84R23826 JSC-D
By: Sheffield H.B. No. 2271
Substitute the following for H.B. No. 2271:
By: Crownover C.S.H.B. No. 2271
A BILL TO BE ENTITLED
AN ACT
relating to a pilot program for donation and redistribution of
certain unused prescription medications; authorizing a fee.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
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.
(5) "Pilot program" means the prescription drug
donation pilot program under this subchapter.
(6) "Prescription drug" has the meaning assigned by
Section 551.003, Occupations Code.
(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.
SECTION 2. Not later than December 1, 2015, the Department
of State Health Services shall establish the central repository and
database required by Subchapter O, Chapter 431, Health and Safety
Code, as added by this Act.
SECTION 3. The change in law made by this Act applies only
to a drug that is donated, accepted, provided, or administered on or
after January 1, 2016.
SECTION 4. This Act takes effect September 1, 2015.