Amendment ID: S1899-18-R1

Redraft Amendment 18

Non-Sterile Compounding

Mr. Richard T. Moore moves to amend the amendment in section 18, in proposed section 39D of chapter 112 of the General Laws, by striking out the definition of “Compounded complex non-sterile drug preparation” and inserting in place thereof the following definition:-

““Compounded complex non-sterile drug preparation”, a compounded preparation which requires special training, a special environment or special facilities or equipment or the use of compounding techniques and procedures that may present an elevated risk to the compounder or the patient, as defined by the board through regulation; provided, that the regulations promulgated by the board, which are applicable to this definition, shall be consistent with the category of complex non-sterile compounding described in chapter 795 of the USP.”; and

in said section 18, in proposed section 39F of said chapter 112, by striking out subsection (c) and inserting in place thereof the following subsection:-

“(c) A pharmacy licensed by the commonwealth that intends to compound sterile drug preparations and dispense compounded sterile drug preparations in or out of the commonwealth shall adhere to regulations promulgated by the board pursuant to subsection (h) of section 39H, in consultation with the advisory committee, established by section 42C.”; and

in said section 18, in proposed section 39G of said chapter 112, by striking out subsection (c) and inserting in place thereof the following subsection:-

“(c) A pharmacy licensed by the commonwealth that intends to compound complex non-sterile drug preparations and dispense compounded complex non-sterile drug preparations in or out of the commonwealth shall adhere to regulations promulgated by the board pursuant to subsection (h) of section 39H, in consultation with the advisory committee, established by section 42C.”; and

in said section 18, in proposed section 39H of said chapter 112, by striking out subsection (h) and inserting in place thereof the following subsection:-

“(h) The board shall establish regulations for all pharmacies intending to compound or dispense sterile or complex non-sterile drug preparations in the commonwealth.  The board shall establish regulations in consultation with the advisory committee, established by section 42C.  The regulations shall include, but not be limited to: (1) enhancing environmental monitoring procedures; (2) enhancing media fill testing procedures; (3) enhancing non-sterile active pharmaceutical ingredient controls; (4) enhancing procedures testing endotoxin and bioburden levels of compounded drug preparations; (5) enhancing procedures surrounding process validation and reproducibility of compounded drug preparations; (6) enhancing procedures related to end stage testing of compounded drug preparations; (7) enhancing procedures relating to the storage and beyond-use-dating of compounded drug preparations; (8) enhancing the physical inspection process for finished sterile compounded drug preparations; (9) developing effective formulation records for sterile compounding pharmacies; (10) developing effective compounding records for compounded drug preparations produced at sterile compounding pharmacies; and (11) developing effective procedures to maintain a preparation’s quality and control after the compounded sterile or complex non-sterile drug preparation leaves the pharmacy.  Said regulations shall not conflict with chapters 795 and 797 of the USP, but may be more expansive than those chapters of the USP.”