House File 724 - Enrolled

PAG LIN

  1  1                                             HOUSE FILE 724
  1  2
  1  3                             AN ACT
  1  4 CREATING A PRESCRIPTION DRUG DONATION REPOSITORY PROGRAM.
  1  5
  1  6 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA:
  1  7
  1  8    Section 1.  NEW SECTION.  135M.1  PURPOSE.
  1  9    The purpose of this chapter is to improve the health of
  1 10 low=income Iowans through a prescription drug donation
  1 11 repository that authorizes medical facilities and pharmacies
  1 12 to redispense prescription drugs and supplies that would
  1 13 otherwise be destroyed.
  1 14    Sec. 2.  NEW SECTION.  135M.2  DEFINITIONS.
  1 15    1.  "Anti=rejection drug" means a prescription drug that
  1 16 suppresses the immune system to prevent or reverse rejection
  1 17 of a transplanted organ.
  1 18    2.  "Cancer drug" means a prescription drug that is used to
  1 19 treat any of the following:
  1 20    a.  Cancer or the side effects of cancer.
  1 21    b.  The side effects of any prescription drug that is used
  1 22 to treat cancer or the side effects of cancer.
  1 23    3.  "Controlled substance" means the same as defined in
  1 24 section 155A.3.
  1 25    4.  "Department" means the Iowa department of public
  1 26 health.
  1 27    5.  "Indigent" means a person with an income that is below
  1 28 two hundred percent of the federal poverty level as defined by
  1 29 the most recently revised poverty income guidelines published
  1 30 by the United States department of health and human services.
  1 31    6.  "Medical facility" means any of the following:
  1 32    a.  A physician's office.
  1 33    b.  A hospital.
  1 34    c.  A health clinic.
  1 35    d.  A nonprofit health clinic which includes a federally
  2  1 qualified health center as defined in 42 U.S.C. }
  2  2 1396d(l)(2)(B); a rural health clinic as defined in 42 U.S.C.
  2  3 } 1396d(l)(1); and a nonprofit health clinic that provides
  2  4 medical care to patients who are indigent, uninsured, or
  2  5 underinsured.
  2  6    e.  A free clinic as defined in section 135.24.
  2  7    f.  A charitable organization as defined in section 135.24.
  2  8    g.  A nursing facility as defined in section 135C.1.
  2  9    7.  "Pharmacy" means a pharmacy as defined in section
  2 10 155A.3.
  2 11    8.  "Prescription drug" means the same as defined in
  2 12 section 155A.3, and includes cancer drugs and anti=rejection
  2 13 drugs, but does not include controlled substances.
  2 14    9.  "Supplies" means the supplies necessary to administer
  2 15 the prescription drugs donated.
  2 16    Sec. 3.  NEW SECTION.  135M.3  PRESCRIPTION DRUG DONATION
  2 17 REPOSITORY PROGRAM AUTHORIZED.
  2 18    1.  The department, in cooperation with the board of
  2 19 pharmacy examiners, may establish and maintain a prescription
  2 20 drug donation repository program under which any person may
  2 21 donate prescription drugs and supplies for use by an
  2 22 individual who meets eligibility criteria specified by the
  2 23 department by rule.  The department may contract with a third
  2 24 party to implement and administer the program.
  2 25    2.  Donations of prescription drugs and supplies under the
  2 26 program may be made on the premises of a medical facility or
  2 27 pharmacy that elects to participate in the program and meets
  2 28 the requirements established by the department.
  2 29    3.  The medical facility or pharmacy may charge an
  2 30 individual who receives a prescription drug or supplies a
  2 31 handling fee that shall not exceed an amount established by
  2 32 rule by the department.
  2 33    4.  A medical facility or pharmacy that receives
  2 34 prescription drugs or supplies may distribute the prescription
  2 35 drugs or supplies to another eligible medical facility or
  3  1 pharmacy for use pursuant to the program.
  3  2    5.  Participation in the program shall be voluntary.
  3  3    Sec. 4.  NEW SECTION.  135M.4  PRESCRIPTION DRUG DONATION
  3  4 REPOSITORY PROGRAM REQUIREMENTS.
  3  5    1.  A prescription drug or supplies may be accepted and
  3  6 dispensed under the prescription drug donation repository
  3  7 program if all of the following conditions are met:
  3  8    a.  The prescription drug is in its original sealed and
  3  9 tamper=evident packaging.  However, a prescription drug in a
  3 10 single=unit dose or blister pack with the outside packaging
  3 11 opened may be accepted if the single=unit dose packaging
  3 12 remains intact.
  3 13    b.  The prescription drug bears an expiration date that is
  3 14 more than six months after the date the prescription drug was
  3 15 donated.
  3 16    c.  The prescription drug or supplies are inspected before
  3 17 the prescription drug or supplies are dispensed by a licensed
  3 18 pharmacist employed by or under contract with the medical
  3 19 facility or pharmacy, and the licensed pharmacist determines
  3 20 that the prescription drug or supplies are not adulterated or
  3 21 misbranded.
  3 22    d.  The prescription drug or supplies are prescribed by a
  3 23 health care practitioner for use by an eligible individual and
  3 24 are dispensed by a pharmacist.
  3 25    2.  A prescription drug or supplies donated under this
  3 26 chapter shall not be resold.
  3 27    3.  a.  If a person who donates prescription drugs under
  3 28 this chapter to a medical facility or pharmacy receives a
  3 29 notice from a pharmacy that a prescription drug has been
  3 30 recalled, the person shall inform the medical facility or
  3 31 pharmacy of the recall.
  3 32    b.  If a medical facility or pharmacy receives a recall
  3 33 notification from a person who donated prescription drugs
  3 34 under this chapter, the medical facility or pharmacy shall
  3 35 perform a uniform destruction of all of the recalled
  4  1 prescription drugs in the medical facility or pharmacy.
  4  2    4.  A prescription drug dispensed through the prescription
  4  3 drug donation repository program shall not be eligible for
  4  4 reimbursement under the medical assistance program.
  4  5    5.  The department shall adopt rules establishing all of
  4  6 the following:
  4  7    a.  Requirements for medical facilities and pharmacies to
  4  8 accept and dispense donated prescription drugs and supplies,
  4  9 including all of the following:
  4 10    (1)  Eligibility criteria for participation by medical
  4 11 facilities and pharmacies.
  4 12    (2)  Standards and procedures for accepting, safely
  4 13 storing, and dispensing donated prescription drugs and
  4 14 supplies.
  4 15    (3)  Standards and procedures for inspecting donated
  4 16 prescription drugs to determine if the prescription drugs are
  4 17 in their original sealed and tamper=evident packaging, or if
  4 18 the prescription drugs are in single=unit doses or blister
  4 19 packs and the outside packaging is opened, if the single=unit
  4 20 dose packaging remains intact.
  4 21    (4)  Standards and procedures for inspecting donated
  4 22 prescription drugs and supplies to determine that the
  4 23 prescription drugs and supplies are not adulterated or
  4 24 misbranded.
  4 25    b.  Eligibility criteria for individuals to receive donated
  4 26 prescription drugs and supplies dispensed under the program.
  4 27 The standards shall prioritize dispensing to individuals who
  4 28 are indigent or uninsured, but may permit dispensing to other
  4 29 individuals if an uninsured or indigent individual is
  4 30 unavailable.
  4 31    c.  Necessary forms for administration of the prescription
  4 32 drug donation repository program, including forms for use by
  4 33 individuals who donate, accept, distribute, or dispense the
  4 34 prescription drugs or supplies under the program.
  4 35    d.  A means by which an individual who is eligible to
  5  1 receive donated prescription drugs and supplies may indicate
  5  2 such eligibility.
  5  3    e.  The maximum handling fee that a medical facility or
  5  4 pharmacy may charge for accepting, distributing, or dispensing
  5  5 donated prescription drugs and supplies under the program.
  5  6    f.  A list of prescription drugs that the prescription drug
  5  7 donation repository program will accept.
  5  8    Sec. 5.  NEW SECTION.  135M.5  EXEMPTION FROM DISCIPLINARY
  5  9 ACTION, CIVIL LIABILITY, AND CRIMINAL PROSECUTION.
  5 10    1.  A drug manufacturer acting reasonably and in good
  5 11 faith, is not subject to criminal prosecution or civil
  5 12 liability for injury, death, or loss to a person or property
  5 13 for matters related to the donation, acceptance, or dispensing
  5 14 of a prescription drug manufactured by the drug manufacturer
  5 15 that is donated under this chapter, including liability for
  5 16 failure to transfer or communicate product or consumer
  5 17 information or the expiration date of the donated prescription
  5 18 drug.
  5 19    2.  Except as provided in subsection 3, a person other than
  5 20 a drug manufacturer subject to subsection 1, acting reasonably
  5 21 and in good faith, is immune from civil liability and criminal
  5 22 prosecution for injury to or the death of an individual to
  5 23 whom a donated prescription drug is dispensed under this
  5 24 chapter and shall be exempt from disciplinary action related
  5 25 to the person's acts or omissions related to the donation,
  5 26 acceptance, distribution, or dispensing of a donated
  5 27 prescription drug under this chapter.
  5 28    3.  The immunity and exemption provided in subsection 2 do
  5 29 not extend to any of the following:
  5 30    a.  The donation, acceptance, distribution, or dispensing
  5 31 of a donated prescription drug under this chapter by a person
  5 32 if the person's acts or omissions are not performed reasonably
  5 33 and in good faith.
  5 34    b.  To acts or omissions outside the scope of the program.
  5 35    Sec. 6.  NEW SECTION.  135M.6  SAMPLE PRESCRIPTION DRUGS.
  6  1    This chapter shall not be construed to restrict the use of
  6  2 samples by a physician or other person legally authorized to
  6  3 prescribe drugs pursuant to section 147.107 during the course
  6  4 of the physician's or other person's duties at a medical
  6  5 facility or pharmacy.
  6  6    Sec. 7.  NEW SECTION.  135M.7  RESALE PROHIBITED.
  6  7    This chapter shall not be construed to authorize the resale
  6  8 of prescription drugs by any person.
  6  9
  6 10
  6 11                                                             
  6 12                               CHRISTOPHER C. RANTS
  6 13                               Speaker of the House
  6 14
  6 15
  6 16                                                             
  6 17                               JOHN P. KIBBIE
  6 18                               President of the Senate
  6 19
  6 20    I hereby certify that this bill originated in the House and
  6 21 is known as House File 724, Eighty=first General Assembly.
  6 22
  6 23
  6 24                                                             
  6 25                               MARGARET THOMSON
  6 26                               Chief Clerk of the House
  6 27 Approved                , 2005
  6 28
  6 29
  6 30                            
  6 31 THOMAS J. VILSACK
  6 32 Governor