Present law authorizes the department of health, in cooperation with the board of pharmacy, to promulgate rules to establish and enforce a prescription drug donation repository program under which a person or organization may donate prescription drugs and supplies for use by a 501(c)(3) organization that meets certain eligibility criteria. This bill rewrites the provisions of law establishing the current program and recreates the program as described below.
NOTIFICATION OF PARTICIPATION
This bill authorizes a pharmacy or medical facility to elect to participate in the prescription drug donation repository program ("program") by providing written notification to the department of health of the name, street address, and telephone number of the pharmacy or facility, and a state issued license or registration number; the name and telephone number of the responsible pharmacist who is employed, or under contract, with the pharmacy or facility; and a statement, signed and dated by the responsible pharmacist indicating that the pharmacy or facility meets the eligibility and compliance requirements in this bill.
STANDARDS AND PROCEDURES
This bill requires the pharmacy or medical facility to develop and implement standards and procedures to determine, based on basic visual inspection, that the prescription drugs appear to be unadulterated, safe, and suitable for dispensing. Under this bill, donated drugs must generally be in unopened tamper-evident packaging. However, drugs packaged in single-use doses may be accepted and dispensed when the outside packaging is opened if the single-unit dose packaging is undisturbed. Other drugs are not ineligible for donation. Specifically, specialty medications, including cancer drugs, that are not in unopened, tamper-evident packaging may be donated.
This bill defines a "donor" as a person, including an individual member of the public and an entity legally authorized to possess medicine in the state in which the entity is located with a license or permit in good standing.
This bill authorizes prescription drugs and supplies to be accepted and dispensed under the program in accordance with the following:
(1) A licensed pharmacist employed, or under contract, with the program inspects donations prior to dispensing to determine if the donations are suitable for dispensing;
(2) Eligible recipients store inventory in a secure area under environmentally appropriate conditions;
(3) Eligible recipients redact donor information from the packaging;
(4) Donated inventory is physically or electronically separated from non-donated inventory;
(5) Prior to dispensing a donated drug, an eligible recipient inspects the drug to determine that it has not been adulterated; and the drug is repackaged into a new container or all previous patient information and pharmacy labeling is redacted or removed from the donated container;
(6) Donated inventory may be used to replenish purchased inventory in compliance with applicable federal law and regulations;
(7) Donated inventory may be repackaged, but repacked drugs must be labeled with the drug name, strength, and expiration date;
(8) Eligible recipients maintain an electronic inventory of accepted donations that includes the drug name, national drug code number or manufacturer, quantity, and date of donation;
(9) An identifier or bar code may be used in place of information required by law for a record or label if the identifier or bar code allows for that information to be readily retrievable;
(10) Eligible recipients return or destroy donated drugs or supplies that are not suitable for dispensing and make a record of the return or destruction that includes the drug name, strength, quantity, method of destruction, and date of destruction;
(11) Eligible recipients dispose of donated prescriptions and supplies by returning them to the donor, transferring them to a reverse distributor, or incinerating them in an incinerator that is approved by the federal environmental protection agency;
(12) The record of transaction history for a drug is maintained;
(13) Eligible recipients dispense in compliance with all applicable federal and state laws and regulations for dispensing, labeling, packaging, and recordkeeping, except as provided in this bill;
(14) An expiration date is required on all dispensed drugs and supplies, and a drug or supply must not be dispensed after its expiration date;
(15) Dispensed drugs must not expire before the end-use date by the patient based on the prescriber's directions;
(16) Controlled substances are not accepted for donation;
(17) Prescription drugs that are part of a risk evaluation and mitigation strategy program of the federal food and drug administration must not be accepted for donation;
(18) Prior to the first donation from a new donor, an eligible recipient must verify and record the donor meets the definition of a "donor" under this bill; the donor's name, address, phone number, and license number, if applicable; and the donor will only make donations of prescription drugs and supplies in accordance with this bill;
(19) Records required pursuant to this bill must be retained in physical or electronic format for a period of three years; and
(20) When performing an action associated with this program or otherwise processing donated medicine for tax, manufacture, or other credit, an eligible recipient is considered to be acting as a returns processor and must comply with all recordkeeping requirements or nonsaleable returns pursuant to federal law.
ACCEPTANCE OF DONATIONS
This bill authorizes donations of prescription drugs and supplies under the program to be made on the premises of an eligible recipient, or via mail to an eligible recipient, that elects to participate in the program. An eligible recipient may receive, accept, replenish, repackage, and store donated prescription drugs and supplies in accordance with this bill. This bill clarifies that the donation and facilitation of a donation are not considered wholesale distribution, and a person donating or facilitating a donation does not require licensure as a wholesaler.
PRIORITY FOR DISPENSING
This bill requires eligible recipients to prioritize the dispensing of donated prescriptions and supplies by, first distributing to an indigent patient; then, to a patient who has no prescription insurance or cannot afford the out-of-pocket expenses for the drug prescribed; and lastly, to another individual if an indigent, uninsured, or underinsured patient is unavailable. Additionally, a medical facility or pharmacy that receives donated drugs or supplies may distribute the donated drugs and supplies to another eligible recipient for use pursuant to the program or to similar repository programs in other states.
FEES
This bill generally prohibits an eligible recipient from charging or collecting fees from an eligible patient for prescriptions or supplies dispensed pursuant to the program. However, an eligible recipient may charge a handling fee for each donated drug or supply that is dispensed and may charge fees to donors, eligible recipients, health plans, pharmacy benefits managers, drug manufacturers, veterans affairs hospitals, and government agencies.
IMMUNITY AND EXEMPTIONS
This bill provides that a drug manufacturer acting reasonably and in good faith is not subject to criminal prosecution or civil liability for injury, death, or loss to a person or property for matters related to the donation, acceptance, or dispensing of a prescription drug manufactured by the drug manufacturer that is donated under this bill.
This bill provides that a person, other than a drug manufacturer described above, acting reasonably and in good faith, is generally immune from civil liability and criminal prosecution for injury to or the death of an individual to whom a donated prescription drug is dispensed under this bill and is exempt from disciplinary action related to the person's acts or omissions related to the donation, acceptance, distribution, or dispensing of a donated prescription drug under this bill. However, this immunity and exemption does not extend to the donation, acceptance, distribution, or dispensing of a donated drug by a person if the person's acts or omissions are not performed reasonably and in good faith or the acts or omissions are outside the scope of the program.
NO RESTRICTION ON SAMPLES
This bill does not restrict the use of samples by a physician or other person legally authorized to prescribe drugs during the course of the physician's or other person's duties at a medical facility or pharmacy.
RESALE PROHIBITED
This bill does not authorize a person to resell prescription drugs.
ON MARCH 13, 2023, THE SENATE ADOPTED AMENDMENTS #1 AND #2 AND PASSED SENATE BILL 675, AS AMENDED.
AMENDMENT #1 makes the following changes to this bill:
(1) Names this bill the "Kevin Clauson Drug Donation Act";
(2) Limits participation in the program to repositories, which are defined as pharmacies that have a license or permit in good standing with the board of pharmacy and meet the requirements established in this bill;
(3) Removes from the definition of "prescription drug" as used in this bill drugs covered by the risk evaluation and mitigation strategy program of the United States food and drug administration;
(4) Limits specialty medications that may be donated to anti-rejection drugs and cancer drugs;
(5) Removes the term "eligible patient" and provides, instead, that an "eligible individual," defined as an indigent, an uninsured person, or an underinsured person who meets the criteria for eligibility under this bill, may receive prescription drugs from the program;
(6) Requires repositories to store donated prescription drugs and supplies in a secure area in compliance with all United States food and drug administration and United States Pharmacopeia packaging and storage requirements;
(7) Requires repositories to redact donor information from the packaging of donated prescription drugs and supplies prior to dispensing;
(8) Requires repositories to return or destroy donated prescription drugs or supplies that are not suitable for dispensing;
(9) Requires repositories to dispose of donated prescription drugs and supplies by returning to the donor, transferring to a reverse distributor, or incinerating in an incinerator that is approved by the federal environmental protection agency;
(10) Provides that the record of transaction history for donated prescription drugs and supplies must be maintained, beginning with the donor, including all prior donations, but not including information that is not required by law to be placed on the prescription drug's label;
(11) Removes the requirement that destruction be accomplished by the use of a reverse distributor or following current regulations promulgated by the DEA regarding destruction of controlled substances;
(12) Removes provisions that provided that, when performing an action associated with this program or otherwise processing donated medicine for tax, manufacture, or other credit, a recipient is considered to be acting as a returns processor and must comply with all recordkeeping requirements or nonsaleable returns pursuant to federal law;
(13) Provides that donated prescription drugs and supplies may be used to replenish inventory in compliance with federal law and regulations;
(14) Limits the liability of a drug manufacturer, medical facility, or other person who is not a drug manufacturer; the department of health; or the board of pharmacy under this bill to only acts of gross negligence, willful misconduct, or bad faith; and
(15) Authorizes a licensed long-term care facility to donate prescription drugs to the program.
AMENDMENT #2 redefines “donor” for the purposes of the prescription drug donation repository program to mean any of the following that donates prescription drugs to a repository program approved by this bill:
(1) A person;
(2) A pharmacy;
(3) A medical facility;
(4) A drug manufacturer or wholesaler licensed by the board; or
(5) A prison or government entity federally authorized to possess prescription drugs with a license or permit in good standing in the state in which the entity is located.