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
SENATE BILL NO. 1251
102ND GENERAL ASSEMBLY
INTRODUCED BY SENATOR CRAWFORD.
4353S.02I KRISTINA MARTIN, Secretary
AN ACT
To repeal section 338.165, RSMo, and to enact in lieu thereof one new section relating to pharmacy
services in hospitals.
Be it enacted by the General Assembly of the State of Missouri, as follows:
Section A. Section 338.165, RSMo, is repealed and one new 1
section enacted in lieu thereof, to be known as section 338.165, 2
to read as follows:3
338.165. 1. As used in this section, the following 1
terms mean: 2
(1) "Board", the Missouri board of pharmacy; 3
(2) "Hospital", a hospital as defined in section 4
197.020; 5
(3) "Hospital clinic or facility", a clinic or 6
facility under the common control , management, or ownership 7
of the same hospital or hospital system; 8
(4) "Medical staff committee", the committee or other 9
body of a hospital or hospital system responsible for 10
formulating policies regarding pharmacy services and 11
medication management; 12
(5) "Medication order", an order for a legend drug or 13
device that is: 14
(a) Authorized or issued by an authorized prescriber 15
acting within the scope of his or her professional practice 16
or pursuant to a protocol or standing order approved by the 17
medical staff committee; and 18 SB 1251 2
(b) To be distributed or administered to the patient 19
by a health care practitioner or lawfully authorized 20
designee at a hospital or a hospital clinic or facility; 21
(6) "Patient", an individual receiving me dical 22
diagnosis, treatment or care at a hospital or a hospital 23
clinic or facility. 24
2. The department of health and senior services shall 25
have sole authority and responsibility for the inspection 26
and licensure of hospitals as provided by chapter 1 97 27
including, but not limited to all parts, services, 28
functions, support functions and activities which contribute 29
directly or indirectly to patient care of any kind 30
whatsoever. However, the board may inspect a class B 31
pharmacy or any portion thereof that is not under the 32
inspection authority vested in the department of health and 33
senior services by chapter 197 to determine compliance with 34
this chapter or the rules of the board. This section shall 35
not be construed to bar the board from conducting an 36
investigation pursuant to a public or governmental complaint 37
to determine compliance by an individual licensee or 38
registrant of the board with any applicable provisions of 39
this chapter or the rules of the board. 40
3. The department of health an d senior services shall 41
have the sole authority to promulgate rules governing 42
pharmacy services in hospitals, but may promulgate rules in 43
conjunction with the board governing medication distribution 44
and the provision of medication therapy services , as 45
described in section 338.010, by a pharmacist at or within a 46
hospital. [Rules may include, but are not limited to, 47
medication management, preparation, compounding, 48
administration, storage, distribution, packaging and 49
labeling. Until such rules are j ointly promulgated, 50 SB 1251 3
hospitals shall comply with all applicable state law and 51
department of health and senior services rules governing 52
pharmacy services and medication management in hospitals. ] 53
The board shall have the sole authority to promulgate rule s 54
governing inspection and licensure of class B pharmacies. 55
The rulemaking authority granted herein to the department of 56
health and senior services shall not include the dispensing 57
of medication by prescription. 58
4. All pharmacists providing medi cation therapy 59
services shall obtain a certificate of medication 60
therapeutic plan authority as provided by rule of the 61
board. Medication therapy services may be provided by a 62
pharmacist for patients of a hospital pursuant to a 63
protocol with a physic ian as required by section 338.010 or 64
pursuant to a protocol approved by the medical staff 65
committee. However, the medical staff protocol shall 66
include a process whereby an exemption to the protocol for a 67
patient may be granted for clinical efficacy s hould the 68
patient's physician make such request. The medical staff 69
protocol shall also include an appeals process to request a 70
change in a specific protocol based on medical evidence 71
presented by a physician on staff. 72
5. Medication may be dispen sed by a class B hospital 73
pharmacy pursuant to a prescription or a medication order. 74
6. A drug distributor license shall not be required to 75
transfer medication from a class B hospital pharmacy to a 76
hospital clinic or facility for patient care or t reatment. 77
7. Medication dispensed by a class A pharmacy located 78
in a hospital to a hospital patient for use or 79
administration outside of the hospital under a medical staff - 80
approved protocol for medication therapy shall be dispensed 81 SB 1251 4
only by a prescription order for medication therapy from an 82
individual physician for a specific patient. 83
8. Medication dispensed by a hospital to a hospital 84
patient for use or administration outside of the hospital 85
shall be labeled as provided by rules jointly promulgated by 86
the department of health and senior services and the board 87
including medication distributed for administration by or 88
under the supervision of a health care practitioner at a 89
hospital clinic or facility. 90
9. This section shall not be construed to preempt any 91
law or rule governing controlled substances. 92
10. Any rule, as that term is defined in section 93
536.010, that is created under the authority delegated in 94
this section shall only become effective if it complies with 95
and is subject to all of the provisions of chapter 536 and, 96
if applicable, section 536.028. This section and chapter 97
536 are nonseverable and if any of the powers vested with 98
the general assembly under chapter 536 to review, to delay 99
the effective date, or t o disapprove and annul a rule are 100
subsequently held unconstitutional, then the grant of 101
rulemaking authority and any rule proposed or adopted after 102
August 28, 2014, shall be invalid and void. 103
11. The board shall appoint an advisory committee to 104
review and make recommendations to the board on the merit of 105
all rules and regulations to be jointly promulgated by the 106
board and the department of health and senior services 107
pursuant to the joint rulemaking authority granted by this 108
section. The advisory committee shall consist of: 109
(1) Two representatives designated by the Missouri 110
Hospital Association, one of whom shall be a pharmacist; 111
(2) One pharmacist designated by the Missouri Society 112
of Health System Pharmacists; 113 SB 1251 5
(3) One pharmacist designated by the Missouri Pharmacy 114
Association; 115
(4) One pharmacist designated by the department of 116
health and senior services from a hospital with a licensed 117
bed count that does not exceed fifty beds or from a critical 118
access hospital as defined by the department of social 119
services for purposes of MO HealthNet reimbursement; 120
(5) One pharmacist designated by the department of 121
health and senior services from a hospital with a licensed 122
bed count that exceeds two hundred beds; and 123
(6) One pharmacist designated by the board with 124
experience in the provision of hospital pharmacy services. 125
12. Nothing in this section shall be construed to 126
limit the authority of a licensed health care provider to 127
prescribe, administer, or dis pense medications and 128
treatments within the scope of their professional practice. 129