Text: HSB00688 Text: HSB00690 Text: HSB00600 - HSB00699 Text: HSB Index Bills and Amendments: General Index Bill History: General Index
PAG LIN
1 1 Section 1. NEW SECTION. 135.26 DRUG REPOSITORY PROGRAM.
1 2 The department shall establish a drug repository program
1 3 for accepting and distributing donated drugs. For purposes of
1 4 this section, "drug" shall have the same meaning as defined in
1 5 section 155A.3.
1 6 1. Any person or entity, including, but not limited to, a
1 7 drug manufacturer or health care facility as defined in
1 8 section 135C.1, may donate drugs to the drug repository
1 9 program. Drugs may be donated at a physician's office,
1 10 pharmacy, hospital, or health clinic that elects to
1 11 participate in the program and meets criteria for such
1 12 participation established by the department. Participation in
1 13 the program shall be on a voluntary basis.
1 14 2. A drug shall only be accepted or distributed under the
1 15 program if the drug is in its original, unopened, sealed, and
1 16 tamper-evident unit dose packaging, except that a drug
1 17 packaged in single unit doses may be accepted and distributed
1 18 if the outside packaging is opened but the single-unit-dose
1 19 packaging is unopened. A drug shall not be accepted or
1 20 distributed if the drug bears an expiration date that is
1 21 earlier than six months after the date the drug was donated,
1 22 or is adulterated or misbranded. Subject to the limitations
1 23 provided in this subsection, unused drugs distributed under
1 24 the medical assistance program established in chapter 249A may
1 25 be accepted and distributed under the drug repository program.
1 26 3. A physician's office, pharmacy, hospital, or health
1 27 clinic that accepts donated drugs under the program shall
1 28 comply with all applicable provisions of state and federal law
1 29 relating to the storage and distribution of such drugs and
1 30 shall inspect all such drugs prior to acceptance and
1 31 distribution to determine if they are adulterated or
1 32 misbranded. Drugs accepted into the program shall be
1 33 distributed by the physician's office, pharmacy, hospital, or
1 34 health clinic to the university of Iowa hospitals and clinics
1 35 for dispensation pursuant to the indigent care program and for
2 1 the benefit of department of corrections patients. A
2 2 physician's office, pharmacy, hospital, or health clinic may
2 3 charge a handling fee for accepting or distributing drugs
2 4 under the program, in an amount to be determined by the
2 5 department by rule. Drugs donated under the program shall not
2 6 be resold.
2 7 4. Any person or entity, including a drug manufacturer,
2 8 exercising reasonable care in donating, accepting,
2 9 distributing, or dispensing drugs under the program shall be
2 10 immune from civil or criminal liability or professional
2 11 disciplinary action for any injury, death, or loss to person
2 12 or property relating to such activities. The donation of a
2 13 drug by a drug manufacturer does not, however, absolve the
2 14 manufacturer of any criminal or civil liability that would
2 15 have existed but for the donation, nor shall such donation
2 16 increase any liability of such drug manufacturer which
2 17 otherwise would have existed.
2 18 5. The department, upon the recommendation of the board of
2 19 pharmacy examiners, shall adopt rules relating to the
2 20 establishment of the program. The rules shall include, but
2 21 not be limited to, determining eligibility criteria and other
2 22 standards and procedures relating to the acceptance,
2 23 distribution, or dispensing of donated drugs; forms necessary
2 24 for administration of the program; the fees that may be
2 25 imposed by physician's offices, pharmacies, hospitals, or
2 26 health clinics; and categories of drugs deemed suitable or
2 27 unsuitable for acceptance by the program.
2 28 EXPLANATION
2 29 This bill provides for the establishment by the Iowa
2 30 department of public health of a voluntary program for
2 31 accepting donated drugs and distributing such drugs to
2 32 university of Iowa hospitals and clinics for dispensation
2 33 pursuant to the indigent care program or for department of
2 34 corrections patients.
2 35 The bill provides that for the purposes of the drug
3 1 repository program, "drug" shall be defined as in Code section
3 2 155A.3. That section defines a "drug" to mean a substance
3 3 recognized as a drug in the current official United States
3 4 Pharmacopoeia and National Formulary, official Homeopathic
3 5 Pharmacopoeia, or other drug compendium or any supplement to
3 6 any of them; a substance intended for use in the diagnosis,
3 7 cure, mitigation, treatment, or prevention of disease in
3 8 humans or other animals; a substance, other than food,
3 9 intended to affect the structure or any function of the body
3 10 of humans or other animals; a substance intended for use as a
3 11 component of any of the preceding substances; or a controlled
3 12 substance.
3 13 The bill provides that any person or entity may donate
3 14 drugs to the drug repository program, at a physician's office,
3 15 pharmacy, hospital, or health clinic that elects to
3 16 participate in the program and meets criteria for such
3 17 participation established by the department. The bill
3 18 provides that a drug shall only be accepted or distributed if
3 19 the drug is in its original, unopened, sealed, and tamper-
3 20 evident unit dose packaging, but that a drug packaged in
3 21 single unit doses may be accepted and dispensed if the outside
3 22 packaging is opened but the single-unit-dose packaging is
3 23 unopened. The bill provides that a drug shall not be accepted
3 24 or distributed if the drug bears an expiration date that is
3 25 earlier than six months after the date the drug was donated,
3 26 or is adulterated or misbranded. The bill provides that
3 27 unused drugs distributed under the medical assistance program
3 28 established in Code chapter 249A may be accepted and
3 29 distributed under the program.
3 30 The bill provides that a physician's office, pharmacy,
3 31 hospital, or health clinic that accepts donated drugs under
3 32 the program shall comply with all applicable provisions of
3 33 state and federal law relating to the storage and distribution
3 34 of such drugs, and that all drugs shall be inspected. The
3 35 bill provides that a physician's office, pharmacy, hospital,
4 1 or health clinic may charge a handling fee for accepting or
4 2 distributing drugs in an amount to be determined by the
4 3 department by rule, and that drugs donated under the program
4 4 shall not be resold.
4 5 The bill provides that a person or entity, including a drug
4 6 manufacturer, exercising reasonable care in donating,
4 7 accepting, distributing, or dispensing drugs under the program
4 8 shall be immune from civil or criminal liability or
4 9 professional disciplinary action for any injury, death, or
4 10 loss to person or property, and that the donation of a drug by
4 11 a drug manufacturer does not absolve the manufacturer of any
4 12 criminal or civil liability that would have existed but for
4 13 the donation or increase any liability which otherwise would
4 14 have existed.
4 15 The bill provides for the adoption of administrative rules
4 16 by the Iowa department of public health, acting with the
4 17 recommendation of the board of pharmacy examiners. The bill
4 18 provides that the rules shall include, but not be limited to,
4 19 determining eligibility criteria relating to the acceptance,
4 20 distribution, or dispensing of the drugs, necessary
4 21 administrative forms, fees, and categories of drugs deemed
4 22 suitable or unsuitable for acceptance.
4 23 LSB 6547HC 80
4 24 rn/pj/5
Text: HSB00688 Text: HSB00690 Text: HSB00600 - HSB00699 Text: HSB Index Bills and Amendments: General Index Bill History: General Index
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