Saturday, February 27, 2016
Compounding Study Draws Heat
By Walter F. Roche Jr.
The association representing pharmacy drug compounders is challenging one of the key conclusions of a new study of the ongoing efforts of state pharmacy boards to regulate drug compounding.
In a statement released this week, officials of the International Association of Compounding Pharmacists took issue with the study's conclusion that many state boards are failing to comply with a new federal law as it applies to drug compounding in physicians' offices. The statement was issued in a response to a report by the Pew Charitable Trusts.
"We have identified a primary point of concern which we believe warrants additional clarification and study," the association statement reads.
The group disputed the study's conclusion that the new federal law bars physicians from preparing compounded drugs in their offices without a patient-specific prescription.
Citing six statements of support from members of Congress, the statement also points to language in an appropriations bill supporting their position.
The association said it did agree with some of the Pew findings, including the need for use of a national standard on sterile compounding practices as set by the U.S. Pharmacopia.
The Pew study concluded that many state pharmacy boards were allowing the preparation of sterile compounded drugs in physicians' office without a prescription in apparent violation of the Drug Quality and Security Act of 2013.
The new law was passed in response to the 2012 nationwide fungal meningitis outbreak which took the lives of 76 patients and sickened hundreds more.
The outbreak was traced to a rogue Massachusetts firm mass producing compounded drugs.When regulators began pressing the New England Compounding Center for failure to have patient specific prescriptions, firm salesmen encouraged clinics to come up with lists.
Clinics purchasing NECC drugs obliged by submitting lists with names including Flash Gordon, Big Baby Jesus and Mickey Mouse.