CHAPTER 43-15.2LEGEND DRUG DONATION AND REPOSITORY PROGRAM43-15.2-01. Definitions. In addition to the definitions under section 43-15-01, in thischapter unless the context otherwise requires:1."Donor" means a person that donates to the program legend drugs, devices, or<br>supplies needed to administer such drugs.2."Participant" means a practitioner or pharmacy that has elected to participate in the<br>program and accepts legend drugs, devices, and supplies from donors for the<br>program.3."Program" means the legend drug donation and repository program established<br>under this chapter.4."Supplies" means any supplies used in the administration of a legend drug.43-15.2-02. Administration.1.The state board of pharmacy shall establish and contract with a third party to<br>administer a legend drug donation and repository program.2.The board may develop and maintain a participant registry for the program.Aparticipant registry created under this subsection must include the name, address,<br>and telephone number of the participants. A participant registry created under this<br>subsection must be available through the board or on the board's web site.3.The board may cooperate with nongovernmental organizations to maintain a<br>web-based list of legend drugs, devices, or supplies that have been donated and are<br>available through the program and the participants from which the donated items<br>may be available.43-15.2-03. Conditions for participation.1.A donor may donate legend drugs, devices, or supplies to the program through a<br>practitioner or pharmacy that meets the criteria established for such participation.<br>Legend drugs, devices, or supplies may not be donated directly to a specific patient<br>and donated items may not be resold.2.The items donated to the program may be prescribed for use by an individual by a<br>practitioner who is authorized by law to prescribe and only a participant may<br>dispense donated items.43-15.2-04. Conditions for acceptance of a donation.1.A drug donated, prescribed, or dispensed under the program must be in the original,<br>unopened, sealed, and tamper-evident unit dose packaging, except a drug<br>packaged in single-unit doses may be accepted and dispensed if the outside<br>packaging has been opened and the single-unit-dose package is unopened.2.A drug may not be accepted or dispensed under the program if the drug has<br>reached its expiration date or if the drug is adulterated or misbranded as determined<br>under subsection 3.3.Before being dispensed to an eligible individual, the legend drugs, devices, and<br>supplies donated under the program must be inspected by a pharmacist toPage No. 1determine that the legend drugs, devices, and supplies are not adulterated or<br>misbranded.43-15.2-05. Storage, distribution, and dispensing.1.A participant that accepts donated legend drugs, devices, or supplies under the<br>program shall comply with all applicable provisions of state and federal law relating<br>to the storage, distribution, and dispensing of the donated legend drugs, devices, or<br>supplies.2.A participant may charge an individual a handling fee that does not exceed two<br>hundred fifty percent of the medicaid prescription dispensing fee for dispensing<br>donated legend drugs, devices, or supplies under the program.3.A dispenser of donated legend drugs, devices, or supplies may not submit a claim or<br>otherwise seek reimbursement from any public or private third-party payer for the<br>cost of donated legend drugs, devices, or supplies dispensed to any eligible<br>individual under the program. A public or private third-party payer is not required to<br>provide reimbursement to a dispenser for the cost of donated legend drugs, devices,<br>or supplies dispensed to any eligible individual under the program.43-15.2-06. Liability.1.A donor of legend drugs, devices, or supplies, or any participant in the program, that<br>exercises reasonable care in donating, accepting, distributing, prescribing, and<br>dispensing legend drugs, devices, or supplies under the program and the rules<br>adopted to implement this chapter is immune from civil or criminal liability and from<br>professional disciplinary action of any kind for any injury, death, or loss to personal<br>property relating to such activities.2.In the absence of intentional misconduct, a pharmaceutical manufacturer is immune<br>from civil or criminal liability for any claim, injury, death, or loss to person or property<br>arising from transfer, donation, dispensing, or acceptance of any legend drugs,<br>devices, or supplies under this chapter, including liability for failure to transfer or<br>communicate product or consumer information regarding the transferred legend<br>drugs, devices, or supplies as well as the expiration date of the legend drugs,<br>devices, or supplies under the program.43-15.2-07. Recordkeeping.1.A participant shall retain separate records detailing the receipt, distribution, and<br>dispensing of legend drugs, devices, and supplies under this program.2.The records of receipt must include:a.The name and address of the donor;b.The drug name and strength;c.The manufacturer of the legend drugs, devices, or supplies;d.The manufacturer lot number;e.The drug expiration date;f.The date received; andg.The quantity received.Page No. 23.Records of distribution and dispensing must include:a.The name and address of the participant;b.The drug or device name;c.The drug strength;d.The quantity distributed;e.The identity of the manufacturer of the legend drugs, devices, or supplies;f.The manufacturer lot number;g.The expiration date;h.The date of distribution or dispensing; andi.The name and address of the individual to whom the donated item was<br>distributed.4.Records of dispensing must include:a.The requirements for a prescription label; andb.The manufacturer's lot number.Page No. 3Document Outlinechapter 43-15.2 legend drug donation and repository program
CHAPTER 43-15.2LEGEND DRUG DONATION AND REPOSITORY PROGRAM43-15.2-01. Definitions. In addition to the definitions under section 43-15-01, in thischapter unless the context otherwise requires:1."Donor" means a person that donates to the program legend drugs, devices, or<br>supplies needed to administer such drugs.2."Participant" means a practitioner or pharmacy that has elected to participate in the<br>program and accepts legend drugs, devices, and supplies from donors for the<br>program.3."Program" means the legend drug donation and repository program established<br>under this chapter.4."Supplies" means any supplies used in the administration of a legend drug.43-15.2-02. Administration.1.The state board of pharmacy shall establish and contract with a third party to<br>administer a legend drug donation and repository program.2.The board may develop and maintain a participant registry for the program.Aparticipant registry created under this subsection must include the name, address,<br>and telephone number of the participants. A participant registry created under this<br>subsection must be available through the board or on the board's web site.3.The board may cooperate with nongovernmental organizations to maintain a<br>web-based list of legend drugs, devices, or supplies that have been donated and are<br>available through the program and the participants from which the donated items<br>may be available.43-15.2-03. Conditions for participation.1.A donor may donate legend drugs, devices, or supplies to the program through a<br>practitioner or pharmacy that meets the criteria established for such participation.<br>Legend drugs, devices, or supplies may not be donated directly to a specific patient<br>and donated items may not be resold.2.The items donated to the program may be prescribed for use by an individual by a<br>practitioner who is authorized by law to prescribe and only a participant may<br>dispense donated items.43-15.2-04. Conditions for acceptance of a donation.1.A drug donated, prescribed, or dispensed under the program must be in the original,<br>unopened, sealed, and tamper-evident unit dose packaging, except a drug<br>packaged in single-unit doses may be accepted and dispensed if the outside<br>packaging has been opened and the single-unit-dose package is unopened.2.A drug may not be accepted or dispensed under the program if the drug has<br>reached its expiration date or if the drug is adulterated or misbranded as determined<br>under subsection 3.3.Before being dispensed to an eligible individual, the legend drugs, devices, and<br>supplies donated under the program must be inspected by a pharmacist toPage No. 1determine that the legend drugs, devices, and supplies are not adulterated or<br>misbranded.43-15.2-05. Storage, distribution, and dispensing.1.A participant that accepts donated legend drugs, devices, or supplies under the<br>program shall comply with all applicable provisions of state and federal law relating<br>to the storage, distribution, and dispensing of the donated legend drugs, devices, or<br>supplies.2.A participant may charge an individual a handling fee that does not exceed two<br>hundred fifty percent of the medicaid prescription dispensing fee for dispensing<br>donated legend drugs, devices, or supplies under the program.3.A dispenser of donated legend drugs, devices, or supplies may not submit a claim or<br>otherwise seek reimbursement from any public or private third-party payer for the<br>cost of donated legend drugs, devices, or supplies dispensed to any eligible<br>individual under the program. A public or private third-party payer is not required to<br>provide reimbursement to a dispenser for the cost of donated legend drugs, devices,<br>or supplies dispensed to any eligible individual under the program.43-15.2-06. Liability.1.A donor of legend drugs, devices, or supplies, or any participant in the program, that<br>exercises reasonable care in donating, accepting, distributing, prescribing, and<br>dispensing legend drugs, devices, or supplies under the program and the rules<br>adopted to implement this chapter is immune from civil or criminal liability and from<br>professional disciplinary action of any kind for any injury, death, or loss to personal<br>property relating to such activities.2.In the absence of intentional misconduct, a pharmaceutical manufacturer is immune<br>from civil or criminal liability for any claim, injury, death, or loss to person or property<br>arising from transfer, donation, dispensing, or acceptance of any legend drugs,<br>devices, or supplies under this chapter, including liability for failure to transfer or<br>communicate product or consumer information regarding the transferred legend<br>drugs, devices, or supplies as well as the expiration date of the legend drugs,<br>devices, or supplies under the program.43-15.2-07. Recordkeeping.1.A participant shall retain separate records detailing the receipt, distribution, and<br>dispensing of legend drugs, devices, and supplies under this program.2.The records of receipt must include:a.The name and address of the donor;b.The drug name and strength;c.The manufacturer of the legend drugs, devices, or supplies;d.The manufacturer lot number;e.The drug expiration date;f.The date received; andg.The quantity received.Page No. 23.Records of distribution and dispensing must include:a.The name and address of the participant;b.The drug or device name;c.The drug strength;d.The quantity distributed;e.The identity of the manufacturer of the legend drugs, devices, or supplies;f.The manufacturer lot number;g.The expiration date;h.The date of distribution or dispensing; andi.The name and address of the individual to whom the donated item was<br>distributed.4.Records of dispensing must include:a.The requirements for a prescription label; andb.The manufacturer's lot number.Page No. 3Document Outlinechapter 43-15.2 legend drug donation and repository program
CHAPTER 43-15.2LEGEND DRUG DONATION AND REPOSITORY PROGRAM43-15.2-01. Definitions. In addition to the definitions under section 43-15-01, in thischapter unless the context otherwise requires:1."Donor" means a person that donates to the program legend drugs, devices, or<br>supplies needed to administer such drugs.2."Participant" means a practitioner or pharmacy that has elected to participate in the<br>program and accepts legend drugs, devices, and supplies from donors for the<br>program.3."Program" means the legend drug donation and repository program established<br>under this chapter.4."Supplies" means any supplies used in the administration of a legend drug.43-15.2-02. Administration.1.The state board of pharmacy shall establish and contract with a third party to<br>administer a legend drug donation and repository program.2.The board may develop and maintain a participant registry for the program.Aparticipant registry created under this subsection must include the name, address,<br>and telephone number of the participants. A participant registry created under this<br>subsection must be available through the board or on the board's web site.3.The board may cooperate with nongovernmental organizations to maintain a<br>web-based list of legend drugs, devices, or supplies that have been donated and are<br>available through the program and the participants from which the donated items<br>may be available.43-15.2-03. Conditions for participation.1.A donor may donate legend drugs, devices, or supplies to the program through a<br>practitioner or pharmacy that meets the criteria established for such participation.<br>Legend drugs, devices, or supplies may not be donated directly to a specific patient<br>and donated items may not be resold.2.The items donated to the program may be prescribed for use by an individual by a<br>practitioner who is authorized by law to prescribe and only a participant may<br>dispense donated items.43-15.2-04. Conditions for acceptance of a donation.1.A drug donated, prescribed, or dispensed under the program must be in the original,<br>unopened, sealed, and tamper-evident unit dose packaging, except a drug<br>packaged in single-unit doses may be accepted and dispensed if the outside<br>packaging has been opened and the single-unit-dose package is unopened.2.A drug may not be accepted or dispensed under the program if the drug has<br>reached its expiration date or if the drug is adulterated or misbranded as determined<br>under subsection 3.3.Before being dispensed to an eligible individual, the legend drugs, devices, and<br>supplies donated under the program must be inspected by a pharmacist toPage No. 1determine that the legend drugs, devices, and supplies are not adulterated or<br>misbranded.43-15.2-05. Storage, distribution, and dispensing.1.A participant that accepts donated legend drugs, devices, or supplies under the<br>program shall comply with all applicable provisions of state and federal law relating<br>to the storage, distribution, and dispensing of the donated legend drugs, devices, or<br>supplies.2.A participant may charge an individual a handling fee that does not exceed two<br>hundred fifty percent of the medicaid prescription dispensing fee for dispensing<br>donated legend drugs, devices, or supplies under the program.3.A dispenser of donated legend drugs, devices, or supplies may not submit a claim or<br>otherwise seek reimbursement from any public or private third-party payer for the<br>cost of donated legend drugs, devices, or supplies dispensed to any eligible<br>individual under the program. A public or private third-party payer is not required to<br>provide reimbursement to a dispenser for the cost of donated legend drugs, devices,<br>or supplies dispensed to any eligible individual under the program.43-15.2-06. Liability.1.A donor of legend drugs, devices, or supplies, or any participant in the program, that<br>exercises reasonable care in donating, accepting, distributing, prescribing, and<br>dispensing legend drugs, devices, or supplies under the program and the rules<br>adopted to implement this chapter is immune from civil or criminal liability and from<br>professional disciplinary action of any kind for any injury, death, or loss to personal<br>property relating to such activities.2.In the absence of intentional misconduct, a pharmaceutical manufacturer is immune<br>from civil or criminal liability for any claim, injury, death, or loss to person or property<br>arising from transfer, donation, dispensing, or acceptance of any legend drugs,<br>devices, or supplies under this chapter, including liability for failure to transfer or<br>communicate product or consumer information regarding the transferred legend<br>drugs, devices, or supplies as well as the expiration date of the legend drugs,<br>devices, or supplies under the program.43-15.2-07. Recordkeeping.1.A participant shall retain separate records detailing the receipt, distribution, and<br>dispensing of legend drugs, devices, and supplies under this program.2.The records of receipt must include:a.The name and address of the donor;b.The drug name and strength;c.The manufacturer of the legend drugs, devices, or supplies;d.The manufacturer lot number;e.The drug expiration date;f.The date received; andg.The quantity received.Page No. 23.Records of distribution and dispensing must include:a.The name and address of the participant;b.The drug or device name;c.The drug strength;d.The quantity distributed;e.The identity of the manufacturer of the legend drugs, devices, or supplies;f.The manufacturer lot number;g.The expiration date;h.The date of distribution or dispensing; andi.The name and address of the individual to whom the donated item was<br>distributed.4.Records of dispensing must include:a.The requirements for a prescription label; andb.The manufacturer's lot number.Page No. 3Document Outlinechapter 43-15.2 legend drug donation and repository program
