Part 2. Drug, Supplies, andMedical Device Repository Program.
§ 90‑85.44. Drug,Supplies, and Medical Device Repository Program established.
(a) Definitions. Asused in this section unless the context clearly requires otherwise, thefollowing definitions apply:
(1) Board. As definedin G.S. 90‑85.3.
(2) Dispense. Asdefined in G.S. 90‑85.3.
(3) Drug. As definedin G.S. 90‑85.3.
(4) Eligible donor. Thefollowing are eligible donors under the Program:
a. A patient or thepatient's family member.
b. A manufacturer,wholesaler, or supplier of drugs, supplies, or medical devices.
c. A pharmacy, freeclinic, hospital, or a hospice care program.
(5) Eligible patient. Anuninsured or underinsured patient who meets the eligibility criteriaestablished by the Board, free clinic, or pharmacy.
(6) Free clinic. Aprivate, nonprofit, community‑based organization that provides healthcare services at little or no charge to low‑income, uninsured, andunderinsured persons through the use of volunteer health care professionals.
(7) Medical device. Adevice as defined in G.S. 90‑85.3(e).
(8) Pharmacist. Asdefined in G.S. 90‑85.3.
(9) Pharmacy. Asdefined in G.S. 90‑85.3.
(10) Practitioner. Aphysician or other provider of health services licensed or otherwise permittedto distribute, dispense, or administer drugs, supplies, or medical devices.
(11) Program. The Drug,Supplies, and Medical Device Repository Program established under this act.
(12) Supplies. Suppliesassociated with or necessary for the administration of a drug.
(b) Program Purpose. TheBoard shall establish and administer the Program. The purpose of the Program isto allow an eligible donor to donate unused drugs, supplies, and medicaldevices to uninsured and underinsured patients in this State. The unused drugs,supplies, and medical devices shall be donated to a free clinic or pharmacythat elects to participate in the Program. A free clinic that receives adonated unused drug, supplies, or medical device under the Program may distributethe drug, supplies, or medical device to another free clinic or pharmacy foruse under the Program.
(c) Requirements ofParticipating Pharmacists or Free Clinics. A pharmacist may accept anddispense drugs, supplies, and medical devices donated to the Program toeligible patients if all of the following requirements are met:
(1) The drug, supplies,or medical device is in the original, unopened, sealed, and tamper‑evidentpackaging or, if packaged in single‑unit doses, the single‑unitdose packaging is unopened.
(2) The pharmacist hasdetermined that the drug, supplies, or medical device is safe forredistribution.
(3) The drug bears anexpiration date that is later than six months after the date that the drug wasdonated.
(4) The drug, supplies,or medical device is not adulterated or misbranded, as determined by apharmacist.
(5) The drug, supplies,or medical device is prescribed by a practitioner for use by an eligiblepatient and is dispensed by a pharmacist.
(d) Fee. Aparticipating pharmacist or free clinic shall not resell a drug, supplies, or amedical device donated to the Program. A pharmacist or free clinic may chargean eligible patient a handling fee to receive a donated drug, supplies, ormedical device, which shall not exceed the amount specified in rules adopted bythe Board.
(e) ProgramParticipation Voluntary. Nothing in this section requires a free clinic orpharmacy to participate in the Program.
(f) Eligible Patient. The Board shall establish eligibility criteria for individuals to receivedonated drugs, supplies, or medical devices. Board eligibility criteria shallprovide that individuals meeting free clinic or pharmacy eligibility criteriaare eligible patients. Dispensing shall be prioritized to patients who areuninsured or underinsured. Dispensing to other patients shall be permitted ifan uninsured or underinsured patient is not available.
(g) Rules. The Boardshall adopt rules necessary for the implementation of the Program. Rulesadopted by the Board shall provide for the following:
(1) Requirements forfree clinics and pharmacies to accept and dispense donated drugs, supplies, andmedical devices pursuant to the Program, including eligibility criteria,confidentiality of donors, and standards and procedures for a free clinic orpharmacy to accept and safely store and dispense donated drugs, supplies, andmedical devices.
(2) The amount of themaximum handling fee that a free clinic or pharmacy may charge for distributingor dispensing donated drugs, supplies, or medical devices.
(3) A list of drugs,supplies, and medical devices, arranged either by category or by individualdrug, supply, or medical device, that the Program will accept for dispensing.
(h) Immunity. Thefollowing limited immunities apply under the Program:
(1) Unless apharmaceutical manufacturer exercises bad faith, the manufacturer is notsubject to criminal or civil liability for injury, death, or loss to a personor property for matters related to the donation, acceptance, or dispensing of adrug or medical device manufactured by the manufacturer that is donated by anyperson under the Program, including liability for failure to transfer orcommunicate product or consumer information or the expiration date of thedonated drug or medical device.
(2) The followingindividuals or entities are immune from civil liability for an act or omissionthat causes injury to or the death of an individual to whom the drug, supplies,or medical device is dispensed under the Program, and no disciplinary actionmay be taken against a pharmacist or practitioner as long as the drug,supplies, or medical device is donated in accordance with the requirements ofthis section:
a. A pharmacy or freeclinic participating in the Program.
b. A pharmacistdispensing a drug, supplies, or medical device pursuant to the Program.
c. A practitioneradministering a drug, supplies, or medical devices pursuant to the Program.
d. An eligible donorwho has donated a drug, supplies, or a medical device pursuant to the Program. (2009‑423, s. 2.)
Part 2. Drug, Supplies, andMedical Device Repository Program.
§ 90‑85.44. Drug,Supplies, and Medical Device Repository Program established.
(a) Definitions. Asused in this section unless the context clearly requires otherwise, thefollowing definitions apply:
(1) Board. As definedin G.S. 90‑85.3.
(2) Dispense. Asdefined in G.S. 90‑85.3.
(3) Drug. As definedin G.S. 90‑85.3.
(4) Eligible donor. Thefollowing are eligible donors under the Program:
a. A patient or thepatient's family member.
b. A manufacturer,wholesaler, or supplier of drugs, supplies, or medical devices.
c. A pharmacy, freeclinic, hospital, or a hospice care program.
(5) Eligible patient. Anuninsured or underinsured patient who meets the eligibility criteriaestablished by the Board, free clinic, or pharmacy.
(6) Free clinic. Aprivate, nonprofit, community‑based organization that provides healthcare services at little or no charge to low‑income, uninsured, andunderinsured persons through the use of volunteer health care professionals.
(7) Medical device. Adevice as defined in G.S. 90‑85.3(e).
(8) Pharmacist. Asdefined in G.S. 90‑85.3.
(9) Pharmacy. Asdefined in G.S. 90‑85.3.
(10) Practitioner. Aphysician or other provider of health services licensed or otherwise permittedto distribute, dispense, or administer drugs, supplies, or medical devices.
(11) Program. The Drug,Supplies, and Medical Device Repository Program established under this act.
(12) Supplies. Suppliesassociated with or necessary for the administration of a drug.
(b) Program Purpose. TheBoard shall establish and administer the Program. The purpose of the Program isto allow an eligible donor to donate unused drugs, supplies, and medicaldevices to uninsured and underinsured patients in this State. The unused drugs,supplies, and medical devices shall be donated to a free clinic or pharmacythat elects to participate in the Program. A free clinic that receives adonated unused drug, supplies, or medical device under the Program may distributethe drug, supplies, or medical device to another free clinic or pharmacy foruse under the Program.
(c) Requirements ofParticipating Pharmacists or Free Clinics. A pharmacist may accept anddispense drugs, supplies, and medical devices donated to the Program toeligible patients if all of the following requirements are met:
(1) The drug, supplies,or medical device is in the original, unopened, sealed, and tamper‑evidentpackaging or, if packaged in single‑unit doses, the single‑unitdose packaging is unopened.
(2) The pharmacist hasdetermined that the drug, supplies, or medical device is safe forredistribution.
(3) The drug bears anexpiration date that is later than six months after the date that the drug wasdonated.
(4) The drug, supplies,or medical device is not adulterated or misbranded, as determined by apharmacist.
(5) The drug, supplies,or medical device is prescribed by a practitioner for use by an eligiblepatient and is dispensed by a pharmacist.
(d) Fee. Aparticipating pharmacist or free clinic shall not resell a drug, supplies, or amedical device donated to the Program. A pharmacist or free clinic may chargean eligible patient a handling fee to receive a donated drug, supplies, ormedical device, which shall not exceed the amount specified in rules adopted bythe Board.
(e) ProgramParticipation Voluntary. Nothing in this section requires a free clinic orpharmacy to participate in the Program.
(f) Eligible Patient. The Board shall establish eligibility criteria for individuals to receivedonated drugs, supplies, or medical devices. Board eligibility criteria shallprovide that individuals meeting free clinic or pharmacy eligibility criteriaare eligible patients. Dispensing shall be prioritized to patients who areuninsured or underinsured. Dispensing to other patients shall be permitted ifan uninsured or underinsured patient is not available.
(g) Rules. The Boardshall adopt rules necessary for the implementation of the Program. Rulesadopted by the Board shall provide for the following:
(1) Requirements forfree clinics and pharmacies to accept and dispense donated drugs, supplies, andmedical devices pursuant to the Program, including eligibility criteria,confidentiality of donors, and standards and procedures for a free clinic orpharmacy to accept and safely store and dispense donated drugs, supplies, andmedical devices.
(2) The amount of themaximum handling fee that a free clinic or pharmacy may charge for distributingor dispensing donated drugs, supplies, or medical devices.
(3) A list of drugs,supplies, and medical devices, arranged either by category or by individualdrug, supply, or medical device, that the Program will accept for dispensing.
(h) Immunity. Thefollowing limited immunities apply under the Program:
(1) Unless apharmaceutical manufacturer exercises bad faith, the manufacturer is notsubject to criminal or civil liability for injury, death, or loss to a personor property for matters related to the donation, acceptance, or dispensing of adrug or medical device manufactured by the manufacturer that is donated by anyperson under the Program, including liability for failure to transfer orcommunicate product or consumer information or the expiration date of thedonated drug or medical device.
(2) The followingindividuals or entities are immune from civil liability for an act or omissionthat causes injury to or the death of an individual to whom the drug, supplies,or medical device is dispensed under the Program, and no disciplinary actionmay be taken against a pharmacist or practitioner as long as the drug,supplies, or medical device is donated in accordance with the requirements ofthis section:
a. A pharmacy or freeclinic participating in the Program.
b. A pharmacistdispensing a drug, supplies, or medical device pursuant to the Program.
c. A practitioneradministering a drug, supplies, or medical devices pursuant to the Program.
d. An eligible donorwho has donated a drug, supplies, or a medical device pursuant to the Program. (2009‑423, s. 2.)
Part 2. Drug, Supplies, andMedical Device Repository Program.
§ 90‑85.44. Drug,Supplies, and Medical Device Repository Program established.
(a) Definitions. Asused in this section unless the context clearly requires otherwise, thefollowing definitions apply:
(1) Board. As definedin G.S. 90‑85.3.
(2) Dispense. Asdefined in G.S. 90‑85.3.
(3) Drug. As definedin G.S. 90‑85.3.
(4) Eligible donor. Thefollowing are eligible donors under the Program:
a. A patient or thepatient's family member.
b. A manufacturer,wholesaler, or supplier of drugs, supplies, or medical devices.
c. A pharmacy, freeclinic, hospital, or a hospice care program.
(5) Eligible patient. Anuninsured or underinsured patient who meets the eligibility criteriaestablished by the Board, free clinic, or pharmacy.
(6) Free clinic. Aprivate, nonprofit, community‑based organization that provides healthcare services at little or no charge to low‑income, uninsured, andunderinsured persons through the use of volunteer health care professionals.
(7) Medical device. Adevice as defined in G.S. 90‑85.3(e).
(8) Pharmacist. Asdefined in G.S. 90‑85.3.
(9) Pharmacy. Asdefined in G.S. 90‑85.3.
(10) Practitioner. Aphysician or other provider of health services licensed or otherwise permittedto distribute, dispense, or administer drugs, supplies, or medical devices.
(11) Program. The Drug,Supplies, and Medical Device Repository Program established under this act.
(12) Supplies. Suppliesassociated with or necessary for the administration of a drug.
(b) Program Purpose. TheBoard shall establish and administer the Program. The purpose of the Program isto allow an eligible donor to donate unused drugs, supplies, and medicaldevices to uninsured and underinsured patients in this State. The unused drugs,supplies, and medical devices shall be donated to a free clinic or pharmacythat elects to participate in the Program. A free clinic that receives adonated unused drug, supplies, or medical device under the Program may distributethe drug, supplies, or medical device to another free clinic or pharmacy foruse under the Program.
(c) Requirements ofParticipating Pharmacists or Free Clinics. A pharmacist may accept anddispense drugs, supplies, and medical devices donated to the Program toeligible patients if all of the following requirements are met:
(1) The drug, supplies,or medical device is in the original, unopened, sealed, and tamper‑evidentpackaging or, if packaged in single‑unit doses, the single‑unitdose packaging is unopened.
(2) The pharmacist hasdetermined that the drug, supplies, or medical device is safe forredistribution.
(3) The drug bears anexpiration date that is later than six months after the date that the drug wasdonated.
(4) The drug, supplies,or medical device is not adulterated or misbranded, as determined by apharmacist.
(5) The drug, supplies,or medical device is prescribed by a practitioner for use by an eligiblepatient and is dispensed by a pharmacist.
(d) Fee. Aparticipating pharmacist or free clinic shall not resell a drug, supplies, or amedical device donated to the Program. A pharmacist or free clinic may chargean eligible patient a handling fee to receive a donated drug, supplies, ormedical device, which shall not exceed the amount specified in rules adopted bythe Board.
(e) ProgramParticipation Voluntary. Nothing in this section requires a free clinic orpharmacy to participate in the Program.
(f) Eligible Patient. The Board shall establish eligibility criteria for individuals to receivedonated drugs, supplies, or medical devices. Board eligibility criteria shallprovide that individuals meeting free clinic or pharmacy eligibility criteriaare eligible patients. Dispensing shall be prioritized to patients who areuninsured or underinsured. Dispensing to other patients shall be permitted ifan uninsured or underinsured patient is not available.
(g) Rules. The Boardshall adopt rules necessary for the implementation of the Program. Rulesadopted by the Board shall provide for the following:
(1) Requirements forfree clinics and pharmacies to accept and dispense donated drugs, supplies, andmedical devices pursuant to the Program, including eligibility criteria,confidentiality of donors, and standards and procedures for a free clinic orpharmacy to accept and safely store and dispense donated drugs, supplies, andmedical devices.
(2) The amount of themaximum handling fee that a free clinic or pharmacy may charge for distributingor dispensing donated drugs, supplies, or medical devices.
(3) A list of drugs,supplies, and medical devices, arranged either by category or by individualdrug, supply, or medical device, that the Program will accept for dispensing.
(h) Immunity. Thefollowing limited immunities apply under the Program:
(1) Unless apharmaceutical manufacturer exercises bad faith, the manufacturer is notsubject to criminal or civil liability for injury, death, or loss to a personor property for matters related to the donation, acceptance, or dispensing of adrug or medical device manufactured by the manufacturer that is donated by anyperson under the Program, including liability for failure to transfer orcommunicate product or consumer information or the expiration date of thedonated drug or medical device.
(2) The followingindividuals or entities are immune from civil liability for an act or omissionthat causes injury to or the death of an individual to whom the drug, supplies,or medical device is dispensed under the Program, and no disciplinary actionmay be taken against a pharmacist or practitioner as long as the drug,supplies, or medical device is donated in accordance with the requirements ofthis section:
a. A pharmacy or freeclinic participating in the Program.
b. A pharmacistdispensing a drug, supplies, or medical device pursuant to the Program.
c. A practitioneradministering a drug, supplies, or medical devices pursuant to the Program.
d. An eligible donorwho has donated a drug, supplies, or a medical device pursuant to the Program. (2009‑423, s. 2.)
