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The 193rd General Court of the Commonwealth of Massachusetts

Section 42A: Rules and regulations of the board of registration in pharmacy; participation in national data reporting systems; suspension or revocation of license or permit; hearing; summary action upon belief of threat to public health, safety or welfare

Section 42A. The board may make such rules and regulations as it deems necessary to enable it to properly enforce the provisions of law relating to the retail drug business, pharmacies and outsourcing facilities, and regarding any other matter within its jurisdiction; provided, that nothing herein shall authorize the board to make a rule or regulation requiring, as a prerequisite to the examination of an applicant under section twenty-four, or to his qualification, that he be the holder of a degree, nor a rule or regulation prohibiting a registered pharmacist connected with and employed by a hospital or clinic from dispensing medicines or drugs to an employee of such hospital or clinic for the use of such employee, his spouse and his children living in the same household with such employee.

The board shall participate in any national data reporting system which provides information on individual pharmacies, pharmacists and pharmacy technicians including, but not limited to, relevant databases maintained by the National Association of Boards of Pharmacy and the federal Food and Drug Administration. The board may enter into agreements with the United States Food and Drug Administration pursuant to 21 C.F.R. 20.88 to obtain records and information. Records and information obtained by the board pursuant to such agreements shall not be public records and shall be exempt from disclosure under clause Twenty-sixth of section 7 of chapter 4 or section 10 of chapter 66.

The board may by rule or regulation adopt, amend or repeal rules of professional conduct. Every person who holds a certificate, license, registration or permit to practice pharmacy, engage in the retail drug business or operate an outsourcing facility in this commonwealth shall be governed and controlled by the rules and regulations of professional conduct adopted by the board. The board may suspend or revoke any certificate, license, registration or permit to practice pharmacy or engage in the retail drug business for any violation of the rules and regulations established hereunder or for aiding or abetting in any violation of such rules or regulations; but before such suspension or revocation, the board shall give a hearing to the holder of the certificate, license, registration or permit, after due notice to him of the charges against him and of the time and place of the hearing. Such holder may appear at the hearing with witnesses and be heard by counsel. Witnesses shall testify on oath and any member of the board may administer oaths to them. The board may require the attendance of persons and compel the production of books and documents. Three members of the board shall be a quorum for such a hearing, but no certificate, license, registration or permit shall be suspended or revoked unless upon the affirmative vote of three or more members thereof. The rules of professional conduct adopted by the board shall be printed as part of the application blank for permits, licenses, certificates and registration and for renewals thereof, and every applicant shall subscribe thereto when making an application.

The board or board president may, without holding a hearing, suspend or refuse to renew a pharmacy license or outsourcing facility registration if the board or board president finds reasonable cause to believe that the health, safety or welfare of the public warrants the summary action; provided, however, that the board shall, within 7 days of such action, afford the licensee the opportunity of a hearing pursuant to chapter 30A. Any suspension imposed by the board or board president shall remain in effect until the conclusion of the proceedings, including any judicial review thereof, unless sooner dissolved by a court of competent jurisdiction or withdrawn by the board.

If, based upon evidence, the board or board president determines that a registrant or licensee or the drug preparations prepared by a registrant or licensee are an immediate threat to the public health, safety or welfare, the board or board president may: (i) issue a cease and desist notice or quarantine notice requiring the cessation or restriction of any and all pharmacy operations or outsourcing facility operations and prohibiting the use of medications prepared by or in possession of a pharmacy or outsourcing facility; or (ii) issue a cease and desist notice or quarantine notice placing non-disciplinary restrictions on a board registrant or licensee, to the extent necessary to avert a continued threat, pending final investigation results. The board shall promulgate regulations pertaining to the issuance of cease and desist and quarantine notices.