Texas 2013 - 83rd Regular

Texas Senate Bill SB1100 Compare Versions

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1	1	By: Van de Putte S.B. No. 1100
2	2	(King of Taylor)
3	3
4	4
5	5	A BILL TO BE ENTITLED
6	6	AN ACT
7	7	relating to the licensing and inspection of certain out-of-state
8	8	pharmacies by the Texas State Board of Pharmacy; authorizing fees.
9	9	BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
10	10	SECTION 1. Subchapter B, Chapter 556, Occupations Code, is
11	11	amended by adding Section 556.0551 to read as follows:
12	12	Sec. 556.0551. INSPECTION OF LICENSED NONRESIDENT
13	13	PHARMACY. (a) The board may inspect a nonresident pharmacy
14	14	licensed by the board that compounds sterile preparations as
15	15	necessary to ensure compliance with the safety standards and other
16	16	requirements of this subtitle and board rules.
17	17	(b) A nonresident pharmacy shall reimburse the board for all
18	18	expenses, including travel, incurred by the board in inspecting the
19	19	pharmacy as provided by Subsection (a).
20	20	SECTION 2. Subsection (b), Section 560.001, Occupations
21	21	Code, is amended to read as follows:
22	22	(b) A pharmacy located in another state may not ship, mail,
23	23	or deliver to this state a prescription drug or device dispensed
24	24	under a prescription drug order, or dispensed or delivered as
25	25	authorized by Subchapter D, Chapter 562, [to a resident of this
26	26	state] unless the pharmacy is licensed by the board or is exempt
27	27	under Section 560.004.
28	28	SECTION 3. Section 560.052, Occupations Code, is amended by
29	29	amending Subsections (b) and (c) and adding Subsections (g) and (h)
30	30	to read as follows:
31	31	(b) To qualify for a pharmacy license, an applicant must
32	32	submit to the board:
33	33	(1) a license fee set by the board, except as provided
34	34	by Subsection (d); and
35	35	(2) a completed application that:
36	36	(A) is on a form prescribed by the board;
37	37	(B) is given under oath; and
38	38	(C) includes a statement of:
39	39	(i) the ownership;
40	40	(ii) the location of the pharmacy;
41	41	(iii) the license number of each pharmacist
42	42	who is employed by the pharmacy, if the pharmacy is located in this
43	43	state, or who is licensed to practice pharmacy in this state, if the
44	44	pharmacy is located in another state [a Class E pharmacy];
45	45	(iv) the license number of the
46	46	pharmacist-in-charge; and
47	47	(v) any other information the board
48	48	determines necessary.
49	49	(c) A pharmacy located in another state that applies for a
50	50	license [To qualify for a Class E pharmacy license, an applicant],
51	51	in addition to satisfying the other requirements of this chapter,
52	52	must provide to the board:
53	53	(1) evidence that the applicant holds a pharmacy
54	54	license, registration, or permit in good standing issued by the
55	55	state in which the pharmacy is located;
56	56	(2) the name of the owner and pharmacist-in-charge of
57	57	the pharmacy for service of process;
58	58	(3) evidence of the applicant's ability to provide to
59	59	the board a record of a prescription drug order dispensed or
60	60	delivered as authorized by Subchapter D, Chapter 562, by the
61	61	applicant to a resident of or practitioner in this state not later
62	62	than 72 hours after the time the board requests the record;
63	63	(4) an affidavit by the pharmacist-in-charge that
64	64	states that the pharmacist has read and understands the laws and
65	65	rules relating to the applicable license [a Class E pharmacy];
66	66	(5) proof of creditworthiness; [and]
67	67	(6) an inspection report issued:
68	68	(A) not more than two years before the date the
69	69	license application is received; and
70	70	(B) by the pharmacy licensing board in the state
71	71	of the pharmacy's physical location, except as provided by
72	72	Subsection (f); and
73	73	(7) any other information the board determines
74	74	necessary.
75	75	(g) A license may not be issued to a pharmacy that compounds
76	76	sterile preparations unless the pharmacy has been inspected by the
77	77	board to ensure the pharmacy meets the safety standards and other
78	78	requirements of this subtitle and board rules.
79	79	(h) The board may accept, as satisfying the inspection
80	80	requirement in Subsection (g) for a pharmacy located in another
81	81	state, an inspection report issued by the pharmacy licensing board
82	82	in the state in which the pharmacy is located if:
83	83	(1) the board determines that the other state has
84	84	comparable standards and regulations applicable to pharmacies,
85	85	including standards and regulations related to health and safety;
86	86	and
87	87	(2) the pharmacy provides to the board any requested
88	88	documentation related to the inspection.
89	89	SECTION 4. Chapter 561, Occupations Code, is amended by
90	90	adding Section 561.0032 to read as follows:
91	91	Sec. 561.0032. ADDITIONAL RENEWAL REQUIREMENT FOR
92	92	COMPOUNDING PHARMACY. (a) In addition to the renewal requirements
93	93	under Section 561.003, a pharmacy that compounds sterile
94	94	preparations may not renew a pharmacy license unless the pharmacy:
95	95	(1) has been inspected as provided by board rule; and
96	96	(2) if the pharmacy is located in another state, has
97	97	reimbursed the board for all expenses, including travel, incurred
98	98	by the board in inspecting the pharmacy during the term of the
99	99	expiring license.
100	100	(b) The board may accept, as satisfying the inspection
101	101	requirement in Subsection (a) for a pharmacy located in another
102	102	state, an inspection report issued by the pharmacy licensing board
103	103	in the state in which the pharmacy is located if:
104	104	(1) the board determines that the other state has
105	105	comparable standards and regulations applicable to pharmacies,
106	106	including standards and regulations related to health and safety;
107	107	and
108	108	(2) the pharmacy provides to the board any requested
109	109	documentation related to the inspection.
110	110	SECTION 5. Subsection (a), Section 562.106, Occupations
111	111	Code, is amended to read as follows:
112	112	(a) A pharmacy shall report in writing to the board not
113	113	later than the 10th day after the date of:
114	114	(1) a permanent closing of the pharmacy;
115	115	(2) a change of ownership of the pharmacy;
116	116	(3) a change of location of the pharmacy;
117	117	(4) a change of the person designated as the
118	118	pharmacist-in-charge of the pharmacy;
119	119	(5) a sale or transfer of any controlled substance or
120	120	dangerous drug as a result of the permanent closing or change of
121	121	ownership of the pharmacy;
122	122	(6) any matter or occurrence that the board requires
123	123	by rule to be reported;
124	124	(7) as determined by the board, an out-of-state
125	125	purchase of any controlled substance;
126	126	(8) a final order against the pharmacy license holder
127	127	by the regulatory or licensing agency of the state in which the
128	128	pharmacy is located if the pharmacy is located in another state [a
129	129	Class E pharmacy]; or
130	130	(9) a final order against a pharmacist who is
131	131	designated as the pharmacist-in-charge of the pharmacy by the
132	132	regulatory or licensing agency of the state in which the pharmacy is
133	133	located if the pharmacy is located in another state [a Class E
134	134	pharmacy].
135	135	SECTION 6. Subchapter D, Chapter 562, Occupations Code, is
136	136	amended by adding Section 562.156 to read as follows:
137	137	Sec. 562.156. COMPOUNDED STERILE PREPARATION; NOTICE TO
138	138	BOARD. (a) A pharmacy may not compound and dispense a sterile
139	139	preparation unless the pharmacy holds a license as required by
140	140	board rule.
141	141	(b) A pharmacy that compounds a sterile preparation shall
142	142	notify the board:
143	143	(1) immediately of any adverse effects reported to the
144	144	pharmacy or that are known by the pharmacy to be potentially
145	145	attributable to a sterile preparation compounded by the pharmacy;
146	146	and
147	147	(2) not later than 24 hours after the pharmacy issues a
148	148	recall for a sterile preparation compounded by the pharmacy.
149	149	SECTION 7. Section 565.003, Occupations Code, is amended to
150	150	read as follows:
151	151	Sec. 565.003. ADDITIONAL GROUNDS FOR DISCIPLINE REGARDING
152	152	APPLICANT FOR OR HOLDER OF NONRESIDENT [CLASS E] PHARMACY LICENSE.
153	153	[(b)] Unless compliance would violate the pharmacy or drug
154	154	statutes or rules in the state in which the pharmacy is located the
155	155	board may discipline an applicant for or the holder of a nonresident
156	156	[Class E] pharmacy license if the board finds that the applicant or
157	157	license holder has failed to comply with:
158	158	(1) Section 481.074 or 481.075, Health and Safety
159	159	Code;
160	160	(2) Texas substitution requirements regarding:
161	161	(A) the practitioner's directions concerning
162	162	generic substitution;
163	163	(B) the patient's right to refuse generic
164	164	substitution; or
165	165	(C) notification to the patient of the patient's
166	166	right to refuse substitution;
167	167	(3) any board rule relating to providing drug
168	168	information to the patient or the patient's agent in written form or
169	169	by telephone; or
170	170	(4) any board rule adopted under Section 554.051(a)
171	171	and determined by the board to be applicable under Section
172	172	554.051(b).
173	173	SECTION 8. Section 565.053, Occupations Code, is amended to
174	174	read as follows:
175	175	Sec. 565.053. DISCIPLINE OF NONRESIDENT [CLASS E] PHARMACY;
176	176	NOTICE TO RESIDENT STATE. The board shall give notice of a
177	177	disciplinary action by the board against a license [the] holder
178	178	located in another state [of a Class E pharmacy license] to the
179	179	regulatory or licensing agency of the state in which the pharmacy is
180	180	located.
181	181	SECTION 9. The heading to Section 565.054, Occupations
182	182	Code, is amended to read as follows:
183	183	Sec. 565.054. SERVICE OF PROCESS ON NONRESIDENT [CLASS E]
184	184	PHARMACY.
185	185	SECTION 10. Subsection (a), Section 565.054, Occupations
186	186	Code, is amended to read as follows:
187	187	(a) Service of process on a nonresident [Class E] pharmacy
188	188	under Section 565.058 or 566.051 or for disciplinary action taken
189	189	by the board under Section 565.061 shall be on the owner and
190	190	pharmacist-in-charge of the pharmacy, as designated on the
191	191	pharmacy's license application.
192	192	SECTION 11. Not later than March 1, 2014, the Texas State
193	193	Board of Pharmacy shall adopt rules necessary to implement the
194	194	changes in law made by this Act.
195	195	SECTION 12. Section 560.052, Occupations Code, as amended
196	196	by this Act, applies only to an application for a pharmacy license
197	197	submitted to the Texas State Board of Pharmacy on or after the
198	198	effective date of this Act. An application for a license submitted
199	199	before the effective date of this Act is governed by the law in
200	200	effect on the date the application was submitted, and the former law
201	201	is continued in effect for that purpose.
202	202	SECTION 13. Section 561.0032, Occupations Code, as added by
203	203	this Act, applies only to the renewal of a pharmacy license that
204	204	expires on or after the effective date of this Act. A license that
205	205	expires before the effective date of this Act is governed by the law
206	206	in effect on the date the license expired, and the former law is
207	207	continued in effect for that purpose.
208	208	SECTION 14. This Act takes effect September 1, 2013.