81R9600 ALB-D
By: Cook H.B. No. 3156
A BILL TO BE ENTITLED
AN ACT
relating to a drug donation program.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. Subtitle A, Title 6, Health and Safety Code, is
amended by adding Chapter 442 to read as follows:
CHAPTER 442. DRUG DONATION PROGRAM
Sec. 442.001. DEFINITIONS. In this chapter:
(1) "Commission" means the Health and Human Services
Commission.
(2) "Department" means the Department of State Health
Services.
(3) "Executive commissioner" means the executive
commissioner of the Health and Human Services Commission.
(4) "Program" means the drug donation program.
Sec. 442.002. DRUG DONATION PROGRAM. The department shall
establish and maintain a drug donation program through which a
person may donate to a participating pharmacy or health care
facility an eligible drug for use by an individual who meets the
eligibility requirements under Section 442.008.
Sec. 442.003. DONATION. The following persons may donate
drugs at a pharmacy or health care facility that participates in the
program:
(1) an individual who is at least 18 years of age; or
(2) a pharmacy or health care facility or a
manufacturer or distributor of an eligible drug.
Sec. 442.004. DRUGS ELIGIBLE FOR PROGRAM. The Texas State
Board of Pharmacy and the Texas Medical Board shall adopt rules
regarding drugs that are eligible for the program, including rules
regarding:
(1) the inclusion of drugs used for the treatment of
cancer;
(2) the inclusion of non-cancer-related drugs that
cost more than $50;
(3) the prohibition of a controlled substance from
eligibility; and
(4) a list of eligible drugs.
Sec. 442.005. DISTRIBUTION OF DONATED DRUGS. A pharmacy or
health care facility that receives a donated drug through the
program may distribute the drug to an eligible pharmacy or health
care facility for use under the program.
Sec. 442.006. DISPENSATION OF DONATED DRUGS. (a) A
pharmacy or health care facility may accept and dispense a drug
through the program only if each of the following conditions is met:
(1) the drug must be in the drug's original, unopened,
sealed, and tamper-evident unit dose packaging and include the
drug's lot number and expiration date, or if packaged in single unit
doses, the single unit dose packaging must be unopened;
(2) the drug must have an expiration date later than
120 days after the date the drug was donated;
(3) the drug must be unadulterated and correctly
branded;
(4) the drug must be accompanied by the signed donor
form under Section 442.009; and
(5) the drug must be inspected by a pharmacist to
ensure compliance with Subdivisions (1)-(4) before the pharmacist
may dispense the drug.
(b) A drug dispensed through the program must be prescribed
by a medical practitioner for use by an eligible individual and
dispensed by a pharmacist.
(c) A pharmacy or health care facility that dispenses a drug
through the program may charge an individual who receives the drug a
fee not to exceed the amount specified by executive commissioner
rule.
(d) A drug dispensed through the program may not be resold.
Sec. 442.007. RULES. The executive commissioner shall
adopt rules regarding the following:
(1) procedures regarding the storage of donated drugs,
including environmental conditions, separation of donated drugs
from non-donated drugs, and security; and
(2) recordkeeping of donor and recipient forms
required under Section 442.009.
Sec. 442.008. ELIGIBILITY REQUIREMENTS. (a) A person is
eligible to receive drugs through the program if the person is:
(1) uninsured, underinsured, or a recipient of
benefits through the medical assistance program under Chapter 32,
Human Resources Code, or Medicare; or
(2) a resident of this state who has been diagnosed
with cancer.
(b) The department shall prioritize dispensation to
individuals who are uninsured or indigent and shall permit
dispensation to other eligible individuals if an uninsured or
indigent individual is unavailable.
Sec. 442.009. DONOR FORM. (a) The department shall develop
forms for individuals who donate drugs to the program and for
recipients of drugs through the program.
(b) A person who donates a drug shall sign the donor form.
(c) A recipient of drugs through the program shall sign a
form that indicates the donated drug may have been previously
dispensed.
Sec. 442.010. REGISTRY FOR ELIGIBLE RECIPIENTS. The
department shall establish a voluntary registry for individuals who
are eligible to receive drugs through the program.
Sec. 442.011. REGISTRY OF PARTICIPATING PHARMACIES. The
department shall establish on the department's website a voluntary
registry for pharmacies and health care facilities participating in
the program.
Sec. 442.012. LIMITATION ON LIABILITY. (a) A pharmacy,
health care facility, physician, or pharmacist that participates in
the program under this chapter is not liable for harm caused by the
accepting, dispensing, or administering of drugs donated and
dispensed in substantial compliance with this chapter 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 limit, or in any way affect or
diminish, the liability of a drug seller or manufacturer under
Chapter 82, Civil Practice and Remedies Code.
(c) This section does not apply if harm results from the
failure to fully and completely comply with the requirements of
Section 442.006 or rules adopted under this chapter.
(d) This section does not apply to a pharmacy, health care
facility, pharmacist, physician, or manufacturer that fails to
comply with the insurance provisions of Chapter 84, Civil Practice
and Remedies Code.
(e) Nothing in this chapter requires a pharmacy,
pharmacist, or medical practitioner to participate in the program.
Nothing in this chapter requires a person to donate drugs to the
program.
Sec. 442.013. OTHER LAW. The drug donation program
established under this chapter is in addition to the method for
redistribution of unused drugs established by Section 562.1085,
Occupations Code, and the drug donation program established under
Subchapter M, Chapter 431.
SECTION 2. If before implementing any provision of this Act
a state agency determines that a waiver or authorization from a
federal agency is necessary for implementation of that provision,
the agency affected by the provision shall request the waiver or
authorization and may delay implementing that provision until the
waiver or authorization is granted.
SECTION 3. This Act takes effect September 1, 2009.