105 CMR, § 700.001
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:
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:
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:
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:
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:
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:
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:
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:
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:
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, 24B1/2 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.
105 CMR, § 700.001