S.B. No. 2173
AN ACT
relating to a pilot program for the safe disposal of prescription
drugs, including controlled substance prescription drugs.
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. PRESCRIPTION DRUG SAFE DISPOSAL PILOT PROGRAM
SUBCHAPTER A. GENERAL PROVISIONS
Sec. 442A.001. 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.
(4) "Pilot program" means the prescription drug safe
disposal pilot program established under this chapter.
(5) "Prescription drug" has the meaning assigned by
Section 551.003, Occupations Code.
(6) "Ultimate user" has the meaning assigned by 21
U.S.C. Section 802.
Sec. 442A.002. PRESCRIPTION DRUG SAFE DISPOSAL PILOT
PROGRAM. The board by rule shall develop and implement a
prescription drug safe disposal pilot program to increase the
number of locations in this state where unused, unwanted, or
expired prescription drugs are collected from the public for safe
disposal.
SUBCHAPTER B. PHARMACY PARTICIPATION
Sec. 442A.051. PHARMACY ELIGIBILITY. A pharmacy operating
in this state may apply to the board to participate in the pilot
program if the pharmacy:
(1) is registered as an authorized drug collection
site with the United States Drug Enforcement Administration;
(2) is not the subject of state or federal opioid
litigation; and
(3) meets the eligibility requirements established by
21 C.F.R. Section 1317.40 and board rules.
Sec. 442A.052. APPLICATION AND SELECTION PROCESSES. (a)
The board shall adopt rules prescribing:
(1) the form and manner for a pharmacy to apply for
participation in the pilot program; and
(2) evaluation and selection criteria and processes.
(b) The board shall give priority to a pharmacy applicant
that:
(1) does not collect unused ultimate user prescription
drugs under 21 C.F.R. Part 1317 at the time the applicant submits
the application; or
(2) is located in a rural or underserved area the board
designates.
(c) A pharmacy that operates multiple locations must submit
an application for each location.
Sec. 442A.053. COLLECTION RECEPTACLE REQUIREMENTS. (a) A
participating pharmacy that provides a collection receptacle for
the safe disposal of prescription drugs shall ensure the
receptacle:
(1) meets the requirements of 21 C.F.R. Section
1317.75;
(2) is accessible during the pharmacy's regular hours
of operation;
(3) allows for the anonymous deposit of unused
controlled substance prescription drugs listed in Schedules II,
III, IV, and V; and
(4) provides disposal of unused prescription drugs at
no cost to the ultimate user.
(b) Controlled substance prescription drugs and
noncontrolled substance prescription drugs may be collected
together and comingled.
Sec. 442A.054. MAIL-BACK PROGRAM REQUIREMENTS. (a) A
participating pharmacy that provides a collection receptacle for
the safe disposal of prescription drugs may, under limited
circumstances as the pharmacy determines necessary, provide at the
time the pharmacy dispenses a controlled substance prescription
drug to the ultimate user a vendor's mail-back envelope, at no cost
to the ultimate user. The mail-back envelope must:
(1) be pre-addressed and return postage paid; and
(2) meet the requirements of 21 C.F.R. Section
1317.70.
(b) A participating pharmacy may provide not more than 250
mail-back envelopes during the duration of the pilot program to
encourage use of the pharmacy's collection receptacle.
Sec. 442A.055. PHARMACY MANAGEMENT; RECORDS. A
participating pharmacy is responsible for the daily management and
recordkeeping of the pharmacy's prescription drug safe disposal
program in accordance with the pharmacy's United States Drug
Enforcement Administration registration and board rules.
Sec. 442A.056. TEXAS PREMIER PHARMACY DESIGNATION. (a)
The board shall designate each pharmacy participating in the pilot
program as a Texas premier pharmacy provider committed to safe
prescription drug disposal.
(b) A participating pharmacy may use the designation for
marketing purposes.
SUBCHAPTER C. BOARD DUTIES
Sec. 442A.101. PILOT PROGRAM INCENTIVES. (a) The board
shall assist each pharmacy participating in the pilot program,
including by paying the costs of:
(1) maintaining one collection receptacle at each
participating pharmacy location and destroying through
incineration of the receptacle's full inner liner the prescription
drugs deposited in the receptacle;
(2) ordering and distributing pre-addressed, return
postage paid mail-back envelopes from a third-party mail-back
program and destroying through incineration the returned mail-back
envelopes containing the collected prescription drugs; and
(3) other operational needs the board determines
appropriate.
(b) The board:
(1) shall directly reimburse a participating pharmacy
for costs the pharmacy incurs under Subsection (a); and
(2) may not reimburse a participating pharmacy for the
cost of using a third-party incineration facility unless the
facility is appropriately registered with the United States Drug
Enforcement Administration.
(c) Subject to money available for purposes of this chapter,
the board may provide financial incentives to a pharmacy to
continue providing prescription drug collection services or expand
those services to accommodate controlled substance prescriptions.
The board may provide financial incentives to a chain retail
pharmacy for not more than 15 locations.
Sec. 442A.102. COMMUNITY OUTREACH. (a) The board shall:
(1) develop and distribute educational outreach
materials for the public about the availability of safe
prescription drug disposal in this state;
(2) post the materials on the board's Internet
website; and
(3) provide the materials to other state agencies for
those agencies to conduct the community outreach.
(b) The educational outreach materials must be in English,
Spanish, and for specific areas of this state as the board
determines appropriate, another language spoken by a substantial
portion of the area's residents.
Sec. 442A.103. REPORT. Not later than December 1 of each
even-numbered year, the board shall submit to the governor and the
legislature a report that:
(1) summarizes the results of the pilot program,
including:
(A) the number and geographic distribution of
collection receptacles at participating pharmacies;
(B) the estimated amount of prescription drugs
collected by participating pharmacies under the program, measured
by:
(i) the number of inner liners fully filled
with collected prescription drugs and sent for incineration by the
pharmacies;
(ii) the number of mail-back envelopes
distributed by the pharmacies; and
(iii) the weight, measured in pounds, of:
(a) inner liners described by
Subparagraph (i); and
(b) returned mail-back envelopes
filled with collected prescription drugs;
(C) the amount of money distributed under the
pilot program and the identity of each participating pharmacy to
which money is distributed; and
(D) a description of the board's educational
efforts and outcomes; and
(2) recommends whether the pilot program should
continue, be expanded, or terminate or whether the board should
permanently implement a prescription drug safe disposal program.
SUBCHAPTER D. FUNDING
Sec. 442A.151. 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 E. EXPIRATION
Sec. 442A.201. EXPIRATION. This chapter expires on the
second anniversary of the date that all money appropriated for the
pilot program has been expended.
SECTION 2. As soon as practicable after the effective date
of this Act, the Texas State Board of Pharmacy shall implement the
prescription drug safe disposal pilot program developed under
Chapter 442A, Health and Safety Code, as added by this Act.
SECTION 3. This Act takes effect September 1, 2023.
______________________________ ______________________________
President of the Senate Speaker of the House
I hereby certify that S.B. No. 2173 passed the Senate on
April 26, 2023, by the following vote: Yeas 31, Nays 0.
______________________________
Secretary of the Senate
I hereby certify that S.B. No. 2173 passed the House on
May 16, 2023, by the following vote: Yeas 130, Nays 11, one
present not voting.
______________________________
Chief Clerk of the House
Approved:
______________________________
Date
______________________________
Governor