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  84R9863 JSC-D
 
  By: Sheffield H.B. No. 2271
 
 
 
A BILL TO BE ENTITLED
 
AN ACT
  relating to the prescription drug donation program; authorizing
  fees.
         BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
         SECTION 1.  Subchapter M, Chapter 431, Health and Safety
  Code, is amended to read as follows:
  SUBCHAPTER M. PRESCRIPTION DRUG DONATION PROGRAM
         Sec. 431.321.  DEFINITIONS. In this subchapter:
               (1)  "Charitable drug donor" means:
                     (A)  a licensed convalescent or nursing home or
  related institution, licensed hospice, hospital, physician, or
  pharmacy; or 
                     (B)  a pharmaceutical seller or manufacturer that
  donates drugs under a qualified patient assistance program.
               (2) [(a)]  "Charitable medical clinic" means a clinic,
  including a licensed pharmacy that is a community pharmaceutical
  access program provider, that provides medical care or drugs
  without charge or for a substantially reduced charge, complies with
  the insurance requirements of Chapter 84, Civil Practice and
  Remedies Code, and is exempt from federal income tax under Section
  501(a) of the Internal Revenue Code of 1986 by being listed as an
  exempt organization in Section 501(c)(3) or 501(c)(4) of the code
  and is operated exclusively for the promotion of social welfare by
  being primarily engaged in promoting the common good and general
  welfare of the people in a community.
               (3)  "Community pharmaceutical access program" means a
  program offered by a licensed pharmacy under which the pharmacy
  assists financially disadvantaged persons by providing access to
  prescription drugs at no charge or at a substantially reduced
  charge.
               (4)  "Department" means the Department of State Health
  Services.
               (5)  [(b)     "Seller" means a person, other than a
  charitable drug donor, as defined in Chapter 82, Civil Practice and
  Remedies Code.
         [(c)]  "Manufacturer" means a person, other than a
  charitable drug donor, as defined in Chapter 82, Civil Practice and
  Remedies Code.
               (6)  "Patient [(d)     "Charitable drug donor" means a
  licensed convalescent or nursing home or related institution,
  licensed hospice, hospital, physician, pharmacy, or a
  pharmaceutical seller or manufacturer that donates drugs pursuant
  to a qualified patient assistance program, that donates drugs to a
  charitable medical clinic.
         [(d-1)     In this subchapter, "community pharmaceutical access
  program" means a program offered by a licensed pharmacy under which
  the pharmacy assists financially disadvantaged persons to access
  prescription drugs at no charge or at a substantially reduced
  charge.
         [(e)  In this subchapter, "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.
               (7)  "Prescription drug" has the meaning assigned by
  Section 551.003, Occupations Code.
               (8)  "Program" means the prescription drug donation
  program under this subchapter.
               (9)  "Seller" means a person, other than a charitable
  drug donor, as defined in Chapter 82, Civil Practice and Remedies
  Code.
         Sec. 431.322.  DONATION OF UNUSED DRUGS [TO CHARITABLE
  MEDICAL CLINIC]. (a) A charitable drug donor may donate certain
  unused prescription drugs to the department for the program under
  [a charitable medical clinic, and a charitable clinic may accept,
  dispense, or administer the donated drugs in accordance with] this
  subchapter.
         (b)  A seller or manufacturer of a drug may not donate drugs
  to the department [a charitable medical clinic] except under 
  [pursuant to] a qualified patient assistance program. A seller or
  manufacturer of a drug that donates drugs through a qualified
  patient assistance program is [shall be] considered a charitable
  drug donor.
         (c)  A [The] charitable drug donor shall use appropriate
  safeguards established by the department [board] to ensure that the
  drugs are not compromised or illegally diverted while being stored
  or transported [to the charitable medical clinic].
         (d)  The department [charitable medical clinic] 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
  [clinic] with a verifiable address and telephone number; and
               (3)  the person transferring possession of the drugs
  presents [the charitable medical clinic with] photographic
  identification.
         Sec. 431.323.  CIRCUMSTANCES UNDER WHICH DONATED DRUGS MAY
  BE ACCEPTED [AND DISPENSED]. (a) The department [A charitable
  medical clinic] may accept [and dispense or administer] donated
  drugs only in accordance with this subchapter.
         (b)  The donated drugs must be:
               (1)  [drugs that require a] prescription drugs;
               (2)  [. A donated drug may not be a controlled substance
  under Chapter 481.
         [(c)  The donated drugs must be] approved by the federal Food
  and Drug Administration and:
                     (A) [(1)  be] sealed in the manufacturer's
  unopened original tamper-evident packaging and either:
                           (i) [(A)]  individually packaged; or
                           (ii) [(B)]  packaged in unit-dose packaging;
                     (B) [(2)]  be oral [or parenteral] medication in
  sealed single-dose containers approved by the federal Food and Drug
  Administration; or
                     (C) [(3)]  be topical or inhalant drugs in sealed
  units-of-use containers approved by the federal Food and Drug
  Administration.
         (c)  Donated drugs may [; or
               [(4)     be parenteral medication in sealed multiple-dose
  containers approved by the federal Food and Drug Administration
  from which no doses have been withdrawn; and
               [(5)  must] 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.
         (d)  The department [charitable medical clinic] may
  distribute [dispense or administer] the donated drugs only[:
               [(1)   before the expiration date or within the
  recommended shelf life of the donated drugs, as applicable; and
               [(2)]  after a licensed pharmacist has determined that
  the drugs are of an acceptable integrity.
         (e)  The department may not charge a fee for the drugs
  donated under the program other than a nominal handling fee to
  defray the costs incurred in implementing the program under this
  subchapter. 
         (f)  The department may not resell the drugs donated under
  the program.
         Sec. 431.3231.  DISPENSATION OF DONATED DRUGS. (a)
  [(e)]  The donated drugs may be accepted and dispensed or
  administered only by:
               (1)  a [the] charitable medical clinic; or
               (2)  a physician's office using the drugs for patients
  who receive assistance from the medical assistance program under
  Chapter 32, Human Resources Code [only in accordance with rules
  adopted by the department].
         (b)  A prescription drug dispensed or administered to a
  patient under the program must be prescribed by a practitioner for
  use by that patient.
         (c)  The clinic or physician dispensing or administering the
  drug may charge a nominal handling fee in an amount prescribed by
  department rule.
         (d)  A clinic or physician receiving donated drugs may not
  resell the drugs.
         Sec. 431.3232.  CENTRAL DRUG REPOSITORY. The department
  shall establish a location to centrally store drugs donated under
  this subchapter for disbursement to qualifying recipients.
         Sec. 431.3233.  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 program; and
               (2)  a charitable medical clinic or physician may
  search for and request donated drugs.
         Sec. 431.324.  RULES. The executive commissioner of the
  Health and Human Services Commission [department] shall adopt rules
  to implement this subchapter 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 dispensing or administering a donated drug;
               (2)  provisions for maintenance of the database of
  donated drugs; and
               (3)  any necessary forms for the administration of the
  program.
         Sec. 431.325.  LIMITATION ON CIVIL AND CRIMINAL LIABILITY.
  (a) Charitable drug donors, charitable medical clinics,
  physicians, and their employees are not civilly or criminally
  liable or subject to professional disciplinary action for harm
  caused by the [accepting,] dispensing[,] or administering of drugs
  donated under [in strict compliance with] this subchapter unless
  the harm is caused by:
               (1)  wilful [(i)  willful] or wanton acts of
  negligence;
               (2) [(ii)]  conscious indifference or reckless
  disregard for the safety of others; or
               (3) [(iii)]  intentional conduct.
         (b)  This section does not limit, or in any way affect or
  diminish, the liability of a drug seller or manufacturer under
  [pursuant to] Chapter 82, Civil Practice and Remedies Code.
         (c)  This section does [shall] not apply if the [where] harm
  results from the failure to [fully and completely] comply with the
  requirements of this subchapter.
         (d)  This section does [shall] not apply to a charitable
  medical clinic that fails to comply with the insurance provisions
  of Chapter 84, Civil Practice and Remedies Code.
         SECTION 2.  Not later than December 1, 2015:
               (1)  the executive commissioner of the Health and Human
  Services Commission shall adopt any rules necessary to implement
  Subchapter M, Chapter 431, Health and Safety Code, as amended by
  this Act; and
               (2)  the Department of State Health Services shall
  establish the central repository and database required by
  Subchapter M, Chapter 431, Health and Safety Code, as amended by
  this Act.
         SECTION 3.  (a) The change in law made by this Act applies
  only to a drug that is donated, accepted, dispensed, or
  administered on or after January 1, 2016.
         (b)  Notwithstanding Subsection (a) of this section, a
  charitable medical clinic that, on January 1, 2016, possesses drugs
  donated under Subchapter M, Chapter 431, Health and Safety Code, as
  it existed immediately before the effective date of this Act, may
  dispense those remaining drugs in accordance with the former law.
         SECTION 4.  This Act takes effect September 1, 2015.