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The 191st General Court of the Commonwealth of Massachusetts

Section 42C: Advisory committee to the board of registration in pharmacy

Section 42C. (a) There shall be an advisory committee to the board. The committee shall consist of the commissioner of public health or a designee and 7 members who shall be appointed by the commissioner: 1 of whom shall be an expert in chapter 71 of the USP; 1 of whom shall be an expert in chapter 795 of the USP; 1 of whom shall be an expert in chapter 797 of the USP; 1 of whom shall be an expert in cGMP for aseptic processing; 1 of whom shall be an expert in pharmacoeconomics; 1 of whom shall be an expert in clinical pharmacology; and 1 of whom shall be a microbiologist. At the request of the board, the commissioner may appoint additional members knowledgeable in the fields of pharmaceutical compounding, pharmaceutical manufacturing, pharmacy, medicine or related specialties.

(b) Each member of the advisory committee appointed by the commissioner shall serve for a term of 3 years; provided, however, that additional members shall serve for a term determined by the commissioner not to exceed 3 years. Any person appointed to fill a vacancy on the committee shall serve for only the unexpired term of the member who vacated. Members shall be eligible for reappointment. A member of the committee appointed by the commissioner may be removed by the commissioner for cause. Members of the committee shall serve without compensation and shall be free of any liability incurred by their proposed recommendations to the board. The advisory committee shall meet at least semi-annually but may meet as often as the members or the board shall determine or at such other intervals as established by the commissioner to fulfill its duties. The department shall provide the advisory committee with support services necessary to complete needed research and analysis and enable the committee to make effective recommendations. Any recommendation made by the advisory committee shall be posted on the department of public health's website and a copy shall be transmitted to the clerks of the senate and house of representatives, who shall forward the report to the joint committee on public health and the joint committee on health care financing.

(c) The advisory committee shall evaluate the practice of pharmacy across all settings and recommend to the board any new or revised regulations and policies necessary to improve the delivery of pharmacy services in the commonwealth. The committee shall advise the board: on the establishment of specialty pharmacy licensure categories; on the development of quality assurance, inspection and testing procedures applicable to compounding; on the application of accountability documentation requirements in licensed sterile pharmacies and complex non-sterile pharmacies; the development of regulations to supplement the USP, all chapters; and any other area as requested by the board.

(d) The advisory committee shall evaluate the volume and revenue of drug preparations generated by each licensed sterile compounding complex non-sterile compounding pharmacy and pharmacy in the commonwealth, provided, that any item of information which is confidential or privileged in nature or under any other law shall not be regarded as a public record. Nothing in this section shall authorize the committee to obtain individually identifiable patient information.

(e) The advisory committee shall monitor existing or potential shortages of medically necessary drug products and recommend to the board options available to the commonwealth to mitigate the impact of drug shortages on patients and providers when a sufficient clinical need or a threat to public health and safety exists.