1 | 1 | | S.B. No. 2173 |
---|
2 | 2 | | |
---|
3 | 3 | | |
---|
4 | 4 | | AN ACT |
---|
5 | 5 | | relating to a pilot program for the safe disposal of prescription |
---|
6 | 6 | | drugs, including controlled substance prescription drugs. |
---|
7 | 7 | | BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
---|
8 | 8 | | SECTION 1. Subtitle A, Title 6, Health and Safety Code, is |
---|
9 | 9 | | amended by adding Chapter 442A to read as follows: |
---|
10 | 10 | | CHAPTER 442A. PRESCRIPTION DRUG SAFE DISPOSAL PILOT PROGRAM |
---|
11 | 11 | | SUBCHAPTER A. GENERAL PROVISIONS |
---|
12 | 12 | | Sec. 442A.001. DEFINITIONS. In this chapter: |
---|
13 | 13 | | (1) "Board" means the Texas State Board of Pharmacy. |
---|
14 | 14 | | (2) "Controlled substance" has the meaning assigned by |
---|
15 | 15 | | Section 481.002. |
---|
16 | 16 | | (3) "Pharmacy" means a facility licensed under Chapter |
---|
17 | 17 | | 560, Occupations Code. |
---|
18 | 18 | | (4) "Pilot program" means the prescription drug safe |
---|
19 | 19 | | disposal pilot program established under this chapter. |
---|
20 | 20 | | (5) "Prescription drug" has the meaning assigned by |
---|
21 | 21 | | Section 551.003, Occupations Code. |
---|
22 | 22 | | (6) "Ultimate user" has the meaning assigned by 21 |
---|
23 | 23 | | U.S.C. Section 802. |
---|
24 | 24 | | Sec. 442A.002. PRESCRIPTION DRUG SAFE DISPOSAL PILOT |
---|
25 | 25 | | PROGRAM. The board by rule shall develop and implement a |
---|
26 | 26 | | prescription drug safe disposal pilot program to increase the |
---|
27 | 27 | | number of locations in this state where unused, unwanted, or |
---|
28 | 28 | | expired prescription drugs are collected from the public for safe |
---|
29 | 29 | | disposal. |
---|
30 | 30 | | SUBCHAPTER B. PHARMACY PARTICIPATION |
---|
31 | 31 | | Sec. 442A.051. PHARMACY ELIGIBILITY. A pharmacy operating |
---|
32 | 32 | | in this state may apply to the board to participate in the pilot |
---|
33 | 33 | | program if the pharmacy: |
---|
34 | 34 | | (1) is registered as an authorized drug collection |
---|
35 | 35 | | site with the United States Drug Enforcement Administration; |
---|
36 | 36 | | (2) is not the subject of state or federal opioid |
---|
37 | 37 | | litigation; and |
---|
38 | 38 | | (3) meets the eligibility requirements established by |
---|
39 | 39 | | 21 C.F.R. Section 1317.40 and board rules. |
---|
40 | 40 | | Sec. 442A.052. APPLICATION AND SELECTION PROCESSES. (a) |
---|
41 | 41 | | The board shall adopt rules prescribing: |
---|
42 | 42 | | (1) the form and manner for a pharmacy to apply for |
---|
43 | 43 | | participation in the pilot program; and |
---|
44 | 44 | | (2) evaluation and selection criteria and processes. |
---|
45 | 45 | | (b) The board shall give priority to a pharmacy applicant |
---|
46 | 46 | | that: |
---|
47 | 47 | | (1) does not collect unused ultimate user prescription |
---|
48 | 48 | | drugs under 21 C.F.R. Part 1317 at the time the applicant submits |
---|
49 | 49 | | the application; or |
---|
50 | 50 | | (2) is located in a rural or underserved area the board |
---|
51 | 51 | | designates. |
---|
52 | 52 | | (c) A pharmacy that operates multiple locations must submit |
---|
53 | 53 | | an application for each location. |
---|
54 | 54 | | Sec. 442A.053. COLLECTION RECEPTACLE REQUIREMENTS. (a) A |
---|
55 | 55 | | participating pharmacy that provides a collection receptacle for |
---|
56 | 56 | | the safe disposal of prescription drugs shall ensure the |
---|
57 | 57 | | receptacle: |
---|
58 | 58 | | (1) meets the requirements of 21 C.F.R. Section |
---|
59 | 59 | | 1317.75; |
---|
60 | 60 | | (2) is accessible during the pharmacy's regular hours |
---|
61 | 61 | | of operation; |
---|
62 | 62 | | (3) allows for the anonymous deposit of unused |
---|
63 | 63 | | controlled substance prescription drugs listed in Schedules II, |
---|
64 | 64 | | III, IV, and V; and |
---|
65 | 65 | | (4) provides disposal of unused prescription drugs at |
---|
66 | 66 | | no cost to the ultimate user. |
---|
67 | 67 | | (b) Controlled substance prescription drugs and |
---|
68 | 68 | | noncontrolled substance prescription drugs may be collected |
---|
69 | 69 | | together and comingled. |
---|
70 | 70 | | Sec. 442A.054. MAIL-BACK PROGRAM REQUIREMENTS. (a) A |
---|
71 | 71 | | participating pharmacy that provides a collection receptacle for |
---|
72 | 72 | | the safe disposal of prescription drugs may, under limited |
---|
73 | 73 | | circumstances as the pharmacy determines necessary, provide at the |
---|
74 | 74 | | time the pharmacy dispenses a controlled substance prescription |
---|
75 | 75 | | drug to the ultimate user a vendor's mail-back envelope, at no cost |
---|
76 | 76 | | to the ultimate user. The mail-back envelope must: |
---|
77 | 77 | | (1) be pre-addressed and return postage paid; and |
---|
78 | 78 | | (2) meet the requirements of 21 C.F.R. Section |
---|
79 | 79 | | 1317.70. |
---|
80 | 80 | | (b) A participating pharmacy may provide not more than 250 |
---|
81 | 81 | | mail-back envelopes during the duration of the pilot program to |
---|
82 | 82 | | encourage use of the pharmacy's collection receptacle. |
---|
83 | 83 | | Sec. 442A.055. PHARMACY MANAGEMENT; RECORDS. A |
---|
84 | 84 | | participating pharmacy is responsible for the daily management and |
---|
85 | 85 | | recordkeeping of the pharmacy's prescription drug safe disposal |
---|
86 | 86 | | program in accordance with the pharmacy's United States Drug |
---|
87 | 87 | | Enforcement Administration registration and board rules. |
---|
88 | 88 | | Sec. 442A.056. TEXAS PREMIER PHARMACY DESIGNATION. (a) |
---|
89 | 89 | | The board shall designate each pharmacy participating in the pilot |
---|
90 | 90 | | program as a Texas premier pharmacy provider committed to safe |
---|
91 | 91 | | prescription drug disposal. |
---|
92 | 92 | | (b) A participating pharmacy may use the designation for |
---|
93 | 93 | | marketing purposes. |
---|
94 | 94 | | SUBCHAPTER C. BOARD DUTIES |
---|
95 | 95 | | Sec. 442A.101. PILOT PROGRAM INCENTIVES. (a) The board |
---|
96 | 96 | | shall assist each pharmacy participating in the pilot program, |
---|
97 | 97 | | including by paying the costs of: |
---|
98 | 98 | | (1) maintaining one collection receptacle at each |
---|
99 | 99 | | participating pharmacy location and destroying through |
---|
100 | 100 | | incineration of the receptacle's full inner liner the prescription |
---|
101 | 101 | | drugs deposited in the receptacle; |
---|
102 | 102 | | (2) ordering and distributing pre-addressed, return |
---|
103 | 103 | | postage paid mail-back envelopes from a third-party mail-back |
---|
104 | 104 | | program and destroying through incineration the returned mail-back |
---|
105 | 105 | | envelopes containing the collected prescription drugs; and |
---|
106 | 106 | | (3) other operational needs the board determines |
---|
107 | 107 | | appropriate. |
---|
108 | 108 | | (b) The board: |
---|
109 | 109 | | (1) shall directly reimburse a participating pharmacy |
---|
110 | 110 | | for costs the pharmacy incurs under Subsection (a); and |
---|
111 | 111 | | (2) may not reimburse a participating pharmacy for the |
---|
112 | 112 | | cost of using a third-party incineration facility unless the |
---|
113 | 113 | | facility is appropriately registered with the United States Drug |
---|
114 | 114 | | Enforcement Administration. |
---|
115 | 115 | | (c) Subject to money available for purposes of this chapter, |
---|
116 | 116 | | the board may provide financial incentives to a pharmacy to |
---|
117 | 117 | | continue providing prescription drug collection services or expand |
---|
118 | 118 | | those services to accommodate controlled substance prescriptions. |
---|
119 | 119 | | The board may provide financial incentives to a chain retail |
---|
120 | 120 | | pharmacy for not more than 15 locations. |
---|
121 | 121 | | Sec. 442A.102. COMMUNITY OUTREACH. (a) The board shall: |
---|
122 | 122 | | (1) develop and distribute educational outreach |
---|
123 | 123 | | materials for the public about the availability of safe |
---|
124 | 124 | | prescription drug disposal in this state; |
---|
125 | 125 | | (2) post the materials on the board's Internet |
---|
126 | 126 | | website; and |
---|
127 | 127 | | (3) provide the materials to other state agencies for |
---|
128 | 128 | | those agencies to conduct the community outreach. |
---|
129 | 129 | | (b) The educational outreach materials must be in English, |
---|
130 | 130 | | Spanish, and for specific areas of this state as the board |
---|
131 | 131 | | determines appropriate, another language spoken by a substantial |
---|
132 | 132 | | portion of the area's residents. |
---|
133 | 133 | | Sec. 442A.103. REPORT. Not later than December 1 of each |
---|
134 | 134 | | even-numbered year, the board shall submit to the governor and the |
---|
135 | 135 | | legislature a report that: |
---|
136 | 136 | | (1) summarizes the results of the pilot program, |
---|
137 | 137 | | including: |
---|
138 | 138 | | (A) the number and geographic distribution of |
---|
139 | 139 | | collection receptacles at participating pharmacies; |
---|
140 | 140 | | (B) the estimated amount of prescription drugs |
---|
141 | 141 | | collected by participating pharmacies under the program, measured |
---|
142 | 142 | | by: |
---|
143 | 143 | | (i) the number of inner liners fully filled |
---|
144 | 144 | | with collected prescription drugs and sent for incineration by the |
---|
145 | 145 | | pharmacies; |
---|
146 | 146 | | (ii) the number of mail-back envelopes |
---|
147 | 147 | | distributed by the pharmacies; and |
---|
148 | 148 | | (iii) the weight, measured in pounds, of: |
---|
149 | 149 | | (a) inner liners described by |
---|
150 | 150 | | Subparagraph (i); and |
---|
151 | 151 | | (b) returned mail-back envelopes |
---|
152 | 152 | | filled with collected prescription drugs; |
---|
153 | 153 | | (C) the amount of money distributed under the |
---|
154 | 154 | | pilot program and the identity of each participating pharmacy to |
---|
155 | 155 | | which money is distributed; and |
---|
156 | 156 | | (D) a description of the board's educational |
---|
157 | 157 | | efforts and outcomes; and |
---|
158 | 158 | | (2) recommends whether the pilot program should |
---|
159 | 159 | | continue, be expanded, or terminate or whether the board should |
---|
160 | 160 | | permanently implement a prescription drug safe disposal program. |
---|
161 | 161 | | SUBCHAPTER D. FUNDING |
---|
162 | 162 | | Sec. 442A.151. FUNDING. (a) Money contained in the opioid |
---|
163 | 163 | | abatement account established under Section 403.505, Government |
---|
164 | 164 | | Code, as added by Chapter 781 (S.B. 1827), Acts of the 87th |
---|
165 | 165 | | Legislature, Regular Session, 2021, may be appropriated to the |
---|
166 | 166 | | board to fund the pilot program established under this chapter. |
---|
167 | 167 | | (b) The board may collect gifts, grants, and donations to |
---|
168 | 168 | | fund the program. |
---|
169 | 169 | | SUBCHAPTER E. EXPIRATION |
---|
170 | 170 | | Sec. 442A.201. EXPIRATION. This chapter expires on the |
---|
171 | 171 | | second anniversary of the date that all money appropriated for the |
---|
172 | 172 | | pilot program has been expended. |
---|
173 | 173 | | SECTION 2. As soon as practicable after the effective date |
---|
174 | 174 | | of this Act, the Texas State Board of Pharmacy shall implement the |
---|
175 | 175 | | prescription drug safe disposal pilot program developed under |
---|
176 | 176 | | Chapter 442A, Health and Safety Code, as added by this Act. |
---|
177 | 177 | | SECTION 3. This Act takes effect September 1, 2023. |
---|
178 | 178 | | ______________________________ ______________________________ |
---|
179 | 179 | | President of the Senate Speaker of the House |
---|
180 | 180 | | I hereby certify that S.B. No. 2173 passed the Senate on |
---|
181 | 181 | | April 26, 2023, by the following vote: Yeas 31, Nays 0. |
---|
182 | 182 | | ______________________________ |
---|
183 | 183 | | Secretary of the Senate |
---|
184 | 184 | | I hereby certify that S.B. No. 2173 passed the House on |
---|
185 | 185 | | May 16, 2023, by the following vote: Yeas 130, Nays 11, one |
---|
186 | 186 | | present not voting. |
---|
187 | 187 | | ______________________________ |
---|
188 | 188 | | Chief Clerk of the House |
---|
189 | 189 | | Approved: |
---|
190 | 190 | | ______________________________ |
---|
191 | 191 | | Date |
---|
192 | 192 | | ______________________________ |
---|
193 | 193 | | Governor |
---|