Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 700.000 - Implementation of M.G.L. c. 94C › Section 700.001 - Definitions

Current through Register 1525, July 5, 2024
For the purpose of
				105 CMR
				700.000, the following definitions apply, in addition
				to those definitions appearing in M.G.L. c. 94C, § 1, unless the context
				or subject matter requires a different meaning.
Additional Drug
means a controlled
				substance in Schedule VI determined by the Department to carry a
bona
				fide
potential for abuse.
Administer
means the direct
				application of a controlled substance whether by injection, inhalation,
				ingestion or any other means to the body of a patient or research subject
				by:
(1) A practitioner; or
(2) A registered nurse or licensed practical
			 nurse at the direction of a practitioner in the course of his or her
			 professional practice; or
(3) A
			 registered pharmacist or pharmacy intern administering medications for
			 treatment of mental health or substance use disorders and at the direction of a
			 prescribing practitioner in the course of the practitioner's professional
			 practice; or
(4) An ultimate user
			 or research subject at the direction of a practitioner in the course of his or
			 her professional practice; or
(5)
			 Persons authorized by the Department to administer controlled substances
			 pursuant to
			 105
			 CMR 700.003
Agent
means an authorized person who
				acts on behalf of or at the direction of a manufacturer, distributor or
				dispenser; except that such term does not include a common or contract carrier,
				public warehouseman or employee of the carrier or warehouseman, when acting in
				the usual and lawful course of the carrier's or warehouseman's business.
Ambulance Service
means an entity
				licensed as an ambulance service by the Department in accordance with M.G.L. c.
				111C, § 6 and
				105 CMR
				170.000:
Emergency Medical Services
				System
.
Analytical Laboratory
means a facility
				maintained primarily for the analysis or examination of controlled substances
				or their precursors, and which is not a facility or part of a facility
				otherwise registered to manufacture, distribute, dispense or possess controlled
				substances.
Certified Nurse Practitioner
means a
				registered nurse authorized to practice as a certified nurse practitioner by
				the Board of Registration in Nursing as provided for in M.G.L. c. 112,
				§§ 80B, 80E and
				244 CMR
				4.00:
Advanced Practice Registered
				Nursing
.
Certified Registered Nurse Anesthetist
means a registered nurse authorized to practice as a certified registered nurse
				anesthetist by the Board of Registration in Nursing as provided for in M.G.L.
				c. 112, §§ 80B, 80H and
				244 CMR
				4.00:
Advanced Practice Registered
				Nursing
.
Chemical Analyst
means a person
				engaged in the qualitative or quantitative analysis of controlled substances
				within an analytical laboratory.
Commissioner
means the Commissioner of
				Public Health or his or her duly authorized designee.
Community EMS Program
means a program
				developed by the primary ambulance service with the approval of the local
				jurisdiction and the affiliate hospital medical director utilizing emergency
				medical service providers acting within their scope of practice to provide
				community outreach and assistance to residents to advance injury and illness
				prevention within the community.
Community Program
means any community
				residential or day program that is funded, operated or licensed by a community
				program sponsor and is authorized by such community program sponsor to
				participate in the Medication Administration Program.
Community Program Sponsor
means any
				Commonwealth agency or program specified in guidance issued by the Department
				as eligible to participate in the Medication Administration Program, and which
				funds, operates or licenses community programs.
Compounding
shall have the same
				meaning as used in M.G.L. c. 112, § 39D.
Controlled Substance
means a drug,
				substance, or immediate precursor in any schedule or class referred to in
				M.G.L. c. 94C or
				105 CMR
				700.000.
Customer Identifier
means the
				identification number on a valid government issued identification, including,
				but not limited to, state issued identification, military identification card,
				permanent resident card, passport, driver's license, or other identification as
				specified by the Department, which a pharmacy obtains by inspecting the
				identification of the ultimate user or agent of the ultimate user to whom a
				prescription is dispensed.
Delegate
means an authorized support
				staff member, or colleague of the participant who is not a primary account
				holder, who may access the prescription monitoring program on behalf of a
				participant.
Deliver
means to transfer, whether by
				actual or constructive transfer, a controlled substance from one person to
				another, regardless of whether there is an agency relationship.
Dental Hygienist
means a dental
				hygienist registered by the Board of Registration in Dentistry pursuant to
				M.G.L. c. 112, § 51.
Department
means the Massachusetts
				Department of Public Health.
Device
means an instrument, apparatus,
				implement, machine, contrivance, implant,
in vitro
reagent, or
				other similar or related article, including any component, part or accessory
				for use as outlined in 21
				U.S.C. §
										321.
Dispense
means to deliver a controlled
				substance to an ultimate user or research subject or to the agent of an
				ultimate user or research subject by a practitioner or pursuant to the order of
				a practitioner, including the prescribing and administering of a controlled
				substance and the packaging, labeling, or compounding necessary for such
				delivery.
Distribute
means to deliver, other
				than by administering or dispensing, a controlled substance.
Drug
means:
(1) Substances recognized as drugs in the
			 official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the
			 United States or official National Formulary or any supplement to any of
			 them;
(2) Substances intended for
			 use in the diagnosis, cure, mitigation, treatment or prevention of disease in
			 people or animals;
(3) Substances,
			 other than food, intended to affect the structure or any function of the body
			 of people and animals; or
(4)
			 Substances intended for use as a component of any article specified in
			 105
			 CMR 700.001:
Drug
(1) through (3), exclusive of devices or their components, parts or
			 accessories.
Drug Enforcement Administration
or
DEA
means the United States Drug Enforcement
				Administration in the United States Department of Justice, or its successor
				agency.
Emergency Medical Technician (EMT)
means a person certified by the Department, pursuant to M.G.L. c. 111C, §
				9 and
				105 CMR
				170.000, in accordance with his or her level of
				training, who is authorized to administer controlled substances pursuant to his
				or her training and the STP.
EMT
shall include
				EMT-basic and the ALS levels of Advanced EMT and Paramedic as defined in
				105 CMR
				170.000:
Emergency Medical Services
				System
.
EMT
shall also include an EMT who is
				authorized to administer controlled substances by the clinical protocols of a
				Department-approved MIH or community EMS program with which they are working in
				accordance with M.G.L. c. 111O.
EMS First Responder (EFR)
means a
				person certified as an EFR by the Department, in accordance with M.G.L. c.
				111C, § 9 and
				105 CMR
				170.000:
Emergency Medical Services
				System
, who is authorized to administer controlled substances pursuant
				to his or her certification and the Statewide Treatment Protocols.
EMS First Responder (EFR)
shall include an EFR who is
				authorized to administer controlled substances by the clinical protocols of a
				Department-approved MIH or community EMS program with which they are working in
				accordance with M.G.L. c. 111O.
EMS First Response Service (EFR
				Service)
means an entity licensed as an EFR service by the
				Department in accordance with M.G.L. c. 111C, § 6 and
				105 CMR
				170.000:
Emergency Medical Services
				System
.
Extended-release Long-acting Opioid in a Non-abuse
				Deterrent Form
means a drug that is:
(1) subject to the United States Food and
			 Drug Administration's extended release and long acting opioid analgesics risk
			 evaluation and mitigation strategy;
(2) an opioid approved for medical use that
			 does not meet the requirements for listing as a drug with abuse deterrent
			 properties pursuant to M.G.L. c. 17, § 13; and
(3) identified by the drug formulary
			 commission as posing a heightened level of public health risk.
First Responder
means a First
				Responder as defined in
				105 CMR
				171.000:
Massachusetts First Responder
				Training
, and who is authorized to administer controlled substances in
				accordance with
				105 CMR
				171.000, his or her training thereunder and the
				Statewide Treatment Protocols.
Fluoride Program Monitor
means a
				dental assistant, school teacher, school nurse, school aide or school
				volunteer.
Health Care Entity
means a provider or
				facility, other than a practitioner or health facility, that is authorized by
				DPH to possess, administer, or dispense controlled substances. A Health Care
				Entity may include, but is not limited to, an ambulance service, a visiting
				nurse association, a community program, a virtual manufacturer, a reverse
				distributor and a home health agency.
Health Care Provider Order
means an
				order issued by a practitioner providing instructions for the administration of
				medications of a person participating in a community program.
Health Facility
means:
(1) A hospital, hospital pharmacy, long-term
			 care facility, clinic, or other facility licensed or maintained by the
			 Department;
(2) a facility exempt
			 from licenusre pursuant to M.G.L. c. 111, § 52; or
(3) A public medical institution as defined
			 in M.G.L. c. 118E, § 8; or
(4)
			 Any institution licensed or maintained by the Department of Mental
			 Health;
(5) Any hospital, long-term
			 care facility or clinic maintained by the Commonwealth; or
(6) Any ambulance service licensed by the
			 Department to provide Advanced Life Support services.
Hospital
means any institution,
				however named, whether conducted for charity or for profit, which is
				advertised, announced, established or maintained for the purpose of caring for
				persons admitted thereto for diagnosis, medical, surgical or restorative
				treatment which is rendered within said institution.
Immediate Precursor
means a substance
				which the Commissioner has found to be and by rule designates as being the
				principal compound commonly used or produced primarily for use, and which is an
				immediate chemical intermediary used or likely to be used in the manufacture of
				a controlled substance, the control of which is necessary to prevent, curtail
				or limit manufacture.
Implantable Infusion Pump
means a
				device that is intended to be implanted in the human body for the purpose of
				delivering a controlled flow of drug(s).
Investigation
means, for the purpose
				of 105 CMR
				700.012(C)(2)(b), an
				inquiry, appropriate to agency authority, that has been opened previously, is
				ongoing, has been undertaken with a stated purpose and is based on a complaint,
				allegation, evidence or other useful information concerning a potential
				violation of law or regulation by a specific prescriber, pharmacy, or patient
				or other individual to whom a controlled substance has reportedly been
				dispensed.
Isomer
means the optical isomer,
				except that wherever appropriate it shall mean the optical, position or
				geometric isomer.
Labeling
means in the definition of
				"manufacture", labeling or relabeling other than by a practitioner, or by a
				pharmacist.
Long-term Care Facility
means any
				institution whether conducted for charity or profit, that is advertised,
				announced or maintained for the express or implied purpose of providing three
				or more individuals admitted thereto with long-term resident, nursing,
				convalescent or rehabilitative care; supervision and care incident to old age
				for ambulatory persons; or retirement home care for elderly persons. Long-term
				care facility shall include convalescent or nursing homes, rest homes,
				infirmaries maintained in towns and charitable homes for the aged.
Manufacture
means the production,
				preparation, propagation, compounding, conversion or processing of a controlled
				substance, either directly or indirectly by extraction from substances of
				natural origin or independently by means of chemical synthesis, including any
				packaging or repackaging of the substance or labeling or relabeling of its
				container, except that this term does not include the preparation or
				compounding of a controlled substance by an individual for his or her own use,
				or the preparation, compounding, packaging or labeling of a controlled
				substance:
(1) By a practitioner as an
			 incident to his or her administering a controlled substance in the course of
			 his or her professional practice; or
(2) By a practitioner, or by his or her
			 authorized agent under his or her supervision, for the purpose of, or as an
			 incident to, research, teaching or chemical analysis and not for sale.
Massachusetts Prescription Awareness Tool
				(MassPAT)
means the online prescription monitoring program
				database created pursuant to M.G.L. c. 94C, § 24A.
Medical Assistant
means an individual
				authorized by M.G.L. c. 112, § 265 to administer immunizations under the
				supervision of a primary care provider and in accordance with Department
				guidance.
Medical Specialty Camp
means a camp
				with a primary purpose to provide programs for campers with special medical or
				health needs, as defined in
				105
				CMR 430.020:
Minimum Standards for
				Recreational Camps for Children
.
Medication Order
means an order for a
				medication entered on a patient's medical record maintained at a hospital,
				other health facility, or ambulatory health care setting and is dispensed for
				immediate administration at the facility to the ultimate user by an individual
				authorized by M.G.L. c. 94C to administer such medication.
Mobile Integrated Health Care
or
MIH
means a health care program approved by the
				Department that utilizes mobile resources to deliver care and services to
				patients in an out-of-hospital environment in coordination with health care
				facilities or other health care providers, for services including, but not
				limited to, community paramedic provider services, chronic disease management,
				behavioral health, preventive care, post-discharge follow-up visits, or
				transport or referral to facilities other than hospital emergency
				departments.
Narcotic Drug
means any of the
				following, whether produced directly or indirectly by extraction from
				substances of vegetable origin, or independently by means of chemical
				synthesis, or by a combination of extraction and chemical synthesis:
(1) Opium and opiate, and any salt, compound,
			 derivative, or preparation of opium or opiate;
(2) Any salt, compound, isomer, derivative or
			 preparation thereof which is chemically equivalent or identical with any of the
			 substances referred to in
			 105
			 CMR 700.001:
Narcotic
			 Drug
, but not including the isoquinoline alkaloids of
			 opium;
(3) Opium poppy and poppy
			 straw; or
(4) Coca leaves and any
			 salt, compound, derivative, or preparation of coca leaves, and any salt,
			 compound, isomer, derivative or preparation thereof which is chemically
			 equivalent or identical with any of these substances, but not including
			 decocainized coca leaves or extractions of coca leaves which do not contain
			 cocaine or ecgonine.
National Drug Code Number (NDC)
means
				a nationally recognized standard which identifies drug products using a unique
				number, issued by the United States Food and Drug Administration, involving
				three components. The first component identifies the drug manufacturer
				("LABELER NO."), the second identifies the product ("PRODUCT NO."), and the
				third identifies the package size ("PKG").
Non-self-administering
means
				personally taking or applying a controlled substance in the manner directed by
				the prescribing practitioner, with more than minimal assistance or direction by
				someone who is not the ultimate user.
Nurse Midwife
means a registered nurse
				authorized to practice as a certified nurse midwife by the Board of
				Registration in Nursing as provided for in M.G.L. c. 112, § 80B, and
				244 CMR
				4.00:
Advanced Practice Registered
				Nursing
.
Opiate
means any substance having an
				addiction-forming or addiction-sustaining liability similar to morphine or
				being capable of conversion into a drug having addiction-forming or
				addiction-sustaining liability. It does not include, unless specifically
				designated as controlled under M.G.L. c. 94C, § 2, the dextrorotatory
				isomer of 3-methoxy-n-methyl-morphinan and its salts, dextromethorphan. It does
				include its racemic and levorotatory forms.
Opium Poppy
means the plant of the
				species
Papaver somniferum L
., except its seeds.
Optometrist
means an optometrist
				licensed by the Board of Registration in Optometry pursuant to the provisions
				of M.G.L. c. 112, § 68.
Packaging
means in the definition of
				"manufacture", packaging or repackaging a controlled substance other
				than:
(1) By a practitioner
			 or;
(2) By a pharmacist.
Participant
means a practitioner or
				other person who is duly authorized to prescribe or dispense a controlled
				substance by a Massachusetts Board of Registration and is authorized by the
				Department to utilize the prescription monitoring program.
Perfusionist
means a perfusionist
				licensed by the Board of Registration of Perfusionists pursuant to M.G.L. c.
				112, § 212.
Person
means individual, corporation,
				government, governmental subdivision or agency, business trust, estate, trust,
				partnership, association, or any other legal entity.
Pharmacist
means a pharmacist duly
				licensed by the Board of Registration in Pharmacy in accordance with M.G.L. c.
				112, § 24 and
				247 CMR
				3.00:
Pharmacist Licensure
.
Pharmacy Intern
means a pharmacy
				intern licensed by the Board of Registration in Pharmacy pursuant to M.G.L. c.
				112, § 24G.
Physician Assistant
means a physician
				assistant authorized to practice by the Board of Registration of Physician
				Assistants, in accordance with M.G.L. c. 112, § 9I, and authorized to
				prescribe in accordance with M.G. L. c. 112, § 9E, and
				263 CMR
				5.00:
Scope of Practice and Employment of
				Physician Assistants
.
Practical Nurse
means a practical
				nurse licensed by the Board of Registration in Nursing pursuant to the
				provisions of M.G.L. c. 112, § 74A.
Practitioner
means:
(1) A physician, dentist, veterinarian,
			 podiatrist, scientific investigator or other person registered to distribute,
			 dispense, prescribe, conduct research with respect to, or use in teaching or
			 chemical analysis, a controlled substance in the course of professional
			 practice or research in the Commonwealth;
(2) A pharmacy, hospital or other institution
			 registered to distribute, dispense, conduct research with respect to or to
			 administer a controlled substance in the course of professional practice or
			 research in the Commonwealth;
(3)
			 An optometrist authorized by M.G.L. c. 112, §§ 66, 66B, and 66C, and
			 registered pursuant to M.G.L. c. 94C, § 7(h).
(4) A certified nurse practitioner registered
			 pursuant to M.G.L. c. 94C, § 7(f) and authorized by M.G.L. c. 112, §
			 80E to distribute, dispense, conduct research with respect to or use in
			 teaching or chemical analysis a controlled substance in the course of
			 professional practice or research in the commonwealth;
(5) A certified registered nurse anesthetist
			 registered pursuant to M.G.L. c. 94C, § 7(f) and authorized by M.G.L. c.
			 112, § 80H to distribute, dispense, conduct research with respect to or
			 use in teaching or chemical analysis a controlled substance in the course of
			 professional practice or research in the commonwealth;
(6) A psychiatric nurse mental health
			 clinical specialist registered pursuant to M.G.L. c. 94C. § 7(f) and
			 authorized by M.G.L. c. 112, § 80J 112 to distribute, dispense, conduct
			 research with respect to or use in teaching or chemical analysis a controlled
			 substance in the course of professional practice or research in the
			 commonwealth;
(7) A physician
			 assistant authorized to practice in accordance with M.G.L. c. 112, § 9I,
			 and authorized to prescribe in accordance with M.G. L. c. 112, § 9E and
			 registered pursuant to M.G.L. c. 94C.
Prescription
means an order for
				medication which is dispensed to or for an ultimate user. A prescription does
				not mean a medication order which is dispensed for immediate administration to
				the ultimate user.
Prescription Drug
means a drug upon
				which the manufacturer or distributor has, in compliance with federal laws and
				regulations, placed the following: "Caution, Federal law prohibits dispensing
				without prescription".
Primary Account Holder
means a
				participant who has sub-accounts or a hospital licensed by the Division of
				Health Facilities Licensure and Certification and approved by the Department,
				for purposes of permitting interns and residents to be delegates of the
				hospital.
Private School
means the board of
				trustees, board of directors or comparable board responsible for operating a
				private elementary or secondary school program.
Provider ID
means the unique six-digit
				number issued by the National Counscil for Prescription Drug Programs.
Psychiatric Nurse Mental Health Clinical
				Specialist
means a registered nurse authorized to practice as a
				psychiatric nurse mental health clinical specialist by the Board of
				Registration in Nursing, as provided for in M.G.L. c. 112, §§ 80B,
				80J and
				244 CMR
				4.00:
Advanced Practice Registered
				Nursing
.
Registered Nurse
means a nurse who is
				registered by the Department pursuant to the provisions of M.G.L. c. 112,
				§ 74.
Registrant
means a person who is
				registered by the Department pursuant to any provision of M.G.L. c. 94C.
Registration
means, unless the context
				specifically indicates otherwise, such registration as is required and
				permitted only pursuant to the provisions of M.G.L. c. 94C.
Registration Number
means the unique
				registration number required with respect to a practitioner by, and assigned to
				a practitioner by, the DEA or by the Department of Public Health or
				both.
Rescue Medication
means a schedule VI
				medication, including epinephrine auto-injectors, naloxone or other opioid
				antagonist approved by the Department, atropine, pralidoxime chloride or other
				designated nerve agent antidotes (nerve agent antidotes), and rescue inhalers,
				that is administered in the event of an allergic reaction, apparent opioid
				overdose or asthma or other acute respiratory event to prevent imminent death
				or serious injury or illness.
Research Drug
means an investigational
				new drug as defined in 21
				CFR 312.3, or the investigational use of any
				scheduled drug in a research study or project where it will be administered or
				dispensed.
Researcher
means a person who engages
				in or conducts research involving substances, whether controlled or not, or the
				direct supervisor, department chair or chief academic officer of such
				person.
Respiratory Therapist
means a
				respiratory therapist licensed by the Board of Registration of Respiratory Care
				pursuant to M.G.L. c. 112, §§ 23R through 23BB.
Reverse Distribute
means to acquire
				controlled substances from a registrant, or Commonwealth or federal law
				enforcement agency, for the purpose of:
(1) Returning the controlled substances to
			 the registered manufacturer or to another person lawfully authorized by the
			 manufacturer to accept returns on the manufacturer's behalf; or
(2) Destruction in compliance with state and
			 federal law.
Reverse Distributor
means a person
				registered with the federal government as a reverse distributor pursuant to
				21 CFR §
										1317.15.
Sample Medication
for the purpose of
				105 CMR
				700.000 shall mean a unit of prescription drug
				distributed by the manufacturer or distributor to practitioners in the original
				package from the manufacturer, not repackaged and given free of charge to
				patients. Such medications shall include, but not be limited to, those
				medications dispensed as part of an indigent patient drug program.
Schedule
means the list of controlled
				substances established by the Commissioner pursuant to the provisions of M.G.L.
				c. 94C, § 2 for purposes of administration and regulation.
School
means a public or private
				elementary or secondary school.
School District
means the local
				educational agency, which includes the school committee, board of trustees,
				educational collaborative board, or other public entity responsible for
				operating a public elementary or secondary school program.
Self-administer
means personally
				taking or applying a controlled substance in the manner directed by the
				prescribing practitioner, with no more than minimal assistance or direction
				from someone who is not the ultimate user.
Statewide Treatment Protocols
or STP
				means the Emergency Medical Service Pre-hospital Treatment Protocols approved
				by the Department for application statewide in accordance with M.G.L. c. 111C
				and 105 CMR
				170.000:
Emergency Medical Services
				System
.
Supervising Practitioner
means a
				practitioner who provides supervision as required by M.G.L. c. 112,
				§§ 9E,
24B½
80E, and 80H.
Teacher
means a person who conducts
				teaching activities using controlled substances in a teaching institution
				accredited by the Commission on Institutions of Higher Education.
Third-party Logistics Provider
or 3PL
				means an entity that provides or coordinates warehousing, or other logistics
				services of a product in interstate commerce on behalf of a manufacturer,
				wholesale distributor, or dispenser of a product, but does not take ownership
				of the product, nor have responsibility to direct the sale or disposition of
				the product.
Ultimate User
means a person who
				lawfully possesses a controlled substance for his or her own use or for the use
				of a member of his or her household or for administering to an animal owned by
				him or her or by a member of his or her household.
Utilize
means to access (directly or
				through a delegate) and assess a patient's prescription history from the
				prescription monitoring program.
Virtual Manufacturer
means a person in
				the business of manufacturing or distributing a controlled substance and who
				has a principal place of business located in the Commonwealth, but at no time
				takes physical possession of any controlled substance in the
				Commonwealth.