[−] removed[+] addedOfficial text
[−]removed: EXPLANATION-Matter enclosed in bold-faced brackets [thus] in this bill is not enacted
and is intended to be omitted in the law.
SECOND REGULAR SESSION
[PERFECTED]
SENATE SUBSTITUTE FOR
SENATE COMMITTEE SUBSTITUTE FOR
[+]added: 5598S05.06S
1
SENATE [−]removed: BILL [+]added: AMENDMENT NO. [−]removed: 878
103RD GENERAL ASSEMBLY
INTRODUCED BY SENATOR FITZWATER.
5598S.05P KRISTINA MARTIN, Secretary
AN ACT
To repeal sections 338.010 and 338.012, RSMo, and to enact in lieu thereof five new sections
relating to the duties of a pharmacist.
Be it enacted [+]added: ___
Offered by [−]removed: the General Assembly of the State of Missouri, as follows:
Section A. Sections 338.010 and 338.012, RSMo, are repealed and five new sections enacted in lieu thereof, to be known as sections 338.010, 338.012, 338.206, 338.208, and 338.010. 1. The "practice of pharmacy" includes: (1) The interpretation, implementation, and evaluation of medical prescription orders, including any legend drugs under 21 U.S.C. [+]added: Of
Amend SS/SCS/Senate Bill No. 878 , Page 8 , Section [−]removed: 353, and the receipt, transmission, or handling of such orders or facilitating the dispensing of such orders; (2) The designing, initiating, implementing, and monitoring of a medication therapeutic plan in accordance with the provisions of this section; (3) The compounding, dispensing, labeling, and administration of drugs and devices pursuant to medical prescription orders; (4) The ordering and administration of vaccines approved or authorized by the U.S. Food and Drug Administration, as of January 1, 2026, or thereafter, excluding vaccines for cholera, monkeypox, Japanese encephalitis, typhoid, rabies, yellow fever, tick-borne encephalitis, anthrax, tuberculosis, dengue, Hib, polio, rotavirus, smallpox, [and any vaccine approved after January 1, 2023] or any vaccine that is not jointly included by joint rules promulgated by the board of pharmacy and the state board of registration for the healing arts, to persons at least seven years of age or the age recommended by the Centers for Disease Control and Prevention, whichever is older, pursuant to joint promulgation of rules established by the board of pharmacy and the state board of registration for the healing arts unless rules are established under a state of emergency as described in section 44.100; (5) The participation in drug selection according to state law and participation in drug utilization reviews; (6) The proper and safe storage of drugs and devices and the maintenance of proper records thereof; (7) Consultation with patients and other health care practitioners, and veterinarians and their clients about legend drugs, about the safe and effective use of drugs and devices; (8) The prescribing and dispensing of any nicotine replacement therapy product under section 338.665; (9) The dispensing of HIV postexposure prophylaxis pursuant to section 338.730; and (10) The offering or performing of those acts, services, operations, or transactions necessary in the conduct, operation, management and control of a pharmacy. 2. No person shall engage in the practice of pharmacy unless he or she is licensed under the provisions of this chapter. 3. This chapter shall not be construed to prohibit the use of auxiliary personnel under the direct supervision of a pharmacist from assisting the pharmacist in any of his or her duties. This assistance in no way is intended to relieve the pharmacist from his or her responsibilities for compliance with this chapter and he or she will be responsible for the actions of the auxiliary personnel acting in his or her assistance. 4. This chapter shall not be construed to prohibit or interfere with any legally registered practitioner of medicine, dentistry, or podiatry, or veterinary medicine only for use in animals, or the practice of optometry in accordance with and as provided in sections 195.070 and 336.220 in the compounding, administering, prescribing, or dispensing of his or her own prescriptions. 5. A pharmacist with a certificate of medication therapeutic plan authority may provide medication therapy services pursuant to a written protocol from a physician licensed under chapter 334 to patients who have established a physician-patient relationship, as described in subdivision (1) of subsection 1 of section 191.1146, with the protocol physician. The written protocol authorized by this section shall come only from the physician and shall not come from a nurse engaged in a collaborative practice arrangement under section 334.104, or from a physician assistant engaged in a collaborative practice arrangement under section 334.735. 6. Nothing in this section shall be construed as to prevent any person, firm or corporation from owning a pharmacy regulated by sections 338.210 to 338.315, provided that a licensed pharmacist is in charge of such pharmacy. 7. Nothing in this section shall be construed to apply to or interfere with the sale of nonprescription drugs and the ordinary household remedies and such drugs or medicines as are normally sold by those engaged in the sale of general merchandise. 8. No health carrier as defined in chapter 376 shall require any physician with which they contract to enter into a written protocol with a pharmacist for medication therapeutic services. 9. This section shall not be construed to allow a pharmacist to diagnose or independently prescribe pharmaceuticals. 10. The state board of registration for the healing arts, under section 334.125, and the state board of pharmacy, under section 338.140, shall jointly promulgate rules regulating the use of protocols for medication therapy services. Such rules shall require protocols to include provisions allowing for timely communication between the pharmacist and the protocol physician or similar body authorized by this section, and any other patient protection provisions deemed appropriate by both boards. In order to take effect, such rules shall be approved by a majority vote of a quorum of each board. Neither board shall separately promulgate rules regulating the use of protocols for medication therapy services. Any rule or portion of a rule, as that term is defined in section 536.010, that is created under the authority delegated in this section shall become effective only if it complies with and is subject to all of the provisions of chapter 536 and, if applicable, section 536.028. This section and chapter 536 are nonseverable and if any of the powers vested with the general assembly pursuant to chapter 536 to review, to delay the effective date, or to disapprove and annul a rule are subsequently held unconstitutional, then the grant of rulemaking authority and any rule proposed or adopted after August 28, 2007, shall be invalid and void. 11. The state board of pharmacy may grant a certificate of medication therapeutic plan authority to a licensed pharmacist who submits proof of successful completion of a board-approved course of academic clinical study beyond a bachelor of science in pharmacy, including but not limited to clinical assessment skills, from a nationally accredited college or university, or a certification of equivalence issued by a nationally recognized professional organization and approved by the board of pharmacy. 12. Any pharmacist who has received a certificate of medication therapeutic plan authority may engage in the designing, initiating, implementing, and monitoring of a medication therapeutic plan as defined by a written protocol from a physician that may be specific to each patient for care by a pharmacist. 13. Nothing in this section shall be construed to allow a pharmacist to make a therapeutic substitution of a pharmaceutical prescribed by a physician unless authorized by the written protocol or the physician's prescription order. 14. "Veterinarian", "doctor of veterinary medicine", "practitioner of veterinary medicine", "DVM", "VMD", "BVSe", "BVMS", "BSe (Vet Science)", "VMB", "MRCVS", or an equivalent title means a person who has received a doctor's degree in veterinary medicine from an accredited school of veterinary medicine or holds an Educational Commission for Foreign Veterinary Graduates (EDFVG) certificate issued by the American Veterinary Medical Association (AVMA). 15. In addition to other requirements established by the joint promulgation of rules by the board of pharmacy and the state board of registration for the healing arts: (1) A pharmacist shall administer vaccines by protocol in accordance with treatment guidelines established by the Centers for Disease Control and Prevention (CDC); (2) A pharmacist who is administering a vaccine shall request a patient to remain in the pharmacy a safe amount of time after administering the vaccine to observe any adverse reactions. Such pharmacist shall have adopted emergency treatment protocols. 16. In addition to other requirements by the board, a pharmacist shall receive additional training as required by the board and evidenced by receiving a certificate from the board upon completion, and shall display the certification in his or her pharmacy where vaccines are delivered. 17. A pharmacist shall inform the patient that the administration of a vaccine will be entered into the ShowMeVax system, as administered by the department of health and senior services. The patient shall attest to the inclusion of such information in the system by signing a form provided by the pharmacist. If the patient indicates that he or she does not want such information entered into the ShowMeVax system, the pharmacist shall provide a written report within fourteen days of administration of a vaccine to the patient's health care provider, if provided by the patient, containing: (1) The identity of the patient; (2) The identity of the vaccine or vaccines administered; (3) The route of administration; (4) The anatomic site of the administration; (5) The dose administered; and (6) The date of administration. 18. A pharmacist licensed under this chapter may order and administer vaccines approved or authorized by the U.S. Food and Drug Administration to address a public health need, as lawfully authorized by the state or federal government, or a department or agency thereof, during a state or federally declared public health emergency. 338.012. 1. A pharmacist with a certificate of medication therapeutic plan authority may provide influenza, group A streptococcus, and COVID-19 medication therapy services pursuant to [a statewide standing order issued by the director or chief medical officer of the department of health and senior services if that person is a licensed physician, or a licensed physician designated by the department of health and senior services] rules established [+]added: 338.206 , Line 36 ,
by [−]removed: the board of pharmacy and the state board of registration for the healing arts, as described in this section. 2. This section shall not be construed to allow a pharmacist to diagnose or independently prescribe pharmaceuticals. 3. The state board of registration for the healing arts, pursuant to section 334.125, and the state board of pharmacy, pursuant to section 338.140, shall jointly promulgate rules to implement the provisions of this section. Any rule or portion of a rule, as that term is defined in section 536.010, that is created under the authority delegated in this section shall become effective only if it complies with and is subject to all of the provisions of chapter 536 and, if applicable, section 536.028. This section and chapter 536 are nonseverable and if any of the powers vested with the general assembly pursuant to chapter 536 to review, to delay the effective date, or to disapprove and annul a rule are subsequently held unconstitutional, then the grant of rulemaking authority and any rule proposed or adopted [+]added: inserting after [−]removed: August 28, 2023, shall be invalid and void. 338.206. 1. As used in this section, the term "medical device" shall mean equipment that is furnished by a supplier or a home health agency and meets the following conditions: (1) Is a device classified by the United States Food and Drug Administration as a Class I or Class II under 21 U.S.C. Section 360 and its implementing regulations under 21 CFR Parts 860 to 892; (2) Is primarily and customarily used to serve a medical purpose; (3) Generally is not useful to an individual in the absence of an illness or injury; and (4) Is appropriate for use in the home. 2. Notwithstanding any provision of this chapter to the contrary, pharmacists may prescribe any medical devices authorized by rule promulgated jointly by the state board of registration for the healing arts and the board of pharmacy in accordance with subsection 3 of this section. 3. The state board of registration for the healing arts, pursuant to section 334.125, and the board of pharmacy, pursuant to section 338.140, shall jointly promulgate rules to implement the provisions of this section. Such rules shall be written and effective within six months of the effective date of this act. 4. Any rule or portion of a rule, as that term is defined in section 536.010, that is created under the authority delegated in this section shall become effective only if it complies with and is subject to all of [−]removed: the provisions of chapter 536 and, if applicable, section 536.028. This section and chapter 536 are nonseverable and if any of the powers vested with the general assembly pursuant to chapter 536 to review, to delay the effective date, or to disapprove and annul a rule are subsequently held unconstitutional, then the grant of rulemaking authority and any rule proposed or adopted after August 28, 2026, shall be invalid and void. 338.208. Notwithstanding any other provision of law to the contrary, a pharmacist may dispense ivermectin and hydroxychloroquine to a person, without requiring a prescription order from a licensed health care practitioner, upon the approval of a warning label for the use and indication in accordance with any written, standardized procedures or protocols for the pharmacist issued by the board of pharmacy, including, if required, providing the person with instructions on [+]added: said line the [−]removed: proper use of ivermectin and hydroxychloroquine. 338.312. [+]added: following:2
"338.312. 1. As used in this section, unless [−]removed: the [+]added: the3
context requires otherwise, the following terms [−]removed: mean: [+]added: mean:4
(1) "Declared state disaster or emergency", a [−]removed: disaster [+]added: disaster5
or emergency event for which a governor's state of [−]removed: emergency [+]added: emergency6
proclamation has been issued or that the President of [−]removed: the [+]added: the7
United States has declared to be a major disaster [−]removed: or emergency; [+]added: or8
emergency;9
(2) "Disaster period", the period of time that [−]removed: begins [+]added: begins10
ten days before a governor's proclamation of a state [−]removed: of [+]added: of1 emergency or the declaration by the President of the [−]removed: United [+]added: United1 States of a major disaster or emergency, whichever [−]removed: occurs [+]added: occurs1 first, and extending for a period of sixty calendar [−]removed: days [+]added: days1 following the end of the period specified in [−]removed: the [+]added: the1 proclamation or declaration or sixty calendar days from [−]removed: the [+]added: the1 proclamation or declaration if no end is provided. [−]removed: The [+]added: The1 governor may extend the disaster period as [−]removed: warranted; [+]added: warranted;1 (3) "Nonprofit pharmacy", any pharmacy licensed [−]removed: in this state that operates as a charitable organization under [+]added: in1 Section 501(c)(3) of the Internal Revenue Code of 1986, [−]removed: as amended. [+]added: as2 amended.2 2. Notwithstanding any provision of law to [−]removed: the [+]added: the2 contrary, the board of pharmacy shall have the authority [−]removed: to [+]added: to2 waive compliance with any Missouri rules and regulations [−]removed: for [+]added: for2 pharmacies licensed in this state when such [−]removed: nonprofit [+]added: nonprofit2 pharmacy is dispensing, shipping, or delivering [−]removed: prescription [+]added: prescription2 drugs into another state or United States territory that [−]removed: is [+]added: is2 experiencing a declared state disaster or [−]removed: emergency, provided that: [+]added: emergency,2 (1) The nonprofit pharmacy is a licensed pharmacy [−]removed: in [+]added: in3 good standing under this chapter and is authorized to [−]removed: ship [+]added: ship3 prescription drugs into the state or territory in [−]removed: question; [+]added: question;3 (2) The nonprofit pharmacy is responding to an [−]removed: active [+]added: active3 declared state disaster or [−]removed: emergency; [+]added: emergency;3 (3) The nonprofit pharmacy complies with all [−]removed: emergency [+]added: emergency3 rules and regulations for pharmacies and [−]removed: nonprofit [+]added: nonprofit3 pharmacies established by the state or territory for [−]removed: the [+]added: the3 duration of the disaster [−]removed: period; (4) The nonprofit pharmacy complies with all [+]added: period;3 applicable federal laws and regulations; [−]removed: and [+]added: and4 (5) The waiver applies only to prescription [−]removed: drugs [+]added: drugs4 dispensed, shipped, or delivered to residents or health [−]removed: care [+]added: care4 facilities located within the geographic area specified [−]removed: in [+]added: in4 the declared state disaster or [−]removed: emergency. [+]added: emergency.4 3. The board of pharmacy may promulgate rules [−]removed: to [+]added: to4 implement the provisions of this section. Any rule [−]removed: or [+]added: or4 portion of a rule, as that term is defined in [−]removed: section [+]added: section4 536.010, that is created under the authority delegated [−]removed: in this section shall become effective only if it complies with [+]added: in4 and is subject to all of the provisions of chapter 536 [−]removed: and, [+]added: and,5 if applicable, section 536.028. This section and [−]removed: chapter [+]added: chapter5 536 are nonseverable and if any of the powers vested [−]removed: with [+]added: with5 the general assembly pursuant to chapter 536 to review, [−]removed: to [+]added: to5 delay the effective date, or to disapprove and annul a [−]removed: rule [+]added: rule5 are subsequently held unconstitutional, then the grant [−]removed: of [+]added: of5 rulemaking authority and any rule proposed or adopted [−]removed: after [+]added: after5 August 28, 2026, shall be invalid and [−]removed: void.[+]added: void."; and5 Further amend the title and enacting clause accordingly.5