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General Laws

Section 13. There shall be in the department a drug formulary commission consisting of nine members appointed by the governor. The membership shall include a clinical pharmacist, a pharmaceutical chemist, a clinical pharmacologist, a retail pharmacist, a person with experience in pharmaceutical manufacturing, two practicing physicians and two persons not involved in the delivery of health services who shall be representatives of the public. One of the two public appointees by reason of age, training, experience and affiliation shall represent the interests of the elderly. None of the members may be employed by any pharmaceutical manufacturing company.

Members shall serve for a term of three years. Of the first appointments under this section, three shall be appointed for a term of three years; three shall be appointed for a term of two years; and three shall be appointed for a term of one year. As the term of a member expires, his successor shall be appointed to serve for a term of three years.

The commission shall prepare a drug formulary of interchangeable drug products which shall be adopted by regulations of the department. Said formulary shall be based on assessment and evaluation of the United States Pharmacopeia and its supplements, additional pertinent listings of the Department of Health, Education, and Welfare, Food and Drug Administration, other state formularies, formularies of various hospitals of the commonwealth, as well as data submitted by manufacturers. The commission shall assess and evaluate chemical and laboratory testing data, clinical proof of bioequivalence, and therapeutic equivalence where available. The commission shall also adopt for inclusion in said formulary the list of drugs determined by the regulation of the Food and Drug Administration to be therapeutically equivalent and interchangeable when said list becomes available.

Said formulary shall not include drugs which are the subject matter of patent rights issued by the United States Patent Office nor shall it include those drug products for which bioequivalence is considered essential, but for which bioequivalence has not been established by the Food and Drug Administration.

The commission shall provide for distribution copies of such formulary and revisions thereto amongst physicians and pharmacists licensed to practice within the commonwealth and to other appropriate individuals and shall supply a copy to any person on request upon payment of the cost of printing.

Said formulary shall be revised from time to time but in no event less frequently than once a year so as to include new pertinent information on drugs approved for inclusion or drugs to be deleted and to reflect current information as to the therapeutic efficacy of drugs and pharmaceuticals.

The department, in cooperation with the commission, shall promulgate rules and regulations to insure public education regarding the provisions of this section.

Any person or party in interest aggrieved by a finding or report of the commission shall be entitled to a judicial review thereof as provided in section fourteen of chapter thirty A.

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