247 CMR 11.13 - Summary Suspension of a Controlled Substance Registration

(1) The Board may, without hearing, suspend or refuse to renew any controlled substance registration issued by it if it finds that there is an imminent danger to the public health or safety which warrants this action; provided, however, that the Board promptly affords the registrant an opportunity for a hearing in accordance with M.G.L. c. 30A, 801 CMR 1.01: Formal Rules and 247 CMR 10.00: Disciplinary Proceedings.

(2) Any suspension summarily imposed by the Board shall continue in effect until the conclusion of the final hearing on the merits of any Order to Show Cause issued by the Board in connection with its investigation of the pharmacy, outsourcing facility, or wholesale druggist, including judicial review thereof, unless sooner dissolved by a court of competent jurisdiction, or withdrawn by the Board.

(3) The procedure for summary suspension is as follows:

(a) Closure of Pharmacy, Outsourcing Facility, or Wholesale Druggist. Upon receipt by the Board of reliable information that a registrant is an imminent and serious threat to the public health or safety, the Board shall vote to take summary action on the registrant's controlled substances registration. Upon the Board's vote to summarily suspend such registration, Board Agents are authorized to:

1. immediately close the registrant's establishment or business;

2. at the registrant's expense, replace the locks on all doors to the registrant's establishment or business and retain the key(s);

3. conspicuously display at the entrance(s) to the registrant's establishment or business a sign, in letters no less than one inch in height and one inch wide, stating: "THE REGISTRATION OF THIS ESTABLISHMENT HAS BEEN SUSPENDED BY ORDER OF THE MASSACHUSETTS BOARD OF REGISTRATION IN PHARMACY."; and

4. conduct an inventory and audit of all drugs and record of drugs within the registrant's establishment or business.

(b) Order of Suspension. The Board shall promptly issue an Order of Suspension of Controlled Substance Registration and shall send such Order, with a Notice of Hearing as set forth in 247 CMR 11.15(3)(c), to the establishment's owner or pharmacy's Manager of Record by certified mail, or shall deliver such Order and Notice of Hearing by hand.

(c) Hearing on Necessity for the Summary Action. The Board shall convene a hearing on the necessity for the summary suspension of a controlled substance registration within seven days after the order of suspension. The establishment's owner and/or pharmacy's Manager of Record shall be notified of the date, time and place of the hearing.

At the hearing, the Board shall receive testimony and documentary evidence limited to determining whether the summary suspension of the controlled substance registration shall continue in effect pending a final hearing on the merits of any Order to Show Cause issued by the Board against the pharmacy or establishment in connection with its investigation.

Following the hearing, the Board shall vote on whether to continue the summary suspension in effect and shall promptly notify the registrant in writing of its decision.

(4) The Board's summary suspension of a controlled substance registration shall be grounds for the summary suspension of a pharmacy license, outsourcing facility registration, or wholesale druggist's license issued by the Board. The summary suspension of a pharmacy license, outsourcing registration, or wholesale druggist's license shall continue in effect pending a final hearing on the merits of any Order to Show Cause issued by the Board against the pharmacy, outsourcing facility, or wholesale druggist in connection with its investigation, including judicial review thereof, unless sooner dissolved by a court of competent jurisdiction or withdrawn by the Board.

Notes

247 CMR 11.13

Amended by Mass Register Issue 1305, eff. 1/29/2016.