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SECOND REGULAR SESSION
HOUSE BILL NO. 3008
103RD GENERAL ASSEMBL Y
INTRODUCED BY REPRESENT A TIVE COOK.
5158H.01I JOSEPH ENGLER, Chief Clerk
AN ACT
T o repeal sections 338.010 and 338.055, RSMo, and to enact in lieu thereof two new sections
relating to the practice of pharmacy .
Be it enacted by the General Assembly of the state of Missouri, as follows:
Section A. Sections 338.010 and 338.055, RSMo, are repealed and two new sections
2 enacted in lieu thereof, to be known as sections 338.010 and 338.055, to read as follows:
338.010. 1. The "practice of pharmacy" includes:
2 (1) The interpretation, implementation, and evaluation of medical prescription orders,
3 including any legend drugs under 21 U.S.C. Section 353, and the receipt, transmission, or
4 handling of such orders or facilitating the dispensing of such orders;
5 (2) The designing, initiating, implementing, and monitoring of a medication
6 therapeutic plan in accordance with the provisions of this section;
7 (3) The compounding, dispensing, labeling, and administration of drugs and devices
8 pursuant to medical prescription orders;
9 (4) The ordering and administration of vaccines approved or authorized by the U.S.
10 Food and Drug Administration, excluding vaccines for cholera, monkeypox, Japanese
11 encephalitis, typhoid, rabies, yellow fever , tick-borne encephalitis, anthrax, tuberculosis,
12 dengue, Hib, polio, rotavirus, smallpox, and any vaccine approved after January 1, 2023, to
13 persons at least seven years of age or the age recommended by the Centers for Disease
14 Control and Prevention, whichever is older , pursuant to joint promulgation of rules
15 established by the board of pharmacy and the state board of registration for the healing arts
16 unless rules are established under a state of emer gency as described in section 44.100;
EXPLANA TION — Matter enclosed in bold-faced brackets [thus] in the above bill is not enacted and is
intended to be omitted from the law . Matter in bold-face type in the above bill is proposed language.
17 (5) The participation in drug selection according to state law and participation in drug
18 utilization reviews;
19 (6) The proper and safe storage of drugs and devices and the maintenance of proper
20 records thereof;
21 (7) Consultation with patients and other health care practitioners, and veterinarians
22 and their clients about legend drugs, about the safe and ef fective use of drugs and devices;
23 (8) The prescribing and dispensing of any nicotine replacement therapy product under
24 section 338.665;
25 (9) The pr escribing of drugs and devices for any of the following conditions:
26 (a) A condition that does not requ ire a new diagnosis;
27 (b) A condition that is minor and generally self-limiting;
28 (c) A condition for which a test waived under the Clinical Laboratory
29 Impr ovement Amendments of 1988 is used to guide diagnosis or clinical decision-
30 making; or
31 (d) A condition that is an emergency for the patient in the pro fessional judgment
32 of the pharmacist;
33 (10) The dispensing of HIV postexposure prophylaxis pursuant to section 338.730;
34 and
35 [ (10) ] (1 1) The of fering or performing of those acts, services, operations, or
36 transactions necessary in the conduct, operation, management and control of a pharmacy .
37 2. No person shall engage in the practice of pharmacy unless he or she is licensed
38 under the provisions of this chapter .
39 3. (1) This chapter shall not be construed to prohibit the use of auxiliary personnel
40 under the direct supervision of a pharmacist from assisting the pharmacist in any of his or her
41 duties. This assistance in no way is intended to relieve the pharmacist from his or her
42 responsibilities for compliance with this chapter and he or she will be responsible for the
43 actions of the auxiliary personnel acting in his or her assistance.
44 (2) T o determine whether a specific act is within the scope of the practice of
45 pharmacy in or into this state, or whether an act can be delegated to other individuals
46 under the supervision of a licensee or registra nt, the licensee or re gistrant shall
47 independently determine whether the act is:
48 (a) Expressl y pr ohibited by:
49 a. This chapter; or
50 b. Any applicable state or federal laws;
51 (b) Consistent with the education, training, and experience of the licensee or
52 r egistrant; and
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53 (c) W ithin the accepted standard of car e that would be pr ovided in a similar
54 setting by a reas onable and prudent licensee or r egistrant with similar education,
55 training, and experience.
56 4. This chapter shall not be construed to prohibit or interfere with any legally
57 registered practitioner of medicine, dentistry , or podiatry , or veterinary medicine only for use
58 in animals, or the practice of optometry in accordance with and as provided in sections
59 195.070 and 336.220 in the compounding, administering, prescribing, or dispensing of his or
60 her own prescriptions.
61 5. A pharmacist with a certificate of medication therapeutic plan authority may
62 provide medication therapy services pursuant to a written protocol from a physician licensed
63 under chapter 334 to patients who have established a physician-patient relationship, as
64 described in subdivision (1) of subsection 1 of section 191.1 146, with the protocol physician.
65 The written protocol authorized by this section shall come only from the physician and shall
66 not come from a nurse engaged in a collaborative practice arrangement under section
67 334.104, or from a physician assistant engaged in a collaborative practice arrangement under
68 section 334.735.
69 6. Nothing in this section shall be construed as to prevent any person, firm or
70 corporation from owning a pharmacy regulated by sections 338.210 to 338.315, provided that
71 a licensed pharmacist is in char ge of such pharmacy .
72 7. Nothing in this section shall be construed to apply to or interfere with the sale of
73 nonprescription drugs and the ordinary household remedies and such drugs or medicines as
74 are normally sold by those engaged in the sale of general merchandise.
75 8. No health carrier as defined in chapter 376 shall require any physician with which
76 they contract to enter into a written protocol with a pharmacist for medication therapeutic
77 services.
78 9. This section shall not be construed to allow a pharmacist to diagnose or
79 independently prescribe pharmaceuticals or devices for any purpose other than the
80 purposes specifically described in this section .
81 10. The state board of registration for the healing arts, under section 334.125, and the
82 state board of pharmacy , under section 338.140, shall jointly promulgate rules regulating the
83 use of protocols for medication therapy services. Such rules shall require protocols to include
84 provisions allowing for timely communication between the pharmacist and the protocol
85 physician or similar body authorized by this section, and any other patient protection
86 provisions deemed appropriate by both boards. In order to take ef fect, such rules shall be
87 approved by a majority vote of a quorum of each board. Neither board shall separately
88 promulgate rules regulating the use of protocols for medication therapy services. Any rule or
89 portion of a rule, as that term is defined in section 536.010, that is created under the authority
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90 delegated in this section shall become effectiv e only if it complies with and is subject to all of
91 the provisions of chapter 536 and, if applicable, section 536.028. This section and chapter
92 536 are nonseverable and if any of the powers vested with the general assembly pursuant to
93 chapter 536 to review , to delay the ef fective date, or to disapprove and annul a rule are
94 subsequently held unconstitutional, then the grant of rulemaking authority and any rule
95 proposed or adopted after August 28, 2007, shall be invalid and void.
96 1 1. The state board of pharmacy may grant a certificate of medication therapeutic
97 plan authority to a licensed pharmacist who submits proof of successful completion of a
98 board-approved course of academic clinical study beyond a bachelor of science in pharmacy ,
99 including but not limited to clinical assessment skills, from a nationally accredited college or
100 university , or a certification of equivalence issued by a nationally recognized professional
101 or ganization and approved by the board of pharmacy .
102 12. Any pharmacist who has received a certificate of medication therapeutic plan
103 authority may engage in the designing, initiating, implementing, and monitoring of a
104 medication therapeutic plan as defined by a written protocol from a physician that may be
105 specific to each patient for care by a pharmacist.
106 13. Nothing in this section shall be construed to allow a pharmacist to make a
107 therapeutic substitution of a pharmaceutical prescribed by a physician unless authorized by
108 the written protocol or the physician's prescription order .
109 14. "V eterinarian", "doctor of veterinary medicine", "practitioner of veterinary
110 medicine", "DVM", "VMD", "BVSe", "BVMS", "BSe (V et Science)", "VMB", "MRCVS", or
111 an equivalent title means a person who has received a doctor's degree in veterinary medicine
112 from an accredited school of veterinary medicine or holds an Educational Commission for
113 Foreign V eterinary Graduates (EDFVG) certificate issued by the American V eterinary
114 Medical Association (A VMA).
115 15. In addition to other requirements established by the joint promulgation of rules by
116 the board of pharmacy and the state board of registration for the healing arts:
117 (1) A pharmacist shall administer vaccines by protocol in accordance with treatment
118 guidelines established by the Centers for Disease Control and Prevention (CDC);
119 (2) A pharmacist who is administering a vaccine shall request a patient to remain in
120 the pharmacy a safe amount of time after administering the vaccine to observe any adverse
121 reactions. Such pharmacist shall have adopted emer gency treatment protocols.
122 16. In addition to other requirements by the board, a pharmacist shall receive
123 additional training as required by the board and evidenced by receiving a certificate from the
124 board upon completion, and shall display the certification in his or her pharmacy where
125 vaccines are delivered.
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126 17. A pharmacist shall inform the patient that the administration of a vaccine will be
127 entered into the ShowMeV ax system, as administered by the department of health and senior
128 services. The patient shall attest to the inclusion of such information in the system by signing
129 a form provided by the pharmacist. If the patient indicates that he or she does not want such
130 information entered into the ShowMeV ax system, the pharmacist shall provide a written
131 report within fourteen days of administration of a vaccine to the patient's health care provider ,
132 if provided by the patient, containing:
133 (1) The identity of the patient;
134 (2) The identity of the vaccine or vaccines administered;
135 (3) The route of administration;
136 (4) The anatomic site of the administration;
137 (5) The dose administered; and
138 (6) The date of administration.
139 18. A pharmacist licensed under this chapter may order and administer vaccines
140 approved or authorized by the U.S. Food and Drug Administration to address a public health
141 need, as lawfully authorized by the state or federal government, or a department or agency
142 thereof, during a state or federally declared public health emer gency .
338.055. 1. The board may refuse to issue any certificate of registration or authority ,
2 permit or license required pursuant to this chapter for one or any combination of causes stated
3 in subsection 2 of this section or if the designated pharmacist-in-charg e, manager- in-char ge,
4 or any of ficer , owner , manager , or controlling shareholder of the applicant has committed any
5 act or practice in subsection 2 of this section. The board shall notify the applicant in writing
6 of the reasons for the refusal and shall advise the applicant of his or her right to file a
7 complaint with the administrative hearing commission as provided by chapter 621.
8 2. The board may cause a complaint to be filed with the administrative hearing
9 commission as provided by chapter 621 against any holder of any certificate of registration or
10 authority , permit or license required by this chapter or any person who has failed to renew or
11 has surrendered his or her certificate of registration or authority , permit or license for any one
12 or any combination of the following causes:
13 (1) Use of any controlled substance, as defined in chapter 195, or alcoholic beverage
14 to an extent that such use impairs a person's ability to perform the work of any profession
15 licensed or regulated by this chapter;
16 (2) The person has been finally adjudicated and found guilty , or entered a plea of
17 guilty or nolo contendere, in a criminal prosecution under the laws of any state or of the
18 United States, for any of fense reasonably related to the qualifications, functions or duties of
19 any profession licensed or regulated under this chapter , for any of fense an essential element
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20 of which is fraud, dishonesty or an act of violence, or for any of fense involving moral
21 turpitude, whether or not sentence is imposed;
22 (3) Use of fraud, deception, misrepresentation or bribery in securing any certificate of
23 registration or authority , permit or license issued pursuant to this chapter or in obtaining
24 permission to take any examination given or required pursuant to this chapter;
25 (4) Obtaining or attempting to obtain any fee, char ge, tuition or other compensation
26 by fraud, deception or misrepresentation;
27 (5) Incompetence, misconduct, gross negligence, fraud, misrepresentation or
28 dishonesty in the performance of the functions or duties of any profession licensed or
29 regulated by this chapter;
30 (6) V iolation of, or assisting or enabling any person to violate, any provision of this
31 chapter , or of any lawful rule or regulation adopted pursuant to this chapter;
32 (7) Impersonation of any person holding a certificate of registration or authority ,
33 permit or license or allowing any person to use his or her certificate of registration or
34 authority , permit, license, or diploma from any school;
35 (8) Denial of licensure to an applicant or disciplinary action against an applicant or
36 the holder of a license or other right to practice any profession regulated by this chapter
37 granted by another state, territory , federal agency , or country whether or not voluntarily
38 agreed to by the licensee or applicant, including, but not limited to, surrender of the license
39 upon grounds for which denial or discipline is authorized in this state;
40 (9) A person is finally adjudged incapacitated by a court of competent jurisdiction;
41 (10) Assisting or enabling any person to practice or of fer to practice any profession
42 licensed or regulated by this chapter who is not registered and currently eligible to practice
43 under this chapter;
44 (1 1) Issuance of a certificate of registration or authority , permit or license based upon
45 a material mistake of fact;
46 (12) Failure to display a valid certificate or license if so required by this chapter or
47 any rule promulgated hereunder;
48 (13) V iolation of any professional trust or confidence;
49 (14) Use of any advertisement or solicitation which is false, misleading or deceptive
50 to the general public or persons to whom the advertisement or solicitation is primarily
51 directed;
52 (15) V iolation of the drug laws or rules and regulations of this state, any other state or
53 the federal government;
54 (16) The intentional act of substituting or otherwise changing the content, formula or
55 brand of any drug prescribed by written, electronic, or oral prescription without prior written
56 or oral approval from the prescriber for the respective change in each prescription; provided,
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57 however , that nothing contained herein shall prohibit a pharmacist from substituting or
58 changing the brand of any drug as provided under section 338.056, and any such substituting
59 or changing of the brand of any drug as provided for in section 338.056 shall not be deemed
60 unprofessional or dishonorable conduct unless a violation of section 338.056 occurs;
61 (17) Personal use or consumption of any controlled substance unless it is prescribed,
62 dispensed, or administered by a health care provider who is authorized by law to do so ; or
63 (18) Any act or omission within the practice of pharmacy that fails to meet the
64 standard of car e pr ovided by other qualified licensees or r egistrants in the same or
65 similar setting .
66 3. After the filing of such complaint, the proceedings shall be conducted in
67 accordance with the provisions of chapter 621. Upon a finding by the administrative hearing
68 commission that the grounds, provided in subsection 2 of this section, for disciplinary action
69 are met, the board may , singly or in combination, censure or place the person named in the
70 complaint on probation on such terms and conditions as the board deems appropriate for a
71 period not to exceed five years, or may suspend, for a period not to exceed three years, or
72 revoke the license, certificate, or permit. The board may impose additional discipline on a
73 licensee, registrant, or permittee found to have violated any disciplinary terms previously
74 imposed under this section or by agreement. The additional discipline may include, singly or
75 in combination, censure, placing the licensee, registrant, or permittee named in the complaint
76 on additional probation on such terms and conditions as the board deems appropriate, which
77 additional probation shall not exceed five years, or suspension for a period not to exceed three
78 years, or revocation of the license, certificate, or permit.
79 4. If the board concludes that a licensee or registrant has committed an act or is
80 engaging in a course of conduct which would be grounds for disciplinary action which
81 constitutes a clear and present danger to the public health and safety , the board may file a
82 complaint before the administrative hearing commission requesting an expedited hearing and
83 specifying the activities which give rise to the danger and the nature of the proposed
84 restriction or suspension of the licensee's or registrant's license or regi stration . W ithin
85 fifteen days after service of the complaint on the licensee or registrant, the administrative
86 hearing commission shall conduct a preliminary hearing to determine whether the alleged
87 activities of the licensee or registrant appear to constitute a clear and present danger to the
88 public health and safety which justify that the licensee's or registrant's license or registration
89 be immediately restricted or suspended. The burden of proving that the actions of a licensee
90 or registrant constitute a clear and present danger to the public health and safety shall be upon
91 the state board of pharmacy . The administrative hearing commission shall issue its decision
92 immediately after the hearing and shall either grant to the board the authority to suspend or
93 restrict the license or registr ation or dismiss the action.
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94 5. If the administrative hearing commission grants temporary authority to the board to
95 restrict or suspend the licensee's or registrant's license or re gistration , such temporary
96 authority of the board shall become final authority if there is no request by the licensee or
97 registrant for a full hearing within thirty days of the preliminary hearing. The administrative
98 hearing commission shall, if requested by the licensee or registrant named in the complaint,
99 set a date to hold a full hearing under the provisions of chapter 621 regarding the activities
100 alleged in the initial complaint filed by the board.
101 6. If the administrative hearing commission dismisses the action filed by the board
102 pursuant to subsection 4 of this section, such dismissal shall not bar the board from initiating
103 a subsequent action on the same grounds.
104 7. The board shall not deny , revoke, or suspend, or otherwise take any disciplinary
105 action against, a certificate of registration or authority , permit, or license required by this
106 chapter for any person due to the lawful dispensing, distributing, or selling of ivermectin
107 tablets or hydroxychloroquine sulfate tablets for human use in accordance with prescriber
108 directions. A pharmacist shall not contact the prescribing physician or the patient to dispute
109 the ef ficacy of ivermectin tablets or hydroxychloroquine sulfate tablets for human use unless
110 the physician or patient inquires of the pharmacist about the ef ficacy of ivermectin tablets or
111 hydroxychloroquine sulfate tablets.
✔
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