Bill Text: TX SB382 | 2017-2018 | 85th Legislature | Engrossed
Bill Title: Relating to donation of unused prescription drugs; authorizing a fee.
Spectrum: Bipartisan Bill
Status: (Engrossed - Dead) 2017-05-09 - Referred to Public Health [SB382 Detail]
Download: Texas-2017-SB382-Engrossed.html
By: Burton, Zaffirini | S.B. No. 382 |
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relating to donation of unused prescription drugs; authorizing a | ||
fee. | ||
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: | ||
SECTION 1. Subtitle A, Title 6, Health and Safety Code, is | ||
amended by adding Chapter 442 to read as follows: | ||
CHAPTER 442. DONATION OF PRESCRIPTION DRUGS | ||
SUBCHAPTER A. GENERAL PROVISIONS | ||
Sec. 442.001. DEFINITIONS. In this chapter: | ||
(1) "Donor" means an individual who donates unused | ||
prescription drugs under this chapter to a participating provider. | ||
(2) "Health care facility" means a facility that | ||
provides health care services to patients and maintains a pharmacy | ||
in the facility. The term includes the following facilities if a | ||
pharmacy is maintained in the facility: | ||
(A) a general or special hospital as defined by | ||
Chapter 241; | ||
(B) an ambulatory surgical center licensed under | ||
Chapter 243; and | ||
(C) an institution licensed under Chapter 242. | ||
(3) "Health care professional" means an individual | ||
licensed, certified, or otherwise authorized to administer health | ||
care and prescribe prescription drugs, for profit or otherwise, in | ||
the ordinary course of business or professional practice. The term | ||
does not include a health care facility. | ||
(4) "Participating provider" means a health care | ||
facility or pharmacy, or a pharmacist who is an employee of the | ||
facility or pharmacy, that elects to participate in the collection | ||
and redistribution of donated prescription drugs under this | ||
chapter. | ||
(5) "Pharmacist" means a person licensed under Chapter | ||
558, Occupations Code. | ||
(6) "Pharmacy" means an entity licensed under Chapter | ||
560, Occupations Code. | ||
(7) "Prescription drug" has the meaning assigned by | ||
Section 551.003, Occupations Code. | ||
(8) "Recipient" means an individual who voluntarily | ||
receives donated prescription drugs under this chapter. | ||
(9) "Tamper-evident" means packaging that allows for | ||
detection of unauthorized access to a prescription drug. | ||
Sec. 442.002. RULEMAKING AUTHORITY. The executive | ||
commissioner may adopt rules to implement this chapter. | ||
Sec. 442.003. CONSTRUCTION WITH OTHER LAW. This chapter | ||
does not limit the authority of this state or a political | ||
subdivision of this state to regulate or prohibit a prescription | ||
drug. | ||
SUBCHAPTER B. DONATION AND REDISTRIBUTION OF UNUSED PRESCRIPTION | ||
DRUGS | ||
Sec. 442.051. DONATION AND REDISTRIBUTION OF PRESCRIPTION | ||
DRUGS. (a) A donor may donate unused prescription drugs to a | ||
participating provider in accordance with this chapter and rules | ||
adopted under this chapter. | ||
(b) A participating provider may dispense donated | ||
prescription drugs to a recipient in accordance with this chapter | ||
and rules adopted under this chapter. | ||
Sec. 442.052. STANDARDS FOR DONATION AND REDISTRIBUTION. | ||
(a) The executive commissioner by rule shall adopt standards and | ||
procedures for: | ||
(1) accepting, storing, labeling, and dispensing | ||
donated prescription drugs; and | ||
(2) inspecting donated prescription drugs to | ||
determine whether the drugs are adulterated and whether the drugs | ||
are safe and suitable for redistribution. | ||
(b) In adopting standards and procedures under this | ||
section, the executive commissioner shall ensure that the donation | ||
and redistribution process is consistent with public health and | ||
safety standards. | ||
Sec. 442.053. REQUIREMENTS FOR DONATED PRESCRIPTION DRUGS. | ||
(a) A donated prescription drug may be accepted or dispensed under | ||
this chapter only if the drug is in its original, unopened, sealed, | ||
and tamper-evident unit-dose packaging. A drug packaged in single | ||
unit doses may be accepted and dispensed if the outside packaging is | ||
opened but the single unit-dose packaging is unopened. | ||
(b) A donated prescription drug may not be accepted or | ||
dispensed under this chapter if: | ||
(1) the drug is a controlled substance; | ||
(2) the drug is adulterated or misbranded; | ||
(3) the drug is not stored in compliance with the | ||
drug's product label; or | ||
(4) the United States Food and Drug Administration | ||
requires the drug to have a risk evaluation or mitigation strategy. | ||
(c) A participating provider shall comply with all | ||
applicable provisions of state and federal law relating to the | ||
inspection, storage, labeling, and dispensing of prescription | ||
drugs. | ||
Sec. 442.054. DONATION PROCESS. (a) Before being | ||
dispensed to a recipient, a prescription drug donated under this | ||
chapter must be inspected by the participating provider in | ||
accordance with federal law, laws of this state, and department | ||
rule to determine whether the drug is adulterated or misbranded and | ||
whether the drug has been stored in compliance with the | ||
requirements of the product label. | ||
(b) A donated prescription drug dispensed to a recipient | ||
under this chapter must be prescribed by a health care professional | ||
for use by the recipient. | ||
(c) A participating provider may charge a handling fee not | ||
to exceed $20 to a recipient to cover the costs of inspecting, | ||
storing, labeling, and dispensing the donated prescription drug. A | ||
participating provider may not resell a prescription drug donated | ||
under this chapter. A donor may not sell a prescription drug to a | ||
participating provider. | ||
(d) A participating provider may not submit a claim or | ||
otherwise seek reimbursement from any public or private third-party | ||
payor for donated prescription drugs dispensed to a recipient under | ||
this chapter. A public or private third-party payor is not required | ||
to provide reimbursement for donated drugs dispensed to a recipient | ||
under this chapter. | ||
Sec. 442.055. DONOR FORM. Before donating a prescription | ||
drug under this chapter, a donor shall sign a form prescribed by the | ||
department stating that: | ||
(1) the donor is the owner of the donated prescription | ||
drug; | ||
(2) the donated prescription drug has been properly | ||
stored and the container has not been opened or tampered with; | ||
(3) the donated prescription drug has not been | ||
adulterated or misbranded; and | ||
(4) the donor is voluntarily donating the prescription | ||
drug. | ||
Sec. 442.056. RECIPIENT FORM. Before accepting a donated | ||
prescription drug under this chapter, a recipient shall sign a form | ||
prescribed by the department stating that: | ||
(1) the recipient acknowledges that the donor is not a | ||
pharmacist and the donor took ordinary care of the prescription | ||
drug; | ||
(2) the recipient acknowledges that the donor is known | ||
to the participating provider and that there is no reason to believe | ||
that the prescription drug was improperly handled or stored; | ||
(3) by accepting the prescription drug, the recipient | ||
accepts any risk that an accidental mishandling could create; and | ||
(4) the recipient releases the donor, participating | ||
provider, and manufacturer of the drug from liability related to | ||
the prescription drug. | ||
Sec. 442.057. LIMITATION OF LIABILITY. (a) A donor or | ||
participating provider who acts in good faith in donating, | ||
accepting, storing, labeling, distributing, or dispensing | ||
prescription drugs under this chapter: | ||
(1) is not criminally liable and is not subject to | ||
professional disciplinary action for those activities; and | ||
(2) is not civilly liable for damages for bodily | ||
injury, death, or property damage that arises from those activities | ||
unless the injury, death, or damage arises from the donor or | ||
participating provider's recklessness or intentional conduct. | ||
(b) A manufacturer of a prescription drug that donates a | ||
drug under this chapter is not, in the absence of bad faith, | ||
criminally or civilly liable for bodily injury, death, or property | ||
damage arising from the donation, acceptance, or dispensing of the | ||
drug, including the manufacturer's failure to communicate to a | ||
donor or other person: | ||
(1) product or consumer information about the donated | ||
prescription drug; or | ||
(2) the expiration date of the donated prescription | ||
drug. | ||
Sec. 442.058. DATABASE OF PARTICIPATING PROVIDERS. The | ||
department shall establish and maintain an electronic database that | ||
lists each participating provider. The department shall post the | ||
database on its Internet website. | ||
SECTION 2. Not later than December 1, 2017, the executive | ||
commissioner of the Health and Human Services Commission shall | ||
adopt the rules necessary for the implementation of Chapter 442, | ||
Health and Safety Code, as added by this Act. | ||
SECTION 3. If before implementing any provision of this Act | ||
a state agency determines that a waiver or authorization from a | ||
federal agency is necessary for implementation of that provision, | ||
the agency affected by the provision shall request the waiver or | ||
authorization and may delay implementing that provision until the | ||
waiver or authorization is granted. | ||
SECTION 4. This Act takes effect September 1, 2017. |