Text: HF02190 Text: HF02192 Text: HF02100 - HF02199 Text: HF Index Bills and Amendments: General Index Bill History: General Index
PAG LIN
1 1 Section 1. NEW SECTION. 135.26 CANCER DRUG REPOSITORY
1 2 PROGRAM.
1 3 The department shall establish a cancer drug repository
1 4 program for accepting donated cancer drugs and dispensing such
1 5 drugs to residents of this state.
1 6 1. Any person or entity, including, but not limited to, a
1 7 cancer drug manufacturer, or health care facility as defined
1 8 in section 135C.1, may donate cancer drugs to the cancer drug
1 9 repository program. Cancer drugs may be donated at a
1 10 physician's office, pharmacy, hospital, or health clinic that
1 11 elects to participate in the program and meets criteria for
1 12 such participation established by the department.
1 13 Participation in the program shall be on a voluntary basis.
1 14 2. A cancer drug shall only be accepted or dispensed under
1 15 the program if the drug is in its original, unopened, sealed,
1 16 and tamper-evident unit dose packaging, except that a cancer
1 17 drug packaged in single unit doses may be accepted and
1 18 dispensed if the outside packaging is opened but the single-
1 19 unit-dose packaging is unopened. A cancer drug shall not be
1 20 accepted or dispensed if the drug bears an expiration date
1 21 that is earlier than six months after the date the drug was
1 22 donated, or is adulterated or misbranded. Subject to the
1 23 limitations provided in this subsection, unused cancer drugs
1 24 dispensed under the medical assistance program established in
1 25 chapter 249A may be accepted and dispensed under the cancer
1 26 drug repository program.
1 27 3. A physician's office, pharmacy, hospital, or health
1 28 clinic that accepts donated cancer drugs under the program
1 29 shall comply with all applicable provisions of state and
1 30 federal law relating to the storage, distribution, and
1 31 dispensing of such drugs and shall inspect all such drugs
1 32 prior to dispensing to determine if they are adulterated or
1 33 misbranded. Drugs accepted into the program shall only be
1 34 dispensed to eligible persons pursuant to a prescription
1 35 issued by a prescribing practitioner, as defined in section
2 1 155A.3, and may be distributed to another participating
2 2 physician's office, pharmacy, hospital, or health clinic for
2 3 dispensing. A physician's office, pharmacy, hospital, or
2 4 health clinic may charge a handling fee for distributing or
2 5 dispensing cancer drugs under the program, in an amount to be
2 6 determined by the department by rule. Cancer drugs donated
2 7 under the program shall not be resold.
2 8 4. Any person or entity, including a cancer drug
2 9 manufacturer, exercising reasonable care in donating,
2 10 accepting, distributing, or dispensing cancer drugs under the
2 11 program shall be immune from civil or criminal liability or
2 12 professional disciplinary action for any injury, death, or
2 13 loss to person or property relating to such activities. The
2 14 donation of a cancer drug by a cancer drug manufacturer does
2 15 not, however, absolve the manufacturer of any criminal or
2 16 civil liability that would have existed but for the donation,
2 17 nor shall such donation increase any liability of such cancer
2 18 drug manufacturer which otherwise would have existed.
2 19 5. The department, upon the recommendation of the board of
2 20 pharmacy examiners, shall adopt rules relating to the
2 21 establishment of the program. The rules shall include, but
2 22 not be limited to, determining eligibility criteria and other
2 23 standards and procedures relating to the acceptance,
2 24 distribution, or dispensing of donated cancer drugs; forms
2 25 necessary for administration of the program; the fees that may
2 26 be imposed by physician's offices, pharmacies, hospitals, or
2 27 health clinics; and categories of cancer drugs deemed suitable
2 28 or unsuitable for acceptance by the program.
2 29 EXPLANATION
2 30 This bill provides for the establishment by the Iowa
2 31 department of public health of a voluntary program for
2 32 accepting donated cancer drugs and dispensing such drugs to
2 33 residents of this state.
2 34 The bill provides that any person or entity may donate
2 35 cancer drugs to the cancer drug repository program, at a
3 1 physician's office, pharmacy, hospital, or health clinic that
3 2 elects to participate in the program and meets criteria for
3 3 such participation established by the department. The bill
3 4 provides that a cancer drug shall only be accepted or
3 5 dispensed if the drug is in its original, unopened, sealed,
3 6 and tamper-evident unit dose packaging, but that a drug
3 7 packaged in single unit doses may be accepted and dispensed if
3 8 the outside packaging is opened but the single-unit-dose
3 9 packaging is unopened. The bill provides that a cancer drug
3 10 shall not be accepted or dispensed if the drug bears an
3 11 expiration date that is earlier than six months after the date
3 12 the drug was donated, or is adulterated or misbranded. The
3 13 bill provides that unused cancer drugs dispensed under the
3 14 medical assistance program established in Code chapter 249A
3 15 may be accepted and dispensed under the program.
3 16 The bill provides that a physician's office, pharmacy,
3 17 hospital, or health clinic that accepts donated cancer drugs
3 18 under the program shall comply with all applicable provisions
3 19 of state and federal law relating to the storage,
3 20 distribution, and dispensing of such drugs, that all drugs
3 21 shall be inspected prior to dispensing, and that drugs
3 22 accepted into the program shall only be dispensed to eligible
3 23 persons pursuant to a prescription issued by a prescribing
3 24 practitioner as defined in Code section 155A.3. The bill
3 25 provides that a physician's office, pharmacy, hospital, or
3 26 health clinic may charge a handling fee for distributing or
3 27 dispensing cancer drugs in an amount to be determined by the
3 28 department by rule, and that cancer drugs donated under the
3 29 program shall not be resold.
3 30 The bill provides that a person or entity, including a
3 31 cancer drug manufacturer, exercising reasonable care in
3 32 donating, accepting, distributing, or dispensing cancer drugs
3 33 under the program shall be immune from civil or criminal
3 34 liability or professional disciplinary action for any injury,
3 35 death, or loss to person or property, and that the donation of
4 1 a cancer drug by a cancer drug manufacturer does not absolve
4 2 the manufacturer of any criminal or civil liability that would
4 3 have existed but for the donation or increase any liability
4 4 which otherwise would have existed.
4 5 The bill provides for the adoption of administrative rules
4 6 by the Iowa department of public health, acting with the
4 7 recommendation of the board of pharmacy examiners. The bill
4 8 provides that the rules shall include, but not be limited to,
4 9 determining eligibility criteria relating to the acceptance,
4 10 distribution, or dispensing of the drugs, necessary
4 11 administrative forms, fees, and categories of cancer drugs
4 12 deemed suitable or unsuitable for acceptance.
4 13 LSB 5056HH 80
4 14 rn/pj/5
Text: HF02190 Text: HF02192 Text: HF02100 - HF02199 Text: HF Index Bills and Amendments: General Index Bill History: General Index
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