1.1 	A bill for an act
1.2 	relating to health; establishing a cancer drug
1.3 	repository program; requiring rulemaking; proposing
1.4 	coding for new law in 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) "Dispense" has the meaning given in section 151.01,
1.16 	subdivision 30.
1.17 	(d) "Medical facility" means an institution defined in
1.18 	section 144.50, subdivision 2.
1.19 	(e) "Medical supplies" means any medical supply needed to
1.20 	administer a cancer drug.
1.21 	(f) "Pharmacist" has the meaning given in section 151.01,
1.22 	subdivision 3.
1.23 	(g) "Pharmacy" means any pharmacy registered with the Board
1.24 	of Pharmacy according to section 151.19, subdivision 1.
1.25 	(h) "Practitioner" has the meaning given in section 151.01,
2.1 	subdivision 23.
2.2 	(i) "Prescription drug" means a legend drug as defined in
2.3 	section 151.01, subdivision 17.
2.4 		Subd. 2.Establishment. The commissioner of health shall
2.5 	establish and maintain a cancer drug repository program, under
2.6 	which any person may donate a cancer drug or medical supply for
2.7 	use by an individual who meets eligibility criteria specified by
2.8 	rule.  Under the program, donations may be made on the premises
2.9 	of a medical facility or pharmacy that elects to participate in
2.10 	the program and meets the requirements specified by rule.  A
2.11 	medical facility or pharmacy that accepts a donated cancer drug
2.12 	or supply may dispense the drug or supply to an eligible
2.13 	individual or may distribute the cancer drug or supply to
2.14 	another participating medical facility or pharmacy.
2.15 		Subd. 3.Requirements to be met. A cancer drug or
2.16 	medical supply may be accepted and dispensed as part of this
2.17 	program only if the following requirements are met:
2.18 	(1) the cancer drug or medical supply is in its original,
2.19 	unopened, sealed, and tamper-evident unit dose packaging or, if
2.20 	packaged in single-unit doses, the single-unit-dose packaging is
2.21 	unopened;
2.22 	(2) the cancer drug bears an expiration date that is later
2.23 	than six months after the date that the drug is donated;
2.24 	(3) the cancer drug or supply is not adulterated or
2.25 	misbranded, as determined by a pharmacist employed by, or under
2.26 	contract with, the medical facility or pharmacy accepting the
2.27 	donation.  The pharmacist shall inspect the drug or supply
2.28 	before the drug or supply is dispensed; and 
2.29 	(4) the cancer drug or supply is prescribed by a
2.30 	practitioner for use by an eligible individual and is dispensed
2.31 	to that individual by a pharmacist.
2.32 		Subd. 4.Administration cost. No cancer drug or supply
2.33 	that is donated for use under this section shall be resold.  The
2.34 	medical facility or pharmacy may charge the individual who
2.35 	receives a cancer drug or supply under the program a handling
2.36 	fee that may not exceed an amount specified by the commissioner.
3.1 		Subd. 5.Participation. Nothing in this section requires
3.2 	that a medical facility, pharmacy, pharmacist, or practitioner
3.3 	participate in the program.
3.4 		Subd. 6.Liability. (a) Unless a manufacturer of a drug
3.5 	or supply exercises bad faith, the manufacturer is not subject
3.6 	to criminal or civil liability for injury, death, or loss to a
3.7 	person or property for matters related to the donation,
3.8 	acceptance, or dispensing of a cancer drug or supply
3.9 	manufactured by the manufacturer that is donated by any
3.10 	individual under this section, including liability for failure
3.11 	to transfer or communicate product or consumer information or
3.12 	the expiration date of the donated cancer drug or supply.
3.13 	(b) A medical facility, pharmacy, pharmacist, or
3.14 	practitioner participating in the program is immune from civil
3.15 	liability for injury to or for the death of an individual to
3.16 	whom the cancer drug or supply is dispensed and no disciplinary
3.17 	action shall be taken for unprofessional conduct for acts or
3.18 	omissions related to donating, accepting, distributing, or
3.19 	dispensing a cancer drug or supply under this section, unless
3.20 	the act or omission involves reckless, wanton, or intentional
3.21 	misconduct.
3.22 		Subd. 7.Rules. The commissioner shall adopt rules to
3.23 	implement the program, including:
3.24 	(1) requirements for medical facilities and pharmacies to
3.25 	accept, distribute, and dispense donated cancer drugs and
3.26 	supplies under this section, including:
3.27 	(i) eligibility criteria;
3.28 	(ii) standards and procedures for accepting, safely
3.29 	storing, and dispensing donated cancer drugs and supplies;
3.30 	(iii) standards and procedures for inspecting donated
3.31 	cancer drugs and supplies to determine if the cancer drug or
3.32 	supply is in its original, unopened, sealed, and tamper-evident
3.33 	unit dose packaging or, if packaged in single-unit doses, the
3.34 	single-unit-dose packaging is unopened; and 
3.35 	(iv) standards and procedures for inspecting donated cancer
3.36 	drugs and supplies to determine that the cancer drug or supply
4.1 	is not adulterated or misbranded;
4.2 	(2) eligibility criteria for individuals to receive donated
4.3 	cancer drugs or supplies under the program.  The standards shall
4.4 	prioritize dispensation to individuals who are uninsured or
4.5 	indigent but must permit dispensation to others if an uninsured
4.6 	or indigent individual is unavailable;
4.7 	(3) a maximum handling fee that a medical facility or
4.8 	pharmacy may charge for accepting, distributing, or dispensing
4.9 	donated cancer drugs or supplies; and 
4.10 	(4) a list of cancer drugs and supplies arranged by
4.11 	category or by individual cancer drug or supply that will be
4.12 	accepted under the program and a list of cancer drugs and
4.13 	supplies that will not be accepted under the program.  The list
4.14 	shall include a statement that specifies the reason that a
4.15 	cancer drug or supply is ineligible for donation.