Section 2: Operation or participation in drug stewardship program required; powers and duties of department

263 words·~1 min read·/ma/part-i/title-xv/chapter-94h/2

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[Text of section effective until December 31, 2026. Repealed by 2016, 52, Sec. 55 as amended by 2016, 351, Sec. 6. See 2016, 52, Sec. 77 as amended by 2021, 102, Sec. 45.]

Section 2.

(a)Any pharmaceutical product manufacturer selling or distributing a covered drug to consumers in the commonwealth, whether directly or through a wholesaler, retailer or other agent, shall:

(i)operate a drug stewardship program approved by the department individually or jointly with other manufacturers;

(ii)enter into an agreement with a stewardship organization that shall operate a drug stewardship program approved by the department; or

(iii)enter into an agreement with the department to operate an alternative plan under section 6.

(b)The department shall establish a process to review applications for approval and renewal of a manufacturer's drug stewardship plan. The department shall consult with the Massachusetts Biotechnology Council, the Interagency Council on Substance Abuse and other interested parties in developing the requirements of a drug stewardship program.

(c)Each operator of a drug stewardship program shall file an annual written report to the department describing the program's activities for the prior year and the volume and type of unwanted drugs collected not later than March 1.

(d)The department shall review for renewal each drug stewardship program at a frequency to be determined by the department.

(e)The department shall publish and make publicly available a list and description of each approved drug stewardship program and shall update this list at a frequency determined by the department.

(f)The department may promulgate regulations to implement this chapter.