Outside Section 98
Data Current as of: 8/19/2015
Section 39F of said chapter 112, as so appearing, is hereby amended by striking out subsection (c) and inserting in place thereof the following subsection:-
(c) An entity that intends to compound and distribute a sterile drug preparation or a complex nonsterile drug within or outside of the commonwealth in volumes inconsistent with routinely observed volume patterns associated with patient-specific prescriptions or in the absence of accountability documentation shall adhere to the most current standards established under cGMP when engaging in any form of compounding. The entities shall either register as a producer of drugs with the federal Food and Drug Administration pursuant to section 510 of the Federal Food, Drug, and Cosmetic Act, codified at 21 U.S.C. section 360 or register as an outsourcing facility with both the federal Food and Drug Administration pursuant to section 503B of the Federal Food, Drug, and Cosmetic Act, codified at 21 U.S.C. § 353b, and the board of registration in pharmacy pursuant to section 36E before engaging in any sterile compounding or complex nonsterile compounding.