Texas 2015 - 84th Regular

Texas Senate Bill SB460 Compare Versions

Version 1 (Old)

Version 2 (New)

Old	New		Differences
1		-	By: Schwertner S.B. No. 460
2		-	(Crownover)
	1	+	S.B. No. 460
3	2
4	3
5		-	A BILL TO BE ENTITLED
6	4		AN ACT
7	5		relating to the licensing and regulation of pharmacists and
8	6		pharmacies.
9	7		BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
10	8		SECTION 1. Section 483.047, Health and Safety Code, is
11	9		amended by amending Subsection (a) and adding Subsections (b-1) and
12	10		(b-2) to read as follows:
13	11		(a) Except as authorized by Subsections [Subsection] (b)
14	12		and (b-1), a pharmacist commits an offense if the pharmacist
15	13		refills a prescription unless:
16	14		(1) the prescription contains an authorization by the
17	15		practitioner for the refilling of the prescription, and the
18	16		pharmacist refills the prescription in the manner provided by the
19	17		authorization; or
20	18		(2) at the time of refilling the prescription, the
21	19		pharmacist is authorized to do so by the practitioner who issued the
22	20		prescription.
23	21		(b-1) Notwithstanding Subsection (b), in the event of a
24	22		natural or manmade disaster, a pharmacist may dispense not more
25	23		than a 30-day supply of a dangerous drug without the authorization
26	24		of the prescribing practitioner if:
27	25		(1) failure to refill the prescription might result in
28	26		an interruption of a therapeutic regimen or create patient
29	27		suffering;
30	28		(2) the natural or manmade disaster prohibits the
31	29		pharmacist from being able to contact the practitioner;
32	30		(3) the governor has declared a state of disaster
33	31		under Chapter 418, Government Code; and
34	32		(4) the board, through the executive director, has
35	33		notified pharmacies in this state that pharmacists may dispense up
36	34		to a 30-day supply of a dangerous drug.
37	35		(b-2) The prescribing practitioner is not liable for an act
38	36		or omission by a pharmacist in dispensing a dangerous drug under
39	37		Subsection (b-1).
40	38		SECTION 2. Section 555.002(a), Occupations Code, is amended
41	39		to read as follows:
42	40		(a) The board by rule shall establish methods by which
43	41		consumers and service recipients are notified of the name, mailing
44	42		address, and telephone number of the board for the purpose of
45	43		directing complaints to the board. The board may provide for that
46	44		notice:
47	45		(1) on each registration form, application, or written
48	46		contract for services of a person regulated by the board;
49	47		(2) on a sign prominently displayed in the place of
50	48		business of each person regulated by the board; [or]
51	49		(3) on an electronic messaging system in a font
52	50		specified by board rule prominently displayed in the place of
53	51		business of each person regulated by the board; or
54	52		(4) in a bill for service provided by a person
55	53		regulated by the board.
56	54		SECTION 3. Section 556.051, Occupations Code, is amended to
57	55		read as follows:
58	56		Sec. 556.051. AUTHORIZATION TO ENTER AND INSPECT. (a) The
59	57		board or a representative of the board may enter and inspect a
60	58		facility relative to the following:
61	59		(1) drug storage and security;
62	60		(2) equipment;
63	61		(3) components used in compounding, finished and
64	62		unfinished products, containers, and labeling of any item;
65	63		(4) sanitary conditions; [or]
66	64		(5) records, reports, or other documents required to
67	65		be kept or made under this subtitle, Chapter 481 or 483, Health and
68	66		Safety Code, or the Comprehensive Drug Abuse Prevention and Control
69	67		Act of 1970 (21 U.S.C. Section 801 et seq.) or rules adopted under
70	68		one of those laws; or
71	69		(6) subject to Subsection (b), financial records
72	70		relating to the operation of the facility.
73	71		(b) The board or a representative of the board may inspect
74	72		financial records under Subsection (a) only in the course of the
75	73		investigation of a specific complaint. The board or representative
76	74		may inspect only records related to the specific complaint. The
77	75		inspection is subject to Section 565.055.
78	76		SECTION 4. Section 556.054, Occupations Code, is amended to
79	77		read as follows:
80	78		Sec. 556.054. CONFIDENTIALITY OF CERTAIN INFORMATION
81	79		[LIMITATION ON INSPECTION]. The following information obtained by
82	80		the board during an inspection of a facility is confidential and not
83	81		subject to disclosure under Chapter 552, Government Code [Unless
84	82		the owner, pharmacist, or agent in charge of a facility consents in
85	83		writing, an inspection of the facility authorized by this chapter
86	84		may not extend to]:
87	85		(1) financial data;
88	86		(2) sales data, other than shipment data; and [or]
89	87		(3) pricing data.
90	88		SECTION 5. Subchapter B, Chapter 556, Occupations Code, is
91	89		amended by adding Section 556.057 to read as follows:
92	90		Sec. 556.057. INSPECTION OF PHARMACIST RECORDS. A
93	91		pharmacist shall provide to the board, on request, records of the
94	92		pharmacist's practice that occurs outside of a pharmacy. The
95	93		pharmacist shall provide the records at a time specified by board
96	94		rule.
97	95		SECTION 6. Sections 558.055(a) and (b), Occupations Code,
98	96		are amended to read as follows:
99	97		(a) An applicant who on the applicant's first attempt fails
100	98		the examination may take the examination four [two] additional
101	99		times.
102	100		(b) Before an applicant who has failed the examination five
103	101		[three] times is allowed to retake the examination, the applicant
104	102		must provide documentation from a college of pharmacy that the
105	103		applicant has successfully completed additional college course
106	104		work in each examination subject area the applicant failed.
107	105		SECTION 7. Section 560.052(b), Occupations Code, is amended
108	106		to read as follows:
109	107		(b) To qualify for a pharmacy license, an applicant must
110	108		submit to the board:
111	109		(1) a license fee set by the board, except as provided
112	110		by Subsection (d); and
113	111		(2) a completed application that:
114	112		(A) is on a form prescribed by the board;
115	113		(B) is given under oath;
116	114		(C) includes proof that:
117	115		(i) a pharmacy license held by the
118	116		applicant in this state or another state, if applicable, has not
119	117		been restricted, suspended, revoked, or surrendered for any reason;
120	118		and
121	119		(ii) no owner of the pharmacy for which the
122	120		application is made has held a pharmacist license in this state or
123	121		another state, if applicable, that has been restricted, suspended,
124	122		revoked, or surrendered for any reason; and
125	123		(D) includes a statement of:
126	124		(i) the ownership;
127	125		(ii) the location of the pharmacy;
128	126		(iii) the license number of each pharmacist
129	127		who is employed by the pharmacy, if the pharmacy is located in this
130	128		state, or who is licensed to practice pharmacy in this state, if the
131	129		pharmacy is located in another state;
132	130		(iv) the pharmacist license number of the
133	131		pharmacist-in-charge; and
134	132		(v) any other information the board
135	133		determines necessary.
136	134		SECTION 8. Section 561.003(e), Occupations Code, is amended
137	135		to read as follows:
138	136		(e) If a pharmacy's license has been expired for 91 days
139	137		[one year] or more, the pharmacy may not renew the license. The
140	138		pharmacy may obtain a new license by complying with the
141	139		requirements and procedures for obtaining an original license.
142	140		SECTION 9. Sections 562.056(a) and (a-1), Occupations Code,
143	141		are amended to read as follows:
144	142		(a) Before dispensing a prescription, a pharmacist shall
145	143		determine, in the exercise of sound professional judgment, that the
146	144		prescription is a valid prescription. A pharmacist may not
147	145		dispense a prescription drug if the pharmacist knows or should know
148	146		that the prescription was issued [on the basis of an Internet-based
149	147		or telephonic consultation] without a valid practitioner-patient
150	148		relationship.
151	149		(a-1) To be a valid prescription, a prescription [for a
152	150		controlled substance] must be issued for a legitimate medical
153	151		purpose by a practitioner acting in the usual course of the
154	152		practitioner's professional practice. The responsibility for the
155	153		proper prescribing and dispensing of prescription drugs
156	154		[controlled substances] is on the prescribing practitioner, but a
157	155		corresponding responsibility rests with the pharmacist who fills
158	156		the prescription.
159	157		SECTION 10. Section 562.106, Occupations Code, is amended
160	158		by amending Subsection (a) and adding Subsection (a-1) to read as
161	159		follows:
162	160		(a) A pharmacy shall report in writing to the board not
163	161		later than the 10th day after the date of:
164	162		(1) a permanent closing of the pharmacy;
165	163		(2) a change of ownership of the pharmacy;
166	164		(3) [a change of location of the pharmacy;
167	165		[(4)] a change of the person designated as the
168	166		pharmacist-in-charge of the pharmacy;
169	167		(4) [(5)] a sale or transfer of any controlled
170	168		substance or dangerous drug as a result of the permanent closing or
171	169		change of ownership of the pharmacy;
172	170		(5) [(6)] any matter or occurrence that the board
173	171		requires by rule to be reported;
174	172		(6) [(7)] as determined by the board, an out-of-state
175	173		purchase of any controlled substance;
176	174		(7) [(8)] a final order against the pharmacy license
177	175		holder by the regulatory or licensing agency of the state in which
178	176		the pharmacy is located if the pharmacy is located in another state;
179	177		or
180	178		(8) [(9)] a final order against a pharmacist who is
181	179		designated as the pharmacist-in-charge of the pharmacy by the
182	180		regulatory or licensing agency of the state in which the pharmacy is
183	181		located if the pharmacy is located in another state.
184	182		(a-1) A pharmacy shall report in writing to the board not
185	183		later than the 30th day before the date of a change of location of
186	184		the pharmacy.
187	185		SECTION 11. Section 565.002(a), Occupations Code, is
188	186		amended to read as follows:
189	187		(a) The board may discipline an applicant for or the holder
190	188		of a pharmacy license, including a Class E pharmacy license subject
191	189		to Section 565.003 [565.003(b)], if the board finds that the
192	190		applicant or license holder has:
193	191		(1) been convicted of or placed on deferred
194	192		adjudication community supervision or deferred disposition or the
195	193		applicable federal equivalent for:
196	194		(A) a misdemeanor:
197	195		(i) involving moral turpitude; or
198	196		(ii) under Chapter 481 or 483, Health and
199	197		Safety Code, or the Comprehensive Drug Abuse Prevention and Control
200	198		Act of 1970 (21 U.S.C. Section 801 et seq.); or
201	199		(B) a felony;
202	200		(2) advertised a prescription drug or device in a
203	201		deceitful, misleading, or fraudulent manner;
204	202		(3) violated any provision of this subtitle or any
205	203		rule adopted under this subtitle or that an owner or employee of a
206	204		pharmacy has violated any provision of this subtitle or any rule
207	205		adopted under this subtitle;
208	206		(4) sold without legal authorization a prescription
209	207		drug or device to a person other than:
210	208		(A) a pharmacy licensed by the board;
211	209		(B) a practitioner;
212	210		(C) a person who procures a prescription drug or
213	211		device for lawful research, teaching, or testing, and not for
214	212		resale;
215	213		(D) a manufacturer or wholesaler licensed by the
216	214		commissioner of public health as required by Chapter 431, Health
217	215		and Safety Code; or
218	216		(E) a carrier or warehouseman;
219	217		(5) allowed an employee who is not a pharmacist to
220	218		practice pharmacy;
221	219		(6) sold an adulterated or misbranded prescription or
222	220		nonprescription drug;
223	221		(7) failed to engage in or ceased to engage in the
224	222		business described in the application for a license;
225	223		(8) failed to maintain records as required by this
226	224		subtitle, Chapter 481 or 483, Health and Safety Code, the
227	225		Comprehensive Drug Abuse Prevention and Control Act of 1970 (21
228	226		U.S.C. Section 801 et seq.), or any rule adopted under this subtitle
229	227		or Chapter 483, Health and Safety Code;
230	228		(9) failed to establish and maintain effective
231	229		controls against diversion of prescription drugs into other than a
232	230		legitimate medical, scientific, or industrial channel as provided
233	231		by this subtitle, another state statute or rule, or a federal
234	232		statute or rule;
235	233		(10) engaged in fraud, deceit, or misrepresentation as
236	234		defined by board rule in operating a pharmacy or in applying for a
237	235		license to operate a pharmacy;
238	236		(11) violated a disciplinary order;
239	237		(12) been responsible for a drug audit shortage; [or]
240	238		(13) been disciplined by the regulatory board of
241	239		another state for conduct substantially equivalent to conduct
242	240		described under this subsection; or
243	241		(14) waived, discounted, or reduced, or offered to
244	242		waive, discount, or reduce, a patient copayment or deductible for a
245	243		compounded drug in the absence of:
246	244		(A) a legitimate, documented financial hardship
247	245		of the patient; or
248	246		(B) evidence of a good faith effort to collect
249	247		the copayment or deductible from the patient.
250	248		SECTION 12. Section 565.060(d), Occupations Code, is
251	249		amended to read as follows:
252	250		(d) If a license holder complies with and successfully
253	251		completes the terms of a remedial plan, the board shall remove all
254	252		records of the remedial plan from the board's records at the end of
255	253		the state fiscal year in which [on] the fifth anniversary of the
256	254		date the board issued the terms of the remedial plan occurs.
257	255		SECTION 13. Section 565.061(a), Occupations Code, is
258	256		amended to read as follows:
259	257		(a) Except as provided by Chapter 564, a disciplinary action
260	258		taken by the board [under Section 565.060 or] on the basis of a
261	259		ground for discipline under Subchapter A is governed by Chapter
262	260		2001, Government Code, and the rules of practice and procedure
263	261		before the board.
264	262		SECTION 14. The following provisions of the Occupations
265	263		Code are repealed:
266	264		(1) Section 561.003(d);
267	265		(2) Section 562.009(a-1); and
268	266		(3) Section 562.051.
269	267		SECTION 15. The change in law made by this Act to Section
270	268		483.047, Health and Safety Code, applies only to an offense
271	269		committed on or after the effective date of this Act. An offense
272	270		committed before the effective date of this Act is governed by the
273	271		law in effect on the date the offense was committed, and the former
274	272		law is continued in effect for that purpose. For purposes of this
275	273		section, an offense was committed before the effective date of this
276	274		Act if any element of the offense occurred before that date.
277	275		SECTION 16. Section 560.052(b), Occupations Code, as
278	276		amended by this Act, applies only to an application for a pharmacy
279	277		license submitted on or after the effective date of this Act. An
280	278		application submitted before the effective date of this Act is
281	279		governed by the law in effect on the date the application was
282	280		submitted, and the former law is continued in effect for that
283	281		purpose.
284	282		SECTION 17. Section 561.003(e), Occupations Code, as
285	283		amended by this Act, and the repeal by this Act of Section
286	284		561.003(d), Occupations Code, apply only to a pharmacy license that
287	285		expires on or after the effective date of this Act. A pharmacy
288	286		license that expired before the effective date of this Act is
289	287		governed by the law in effect on the date the license expired, and
290	288		the former law is continued in effect for that purpose.
291	289		SECTION 18. Section 562.106(a), Occupations Code, as
292	290		amended by this Act, and Section 562.106(a-1), Occupations Code, as
293	291		added by this Act, apply only to a pharmacy that changes location on
294	292		or after October 1, 2015. A pharmacy that changes location before
295	293		that date is governed by the law in effect immediately before the
296	294		effective date of this Act, and the former law is continued in
297	295		effect for that purpose.
298	296		SECTION 19. The change in law made by this Act to Section
299	297		565.002(a), Occupations Code, applies only to conduct that occurs
300	298		on or after the effective date of this Act. Conduct that occurs
301	299		before that date is governed by the law in effect on the date the
302	300		conduct occurred, and the former law is continued in effect for that
303	301		purpose.
304	302		SECTION 20. The change in law made by this Act to Section
305	303		565.061(a), Occupations Code, is a clarification of existing law
306	304		and does not imply that existing law may be construed as
307	305		inconsistent with the law as amended by this Act.
308	306		SECTION 21. This Act takes effect September 1, 2015.
	307	+	______________________________ ______________________________
	308	+	President of the Senate Speaker of the House
	309	+	I hereby certify that S.B. No. 460 passed the Senate on
	310	+	April 14, 2015, by the following vote: Yeas 31, Nays 0.
	311	+	______________________________
	312	+	Secretary of the Senate
	313	+	I hereby certify that S.B. No. 460 passed the House on
	314	+	May 22, 2015, by the following vote: Yeas 137, Nays 3, two
	315	+	present not voting.
	316	+	______________________________
	317	+	Chief Clerk of the House
	318	+	Approved:
	319	+	______________________________
	320	+	Date
	321	+	______________________________
	322	+	Governor