Texas 2017 - 85th Regular

Texas Senate Bill SB382 Compare Versions

Version 1 (Old)

Version 2 (New)

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1		-	By: Burton S.B. No. 382
2		-	(In the Senate - Filed December 20, 2016; February 1, 2017,
3		-	read first time and referred to Committee on Health & Human
4		-	Services; April 26, 2017, reported adversely, with favorable
5		-	Committee Substitute by the following vote: Yeas 9, Nays 0;
6		-	April 26, 2017, sent to printer.)
7		-	Click here to see the committee vote
8		-	COMMITTEE SUBSTITUTE FOR S.B. No. 382 By: Burton
	1	+	By: Burton, Zaffirini S.B. No. 382
9	2
10	3
11	4		A BILL TO BE ENTITLED
12	5		AN ACT
13	6		relating to donation of unused prescription drugs; authorizing a
14	7		fee.
15	8		BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
16	9		SECTION 1. Subtitle A, Title 6, Health and Safety Code, is
17	10		amended by adding Chapter 442 to read as follows:
18	11		CHAPTER 442. DONATION OF PRESCRIPTION DRUGS
19	12		SUBCHAPTER A. GENERAL PROVISIONS
20	13		Sec. 442.001. DEFINITIONS. In this chapter:
21	14		(1) "Donor" means an individual who donates unused
22	15		prescription drugs under this chapter to a participating provider.
23	16		(2) "Health care facility" means a facility that
24	17		provides health care services to patients and maintains a pharmacy
25	18		in the facility. The term includes the following facilities if a
26	19		pharmacy is maintained in the facility:
27	20		(A) a general or special hospital as defined by
28	21		Chapter 241;
29	22		(B) an ambulatory surgical center licensed under
30	23		Chapter 243; and
31	24		(C) an institution licensed under Chapter 242.
32	25		(3) "Health care professional" means an individual
33	26		licensed, certified, or otherwise authorized to administer health
34	27		care and prescribe prescription drugs, for profit or otherwise, in
35	28		the ordinary course of business or professional practice. The term
36	29		does not include a health care facility.
37	30		(4) "Participating provider" means a health care
38	31		facility or pharmacy, or a pharmacist who is an employee of the
39	32		facility or pharmacy, that elects to participate in the collection
40	33		and redistribution of donated prescription drugs under this
41	34		chapter.
42	35		(5) "Pharmacist" means a person licensed under Chapter
43	36		558, Occupations Code.
44	37		(6) "Pharmacy" means an entity licensed under Chapter
45	38		560, Occupations Code.
46	39		(7) "Prescription drug" has the meaning assigned by
47	40		Section 551.003, Occupations Code.
48	41		(8) "Recipient" means an individual who voluntarily
49	42		receives donated prescription drugs under this chapter.
50	43		(9) "Tamper-evident" means packaging that allows for
51	44		detection of unauthorized access to a prescription drug.
52	45		Sec. 442.002. RULEMAKING AUTHORITY. The executive
53	46		commissioner may adopt rules to implement this chapter.
54	47		Sec. 442.003. CONSTRUCTION WITH OTHER LAW. This chapter
55	48		does not limit the authority of this state or a political
56	49		subdivision of this state to regulate or prohibit a prescription
57	50		drug.
58	51		SUBCHAPTER B. DONATION AND REDISTRIBUTION OF UNUSED PRESCRIPTION
59	52		DRUGS
60	53		Sec. 442.051. DONATION AND REDISTRIBUTION OF PRESCRIPTION
61	54		DRUGS. (a) A donor may donate unused prescription drugs to a
62	55		participating provider in accordance with this chapter and rules
63	56		adopted under this chapter.
64	57		(b) A participating provider may dispense donated
65	58		prescription drugs to a recipient in accordance with this chapter
66	59		and rules adopted under this chapter.
67	60		Sec. 442.052. STANDARDS FOR DONATION AND REDISTRIBUTION.
68	61		(a) The executive commissioner by rule shall adopt standards and
69	62		procedures for:
70	63		(1) accepting, storing, labeling, and dispensing
71	64		donated prescription drugs; and
72	65		(2) inspecting donated prescription drugs to
73	66		determine whether the drugs are adulterated and whether the drugs
74	67		are safe and suitable for redistribution.
75	68		(b) In adopting standards and procedures under this
76	69		section, the executive commissioner shall ensure that the donation
77	70		and redistribution process is consistent with public health and
78	71		safety standards.
79	72		Sec. 442.053. REQUIREMENTS FOR DONATED PRESCRIPTION DRUGS.
80	73		(a) A donated prescription drug may be accepted or dispensed under
81	74		this chapter only if the drug is in its original, unopened, sealed,
82	75		and tamper-evident unit-dose packaging. A drug packaged in single
83	76		unit doses may be accepted and dispensed if the outside packaging is
84	77		opened but the single unit-dose packaging is unopened.
85	78		(b) A donated prescription drug may not be accepted or
86	79		dispensed under this chapter if:
87	80		(1) the drug is a controlled substance;
88	81		(2) the drug is adulterated or misbranded;
89	82		(3) the drug is not stored in compliance with the
90	83		drug's product label; or
91	84		(4) the United States Food and Drug Administration
92	85		requires the drug to have a risk evaluation or mitigation strategy.
93	86		(c) A participating provider shall comply with all
94	87		applicable provisions of state and federal law relating to the
95	88		inspection, storage, labeling, and dispensing of prescription
96	89		drugs.
97	90		Sec. 442.054. DONATION PROCESS. (a) Before being
98	91		dispensed to a recipient, a prescription drug donated under this
99	92		chapter must be inspected by the participating provider in
100	93		accordance with federal law, laws of this state, and department
101	94		rule to determine whether the drug is adulterated or misbranded and
102	95		whether the drug has been stored in compliance with the
103	96		requirements of the product label.
104	97		(b) A donated prescription drug dispensed to a recipient
105	98		under this chapter must be prescribed by a health care professional
106	99		for use by the recipient.
107	100		(c) A participating provider may charge a handling fee not
108	101		to exceed $20 to a recipient to cover the costs of inspecting,
109	102		storing, labeling, and dispensing the donated prescription drug. A
110	103		participating provider may not resell a prescription drug donated
111	104		under this chapter. A donor may not sell a prescription drug to a
112	105		participating provider.
113	106		(d) A participating provider may not submit a claim or
114	107		otherwise seek reimbursement from any public or private third-party
115	108		payor for donated prescription drugs dispensed to a recipient under
116	109		this chapter. A public or private third-party payor is not required
117	110		to provide reimbursement for donated drugs dispensed to a recipient
118	111		under this chapter.
119	112		Sec. 442.055. DONOR FORM. Before donating a prescription
120	113		drug under this chapter, a donor shall sign a form prescribed by the
121	114		department stating that:
122	115		(1) the donor is the owner of the donated prescription
123	116		drug;
124	117		(2) the donated prescription drug has been properly
125	118		stored and the container has not been opened or tampered with;
126	119		(3) the donated prescription drug has not been
127	120		adulterated or misbranded; and
128	121		(4) the donor is voluntarily donating the prescription
129	122		drug.
130	123		Sec. 442.056. RECIPIENT FORM. Before accepting a donated
131	124		prescription drug under this chapter, a recipient shall sign a form
132	125		prescribed by the department stating that:
133	126		(1) the recipient acknowledges that the donor is not a
134	127		pharmacist and the donor took ordinary care of the prescription
135	128		drug;
136	129		(2) the recipient acknowledges that the donor is known
137	130		to the participating provider and that there is no reason to believe
138	131		that the prescription drug was improperly handled or stored;
139	132		(3) by accepting the prescription drug, the recipient
140	133		accepts any risk that an accidental mishandling could create; and
141	134		(4) the recipient releases the donor, participating
142	135		provider, and manufacturer of the drug from liability related to
143	136		the prescription drug.
144	137		Sec. 442.057. LIMITATION OF LIABILITY. (a) A donor or
145	138		participating provider who acts in good faith in donating,
146	139		accepting, storing, labeling, distributing, or dispensing
147	140		prescription drugs under this chapter:
148	141		(1) is not criminally liable and is not subject to
149	142		professional disciplinary action for those activities; and
150	143		(2) is not civilly liable for damages for bodily
151	144		injury, death, or property damage that arises from those activities
152	145		unless the injury, death, or damage arises from the donor or
153	146		participating provider's recklessness or intentional conduct.
154	147		(b) A manufacturer of a prescription drug that donates a
155	148		drug under this chapter is not, in the absence of bad faith,
156	149		criminally or civilly liable for bodily injury, death, or property
157	150		damage arising from the donation, acceptance, or dispensing of the
158	151		drug, including the manufacturer's failure to communicate to a
159	152		donor or other person:
160	153		(1) product or consumer information about the donated
161	154		prescription drug; or
162	155		(2) the expiration date of the donated prescription
163	156		drug.
164	157		Sec. 442.058. DATABASE OF PARTICIPATING PROVIDERS. The
165	158		department shall establish and maintain an electronic database that
166	159		lists each participating provider. The department shall post the
167	160		database on its Internet website.
168	161		SECTION 2. Not later than December 1, 2017, the executive
169	162		commissioner of the Health and Human Services Commission shall
170	163		adopt the rules necessary for the implementation of Chapter 442,
171	164		Health and Safety Code, as added by this Act.
172	165		SECTION 3. If before implementing any provision of this Act
173	166		a state agency determines that a waiver or authorization from a
174	167		federal agency is necessary for implementation of that provision,
175	168		the agency affected by the provision shall request the waiver or
176	169		authorization and may delay implementing that provision until the
177	170		waiver or authorization is granted.
178	171		SECTION 4. This Act takes effect September 1, 2017.
179		-	* * * * *