Second Regular Session Seventy-third General Assembly STATE OF COLORADO REVISED This Version Includes All Amendments Adopted on Second Reading in the Second House LLS NO. 22-0947.01 Brita Darling x2241 SENATE BILL 22-173 Senate Committees House Committees Business, Labor, & Technology Public & Behavioral Health & Human Services Finance Finance Appropriations Appropriations A BILL FOR AN ACT C ONCERNING CRITERIA RELATI NG TO THE OPERATION OF101 TELEPHARMACY OUTLETS .102 Bill Summary (Note: This summary applies to this bill as introduced and does not reflect any amendments that may be subsequently adopted. If this bill passes third reading in the house of introduction, a bill summary that applies to the reengrossed version of this bill will be available at http://leg.colorado.gov .) Currently, a "telepharmacy outlet" must be located more than 20 miles from the nearest prescription drug outlet or other telepharmacy outlet. The bill removes this geographic restriction on the operation of telepharmacy outlets. The bill authorizes the state board of pharmacy (board) to adopt limited rules concerning telepharmacy outlets. HOUSE Amended 2nd Reading May 10, 2022 SENATE 3rd Reading Unamended April 27, 2022 SENATE Amended 2nd Reading April 26, 2022 SENATE SPONSORSHIP Rodriguez and Smallwood, Buckner, Coram, Ginal, Gonzales, Pettersen, Priola, Rankin, Simpson, Winter, Woodward HOUSE SPONSORSHIP Bird and McKean, Shading denotes HOUSE amendment. Double underlining denotes SENATE amendment. Capital letters or bold & italic numbers indicate new material to be added to existing statute. Dashes through the words indicate deletions from existing statute. Be it enacted by the General Assembly of the State of Colorado:1 SECTION 1. In Colorado Revised Statutes, 12-280-103, amend2 (32)(a)(II), (32)(b)(II), (36), (43), and (50); and repeal (32)(c) as follows:3 12-280-103. Definitions - rules. As used in this article 280, unless4 the context otherwise requires or the term is otherwise defined in another5 part of this article 280:6 (32) "Other outlet" means:7 (a) A hospital that does not operate a registered pharmacy, a rural8 health clinic, a federally qualified health center, as defined in the federal9 "Social Security Act", 42 U.S.C. sec. 1395x (aa)(4), a family planning10 clinic, an acute treatment unit licensed by the department of public health11 and environment, a school, a jail, a county or district public health12 agency, a community health clinic, a community mental health clinic, a13 behavioral health entity, an approved treatment facility, a university, or14 a college that:15 (II) Engages in the compounding, dispensing, and delivery of16 drugs or devices; OR17 (b) An ambulatory surgical center, a hospice, or a convalescent18 center, each of which is licensed pursuant to part 1 of article 3 of title 25,19 or a medical clinic operated by a hospital, each of which:20 (II) Engages in the compounding, dispensing, and delivery of21 drugs or devices for administration to patients while being treated in the22 facility. or23 (c) A telepharmacy outlet.24 (36) "Pharmacist manager" means an individual, licensed in this25 state as a pharmacist, who has direct control of the pharmaceutical affairs26 173-2- of a prescription drug outlet and who, EXCEPT AS PROVIDED IN SECTION1 12-280-118 (1)(a), is not the manager of any other prescription drug2 outlet.3 (43) "Prescription drug outlet" or "pharmacy" means any4 pharmacy outlet registered pursuant to this article 280 where prescriptions5 are compounded and dispensed. "Prescription drug outlet" includes,6 without limitation, a specialized prescription drug outlet registered7 pursuant to section 12-280-119 (11) AND A TELEPHARMACY OUTLET .8 (50) (a) "Telepharmacy outlet" means a remote pharmacy site that:9 (I) Is registered as an other A PRESCRIPTION DRUG outlet OR10 PHARMACY under this article 280;11 (II) At the time of registration, is located more than twenty miles12 from the nearest prescription drug outlet and from any other telepharmacy13 outlet registered under this article 280 IN AN AREA OF NEED;14 (III) Is connected via computer link, video link, and audio link, or15 via other functionally equivalent telecommunication equipment, with a16 central pharmacy LOCATED IN THIS STATE that is registered under this17 article 280; and18 (IV) Has a pharmacy technician on site who, under the remote 19 supervision of a licensed pharmacist located at the central pharmacy IN 20 THIS STATE, performs the tasks described in subsection (38.5)(a) of this21 section.22 (b) The board may adopt rules as necessary to specify additional23 criteria for a telepharmacy outlet that the board deems necessary.24 (c) AS USED IN THIS SUBSECTION (50):25 (I) "AREA OF NEED" MEANS:26 (A) ANY HEALTH FACILITY LICENSED OR CERTIFIED BY THE27 173 -3- DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENT PURSUANT TO1 SECTION 25-1.5-103 (1); OR2 (B) ANY AREA WHERE A DEMONSTRATION OF NEED IS APPROVED3 BY THE BOARD.4 (II) "CENTRAL PHARMACY" MEANS A REGISTERED PHARMACY5 OUTLET RESPONSIBLE FOR OVERSEEING THE OPERATION OF A6 TELEPHARMACY OUTLET . 7 8 9 SECTION 2. In Colorado Revised Statutes, 12-280-107, add (3)10 as follows:11 12-280-107. Rules. (3) THE BOARD MAY ADOPT RULES TO SPECIFY12 ADDITIONAL CRITERIA NECESSARY TO FACILITATE THE OPERATION OF13 TELEPHARMACY OUTLETS. THE BOARD'S ADDITIONAL RULES FOR A14 TELEPHARMACY OUTLET ARE LIMITED TO RULES CONCERNING THE15 FOLLOWING:16 (a) APPLICATION REQUIREMENTS;17 (b) STRUCTURAL AND EQUIPMENT REQUIREMENTS ;18 (c) STAFFING AND TRAINING REQUIREMENTS ;19 (d) PHARMACIST MANAGER VISITATION REQUIREMENTS ;20 (e) INVENTORY RECORD-KEEPING AND STORAGE REQUIREMENTS;21 (f) ESTABLISHING POLICIES AND PROCEDURES RELATING TO22 TELEPHARMACY OPERATIONS ; AND23 (g) THE NUMBER OF TELEPHARMACY OUTLETS THAT MAY BE24 OPERATED BY A CENTRAL PHARMACY .25 SECTION 3. In Colorado Revised Statutes, 12-280-118, amend26 (1)(a) and add (3)(c) as follows:27 173 -4- 12-280-118. Prescription drug outlet under charge of1 pharmacist - rules. (1) (a) A prescription drug outlet must be under the2 direct charge of a pharmacist manager. A proprietor who is not a3 pharmacist shall comply with this requirement and shall provide a4 manager who is a pharmacist. NOTHING IN THIS ARTICLE 280 OR RULES5 IMPLEMENTING THIS ARTICLE 280 SHALL PROHIBIT THE PHARMACIST6 MANAGER OF A CENTRAL PHARMACY FROM SIMULTANEOUSLY SERVING AS7 THE PHARMACIST MANAGER OF A TELEPHARMACY OUTLET .8 (3) (c) A TELEPHARMACY OUTLET IS REQUIRED TO HAVE A9 PHARMACIST MANAGER. A TELEPHARMACY OUTLET IS CONSIDERED TO BE10 UNDER THE DIRECT CHARGE OR CONTROL OF THE PHARMACIST MANAGER,11 OR THE LICENSED PHARMACIST DELEGATE , WHO PROVIDES REMOTE12 SUPERVISION TO THE TELEPHARMACY OUTLET .13 SECTION 4. In Colorado Revised Statutes, 12-280-402, amend14 (3) as follows:15 12-280-402. Definitions. As used in this part 4, unless the context16 otherwise requires:17 (3) "Prescription drug outlet" or "pharmacy" means:18 (a) Any resident or nonresident pharmacy outlet registered or19 licensed pursuant to this article 280 where prescriptions are compounded20 and dispensed; and21 (b) Any federally owned and operated pharmacy registered with22 the federal drug enforcement administration; AND23 (c) A TELEPHARMACY OUTLET.24 25 SECTION 5. Act subject to petition - effective date. This act26 takes effect at 12:01 a.m. on the day following the expiration of the27 173 -5- ninety-day period after final adjournment of the general assembly; except1 that, if a referendum petition is filed pursuant to section 1 (3) of article V2 of the state constitution against this act or an item, section, or part of this3 act within such period, then the act, item, section, or part will not take4 effect unless approved by the people at the general election to be held in5 November 2022 and, in such case, will take effect on the date of the6 official declaration of the vote thereon by the governor.7 173 -6-