House File 245 - Introduced
HOUSE FILE
BY MURPHY and SHOULTZ
Passed House, Date Passed Senate, Date
Vote: Ayes Nays Vote: Ayes Nays
Approved
A BILL FOR
1 An Act providing for the establishment of a cancer drug
2 repository program.
3 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA:
4 TLSB 1581HH 81
5 rn/pj/5
PAG LIN
1 1 Section 1. NEW SECTION. 135.27 CANCER DRUG REPOSITORY
1 2 PROGRAM.
1 3 1. DEFINITIONS. For the purposes of this section, unless
1 4 the context otherwise requires:
1 5 a. "Cancer drug" means a prescription drug that is used to
1 6 treat any of the following:
1 7 (1) Cancer or the side effects of cancer.
1 8 (2) The side effects of any prescription drug that is used
1 9 to treat cancer or the side effects of cancer.
1 10 b. "Medical facility" means a physician's office,
1 11 hospital, or health clinic.
1 12 2. The department shall establish and maintain a cancer
1 13 drug repository program, under which any person may donate a
1 14 cancer drug or supplies needed to administer a cancer drug for
1 15 use by an individual who meets eligibility criteria specified
1 16 by the department by rule. Donations may be made on the
1 17 premises of a medical facility or pharmacy that elects to
1 18 participate in the program and meets requirements established
1 19 by the department. The medical facility or pharmacy may
1 20 charge an individual who receives a cancer drug or supplies
1 21 needed to administer a cancer drug a handling fee that may not
1 22 exceed an amount established by the department. A medical
1 23 facility or pharmacy that receives a donated cancer drug or
1 24 supplies needed to administer a cancer drug may distribute the
1 25 cancer drug or supplies to another eligible medical facility
1 26 or pharmacy for use pursuant to the program.
1 27 3. A cancer drug or supplies needed to administer a cancer
1 28 drug may be accepted and dispensed under the program only if
1 29 all of the following conditions are met:
1 30 a. The cancer drug or supplies needed to administer a
1 31 cancer drug are in their original, unopened, sealed, and
1 32 tamper=evident unit dose packaging or, if packaged in single=
1 33 unit doses, the single=unit=dose packaging is unopened.
1 34 b. The cancer drug bears an expiration date that is later
1 35 than six months after the date the drug was donated.
2 1 c. The cancer drug or supplies needed to administer a
2 2 cancer drug are not adulterated or misbranded, as determined
2 3 by a licensed pharmacist employed by, or under contract with,
2 4 the medical facility or pharmacy, who shall inspect the drug
2 5 or supplies needed to administer a cancer drug before the drug
2 6 or supplies are dispensed.
2 7 d. The cancer drug or supplies needed to administer a
2 8 cancer drug are prescribed by a health care practitioner for
2 9 use by an eligible individual and are dispensed by a
2 10 pharmacist.
2 11 4. A cancer drug or supplies needed to administer a cancer
2 12 drug that are donated for use under this section may not be
2 13 resold.
2 14 5. A medical facility, pharmacy, pharmacist, or health
2 15 care practitioner shall not be required to participate in the
2 16 program.
2 17 6. a. Unless the manufacturer of a drug or supplies
2 18 exercises bad faith, the manufacturer is not subject to
2 19 criminal or civil liability for injury, death, or loss to a
2 20 person or property for matters related to the donation,
2 21 acceptance, or dispensing of a cancer drug or supplies
2 22 manufactured by the manufacturer that are donated by any
2 23 person under this section, including liability for failure to
2 24 transfer or communicate product or consumer information or the
2 25 expiration date of the donated cancer drug or supplies.
2 26 b. Except as provided in paragraph "c", any person, except
2 27 the manufacturer of a cancer drug or supplies, is immune from
2 28 civil liability for injury to or the death of the individual
2 29 to whom the cancer drug or supplies are dispensed and may not
2 30 be found guilty of unprofessional conduct for the person's
2 31 acts or omissions relating to donating, accepting,
2 32 distributing, or dispensing a cancer drug or supplies under
2 33 this section.
2 34 c. The immunity or the prohibition on a finding of guilty
2 35 of unprofessional conduct under paragraph "b" does not extend
3 1 to donation, acceptance, distribution, or dispensation of a
3 2 cancer drug by a person whose act or omission involves
3 3 reckless, wanton, or intentional misconduct.
3 4 7. The department shall adopt rules establishing the
3 5 following:
3 6 a. Requirements for medical facilities and pharmacies to
3 7 accept and dispense donated cancer drugs or supplies needed to
3 8 administer cancer drugs under this section, including:
3 9 (1) Eligibility criteria.
3 10 (2) Standards and procedures for accepting, safely
3 11 storing, and dispensing donated cancer drugs or supplies
3 12 needed to administer cancer drugs.
3 13 (3) Standards and procedures for inspecting donated cancer
3 14 drugs or supplies needed to administer cancer drugs to
3 15 determine if the cancer drug or supplies needed to administer
3 16 a cancer drug are in their original, unopened, sealed, and
3 17 tamper=evident unit dose packaging or, if packaged in single=
3 18 unit doses, the single=unit=dose packaging is unopened.
3 19 (4) Standards and procedures for inspecting donated cancer
3 20 drugs or supplies needed to administer cancer drugs to
3 21 determine that the cancer drug or supplies needed to
3 22 administer a cancer drug are not adulterated or misbranded.
3 23 b. Eligibility criteria for individuals to receive donated
3 24 cancer drugs or supplies needed to administer cancer drugs
3 25 dispensed under the program. The standards shall prioritize
3 26 dispensation to individuals who are uninsured or indigent, but
3 27 shall permit dispensation to others if an uninsured or
3 28 indigent individual is unavailable.
3 29 c. A means, such as an identification card, by which an
3 30 individual who is eligible to receive a donated cancer drug or
3 31 supplies needed to administer a cancer drug may indicate that
3 32 eligibility.
3 33 d. Necessary forms for administration of the cancer drug
3 34 repository program, including forms for use by persons that
3 35 donate, accept, distribute, or dispense cancer drugs or
4 1 supplies needed to administer cancer drugs under the program.
4 2 e. The maximum handling fee that a medical facility or
4 3 pharmacy may charge for accepting, distributing, or dispensing
4 4 donated cancer drugs or supplies needed to administer cancer
4 5 drugs.
4 6 f. A list of cancer drugs and supplies needed to
4 7 administer cancer drugs, arranged by category or by individual
4 8 cancer drug or supply, that the cancer drug repository program
4 9 will not accept for dispensing. The list shall include a
4 10 statement that specifies the reason that the cancer drug or
4 11 supplies needed to administer a cancer drug are ineligible for
4 12 donation.
4 13 EXPLANATION
4 14 This bill provides for the establishment of a cancer drug
4 15 repository program by the Iowa department of public health.
4 16 The bill defines a "cancer drug" to mean a prescription
4 17 drug that is used to treat cancer or the side effects of
4 18 cancer, or to treat the side effects of any prescription drug
4 19 that is used to treat cancer or the side effects of cancer.
4 20 The bill provides that the program allows for the donation of
4 21 a cancer drug or supplies needed to administer a cancer drug
4 22 for use by an individual who meets eligibility criteria
4 23 specified by the department by rule. The bill specifies that
4 24 donations may be made on the premises of a medical facility or
4 25 pharmacy that elects to participate in the program and meets
4 26 requirements established by the department by rule, and that
4 27 the medical facility or pharmacy may charge an individual who
4 28 receives a cancer drug or supplies needed to administer a
4 29 cancer drug a handling fee that may not exceed an amount
4 30 established by the department by rule. The bill provides that
4 31 a medical facility or pharmacy that receives a donated cancer
4 32 drug or supplies needed to administer a cancer drug may
4 33 distribute the cancer drug or supplies to another eligible
4 34 medical facility or pharmacy for use pursuant to the program.
4 35 The bill specifies a number of requirements relating to
5 1 acceptance and dispensation of cancer drugs or supplies. The
5 2 bill provides that a cancer drug or supplies must be in their
5 3 original, unopened, sealed, and tamper=evident unit dose
5 4 packaging or in unopened single=unit=dose packaging, and must
5 5 bear an expiration date later than six months after the date
5 6 the drug was donated. The bill provides that the cancer drug
5 7 or supplies must not be adulterated or misbranded, as
5 8 determined by a licensed pharmacist, that the cancer drug or
5 9 supplies must be prescribed by a health care practitioner for
5 10 use by an eligible individual and dispensed by a pharmacist,
5 11 and that they may not be resold. The bill also provides that
5 12 a medical facility, pharmacy, pharmacist, or health care
5 13 practitioner cannot be required to participate in the program.
5 14 The bill provides for immunity from civil or criminal
5 15 liability for manufacturers and dispensers under specified
5 16 circumstances. The bill also provides that the department
5 17 shall adopt rules relating to eligibility criteria to
5 18 participate in the program and receive distributions; rules
5 19 relating to standards and procedures for accepting, storing,
5 20 dispensing, and inspecting drugs and supplies; necessary forms
5 21 for administration of the program; the level of fees which may
5 22 be imposed; and a listing of drugs and supplies which may not
5 23 be accepted for dispensation.
5 24 LSB 1581HH 81
5 25 rn:nh/pj/5