68th Legislature SB 112.1
1 SENATE BILL NO. 112
2 INTRODUCED BY T. MCGILLVRAY
3
4 A BILL FOR AN ACT ENTITLED: “AN ACT REVISING PHARMACIST PRESCRIBING AUTHORITY TO
5 ALLOW THE PRESCRIBING OF CERTAIN DRUGS OR DEVICES UNDER LIMITED CIRCUMSTANCES;
6 PROVIDING DEFINITIONS; AMENDING SECTIONS 37-2-101, 37-2-102, 37-2-103, 37-2-104, 37-2-108, 37-7-
7 101, AND 37-7-103, MCA.”
8
9 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MONTANA:
10
11 NEW SECTION. Section 1. Pharmacist prescribing authority -- exception. (1) A pharmacist may
12 prescribe a drug or device for a legitimate medical purpose as allowed under this section for a person with
13 whom the pharmacist has a patient-prescriber relationship.
14 (2) A pharmacist shall establish the patient-prescriber relationship through a documented patient
15 evaluation that is adequate to:
16 (a) establish diagnoses, if the drug or device is being prescribed pursuant to subsection (3)(b); and
17 (b) identify underlying conditions and contraindications to the treatment.
18 (3) A pharmacist's prescribing authority is limited to drugs and devices that are prescribed for
19 conditions that:
20 (a) do not require a new diagnosis; or
21 (b) (i) are minor and generally self-limiting;
22 (ii) are diagnosed by or for which clinical decisions are made using a test that is waived under the
23 federal clinical laboratory improvement amendments of 1988; or
24 (iii) are patient emergencies.
25 (4) A pharmacist may prescribe only the drugs or devices for which the pharmacist is educationally
26 prepared and for which competency has been achieved and maintained.
27 (5) A pharmacist may not prescribe a controlled substance.
28 (6) A pharmacist prescribing a drug or device pursuant to this section shall:
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1 (a) recognize the limits of the pharmacist's knowledge and experience and consult with and refer
2 to other health care providers as appropriate; and
3 (b) maintain documentation sufficient to justify the care provided, including but not limited to the:
4 (i) information collected as part of the patient record;
5 (ii) prescription record;
6 (iii) provider notification; and
7 (iv) follow-up care plan.
8 (7) This section does not apply to a pharmacist who is operating within a collaborative pharmacy
9 practice agreement.
10
11 Section 2. Section 37-2-101, MCA, is amended to read:
12 "37-2-101. Definitions. As used in this part, the following definitions apply:
13 (1) "Collaborative pharmacy practice agreement" has the meaning provided in 37-7-101.
14 (1)(2) "Community pharmacy", when used in relation to a medical practitioner, means a pharmacy
15 situated within 10 miles of any place at which the medical practitioner maintains an office for professional
16 practice.
17 (2)(3) "Controlled substance" has the meaning provided in 37-7-101.
18 (3)(4) "Device" means any instrument, apparatus, or contrivance intended:
19 (a) for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans;
20 (b) to affect the structure or any function of the body of humans.
21 (4)(5) "Dispense" has the meaning provided in 37-7-101.
22 (5)(6) "Drug" has the meaning provided in 37-7-101.
23 (6)(7) "Drug company" means any person engaged in the manufacturing, processing, packaging, or
24 distribution of drugs. The term does not include a pharmacy.
25 (7)(8) "Medical practitioner" means any person licensed by the state of Montana to engage in:
26 (a) the practice of medicine, dentistry, osteopathy, podiatry, or optometry;
27 (b) the practice of pharmacy and authorized to:
28 (i) prescribe immunizations pursuant to 37-7-105; or
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1 (ii) prescribe drugs pursuant to [section 1] or in accordance with a collaborative pharmacy practice
2 agreement;, or
3 (c) a nursing specialty as described in 37-8-202 and in the licensed practice to administer or
4 prescribe drugs.
5 (8)(9) "Naturopathic physician" means a person licensed under Title 37, chapter 26, to practice
6 naturopathic health care.
7 (9)(10) "Opioid" has the meaning of "opiate" provided in 50-32-101.
8 (10)(11) "Opioid-naive patient" means a patient who has not been prescribed a drug containing
9 an opioid in the 90 days prior to the acute event or surgery for which an opioid is prescribed.
10 (11)(12) "Person" means any individual and any partnership, firm, corporation, association, or
11 other business entity.
12 (12)(13) "Pharmacy" has the meaning provided in 37-7-101.
13 (13)(14) "State" means the state of Montana or any political subdivision of the state."
14
15 Section 3. Section 37-2-102, MCA, is amended to read:
16 "37-2-102. Practices declared unlawful between drug companies and medical practitioners --
17 exception. (1) It Except as provided in subsection (2), it is unlawful:
18 (1)(a) for a drug company to give or sell to a medical practitioner any legal or beneficial interest in the
19 company or in the income of the company with the intent or for the purpose of inducing the medical practitioner
20 to prescribe to patients the drugs of the company. The giving or selling of an interest by the company to a
21 medical practitioner without the interest first having been publicly offered to the general public is prima facie
22 evidence of the intent or purpose.
23 (2)(b) for a medical practitioner to acquire or own a legal or beneficial interest in any drug company,
24 provided it is not unlawful for a medical practitioner to acquire or own an interest solely for investment, and the
25 acquisition of an interest that is publicly offered to the general public is prima facie evidence of its acquisition
26 solely for investment; or
27 (3)(c) for a medical practitioner to solicit or to knowingly receive from a drug company or for a drug
28 company to pay or to promise to pay to a medical practitioner any rebate, refund, discount, commission, or
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1 other valuable consideration for, on account of, or based upon the volume of wholesale or retail sales, at any
2 place, of drugs manufactured, processed, packaged, or distributed by the company.
3 (2) Subsection (1)(c) does not prohibit a pharmacy licensed under Title 37, chapter 7, from
4 undertaking activities allowed under Title 37, chapter 7."
5
6 Section 4. Section 37-2-103, MCA, is amended to read:
7 "37-2-103. Practices declared unlawful between medical practitioners and pharmacies --
8 exceptions. (1) It is unlawful for a medical practitioner other than a pharmacist to own, directly or indirectly, a
9 community pharmacy. This subsection does not prohibit a medical practitioner from dispensing a drug that the
10 medical practitioner is permitted to dispense under 37-2-104.
11 (2) It is unlawful for a medical practitioner, directly or indirectly, to solicit or to knowingly receive
12 from a community pharmacy or for a community pharmacy knowingly to pay or promise to pay to a medical
13 practitioner any rebate, refund, discount, commission, or other valuable consideration for, on account of, or
14 based upon income received or resulting from the sale or furnishing by the community pharmacy of drugs to
15 patients of a medical practitioner.
16 (3) Subsection (2) does not prohibit a pharmacy licensed under Title 37, chapter 7, from
17 undertaking activities allowed under Title 37, chapter 7."
18
19 Section 5. Section 37-2-104, MCA, is amended to read:
20 "37-2-104. Dispensing of drugs by medical practitioners -- registration -- exceptions. (1) Subject
21 to subsection (7), a medical practitioner may dispense drugs if the practitioner:
22 (a) registers with the board of pharmacy provided for in 2-15-1733; and
23 (b) complies with the requirements of this section.
24 (2) Drugs dispensed by a medical practitioner must be:
25 (a) dispensed directly by the practitioner at the practitioner's office or place of practice;
26 (b) dispensed only to the practitioner's own patients; and
27 (c) necessary in the treatment of the condition for which the practitioner is attending the patient.
28 (3) Before dispensing a drug, a medical practitioner shall offer to give a patient the prescription in a
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1 written, electronic, or facsimile form that the patient may choose to have filled by the practitioner or any
2 pharmacy.
3 (4) Except as otherwise provided in this section, a medical practitioner:
4 (a) may dispense only those drugs that the practitioner is allowed to prescribe under the
5 practitioner's scope of practice unless the practitioner is engaged in the practice of pharmacy and dispensing a
6 drug pursuant to Title 37, chapter 7; and
7 (b) may not dispense a controlled substance unless the practitioner is engaged in the practice of
8 pharmacy and is dispensing a controlled substance pursuant to Title 37, chapter 7.
9 (5) A medical practitioner dispensing drugs shall comply with and is subject to the provisions of this
10 part and the provisions of:
11 (a) Title 37, chapter 7, parts 4, 5, and 15;
12 (b) Title 50, chapter 31, parts 3 and 5;
13 (c) the labeling, storage, inspection, and recordkeeping requirements established by the board of
14 pharmacy; and
15 (d) all applicable federal laws and regulations.
16 (6) A medical practitioner registering with the board of pharmacy shall pay a fee established by the
17 board by rule. The fee must be paid at the time of registration and on each renewal of the practitioner's license.
18 (7) Except as provided in subsection (8), a medical practitioner registered with the board of
19 pharmacy may not dispense drugs to an injured worker being treated pursuant to Title 39, chapter 71.
20 (8) This section does not prohibit any of the following when a medical practitioner has not
21 registered to dispense drugs or when a practitioner registered to dispense drugs is treating an injured worker
22 pursuant to Title 39, chapter 71:
23 (a) a medical practitioner from furnishing a patient any drug in an emergency;
24 (b) the administration of a unit dose of a drug to a patient by or under the supervision of a medical
25 practitioner;
26 (c) dispensing a drug to a patient by a medical practitioner whenever there is no community
27 pharmacy available to the patient;
28 (d) the dispensing of drugs occasionally, but not as a usual course of doing business, by a medical
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1 practitioner;
2 (e) a medical practitioner from dispensing drug samples;
3 (f) the dispensing of factory prepackaged contraceptives, other than mifepristone, by a registered
4 nurse employed by a family planning clinic under contract with the department of public health and human
5 services if the dispensing is in accordance with:
6 (i) a physician's written protocol specifying the circumstances under which dispensing is
7 appropriate; and
8 (ii) the drug labeling, storage, and recordkeeping requirements of the board of pharmacy;
9 (g) a contract physician at an urban Indian clinic from dispensing drugs to qualified patients of the
10 clinic. The clinic may not stock or dispense any dangerous drug, as defined in 50-32-101, or any controlled
11 substance. The contract physician may not delegate the authority to dispense any drug for which a prescription
12 is required under 21 U.S.C. 353(b).
13 (h) a medical practitioner from dispensing a drug if the medical practitioner has prescribed the drug
14 and verified that the drug is not otherwise available from a community pharmacy. A drug dispensed pursuant to
15 this subsection (8)(h) must meet the labeling, storage, and recordkeeping requirements of the board of
16 pharmacy.
17 (i) a medical practitioner from dispensing an opioid antagonist as provided in 50-32-605."
18
19 Section 6. Section 37-2-108, MCA, is amended to read:
20 "37-2-108. (Temporary) Restriction on prescriptions for opioid-naive patients -- exceptions. (1)
21 Except as provided in subsection (2), when a medical practitioner or a naturopathic physician authorized to
22 prescribe an opioid prescribes an opioid to an opioid-naive patient on an outpatient basis, the prescription may
23 not be for more than a 7-day supply.
24 (2) The restriction imposed under subsection (1) does not apply if:
25 (a) in the professional medical judgment of the medical practitioner or naturopathic physician, a
26 prescription for more than a 7-day supply is necessary to treat chronic pain, pain associated with cancer, or
27 pain experienced while the patient is in palliative care; or
28 (b) the opioid being prescribed is designed for the treatment of opioid abuse or dependence,
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1 including but not limited to opioid agonists and opioid antagonists. (Terminates June 30, 2025--sec. 8, Ch. 89,
2 L. 2019.)"
3
4 Section 7. Section 37-7-101, MCA, is amended to read:
5 "37-7-101. Definitions. As used in this chapter, the following definitions apply:
6 (1) (a) "Administer" means the direct application of a drug to the body of a patient by injection,
7 inhalation, ingestion, or any other means.
8 (b) Except as provided in 37-7-105, the term does not include immunization by injection for
9 children under 18 years of age.
10 (2) "Board" means the board of pharmacy provided for in 2-15-1733.
11 (3) "Cancer drug" means a prescription drug used to treat:
12 (a) cancer or its side effects; or
13 (b) the side effects of a prescription drug used to treat cancer or its side effects.
14 (4) "Chemical" means medicinal or industrial substances, whether simple, compound, or obtained
15 through the process of the science and art of chemistry, whether of organic or inorganic origin.
16 (5) "Clinical pharmacist practitioner" means a licensed pharmacist in good standing who meets the
17 requirements specified in 37-7-306.
18 (6) "Collaborative pharmacy practice" means the practice of pharmacy by a pharmacist who has
19 agreed to work in conjunction with one or more prescribers, on a voluntary basis and under protocol, and who
20 may perform certain patient care functions under certain specified conditions or limitations authorized by the
21 prescriber.
22 (7) "Collaborative pharmacy practice agreement" means a written and signed agreement between
23 one or more pharmacists and one or more prescribers that provides for collaborative pharmacy practice for the
24 purpose of drug therapy management of patients.
25 (8) "Commercial purposes" means the ordinary purposes of trade, agriculture, industry, and
26 commerce, exclusive of the practices of medicine and pharmacy.
27 (9) "Compounding" means the preparation, mixing, assembling, packaging, or labeling of a drug or
28 device based on:
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