HOUSE BILL NO. 3008 103RD GENERAL ASSEMBLY
INTRODUCED BY REPRESENTATIVE COOK.
5158H.01I JOSEPH ENGLER, Chief Clerk
AN ACT To 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Section A. Sections 338.010 and 338.055, RSMo, are repealed and two new sections 2 enacted in lieu thereof, to be known as sections 338.010 and 338.055, to read as follows: 338.010. 1.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 emergency as described in section 44.100;
EXPLANATION — 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. HB 3008 2
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 effective 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 prescribing of drugs and devices for any of the following conditions: 26 (a) A condition that does not require 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 Improvement 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 professional judgment 32 of the pharmacist; 33 (10) The dispensing of HIV postexposure prophylaxis pursuant to section 338.730; 34 and 35 [(10)] (11) The offering 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) To 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 registrant, the licensee or registrant shall 47 independently determine whether the act is: 48 (a) Expressly prohibited 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 registrant; and HB 3008 3
53 (c) Within the accepted standard of care that would be provided in a similar 54 setting by a reasonable and prudent licensee or registrant 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 191.1146, 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 charge 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 effect, 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 HB 3008 4
90 delegated in this section shall become effective 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 effective 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 11. 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 organization 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. "Veterinarian", "doctor of veterinary medicine", "practitioner of veterinary 110 medicine", "DVM", "VMD", "BVSe", "BVMS", "BSe (Vet 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 Veterinary Graduates (EDFVG) certificate issued by the American Veterinary 114 Medical Association (AVMA). 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 emergency 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. HB 3008 5
126 17. A pharmacist shall inform the patient that the administration of a vaccine will be 127 entered into the ShowMeVax 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 ShowMeVax 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 emergency. 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-charge, manager-in-charge, 4 or any officer, 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 offense reasonably related to the qualifications, functions or duties of 19 any profession licensed or regulated under this chapter, for any offense an essential element HB 3008 6
20 of which is fraud, dishonesty or an act of violence, or for any offense 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, charge, 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) Violation 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 offer 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 (11) 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) Violation 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) Violation 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, HB 3008 7
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 care provided by other qualified licensees or registrants 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