89R17060 LRM-D     By: Guillen H.B. No. 5248     Substitute the following for H.B. No. 5248:     By:  VanDeaver C.S.H.B. No. 5248       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.  Section 442A.001, Health and Safety Code, is   amended to read as follows:          Sec. 442A.001.  DEFINITIONS. In this chapter:                (1)  "Collection receptacle" means a receptacle as   described by 21 C.F.R. Section 1317.75 ["Board" means the Texas   State Board of Pharmacy].                (2)  "Commission" means the Health and Human Services   Commission.                (3)  "Controlled substance" has the meaning assigned by   Section 481.002.                (4)  "Department" means the Department of State Health   Services.                (5) [(3)]  "Pharmacy" means a facility licensed under   Chapter 560, Occupations Code.                (6) [(4)]  "Pilot program" means the prescription drug   safe disposal pilot program established under this chapter.                (7) [(5)]  "Prescription drug" has the meaning   assigned by Section 551.003, Occupations Code.                (8) [(6)]  "Ultimate user" has the meaning assigned by   21 U.S.C. Section 802.          SECTION 2.  Section 442A.002, Health and Safety Code, is   amended to read as follows:          Sec. 442A.002.  PRESCRIPTION DRUG SAFE DISPOSAL PILOT   PROGRAM. The executive commissioner of the commission [board] by   rule shall develop and implement a prescription drug safe disposal   pilot program administered by the department to increase the number   of collection receptacles [locations] in this state where unused,   unwanted, or expired prescription drugs are collected from the   public for safe disposal.          SECTION 3.  Section 442A.051, Health and Safety Code, is   amended to read as follows:          Sec. 442A.051.  PHARMACY ELIGIBILITY. A pharmacy operating   in this state may apply to the department [board] to participate in   the pilot program if the pharmacy:                (1)  is eligible to register [registered] as an   authorized drug collection site with the United States Drug   Enforcement Administration; and                (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].          SECTION 4.  Section 442A.052, Health and Safety Code, is   amended to read as follows:          Sec. 442A.052.  APPLICATION AND SELECTION PROCESSES. (a)   The department [board] shall prescribe [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 department [board] shall give priority for   participation in the pilot program 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   department [board] designates.          (b) [(c)]  A pharmacy that operates multiple locations may   [must] submit one [an] application to apply for the program for all   of the locations, provided the application contains information   specific to each location, including the physical address, phone   number, location name, and pharmacy manager's name [for each   location]. Each location is separately evaluated for   prioritization under Subsection (a).          SECTION 5.  Section 442A.053(b), Health and Safety Code, is   amended to read as follows:          (b)  Controlled substance prescription drugs, [and]   noncontrolled substance prescription drugs, and over-the-counter   drugs may be collected together and comingled.          SECTION 6.  Section 442A.055, Health and Safety Code, is   amended to read as follows:          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].          SECTION 7.  The heading to Subchapter C, Chapter 442A,   Health and Safety Code, is amended to read as follows:   SUBCHAPTER C. DEPARTMENT [BOARD] DUTIES          SECTION 8.  Sections 442A.101(a) and (b), Health and Safety   Code, are amended to read as follows:          (a)  The department [board] shall assist each pharmacy   participating in the pilot program, including by paying [the costs   of]:                (1)  the costs of maintaining one collection receptacle   at each participating pharmacy location and destroying through   incineration of the receptacle's full inner liner containing the   prescription drugs collected [deposited] in the receptacle; and                (2)  a one-time fee to offset the initial costs of   program participation [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 department may contract with a reverse distributor   registered with the United States Drug Enforcement Administration   to install the collection receptacles at participating pharmacy   locations and to treat at an incineration facility registered with   the United States Drug Enforcement Administration the drugs   collected in the receptacles [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].          SECTION 9.  Section 442A.102, Health and Safety Code, is   amended to read as follows:          Sec. 442A.102.  COMMUNITY OUTREACH. (a) The department   [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 department's [board's]   Internet website; [and]                (3)  provide the materials to other state agencies,   including the Texas State Board of Pharmacy, for those agencies to   conduct the community outreach; and                (4)  create education materials for voluntary use by a   participating pharmacy.          (b)  The educational outreach materials must be in English,   Spanish, and for specific areas of this state as the department   [board] determines appropriate, another language spoken by a   substantial portion of the area's residents.          SECTION 10.  Section 442A.103, Health and Safety Code, is   amended to read as follows:          Sec. 442A.103.  REPORT. Not later than December 1 of each   even-numbered year, the department [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; and                            (ii)  [the number of mail-back envelopes   distributed by the pharmacies; and                            [(iii)]  the weight, measured in pounds, of   the[:                                  [(a)]  inner liners described by   Subparagraph (i)[; and                                  [(b)  returned mail-back envelopes   filled with collected prescription drugs];                      (C)  the cost of the pilot program;                      (D)  [amount of money distributed under the pilot   program and] the identity of each participating pharmacy to which   money is distributed; and                      (E) [(D)]  a description of the department's   [board's] educational efforts and outcomes; and                (2)  recommends whether the pilot program should   continue, be expanded, or terminate or whether the department   [board] should permanently implement a prescription drug safe   disposal program.          SECTION 11.  Section 442A.151, Health and Safety Code, is   amended to read as follows:          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], shall [may] be appropriated to   the department [board] to fund the pilot program established under   this chapter.          (b)  The department [board] may collect gifts, grants, and   donations to fund the program.          SECTION 12.  Sections 442A.056 and 442A.101(c), Health and   Safety Code, are repealed.          SECTION 13.  As soon as practicable after the effective date   of this Act, the executive commissioner of the Health and Human   Services Commission shall adopt rules to allow the Department of   State Health Services to implement the prescription drug safe   disposal pilot program developed under Chapter 442A, Health and   Safety Code, as required by this Act.          SECTION 14.  This Act takes effect September 1, 2025.