Texas 2015 - 84th Regular

Texas Senate Bill SB542 Compare Versions

Only one version of the bill is available at this time.

Old	New	Differences
1	1	84R3483 NC-F
2	2	By: Kolkhorst S.B. No. 542
3	3
4	4
5	5	A BILL TO BE ENTITLED
6	6	AN ACT
7	7	relating to the prescription and pharmaceutical substitution of
8	8	biological products.
9	9	BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
10	10	SECTION 1. Section 562.001, Occupations Code, is amended by
11	11	amending Subdivision (1) and adding Subdivisions (1-a) and (1-b) to
12	12	read as follows:
13	13	(1) "Biological product" has the meaning assigned by
14	14	Section 351, Public Health Service Act (42 U.S.C. Section 262).
15	15	(1-a) "Generically equivalent" means a drug that is
16	16	pharmaceutically equivalent and therapeutically equivalent to the
17	17	drug prescribed.
18	18	(1-b) "Interchangeable," in reference to a biological
19	19	product, has the meaning assigned by Section 351, Public Health
20	20	Service Act (42 U.S.C. Section 262), or means a biological product
21	21	that is designated as therapeutically equivalent to another product
22	22	by the United States Food and Drug Administration in the most recent
23	23	edition or supplement of the United States Food and Drug
24	24	Administration's Approved Drug Products with Therapeutic
25	25	Equivalence Evaluations, also known as the Orange Book.
26	26	SECTION 2. Section 562.002, Occupations Code, is amended to
27	27	read as follows:
28	28	Sec. 562.002. LEGISLATIVE INTENT. It is the intent of the
29	29	legislature to save consumers money by allowing the substitution of
30	30	lower-priced generically equivalent drug products for certain
31	31	brand name drug products and the substitution of interchangeable
32	32	biological products for certain biological products and for
33	33	pharmacies and pharmacists to pass on the net benefit of the lower
34	34	costs of the generically equivalent drug product or interchangeable
35	35	biological product to the purchaser.
36	36	SECTION 3. Section 562.003, Occupations Code, is amended to
37	37	read as follows:
38	38	Sec. 562.003. DISCLOSURE OF PRICE; PATIENT'S OPTION. If
39	39	the price of a drug or biological product to a patient is lower than
40	40	the amount of the patient's copayment under the patient's
41	41	prescription drug insurance plan, the pharmacist shall offer the
42	42	patient the option of paying for the drug or biological product at
43	43	the lower price instead of paying the amount of the copayment.
44	44	SECTION 4. Section 562.005, Occupations Code, is amended to
45	45	read as follows:
46	46	Sec. 562.005. RECORD OF DISPENSED DRUG OR BIOLOGICAL
47	47	PRODUCT. A pharmacist shall record on the prescription form the
48	48	name, strength, and manufacturer or distributor of a drug or
49	49	biological product dispensed as authorized by this subchapter.
50	50	SECTION 5. Subchapter A, Chapter 562, Occupations Code, is
51	51	amended by adding Section 562.0051 to read as follows:
52	52	Sec. 562.0051. COMMUNICATION REGARDING CERTAIN DISPENSED
53	53	BIOLOGICAL PRODUCTS. (a) Within a reasonable time after
54	54	dispensing a biological product, the dispensing pharmacist or the
55	55	pharmacist's designee shall communicate to the prescribing
56	56	practitioner the specific product provided to the patient,
57	57	including the name of the product and the manufacturer.
58	58	(b) The communication must be conveyed by making an entry
59	59	into an interoperable electronic medical records system or through
60	60	electronic prescribing technology or a pharmacy record that is
61	61	electronically accessible by the prescribing practitioner.
62	62	Otherwise, the pharmacist shall communicate the biological product
63	63	dispensed to the prescribing practitioner, using facsimile,
64	64	telephone, electronic transmission, or other prevailing means,
65	65	provided that communication is not required if:
66	66	(1) there is no interchangeable biological product
67	67	approved by the United States Food and Drug Administration for the
68	68	product prescribed; or
69	69	(2) a refill prescription is not changed from the
70	70	product dispensed on the prior filling of the prescription.
71	71	SECTION 6. Section 562.006, Occupations Code, is amended to
72	72	read as follows:
73	73	Sec. 562.006. LABEL. (a) Unless otherwise directed by the
74	74	practitioner, the label on the dispensing container must indicate
75	75	the actual drug or biological product dispensed, indicated by
76	76	either:
77	77	(1) the brand name; or
78	78	(2) if there is not a brand name, the drug's generic
79	79	name or the name of the biological product, the strength of the drug
80	80	or biological product, and the name of the manufacturer or
81	81	distributor of the drug or biological product.
82	82	(b) [(a-1)] In addition to the information required by
83	83	Subsection (a), the label on the dispensing container of a drug or
84	84	biological product dispensed by a Class A or Class E pharmacy must
85	85	indicate:
86	86	(1) the name, address, and telephone number of the
87	87	pharmacy;
88	88	(2) the date the prescription is dispensed;
89	89	(3) the name of the prescribing practitioner;
90	90	(4) the name of the patient or, if the drug or
91	91	biological product was prescribed for an animal, the species of the
92	92	animal and the name of the owner;
93	93	(5) instructions for use;
94	94	(6) the quantity dispensed;
95	95	(7) if the drug or biological product is dispensed in a
96	96	container other than the manufacturer's original container, the
97	97	date after which the prescription should not be used, determined
98	98	according to criteria established by board rule based on standards
99	99	in the United States Pharmacopeia-National Formulary; and
100	100	(8) any other information required by board rule.
101	101	(c) [(a-2)] The information required by Subsection (b)(7)
102	102	[(a-1)(7)] may be recorded on any label affixed to the dispensing
103	103	container.
104	104	(d) [(a-3)] Subsection (b) [(a-1)] does not apply to a
105	105	prescription dispensed to a person at the time of release from
106	106	prison or jail if the prescription is for not more than a 10-day
107	107	supply of medication.
108	108	(e) [(b)] If a drug or biological product has been selected
109	109	other than the one prescribed, the pharmacist shall place on the
110	110	container the words "Substituted for brand prescribed" or
111	111	"Substituted for 'brand name'" where "brand name" is the name of the
112	112	brand name drug or biological product prescribed.
113	113	(f) [(c)] The board shall adopt rules requiring the label on
114	114	a dispensing container to be in plain language and printed in an
115	115	easily readable font size for the consumer.
116	116	SECTION 7. Section 562.008, Occupations Code, is amended to
117	117	read as follows:
118	118	Sec. 562.008. GENERIC EQUIVALENT OR INTERCHANGEABLE
119	119	BIOLOGICAL PRODUCT AUTHORIZED. (a) If a practitioner certifies on
120	120	the prescription form that a specific prescribed brand is medically
121	121	necessary, the pharmacist shall dispense the drug or biological
122	122	product as written by the practitioner. The certification must be
123	123	made as required by the dispensing directive adopted under Section
124	124	562.015. This subchapter does not permit a pharmacist to substitute
125	125	a generically equivalent drug or interchangeable biological
126	126	product unless the substitution is made as provided by this
127	127	subchapter.
128	128	(b) Except as otherwise provided by this subchapter, a
129	129	pharmacist who receives a prescription for a drug or biological
130	130	product for which there is one or more generic equivalents or one or
131	131	more interchangeable biological products may dispense any of the
132	132	generic equivalents or interchangeable biological products.
133	133	SECTION 8. Section 562.009, Occupations Code, is amended to
134	134	read as follows:
135	135	Sec. 562.009. REQUIREMENTS CONCERNING SELECTION OF
136	136	GENERICALLY EQUIVALENT DRUG OR INTERCHANGEABLE BIOLOGICAL PRODUCT.
137	137	(a) Before delivery of a prescription for a generically equivalent
138	138	drug or interchangeable biological product, a pharmacist
139	139	must personally, or through the pharmacist's agent or employee:
140	140	(1) inform the patient or the patient's agent that a
141	141	less expensive generically equivalent drug or interchangeable
142	142	biological product is available for the brand prescribed; and
143	143	(2) ask the patient or the patient's agent to choose
144	144	between the generically equivalent drug or interchangeable
145	145	biological product and the brand prescribed.
146	146	(b) [(a-1)] In addition to the requirements of Subsection
147	147	(a), a pharmacist must display, in a prominent place that is in
148	148	clear public view where prescription drugs or biological products
149	149	are dispensed, a sign in block letters not less than one inch in
150	150	height that reads, in both English and Spanish:
151	151	"TEXAS LAW REQUIRES A PHARMACIST TO INFORM YOU IF A LESS
152	152	EXPENSIVE GENERICALLY EQUIVALENT DRUG OR INTERCHANGEABLE
153	153	BIOLOGICAL PRODUCT IS AVAILABLE FOR CERTAIN BRAND NAME DRUGS OR
154	154	PRODUCTS AND TO ASK YOU TO CHOOSE BETWEEN THE GENERIC OR
155	155	INTERCHANGEABLE BIOLOGICAL PRODUCT AND THE BRAND NAME DRUG OR
156	156	PRODUCT. YOU HAVE A RIGHT TO ACCEPT OR REFUSE THE GENERICALLY
157	157	EQUIVALENT DRUG OR INTERCHANGEABLE BIOLOGICAL PRODUCT."
158	158	(c) [(b)] A pharmacy is not required to comply with the
159	159	provisions of Subsection (a):
160	160	(1) in the case of the refill of a prescription for
161	161	which the pharmacy previously complied with Subsection (a) with
162	162	respect to the same patient or patient's agent; or
163	163	(2) if the patient's physician or physician's agent
164	164	advises the pharmacy that:
165	165	(A) the physician has informed the patient or the
166	166	patient's agent that a less expensive generically equivalent drug
167	167	or interchangeable biological product is available for the brand
168	168	prescribed; and
169	169	(B) the patient or the patient's agent has chosen
170	170	either the brand prescribed or the less expensive generically
171	171	equivalent drug or interchangeable biological product.
172	172	(d) [(c)] A pharmacy that supplies a prescription by mail is
173	173	considered to have complied with the provisions of Subsection (a)
174	174	if the pharmacy includes on the prescription order form completed
175	175	by the patient or the patient's agent language that clearly and
176	176	conspicuously:
177	177	(1) states that if a less expensive generically
178	178	equivalent drug or interchangeable biological product is available
179	179	for the brand prescribed, the patient or the patient's agent may
180	180	choose between the generically equivalent drug or interchangeable
181	181	biological product and the brand prescribed; and
182	182	(2) allows the patient or the patient's agent to
183	183	indicate the choice between [of] the generically equivalent drug or
184	184	interchangeable biological product and [or] the brand prescribed.
185	185	(e) [(d)] If the patient or the patient's agent fails to
186	186	indicate otherwise to a pharmacy on the prescription order form
187	187	under Subsection (d) [(c)], the pharmacy may dispense a generically
188	188	equivalent drug or interchangeable biological product.
189	189	(f) [(e)] If the prescription is for an immunosuppressant
190	190	drug, as defined by Section 562.0141(a)(1), the pharmacist must
191	191	comply with the provisions of Section 562.0141. This subsection
192	192	expires if Section 562.0141 expires under the requirements of
193	193	Section 562.0142.
194	194	SECTION 9. Section 562.010, Occupations Code, is amended to
195	195	read as follows:
196	196	Sec. 562.010. RESPONSIBILITY CONCERNING GENERICALLY
197	197	EQUIVALENT DRUG OR INTERCHANGEABLE BIOLOGICAL PRODUCT; LIABILITY.
198	198	(a) A pharmacist who selects a generically equivalent drug or
199	199	interchangeable biological product to be dispensed under this
200	200	subchapter assumes the same responsibility for selecting the
201	201	generically equivalent drug or interchangeable biological product
202	202	as the pharmacist does in filling a prescription for a drug
203	203	prescribed by generic or biological product name.
204	204	(b) The prescribing practitioner is not liable for a
205	205	pharmacist's act or omission in selecting, preparing, or dispensing
206	206	a drug or biological product under this subchapter.
207	207	SECTION 10. Section 562.011, Occupations Code, is amended
208	208	to read as follows:
209	209	Sec. 562.011. RESTRICTION ON SELECTION OF AND CHARGING FOR
210	210	GENERICALLY EQUIVALENT DRUG OR INTERCHANGEABLE BIOLOGICAL PRODUCT.
211	211	(a) A pharmacist may not select a generically equivalent drug or
212	212	interchangeable biological product unless the generically
213	213	equivalent drug or interchangeable biological product selected
214	214	costs the patient less than the prescribed drug or biological
215	215	product.
216	216	(b) A pharmacist may not charge for dispensing a generically
217	217	equivalent drug or interchangeable biological product a
218	218	professional fee higher than the fee the pharmacist customarily
219	219	charges for dispensing the brand name drug or biological product
220	220	prescribed.
221	221	SECTION 11. Section 562.013, Occupations Code, is amended
222	222	to read as follows:
223	223	Sec. 562.013. APPLICABILITY OF SUBCHAPTER. Unless a drug
224	224	is determined to be generically equivalent to, or a biological
225	225	product is determined to be interchangeable with, the brand
226	226	prescribed, drug or biological product selection as authorized by
227	227	this subchapter does not apply to:
228	228	(1) an enteric-coated tablet;
229	229	(2) a controlled release product;
230	230	(3) an injectable suspension, other than an
231	231	antibiotic;
232	232	(4) a suppository containing active ingredients for
233	233	which systemic absorption is necessary for therapeutic activity; or
234	234	(5) a different delivery system for aerosol or
235	235	nebulizer drugs.
236	236	SECTION 12. Section 562.015(a), Occupations Code, is
237	237	amended to read as follows:
238	238	(a) The board shall adopt rules to provide a dispensing
239	239	directive to instruct pharmacists on the manner in which to
240	240	dispense a drug or biological product according to the contents of a
241	241	prescription. The rules adopted under this section must:
242	242	(1) require the use of the phrase "brand necessary" or
243	243	"brand medically necessary" on a prescription form to prohibit the
244	244	substitution of a generically equivalent drug or interchangeable
245	245	biological product for a brand name drug or biological product;
246	246	(2) be in a format that protects confidentiality as
247	247	required by the Health Insurance Portability and Accountability Act
248	248	of 1996 (Pub. L. No. 104-191) [(29 U.S.C. Section 1181 et seq.)] and
249	249	its subsequent amendments;
250	250	(3) comply with federal and state law, including
251	251	rules, with regard to formatting and security requirements;
252	252	(4) be developed to coordinate with 42 C.F.R. Section
253	253	447.512 [447.331(c)]; and
254	254	(5) include an exemption for electronic prescriptions
255	255	as provided by Subsection (b).
256	256	SECTION 13. (a) Chapter 562, Occupations Code, as amended
257	257	by this Act, applies only to a prescription issued for a biological
258	258	product on or after December 1, 2015. A prescription issued for a
259	259	biological product before December 1, 2015, is governed by the law
260	260	in effect immediately before that date, and the former law is
261	261	continued in effect for that purpose.
262	262	(b) The Texas State Board of Pharmacy shall adopt rules
263	263	necessary to implement the changes in law made by this Act not later
264	264	than December 1, 2015.
265	265	SECTION 14. This Act takes effect September 1, 2015.