151.55 Cancer drug repository program.
Subdivision 1. Definitions. (a) For the purposes of this section, the terms defined in this subdivision have the meanings given.
(b) "Board" means the Board of Pharmacy.
(c) "Cancer drug" means a prescription drug that is used to treat:
(1) cancer or the side effects of cancer; or
(2) the side effects of any prescription drug that is used to treat cancer or the side effects of cancer.
(d) "Cancer drug repository" means a medical facility or pharmacy that has notified the board of its election to participate in the cancer drug repository program.
(e) "Cancer supply" or "supplies" means prescription and nonprescription cancer supplies needed to administer a cancer drug.
(f) "Dispense" has the meaning given in section 151.01, subdivision 30.
(g) "Distribute" means to deliver, other than by administering or dispensing.
(h) "Donor" means an individual and not a drug manufacturer or wholesale drug distributor who donates a cancer drug or supply according to the requirements of the cancer drug repository program.
(i) "Medical facility" means an institution defined in section 144.50, subdivision 2.
(j) "Medical supplies" means any prescription and nonprescription medical supply needed to administer a cancer drug.
(k) "Pharmacist" has the meaning given in section 151.01, subdivision 3.
(l) "Pharmacy" means any pharmacy registered with the Board of Pharmacy according to section 151.19, subdivision 1.
(m) "Practitioner" has the meaning given in section 151.01, subdivision 23.
(n) "Prescription drug" means a legend drug as defined in section 151.01, subdivision 17.
(o) "Side effects of cancer" means symptoms of cancer.
(p) "Single-unit-dose packaging" means a single-unit container for articles intended for administration as a single dose, direct from the container.
(q) "Tamper-evident unit dose packaging" means a container within which a drug is sealed so that the contents cannot be opened without obvious destruction of the seal.
Subd. 2. Establishment. The Board of Pharmacy shall establish and maintain a cancer drug repository program, under which any person may donate a cancer drug or supply for use by an individual who meets the eligibility criteria specified under subdivision 4. Under the program, donations may be made on the premises of a medical facility or pharmacy that elects to participate in the program and meets the requirements specified under subdivision 3.
Subd. 3. Requirements for participation by pharmacies and medical facilities. (a) To be eligible for participation in the cancer drug repository program, a pharmacy or medical facility must be licensed and in compliance with all applicable federal and state laws and administrative rules.
(b) Participation in the cancer drug repository program is voluntary. A pharmacy or medical facility may elect to participate in the cancer drug repository program by submitting the following information to the board, in a form provided by the board:
(1) the name, street address, and telephone number of the pharmacy or medical facility;
(2) the name and telephone number of a pharmacist who is employed by or under contract with the pharmacy or medical facility, or other contact person who is familiar with the pharmacy's or medical facility's participation in the cancer drug repository program; and
(3) a statement indicating that the pharmacy or medical facility meets the eligibility requirements under paragraph (a) and the chosen level of participation under paragraph (c).
(c) A pharmacy or medical facility may fully participate in the cancer drug repository program by accepting, storing, and dispensing or administering donated drugs and supplies, or may limit its participation to only accepting and storing donated drugs and supplies. If a pharmacy or facility chooses to limit its participation, the pharmacy or facility shall distribute any donated drugs to a fully participating cancer drug repository according to subdivision 8.
(d) A pharmacy or medical facility may withdraw from participation in the cancer drug repository program at any time upon notification to the board. A notice to withdraw from participation may be given by telephone or regular mail.
Subd. 4. Individual eligibility requirements. Any Minnesota resident who is diagnosed with cancer is eligible to receive drugs or supplies under the cancer drug repository program. Drugs and supplies shall be dispensed or administered according to the priority given under subdivision 6, paragraph (d).
Subd. 5. Donations of cancer drugs and supplies. (a) Any one of the following persons may donate legally obtained cancer drugs or supplies to a cancer drug repository, if the drugs or supplies meet the requirements under paragraph (b) or (c) as determined by a pharmacist who is employed by or under contract with a cancer drug repository:
(1) an individual who is 18 years old or older; or
(2) a pharmacy, medical facility, drug manufacturer, or wholesale drug distributor, if the donated drugs have not been previously dispensed.
(b) A cancer drug is eligible for donation under the cancer drug repository program only if the following requirements are met:
(1) the donation is accompanied by a cancer drug repository donor form described under paragraph (d) that is signed by the person making the donation or that person's authorized representative;
(2) the drug's expiration date is at least six months later than the date that the drug was donated;
(3) the drug is in its original, unopened, tamper-evident unit dose packaging that includes the drug's lot number and expiration date. Single-unit dose drugs may be accepted if the single-unit-dose packaging is unopened; and
(4) the drug is not adulterated or misbranded.
(c) Cancer supplies are eligible for donation under the cancer drug repository program only if the following requirements are met:
(1) the supplies are not adulterated or misbranded;
(2) the supplies are in their original, unopened, sealed packaging; and
(3) the donation is accompanied by a cancer drug repository donor form described under paragraph (d) that is signed by the person making the donation or that person's authorized representative.
(d) The cancer drug repository donor form must be provided by the board and shall state that to the best of the donor's knowledge the donated drug or supply has been properly stored and that the drug or supply has never been opened, used, tampered with, adulterated, or misbranded. The board shall make the cancer drug repository donor form available on the Board of Pharmacy's Web site.
(e) Controlled substances and drugs and supplies that do not meet the criteria under this subdivision are not eligible for donation or acceptance under the cancer drug repository program.
(f) Drugs and supplies may be donated on the premises of a cancer drug repository to a pharmacist designated by the repository. A drop box may not be used to deliver or accept donations.
(g) Cancer drugs and supplies donated under the cancer drug repository program must be stored in a secure storage area under environmental conditions appropriate for the drugs or supplies being stored. Donated drugs and supplies may not be stored with nondonated inventory.
Subd. 6. Dispensing requirements. (a) Drugs and supplies must be dispensed by a licensed pharmacist pursuant to a prescription by a practitioner or may be dispensed or administered by a practitioner according to the requirements of chapter 151 and within the practitioner's scope of practice.
(b) Cancer drugs and supplies shall be visually inspected by the pharmacist or practitioner before being dispensed or administered for adulteration, misbranding, and date of expiration. Drugs or supplies that have expired or appear upon visual inspection to be adulterated, misbranded, or tampered with in any way may not be dispensed or administered.
(c) Before a cancer drug or supply may be dispensed or administered to an individual, the individual must sign a cancer drug repository recipient form provided by the board acknowledging that the individual understands the information stated on the form. The form shall include the following information:
(1) that the drug or supply being dispensed or administered has been donated and may have been previously dispensed;
(2) that a visual inspection has been conducted by the pharmacist or practitioner to ensure that the drug has not expired, has not been adulterated or misbranded, and is in its original, unopened packaging; and
(3) that the dispensing pharmacist, the dispensing or administering practitioner, the cancer drug repository, the Board of Pharmacy, and any other participant of the cancer drug repository program cannot guarantee the safety of the drug or supply being dispensed or administered and that the pharmacist or practitioner has determined that the drug or supply is safe to dispense or administer based on the accuracy of the donor's form submitted with the donated drug or supply and the visual inspection required to be performed by the pharmacist or practitioner before dispensing or administering.
The board shall make the cancer drug repository form available on the Board of Pharmacy's Web site.
(d) Drugs and supplies shall only be dispensed or administered to individuals who meet the eligibility requirements in subdivision 4 and in the following order of priority:
(1) individuals who are uninsured;
(2) individuals who are enrolled in medical assistance, general assistance medical care, MinnesotaCare, Medicare, or other public assistance health care; and
(3) all other individuals who are otherwise eligible under subdivision 4 to receive drugs or supplies from a cancer drug repository.
Subd. 7. Handling fees. A cancer drug repository may charge the individual receiving a drug or supply a handling fee of no more than 250 percent of the medical assistance program dispensing fee for each cancer drug or supply dispensed or administered.
Subd. 8. Distribution of donated cancer drugs and supplies. (a) Cancer drug repositories may distribute drugs and supplies donated under the cancer drug repository program to other repositories if requested by a participating repository.
(b) A cancer drug repository that has elected not to dispense donated drugs or supplies shall distribute any donated drugs and supplies to a participating repository upon request of the repository.
(c) If a cancer drug repository distributes drugs or supplies under paragraph (a) or (b), the repository shall complete a cancer drug repository donor form provided by the board. The completed form and a copy of the donor form that was completed by the original donor under subdivision 5 shall be provided to the fully participating cancer drug repository at the time of distribution.
Subd. 9. Resale of donated drugs or supplies. Donated drugs and supplies may not be resold.
Subd. 10. Record-keeping requirements. (a) Cancer drug repository donor and recipient forms shall be maintained for at least five years.
(b) A record of destruction of donated drugs and supplies that are not dispensed under subdivision 6 shall be maintained by the dispensing repository for at least five years. For each drug or supply destroyed, the record shall include the following information:
(1) the date of destruction;
(2) the name, strength, and quantity of the cancer drug destroyed;
(3) the name of the person or firm that destroyed the drug; and
(4) the source of the drugs or supplies destroyed.
Subd. 11. Liability. (a) The manufacturer of a drug or supply is not subject to criminal or civil liability for injury, death, or loss to a person or to property for causes of action described in clauses (1) and (2). A manufacturer is not liable for:
(1) the intentional or unintentional alteration of the drug or supply by a party not under the control of the manufacturer; or
(2) the failure of a party not under the control of the manufacturer to transfer or communicate product or consumer information or the expiration date of the donated drug or supply.
(b) A medical facility or pharmacy participating in the program, a pharmacist dispensing a drug or supply pursuant to the program, a practitioner dispensing or administering a drug or supply pursuant to the program, or a donor of a cancer drug or supply as defined in subdivision 1 is immune from civil liability for an act or omission that causes injury to or the death of an individual to whom the cancer drug or supply is dispensed and no disciplinary action shall be taken against a pharmacist or practitioner so long as the drug or supply is donated, accepted, distributed, and dispensed according to the requirements of this section. This immunity does not apply if the act or omission involves reckless, wanton, or intentional misconduct, or malpractice unrelated to the quality of the cancer drug or supply.
HIST: 1Sp2005 c 4 art 5 s 2
Official Publication of the State of Minnesota
Revisor of Statutes