reglab/statecodes huggingface dataset:
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 675.000 - Requirements To Maintain Airqualityin Indoorskating Rinks (state Sanitary Code, Chapter Xi) › Section 675.020 - Hearings

Current through Register 1525, July 5, 2024
(A) The person or persons to whom any
			 correction order, emergency closure order or notice of intent to suspend or
			 revoke a certificate of approval has been issued pursuant to
			 105 CMR
			 675.018 or
			 675.019 has been directed,
			 may request a hearing before the board of health. Such request shall be in
			 writing and shall be filed in the office of the board of health within ten days
			 after receipt of the order or notice, unless a shorter or longer period is
			 specified in
			 105 CMR 675.000. Upon
			 receipt of such request, the board of health shall set a time and a place for
			 such hearing and shall inform the petitioner thereof in writing. Except in the
			 case of an emergency suspension under
			 105 CMR
			 675.018(A), the hearing
			 shall be commenced not later than ten days after the day on which the request
			 was filed. However, upon application of the petitioner, the board of health may
			 postpone the date of the hearing for a reasonable time beyond such ten-day
			 period if in the judgment of the board of health the petitioner has submitted a
			 good and sufficient reason for such postponement.
(B) At the hearing the petitioner shall be
			 given an opportunity to be heard and to show why the order should be modified
			 or withdrawn or why the suspension or revocation is not justified.
(C) After the hearing, the board of health
			 shall issue a written decision which contains a summary of the testimony and
			 evidence considered and the reasons for the decision.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 675.000 - Requirements To Maintain Airqualityin Indoorskating Rinks (state Sanitary Code, Chapter Xi) › Section 675.021 - Appeals

Current through Register 1525, July 5, 2024
Any person aggrieved by a decision of the board of health with
				respect to the provisions of
				105 CMR 675.000 may seek
				relief therefrom in any court of competent jurisdiction, as provided by the
				laws of the Commonwealth.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 675.000 - Requirements To Maintain Airqualityin Indoorskating Rinks (state Sanitary Code, Chapter Xi) › Section 675.022 - Penalties

Current through Register 1525, July 5, 2024
(A) Any person who violates any provision of
			 105 CMR 675.000 shall, upon
			 conviction, be fined not more than $100 for the first offense and not more than
			 $500 for a subsequent offense unless a different penalty is set by
			 statute.
(B) Any person who fails
			 to comply with any order issued pursuant to
			 105 CMR 675.000 or who
			 interferes with the board, Bureau, or either of its authorized agents in the
			 conduct of an inspection, shall, upon conviction, be fined not more than $100
			 for the first offense and not more than $500 for a subsequent offense. Each
			 day's failure to comply with an order shall constitute a separate
			 offense.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 675.000 - Requirements To Maintain Airqualityin Indoorskating Rinks (state Sanitary Code, Chapter Xi) › Section 675.023 - Severability

Current through Register 1525, July 5, 2024
If any provision of
				105 CMR 675.000 shall be
				declared invalid for any reason whatsoever, that decision shall not affect any
				other portion of
				105 CMR 675.000, which
				shall remain in full force and effect, and to this end the provisions of
				105 CMR 675.000 are hereby
				declared severable.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 675.000 - Requirements To Maintain Airqualityin Indoorskating Rinks (state Sanitary Code, Chapter Xi) › Section 675.024 - Variances

Current through Register 1525, July 5, 2024
Variances may be granted only as follows: the Board of Health
				or the Bureau may vary the application of any provision of
				105 CMR 675.000 with
				respect to any particular case when, in its opinion
(A) the enforcement thereof would do manifest
			 injustice; and
(B) the applicant
			 has proved that the same degree of protection required under
			 105 CMR 675.000 can be
			 achieved without strict application of the particular provision.
Every request for a variance shall be in writing and shall
				state the specific variance sought and the reasons therefore. Any variance
				granted by the Board of Health or the Bureau shall be in writing. Any denial of
				a variance shall also be in writing and shall contain a brief statement of the
				reasons for the denial. A copy of each variance shall be conspicuously posted
				for 30 days following its issuance, and shall thereafter be available to the
				public at all reasonable hours, in the office of the city or town clerk or the
				office of the Board of Health while it is in effect. A copy of the variance
				shall also be posted at the ice skating rink for one year and kept thereafter
				with the record keeping log. Notice of the grant of each variance shall be
				filed with the Bureau, which shall approve, disapprove, or modify the variance
				within 30 days of receipt thereof. If the Bureau fails to comment within 30
				days, its approval will be presumed. No work shall be done under any variance
				until the Bureau approves it or 30 days elapse without any comment by the
				Bureau, unless the Board of Health or the Bureau certifies in writing that an
				emergency exists. Any variance by the Board of Health or Bureau authorized to
				be made by
				105 CMR 675.000 may be
				subject to such qualification, revocation, suspension, expiration as the Board
				of Health or Bureau expresses in its grant. A variance authorized to be made by
				105 CMR 675.000 may
				otherwise be revoked, modified, or suspended, in whole or in part, only after
				the holder thereof has been notified in writing and has been given a n
				opportunity to be heard, in conformity with the requirements for an order and
				hearing of
				105 CMR
				675.000.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 700.000 - Implementation of M.G.L. c. 94C › Section 700.002 - Schedules of Controlled Substances

Current through Register 1525, July 5, 2024
The following schedules of controlled substances are
				established:
(A)
Schedule
			 I
. Schedule I shall consist of the drugs and other substances, by
			 whatever official name, common or usual name, chemical name, or brand name
			 designated, listed in 21 CFR
			 1308.11.
(B)
Schedule II
.
			 Schedule II shall consist of the drugs and other substances, by whatever
			 official name, common or usual name, chemical name, or brand name designated,
			 listed in 21 CFR
			 1308.12.
(C)
Schedule III
.
			 Schedule III shall consist of the drugs and other substances, by whatever
			 official name, common or usual name, chemical name, or brand name designated,
			 listed in 21 CFR
			 1308.13.
(D)
Schedule IV
.
			 Schedule IV shall consist of the drugs and other substances, by whatever
			 official name, common or usual name, chemical name, or brand name designated,
			 listed in 21 CFR
			 1308.14.
(E)
Schedule V
.
			 Schedule V shall consist of the drugs and other substances, by whatever
			 official name, common or usual name, chemical name, or brand name designated,
			 listed in 21 CFR
			 1308.15.
(F)
Schedule VI
.
			 Schedule VI shall consist of all prescription drugs, which are not included in
			 any other schedule established by the Commissioner.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 700.000 - Implementation of M.G.L. c. 94C › Section 700.003 - Registration of Persons for a Specific Activity or Activities in Accordance with M.G.L. c. 94C, Section 7(g)

Current through Register 1525, July 5, 2024
(A)
(1) A Paramedic or a Paramedic student, as
			 part of their participation in a Department-approved Paramedic training
			 program, may administer only those controlled substances, in quantity and kind,
			 that are necessary for the performance of their duties in accordance with
			 105 CMR
			 170.000:
Emergency Medical Services
			 System
and the STPs, or in accordance with their duties as authorized
			 by clinical protocols in a Department-approved MIH program or community EMS
			 program pursuant to M.G.L. c. 111O;
(2) An Advanced EMT, Advanced EMT student as
			 part of their participation in a Department-approved training program, EMT or
			 EFR may administer only those controlled substances for which they have been
			 approved by the Department and that are necessary for the performance of their
			 duties in accordance with
			 105 CMR
			 170.000:
Emergency Medical Services
			 System
and the provisions of the Statewide Treatment Protocols, or in
			 accordance with their duties as authorized by clinical protocols in a
			 Department-approved MIH program or community EMS program pursuant to M.G.L. c.
			 111O;
(3) Administration of
			 controlled substances by EMTs at all levels, and EMT students at all levels, is
			 also subject to the following conditions:
(a)
			 The ambulance service, EFR service, or Department-approved MIH or community EMS
			 program for which the individual serves, shall be registered in accordance with
			 105
			 CMR 700.004 for the appropriate controlled
			 substances;
(b) The ambulance
			 service, EFR service, or Department-approved MIH or community EMS program shall
			 maintain a current listing of names of its employees and volunteers who are
			 authorized to administer controlled substances;
(c) The EMT, Paramedic student, Advanced EMT
			 student or EFR shall perform only those functions for which they are authorized
			 by, and trained in accordance with
			 105 CMR
			 170.000:
Emergency Medical Services
			 System
;
(d) Administration
			 of controlled substances shall be conducted:
1. pursuant to the order of a practitioner
			 and the STP; and
2. in accordance
			 with 105 CMR
			 170.000:
Emergency Medical Services
			 System
and the provisions of the STP.
(4) A Paramedic may dispense by
			 administration influenza vaccine and other immunizations designated by the
			 Department to persons 18 years of age or older, as authorized by clinical
			 protocols in a Department-approved MIH program or community EMS
			 program.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 700.000 - Implementation of M.G.L. c. 94C › Section 700.004 - Registration Requirements

Current through Register 1525, July 5, 2024
(A)
Persons Required to Register
. Every person who is
			 required to be registered with the Commissioner under M.G.L. c. 94C shall
			 register with said Commissioner as hereafter provided:
(1) Every person other than a registered
			 retail drug business or wholesale druggist shall register if they are:
(a) Manufactures, distributes, or dispenses
			 any controlled substance; or
(b)
			 Uses any controlled substance in research, teaching, or chemical analysis;
			 or
(c) Possesses controlled
			 substances with the intent to manufacture, distribute; or dispense any such
			 substance; or
(d) Possesses
			 controlled substances with the intent to conduct research, teaching or chemical
			 analysis using any such substance.
(e) Is required to register pursuant to
			 M.G.L. c. 94C.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 700.000 - Implementation of M.G.L. c. 94C › Section 700.005 - Security Requirements

Current through Register 1525, July 5, 2024
(A)
Physical Security Requirements
. All applicants and
			 registrants shall provide effective physical security controls against theft
			 and other diversion of controlled substances. All applicants and registrants
			 shall provide physical security controls which meet the conditions set forth in
			 guidelines issued by the Department.
(B)
Personnel Security
			 Requirements
. All applicants and registrants shall screen before
			 employing new employees who may work in or around areas where controlled
			 substances are handled.
(1) Such screening
			 shall be made solely for the purpose of determining whether the prospective
			 employee is a responsible person who can be trusted to work in and around
			 controlled substances. Documentation of such screening shall be made available
			 by applicants and registrants to the Commissioner upon their request.
(2) No registrant shall knowingly employ any
			 agent or employee who has had an application for registration denied for
			 violation of any law or regulation or has had their registration revoked for
			 violation of any law or regulation at any time.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 700.000 - Implementation of M.G.L. c. 94C › Section 700.008 - Reporting Theft, Loss or Tampering

Current through Register 1525, July 5, 2024
A registrant shall report the theft, loss or suspected
				tampering of any controlled substances to the Drug Control Program within the
				Department within 24 hours of discovery of such theft, loss or suspected
				tampering, by completing and submitting the form provided or approved by the
				Drug Control Program for such purpose.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 700.000 - Implementation of M.G.L. c. 94C › Section 700.007 - Inspection of Premises

Current through Register 1525, July 5, 2024
(A)
Inspections and Investigations
. The Department may
			 visit the registered site of a registrant at any time without prior notice and
			 inspect it, its staff, activities and records to determine compliance with
			 state law,
			 105 CMR
			 700.000,
			 105 CMR
			 721.000:
Standards for Prescription Format and
			 Security in Massachusetts
and
			 105 CMR
			 722.000:
Dispensing Procedures for
			 Pharmacists
upon stating his or her purpose, and presenting his or her
			 appropriate credentials.
(B)
Statement of Deficiencies
. After every inspection
			 conducted pursuant to
			 105
			 CMR 700.007(A)  in which any
			 violation of law or regulation is observed, the Department shall prepare a
			 deficiency statement citing every violation observed, a copy of which shall be
			 sent to the registrant.
(C)
Plans of Correction
. A registrant shall submit to the
			 Department a written plan of correction of each violation cited in a deficiency
			 statement prepared pursuant to
			 105
			 CMR 700.007(B)  within 30
			 business days after the deficiency statement is sent. Every plan of correction
			 shall set forth, with respect to each deficiency, the specific corrective
			 step(s) to be taken, a timetable for such steps, and the date by which
			 compliance with the relevant section of law or regulation will be achieved. The
			 timetable and compliance dates shall be consistent with achievement of
			 compliance in the most expeditious manner possible. A plan of correction which
			 does not meet the requirements of the relevant section of law or regulation
			 shall be considered unacceptable by the Department and returned to the
			 registrant.
(D)
Investigations of Drug Incidents and Complaints
. When
			 the Department is investigating a possible drug diversion or tampering matter,
			 or a drug related complaint, registrants shall provide the Department with
			 timely access to potential witnesses and records, including, but not limited
			 to, controlled substance, medical, employee and security records. Access to
			 documents may be provided by production of copies of the relevant records to
			 the Department, unless the Department requests access to the original
			 record.
(E)
Interference with Investigations
. Whoever hinders,
			 obstructs or in any way interferes with a Department inspector in the
			 performance of such inspector's official duty, shall, for the first offense be
			 punished by a fine of not more than $50.00 for each day the violation
			 continues. Each subsequent offense may be punished by a fine of not more than
			 $100.00 for each day the violation continues.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 700.000 - Implementation of M.G.L. c. 94C › Section 700.009 - Research Involving Controlled Substances

Current through Register 1525, July 5, 2024
105 CMR 700.009 applies to
				the safety and security of research drugs for research projects or studies
				which have federal approval to proceed.
(A)
Persons Covered
.
			 No person shall carry out any research projects or studies involving any
			 research drug unless the researcher or the research project applies to the
			 Commissioner for registration. In the case of research involving an
			 investigational new drug, as defined in
			 21 CFR
			 312.3, the researcher shall be the principal
			 investigator, as required therein. Applicants shall supply the Commissioner
			 with:
(1) satisfactory evidence of compliance
			 with any applicable Federal law; and
(2) such information regarding the research
			 project as the Commissioner requires, including a list of all research drugs
			 and other controlled substances involved in the research project.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 700.000 - Implementation of M.G.L. c. 94C › Section 700.010 - Dispensing and Labeling of Sample Medications by Practitioners

Current through Register 1525, July 5, 2024
(A) Other than for immediate administration,
			 a practitioner shall not dispense controlled substances to an ultimate user in
			 the course of professional practice, except as follows:
(1) A Schedule VI sample medication in a
			 single dose or in such quantity as is in the opinion of the practitioner
			 appropriate for the treatment of the patient but not exceeding a 30-day supply
			 per dispensing; provided, however, that this quantity may be increased to a
			 90-day supply if dispensed as part of an indigent patient drug program and
			 deemed appropriate in the professional judgment of the practitioner;
(2) A Schedule II through V sample medication
			 in a single dose or in such quantity as in the opinion of the practitioner is
			 essential for the immediate treatment of the patient.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 700.000 - Implementation of M.G.L. c. 94C › Section 700.011 - Issuance of Prescriptions or Medication Orders for Implantable Infusion Pumps Containing Schedule II or Schedule III Controlled Substance

Current through Register 1525, July 5, 2024
A prescription or medication order for an implantable infusion
				pump containing a Schedule II or Schedule III controlled substance may be
				filled for a maximum of a 90 day supply.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 700.000 - Implementation of M.G.L. c. 94C › Section 700.100 - Complaints

Current through Register 1525, July 5, 2024
(A) The Department shall investigate every
			 complaint about drug diversion or tampering received related to a registrant's
			 registration pursuant to M.G.L. c. 94C and
			 105 CMR
			 700.000.
(B) If the Department finds that an
			 investigation is not required because the alleged act or practice is not in
			 violation of M.G.L. c. 94C or
			 105 CMR
			 700.000, or any policies of the Department pursuant
			 thereto, the Department shall make a note in the complaint file of this finding
			 and the reasons on which it is based.
(C) If the Department finds that an
			 investigation is required, because the alleged act or practice may be in
			 violation of M.G.L. c. 94C or
			 105 CMR
			 700.000, or any policies of the Department pursuant
			 thereto, the Department shall investigate. If a finding is made that the act or
			 practice does constitute such a violation, the Department shall apply whichever
			 enforcement procedure(s), as provided in
			 105 CMR
			 700.000, is appropriate to remedy the situation and
			 the Department shall notify other interested parties, including law enforcement
			 or a licensing board, as appropriate, of its action in this matter.
(D) Investigation of complaints may lead to
			 enforcement actions, including a warning letter or a letter of reprimand; or a
			 revocation, suspension, or refusal to renew a registration by the Department.
			 The Department may specify in any such enforcement action taken against a
			 registrant a requirement to undergo and successfully complete remedial
			 training, in accordance with terms set out in the enforcement action.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 700.000 - Implementation of M.G.L. c. 94C › Section 700.105 - Grounds for Revocation, Suspension, or Refusal to Renew a Registration

Current through Register 1525, July 5, 2024
(A) Grounds for revocation, suspension, or
			 refusal to renew a registration include, but are not limited to, whether the
			 registrant:
(1) has furnished false or
			 fraudulent material information in any application filed under the provisions
			 of 105 CMR
			 700.000;
(2) has been convicted under any state or
			 federal law of any criminal violation relating to their fitness to be
			 registered under
			 105 CMR
			 700.000;
(3) has had their federal registration
			 suspended or revoked to manufacture, distribute, dispense, administer or
			 possess controlled substances;
(4)
			 has failed to cooperate with a Department inspection or
			 investigation;
(5) is, upon good
			 cause, found to be unfit or unqualified to manufacture, distribute, dispense,
			 or possess any controlled substance;
(6) has violated any provision of M.G.L. c.
			 94C or
			 105 CMR
			 700.000; or
(7) has used the online prescription
			 monitoring program system, or prescription data derived therefrom, in a manner
			 inconsistent with the terms and conditions for such use.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 700.000 - Implementation of M.G.L. c. 94C › Section 700.110 - Summary Suspension of Registration

Current through Register 1525, July 5, 2024
(A)
			 Pursuant to M.G.L. c. 94C, § 14, the Commissioner may, without a hearing,
			 if the Commissioner finds that public or individual health or safety is
			 endangered, immediately suspend a registration. Written notice of the reasons
			 for the suspension shall promptly be issued by the Department. The affected
			 person shall also be notified in writing of the right to an adjudicatory
			 hearing and shall be promptly afforded an opportunity for a hearing provided
			 that written request for a hearing is submitted within 14 days after
			 notification of suspension.
(B)
			 After hearing or waiver thereof, the Department may modify a registration or
			 suspend, revoke, or refuse to renew a registration pursuant to
			 105
			 CMR 700.115.
(C) Upon receipt of notice of the
			 Department's final decision, the affected person must promptly comply with
			 105
			 CMR 700.006(H).
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 700.000 - Implementation of M.G.L. c. 94C › Section 700.115 - Suspension, Revocation, or Refusal to Renew a Registration

Current through Register 1525, July 5, 2024
(A) If the Department suspends, revokes, or
			 refuses to renew a registration, the affected person shall be notified in
			 writing of the reasons for the Department's action and of their right to an
			 adjudicatory proceeding.
(B)
			 Written request for a hearing must be submitted within 14 days of receipt of
			 notification of Department action.
(C) After hearing or waiver thereof, the
			 Department may modify, suspend, revoke, or refuse to renew a
			 registration.
(D) If the Department
			 requires a suspension of a registration, the Department must indicate the term
			 of the suspension.
(E) If the
			 Department requires a revocation or refusal to renew a registration, the
			 Department shall indicate whether or not the registrant may, at a future date,
			 reapply for a registration.
(F)
			 Upon receipt of notice of the Department's final decision, the affected person
			 must promptly comply with
			 105
			 CMR 700.006(H).
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 700.000 - Implementation of M.G.L. c. 94C › Section 700.120 - Void Registrations

Current through Register 1525, July 5, 2024
A registration is void if the registrant's underlying
				professional licensure on which the registration is based or associated DEA
				registration is suspended or revoked. Upon receipt of notice of the voiding of
				such registration, the affected person must promptly comply with
				105
				CMR 700.006(H).
(A) All adjudicatory proceedings will be
			 conducted in accordance with M.G.L. c. 30A and
			 801
			 CMR 1.01:
Formal
			 Rules
.
(B) The
			 Commissioner shall designate a Presiding Officer to conduct a hearing and
			 render a tentative decision containing findings of fact and rulings of law. If
			 the Presiding Officer finds any single ground for revocation, suspension, or
			 refusal to renew any registration, the Presiding Officer shall render a
			 decision affirming the action initiated by the Department.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 700.000 - Implementation of M.G.L. c. 94C › Section 700.125 - Adjudicatory Proceedings

Current through Register 1525, July 5, 2024
(A) All adjudicatory
			 proceedings will be conducted in accordance with M.G.L. c. 30A and
			 801 CMR 1.01:
Formal Rules
.
(B)
			 The Commissioner shall designate a Presiding Officer to conduct a hearing and
			 render a tentative decision containing findings of fact and rulings of law. If
			 the Presiding Officer finds any single ground for revocation, suspension, or
			 refusal to renew any registration, the Presiding Officer shall render a
			 decision affirming the action initiated by the Department.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 700.000 - Implementation of M.G.L. c. 94C › Section 700.130 - Nonexclusivity of Enforcement Procedures

Current through Register 1525, July 5, 2024
The enforcement procedures contained in
				105 CMR
				700.000 are not mutually exclusive. Any enforcement
				procedures may be invoked simultaneously if the situation so
				requires.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 700.000 - Implementation of M.G.L. c. 94C › Section 700.140 - Waiver of Requirements Imposed on Registrants

Current through Register 1525, July 5, 2024
The Commissioner may issue a waiver of one or more of the
				requirements imposed through
				105 CMR
				700.000 upon a finding that:
(1) compliance would cause undue hardship to
			 the registrant;
(2) the
			 registrant's noncompliance does not jeopardize the health or safety of
			 individuals or the public;
(3) the
			 registrant has instituted compensating measures that are acceptable to the
			 Commissioner; and
(4) the
			 registrant provides to the Commissioner, or their designee, written
			 documentation supporting its request for a waiver.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 700.000 - Implementation of M.G.L. c. 94C › Section 700.200 - Severability

Current through Register 1525, July 5, 2024
The provisions of
				105 CMR
				700.000 are severable, and if any provision shall be
				in violation of any Federal rule or regulation or any Federal or Massachusetts
				law, such provision shall be null and void and such violation shall not affect
				or impair any of the remaining provisions.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 720.000 - List Of Interchangeable Drug Products › Section 720.001 - Purpose

Current through Register 1525, July 5, 2024
The purpose of
				105 CMR 720.000 is to
				establish a drug formulary, or list of interchangeable drug products, for use
				by physicians, other practitioners, and pharmacists licensed to practice within
				the commonwealth, so that consumers of prescription drug products may realize
				cost savings by buying less expensive, safe drug products.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 720.000 - List Of Interchangeable Drug Products › Section 720.002 - Citation

Current through Register 1525, July 5, 2024
105 CMR 720.000 shall be
				known as the
				105 CMR 720.000:
Massachusetts List of Interchangeable Drug
				Products
.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 720.000 - List Of Interchangeable Drug Products › Section 720.010 - Scope and Application

Current through Register 1525, July 5, 2024
105 CMR 720.000 establishes
				the list of interchangeable drug products from which a pharmacist must
				interchange a reasonably available less expensive drug product than that
				written, when a prescription written by a practitioner indicates "interchange".
				105 CMR 720.000 also
				establishes criteria and procedures for inclusion of drug products on this
				list.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 720.000 - List Of Interchangeable Drug Products › Standards › Section 720.040 - Commission Review of Relevant Drug Products

Current through Register 1525, July 5, 2024
In preparing the List of Interchangeable Drug Products and
				  amendments thereto, the Drug Formulary Commission shall determine whether drug
				  products meet the standards set forth in
				  105 CMR
				  720.050. In making this determination, the
				  Commission shall assess and evaluate pertinent data, including, but not limited
				  to, the United States Pharmacopeia and its supplements, additional pertinent
				  listings of the FDA, other state formularies, formularies of various hospitals
				  of the commonwealth, and data submitted by manufacturers and other interested
				  persons, including chemical and laboratory listing data and clinical evidence
				  concerning bioequivalence and therapeutic equivalence where available. In
				  reviewing this material, the Commission shall utilize the pharmaceutical and
				  medical expertise of its members.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 720.000 - List Of Interchangeable Drug Products › Standards › Section 720.050 - List of Interchangeable Drug Products

Current through Register 1525, July 5, 2024
The Massachusetts List of Interchangeable Drug Products
				  (MLID) shall consist of:
(1) drug
				products which are considered by FDA to be therapeutically equivalent to other
				pharmaceutically equivalent products listed with the same generic or chemical
				name according to the most recent edition of "Approved Drug Products with
				Therapeutic Equivalence Evaluations" and its supplements as published by the
				United States Department of Health and Human Services:
(2) drug products specified on a list
				established by the Department and set forth in
				105 CMR
				720.200, for which the Commission has
				determined that the bioequivalence is not essential, or if the Commission has
				determined that the bioequivalence may be essential, bioequivalence has been
				established. The list may include the following categories of drug products:
(a) drug products which hold New Drug
				Applications (NDAs) or Abbreviated New Drug Applications (ANDAs) approved by
				the FDA, which FDA does not consider to be therapeutically equivalent to other
				pharmaceutically equivalent products listed with the same generic or chemical
				name; and
(b) drug products exempt
				from the Food, Drug and Cosmetic Act of 1962, and included in the Drug Efficacy
				Study Implementation (DESI) done by the National Academy of Sciences/National
				Research Council; and
(c)
				frequently prescribed drug products which were manufactured prior to 1938 and
				meet the FDA Good Manufacturing Practices Requirements; and
(d) frequently prescribed over-the-counter
				drug products which contain the same amounts of active ingredients, in the same
				dosage forms, as other drug products with the same general or chemical
				name.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 720.000 - List Of Interchangeable Drug Products › Standards › Section 720.060 - Drug Products Excluded

Current through Register 1525, July 5, 2024
The following categories of drug products are excluded from
				  the list of interchangeable drug products:
(a) drug products for which the Commonwealth
				has determined that bioequivalence may be essential, but for which
				bioequivalence has not been established; and
(b) drug products which are the subject
				matter of patent rights issued by the U.S. Patent Office, for which provision
				by other than the patent-holder would violate the patent; and
(c) drug products available from only one
				manufacturer at one price.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 720.000 - List Of Interchangeable Drug Products › Standards › Section 720.070 - Amendments to the Massachusetts List of Interchangeable Drugs

Current through Register 1525, July 5, 2024
(1) Drug products which meet the criteria
				specified in
				105 CMR
				720.050(1)  shall be deemed
				interchangeable and added to the Massachusetts List of Drugs upon publication
				by the United States Department of Health and Human Services of the most recent
				edition of "Approved Drug Products with Therapeutic Equivalence Evaluations"
				and its supplements.
(2) Drug
				products which meet criteria specified in
				105 CMR
				720.050(2)  shall be deemed
				interchangeable and added to the Massachusetts List of Interchangeable Drugs in
				accordance with procedures set forth in
				105
				CMR 720.080.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 720.000 - List Of Interchangeable Drug Products › Procedures for Amending List of Interchangeable Drug Products › Section 720.080 - Procedures for Amending the Massachusetts List of Interchangeable Drugs

Current through Register 1525, July 5, 2024
The Department, working with the Commission, shall review at
				  least one a year and revise as necessary the list of interchangeable drug
				  products adopted pursuant to
				  105 CMR
				  720.050(2), and shall have
				  the authority to review and revise the list of interchangeable drug products
				  adopted pursuant to
				  105 CMR
				  720.050(1)  as necessary.
				  The revisions to
				  105 CMR
				  720.050(1)  shall be
				  specified on an exception list established by the Department and set forth in
				  105 CMR
				  720.200. The revisions will add and delete
				  drug products, based on current information concerning therapeutic efficacy and
				  interchangeability of drug products.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 720.000 - List Of Interchangeable Drug Products › Procedures for Amending List of Interchangeable Drug Products › Section 720.081 - Petition to Amend List of Interchangeable Drug Products

Current through Register 1525, July 5, 2024
Any person who desires a drug product or products to be added
				  to or deleted from the List of Interchangeable Drug Products, shall file a
				  written petition with the Department to amend the List, pursuant to M.G.L. c.
				  30A, § 4. Each petition shall be in such form as the Department may
				  require and shall be submitted to the Drug Formulary
				  Commission.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 720.000 - List Of Interchangeable Drug Products › Procedures for Amending List of Interchangeable Drug Products › Section 720.082 - Commission Review of Petition

Current through Register 1525, July 5, 2024
Upon receipt of a petition, the Department shall submit the
				  petition and the supporting information to the Commission for review. The
				  Commission shall make a preliminary determination whether the List of
				  Interchangeable Drug Products should be amended as proposed.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 720.000 - List Of Interchangeable Drug Products › Procedures for Amending List of Interchangeable Drug Products › Section 720.083 - Notice of Public Comment Period

Current through Register 1525, July 5, 2024
Upon completion of the review of all relevant information,
				  including petitions, by the Commission, the Department shall propose amendments
				  to the List of Interchangeable Drug Products by issuing a Notice of Public
				  Comment Period pursuant to M.G.L. c. 30A, §§ 2 and 3. The Department
				  shall mail a Notice of Public Comment Period to each person who filed a
				  petition during the period ending 30 days before the Notice of Public Comment
				  Period is issued. In addition, the Department shall mail a Notice of the Public
				  Comment Period to each person who has filed a written request therefore with
				  the Department during December of the previous year pursuant to M.G.L. c. 30A,
				  § 2.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 720.000 - List Of Interchangeable Drug Products › Procedures for Amending List of Interchangeable Drug Products › Section 720.084 - Commission Recommendation of Amendments to Department

Current through Register 1525, July 5, 2024
Following the comment period Department staff shall review
				  all evidence and commentary concerning the proposed amendments, and shall
				  report its recommendation to the Commission. The Commission shall consider the
				  staff recommendations, make such revisions as it deems appropriate, and shall
				  recommend Amendments to the List of Interchangeable Drug Products for adoption
				  by the Commissioner and the Public Health Council.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 720.000 - List Of Interchangeable Drug Products › Procedures for Amending List of Interchangeable Drug Products › Section 720.090 - Department Adoption of Amendments

Current through Register 1525, July 5, 2024
The Commissioner and the Public Health Council shall consider
				  the recommendations of the Drug Formulary Commission, and shall adopt
				  Amendments to the List of Interchangeable Drug Products.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 720.000 - List Of Interchangeable Drug Products › Procedures for Amending List of Interchangeable Drug Products › Section 720.100 - Severability

Current through Register 1525, July 5, 2024
The provisions of
				  105 CMR 720.000 are
				  severable. If any provision shall be declared invalid by any court, such
				  provision shall be null and void and such determination shall not affect or
				  impair any of the remaining provisions.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 721.000 - Standards for Prescription Format and Security in Massachusetts › Section 721.003 - Scope and Application

Current through Register 1525, July 5, 2024
105 CMR 721.000 establishes
				the standards for format and security in the Commonwealth that all
				Prescriptions issued by practitioners or reduced to writing by pharmacists must
				meet in order to comply with M.G.L. c. 112, § 12D and M.G.L. c.
				94C.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 721.000 - Standards for Prescription Format and Security in Massachusetts › Section 721.020 - Prescription Formats

Current through Register 1525, July 5, 2024
(A) Every
			 Prescription generated in the Commonwealth of Massachusetts must be an
			 Electronic Prescription and include an Electronic Signature unless it is a
			 Prescription issued in accordance with an exception listed in 105 CMR
			 721.070.
(B) A Prescription must
			 enable the practitioner to instruct the pharmacist to dispense a brand name
			 Drug Product by indicating "no substitution", provided that:
(1) the indication of "no substitution" is
			 not the default indication;
(2) the
			 Prescription indicates that "Interchange is mandated unless the practitioner
			 indicates 'no substitution' in accordance with the law"; and
(3) the indication of "no substitution" is a
			 unique element in the Prescription and shall not be satisfied by use of any
			 other element, including the signature.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 721.000 - Standards for Prescription Format and Security in Massachusetts › Section 721.040 - Invalid Prescriptions

Current through Register 1525, July 5, 2024
(A) A Prescription
			 in a format that does not conform to
			 105 CMR 721.000 is invalid
			 and shall not be filled.
(B) A
			 Prescription that does not meet the security requirements of
			 105 CMR 721.000 is invalid
			 and shall not be filled.
(C) An
			 Electronic Prescription transmitted through means other than Electronic
			 Transmission is invalid, except in the event of a Failover, as verified
			 pursuant to
			 105 CMR
			 721.020(G).
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 721.000 - Standards for Prescription Format and Security in Massachusetts › Section 721.050 - Prescribing More than One Drug Product

Current through Register 1525, July 5, 2024
Practitioners who wish to prescribe more than one Drug Product,
				with the same or different dispensing instructions, shall place each
				Prescription on a separate Prescription form or record. More than one Drug
				Product may be prescribed in the hospital setting on a single form or record
				provided, however, that the Prescription provides clear directions for use and
				interchange of each Drug Product.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 721.000 - Standards for Prescription Format and Security in Massachusetts › Section 721.055 - Partial Fill Prescriptions

Current through Register 1525, July 5, 2024
(A) A pharmacist
			 filling a Prescription for a schedule II controlled substance shall, if
			 requested by the patient, dispense the prescribed controlled substance in a
			 lesser quantity than indicated on the Prescription, pursuant to M.G.L. c. 94C,
			 § 18(d¾). If the Prescription was issued by a prescriber from a
			 location other than the Commonwealth of Massachusetts, as indicated by the
			 address of the prescriber on the Prescription, the Prescription must be
			 presented for initial partial fill not later than five calendar days after the
			 Prescription issue date.
(B) Where
			 a Prescription has been partially filled in accordance with 105 CMR 721.055(A),
			 the remaining portion of the Prescription may be filled upon patient request in
			 accordance with federal law; provided, however, that:
(1) only the same pharmacy that originally
			 dispensed the lesser quantity shall dispense the remaining portion;
			 and
(2) the remaining portion of
			 the Prescription is filled not later than 30 days after the Prescription issue
			 date.
Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 721.000 - Standards for Prescription Format and Security in Massachusetts › Section 721.060 - Prescribing in Emergency Situations

Current through Register 1525, July 5, 2024
(A) In case
			 of an Emergency Situation, the requirements of
			 105 CMR 721.000 to use an
			 Electronic Prescribing System to generate, transmit and receive a Prescription
			 are waived. In these situations, Written and Oral Prescriptions may be issued
			 and must comply with all other Prescription requirements, including
			 requirements outlined in 105 CMR 721.070(B).
(B) In case of an Emergency Situation a
			 pharmacist may dispense a controlled substance in schedule II upon receiving
			 the written or orally transmitted authorization of a prescribing practitioner,
			 provided:
(1) the quantity prescribed and
			 dispensed is limited to the amount adequate to treat the patient during the
			 emergency period;
(2) the
			 Prescription contains all information required by M.G.L. c. 94C, § 20(a),
			 except for the actual signature of the prescribing practitioner, and the
			 Prescription is immediately entered into a compliant electronic pharmacy system
			 or otherwise reduced to writing by the dispensing pharmacist;
(3) if the prescribing practitioner is not
			 known to the dispensing pharmacist, the dispensing pharmacist makes a
			 reasonable good faith effort to determine that the orally transmitted
			 authorization was issued by a prescribing practitioner;
(4) within seven business days after
			 authorizing an emergency orally transmitted Prescription, the prescribing
			 practitioner shall cause an Electronic or Written Prescription for the
			 emergency quantity prescribed to be delivered to the pharmacy which must have
			 written on its face "Authorization for Emergency Dispensing" and shall comply
			 with federal and state law. The Written Prescription may be delivered to the
			 pharmacist in person or by mail, but if delivered by mail, it must be
			 postmarked within the seven day period; and
(5) upon receipt of the Prescription issued
			 under 105 CMR 721.060(B)(4), the dispensing pharmacist shall attach the
			 Prescription to the orally transmitted emergency Prescription which had earlier
			 been reduced to writing. The pharmacist shall notify the nearest office of the
			 Drug Enforcement Administration if the prescribing individual practitioner
			 fails to deliver a Written Prescription to the pharmacist in accordance with
			 105 CMR 721.060(B)(4).