By: Burton S.B. No. 382
(In the Senate - Filed December 20, 2016; February 1, 2017,
read first time and referred to Committee on Health & Human
Services; April 26, 2017, reported adversely, with favorable
Committee Substitute by the following vote: Yeas 9, Nays 0;
April 26, 2017, sent to printer.)
Click here to see the committee vote
COMMITTEE SUBSTITUTE FOR S.B. No. 382 By: Burton
A BILL TO BE ENTITLED
AN ACT
relating to donation of unused prescription drugs; authorizing a
fee.
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. DONATION OF PRESCRIPTION DRUGS
SUBCHAPTER A. GENERAL PROVISIONS
Sec. 442.001. DEFINITIONS. In this chapter:
(1) "Donor" means an individual who donates unused
prescription drugs under this chapter to a participating provider.
(2) "Health care facility" means a facility that
provides health care services to patients and maintains a pharmacy
in the facility. The term includes the following facilities if a
pharmacy is maintained in the facility:
(A) a general or special hospital as defined by
Chapter 241;
(B) an ambulatory surgical center licensed under
Chapter 243; and
(C) an institution licensed under Chapter 242.
(3) "Health care professional" means an individual
licensed, certified, or otherwise authorized to administer health
care and prescribe prescription drugs, for profit or otherwise, in
the ordinary course of business or professional practice. The term
does not include a health care facility.
(4) "Participating provider" means a health care
facility or pharmacy, or a pharmacist who is an employee of the
facility or pharmacy, that elects to participate in the collection
and redistribution of donated prescription drugs under this
chapter.
(5) "Pharmacist" means a person licensed under Chapter
558, Occupations Code.
(6) "Pharmacy" means an entity licensed under Chapter
560, Occupations Code.
(7) "Prescription drug" has the meaning assigned by
Section 551.003, Occupations Code.
(8) "Recipient" means an individual who voluntarily
receives donated prescription drugs under this chapter.
(9) "Tamper-evident" means packaging that allows for
detection of unauthorized access to a prescription drug.
Sec. 442.002. RULEMAKING AUTHORITY. The executive
commissioner may adopt rules to implement this chapter.
Sec. 442.003. CONSTRUCTION WITH OTHER LAW. This chapter
does not limit the authority of this state or a political
subdivision of this state to regulate or prohibit a prescription
drug.
SUBCHAPTER B. DONATION AND REDISTRIBUTION OF UNUSED PRESCRIPTION
DRUGS
Sec. 442.051. DONATION AND REDISTRIBUTION OF PRESCRIPTION
DRUGS. (a) A donor may donate unused prescription drugs to a
participating provider in accordance with this chapter and rules
adopted under this chapter.
(b) A participating provider may dispense donated
prescription drugs to a recipient in accordance with this chapter
and rules adopted under this chapter.
Sec. 442.052. STANDARDS FOR DONATION AND REDISTRIBUTION.
(a) The executive commissioner by rule shall adopt standards and
procedures for:
(1) accepting, storing, labeling, and dispensing
donated prescription drugs; and
(2) inspecting donated prescription drugs to
determine whether the drugs are adulterated and whether the drugs
are safe and suitable for redistribution.
(b) In adopting standards and procedures under this
section, the executive commissioner shall ensure that the donation
and redistribution process is consistent with public health and
safety standards.
Sec. 442.053. REQUIREMENTS FOR DONATED PRESCRIPTION DRUGS.
(a) A donated prescription drug may be accepted or dispensed under
this chapter only if the drug is in its original, unopened, sealed,
and tamper-evident unit-dose packaging. A drug packaged in single
unit doses may be accepted and dispensed if the outside packaging is
opened but the single unit-dose packaging is unopened.
(b) A donated prescription drug may not be accepted or
dispensed under this chapter if:
(1) the drug is a controlled substance;
(2) the drug is adulterated or misbranded;
(3) the drug is not stored in compliance with the
drug's product label; or
(4) the United States Food and Drug Administration
requires the drug to have a risk evaluation or mitigation strategy.
(c) A participating provider shall comply with all
applicable provisions of state and federal law relating to the
inspection, storage, labeling, and dispensing of prescription
drugs.
Sec. 442.054. DONATION PROCESS. (a) Before being
dispensed to a recipient, a prescription drug donated under this
chapter must be inspected by the participating provider in
accordance with federal law, laws of this state, and department
rule to determine whether the drug is adulterated or misbranded and
whether the drug has been stored in compliance with the
requirements of the product label.
(b) A donated prescription drug dispensed to a recipient
under this chapter must be prescribed by a health care professional
for use by the recipient.
(c) A participating provider may charge a handling fee not
to exceed $20 to a recipient to cover the costs of inspecting,
storing, labeling, and dispensing the donated prescription drug. A
participating provider may not resell a prescription drug donated
under this chapter. A donor may not sell a prescription drug to a
participating provider.
(d) A participating provider may not submit a claim or
otherwise seek reimbursement from any public or private third-party
payor for donated prescription drugs dispensed to a recipient under
this chapter. A public or private third-party payor is not required
to provide reimbursement for donated drugs dispensed to a recipient
under this chapter.
Sec. 442.055. DONOR FORM. Before donating a prescription
drug under this chapter, a donor shall sign a form prescribed by the
department stating that:
(1) the donor is the owner of the donated prescription
drug;
(2) the donated prescription drug has been properly
stored and the container has not been opened or tampered with;
(3) the donated prescription drug has not been
adulterated or misbranded; and
(4) the donor is voluntarily donating the prescription
drug.
Sec. 442.056. RECIPIENT FORM. Before accepting a donated
prescription drug under this chapter, a recipient shall sign a form
prescribed by the department stating that:
(1) the recipient acknowledges that the donor is not a
pharmacist and the donor took ordinary care of the prescription
drug;
(2) the recipient acknowledges that the donor is known
to the participating provider and that there is no reason to believe
that the prescription drug was improperly handled or stored;
(3) by accepting the prescription drug, the recipient
accepts any risk that an accidental mishandling could create; and
(4) the recipient releases the donor, participating
provider, and manufacturer of the drug from liability related to
the prescription drug.
Sec. 442.057. LIMITATION OF LIABILITY. (a) A donor or
participating provider who acts in good faith in donating,
accepting, storing, labeling, distributing, or dispensing
prescription drugs under this chapter:
(1) is not criminally liable and is not subject to
professional disciplinary action for those activities; and
(2) is not civilly liable for damages for bodily
injury, death, or property damage that arises from those activities
unless the injury, death, or damage arises from the donor or
participating provider's recklessness or intentional conduct.
(b) A manufacturer of a prescription drug that donates a
drug under this chapter is not, in the absence of bad faith,
criminally or civilly liable for bodily injury, death, or property
damage arising from the donation, acceptance, or dispensing of the
drug, including the manufacturer's failure to communicate to a
donor or other person:
(1) product or consumer information about the donated
prescription drug; or
(2) the expiration date of the donated prescription
drug.
Sec. 442.058. DATABASE OF PARTICIPATING PROVIDERS. The
department shall establish and maintain an electronic database that
lists each participating provider. The department shall post the
database on its Internet website.
SECTION 2. Not later than December 1, 2017, the executive
commissioner of the Health and Human Services Commission shall
adopt the rules necessary for the implementation of Chapter 442,
Health and Safety Code, as added by this Act.
SECTION 3. 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 4. This Act takes effect September 1, 2017.
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