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