Tuesday, May 6, 2014
IACP Sponsors Third Annual, “Virtual Hill Day”
Just Like Being There in Person Without the Travel!
On May 17-20, 2014, more than 400 compounding pharmacists and pharmacy technicians just like you will be gathered together for IACP’s 20th Annual Compounders on Capitol Hill conference in Washington, DC. On Tuesday, May 20th,
your colleagues will be pounding the hallways of Congress, meeting with
representatives and Senators to educate and secure their support of our
But you’ve got a business to run. Patients
to take care of. Prescriptions to compound, prepare and dispense. You
can’t make it to Washington, DC this year.
And that’s okay. Because even if you’re not at Compounders on Capitol Hill
in person, you can still add your voice along with those of pharmacists
nationwide and make a real impact on legislation that can hurt or harm
your business and your profession.
Once again, IACP is using
technology to put you right there in those hallways and on the Capitol
steps… at least virtually. Our unique Action Alert system lets you send a
personalized, IACP-prepared request for support directly from your home
or pharmacy straight to the offices of both your Representative and
Watch your in-box on Monday, May 19, 2014
for information and links on how to send a message to Capitol Hill. It
takes just a few minutes and can literally quadruple the number of
compounding pharmacist voices ringing through the halls of Congress.
give you some background on our legislative agenda this year, here’s a
quick recap of our three, big issues along with the same 2014 Congressional Ask Documents that attendees at Compounders on Capitol Hill will see and take to the Hill in person.
Hold FDA Accountable to Congressional Intent in DQSA Implementation
- FDA ignores Congressional intent by prohibiting all Office-Use Compounding in 503A
continues down a path to ignore Congressional intent in implementing
provisions on repackaging and the Memorandum of Understanding
causes confusion for pharmacists and other stakeholders thru their
letters sent to States and hospitals requesting they only do business
with Outsourcing Facilities (OFs)
FDA to explain their rationale for ignoring Congressional intent;
Require FDA to provide clear explanation to the medical and practice
community; Obtain answers needed by the state legislatures and
regulatory boards which find their laws in conflict with FDA
For a complete background on this issue, click here
to read the IACP-prepared 2014 Congressional Ask Document on “Hold FDA
Accountable to Congressional Intent in DQSA Implementation.”
Restrict FDA Appropriations to Prevent the Agency’s Continued Disregard of Congressional Intent
- FDA released its FY2015 budget request detailing how the President’s funding of $4.7 billion would be used in 2015
- FDA plans to invest $25 million to “enhance compounding oversight activities in FY2015
also has requested almost $7 million in additional funding for field
activities including: “conducting additional inspections of high-risk
human drug compounding pharmacies including sterile compounding
facilities that seek to qualify for the section 503A exemptions and
facilities that register as OFs under 503B.”
appropriations language that none of the funds made available in FY2015
budget may be used to prohibit the compounding of drug products under
503A of the Food, Drug, and Cosmetic Act when such compounding is
permitted by state laws, regulations or rules.
For a complete background on this issue, click here
to read the IACP prepared 2014 Congressional Ask Document on “Restrict
FDA Appropriations to Prevent the Agency’s Continued Disregard of
Support and Co-Sponsor H.R. 4069 – Ensuring Patient Access and Effective Drug Enforcement Act – with a Manager’s Amendment
- The DEA does not permit a pharmacist to dispense a controlled substance to the patient’s doctor
- There are medicines which should only be handled and managed by healthcare professionals to ensure stability and integrity.
- The DEA has statutory authority to engage in rulemaking but has not done so despite repeated requests.
DEA has informed organized pharmacy that it’s not willing to change its
position despite a court opinion to the contrary, mounting evidence
that there is resulting drug diversion, patient safety issues and drug
Support and Co-Sponsor Congressman Marino (R-PA) and Congressman Blackburn (R-TN)’s H.R. 4069 with a Manager’s Amendment to enable a pharmacist to deliver a patient’s controlled substance to a prescriber.
For a complete background on this issue, click here to read the IACP prepared 2014 Congressional Ask Document on “Support and Co-Sponsor H.R. 4069.”
to learn more about being a successful advocate for compounding and
your practice? IACP has a one-hour continuing education program that
covers the ins and outs of preparing for and delivering a simple and
clear message to legislators both on Capitol Hill and in your own
district. Updated with brand new information this week, Being A Successful Compounding Advocate: Tips for Working with Your Legislators is now available in the IACP AdvanCE library of CE programs. To take the course, please click here.
advance, IACP appreciates your help on these important issues. Should
you need IACP staff to follow-up on any of the contacts you make, please
don’t hesitate to let us know by contacting Cynthia Blankenship, ESQ., IACP’s Vice-President of Government Affairs at (703) 299-0796 or via e-mail at email@example.com. Your participation and efforts will help give the profession of compounding a stronger voice in Washington.
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