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The 191st General Court of the Commonwealth of Massachusetts

Section 39H: Retail complex non-sterile compounding pharmacies; licensure; designation of manager of record; inspection and quality assurance procedures; supplementary regulations

Section 39H. (a)(1) The board shall establish a category of pharmacy licensure for retail pharmacies engaged in complex non-sterile compounding. A retail complex non-sterile compounding pharmacy license issued by the board shall be obtained in addition to and not in place of any other permit or license a pharmacy holds.

(2) A retail complex non-sterile compounding pharmacy license shall be non-transferable and shall be renewed annually. The fee for the renewal shall be determined annually by the secretary of administration and finance pursuant to section 3B of chapter 7.

(3) A retail complex non-sterile compounding pharmacy license shall not be renewed until each location where a licensee compounds complex non-sterile drug preparations has been inspected by the board and found to be in compliance with this chapter and regulations adopted by the board. The board shall conduct unannounced random and risk-based inspections of all retail complex non-sterile compounding pharmacies licensed under this chapter, as well as the complex non-sterile drug preparations compounded by these pharmacies.

(4) A retail complex non-sterile compounding pharmacy licensed by the commonwealth shall adhere to the most current standards established by USP, all chapters, when engaging in any form of complex non-sterile compounding. Such pharmacy shall also adhere to the additional regulations promulgated by the board pursuant to subsection (c).

(5) All retail complex non-sterile compounding pharmacies shall report to the board, on an annual basis, a list of prescriptions dispensed within and outside of the commonwealth, as well as the volume of these prescriptions. A retail complex non-sterile compounding pharmacy that ships compounded drug preparations outside of the commonwealth shall, in addition to the requirements in this section, report to the board the names of the states to which the pharmacy has shipped complex non-sterile drug preparations.

(6) A retail complex non-sterile compounding pharmacy license shall not be renewed until the licensee certifies that their employees have been trained in lean concepts, which are tools that assist in the identification and steady elimination of waste and promote continuous improvement in quality and efficiency.

(b) A retail complex non-sterile compounding pharmacy shall designate a manager of record who shall:

(i) disclose to the board the location, name and title of all principal managers and the name and Massachusetts license number of the designated manager of record;

(ii) certify the retail complex non-sterile compounding pharmacy's compliance with reasonable informational requests made by the board;

(iii) certify to the board that the manager of record has fulfilled continuing education requirements for complex non-sterile compounding and ensured that all pharmacy staff has received the appropriate training and education required by law and regulations before engaging in compounding; and

(iv) submit to the board the names and titles of all individuals employed by the pharmacy; and

(v) annually, and within 30 days after any change of office, corporate office or manager of record, file a report containing the information disclosed under clause (i)..

(c)(1) The board shall establish a list of procedural criteria on which a retail complex non-sterile compounding pharmacy shall be evaluated at the time of inspection. The procedural criteria shall contain a predetermined list of standards and safeguards upon which a retail complex non-sterile compounding pharmacy shall be inspected, as well as a predetermined yet alternating list of variable criteria upon which the pharmacy may be inspected without prior notice as to which subset of these variable criteria shall be included in the inspection.

(2) The board shall develop a quality assurance procedure for retail complex non-sterile compounding pharmacies to adhere to including, but not limited to, procedures to enhance physical inspection and compounding accuracy checks.

(3) The board shall establish supplementary regulations for all retail complex non-sterile compounding pharmacies intending to compound or dispense complex non-sterile drug preparations in the commonwealth. The regulations shall include, but not be limited to: (i) enhancing non-sterile active pharmaceutical ingredient controls; (ii) enhancing procedures surrounding process validation and reproducibility of complex non-sterile drug preparations; (iii) enhancing procedures related to end stage testing of complex non-sterile drug preparations; (iv) enhancing procedures relating to the storage and beyond-use-dating of complex non-sterile drug preparations; (v) developing effective formulation records for retail complex non-sterile compounding pharmacies; and (vi) developing effective procedures to maintain a drug preparation's quality and control after the complex non-sterile drug preparation leaves the retail complex non-sterile compounding pharmacy.

(4) The board shall promulgate regulations for the administration of paragraphs (1), (2) and (3) of this subsection, provided that no such regulation shall exempt a retail complex non-sterile compounding pharmacy from compliance with the most current standards established by USP, all chapters.