Amendment #1 to H.3672

Sanchez Amendment

Mr. Sánchez of Boston move that the bill be amended by striking out, in lines 39 to 40, inclusive, the words “compounding sterile drug preparations, as defined in section 39D of chapter 112, and shall be engaged in compounding sterile drug preparations” and inserting in place thereof the following words:-



“sterile compounding, as defined in section 39D of chapter 112, and shall be engaged in sterile compounding”;



by striking out the text in lines 53 to 76, inclusive, and inserting in place thereof the following:-



“(l) Board members shall be appointed and shall serve for a term of 3 years from the first of the month following appointment. No member may serve more than 2 consecutive terms on the board. Members who have served the maximum number of consecutive terms shall be eligible for reappointment after not serving for at least 1 term.



(m) Board members may be removed by the governor, only for reasonable cause of neglect of duty, misconduct, malfeasance or misfeasance in office. Prior to removal, such member shall be given written notice of the basis for removal and be afforded a hearing before the governor or designee. Such member may appear at the hearing with witnesses and be represented by counsel. The hearing shall be held within 21 days of the notice.



(n) Chapters 268A and 268B shall apply to the members of the board; provided, however, that the board shall establish a code of ethics for all members and employees that shall be more restrictive than said chapters 268A and 268B. A copy of the code shall be filed with the state ethics commission. The code shall include provisions reasonably necessary to carry out the purposes of this section and any other laws pertaining to the jurisdiction of the board including, but not limited to: (i) requiring the disclosure of any gifts received by board members by any person or entity subject to the jurisdiction of the board; (ii) prohibiting the participation by board members in a particular matter as defined in section 1 of said chapter 268A that affects the financial interest of a relative within the third degree of consanguinity or a person with whom such board member has a significant relationship as defined in the code; and (iii) providing for recusal of a board member in a licensing decision due to a potential conflict of interest.”;



by striking out the text in lines 265 to 282, inclusive, and inserting in place thereof the following:-



“(e) If a sterile compounding pharmacy believes that a compounded sterile drug preparation dispensed or distributed by the pharmacy is or may be defective in any way, the pharmacy shall immediately recall the compounded sterile drug preparation. Any of the same preparation remaining in the possession of the pharmacy shall be located and segregated, and shall not be distributed or dispensed. A defective compounded sterile drug preparation log documenting the recalled compounded sterile drug preparation shall be kept by the pharmacy including information on:



(1) the preparation name, potency and dosage form;



(2) the reason for the recall;



(3) the amount of the preparation made;



(4) the date that the preparation was made;



(5) the amount of the preparation dispensed or distributed;



(6) the actual preparation potency and dosage form; and



(7) any and all serious adverse drug events related to the drug in question.



The defective compounded sterile drug preparation log shall be made available to the board within 7 days of the recall, and shall be kept on record for at least 2 years. Upon submission of the defective compounded sterile drug preparation log to the board, the pharmacy shall work with the board to develop a corrective action plan that rectifies the error which resulted in the defective compounded sterile drug preparation.”;



by striking out, in line 383, the words “manager of record” and inserting in place thereof the following words:-



“designated pharmacist in charge”,



and by inserting, in line 466, after the word “concerns. " the following sentence:-



“In developing the licensure and reporting requirements for sterile compounding pharmacies, the advisory committee shall further evaluate and may make recommendations on an annual basis to the board that take into consideration the application of all pertinent federal statutory and regulatory criteria.”