By: Alvarado, West S.B. No. 2173
 
 
A BILL TO BE ENTITLED
 
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.