7 | | - | ONCERNING CRITERIA RELATING TO THE OPERATION OF TELEPHARMACY |
---|
8 | | - | OUTLETS |
---|
9 | | - | . |
---|
10 | | - | |
---|
11 | | - | Be it enacted by the General Assembly of the State of Colorado: |
---|
12 | | - | SECTION 1. In Colorado Revised Statutes, 12-280-103, amend |
---|
13 | | - | (32)(a)(II), (32)(b)(II), (36), (43), and (50); and repeal (32)(c) as follows: |
---|
14 | | - | 12-280-103. Definitions - rules. As used in this article 280, unless |
---|
15 | | - | the context otherwise requires or the term is otherwise defined in another |
---|
16 | | - | part of this article 280: |
---|
17 | | - | (32) "Other outlet" means: |
---|
18 | | - | (a) A hospital that does not operate a registered pharmacy, a rural |
---|
19 | | - | health clinic, a federally qualified health center, as defined in the federal |
---|
20 | | - | "Social Security Act", 42 U.S.C. sec. 1395x (aa)(4), a family planning |
---|
21 | | - | NOTE: This bill has been prepared for the signatures of the appropriate legislative |
---|
22 | | - | officers and the Governor. To determine whether the Governor has signed the bill |
---|
23 | | - | or taken other action on it, please consult the legislative status sheet, the legislative |
---|
24 | | - | history, or the Session Laws. |
---|
25 | | - | ________ |
---|
26 | | - | Capital letters or bold & italic numbers indicate new material added to existing law; dashes |
---|
27 | | - | through words or numbers indicate deletions from existing law and such material is not part of |
---|
28 | | - | the act. clinic, an acute treatment unit licensed by the department of public health |
---|
29 | | - | and environment, a school, a jail, a county or district public health agency, |
---|
30 | | - | a community health clinic, a community mental health clinic, a behavioral |
---|
31 | | - | health entity, an approved treatment facility, a university, or a college that: |
---|
32 | | - | (II) Engages in the compounding, dispensing, and delivery of drugs |
---|
33 | | - | or devices; |
---|
34 | | - | OR |
---|
35 | | - | (b) An ambulatory surgical center, a hospice, or a convalescent |
---|
36 | | - | center, each of which is licensed pursuant to part 1 of article 3 of title 25, |
---|
37 | | - | or a medical clinic operated by a hospital, each of which: |
---|
38 | | - | (II) Engages in the compounding, dispensing, and delivery of drugs |
---|
39 | | - | or devices for administration to patients while being treated in the facility. |
---|
40 | | - | or |
---|
41 | | - | (c) A telepharmacy outlet. |
---|
42 | | - | (36) "Pharmacist manager" means an individual, licensed in this |
---|
43 | | - | state as a pharmacist, who has direct control of the pharmaceutical affairs |
---|
44 | | - | of a prescription drug outlet and who, |
---|
45 | | - | EXCEPT AS PROVIDED IN SECTION |
---|
46 | | - | 12-280-118 (1)(a), is not the manager of any other prescription drug outlet. |
---|
47 | | - | (43) "Prescription drug outlet" or "pharmacy" means any pharmacy |
---|
48 | | - | outlet registered pursuant to this article 280 where prescriptions are |
---|
49 | | - | compounded and dispensed. "Prescription drug outlet" includes, without |
---|
50 | | - | limitation, a specialized prescription drug outlet registered pursuant to |
---|
51 | | - | section 12-280-119 (11) |
---|
52 | | - | AND A TELEPHARMACY OUTLET . |
---|
53 | | - | (50) (a) "Telepharmacy outlet" means a remote pharmacy site that: |
---|
54 | | - | (I) Is registered as an other |
---|
55 | | - | A PRESCRIPTION DRUG outlet OR |
---|
56 | | - | PHARMACY |
---|
57 | | - | under this article 280; |
---|
58 | | - | (II) At the time of registration, is located more than twenty milesfrom the nearest prescription drug outlet and from any other telepharmacy |
---|
59 | | - | outlet registered under this article 280 IN AN AREA OF NEED; |
---|
60 | | - | (III) Is connected via computer link, video link, and audio link, or |
---|
61 | | - | via other functionally equivalent telecommunication equipment, with a |
---|
62 | | - | PAGE 2-SENATE BILL 22-173 central pharmacy LOCATED IN THIS STATE that is registered under this article |
---|
63 | | - | 280; and |
---|
| 15 | + | ONCERNING CRITERIA RELATI NG TO THE OPERATION OF101 |
---|
| 16 | + | TELEPHARMACY OUTLETS .102 |
---|
| 17 | + | Bill Summary |
---|
| 18 | + | (Note: This summary applies to this bill as introduced and does |
---|
| 19 | + | not reflect any amendments that may be subsequently adopted. If this bill |
---|
| 20 | + | passes third reading in the house of introduction, a bill summary that |
---|
| 21 | + | applies to the reengrossed version of this bill will be available at |
---|
| 22 | + | http://leg.colorado.gov |
---|
| 23 | + | .) |
---|
| 24 | + | Currently, a "telepharmacy outlet" must be located more than 20 |
---|
| 25 | + | miles from the nearest prescription drug outlet or other telepharmacy |
---|
| 26 | + | outlet. The bill removes this geographic restriction on the operation of |
---|
| 27 | + | telepharmacy outlets. |
---|
| 28 | + | The bill authorizes the state board of pharmacy (board) to adopt |
---|
| 29 | + | limited rules concerning telepharmacy outlets. |
---|
| 30 | + | HOUSE |
---|
| 31 | + | Amended 2nd Reading |
---|
| 32 | + | May 10, 2022 |
---|
| 33 | + | SENATE |
---|
| 34 | + | 3rd Reading Unamended |
---|
| 35 | + | April 27, 2022 |
---|
| 36 | + | SENATE |
---|
| 37 | + | Amended 2nd Reading |
---|
| 38 | + | April 26, 2022 |
---|
| 39 | + | SENATE SPONSORSHIP |
---|
| 40 | + | Rodriguez and Smallwood, Buckner, Coram, Ginal, Gonzales, Pettersen, Priola, Rankin, |
---|
| 41 | + | Simpson, Winter, Woodward |
---|
| 42 | + | HOUSE SPONSORSHIP |
---|
| 43 | + | Bird and McKean, |
---|
| 44 | + | Shading denotes HOUSE amendment. Double underlining denotes SENATE amendment. |
---|
| 45 | + | Capital letters or bold & italic numbers indicate new material to be added to existing statute. |
---|
| 46 | + | Dashes through the words indicate deletions from existing statute. Be it enacted by the General Assembly of the State of Colorado:1 |
---|
| 47 | + | SECTION 1. In Colorado Revised Statutes, 12-280-103, amend2 |
---|
| 48 | + | (32)(a)(II), (32)(b)(II), (36), (43), and (50); and repeal (32)(c) as follows:3 |
---|
| 49 | + | 12-280-103. Definitions - rules. As used in this article 280, unless4 |
---|
| 50 | + | the context otherwise requires or the term is otherwise defined in another5 |
---|
| 51 | + | part of this article 280:6 |
---|
| 52 | + | (32) "Other outlet" means:7 |
---|
| 53 | + | (a) A hospital that does not operate a registered pharmacy, a rural8 |
---|
| 54 | + | health clinic, a federally qualified health center, as defined in the federal9 |
---|
| 55 | + | "Social Security Act", 42 U.S.C. sec. 1395x (aa)(4), a family planning10 |
---|
| 56 | + | clinic, an acute treatment unit licensed by the department of public health11 |
---|
| 57 | + | and environment, a school, a jail, a county or district public health12 |
---|
| 58 | + | agency, a community health clinic, a community mental health clinic, a13 |
---|
| 59 | + | behavioral health entity, an approved treatment facility, a university, or14 |
---|
| 60 | + | a college that:15 |
---|
| 61 | + | (II) Engages in the compounding, dispensing, and delivery of16 |
---|
| 62 | + | drugs or devices; OR17 |
---|
| 63 | + | (b) An ambulatory surgical center, a hospice, or a convalescent18 |
---|
| 64 | + | center, each of which is licensed pursuant to part 1 of article 3 of title 25,19 |
---|
| 65 | + | or a medical clinic operated by a hospital, each of which:20 |
---|
| 66 | + | (II) Engages in the compounding, dispensing, and delivery of21 |
---|
| 67 | + | drugs or devices for administration to patients while being treated in the22 |
---|
| 68 | + | facility. or23 |
---|
| 69 | + | (c) A telepharmacy outlet.24 |
---|
| 70 | + | (36) "Pharmacist manager" means an individual, licensed in this25 |
---|
| 71 | + | state as a pharmacist, who has direct control of the pharmaceutical affairs26 |
---|
| 72 | + | 173-2- of a prescription drug outlet and who, EXCEPT AS PROVIDED IN SECTION1 |
---|
| 73 | + | 12-280-118 (1)(a), is not the manager of any other prescription drug2 |
---|
| 74 | + | outlet.3 |
---|
| 75 | + | (43) "Prescription drug outlet" or "pharmacy" means any4 |
---|
| 76 | + | pharmacy outlet registered pursuant to this article 280 where prescriptions5 |
---|
| 77 | + | are compounded and dispensed. "Prescription drug outlet" includes,6 |
---|
| 78 | + | without limitation, a specialized prescription drug outlet registered7 |
---|
| 79 | + | pursuant to section 12-280-119 (11) AND A TELEPHARMACY OUTLET .8 |
---|
| 80 | + | (50) (a) "Telepharmacy outlet" means a remote pharmacy site that:9 |
---|
| 81 | + | (I) Is registered as an other A PRESCRIPTION DRUG outlet OR10 |
---|
| 82 | + | PHARMACY under this article 280;11 |
---|
| 83 | + | (II) At the time of registration, is located more than twenty miles12 |
---|
| 84 | + | from the nearest prescription drug outlet and from any other telepharmacy13 |
---|
| 85 | + | outlet registered under this article 280 IN AN AREA OF NEED;14 |
---|
| 86 | + | (III) Is connected via computer link, video link, and audio link, or15 |
---|
| 87 | + | via other functionally equivalent telecommunication equipment, with a16 |
---|
| 88 | + | central pharmacy |
---|
| 89 | + | LOCATED IN THIS STATE that is registered under this17 |
---|
| 90 | + | article 280; and18 |
---|
66 | | - | IN THIS |
---|
67 | | - | STATE |
---|
68 | | - | , performs the tasks described in subsection (38.5)(a) of this section. |
---|
69 | | - | (b) The board may adopt rules as necessary to specify additional |
---|
70 | | - | criteria for a telepharmacy outlet that the board deems necessary. |
---|
71 | | - | (c) AS USED IN THIS SUBSECTION (50): |
---|
72 | | - | (I) "A |
---|
73 | | - | REA OF NEED" MEANS: |
---|
74 | | - | (A) A |
---|
75 | | - | NY HEALTH FACILITY LICENSED OR CERTIFIED BY THE |
---|
76 | | - | DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENT PURSUANT TO SECTION |
---|
77 | | - | 25-1.5-103 (1); OR |
---|
78 | | - | (B) ANY AREA WHERE A DEMONSTRATION OF NEED IS APPROVED BY |
---|
79 | | - | THE BOARD |
---|
80 | | - | . |
---|
81 | | - | (II) "C |
---|
82 | | - | ENTRAL PHARMACY " MEANS A REGISTERED PHARMACY |
---|
83 | | - | OUTLET RESPONSIBLE FOR OVERSEEING THE OPERATION OF A |
---|
84 | | - | TELEPHARMACY OUTLET |
---|
85 | | - | . |
---|
86 | | - | SECTION 2. In Colorado Revised Statutes, 12-280-107, add (3) as |
---|
87 | | - | follows: |
---|
88 | | - | 12-280-107. Rules. (3) T |
---|
89 | | - | HE BOARD MAY ADOPT RULES TO SPECIFY |
---|
90 | | - | ADDITIONAL CRITERIA NECESSARY TO FACILITATE THE OPERATION OF |
---|
91 | | - | TELEPHARMACY OUTLETS |
---|
92 | | - | . THE BOARD'S ADDITIONAL RULES FOR A |
---|
93 | | - | TELEPHARMACY OUTLET ARE LIMITED TO RULES CONCERNING THE |
---|
94 | | - | FOLLOWING |
---|
95 | | - | : |
---|
96 | | - | (a) A |
---|
97 | | - | PPLICATION REQUIREMENTS; |
---|
98 | | - | (b) S |
---|
99 | | - | TRUCTURAL AND EQUIPMENT REQUIREMENTS ; |
---|
100 | | - | (c) S |
---|
101 | | - | TAFFING AND TRAINING REQUIREMENTS ; |
---|
102 | | - | PAGE 3-SENATE BILL 22-173 (d) PHARMACIST MANAGER VISITATION REQUIREMENTS ; |
---|
103 | | - | (e) I |
---|
104 | | - | NVENTORY RECORD-KEEPING AND STORAGE REQUIREMENTS ; |
---|
105 | | - | (f) E |
---|
106 | | - | STABLISHING POLICIES AND PROCEDURES RELATING TO |
---|
107 | | - | TELEPHARMACY OPERATIONS |
---|
108 | | - | ; AND |
---|
109 | | - | (g) THE NUMBER OF TELEPHARMACY OUTLETS THAT MAY BE |
---|
110 | | - | OPERATED BY A CENTRAL PHARMACY |
---|
111 | | - | . |
---|
112 | | - | SECTION 3. In Colorado Revised Statutes, 12-280-118, amend |
---|
113 | | - | (1)(a) and add (3)(c) as follows: |
---|
114 | | - | 12-280-118. Prescription drug outlet under charge of pharmacist |
---|
115 | | - | - rules. (1) (a) A prescription drug outlet must be under the direct charge |
---|
116 | | - | of a pharmacist manager. A proprietor who is not a pharmacist shall comply |
---|
117 | | - | with this requirement and shall provide a manager who is a pharmacist. |
---|
118 | | - | N |
---|
119 | | - | OTHING IN THIS ARTICLE 280 OR RULES IMPLEMENTING THIS ARTICLE 280 |
---|
120 | | - | SHALL PROHIBIT THE PHARMACIST MANAGER OF A CENTRAL PHARMACY |
---|
121 | | - | FROM SIMULTANEOUSLY SERVING AS THE PHARMACIST MANAGER OF A |
---|
122 | | - | TELEPHARMACY OUTLET |
---|
123 | | - | . |
---|
124 | | - | (3) (c) A |
---|
125 | | - | TELEPHARMACY OUTLET IS REQUIRED TO HAVE A |
---|
126 | | - | PHARMACIST MANAGER |
---|
127 | | - | . A TELEPHARMACY OUTLET IS CONSIDERED TO BE |
---|
128 | | - | UNDER THE DIRECT CHARGE OR CONTROL OF THE PHARMACIST MANAGER |
---|
129 | | - | , OR |
---|
130 | | - | THE LICENSED PHARMACIST DELEGATE |
---|
131 | | - | , WHO PROVIDES REMOTE SUPERVISION |
---|
132 | | - | TO THE TELEPHARMACY OUTLET |
---|
133 | | - | . |
---|
134 | | - | SECTION 4. In Colorado Revised Statutes, 12-280-402, amend (3) |
---|
135 | | - | as follows: |
---|
136 | | - | 12-280-402. Definitions. As used in this part 4, unless the context |
---|
137 | | - | otherwise requires: |
---|
138 | | - | (3) "Prescription drug outlet" or "pharmacy" means: |
---|
139 | | - | (a) Any resident or nonresident pharmacy outlet registered or |
---|
140 | | - | licensed pursuant to this article 280 where prescriptions are compounded |
---|
141 | | - | and dispensed; and |
---|
142 | | - | PAGE 4-SENATE BILL 22-173 (b) Any federally owned and operated pharmacy registered with the |
---|
143 | | - | federal drug enforcement administration; |
---|
144 | | - | AND |
---|
145 | | - | (c) A TELEPHARMACY OUTLET. |
---|
146 | | - | SECTION 5. Act subject to petition - effective date. This act |
---|
147 | | - | takes effect at 12:01 a.m. on the day following the expiration of the |
---|
148 | | - | ninety-day period after final adjournment of the general assembly; except |
---|
149 | | - | that, if a referendum petition is filed pursuant to section 1 (3) of article V |
---|
150 | | - | of the state constitution against this act or an item, section, or part of this act |
---|
151 | | - | within such period, then the act, item, section, or part will not take effect |
---|
152 | | - | unless approved by the people at the general election to be held in |
---|
153 | | - | PAGE 5-SENATE BILL 22-173 November 2022 and, in such case, will take effect on the date of the official |
---|
154 | | - | declaration of the vote thereon by the governor. |
---|
155 | | - | ____________________________ ____________________________ |
---|
156 | | - | Steve Fenberg Alec Garnett |
---|
157 | | - | PRESIDENT OF SPEAKER OF THE HOUSE |
---|
158 | | - | THE SENATE OF REPRESENTATIVES |
---|
159 | | - | ____________________________ ____________________________ |
---|
160 | | - | Cindi L. Markwell Robin Jones |
---|
161 | | - | SECRETARY OF CHIEF CLERK OF THE HOUSE |
---|
162 | | - | THE SENATE OF REPRESENTATIVES |
---|
163 | | - | APPROVED________________________________________ |
---|
164 | | - | (Date and Time) |
---|
165 | | - | _________________________________________ |
---|
166 | | - | Jared S. Polis |
---|
167 | | - | GOVERNOR OF THE STATE OF COLORADO |
---|
168 | | - | PAGE 6-SENATE BILL 22-173 |
---|
| 94 | + | IN |
---|
| 95 | + | 20 |
---|
| 96 | + | THIS STATE, performs the tasks described in subsection (38.5)(a) of this21 |
---|
| 97 | + | section.22 |
---|
| 98 | + | (b) The board may adopt rules as necessary to specify additional23 |
---|
| 99 | + | criteria for a telepharmacy outlet that the board deems necessary.24 |
---|
| 100 | + | (c) AS USED IN THIS SUBSECTION (50):25 |
---|
| 101 | + | (I) "AREA OF NEED" MEANS:26 |
---|
| 102 | + | (A) ANY HEALTH FACILITY LICENSED OR CERTIFIED BY THE27 |
---|
| 103 | + | 173 |
---|
| 104 | + | -3- DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENT PURSUANT TO1 |
---|
| 105 | + | SECTION 25-1.5-103 (1); OR2 |
---|
| 106 | + | (B) ANY AREA WHERE A DEMONSTRATION OF NEED IS APPROVED3 |
---|
| 107 | + | BY THE BOARD.4 |
---|
| 108 | + | (II) "CENTRAL PHARMACY" MEANS A REGISTERED PHARMACY5 |
---|
| 109 | + | OUTLET RESPONSIBLE FOR OVERSEEING THE OPERATION OF A6 |
---|
| 110 | + | TELEPHARMACY OUTLET . 7 |
---|
| 111 | + | 8 |
---|
| 112 | + | 9 |
---|
| 113 | + | SECTION 2. In Colorado Revised Statutes, 12-280-107, add (3)10 |
---|
| 114 | + | as follows:11 |
---|
| 115 | + | 12-280-107. Rules. (3) THE BOARD MAY ADOPT RULES TO SPECIFY12 |
---|
| 116 | + | ADDITIONAL CRITERIA NECESSARY TO FACILITATE THE OPERATION OF13 |
---|
| 117 | + | TELEPHARMACY OUTLETS. THE BOARD'S ADDITIONAL RULES FOR A14 |
---|
| 118 | + | TELEPHARMACY OUTLET ARE LIMITED TO RULES CONCERNING THE15 |
---|
| 119 | + | FOLLOWING:16 |
---|
| 120 | + | (a) APPLICATION REQUIREMENTS;17 |
---|
| 121 | + | (b) STRUCTURAL AND EQUIPMENT REQUIREMENTS ;18 |
---|
| 122 | + | (c) STAFFING AND TRAINING REQUIREMENTS ;19 |
---|
| 123 | + | (d) PHARMACIST MANAGER VISITATION REQUIREMENTS ;20 |
---|
| 124 | + | (e) INVENTORY RECORD-KEEPING AND STORAGE REQUIREMENTS;21 |
---|
| 125 | + | (f) ESTABLISHING POLICIES AND PROCEDURES RELATING TO22 |
---|
| 126 | + | TELEPHARMACY OPERATIONS ; AND23 |
---|
| 127 | + | (g) THE NUMBER OF TELEPHARMACY OUTLETS THAT MAY BE24 |
---|
| 128 | + | OPERATED BY A CENTRAL PHARMACY .25 |
---|
| 129 | + | SECTION 3. In Colorado Revised Statutes, 12-280-118, amend26 |
---|
| 130 | + | (1)(a) and add (3)(c) as follows:27 |
---|
| 131 | + | 173 |
---|
| 132 | + | -4- 12-280-118. Prescription drug outlet under charge of1 |
---|
| 133 | + | pharmacist - rules. (1) (a) A prescription drug outlet must be under the2 |
---|
| 134 | + | direct charge of a pharmacist manager. A proprietor who is not a3 |
---|
| 135 | + | pharmacist shall comply with this requirement and shall provide a4 |
---|
| 136 | + | manager who is a pharmacist. NOTHING IN THIS ARTICLE 280 OR RULES5 |
---|
| 137 | + | IMPLEMENTING THIS ARTICLE 280 SHALL PROHIBIT THE PHARMACIST6 |
---|
| 138 | + | MANAGER OF A CENTRAL PHARMACY FROM SIMULTANEOUSLY SERVING AS7 |
---|
| 139 | + | THE PHARMACIST MANAGER OF A TELEPHARMACY OUTLET .8 |
---|
| 140 | + | (3) (c) A TELEPHARMACY OUTLET IS REQUIRED TO HAVE A9 |
---|
| 141 | + | PHARMACIST MANAGER. A TELEPHARMACY OUTLET IS CONSIDERED TO BE10 |
---|
| 142 | + | UNDER THE DIRECT CHARGE OR CONTROL OF THE PHARMACIST MANAGER,11 |
---|
| 143 | + | OR THE LICENSED PHARMACIST DELEGATE , WHO PROVIDES REMOTE12 |
---|
| 144 | + | SUPERVISION TO THE TELEPHARMACY OUTLET .13 |
---|
| 145 | + | SECTION 4. In Colorado Revised Statutes, 12-280-402, amend14 |
---|
| 146 | + | (3) as follows:15 |
---|
| 147 | + | 12-280-402. Definitions. As used in this part 4, unless the context16 |
---|
| 148 | + | otherwise requires:17 |
---|
| 149 | + | (3) "Prescription drug outlet" or "pharmacy" means:18 |
---|
| 150 | + | (a) Any resident or nonresident pharmacy outlet registered or19 |
---|
| 151 | + | licensed pursuant to this article 280 where prescriptions are compounded20 |
---|
| 152 | + | and dispensed; and21 |
---|
| 153 | + | (b) Any federally owned and operated pharmacy registered with22 |
---|
| 154 | + | the federal drug enforcement administration; AND23 |
---|
| 155 | + | (c) A TELEPHARMACY OUTLET.24 |
---|
| 156 | + | 25 |
---|
| 157 | + | SECTION 5. Act subject to petition - effective date. This act26 |
---|
| 158 | + | takes effect at 12:01 a.m. on the day following the expiration of the27 |
---|
| 159 | + | 173 |
---|
| 160 | + | -5- ninety-day period after final adjournment of the general assembly; except1 |
---|
| 161 | + | that, if a referendum petition is filed pursuant to section 1 (3) of article V2 |
---|
| 162 | + | of the state constitution against this act or an item, section, or part of this3 |
---|
| 163 | + | act within such period, then the act, item, section, or part will not take4 |
---|
| 164 | + | effect unless approved by the people at the general election to be held in5 |
---|
| 165 | + | November 2022 and, in such case, will take effect on the date of the6 |
---|
| 166 | + | official declaration of the vote thereon by the governor.7 |
---|
| 167 | + | 173 |
---|
| 168 | + | -6- |
---|