal Star
Compounding Pharmacies Committed To Quality - Times-Union Indiana
Column: Pharmacists ready to work with leaders - Cincinnati.com
Zale Continues Commitment To Customers - Stacey Page Online
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