§ 39F — Compounding and distribution of sterile or complex non-sterile drug preparation prohibited without license; adherence to current standards under cGMP

Section 39F. (a) A pharmacy shall not engage in sterile compounding nor shall a pharmacy prescribe, ship, mail, sell, transfer or dispense sterile drug preparations in the commonwealth unless the pharmacy has obtained a license from the board pursuant to section 39G, 39I or 39J.(b) No pharmacy shall engage in complex non-sterile compounding nor shall a pharmacy prescribe, ship, mail, sell, transfer or dispense complex non-sterile drug preparations in the commonwealth unless the pharmacy has obtained a license from the board pursuant to section 39H or 39J.(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.(d) A pharmacy shall not compound any drug preparations banned by the federal Food and Drug Administration because of safety concerns.