84R23826 JSC-D
 
  By: Sheffield H.B. No. 2271
 
  Substitute the following for H.B. No. 2271:
 
  By:  Crownover C.S.H.B. No. 2271
 
 
 
A BILL TO BE ENTITLED
 
AN ACT
  relating to a pilot program for donation and redistribution of
  certain unused prescription medications; authorizing a fee.
         BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
         SECTION 1.  Chapter 431, Health and Safety Code, is amended
  by adding Subchapter O to read as follows:
  SUBCHAPTER O. PRESCRIPTION DRUG DONATION PILOT PROGRAM
         Sec. 431.451.  DEFINITIONS. In this subchapter:
               (1)  "Charitable drug donor" means:
                     (A)  a licensed convalescent or nursing facility
  or related institution, licensed hospice, hospital, physician, or
  pharmacy;
                     (B)  a pharmaceutical seller or manufacturer that
  donates drugs under a qualified patient assistance program; or
                     (C)  the licensed health care professional
  responsible for administration of drugs in a penal institution, as
  defined by Section 1.07, Penal Code, in this state.
               (2)  "Charitable medical clinic" has the meaning
  assigned by Section 431.321.
               (3)  "Manufacturer" means a person, other than a
  charitable drug donor, as defined in Chapter 82, Civil Practice and
  Remedies Code.
               (4)  "Patient assistance program" means a qualified
  program offered by a pharmaceutical manufacturer under which the
  manufacturer provides drugs to financially disadvantaged persons
  at no charge or at a substantially reduced cost. The term does not
  include the provision of a drug as part of a clinical trial.
               (5)  "Pilot program" means the prescription drug
  donation pilot program under this subchapter.
               (6)  "Prescription drug" has the meaning assigned by
  Section 551.003, Occupations Code.
               (7)  "Seller" means a person, other than a charitable
  drug donor, as defined in Chapter 82, Civil Practice and Remedies
  Code.
         Sec. 431.452.  ESTABLISHMENT OF PILOT PROGRAM. (a) The
  department shall establish a pilot program for donation and
  redistribution of prescription drugs under this subchapter.
         (b)  The department shall conduct the pilot program in one or
  more municipalities with a population of more than 500,000 but less
  than one million.
         Sec. 431.453.  DONATION OF UNUSED DRUGS. (a) A charitable
  drug donor may donate certain unused prescription drugs to the
  department for the pilot program under this subchapter.
         (b)  A seller or manufacturer of a drug that donates drugs
  through a qualified patient assistance program is considered a
  charitable drug donor.
         (c)  A charitable drug donor shall use appropriate
  safeguards established by department rule to ensure that the drugs
  are not compromised or illegally diverted while being stored or
  transported.
         (d)  The department may not accept the donated drugs unless:
               (1)  the charitable drug donor certifies that the drugs
  have been properly stored while in the possession of the donor or of
  the person for whom the drugs were originally dispensed;
               (2)  the charitable drug donor provides the department
  with a verifiable address and telephone number; and
               (3)  the person transferring possession of the drugs
  presents photographic identification.
         Sec. 431.454.  CIRCUMSTANCES UNDER WHICH DONATED DRUGS MAY
  BE ACCEPTED. (a) The department may accept donated drugs only in
  accordance with this subchapter.
         (b)  The donated drugs must be:
               (1)  prescription drugs; and
               (2)  approved by the federal Food and Drug
  Administration and:
                     (A)  sealed in unopened tamper-evident unit dose
  packaging;
                     (B)  be oral medication in sealed single-dose
  containers approved by the federal Food and Drug Administration; or
                     (C)  be topical or inhalant drugs in sealed
  units-of-use containers approved by the federal Food and Drug
  Administration.
         (c)  A drug packaged in single unit doses may be accepted and
  distributed if the outside packaging is opened but the single unit
  dose packaging is unopened.
         (d)  Donated drugs may not:
               (1)  be the subject of a mandatory recall by a state or
  federal agency or a voluntary recall by a drug seller or
  manufacturer;
               (2)  be adulterated or misbranded;
               (3)  be a controlled substance under Chapter 481;
               (4)  be a parenteral or injectable medication;
               (5)  require refrigeration; or
               (6)  expire less than 60 days after the date of the
  donation.
         (e)  The department may distribute the donated drugs only
  after a licensed pharmacist has determined that the drugs are of an
  acceptable integrity.
         (f)  The department may not charge a fee for the drugs
  donated under the pilot program other than a nominal handling fee to
  defray the costs incurred in implementing the pilot program under
  this subchapter. 
         (g)  The department may not resell the drugs donated under
  the pilot program.
         Sec. 431.455.  PRESCRIPTION, PROVISION, AND ADMINISTRATION
  OF DONATED DRUGS. (a)  The donated drugs may be accepted and
  provided or administered to patients only by:
               (1)  a charitable medical clinic;
               (2)  a physician's office using the drugs for patients
  who receive assistance from the medical assistance program under
  Chapter 32, Human Resources Code, or for other indigent health
  care; or
               (3)  a licensed health care professional responsible
  for administration of drugs in a penal institution, as defined by
  Section 1.07, Penal Code, in this state.
         (b)  A prescription drug provided or administered to a
  patient under the pilot program must be prescribed by a
  practitioner for use by that patient.
         (c)  The clinic or physician providing or administering the
  drug may charge a nominal handling fee in an amount prescribed by
  department rule.
         (d)  A clinic, physician, or other licensed health care
  professional receiving donated drugs may not resell the drugs.
         Sec. 431.456.  CENTRAL DRUG REPOSITORY. The department
  shall establish a location to centrally store drugs donated under
  this subchapter for distribution to qualifying recipients.
         Sec. 431.457.  DATABASE OF DONATED DRUGS. The department
  shall establish and maintain an electronic database in which:
               (1)  the department shall list the name and quantity of
  each drug donated to the department under the pilot program; and
               (2)  a charitable medical clinic, physician, or other
  licensed health care professional may search for and request
  donated drugs.
         Sec. 431.458.  RULES. This subchapter shall be governed by
  department rules that are designed to protect the public health and
  safety, including:
               (1)  the maximum handling fee that may be imposed by a
  clinic or physician providing or administering a donated drug to a
  patient;
               (2)  provisions for maintenance of the database of
  donated drugs; and
               (3)  any necessary forms for the administration of the
  pilot program.
         Sec. 431.459.  LIMITATION ON CIVIL AND CRIMINAL LIABILITY.
  (a) Charitable drug donors, manufacturers and sellers of donated
  drugs, charitable medical clinics, physicians, penal institutions,
  and their employees acting in good faith in providing or
  administering prescription drugs under the pilot program are not
  civilly or criminally liable or subject to professional
  disciplinary action for harm caused by providing or administering
  drugs donated under this subchapter unless the harm is caused by:
               (1)  wilful or wanton acts of negligence;
               (2)  conscious indifference or reckless disregard for
  the safety of others; or
               (3)  intentional conduct.
         (b)  This section does not apply if the harm results from the
  failure to comply with the requirements of this subchapter.
         (c)  This section does not apply to a charitable medical
  clinic that fails to comply with the insurance provisions of
  Chapter 84, Civil Practice and Remedies Code.
         Sec. 431.460.  REPORTS TO LEGISLATURE. Not later than
  January 1 of each odd-numbered year, the department shall report to
  the legislature on the results of the pilot program. The report
  must include:
               (1)  the pilot program's efficacy in expanding access
  to prescription medications;
               (2)  any cost savings to the state or local governments
  resulting from or projected to result from the pilot program;
               (3)  an evaluation of the pilot program's database and
  system of distribution;
               (4)  any health and safety issues posed by providing or
  administering donated drugs;
               (5)  recommendations on improvements to the pilot
  program; and
               (6)  an evaluation of potential expansion of the pilot
  program.
         SECTION 2.  Not later than December 1, 2015, the Department
  of State Health Services shall establish the central repository and
  database required by Subchapter O, Chapter 431, Health and Safety
  Code, as added by this Act.
         SECTION 3.  The change in law made by this Act applies only
  to a drug that is donated, accepted, provided, or administered on or
  after January 1, 2016.
         SECTION 4.  This Act takes effect September 1, 2015.