1.1 	A bill for an act
1.2 	relating to health; establishing a cancer drug
1.3 	repository program; proposing coding for new law in
1.4 	Minnesota Statutes, chapter 144.
1.5 	BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

1.6 	Section 1. [144.707] CANCER DRUG REPOSITORY PROGRAM.
1.7 		Subdivision 1.Definitions. (a) For the purposes of this
1.8 	section, the terms defined in this subdivision have the meanings
1.9 	given.
1.10 	(b) "Cancer drug" means a prescription drug that is used to
1.11 	treat:
1.12 	(1) cancer or the side effects of cancer; or 
1.13 	(2) the side effects of any prescription drug that is used
1.14 	to treat cancer or the side effects of cancer.
1.15 	(c) "Cancer drug repository" means a medical facility or
1.16 	pharmacy that has notified the commissioner of its election to
1.17 	participate in the cancer drug repository program.
1.18 	(d) "Cancer supply" or "supplies" means prescription and
1.19 	nonprescription cancer supplies needed to administer a cancer
1.20 	drug.
1.21 	(e) "Commissioner" means the commissioner of health.
1.22 	(f) "Dispense" has the meaning given in section 151.01,
1.23 	subdivision 30.
1.24 	(g) "Distribute" means to deliver, other than by
1.25 	administering or dispensing.
2.1 	(h) "Medical facility" means an institution defined in
2.2 	section 144.50, subdivision 2.
2.3 	(i) "Medical supplies" means any prescription and
2.4 	nonprescription medical supply needed to administer a cancer
2.5 	drug.
2.6 	(j) "Pharmacist" has the meaning given in section 151.01,
2.7 	subdivision 3.
2.8 	(k) "Pharmacy" means any pharmacy registered with the Board
2.9 	of Pharmacy according to section 151.19, subdivision 1.
2.10 	(l) "Practitioner" has the meaning given in section 151.01,
2.11 	subdivision 23.
2.12 	(m) "Prescription drug" means a legend drug as defined in
2.13 	section 151.01, subdivision 17.
2.14 	(n) "Side effects of cancer" means symptoms of cancer.
2.15 	(o) "Single-unit-dose packaging" means a single-unit
2.16 	container for articles intended for administration as a single
2.17 	dose, direct from the container.
2.18 	(p) "Tamper-evident unit dose packaging" means a container
2.19 	within which a drug is sealed so that the contents cannot be
2.20 	opened without obvious destruction of the seal.
2.21 		Subd. 2.Establishment. The commissioner shall establish
2.22 	and maintain a cancer drug repository program under which any
2.23 	person may donate a cancer drug or supply for use by an
2.24 	individual who meets the eligibility criteria specified under
2.25 	subdivision 4.  Under the program, donations may be made on the
2.26 	premises of a medical facility or pharmacy that elects to
2.27 	participate in the program and meets the requirements specified
2.28 	under subdivision 3.
2.29 		Subd. 3.Requirements for participation by pharmacies and
2.30 	medical facilities. (a) To be eligible for participation in the
2.31 	cancer drug repository program, a pharmacy or medical facility
2.32 	must be licensed and in compliance with all applicable federal
2.33 	and state laws and administrative rules.
2.34 	(b) Participation in the cancer drug repository program is
2.35 	voluntary.  A pharmacy or medical facility may elect to
2.36 	participate in the cancer drug repository program by submitting
3.1 	the following information to the commissioner, in a form
3.2 	provided by the commissioner:
3.3 	(1) the name, street address, and telephone number of the
3.4 	pharmacy or medical facility;
3.5 	(2) the name and telephone number of a pharmacist who is
3.6 	employed by or under contract with the pharmacy or medical
3.7 	facility, or other contact person who is familiar with the
3.8 	pharmacy's or medical facility's participation in the cancer
3.9 	drug repository program; and 
3.10 	(3) a statement indicating that the pharmacy or medical
3.11 	facility meets the eligibility requirements under paragraph (a)
3.12 	and the chosen level of participation under paragraph (c).
3.13 	(c) A pharmacy or medical facility may fully participate in
3.14 	the cancer drug repository program by accepting, storing, and
3.15 	dispensing donated drugs and supplies, or may limit its
3.16 	participation to only accepting and storing donated drugs and
3.17 	supplies.  If a pharmacy or facility chooses to limit its
3.18 	participation, the pharmacy or facility shall distribute any
3.19 	donated drugs to a fully participating cancer drug repository in
3.20 	accordance with subdivision 8.
3.21 	(d) A pharmacy or medical facility may withdraw from
3.22 	participation in the cancer drug repository program at any time
3.23 	upon notification to the commissioner.  A notice to withdraw
3.24 	from participation may be given by telephone or regular mail.
3.25 		Subd. 4.Individual eligibility requirements. Any
3.26 	Minnesota resident who is diagnosed with cancer is eligible to
3.27 	receive drugs or supplies under the cancer drug repository
3.28 	program.  Drugs and supplies shall be dispensed according to the
3.29 	priority given under subdivision 6.
3.30 		Subd. 5.Donations of cancer drugs and supplies. (a) Any
3.31 	one of the following persons may donate legally obtained cancer
3.32 	drugs or supplies to a cancer drug repository if the drugs or
3.33 	supplies meet the requirements under paragraph (b) or (c) as
3.34 	determined by a pharmacist who is employed by or under contract
3.35 	with a cancer drug repository:
3.36 	(1) an individual who is 18 years of age or older; or 
4.1 	(2) a pharmacy, medical facility, drug manufacturer, or
4.2 	wholesale drug distributor, if the donated drugs have not been
4.3 	previously dispensed.
4.4 	(b) A cancer drug is eligible for donation under the cancer
4.5 	drug repository program only if the following requirements are
4.6 	met:
4.7 	(1) the donation is accompanied by a cancer drug repository
4.8 	donor form described under paragraph (d) that is signed by the
4.9 	person making the donation or that person's authorized
4.10 	representative;
4.11 	(2) the drug's expiration date is at least six months later
4.12 	than the date that the drug was donated;
4.13 	(3) the drug is in its original, unopened, tamper-evident
4.14 	unit dose packaging that includes the drug's lot number and
4.15 	expiration date.  Single-unit dose drugs may be accepted if the
4.16 	single-unit-dose packaging is unopened; and 
4.17 	(4) the drug is not adulterated or misbranded.
4.18 	(c) Cancer supplies are eligible for donation under the
4.19 	cancer drug repository program only if the following
4.20 	requirements are met:
4.21 	(1) the supplies are not adulterated or misbranded;
4.22 	(2) the supplies are in their original, unopened, sealed
4.23 	packaging; and 
4.24 	(3) the donation is accompanied by a cancer drug repository
4.25 	donor form described under paragraph (d) that is signed by the
4.26 	person making the donation or that person's authorized
4.27 	representative.
4.28 	(d) The cancer drug repository donor form must be provided
4.29 	by the commissioner and shall state that to the best of the
4.30 	donor's knowledge the donated drug or supply has been properly
4.31 	stored and that the drug or supply has never been opened, used,
4.32 	tampered with, adulterated, or misbranded.  The commissioner
4.33 	shall make the cancer drug repository donor form available on
4.34 	the Department of Health's Web site.
4.35 	(e) Controlled substances and drugs and supplies that do
4.36 	not meet the criteria under this subdivision are not eligible
5.1 	for donation or acceptance under the cancer drug repository
5.2 	program.
5.3 	(f) Drugs and supplies may be donated on the premises of a
5.4 	cancer drug repository to a pharmacist designated by the
5.5 	repository.  A drop box may not be used to deliver or accept
5.6 	donations.
5.7 	(g) Cancer drugs and supplies donated under the cancer drug
5.8 	repository program must be stored in a secure storage area under
5.9 	environmental conditions appropriate for the drugs or supplies
5.10 	being stored.  Donated drugs and supplies may not be stored with
5.11 	nondonated inventory.
5.12 		Subd. 6.Dispensing requirements. (a) Drugs and supplies
5.13 	must be dispensed by a licensed pharmacist pursuant to a
5.14 	prescription by a practitioner and in accordance with the
5.15 	requirements of chapter 151.
5.16 	(b) Before being dispensed, cancer drugs and supplies shall
5.17 	be visually inspected by the pharmacist for adulteration,
5.18 	misbranding, and date of expiration.  Drugs or supplies that
5.19 	have expired or appear upon visual inspection to be adulterated,
5.20 	misbranded, or tampered with in any way may not be dispensed.
5.21 	(c) Before a cancer drug or supply may be dispensed to an
5.22 	individual, the individual must sign a cancer drug repository
5.23 	recipient form provided by the commissioner acknowledging that
5.24 	the individual understands the information stated on the form.
5.25 	The form shall include the following information:
5.26 	(1) that the drug or supply being dispensed has been
5.27 	donated and may have been previously dispensed;
5.28 	(2) that a visual inspection has been conducted by the
5.29 	pharmacist to ensure that the drug has not expired, has not been
5.30 	adulterated or misbranded, and is in its original, unopened
5.31 	packaging; and 
5.32 	(3) that the dispensing pharmacist, the cancer drug
5.33 	repository, the Department of Health, and any other participant
5.34 	in the cancer drug repository program cannot guarantee the
5.35 	safety of the drug or supply being dispensed and that the
5.36 	pharmacist has determined that the drug or supply is safe to
6.1 	dispense based on the accuracy of the donor's form submitted
6.2 	with the donated drug or supply and the visual inspection
6.3 	required to be performed by the pharmacist before dispensing.
6.4 	The commissioner shall make the cancer drug repository form
6.5 	available on the Department of Health's Web site.
6.6 	(d) Drugs and supplies shall only be dispensed to
6.7 	individuals who meet the eligibility requirements in subdivision
6.8 	4 and in the following order of priority:
6.9 	(1) individuals who are uninsured;
6.10 	(2) individuals who are enrolled in medical assistance,
6.11 	general assistance medical care, MinnesotaCare, Medicare, or
6.12 	other public assistance health care; and 
6.13 	(3) all other individuals who are otherwise eligible under
6.14 	subdivision 4 to receive drugs or supplies from a cancer drug
6.15 	repository.
6.16 		Subd. 7.Handling fees. A cancer drug repository may
6.17 	charge the individual receiving a drug or supply a handling fee
6.18 	of no more than 250 percent of the medical assistance program
6.19 	dispensing fee for each cancer drug or supply dispensed.
6.20 		Subd. 8.Distribution of donated cancer drugs and
6.21 	supplies. (a) Cancer drug repositories may distribute drugs and
6.22 	supplies donated under the cancer drug repository program to
6.23 	other repositories if requested by a participating repository.
6.24 	(b) A cancer drug repository that has elected not to
6.25 	dispense donated drugs or supplies shall distribute any donated
6.26 	drugs and supplies to a participating repository upon request of
6.27 	the repository.
6.28 	(c) If a cancer drug repository distributes drugs or
6.29 	supplies under paragraph (a) or (b), the repository shall
6.30 	complete a cancer drug repository donor form provided by the
6.31 	commissioner.  The completed form and a copy of the donor form
6.32 	that was completed by the original donor under subdivision 5
6.33 	shall be provided to the fully participating cancer drug
6.34 	repository at the time of distribution.
6.35 		Subd. 9.Resale of donated drugs or supplies. Donated
6.36 	drugs and supplies may not be resold.
7.1 		Subd. 10.Record-keeping requirements. (a) Cancer drug
7.2 	repository donor and recipient forms shall be maintained for at
7.3 	least five years.
7.4 	(b) A record of destruction of donated drugs and supplies
7.5 	that are not dispensed under subdivision 6 shall be maintained
7.6 	by the dispensing repository for at least five years.  For each
7.7 	drug or supply destroyed, the record shall include the following
7.8 	information:
7.9 	(1) the date of destruction;
7.10 	(2) the name, strength, and quantity of the cancer drug
7.11 	destroyed;
7.12 	(3) the name of the person or firm that destroyed the drug;
7.13 	and 
7.14 	(4) the source of the drugs or supplies destroyed.
7.15 		Subd. 11.Liability. (a) The manufacturer of a drug or
7.16 	supply is not subject to criminal or civil liability for injury,
7.17 	death, or loss to a person or to property related to the
7.18 	donation of one of its drugs and caused by:
7.19 	(1) the intentional or unintentional alteration of the drug
7.20 	or supply by a party not under the control of the manufacturer;
7.21 	or 
7.22 	(2) failure of a party not under the control of the
7.23 	manufacturer to transfer or communicate product or consumer
7.24 	information or the expiration date of the donated drug or supply.
7.25 	(b) A medical facility or pharmacy participating in the
7.26 	program, a pharmacist dispensing a drug or supply pursuant to
7.27 	the program, a practitioner administering a drug or supply
7.28 	pursuant to the program, or the donor of a cancer drug or supply
7.29 	is immune from civil liability for an act or omission that
7.30 	causes injury to or the death of an individual to whom the
7.31 	cancer drug or supply is dispensed and no disciplinary action
7.32 	shall be taken against a pharmacist or practitioner so long as
7.33 	the drug or supply is donated, accepted, distributed, and
7.34 	dispensed in accordance with the requirements of this section.
7.35 	This immunity does not apply if the act or omission involves
7.36 	reckless, wanton, or intentional misconduct, or malpractice
8.1 	unrelated to the quality of the cancer drug or supply.