84R9863 JSC-D

By: Sheffield H.B. No. 2271

A BILL TO BE ENTITLED

AN ACT

relating to the prescription drug donation program; authorizing fees.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:

SECTION 1. Subchapter M, Chapter 431, Health and Safety Code, is amended to read as follows:

SUBCHAPTER M. PRESCRIPTION DRUG DONATION PROGRAM

Sec. 431.321. DEFINITIONS. In this subchapter:

(1) "Charitable drug donor" means:

(A) a licensed convalescent or nursing home or related institution, licensed hospice, hospital, physician, or pharmacy; or

(B) a pharmaceutical seller or manufacturer that donates drugs under a qualified patient assistance program.

(2) [(a)] "Charitable medical clinic" means a clinic, including a licensed pharmacy that is a community pharmaceutical access program provider, that provides medical care or drugs without charge or for a substantially reduced charge, complies with the insurance requirements of Chapter 84, Civil Practice and Remedies Code, and is exempt from federal income tax under Section 501(a) of the Internal Revenue Code of 1986 by being listed as an exempt organization in Section 501(c)(3) or 501(c)(4) of the code and is operated exclusively for the promotion of social welfare by being primarily engaged in promoting the common good and general welfare of the people in a community.

(3) "Community pharmaceutical access program" means a program offered by a licensed pharmacy under which the pharmacy assists financially disadvantaged persons by providing access to prescription drugs at no charge or at a substantially reduced charge.

(4) "Department" means the Department of State Health Services.

(5) [(b) "Seller" means a person, other than a charitable drug donor, as defined in Chapter 82, Civil Practice and Remedies Code.

[(c)] "Manufacturer" means a person, other than a charitable drug donor, as defined in Chapter 82, Civil Practice and Remedies Code.

(6) "Patient [(d) "Charitable drug donor" means a licensed convalescent or nursing home or related institution, licensed hospice, hospital, physician, pharmacy, or a pharmaceutical seller or manufacturer that donates drugs pursuant to a qualified patient assistance program, that donates drugs to a charitable medical clinic.

[(d-1) In this subchapter, "community pharmaceutical access program" means a program offered by a licensed pharmacy under which the pharmacy assists financially disadvantaged persons to access prescription drugs at no charge or at a substantially reduced charge.

[(e) In this subchapter, "patient] assistance program" means a qualified program offered by a pharmaceutical manufacturer under which the manufacturer provides drugs to financially disadvantaged persons at no charge or at a substantially reduced cost. The term does not include the provision of a drug as part of a clinical trial.

(7) "Prescription drug" has the meaning assigned by Section 551.003, Occupations Code.

(8) "Program" means the prescription drug donation program under this subchapter.

(9) "Seller" means a person, other than a charitable drug donor, as defined in Chapter 82, Civil Practice and Remedies Code.

Sec. 431.322. DONATION OF UNUSED DRUGS [TO CHARITABLE MEDICAL CLINIC]. (a) A charitable drug donor may donate certain unused prescription drugs to the department for the program under [a charitable medical clinic, and a charitable clinic may accept, dispense, or administer the donated drugs in accordance with] this subchapter.

(b) A seller or manufacturer of a drug may not donate drugs to the department [a charitable medical clinic] except under [pursuant to] a qualified patient assistance program. A seller or manufacturer of a drug that donates drugs through a qualified patient assistance program is [shall be] considered a charitable drug donor.

(c) A [The] charitable drug donor shall use appropriate safeguards established by the department [board] to ensure that the drugs are not compromised or illegally diverted while being stored or transported [to the charitable medical clinic].

(d) The department [charitable medical clinic] may not accept the donated drugs unless:

(1) the charitable drug donor certifies that the drugs have been properly stored while in the possession of the donor or of the person for whom the drugs were originally dispensed;

(2) the charitable drug donor provides the department [clinic] with a verifiable address and telephone number; and

(3) the person transferring possession of the drugs presents [the charitable medical clinic with] photographic identification.

Sec. 431.323. CIRCUMSTANCES UNDER WHICH DONATED DRUGS MAY BE ACCEPTED [AND DISPENSED]. (a) The department [A charitable medical clinic] may accept [and dispense or administer] donated drugs only in accordance with this subchapter.

(b) The donated drugs must be:

(1) [drugs that require a] prescription drugs;

(2) [. A donated drug may not be a controlled substance under Chapter 481.

[(c) The donated drugs must be] approved by the federal Food and Drug Administration and:

(A) [(1) be] sealed in the manufacturer's unopened original tamper-evident packaging and either:

(i) [(A)] individually packaged; or

(ii) [(B)] packaged in unit-dose packaging;

(B) [(2)] be oral [or parenteral] medication in sealed single-dose containers approved by the federal Food and Drug Administration; or

(C) [(3)] be topical or inhalant drugs in sealed units-of-use containers approved by the federal Food and Drug Administration.

(c) Donated drugs may [; or

[(4) be parenteral medication in sealed multiple-dose containers approved by the federal Food and Drug Administration from which no doses have been withdrawn; and

[(5) must] not:

(1) be the subject of a mandatory recall by a state or federal agency or a voluntary recall by a drug seller or manufacturer;

(2) be adulterated or misbranded;

(3) be a controlled substance under Chapter 481;

(4) be a parenteral or injectable medication;

(5) require refrigeration; or

(6) expire less than 60 days after the date of the donation.

(d) The department [charitable medical clinic] may distribute [dispense or administer] the donated drugs only[:

[(1) before the expiration date or within the recommended shelf life of the donated drugs, as applicable; and

[(2)] after a licensed pharmacist has determined that the drugs are of an acceptable integrity.

(e) The department may not charge a fee for the drugs donated under the program other than a nominal handling fee to defray the costs incurred in implementing the program under this subchapter.

(f) The department may not resell the drugs donated under the program.

Sec. 431.3231. DISPENSATION OF DONATED DRUGS. (a) [(e)] The donated drugs may be accepted and dispensed or administered only by:

(1) a [the] charitable medical clinic; or

(2) a physician's office using the drugs for patients who receive assistance from the medical assistance program under Chapter 32, Human Resources Code [only in accordance with rules adopted by the department].

(b) A prescription drug dispensed or administered to a patient under the program must be prescribed by a practitioner for use by that patient.

(c) The clinic or physician dispensing or administering the drug may charge a nominal handling fee in an amount prescribed by department rule.

(d) A clinic or physician receiving donated drugs may not resell the drugs.

Sec. 431.3232. CENTRAL DRUG REPOSITORY. The department shall establish a location to centrally store drugs donated under this subchapter for disbursement to qualifying recipients.

Sec. 431.3233. DATABASE OF DONATED DRUGS. The department shall establish and maintain an electronic database in which:

(1) the department shall list the name and quantity of each drug donated to the department under the program; and

(2) a charitable medical clinic or physician may search for and request donated drugs.

Sec. 431.324. RULES. The executive commissioner of the Health and Human Services Commission [department] shall adopt rules to implement this subchapter that are designed to protect the public health and safety, including:

(1) the maximum handling fee that may be imposed by a clinic or physician dispensing or administering a donated drug;

(2) provisions for maintenance of the database of donated drugs; and

(3) any necessary forms for the administration of the program.

Sec. 431.325. LIMITATION ON CIVIL AND CRIMINAL LIABILITY. (a) Charitable drug donors, charitable medical clinics, physicians, and their employees are not civilly or criminally liable or subject to professional disciplinary action for harm caused by the [accepting,] dispensing[,] or administering of drugs donated under [in strict compliance with] this subchapter unless the harm is caused by:

(1) wilful [(i) willful] or wanton acts of negligence;

(2) [(ii)] conscious indifference or reckless disregard for the safety of others; or

(3) [(iii)] intentional conduct.

(b) This section does not limit, or in any way affect or diminish, the liability of a drug seller or manufacturer under [pursuant to] Chapter 82, Civil Practice and Remedies Code.

(c) This section does [shall] not apply if the [where] harm results from the failure to [fully and completely] comply with the requirements of this subchapter.

(d) This section does [shall] not apply to a charitable medical clinic that fails to comply with the insurance provisions of Chapter 84, Civil Practice and Remedies Code.

SECTION 2. Not later than December 1, 2015:

(1) the executive commissioner of the Health and Human Services Commission shall adopt any rules necessary to implement Subchapter M, Chapter 431, Health and Safety Code, as amended by this Act; and

(2) the Department of State Health Services shall establish the central repository and database required by Subchapter M, Chapter 431, Health and Safety Code, as amended by this Act.

SECTION 3. (a) The change in law made by this Act applies only to a drug that is donated, accepted, dispensed, or administered on or after January 1, 2016.

(b) Notwithstanding Subsection (a) of this section, a charitable medical clinic that, on January 1, 2016, possesses drugs donated under Subchapter M, Chapter 431, Health and Safety Code, as it existed immediately before the effective date of this Act, may dispense those remaining drugs in accordance with the former law.

SECTION 4. This Act takes effect September 1, 2015.