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.