Mass. Gen. Laws ch. 112, sec. 39J — MA Code / Part I / Title XVI / Chapter 112 / Section 39J
Non-resident pharmacies; licensure; designation of pharmacist in charge; distribution of drug preparations produced or compounded by a pharmacy not granted a non-resident license prohibited
Status: in_force

Section 39J. (a) The board shall establish a procedure to license non-resident pharmacies, which prescribe, ship, mail, sell or dispense medications in the commonwealth, that pertains to the practice of pharmacy. The board shall also take steps to ensure that all shipments of pharmaceuticals from in-state pharmacies to out-of-state destinations are in compliance with the licensing procedures applicable to pharmacies in the commonwealth. (b) A non-resident pharmacy shall designate a pharmacist in charge who shall register with the board and shall be responsible for the pharmacy's compliance with this chapter. Such pharmacist in charge shall be licensed and in good standing with the state board of registration in pharmacy in which the pharmacy is located. (1) The designated pharmacist in charge shall disclose to the board the location, name and title of all principal managers and the name and Massachusetts license number of the designated pharmacist in charge, if applicable, and a letter from the in-state board of registration of pharmacy certifying that the pharmacist in charge is in good standing with the in-state board of registration. The designated pharmacist in charge shall submit a report containing this information and a copy of the certifying letter of good standing on an annual basis and within 30 days after any change of office, corporate office or manager of record. (2) The designated pharmacist in charge shall certify to the board that the pharmacy maintains, at all times, a current unrestricted license, permit or registration to conduct the pharmacy in compliance with the laws and regulations of the jurisdiction in which it is licensed to practice. The pharmacy shall certify its compliance with reasonable informational requests made by the board. The pharmacy shall also notify the board of any enforcement or disciplinary action taken against the pharmacy regardless of the state in which the enforcement action is taken. (3) The designated pharmacist in charge shall certify to the board that the pharmacy maintains records of all drugs dispensed to patients in the commonwealth, and that these records are readily available, upon the request of the board. A list of drugs dispensed in the commonwealth shall be sent to the board annually. (c) No pharmacy or pharmacist operating outside of the state shall prescribe, ship, mail, sell, transfer or dispense drug preparations in the commonwealth unless the drug preparations are produced in a pharmacy that has been granted a non-resident license pursuant to this section. (d) No pharmacy, pharmacist or outsourcing facility operating outside of the commonwealth may prescribe, ship, mail, sell, transfer or dispense sterile drug preparations or complex nonsterile drug preparations in the commonwealth unless the sterile drug preparations or complex non-sterile drug preparations are compounded in a pharmacy or outsourcing facility that has been granted a nonresident sterile compounding license, nonresident complex non-sterile compounding license or nonresident outsourcing facility registration pursuant to this chapter. (e) Non-resident pharmacies holding a nonresident pharmacy license under this section shall be subject to the requirements of section 24A of chapter 94C; provided, however, that nonresident pharmacies shall not be eligible for a waiver under said section 24A. An application for licensure under this section shall not be approved unless the applicant has demonstrated the ability to comply with said section 24A. The board may revoke a nonresident pharmacy license for failure to comply with said section 24A.

Section 39J. (a) The board shall establish a procedure to license non-resident pharmacies, which prescribe, ship, mail, sell or dispense medications in the commonwealth, that pertains to the practice of pharmacy. The board shall also take steps to ensure that all shipments of pharmaceuticals from in-state pharmacies to out-of-state destinations are in compliance with the licensing procedures applicable to pharmacies in the commonwealth.

(b) A non-resident pharmacy shall designate a pharmacist in charge who shall register with the board and shall be responsible for the pharmacy's compliance with this chapter. Such pharmacist in charge shall be licensed and in good standing with the state board of registration in pharmacy in which the pharmacy is located.

(1) The designated pharmacist in charge shall disclose to the board the location, name and title of all principal managers and the name and Massachusetts license number of the designated pharmacist in charge, if applicable, and a letter from the in-state board of registration of pharmacy certifying that the pharmacist in charge is in good standing with the in-state board of registration. The designated pharmacist in charge shall submit a report containing this information and a copy of the certifying letter of good standing on an annual basis and within 30 days after any change of office, corporate office or manager of record.

(2) The designated pharmacist in charge shall certify to the board that the pharmacy maintains, at all times, a current unrestricted license, permit or registration to conduct the pharmacy in compliance with the laws and regulations of the jurisdiction in which it is licensed to practice. The pharmacy shall certify its compliance with reasonable informational requests made by the board. The pharmacy shall also notify the board of any enforcement or disciplinary action taken against the pharmacy regardless of the state in which the enforcement action is taken.

(3) The designated pharmacist in charge shall certify to the board that the pharmacy maintains records of all drugs dispensed to patients in the commonwealth, and that these records are readily available, upon the request of the board. A list of drugs dispensed in the commonwealth shall be sent to the board annually.

(c) No pharmacy or pharmacist operating outside of the state shall prescribe, ship, mail, sell, transfer or dispense drug preparations in the commonwealth unless the drug preparations are produced in a pharmacy that has been granted a non-resident license pursuant to this section.

(d) No pharmacy, pharmacist or outsourcing facility operating outside of the commonwealth may prescribe, ship, mail, sell, transfer or dispense sterile drug preparations or complex nonsterile drug preparations in the commonwealth unless the sterile drug preparations or complex non-sterile drug preparations are compounded in a pharmacy or outsourcing facility that has been granted a nonresident sterile compounding license, nonresident complex non-sterile compounding license or nonresident outsourcing facility registration pursuant to this chapter.

(e) Non-resident pharmacies holding a nonresident pharmacy license under this section shall be subject to the requirements of section 24A of chapter 94C; provided, however, that nonresident pharmacies shall not be eligible for a waiver under said section 24A. An application for licensure under this section shall not be approved unless the applicant has demonstrated the ability to comply with said section 24A. The board may revoke a nonresident pharmacy license for failure to comply with said section 24A.