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 personallytaking 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 anysubstance having an addiction-forming or addiction-sustaining liabilitysimilar
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-partyLogistics 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.