Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 700.000 - Implementation of M.G.L. c. 94C › Section 700.012 - Prescription Monitoring Program

Current through Register 1525, July 5, 2024
(A)
Pharmacy Reporting Requirements
.
(1) The reporting requirement of
			 105
			 CMR 700.012 applies to every pharmacy
			 registered with the Commissioner that dispenses a controlled substance pursuant
			 to a prescription in Schedules II through V, or a controlled substance
			 classified by the Department as an additional drug as outlined in
			 105
			 CMR 700.012, and to any pharmacy in another
			 state, commonwealth, district or territory that delivers such a controlled
			 substance to a person in Massachusetts. Such a pharmacy shall, in accordance
			 with standards established by the Commissioner, transmit to the Department or
			 its agent the pharmacy identifier, customer identification number and
			 associated information as specified in the PMP Dispensing Guide issued by the
			 Commissioner.
(2)
									105
			 CMR 700.012 shall not apply to the dispensing
			 pursuant to a medication order of a controlled substance to an inpatient in a
			 hospital.
(3) A pharmacy that
			 dispenses a controlled substance subject to the requirements in
			 105
			 CMR 700.012 must require that a customer
			 identifier is presented whenever a controlled substance in Schedules II through
			 V, or an additional drug is dispensed. The pharmacy may dispense a controlled
			 substance in Schedules II through V or an additional drug without reviewing the
			 customer identifier if the pharmacy has reason to believe that the failure to
			 dispense the controlled substance or additional drug would result in a serious
			 hardship for the ultimate user or agent of the ultimate user, and documents the
			 reason; and the ultimate user or agent of the ultimate user prints their name
			 and address on the reverse side of the prescription and signs their name
			 thereto, or in the case of an electronic prescription, provides an electronic
			 signature; and the pharmacy provides to the Department those informational
			 fields required by the Department.
(4) The Commissioner may waive or modify the
			 requirements in
			 105
			 CMR 700.012(A)  for a
			 pharmacy to report customer information as specified by the
			 Commissioner.
(5) The information
			 required by
			 105
			 CMR 700.012 shall be transmitted to the
			 Department or its agent in accordance with any procedures established by the
			 Commissioner by the end of the next business day and shall include data for all
			 controlled substances dispensed since the previous transmission or report or as
			 otherwise specified in guidelines of the Department, by use of encrypted
			 electronic device or electronic transmission method in a format approved by the
			 Commissioner.
(6) If a pharmacy is
			 not able to submit dispensing information by electronic means, the Commissioner
			 may issue a waiver to authorize another means of transmission, provided that
			 all information required in accordance with
			 105
			 CMR 700.012(A)  is submitted
			 in this alternate format.