Amendment ID: S1899-20-R1

Redraft Amendment 20

Corrective Amendment

Mr. Brewer moves to amend the amendment in section 13, by striking out, in line 162, the word “American Council on Pharmaceutical” and inserting in place thereof the following word:- “Accreditation Council for Pharmacy”; and

in section 18, by inserting after the word “a”, in line 212 the following words:- “compounded complex non-sterile”; and

in said section 18, by striking out, in line 213, the word “sterile”; and

in the definition of “compounding”, in said section 18, by striking out clause (4); and

in said section 18 by inserting after subsection (e) of proposed section 39F of chapter 112 of the General Laws the following subsection:-

“(f) A pharmacy shall not compound sterile drug products that are essentially copies of commercially available, federal Food and Drug Administration-approved drug preparations or drug preparations banned by the federal Food and Drug Administration because of safety concerns. A drug product shall not be considered a copy of a commercially available preparation if the compounded preparation produces, for the patient, a significant difference between the compounded drug and the comparable commercially available drug preparation, as determined by the prescriber as necessary for the medical best interest of the patient. A significant difference may include, but shall not be limited to, the removal of a dye for medical reasons, a change in strength, dosage form or delivery mechanism. A price difference shall not be a significant difference to justify compounding.”; and

in said section 18, by inserting after subsection (e) of proposed section 39G of chapter 112 of the General Laws the following subsection:-

“(f) A pharmacy shall not compound non-sterile drug products that are essentially copies of commercially available, federal Food and Drug Administration-approved drug preparations or drug preparations banned by the federal Food and Drug Administration because of safety concerns. A drug product shall not be considered a copy of a commercially available preparation if the compounded preparation produces, for the patient, a significant difference between the compounded drug and the comparable commercially available drug preparation, as determined by the prescriber as necessary for the medical best interest of the patient. A significant difference may include, but shall not be limited to, the removal of a dye for medical reasons, a change in strength, dosage form or delivery mechanism. A price difference shall not be a significant difference to justify compounding.”; and

in said section 18, by striking out, in lines 398 and 399, inclusive, the following words:- “, the efficacy of the products”; and

in said section 18, by striking out, in line 465, the word “change” and inserting in place thereof the following word:- “charge”; and

in said section 18, by striking out, in line 466, the words “A report” and inserting in place thereof the following words:- “The designated pharmacist in charge shall submit a report”; and

in said section 18, by striking out, in line 467, the following words:- “shall be made”; and

by inserting after section 29 the following section:-

“SECTION 30. The department of public health shall promulgate regulations as necessary to implement sections 24A, 39D, 39F, 39G, 39H and 42A of chapter 112 of the General Laws not later than 180 days after the passage of this act.”; and

in section 32, by striking out, in line 691, the figure “32” and inserting in place thereof the following figure:- “31”; and

by adding the following 2 sections:-

“SECTION 33. Sections 27, 28A, 29A and 30 shall take effect upon the passage of this act.

SECTION 34. Section 42C of chapter 112 of the General Laws shall take effect upon the passage of this act.”; and

by inserting before the enacting clause the following emergency preamble:-

“Whereas, The deferred operation of this act would tend to defeat its purpose, which is to further regulate forthwith the practice of compounding and dispensing of prescription drugs, therefore it is hereby declared to be an emergency law, necessary for the immediate preservation of the public safety.”.