105 Mass. Reg. 700.004

Current through Register 1524, June 21, 2024

Section 700.004 - Registration Requirements

(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.

(2) The following practitioners are required to be registered under 105 CMR 700.004(A)(1) and shall register separately for each business or professional activity.

(a) Certified Nurse Practitioner;

(b) Certified Registered Nurse Anesthetist;

(c) Dentist;

(d) Nurse Midwife;

(e) Optometrist;

(f) Pharmacist;

(g) Physician;

(h) Physician Assistant;

(i) Podiatrist;

(j) Psychiatric Nurse Mental Health Clinical Specialist; and

(k) Researcher;

(3) The following facilities shall register for the purpose of purchase and storage of controlled substances in Massachusetts:

(a) Ambulance/EFR Service;

(b) Analytical Laboratory;

(c) Distributor;

(d) Health Facility, however, a health facility shall not dispense controlled substances, pursuant to 105 CMR 722.00: Dispensing Procedures for Clinics and Hospital Pharmacies, other than by immediate administration or in accordance with 105 CMR 700.010, unless pharmacy services is listed on the health facility license or approval, issued by the appropriate regulatory authority;

(e) Manufacturer;

(f) A Department approved MIH program;

(g) Reverse Distributor.

(4) A health care entity choosing to engage in the following activities, shall register for a limited controlled substance registration as follows:

(a) A health professions school or training program for purposes of purchase and storage of Schedule VI controlled substances to be used for instructional purposes;

(b) A state or municipal public agency or program, or the partner of such an agency or program, for purposes of purchase, storage and distribution, as authorized by 105 CMR 700.003(C);

(c) A School District, for purposes of storage and authorizing nurse delegation of medication administration, pursuant to 105 CMR 700.003(D);

(d) A Private School, for purposes of storage and authorizing nurse delegation of medication administration pursuant to 105 CMR 700.003(D);

(e) A community program, for the purpose of storage and medication administration pursuant to 105 CMR 700.003(E);

(f) A Virtual Manufacturer, for the purposes authorized by M.G.L. c. 94C, § 7(i);

(g) A Virtual Distributor, for the purposes authorized by M.G.L. c. 94C, § 7(i);

(h) Third Party Logistics provider for the purpose authorized by 21 U.S.C. § 360eee-3;

(i) Entities approved by the Bureau of Substance Addiction Services, including Opioid Treatment Programs, and required by such approval to dispense medication for addiction related withdrawal management and/or maintenance purposes, for purposes of purchase and storage for immediate administration, including medications to manage immediate health emergencies;

(j) Reverse Distributors for the purposes of storage, distribution and disposal in accordance with federal law;

(k) Durable Medical Equipment suppliers, for the purposes of purchase, storage and sale of medical devices with controlled substance components;

(l) Medical Device Manufacturers, for the purpose of purchase, storage of specific controlled substances solely for use in manufacturing and quality control processes;

(m) Medical Specialty Camps, for the purpose of permitting unlicensed personnel to administer diabetes medication to campers in accordance with 105 CMR 430.000: Minimum Standards for Recreational Camps for Children (State Sanitary Code Chapter IV); and

(n) Chemical Analysts, for the purpose of engaging in the qualitative or quantitative analysis of controlled substances within an analytical laboratory.

(5) A certified nurse practitioner, psychiatric nurse mental health clinical specialist, certified registered nurse anesthetist or physician assistant may issue prescriptions and medication orders for Schedule II through VI controlled substances, which comply with the prescribing requirements of M.G.L. c. 94C, § 20 and c. 112, § 66B, provided that the following requirements are met:

(a) The certified nurse practitioner, psychiatric nurse mental health clinical specialist, and certified registered nurse anesthetist meet all requirements set forth in 244 CMR 4.00: Advanced Practice Registered Nursing and M.G.L. c. 112, §§ 80B, 80E, and 80H.

(b) The physician assistant meets all requirements set forth in regulations established by the Board of Registration of Physician Assistants in 263 CMR 2.00: Purpose, Authority and Definitions, 263 CMR 3.00: Registration of Individual Physician Assistants, and 263 CMR 5.00: Scope of Practice and Employment of Physician Assistants and M.G.L. c. 112, §§ 9C through 9K.

(c) The certified nurse practitioner, psychiatric nurse mental health clinical specialist, certified registered nurse anesthetist or physician assistant registers with the Department's Prescription Monitoring and Drug Control Program, in accordance with 105 CMR 700.004 and with the DEA, in accordance with 21 CFR 1300.

(d) A supervised professional, a certified nurse practitioner, psychiatric nurse mental health clinical specialist, or certified registered nurse anesthetist with fewer than two years of supervised practice as that term is defined in regulations or guidance issued by the Board of Registration in Nursing, or a physician assistant, practices in accordance with written guidelines governing the prescription of medication mutually developed and agreed upon by the supervised professional and a supervising practitioner pursuant to regulations promulgated under M.G.L. c. 112, §§ 80B, 80E, and 80H and M.G.L. c. 112, § 9E that describes the methods to be followed in managing a health care situation or in resolving a health care problem. All prescriptions issued by the supervised professional shall be consistent with the scope of practice as defined by 244 CMR 4.00: Advanced Practice Registered Nursing for nurses practicing in the expanded role and 263 CMR 5.00: Scope of Practice and Employment of Physician Assistants for physician assistants.

(e) A certified nurse practitioner, psychiatric nurse mental health clinical specialist, certified registered nurse anesthetist or physician assistant may issue prescriptions in accordance with M.G.L. c. 94C, § 20, provided that the person issuing the prescription complies with 105 CMR 721.000: Standards for Prescription Format and Security in Massachusetts.

(f) a certified nurse practitioner, psychiatric nurse mental health clinical specialist, certified registered nurse anesthetist or physician assistant may prescribe controlled substances for a patient in a health facility or other setting through use of written medication orders entered on the patient's medical record maintained at the facility, provided that such written orders meet all applicable provisions of 105 CMR 700.000.

(6) A certified nurse midwife may issue prescriptions and medication orders, in accordance with the provisions of M.G.L. c. 94C, § 20, c. 112 and §§ 80C and 80G, for those controlled substances in Schedules II through VI.

(7) Optometrists may utilize and issue prescriptions and medication orders, in accordance with the provisions of M.G.L. c. 112, §§ 66, 66B, and 66C.

(8) The Department may register third party logistics providers or 3PLs, provided that they comply with this section, as outlined in Department guidance, and 21 U.S.C. § 360eee-3.

(B)Exemptions from Requirement to Register. Persons primarily responsible for activities involving controlled substances in Massachusetts are required to register.

(1) Owners, partners and stockholders and parent corporations of registered businesses shall be exempt with regard to such ownership activities from the requirement to register.

(2) The following persons are exempt from the requirement to register pursuant to M.G.L. c. 94C:

(a) An agent or employee of a registered manufacturer, distributor or dispenser acting in the usual course of their business or employment;

(b) A common or contract carrier or warehouseman or their employee, acting in their usual course of business or employment;

(c) A public official or law enforcement officer acting in the regular performance of their official duties.

(d) An ultimate user or research subject, at the direction of a practitioner in the course of their professional practice;

(e) A registered nurse, licensed practical nurse, EMT, paramedic, respiratory therapist, dental hygienist, or perfusionist, acting under the direction or authorization of a practitioner in the course of their professional practice.

(3) Any student enrolled in a school for nurses, practical nurses, respiratory therapists, dental hygienists, or perfusionists, duly approved in accordance with M.G.L. c. 112, shall be exempt from the requirement to register when:

(a) Performing nursing, respiratory therapy, dental hygiene, or perfusion services incidental to any prescribed course in such school, and

(b) Authorized or directed by a physician, dentist, podiatrist, veterinarian, nurse midwife, certified nurse practitioner, psychiatric nurse mental health clinical specialist, certified registered nurse anesthetist or physician assistant duly registered under 105 CMR 700.000.

(4) Certain persons engaged in interstate or foreign commerce shall be exempt from the requirement to register with respect to the exempted business activities only as follows:

(a) Vessels engaged in international trade or in trade between ocean ports of the United States.

(b) Aircraft operated by air carriers under a certificate or permit issued pursuant to the Federal Aviation Act of 1958.

(c) Persons who import controlled substances into the jurisdiction of the United States, and are in compliance with applicable Federal law.

(d) Persons who export controlled substances from the jurisdiction of the United States, and are in compliance with applicable Federal law.

(5) An intern, fellow, medical officer, alien physician, registered nurse, licensed practical nurse, or other authorized person may dispense controlled substances under the registration of the hospital or other registered health facility by which they are employed and a "responsible person", as defined by the Department, may dispense controlled substances by ingestion only at the direction of a practitioner in the course of his professional practice, under the registration of the registered health facility by which such person is employed, in lieu of being registered himself or herself provided that:

(a) They are authorized to dispense controlled substances in accordance with M.G.L. c. 112 if applicable, and

(b) Such dispensing is done in the usual course of his business or professional practice, and

(c) The hospital or other registered health facility by whom they are employed has verified with the appropriate Board of Registration, if applicable, that the person is permitted to dispense controlled substances within Massachusetts, and

(d) Such person is acting only within the scope of his employment in the hospital or other registered health facility, and

(e) The hospital or other registered health facility authorizes the person to dispense controlled substances under the registration number of the hospital or other registered health facility and designates a specific internal code to consist of a numeric suffix to the health facility registration number preceded by a hyphen for each such person so authorized, and

(f) The hospital or other registered health facility maintains a current list of internal codes and makes such codes available at all times to other registrants, the Commissioner, and authorized law enforcement agencies.

(6) A registered pharmacist, pharmacy intern, and pharmacy technician may dispense by administration influenza vaccine, COVID-19 vaccine, and other immunizations designated by the Department to persons five years of age or older provided that:

(a) Such registered pharmacist, pharmacy intern, or pharmacy technician is authorized to dispense controlled substances in accordance with M.G.L. c. 112 or Department guidance;

(b) Such administration is conducted pursuant to the order of a practitioner;

(c) Each pharmacy that provides immunizations shall follow Department guidelines to disclose whether it receives vaccines free of charge through the Massachusetts Immunization Program and shall notify patients that there may be a difference in cost between immunization services provided at a pharmacy and at a primary care provider's office; and

(d) Such activity is conducted in accordance with guidelines adopted by the Department which shall include, but not be limited to, requirements for:

1. training accredited by the Centers for Disease Control and Prevention, the American Council on Pharmaceutical Education or a similar health authority or professional body;

2. pre-administration education and screening;

3. vaccine storage and handling;

4. administration of medication, including administration of controlled substances as necessary for the management of medical emergencies;

5. where immunization is being administered to a person younger than 18 years old, providing information on primary care providers in the pharmacy's geographic area;

6. if the purpose of the visit is for a childhood immunization other than the influenza vaccine, providing counseling on the importance of establishing and maintaining a relationship with a pediatric or family practice for ongoing medical and well-child care;

7. record keeping; and

8. reporting of adverse events.

(7) A health care professional duly licensed or certified by the Department or a student duly enrolled in an approved or accredited program for such licensure or certification and authorized by 105 CMR 700.003(F) to possess and administer vaccine is exempt from registration for purposes of administering vaccine pursuant to 105 CMR 700.003(F).

(8) Any pharmacist employed as an instructor by a school or educational program for pharmacists shall be exempt when purchasing supplies from Schedule VI for use in instruction at the school or educational program.

(9) A pharmacist or a pharmacy intern is authorized to dispense by administration FDA approved mental health or substance use disorder treatment drugs to persons 18 years of age or older provided that:

(a) The pharmacist or pharmacy intern is authorized to dispense controlled substances in accordance with M.G.L. c. 112.

(b) Such administration is conducted pursuant to a valid prescription;

(c) Such prescription is subject to reassessment at appropriate intervals as determined by the prescriber; and

(d) Such activity is conducted in accordance with guidelines adopted by the Department which shall include, but not be limited to, requirements for:

1. training accredited by the Centers for Disease Control and Prevention, the American Council on Pharmaceutical Education or a similar health authority or professional body;

2. pre-administration education and screening;

3. vaccine storage and handling;

4. administration of medication, including administration of controlled substances as necessary for the management of medical emergencies;

5. where immunization is being administered to a person younger than 18 years old, providing information on primary care providers in the pharmacy's geographic area;

7. record keeping; and

8. reporting of adverse events.

(e) A pharmacist is authorized to administer controlled substances in an Opioid Treatment Program pursuant to an order and in accordance with guidance issued by the Department.

(10) Recreational Camps for Children licensed pursuant to 105 CMR 430.000: Minimum Standards for Recreational Camps for Children (State Sanitary Code, Chapter IV) and camp staff are exempt from registration for the purposes of administering epinephrine through use of an auto-injector to other camp staff and camp participants in compliance with that regulation.

(11) No person shall be required to register with the Department for the purposes of purchasing, storing, possessing, or administering naloxone, or other opioid antagonist approved by the Department.

(12) A medical assistant shall be exempt when administering immunizations under the supervision of a practitioner, as authorized by M.G.L. c. 112, § 265 and in accordance with Departmental guidance.

(13) A municipality or non-municipal public agency that is duly registered pursuant to M.G.L. c. 94C, § 7(g) shall not be required to register with the Department as a distributor in order to convey or exchange naloxone or another opioid antagonist approved by the Department to or with another duly registered entity to ensure the availability and use of unexpired naloxone or other approved opioid antagonist; provided however, that such an exchange shall be recorded in a memorandum between the registered entities as authorized by Department guidance.

(14) Medical device manufacturers and distributors who sell any medical device that does not contain controlled substances do not require an MCSR.

(15) A registered pharmacist may prescribe and dispense hormonal contraceptive patches and self-administered oral hormonal contraceptives to any person, in accordance with guidance issued by the department.

(a) A registered pharmacist may prescribe and dispense hormonal contraceptive patch or self-administered oral hormonal contraceptive regardless of whether the person has evidence of a previous prescription for a hormonal contraceptive patch or self-administered oral hormonal contraceptive, provided all requirements of 105 CMR 700.004(B)(15)(b) and (c) are met.

(b) A registered pharmacist prescribing hormonal contraceptive patches and self-administered oral hormonal contraceptives shall:

1. complete a training program approved by the board of registration in pharmacy that is related to prescribing hormonal contraceptive patches and self-administered oral hormonal contraceptives prior to prescribing hormonal contraceptive patches or self-administered oral hormonal contraceptives;

2. provide a self-screening risk assessment tool that the patient shall use prior to the pharmacist prescribing the hormonal contraceptive patch or self-administered oral hormonal contraceptive;

3. refer the patient to the patient's primary care practitioner or reproductive health care practitioner, if applicable, upon prescribing and dispensing the hormonal contraceptive patch or self-administered oral hormonal contraceptive or advise the patient to consult with a primary care practitioner or reproductive health care practitioner;

4. provide the patient with a written record of the hormonal contraceptive patch or self-administered oral hormonal contraceptive prescribed and dispensed; and

5. dispense the hormonal contraceptive patch or self- administered oral hormonal contraceptive to the patient as soon as practicable after the pharmacist issues the prescription.

(c) A pharmacist shall not require a patient to schedule an appointment with the pharmacist for the prescribing or dispensing of a hormonal contraceptive patch or self-administered oral hormonal contraceptive.

(C)Separate Registrations Required for Separate Activities. Each person shall obtain a separate registration for each group of activities in which they engage.

(1) A person engaged in one of the following business or professions shall be deemed to be registered only for the activities appropriate to that business or profession as follows:

(a) A person registered as a manufacturer is deemed to be:

1. registered to manufacture controlled substances; and

2. registered to distribute controlled substances to registered persons.

(b) A person registered as a chemical analyst or analytical laboratory is deemed to be:

1. registered to manufacture controlled substances;

2. registered to conduct chemical analysis including quality control with respect to controlled substances; and

3. registered to distribute controlled substances to other registrants.

(c) A person registered as a teacher is deemed to be:

1. registered to manufacture controlled substances; and

2. registered to conduct instructional activities with controlled substances.

(d) A registered physician, dentist, veterinarian, or podiatrist, registered by the appropriate Board of Registration is deemed to be registered to dispense controlled substances.

(e) A registered hospital, or other registered health facility is deemed to be registered to dispense controlled substances.

(f) A person registered as a researcher is deemed to be, within the scope of the protocol submitted to the Commissioner, if applicable:

1. registered to manufacture controlled substances;

2. registered to distribute controlled substances to registered persons; and

3. registered to conduct research with respect to controlled substances.

(g) A registered ambulance service or EFR service shall be registered to possess only those controlled substances and instruments used to administer controlled substances, in quantity and in kind, that are necessary for pre-hospital emergency medical care in accordance with 105 CMR 170.000: Emergency Medical Services System and the STP and that are obtained from the hospital pharmacy, provided that auto-injectors containing epinephrine, nerve agent antidotes and medications approved by the Department may be obtained directly from the manufacturer or another source registered by the Department.

(h) A registered school is deemed to be registered solely in order to possess fluoride tablets and mouth rinse and to authorize fluoride program monitors and dental hygienists to administer fluoride tablets and mouth rinse in accordance with 105 CMR 700.000.

(i) A community program is registered for the sole purpose of authorizing its employees to administer or assist in the administration of controlled substances which are obtained from a pharmacy upon the prescription or order of a practitioner.

(j) A municipality or agency of the Commonwealth is registered for the purpose of authorizing possession and administration, in accordance with 105 CMR 700.003(D) of:

1. auto-injectors containing epinephrine for use by first responders and authorized employees and volunteers of a program operated, funded or licensed by the agency;

2. auto-injectors containing epinephrine, atropine, pralidoxime chloride and other nerve agent antidotes approved by the Department for use by public employees and volunteers whose functions include emergency preparedness and response, including first responders;

(k) A pharmacist is registered for the purpose of issuing, modifying or discontinuing a prescription or medication order in accordance with requirements for collaborative drug therapy management specified in 247 CMR 16.00: Collaborative Drug Therapy Management, 243 CMR 2.12: Collaborative Drug Therapy Management (CDTM) with Authorized Pharmacists and M.G.L. c. 112, § 24BG.

(l) A certified nurse practitioner, psychiatric nurse mental health clinical specialist, certified registered nurse anesthetist or physician assistant, authorized and registered by the appropriate board of registration is deemed to be registered to dispense controlled substances in accordance with written guidelines mutually developed and agreed upon with a supervising physician.

(m) A nurse midwife, authorized and registered by the Board of Registration in Nursing, is deemed to be registered to dispense controlled substances.

(n) A registered optometrist registered by the Board of Registration in Optometry may utilize and issue prescriptions and medication orders, in accordance with the provisions of M.G.L. c. 112, §§ 66, 66B and 66C.

(2) No person shall engage in any activities involving any controlled substance in any schedule without appropriate registration.

(D)Automatic Registrations. The Commissioner shall automatically issue a registration to dispense controlled substances other than for research projects and studies pursuant to M.G.L. c. 94C, § 8, to any physician, dentist, podiatrist, or veterinarian who is duly authorized to practice their profession in the Commonwealth, provided that, any such physician, dentist, podiatrist, or veterinarian shall only be registered for Massachusetts Schedule VI and for the same schedules as they are registered with the DEA.

(1) Any physician, dentist, podiatrist or veterinarian who is not registered with the DEA shall be automatically registered to dispense controlled substances but only for Massachusetts Schedule VI.

(2) The Commissioner may periodically recall registrations to dispense controlled substances issued to practitioners, in accordance with M.G.L. c. 94C, § 7(f), and may issue a new registration upon verification that the practitioner continues to be duly authorized to practice their profession in Massachusetts.

(E)Time for Application and Term of Registration. No person required to be registered shall engage in any activity for which registration is required until they are registered for that activity.

(1) Any person who is registered with the Commissioner may apply for renewal on a form provided by the Commissioner not more than 90 days before the expiration date of their registration.

(2) Any registration issued by the Commissioner other than a registration to conduct research activities with Schedule I controlled substances or a registration to dispense automatically issued shall be effective for one year from the date of issuance or until completion of the term of the registrant's licensed issued pursuant to M.G.L. c. 112, whichever occurs later.

(3) A registration issued to conduct research with Schedule I controlled substances shall be for such period, not to exceed one year, as may be specified by the Commissioner.

(4) Any person who is registered may at any time apply to modify their registration to change the contact information.

(F)Separate Registrations Required for Separate Locations. A separate registration is required at each place of business or professional practice where the applicant or registrant manufactures, distributes or dispenses controlled substances, or uses controlled substances in research, teaching, or chemical analysis.

(1) The following locations are deemed not to be places where controlled substances are manufactured, distributed, or dispensed:

(a) A warehouse where controlled substances are stored by or on behalf of a registered person, unless such substances are distributed directly from such warehouse to registered locations other than the registered location from which the substances were delivered.

(b) An office used by an agent of a registrant where sales of controlled substances are solicited, made or supervised but which neither contains such substances, nor serves as a distribution point for filling sales orders.

(c) An office or registered hospital or other registered health facility which is used by a practitioner, pharmacist or optometrist who is registered at another location which is their principal place of professional practice, provided that no controlled substances are maintained by such practitioner at any place where they are not registered.

(2) If a practitioner holds a current registration under 105 CMR 700.000, a separate registration is not required for charitable or volunteer activities which do not exceed ten hours in a calendar month. For the purposes of this exemption, a charitable or volunteer activity is one for which the registrant receives no recompense or remuneration of any kind, and which is performed for or in association with a nonprofit group or organization offering medical services at no cost to patients.

(G)Limitations on Registration for Schedule I. No person other than a person proposing to manufacture controlled substances in Schedule I; or a person proposing to conduct research on research subjects involving controlled substances in Schedule I pursuant to M.G.L. c. 94C, § 8; or a person proposing to engage in qualitative or quantitative analysis of those controlled substances in Schedule I within an analytical laboratory, or a reverse distributer proposing to reverse distribute controlled substances in Schedule I shall be registered for activities involving the manufacture, distribution or dispensing of Schedule I controlled substances unless expressly authorized so to do by the Commissioner. Every applicant for registration pursuant to 105 CMR 700.004 shall demonstrate to the satisfaction of the Commissioner, unless waived by the Commissioner:

(1) That they are registered by the DEA specifically to engage in such activities with regard to controlled substances in Schedule I; and

(2) That their have never had an application denied or suspended or revoked by the DEA or any predecessor agency for violation of any law or regulation; and

(3) That their physical security controls are specifically approved by the DEA.

(H)Content and Form of Application. Each application for registration, renewal of a registration, or modification of a registration shall be on a form provided or approved by the Commissioner. The Commissioner may, in their judgment, require additional information.

(I)Termination of Registration.

(1) The registration of any practitioner registered pursuant to 105 CMR 700.004(A)(2) shall terminate if such practitioner surrenders or otherwise discontinues an associated health professions license or DEA registration, or discontinues professional practice, or dies.

(2) The registration of any health facility registered pursuant to 105 CMR 700.004(A)(3) shall terminate if such health facility surrenders or otherwise discontinues an associated business or health facility license or DEA registration, or moves the place of business stated in the registration, or changes the name which appears on the registration, or ceases legal existence.

(3) The registration of any health care entity registered pursuant to 105 CMR 700.004(A)(4) shall terminate if such health care entity surrenders or discontinues the activity authorized by the registration, or surrenders or otherwise discontinues any license, certification or other government approval required to engage in the registered activity, or moves the drug storage area authorized by the registration. If the health care entity is an individual, the registration terminates immediately upon the death of the individual. If the health care entity is not an individual, the registration terminates immediately if the health care entity changes the name which appears on the registration or ceases legal existence.

(4) In the event of termination due to a change in name or address, the registrant may apply for a new registration up to 90 days in advance of the effective date of such change.

(5) Any registrant whose registration will terminate other than by death, shall notify the Commissioner at least 30 days before such event.

(6) If a registrant dies, the executor or administrator of the registrant's estate shall be responsible for fulfilling the requirements of 105 CMR 700.004 as soon as reasonably feasible.

(J)Transfer of Registration Prohibited. No registration or any authority conferred thereby shall be assigned or otherwise transferred.

(K)Suspension or Revocation of Registration. The Commissioner may suspend or revoke a registration to manufacture, distribute, dispense, or possess a controlled substance in accordance with procedures outlined in 105 CMR 700.100 through 700.120.