This page, Mass. General Laws c.94C § 9, is offered by

Mass. General Laws c.94C § 9

Administering and dispensing of controlled substances in course of professional practice; records, inspection

Table of Contents

Updates

Amended by St.2020, c.260, §§ 14-20, effective January 1, 2021

(a)

A physician, dentist, podiatrist, nurse practitioner, nurse anesthetist, psychiatric nurse mental health clinical specialist optometrist as limited by sections 66, 66B and 66C of chapter 112 and subsection (h) of section 7, physician assistant as limited by said subsection (g) of said section 7 and section 9E of said chapter 112, certified nurse midwife as provided in section 80C of said chapter 112, nurse anesthetist, as limited by subsection (g) of said section 7 and section 80H of said chapter 112, pharmacist as limited by said subsection (g) of said section 7 and section 24B ½ of said chapter 112, or veterinarian when registered under said section 7, may, when acting in accordance with applicable federal law and any provision of this chapter which is consistent with federal law and in good faith and in the course of a professional practice for the alleviation of pain and suffering or for the treatment or alleviation of disease, possess controlled substances as may reasonably be required for the purpose of patient treatment and may administer controlled substances or may cause the same to be administered under his direction by a nurse.

A practitioner may cause controlled substances to be administered under his direction by a licensed dental hygienist for the purposes of local anesthesia only.

A practitioner may cause an immunization to be administered under the practitioner's direction by a certified medical assistant, as defined in section 265 of chapter 112.

(b)

Notwithstanding section 17, a physician, physician assistant, dentist, podiatrist, optometrist, certified nurse midwife, nurse practitioner, psychiatric nurse mental health clinical specialist, nurse anesthetist, pharmacist as limited by said subsection (g) of said section 7 and section 24B ½ of said chapter 112, or veterinarian registered under said section 7, may, when acting in good faith and in the practice of medicine, dentistry, podiatry, optometry, nurse-midwifery, advanced practice nursing, pharmacy or veterinary medicine or as a nurse, as the case may be, and when authorized by a physician, dentist, podiatrist, optometrist, nurse practitioner, physician assistant, certified nurse midwife, psychiatric nurse mental health clinical specialist, nurse anesthetist, or veterinarian in the course of such nurse's professional practice, dispense by delivering to an ultimate user a controlled substance in a single dose or in a quantity that is, in the opinion of such physician, dentist, podiatrist, optometrist, nurse practitioner, physician assistant, certified midwife, psychiatric nurse mental health clinical specialist, nurse anesthetist, pharmacist or veterinarian, essential for the treatment of a patient. The amount or quantity of any controlled substance dispensed under this subsection shall not exceed the quantity of a controlled substance necessary for the immediate and proper treatment of the patient until it is possible for the patient to have a prescription filled by a pharmacy. All controlled substances required by the patient as part of the patient's treatment shall be dispensed by prescription to the ultimate user in accordance with this chapter.

This section shall not prohibit or limit the dispensing of a prescription medication that is classified by the department as schedule VI and that is provided by the manufacturer as part of an indigent patient program or for use as samples if the prescription medication is: (i) dispensed to the patient by a professional authorized to dispense controlled substances pursuant to this section; (ii) dispensed in the package provided by the manufacturer; and (iii) provided at no charge to the patient. The department shall promulgate rules and regulations governing the dispensing of medication pursuant to this section. These rules and regulations shall include, but not be limited to, the types and amounts of medications that may be dispensed and the appropriate safeguards for the labeling and dispensing of such medications.

This section shall not be construed to prohibit a physician or an optometrist from the in-office dispensing and sale of therapeutic contact lenses as long as the medication contained in such lenses is within the profession's designated scope of practice.

For the purposes of this section, “therapeutic contact lenses” shall mean contact lenses which contain 1 or more medications and which deliver such medication to the eye.

(c)

A nurse who has obtained from a physician, dentist, physician assistant, podiatrist, optometrist, certified nurse midwife, nurse practitioner, psychiatric nurse mental health clinical specialist, nurse anesthetist, pharmacist or veterinarian a controlled substance for dispensing to an ultimate user pursuant to subsection (b) or for administration to a patient pursuant to subsection (a) during the absence of the physician, physician assistant, dentist, podiatrist, certified nurse midwife, nurse practitioner, psychiatric nurse mental health clinical specialist, nurse anesthetist, pharmacist or veterinarian, shall return to the physician, physician assistant, dentist, podiatrist, optometrist, certified nurse midwife, nurse practitioner, psychiatric nurse mental health clinical specialist, nurse anesthetist, pharmacist or veterinarian any unused portion of the controlled substance which is no longer required by the patient.

A licensed dental hygienist who has obtained a controlled substance from a practitioner for dispensing to an ultimate user pursuant to subsection (a) shall return to such practitioner any unused portion of the substance which is no longer required by the patient.

(d)

Every physician, physician assistant, dentist, podiatrist, certified nurse midwife, nurse practitioner, psychiatric nurse mental health clinical specialist, nurse anesthetist, pharmacist or veterinarian shall, in the course of a professional practice, keep and maintain records, open to inspection by the commissioner during reasonable business hours, which shall include the following: the names and quantities of any controlled substances in schedules I, II or III received by the practitioner; the name and address of each patient to whom such controlled substance is administered or dispensed; the name, dosage and strength per dosage unit of each such controlled substance; and the date of such administration or dispensing.

(e)

Notwithstanding subsection (b), a physician, nurse practitioner, nurse anesthetist, psychiatric nurse mental health clinical specialist, physician assistant, pharmacist as limited by subsection (g) of section 7 and section 24B ½ of said chapter 112 or certified nurse midwife, when acting in good faith and providing care under a program funded in whole or in part by 42 U.S.C. section 300, or in a clinic licensed by the department to provide comparable medical services or a registered nurse, registered under section 74 of said chapter 112 and authorized by such physician, nurse practitioner, nurse anesthetist, psychiatric nurse mental health clinical specialist, physician assistant, pharmacist as limited by said subsection (g) of said section 7 and section 24B ½ of said chapter 112, certified nurse midwife may lawfully dispense controlled substances pursuant to schedule VI to recipients of such services in such quantity as needed for treatment and shall be exempt from the requirement that such dispensing be in a single dose or as necessary for immediate and proper treatment under subsection (b). A registered nurse shall dispense under this subsection only as provided in section 17. The department may establish rules and regulations controlling the dispensing of these medications, including, but not limited to, the types and amounts of medications dispensed and appropriate safeguards for dispensing.

(f)

Notwithstanding any other provision of this section, the commissioner shall, upon receipt of the fee as hereinbefore provided, automatically issue to any physician, dentist, podiatrist, nurse practitioner, nurse anesthetist, psychiatric nurse mental health clinical specialist or veterinarian who is duly authorized to practice his profession in the commonwealth a registration to dispense, other than for research pursuant to section eight, unless the registration of such physician, dentist, podiatrist, nurse practitioner, nurse anesthetist, psychiatric nurse mental health clinical specialist or veterinarian has been suspended or revoked pursuant to the provisions of sections thirteen or fourteen or unless said registration is denied for cause by the commissioner pursuant to the provisions of chapter thirty A. Such registration shall continue in full force and effect unless it is suspended or revoked, or unless it is recalled and a new registration issued in accordance with the rules and regulations of the commissioner.

(g)

The commissioner may by regulation authorize the registration for a specific activity or activities requiring registration under this section of such persons as he determines to be qualified for such registration.

The commissioner shall promulgate regulations which provide for the registration of nurse practitioners and for psychiatric nurse mental health clinical specialists, as defined in section eighty B of chapter one hundred and twelve, to issue written prescriptions for patients pursuant to guidelines mutually developed and agreed upon by the nurse and supervising physician under regulations approved by the board of registration in nursing and the board of registration in medicine. Prior to promulgating such regulations, the commissioner shall consult with the board of registration in nursing, the board of registration in medicine and the board of registration in pharmacy with regard to those schedules of controlled substances for which nurse practitioners and psychiatric nurse mental health clinical specialists may be registered.

The commissioner shall promulgate regulations which provide for the registration of physicians assistants to issue written prescriptions for patients pursuant to guidelines mutually developed and agreed upon by the supervising physician and the physician assistant. Prior to promulgating such regulations, the commissioner shall consult with the board of registration of physician assistants, the board of registration in medicine and the board of registration in pharmacy with regard to those schedules of controlled substances for which physician assistants may be registered to issue written prescriptions therefor; provided, however, that a physician assistant who has not successfully passed the national certification examination for physician assistants or who does not meet all of the current requirements for obtaining an initial physician assistant's registration as listed in section nine I of chapter one hundred and twelve may not be authorized to write prescriptions under any circumstances.

The commissioner shall issue regulations authorizing pharmacists, who have been duly registered in accordance with section 24 ½ of chapter 112, to engage in collaborative drug therapy management and to issue written prescriptions in accordance with the provisions of said section 24 ½ of said chapter 112 and guidelines mutually developed and agreed upon by the supervising physician and the pharmacist in a collaborative practice agreement, as defined in section 24 ½ of said chapter 112, established in accordance with regulations of the board of registration in medicine and board of registration in pharmacy. Prior to issuing such regulations, the commissioner shall consult with the board of registration in medicine and the board of registration in pharmacy with regard to the schedules of controlled substances for which a pharmacist may be authorized to prescribe within the scope of his collaborative practice.

The commissioner may gather patient outcome and cost-savings data if available from objective sources and review community retail drug business-based collaborative drug therapy management. If the commissioner finds that sufficient data and funding sources exist to conduct a valid study, he shall conduct a study within 2 years after that finding. The study shall include representatives of the board of registration in medicine and the board of registration in pharmacy. In conducting the study, the commissioner shall hold at least 1 public hearing to receive testimony from the public, including representatives of pharmacy and medicine and other concerned parties.

(h)

The commissioner shall promulgate regulations which provide for the automatic registration of optometrists, upon the receipt of the fee as herein provided, to issue written prescriptions in accordance with the provisions of sections 66, 66B and 66C of chapter 112, unless the registration of such optometrist has been suspended or revoked pursuant to the provisions of section 13 or section 14 or unless such registration is denied for cause by the commissioner pursuant to the provisions of chapter 30A. Prior to promulgating such regulations, the commissioner shall consult with the board of registration in optometry.

(i)

Every person who: (i) is in the business of manufacturing or distributing any controlled substances, and (ii) has a principal place of business located in the commonwealth but at no time takes physical possession of any controlled substances, shall register with the commissioner in accordance with the regulations of the department. The registration shall require the payment of a fee, the amount of which shall be determined annually pursuant to section 3B of chapter 7. The registration shall be effective for 1 year from the date of issuance.

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Last updated: January 1, 2021
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