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SPAARx Issues Industry Letter to Inform Legislators and FDA About the Dissimilarity of Specialty Pharmacy vs. Compounding

Apr 2 2013 12:00AM



FLORHAM PARK, NJ -- (Marketwired) -- 04/02/13 -- The Specialty Pharmacy Association of America (SPAARx), the largest national association representing the broad interests of the specialty pharmacy industry, today announced that it is launching a national advocacy initiative focused on pending federal and state legislation and regulation through agencies including the United States Food and Drug Administration (FDA) related to Compounding. The Association believes that a clear understanding of the differentiation between specialty pharmacy and compounding is critical to avoid unintended consequences.

Numerous media reports over recent weeks, including lead articles by The New York Times, The Wall Street Journal, The Boston Globe, The Washington Post, and others, have used the terms 'Specialty Pharmacy' and 'Compounding' interchangeably, which is inaccurate, misleading to the public and to legislators and regulators as they consider actions that could affect pharmacies that create compounded drugs, but specialty pharmacies as well.

In response, SPAARx is sending a letter to appropriate House and Senate Committees, the FDA Commissioner, and state legislators, that differentiates specialty pharmacy from compounding to help inform decision making. The Association supports the accreditation of compounding pharmacies by nationally recognized agencies with the necessary expertise to assess and confirm ongoing compliance with the highest standards for quality compounding. Most importantly, the Association wishes to inform the public that services provided by compounding pharmacies are poles apart from those services provided by specialty pharmacies.

"SPAARx believes that specialty pharmacy and the art and science of extemporaneous compounding are dissimilar," said Bill Sullivan, Interim Executive Director of the Specialty Pharmacy Association of America. Sullivan continued, "Specialty pharmacies dispense FDA approved and commercially available medications requiring patient-specific prescriptions. By comparison, compounding-only pharmacies prepare medications from FDA approved chemical ingredients and commercially available medications which may not require a patient-specific prescription at the time of formulation. New laws and / or regulations should take into account these significant dissimilarities and focus such actions on compounding as appropriate."

Earlier this year the Specialty Pharmacy Association of America endorsed a comprehensive Definition of Specialty Pharmacy in which no mention is made of the practice of compounding. The definition may be downloaded at: Specialty Pharmacy - Definition.doc

About Specialty Pharmacy Association of America (SPAARx)
SPAARx is the largest national Association solely dedicated to the interests of all individuals in the specialty pharmacy segment of healthcare. SPAARx is managed and governed by a board of directors comprised of executives from a diverse group of specialty pharmacies. This association is vendor-neutral and fully-aligned with the interests of all industry stakeholders. SPAARx is setting the standards, leading in advocacy and promoting the value of specialty pharmacy. The association's goal is to protect and promote common industry interests along with fostering professional growth within specialty pharmacy. To learn more about SPAARX or join today, please visit

Bill Sullivan
Interim Executive Director
Specialty Pharmacy Association of America (SPAARx)
100 Campus Drive
Florham Park, NJ 07932

Source: Marketwire

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