Friday, May 31, 2013
IACP Sponsors Second Annual, “Virtual Hill Day”
Just Like Being There in Person Without the Travel!
Next week, nearly 400 of your compounding pharmacist and technician colleagues will be gathering for IACP’s 19th Annual Compounders on Capitol Hill (CCH) in Washington, D.C., June 1-4, 2013. On Tuesday, June 4th, your colleagues will be headed to the Hill, meeting with Representatives and Senators regarding several issues, most notably, S. 959 – pharmacy compounding legislation introduced by the U.S. Senate. We need your help to educate and secure their support of changes to this proposed legislation we believe are vitally necessary on behalf of your patients and practitioners.
To those not attending CCH this year, we’d love to see you in D.C.; but, we know you have a business to run. Patients to take care of. Prescriptions to compound, prepare and dispense. You can’t make it to Washington, D.C. this year.
We have very critical issues before us as a profession. Perhaps like never before. We still need your participation and virtual presence. With IACP’s Virtual Hill Day, you can still make a real difference in helping to influence needed amendments to the current legislation, which as currently written, could potentially hinder your ability to serve your patients and practitioners.
IACP’s 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 your Senator.
Watch your inbox on Monday, June 3, 2013, 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.
Here is some background on our CCH legislative agenda this year. Below is a quick recap of the messages for our 2013 Congressional Ask Document that attendees at Compounders on Capitol Hill will see and take to the Hill in person. S. 959 -- legislation introduced in the United States Senate called the Pharmaceutical Compounding Quality and Account ability Act -- creates more ambiguity and greater potential for confusion about which regulatory agency should oversee pharmacy compounding.
As written, S. 959 is too far-reaching in its scope and micromanagement of practitioner decisions. S. 959 must be amended to eliminate unnecessary FDA oversight of traditional compounding and assure the ability of physicians to make informed decisions about appropriate medication therapy. IACP believes that S. 959 rewards the FDA with new sweeping powers without holding the agency accountable for its past inaction and failure to protect the public.
Because it creates more regulatory ambiguity, we are asking for support in amending S. 959 when it reaches the floor of the Senate later in June Some of those amendments specifically address:
Confuses Pharmacy Practice with Manufacturing
Interferes with State Regulation of Pharmacy Practice
- Defines an individual compounded medication as a “new drug.”
- The definition of a “compounding manufacturer” refers to “prescriptions.” Pharmacies dispense prescriptions, manufacturers sell drugs.
Does Nothing to Hold FDA Accountable for Neglect
- Ignores “office-use” by requiring an “identified individual patient prescription.”
- Repeats that problem in the convoluted description of “anticipatory compounding.”
- Restricts Health Care Decisions by Prescribers
- Severely restricts ability to prescribe a variation of a manufactured drug to meet patient needs.
- Authorizes the FDA to prohibit entire categories of drugs deemed “difficult to compound” with no evidence of patient safety or impact on patient care.
For a complete background on this issue, click here to read the IACP-prepared 2013 Congressional Ask Documents including the extensive section analysis explaining the amendments needed on S. 959.
- Fails to provide for Congressional oversight of the agency’s handling of complaints about compounded medicines.
- Puts the FDA in charge of determining if a pharmacy is acting within the scope of its permit instead of the State Board of Pharmacy.
Thank you for your participation in these absolutely vital issues now facing the compounding profession. Please email email@example.com with any questions.
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