Colorado 2022 Regular Session

Colorado Senate Bill SB173 Compare Versions

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1+Second Regular Session
2+Seventy-third General Assembly
3+STATE OF COLORADO
4+REVISED
5+This Version Includes All Amendments Adopted
6+on Second Reading in the Second House
7+LLS NO. 22-0947.01 Brita Darling x2241
18 SENATE BILL 22-173
2-BY SENATOR(S) Rodriguez and Smallwood, Buckner, Coram, Ginal,
3-Gonzales, Pettersen, Priola, Rankin, Simpson, Winter, Woodward;
4-also REPRESENTATIVE(S) Bird and McKean, Bernett, Bockenfeld,
5-Hooton, Lindsay.
9+Senate Committees House Committees
10+Business, Labor, & Technology Public & Behavioral Health & Human Services
11+Finance Finance
12+Appropriations Appropriations
13+A BILL FOR AN ACT
614 C
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
6491 (IV) Has a pharmacy technician on site who, under the remote
92+19
6593 supervision of a licensed pharmacist located at the central pharmacy
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-