Texas 2025 - 89th Regular

Texas House Bill HB4051 Compare Versions

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11 By: Frank H.B. No. 4051
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66 A BILL TO BE ENTITLED
77 AN ACT
88 relating to the authority of certain healthcare providers to order
99 and provide or dispense limited prescription drugs.
1010 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
1111 SECTION 1. Section 483.001(11), Health and Safety Code, is
1212 amended to read as follows:
1313 (11) "Practice of pharmacy" has the meaning assigned
1414 by Section 551.003, Occupations Code [means:
1515 [(A) provision of those acts or services
1616 necessary to provide pharmaceutical care;
1717 [(B) interpretation and evaluation of
1818 prescription drug orders or medication orders;
1919 [(C) participation in drug and device selection
2020 as authorized by law, drug administration, drug regimen review, or
2121 drug or drug-related research;
2222 [(D) provision of patient counseling;
2323 [(E) responsibility for:
2424 [(i) dispensing of prescription drug orders
2525 or distribution of medication orders in the patient's best
2626 interest;
2727 [(ii) compounding and labeling of drugs and
2828 devices, except labeling by a manufacturer, repackager, or
2929 distributor of nonprescription drugs and commercially packaged
3030 prescription drugs and devices;
3131 [(iii) proper and safe storage of drugs and
3232 devices; or
3333 [(iv) maintenance of proper records for
3434 drugs and devices. In this subdivision, "device" has the meaning
3535 assigned by Subtitle J, Title 3, Occupations Code; or
3636 [(F) performance of a specific act of drug
3737 therapy management for a patient delegated to a pharmacist by a
3838 written protocol from a physician licensed by the state under
3939 Subtitle B, Title 3, Occupations Code].
4040 SECTION 2. Section 151.002, Occupations Code, is amended by
4141 adding Subdivisions (3-a) and (13-a) to read as follows:
4242 (3-a) "Dispense" has the meaning assigned by Section
4343 551.003.
4444 (13-a) "Provision" means the supply of one or more
4545 unit doses of a drug, medicine, or dangerous drug.
4646 SECTION 3. The heading to Section 157.002, Occupations
4747 Code, is amended to read as follows:
4848 Sec. 157.002. GENERAL DELEGATION OF ADMINISTRATION, [AND]
4949 PROVISION, AND DISPENSING OF DANGEROUS DRUGS.
5050 SECTION 4. Sections 157.002(a), (b), (e), and (g),
5151 Occupations Code, are amended to read as follows:
5252 (a) In this section, "administering" [:
5353 [(1) "Administering"] means the direct application of
5454 a drug to the body of a patient by injection, inhalation, ingestion,
5555 or any other means.
5656 [(2) "Provision" means the supply of one or more unit
5757 doses of a drug, medicine, or dangerous drug.]
5858 (b) A physician may delegate to any qualified and properly
5959 trained person acting under the physician's supervision the act of
6060 administering [or providing] dangerous drugs in the physician's
6161 office, as ordered by the physician, that are used or required to
6262 meet the immediate needs of the physician's patients or the act of
6363 providing or dispensing dangerous drugs as ordered by the physician
6464 to the physician's patients. The administration, [or] provision,
6565 or dispensing of the dangerous drugs must be performed in
6666 compliance with laws relating to the practice of medicine and state
6767 and federal laws relating to those dangerous drugs.
6868 (e) The administration, [or] provision, or dispensing of
6969 the drugs may be delegated through a physician's order, a standing
7070 medical order, a standing delegation order, or another order
7171 defined by the board.
7272 (g) A drug or medicine provided or dispensed under
7373 Subsection (b) or (c) must be:
7474 (1) supplied in a child-resistant container unless the
7575 patient request it not be in a child-resistant container or the
7676 product is exempt from requirements of the Poison Prevention
7777 Packaging Act of 1970;
7878 (2) dispensed in a container with a label on the container
7979 that contains the name of the drug, the date the prescription is
8080 dispensed, the name of the prescribing practitioner, the quantity
8181 dispensed, dosage and route of administration, date after which the
8282 prescription should not be used or beyond-use-date, and appropriate
8383 ancillary instructions such as storage instructions or cautionary
8484 statements printed in an easily readable font size;
8585 (3) stored prior to dispensing in a location with a
8686 temperature range compatible with the proper storage of each drug,
8787 including refrigeration where required, and secured against theft
8888 or diversion of prescription drugs and locked to prohibit
8989 unauthorized access when the physician is not on-site; and
9090 (4) dispensed with written consumer information or written
9191 directions to obtain written information online that provides the
9292 therapeutic use of the drug and the names of generically equivalent
9393 drugs.
9494 (h) A physician dispensing a drug under this subchapter
9595 must:
9696 (1) complete a drug utilization review prior to dispensing
9797 for therapeutic duplication, drug-to-disease contraindications,
9898 drug-to-drug interactions, correct dosage, and drug-to-allergy
9999 interactions;
100100 (2) maintain records of dispensed medications including
101101 patient information, prescription details and dispensing
102102 information including the dispensing physicians name and office
103103 address where drugs were dispensed from;
104104 (3) counsel the patient on proper use of a prescription drug
105105 or device; and
106106 (4) perform a final check on all prescriptions filled onsite
107107 for the accuracy and completeness of the prescription.
108108 [supplied in a suitable container labeled in compliance with
109109 applicable drug laws. A qualified and trained person, acting under
110110 the supervision of a physician, may specify at the time of the
111111 provision or dispensing of the drug the inclusion on the container
112112 of the date of the provision or dispensing and the patient's name
113113 and address.]
114114 SECTION 5. The heading to Chapter 158, Occupations Code, is
115115 amended to read as follows:
116116 CHAPTER 158. AUTHORITY OF PHYSICIAN TO PROVIDE OR DISPENSE CERTAIN
117117 DRUGS AND SUPPLIES
118118 SECTION 6. Sections 158.001(a) and (c), Occupations Code,
119119 are amended to read as follows:
120120 (a) A physician licensed under this subtitle may provide
121121 [supply] a patient with any drug, remedy, or clinical supply
122122 necessary to meet the patient's immediate needs.
123123 (c) This chapter does not prohibit a physician from
124124 providing [supplying] to a patient, free of charge, a drug provided
125125 to the physician by a drug manufacturer for an indigent
126126 pharmaceutical program if, in the physician's opinion, it is
127127 advantageous to the patient, in adhering to a course of treatment
128128 prescribed by the physician, to receive the drug.
129129 SECTION 7. Section 158.002(a), Occupations Code, is amended
130130 to read as follows:
131131 (a) This chapter does not prohibit a physician from
132132 providing [supplying] a pharmaceutical sample to a patient free of
133133 charge if, in the physician's opinion, it is advantageous to the
134134 patient, in adhering to a course of treatment prescribed by the
135135 physician, to receive the sample.
136136 SECTION 8. The heading to Section 158.003, Occupations
137137 Code, is amended to read as follows:
138138 Sec. 158.003. DISPENSING OF DANGEROUS DRUGS TO CERTAIN
139139 PATIENTS IN CERTAIN RURAL AREAS.
140140 SECTION 9. Section 158.003, Occupations Code, is amended by
141141 adding Subsection (a-1) to read as follows:
142142 (a-1) This section applies only to a physician providing
143143 care under workers' compensation insurance coverage, as defined by
144144 Section 401.011, Labor Code.
145145 SECTION 10. Chapter 158, Occupations Code, is amended by
146146 adding Section 158.004 to read as follows:
147147 Sec. 158.004. PROVISION AND DISPENSING OF DANGEROUS DRUGS.
148148 (a) In this section, "reimbursement for cost" means an additional
149149 charge, separate from that imposed for the physician's professional
150150 services, that includes the cost of a drug product and all other
151151 actual costs to the physician incidental to providing dispensing
152152 service. The term does not include a separate fee imposed for the
153153 act of dispensing a drug itself.
154154 (b) This section does not apply to a physician providing
155155 care under workers' compensation insurance coverage, as defined by
156156 Section 401.011, Labor Code.
157157 (c) A physician may:
158158 (1) provide or dispense dangerous drugs to the
159159 physician's patients; and
160160 (2) be reimbursed for the cost of providing or
161161 dispensing those drugs without obtaining a license under Chapter
162162 558.
163163 (d) A physician may not provide or dispense under this
164164 section a controlled substance listed in Schedules II through V as
165165 established under Subchapter B, Chapter 481, Health and Safety
166166 Code.
167167 (e) A physician who provides or dispenses dangerous drugs
168168 under this section shall oversee compliance with the laws of this
169169 state and federal law relating to those dangerous drugs.
170170 (f) Before providing or dispensing dangerous drugs under
171171 this section, a physician must notify the patient that the
172172 prescription for the dangerous drug may be filled at a pharmacy.
173173 With respect to dangerous drugs provided or dispensed in a
174174 physician's office, the notification requirement of this
175175 subsection may be satisfied by a written notice placed
176176 conspicuously in the office.
177177 (g) Not later than the 30th day after the date a physician
178178 first provides or dispenses dangerous drugs under this section, the
179179 physician shall notify the Texas State Board of Pharmacy and the
180180 board that the physician is providing or dispensing dangerous drugs
181181 under this section. The Texas State Board of Pharmacy and the board
182182 shall jointly adopt a form by which a physician may provide
183183 notification as required by this subsection.
184184 (h) A physician who notifies the board under Subsection (g)
185185 that the physician is providing or dispensing dangerous drugs under
186186 this section and who intends to continue to provide or dispense
187187 dangerous drugs under this section shall include notice of that
188188 intent in any subsequent registration permit renewal application
189189 submitted to the board. The board by rule shall prescribe the form
190190 of a registration permit renewal application in accordance with
191191 this subsection.
192192 SECTION 11. Section 551.003(31) and (33), Occupations Code,
193193 is amended to read as follows:
194194 (31) "Pharmacy" means a facility at which a
195195 prescription drug or medication order is received, processed, or
196196 dispensed under this subtitle, Chapter 481 or 483, Health and
197197 Safety Code, or the Comprehensive Drug Abuse Prevention and Control
198198 Act of 1970 (21 U.S.C. Section 801 et seq.). The term does not
199199 include:
200200 (A) a narcotic drug treatment program that is
201201 regulated under Chapter 466, Health and Safety Code; or
202202 (B) a location where:
203203 (i) a physician provides or dispenses a
204204 dangerous drug under Section 158.003 or 158.004; or
205205 (ii) a person provides or dispenses a
206206 dangerous drug under a physician's supervision in accordance with
207207 Section 157.002(b).
208208 (33) "Practice of pharmacy" means:
209209 (A) providing an act or service necessary to
210210 provide pharmaceutical care;
211211 (B) interpreting or evaluating a prescription
212212 drug order or medication order;
213213 (C) participating in drug or device selection as
214214 authorized by law, and participating in drug administration, drug
215215 regimen review, or drug or drug-related research;
216216 (D) providing patient counseling;
217217 (E) being responsible for:
218218 (i) dispensing a prescription drug order or
219219 distributing a medication order;
220220 (ii) compounding or labeling a drug or
221221 device, other than labeling by a manufacturer, repackager, or
222222 distributor of a nonprescription drug or commercially packaged
223223 prescription drug or device;
224224 (iii) properly and safely storing a drug or
225225 device; or
226226 (iv) maintaining proper records for a drug
227227 or device;
228228 (F) performing for a patient a specific act of
229229 drug therapy management delegated to a pharmacist by a written
230230 protocol from a physician licensed in this state in compliance with
231231 Subtitle B; [or]
232232 (G) administering an immunization or vaccination
233233 under a physician's written protocol; or
234234 (H) ordering or furnishing a prescription drug to
235235 treat an acute condition in accordance with Section 562.058.
236236 SECTION 12. Section 551.004, Occupations Code, is amended
237237 by adding Subsection (a-1) and amending Subsection (b) to read as
238238 follows:
239239 (a-1) For purposes of Subsection (a)(1), "retailing of
240240 prescription drugs" does not include the collection of a
241241 reimbursement for cost, as defined by Section 158.003(a) or
242242 158.004(a).
243243 (b) This subtitle does not prevent:
244244 (1) a practitioner from:
245245 (A) administering a drug to a patient of the
246246 practitioner; or
247247 (B) providing or dispensing dangerous drugs
248248 under Section 158.003 or 158.004; or
249249 (2) a person from providing or dispensing a dangerous
250250 drug under a physician's supervision in accordance with Section
251251 157.002(b).
252252 SECTION 13. Section 558.001, Occupations Code, is amended
253253 by amending Subsection (c) and adding Subsection (d) to read as
254254 follows:
255255 (c) Except as provided by Subsection (d), a [A] person may
256256 not dispense or distribute prescription drugs unless the person:
257257 (1) is a pharmacist; or
258258 (2) is otherwise authorized by this subtitle to
259259 dispense or distribute prescription drugs.
260260 (d) A physician or person acting under the physician's
261261 supervision may provide or dispense dangerous drugs in accordance
262262 with Section 157.002(b), 158.003, or 158.004.
263263 SECTION 14. Subchapter B, Chapter 562, Occupations Code, is
264264 amended by adding Section 562.058 to read as follows:
265265 Sec. 562.058. ORDERING AND FURNISHING CERTAIN PRESCRIPTION
266266 DRUGS. (a) In this section:
267267 (1) "Acute condition" means a condition or disease
268268 that begins abruptly, intensifies rapidly, and is generally not
269269 long-lasting.
270270 (2) "Waived clinical laboratory test" means a clinical
271271 laboratory test that is classified as waived under federal
272272 regulations issued under the Clinical Laboratory Improvement
273273 Amendments of 1988 (42 U.S.C. Section 263a).
274274 (b) Notwithstanding any other law, a pharmacist may order
275275 and furnish to a patient a prescription drug to treat an acute
276276 condition that is:
277277 (1) identified through performance of one of the following
278278 tests, if the test is a waived clinical laboratory test:
279279 (A) a rapid strep test or rapid antigen detection test
280280 used in the identification of group A streptococcus (GAS);
281281 (B) a rapid influenza diagnostic test used in the
282282 identification of influenza types A and B; or
283283 (C) a rapid diagnostic test for SARS-CoV-2 or a
284284 related virus used in the identification of COVID-19 or a related
285285 illness[.]; or
286286 (2) for treatment of minor, uncomplicated infections,
287287 including lice, skin conditions, such as ringworm and athlete's
288288 foot, and urinary tract infections.
289289 (c) The board shall adopt rules to permit a pharmacist to
290290 order and furnish a prescription drug under this section to a
291291 patient.
292292 (d) A pharmacist who orders and furnishes a prescription
293293 drug under this section must provide notice to the patient's
294294 primary care physician, as identified by the patient if the patient
295295 has a primary care physician, not later than the 14th day after the
296296 date the drug is ordered and furnished by the pharmacist.
297297 (e) The board by rule shall establish requirements to ensure
298298 that a pharmacist possesses the necessary skill and training to
299299 order and furnish prescription drugs under this section.
300300 SECTION 15. The heading to Chapter 563, Occupations Code,
301301 is amended to read as follows:
302302 CHAPTER 563. [PRESCRIPTION REQUIREMENTS;] DELEGATION OF
303303 ADMINISTRATION, [AND] PROVISION, AND DISPENSING OF DANGEROUS DRUGS
304304 SECTION 16. Sections 563.051(a) and (c), Occupations Code,
305305 are amended to read as follows:
306306 (a) A physician may delegate to any qualified and properly
307307 trained person acting under the physician's supervision the act of
308308 administering [or providing] dangerous drugs in the physician's
309309 office, as ordered by the physician, that are used or required to
310310 meet the immediate needs of the physician's patients or the act of
311311 providing or dispensing dangerous drugs, as ordered by the
312312 physician, to the physician's patients. The administration, [or]
313313 provision, or dispensing of the dangerous drugs must be performed
314314 in compliance with laws relating to the practice of medicine and
315315 state and federal laws relating to those dangerous drugs.
316316 (c) The administration, [or] provision, or dispensing of
317317 the drugs may be delegated through a physician's order, a standing
318318 medical order, a standing delegation order, or another order
319319 defined by the Texas Medical [State] Board [of Medical Examiners].
320320 SECTION 17. Section 563.052, Occupations Code, is amended
321321 to read as follows:
322322 Sec. 563.052. SUITABLE CONTAINER REQUIRED. A drug or
323323 medicine provided or dispensed under this subchapter must be
324324 provided or dispensed [supplied] in a suitable container labeled in
325325 compliance with applicable drug laws. A qualified and trained
326326 person, acting under the supervision of a physician, may specify at
327327 the time of the provision or dispensing of the drug the inclusion on
328328 the container of the date of the provision or dispensing and the
329329 patient's name and address.
330330 SECTION 18. The heading to Section 563.053, Occupations
331331 Code, is amended to read as follows:
332332 Sec. 563.053. DISPENSING OF DANGEROUS DRUGS TO CERTAIN
333333 PATIENTS IN CERTAIN RURAL AREAS.
334334 SECTION 19. Section 563.053, Occupations Code, is amended
335335 by adding Subsection (a-1) to read as follows:
336336 (a-1) This section applies only to a physician providing
337337 care under workers' compensation insurance coverage, as defined by
338338 Section 401.011, Labor Code.
339339 SECTION 20. The heading to Subchapter B, Chapter 563,
340340 Occupations Code, is repealed.
341341 SECTION 21. Not later than January 1, 2026, the Texas State
342342 Board of Pharmacy shall adopt the rules required under Section
343343 562.058, Occupations Code, as added by this Act.
344344 SECTION 22. Not later than January 1, 2026, the Texas
345345 Medical Board shall adopt the rules required under Section 558.001,
346346 Occupations Code, as added by this Act.
347347 SECTION 23. This Act takes effect September 1, 2025.