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.