By: Guillen H.B. No. 5298
A BILL TO BE ENTITLED
AN ACT
relating to a pilot program under which lockable, tamper-evident
containers are used by participating pharmacies when dispensing
schedule II controlled substances.
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 442A to read as follows:
CHAPTER 442A. LOCKABLE CONTAINERS FOR SCHEDULE II CONTROLLED
SUBSTANCES PILOT PROGRAM
SUBCHAPTER A. GENERAL PROVISIONS
Sec. 442A.01. DEFINITIONS. In this chapter:
(1) "Board" means the Texas State Board of Pharmacy.
(2) "Controlled substance" has the meaning assigned by
Section 481.002.
(3) "Pharmacy" means a facility licensed under Chapter
560, Occupations Code.
(3) "Special packaging" has the same meaning as in the
"Poison Prevention Packaging Act of 1970," 15 U.S.C. 1471.
(4) "Prescription drug" has the meaning assigned by
Section 551.003, Occupations Code.
(5) "Lockable container" means a container that meets
all three of the following requirements: (a)Has special packaging;
(b) has a locking mechanism that fits or affixes to the container
medication is dispensed in; (c) can be locked in the following ways:
(a) a container that uses a key or other object
capable of locking and unlocking the container;
(b) a container that requires a numeric or
alphanumeric code.
(6) "Tamper-evident container" means a container that
meets both of the following requirements:
(a) Has special packaging;
(b) Displays a visual sign when there is
unauthorized entry into the container or has a numerical display of
the time that the container was last opened.
(7) "Pilot program" means the tamper proof container
for schedule II substances pilot program established under this
chapter.
442A.02. PILOT PROGRAM PARAMETERS. (a)The Board shall
operate a two-year pilot program under which schedule II controlled
substances in solid oral dosage formulations are dispensed by
participating pharmacies in lockable containers or tamper-evident
containers. Under the pilot program, the Board shall reimburse
participating pharmacies or provide grants for the expenses they
incur in participating in the program, including a fee determined
by the Board for dispensing all schedule II controlled substances
in solid oral dosage formulations in those containers.
(b) A pharmacist shall dispense a schedule II controlled
substance in a solid oral dosage formulation in a lockable
container or tamper-evident container unless the patient or an
individual acting on behalf of the patient requests that the drug
not be dispensed in such a container.
(c) Not later than six months after the pilot project ends,
the board shall prepare a report describing its findings regarding
the impact of the program. The board shall submit the report to the
Legislature.
(d) The pilot program shall be operated for two years or
until funds appropriated for the program are expended, whichever
occurs first.
(e) The board shall adopt rules prescribing:
(1) the form and scope of the pilot project; and
(2) the evaluation processes.
442A.03. PHARMACY ELIGIBILITY. (a) Any pharmacy is
eligible may volunteer to participate in the pilot program by
notifying the Board. Each participating pharmacy shall:
(1) be registered with the United States Drug
Enforcement Administration;
(2) not be the subject of state or federal opioid
litigation; and
(3) meets the eligibility requirements established by
board rules.
SUBCHAPTER B. FUNDING
Sec. 442A.101 FUNDING. (a) Money contained in the opioid
abatement account established under Section 403.505, Government
Code, as added by Chapter 781 (S.B. 1827), Acts of the 87th
Legislature, Regular Session, 2021, may be appropriated to the
board to fund the pilot program established under this chapter.
(b) The board may collect gifts, grants, and donations to
fund the program.
SUBCHAPTER C. EXPIRATION
Sec. 442A.201. EXPIRATION. This chapter expires September
1, 2029.
SECTION 2. As soon as practicable after the effective date
of this Act, the Texas State Board of Pharmacy shall implement the
controlled substance lockable cap pilot program developed under
Chapter 442A, Health and Safety Code, as added by this Act.
SECTION 3. This Act takes effect September 1, 2023.