FLORHAM PARK, N.J. — The Specialty Pharmacy Association of America (SPAARx) is launching a national advocacy initiative to clarify the differences between specialty pharmacy and compounding.
SPAARx said Tuesday that the effort — focused on lawmakers, the Food and Drug Administration and the public — comes amid pending federal and state legislation and regulation related to compounding.
According to the association, media reports in recent weeks — including articles by The New York Times, The Wall Street Journal, The Boston Globe and The Washington Post — have used the terms "specialty pharmacy" and "compounding" interchangeably. The group said such a characterization "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 House and Senate committees, the FDA commissioner and state legislators that spells out the differences between specialty pharmacy and compounding.
The association said it supports the accreditation of compounding pharmacies by nationally recognized agencies with the necessary expertise to assess and confirm compliance with the highest standards for quality compounding.
In addition, SPAARx noted that it wants to inform the public that services provided by compounding pharmacies much different than services provided by specialty pharmacies.
"SPAARx believes that specialty pharmacy and the art and science of extemporaneous compounding are dissimilar," Bill Sullivan, interim executive director of SPAARx, said in a statement.
"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," Sullivan explained. "New laws and/or regulations should take into account these significant dissimilarities and focus such actions on compounding as appropriate."
SPAARx added that earlier this year it endorsed a comprehensive definition of specialty pharmacy, which made no mention of compounding.
