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A BILL TO BE ENTITLED
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AN ACT
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relating to a pilot program for donation and redistribution of |
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certain unused prescription medications; authorizing a fee. |
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BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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SECTION 1. Chapter 431, Health and Safety Code, is amended |
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by adding Subchapter O to read as follows: |
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SUBCHAPTER O. PRESCRIPTION DRUG DONATION PILOT PROGRAM |
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Sec. 431.451. DEFINITIONS. In this subchapter: |
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(1) "Charitable drug donor" means: |
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(A) a licensed convalescent or nursing facility |
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or related institution, licensed hospice, hospital, physician, or |
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pharmacy; |
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(B) a pharmaceutical seller or manufacturer that |
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donates drugs under a qualified patient assistance program; or |
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(C) the licensed health care professional |
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responsible for administration of drugs in a penal institution, as |
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defined by Section 1.07, Penal Code, in this state. |
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(2) "Charitable medical clinic" has the meaning |
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assigned by Section 431.321. |
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(3) "Manufacturer" means a person, other than a |
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charitable drug donor, as defined in Chapter 82, Civil Practice and |
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Remedies Code. |
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(4) "Patient assistance program" means a qualified |
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program offered by a pharmaceutical manufacturer under which the |
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manufacturer provides drugs to financially disadvantaged persons |
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at no charge or at a substantially reduced cost. The term does not |
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include the provision of a drug as part of a clinical trial. |
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(5) "Pilot program" means the prescription drug |
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donation pilot program under this subchapter. |
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(6) "Prescription drug" has the meaning assigned by |
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Section 551.003, Occupations Code. |
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(7) "Seller" means a person, other than a charitable |
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drug donor, as defined in Chapter 82, Civil Practice and Remedies |
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Code. |
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Sec. 431.452. ESTABLISHMENT OF PILOT PROGRAM. (a) The |
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department shall establish a pilot program for donation and |
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redistribution of prescription drugs under this subchapter. |
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(b) The department shall conduct the pilot program in one or |
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more municipalities with a population of more than 500,000 but less |
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than one million. |
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Sec. 431.453. DONATION OF UNUSED DRUGS. (a) A charitable |
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drug donor may donate certain unused prescription drugs to the |
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department for the pilot program under this subchapter. |
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(b) A seller or manufacturer of a drug that donates drugs |
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through a qualified patient assistance program is considered a |
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charitable drug donor. |
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(c) A charitable drug donor shall use appropriate |
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safeguards established by department rule to ensure that the drugs |
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are not compromised or illegally diverted while being stored or |
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transported. |
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(d) The department may not accept the donated drugs unless: |
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(1) the charitable drug donor certifies that the drugs |
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have been properly stored while in the possession of the donor or of |
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the person for whom the drugs were originally dispensed; |
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(2) the charitable drug donor provides the department |
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with a verifiable address and telephone number; and |
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(3) the person transferring possession of the drugs |
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presents photographic identification. |
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Sec. 431.454. CIRCUMSTANCES UNDER WHICH DONATED DRUGS MAY |
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BE ACCEPTED. (a) The department may accept donated drugs only in |
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accordance with this subchapter. |
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(b) The donated drugs must be: |
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(1) prescription drugs; and |
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(2) approved by the federal Food and Drug |
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Administration and: |
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(A) sealed in unopened tamper-evident unit dose |
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packaging; |
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(B) be oral medication in sealed single-dose |
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containers approved by the federal Food and Drug Administration; or |
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(C) be topical or inhalant drugs in sealed |
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units-of-use containers approved by the federal Food and Drug |
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Administration. |
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(c) A drug packaged in single unit doses may be accepted and |
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distributed if the outside packaging is opened but the single unit |
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dose packaging is unopened. |
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(d) Donated drugs may not: |
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(1) be the subject of a mandatory recall by a state or |
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federal agency or a voluntary recall by a drug seller or |
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manufacturer; |
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(2) be adulterated or misbranded; |
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(3) be a controlled substance under Chapter 481; |
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(4) be a parenteral or injectable medication; |
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(5) require refrigeration; or |
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(6) expire less than 60 days after the date of the |
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donation. |
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(e) The department may distribute the donated drugs only |
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after a licensed pharmacist has determined that the drugs are of an |
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acceptable integrity. |
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(f) The department may not charge a fee for the drugs |
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donated under the pilot program other than a nominal handling fee to |
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defray the costs incurred in implementing the pilot program under |
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this subchapter. |
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(g) The department may not resell the drugs donated under |
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the pilot program. |
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Sec. 431.455. PRESCRIPTION, PROVISION, AND ADMINISTRATION |
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OF DONATED DRUGS. (a) The donated drugs may be accepted and |
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provided or administered to patients only by: |
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(1) a charitable medical clinic; |
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(2) a physician's office using the drugs for patients |
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who receive assistance from the medical assistance program under |
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Chapter 32, Human Resources Code, or for other indigent health |
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care; or |
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(3) a licensed health care professional responsible |
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for administration of drugs in a penal institution, as defined by |
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Section 1.07, Penal Code, in this state. |
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(b) A prescription drug provided or administered to a |
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patient under the pilot program must be prescribed by a |
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practitioner for use by that patient. |
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(c) The clinic or physician providing or administering the |
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drug may charge a nominal handling fee in an amount prescribed by |
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department rule. |
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(d) A clinic, physician, or other licensed health care |
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professional receiving donated drugs may not resell the drugs. |
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Sec. 431.456. CENTRAL DRUG REPOSITORY. The department |
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shall establish a location to centrally store drugs donated under |
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this subchapter for distribution to qualifying recipients. |
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Sec. 431.457. DATABASE OF DONATED DRUGS. The department |
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shall establish and maintain an electronic database in which: |
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(1) the department shall list the name and quantity of |
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each drug donated to the department under the pilot program; and |
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(2) a charitable medical clinic, physician, or other |
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licensed health care professional may search for and request |
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donated drugs. |
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Sec. 431.458. RULES. This subchapter shall be governed by |
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department rules that are designed to protect the public health and |
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safety, including: |
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(1) the maximum handling fee that may be imposed by a |
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clinic or physician providing or administering a donated drug to a |
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patient; |
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(2) provisions for maintenance of the database of |
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donated drugs; and |
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(3) any necessary forms for the administration of the |
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pilot program. |
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Sec. 431.459. LIMITATION ON CIVIL AND CRIMINAL LIABILITY. |
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(a) Charitable drug donors, manufacturers and sellers of donated |
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drugs, charitable medical clinics, physicians, penal institutions, |
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and their employees acting in good faith in providing or |
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administering prescription drugs under the pilot program are not |
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civilly or criminally liable or subject to professional |
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disciplinary action for harm caused by providing or administering |
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drugs donated under this subchapter unless the harm is caused by: |
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(1) wilful or wanton acts of negligence; |
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(2) conscious indifference or reckless disregard for |
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the safety of others; or |
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(3) intentional conduct. |
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(b) This section does not apply if the harm results from the |
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failure to comply with the requirements of this subchapter. |
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(c) This section does not apply to a charitable medical |
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clinic that fails to comply with the insurance provisions of |
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Chapter 84, Civil Practice and Remedies Code. |
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Sec. 431.460. REPORTS TO LEGISLATURE. Not later than |
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January 1 of each odd-numbered year, the department shall report to |
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the legislature on the results of the pilot program. The report |
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must include: |
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(1) the pilot program's efficacy in expanding access |
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to prescription medications; |
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(2) any cost savings to the state or local governments |
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resulting from or projected to result from the pilot program; |
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(3) an evaluation of the pilot program's database and |
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system of distribution; |
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(4) any health and safety issues posed by providing or |
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administering donated drugs; |
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(5) recommendations on improvements to the pilot |
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program; and |
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(6) an evaluation of potential expansion of the pilot |
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program. |
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SECTION 2. Not later than December 1, 2015, the Department |
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of State Health Services shall establish the central repository and |
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database required by Subchapter O, Chapter 431, Health and Safety |
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Code, as added by this Act. |
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SECTION 3. The change in law made by this Act applies only |
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to a drug that is donated, accepted, provided, or administered on or |
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after January 1, 2016. |
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SECTION 4. This Act takes effect September 1, 2015. |