Compounding remains a key focus for APhA

It’s now been a year since contaminated injectable products were linked to patient illness and death. The spotlight on pharmacy and compounding has been harsh in the ensuing months, but I am proud of the way our profession acknowledged the need for improvements, and worked closely together with federal and state policy makers toward positive change.

At APhA, the focus on pharmaceutical compounding began the day CDC announced a possible association between illnesses and products from the New England Compounding Center (NECC). We immediately launched ourJust the Facts: Compounding page on pharmacist.com to keep our members informed and began populating it withFrequently Asked Questions, news stories, profiles that explained why patients need pharmacists’ compounding services, and CEO blog posts. Many of the compounding-related articles and blog posts published this past year are listed below.

Since the inception of the NECC tragedy, our Government Affairs team has been and is in close contact with Congress and the FDA to help inform and shape the debate on how to protect the public from harm while maintaining access for consumers to important and often life-saving compounded preparations.

We are blessed at APhA with extensive policy, developed through years of House of Delegates engagement on compounding, and with many leaders and active members who advise us on this issue. Our collective efforts are optimized when reinforced by individual APhA member engagement with elected officials. Your APhA staff has led and participated in dozens of meetings, and exchanged hundreds of phone calls and e-mails with congressional staff. Many of these exchanges were initiated by Hill staff and Members of both the House and Senate.

We’ve also sent six detailed comment letters to Congress that specified how such tragedies could be avoided in the future. The House passed the Drug Quality and Security Act (H.R. 3204) last month, which includes numerous provisions for which we advocated. Attention now turns to the Senate. Now is a good time for us all to revisit theJust the Facts page and be ready to use all the information there to educate our senators as they refine the language in the compounding bill. 

Watch pharmacist.com for updates as events unfold in Washington. Be ready to act!
 

News articles on compounding published since January 2013:

Compounding, track-and-trace bill passes House — October 1

House passes new compounding, track-and-trace bill — September 30

Compounding Clarity Act introduced in House — September 16

House hearing considers compounding proposals — August 1

Compounding legislative proposals considered at House hearing — July 22

House Republicans may introduce compounding legislation soon — July 1

House Republicans may introduce compounding legislation soon — June 17

Health subcommittee in House holds compounding hearing — June 4

Compounding pharmacy provides different view of FDA inspections — June 3

Senate considers drug compounding bill — June 1

APhA seeks more clarity on compounder definitions in Senate draft proposal — May 9

FDA, pharmacy groups support Senate draft compounding legislation — May 9

Senate draft proposal would clarify FDA authority over high-risk compounding — May 1

Compounding hearing: FDA seeks more authority — May 1

House hearing: FDA seeks stronger authority over compounding pharmacies — April 16

Markey report: More FDA oversight of compounding pharmacies needed in light of state ‘deficiencies’ — April 16

Pharmacy responds to Washington Post article on larger compounding pharmacies — February 12

Massachusetts governor files compounding bill — February 1

APhA supports FDA’s concept of risk-based framework for pharmacy compounding — January 29

State-related actions on compounding pharmacy — January 1

CEO Blog posts about compounding:

Compounding legislation vote: APhA continues to push for improvements — September 27

Compounding: The American Public Health Association (APHA) does not speak for APhA — August 5

FDA works with pharmacy, states on compounding — December 20, 2012
 

Thomas E. Menighan, BSPharm, MBA, ScD (Hon), FAPhA
APhA Executive Vice President and CEO

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