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