Bill Text: TX SB1243 | 2015-2016 | 84th Legislature | Enrolled
Bill Title: Relating to a pilot program for donation and redistribution of certain unused prescription medications; authorizing a fee.
Spectrum: Partisan Bill (Republican 3-0)
Status: (Passed) 2015-06-19 - Effective on 9/1/15 [SB1243 Detail]
Download: Texas-2015-SB1243-Enrolled.html
S.B. No. 1243 |
|
||
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; | ||
(6) expire less than 60 days after the date of the | ||
donation; or | ||
(7) be a drug that is prohibited from being dispensed | ||
to a patient other than a patient who is registered with the drug's | ||
manufacturer in accordance with federal Food and Drug | ||
Administration requirements. | ||
(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. (a) As soon as practicable after the effective | ||
date of this Act, the Department of State Health Services shall | ||
conduct a study to determine the feasibility of establishing a | ||
program under which: | ||
(1) a hospital, a nursing facility, or another health | ||
facility may transfer to the department, or an entity designated by | ||
the department, for no payment, unused drugs that the hospital, | ||
nursing facility, or health facility received reimbursement for the | ||
cost of under Medicaid; and | ||
(2) the department, or the entity designated by the | ||
department, distributes to public hospitals the unused drugs | ||
transferred to the department or entity under Subdivision (1) of | ||
this subsection. | ||
(b) In conducting the study under Subsection (a) of this | ||
section, the Department of State Health Services shall consider the | ||
rules the executive commissioner of the Health and Human Services | ||
Commission may need to adopt to implement the program described in | ||
Subsection (a) of this section, including rules that provide for: | ||
(1) the types of unused drugs that may be transferred | ||
to the department or an entity designated by the department; | ||
(2) the procedures for transferring unused drugs to | ||
the department or the entity designated by the department; | ||
(3) the procedures for allocating and distributing the | ||
unused drugs to public hospitals; and | ||
(4) the qualifications for an entity to be designated | ||
by the department to receive and distribute unused drugs under the | ||
program, including demonstrated expertise in handling, storing, | ||
and assessing prescription and nonprescription drugs and | ||
coordinating with the state's public hospital system. | ||
(c) Not later than September 1, 2016, the Department of | ||
State Health Services shall submit to the legislature a report | ||
containing the findings of the study conducted under Subsection (a) | ||
of this section. | ||
SECTION 3. 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 4. 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 5. This Act takes effect September 1, 2015. | ||
______________________________ | ______________________________ | |
President of the Senate | Speaker of the House | |
I hereby certify that S.B. No. 1243 passed the Senate on | ||
April 29, 2015, by the following vote: Yeas 31, Nays 0; and that | ||
the Senate concurred in House amendments on May 29, 2015, by the | ||
following vote: Yeas 31, Nays 0. | ||
______________________________ | ||
Secretary of the Senate | ||
I hereby certify that S.B. No. 1243 passed the House, with | ||
amendments, on May 26, 2015, by the following vote: Yeas 144, | ||
Nays 1, two present not voting. | ||
______________________________ | ||
Chief Clerk of the House | ||
Approved: | ||
______________________________ | ||
Date | ||
______________________________ | ||
Governor |