88R1980 KKR-D By: Dean H.B. No. 1373 A BILL TO BE ENTITLED AN ACT relating to a pilot program for the safe disposal of 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. CONTROLLED SUBSTANCE 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 controlled substance prescription drug safe disposal pilot program established under this chapter. (5) "Prescription drug" has the meaning assigned by Section 551.003, Occupations Code. Sec. 442A.002. CONTROLLED SUBSTANCE PRESCRIPTION DRUG SAFE DISPOSAL PILOT PROGRAM. The board by rule shall develop and implement a controlled substance prescription drug safe disposal pilot program to increase the number of locations in this state in which unused controlled substance 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 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 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 controlled substance prescription drugs 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 participating pharmacy that provides a collection receptacle for the safe disposal of controlled substance 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 anonymous returns of unused controlled substance prescription drugs; and (4) provides disposal of unused controlled substance prescription drugs at no cost to the person returning the drugs. Sec. 442A.054. MAIL-BACK REQUIREMENTS. A participating pharmacy that provides a mail-back program for the safe disposal of controlled substance prescription drugs shall: (1) ensure the program meets the requirements of 21 C.F.R. Section 1317.70; and (2) provide at the time the pharmacy dispenses a controlled substance prescription drug, at no cost to the person to whom the drug is prescribed, a mail-in pouch for the person to surrender any unused drugs by mail. Sec. 442A.055. PHARMACY MANAGEMENT; RECORDS. A participating pharmacy is responsible for the daily management and recordkeeping of the pharmacy's controlled substance prescription drug safe disposal program in accordance with the pharmacy's United States Drug Enforcement Administration registration. 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 opioid 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 with establishing and operating a plan for the safe return of controlled substance prescription drugs under the pilot program, including by paying the costs of: (1) one collection receptacle for each pharmacy location; (2) supplies necessary for a mail-back program, including envelopes and shipping costs; (3) destruction of collected drugs through incineration; and (4) other operational needs as the board determines appropriate. (b) The board may: (1) provide reimbursement costs directly to a participating pharmacy for the costs the pharmacy incurs in establishing and operating the plan under Subsection (a); or (2) contract with a vendor to provide directly to the participating pharmacy the supplies and services necessary to implement the plan and reimburse the vendor for providing the supplies and services. (c) Subject to money available for purposes of this chapter, the board may provide financial incentives to a pharmacy that is providing drug collection services to continue providing those services or expand those services to accommodate controlled substance prescriptions. The board may provide 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 controlled substance 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, if applicable, another language spoken by a substantial portion of the residents in a specific area of this state. Sec. 442A.103. REPORT. Not later than December 1 of each even-numbered year, the board shall submit to the governor, the lieutenant 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; (B) the amount of controlled substance prescription drugs disposed by pharmacies under the pilot program; (C) the amount and recipient of money distributed under the pilot program; 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 controlled substance 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 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 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.