2022 -- H 7133

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LC003452

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     STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2022

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A N   A C T

RELATING TO HEALTH AND SAFETY -- PHARMACEUTICAL REDISTRIBUTION

PROGRAM ACT

     

     Introduced By: Representatives McNamara, Potter, Corvese, Donovan, and Ranglin-
Vassell

     Date Introduced: January 20, 2022

     Referred To: House Health & Human Services

     It is enacted by the General Assembly as follows:

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     SECTION 1. Title 23 of the General Laws entitled "HEALTH AND SAFETY" is hereby

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amended by adding thereto the following chapter:

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CHAPTER 25.6

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PHARMACEUTICAL REDISTRIBUTION PROGRAM ACT

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     23-25.6-1. Short title.

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     This act shall be known and may be cited as the "Pharmaceutical Redistribution Program

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Act."

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     23-25.6-2. Definitions.

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     (a) As used in this chapter, the following words shall have the following meanings:

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     (1) "Cancer drug" means a prescription drug that is used to treat cancer, the side effects of

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cancer, or the side effects from a cancer medication. A cancer drug must be deemed a non-harmful

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substance by the Federal Drug Administration (FDA) and shall only be administered by a licensed

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professional of the state.

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     (2) "Controlled substance" means a drug, substance, immediate precursor, or synthetic drug

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in schedules I-V of chapter 28 of title 21 with high risk of dependency and addiction. Controlled

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substances include certain depressants, stimulants, narcotics, hallucinogens, and anabolic steroids.

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Controlled substances are regulated by the Drug Enforcement Agency under the Controlled

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Substances Act. "Controlled substance" does not include distilled spirits, wine, or malt beverages,

 

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as those terms are defined or used in chapter 1 of title 3, nor tobacco.

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     (3) "Donor" means any person or institution who is authorized to possess prescription drugs

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and who is willing to provide them to a redistributor once they are recommended to be discontinued

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by a physician. "Donor" includes, but is not limited to, any patient in legal possession of a

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prescribed drug, a health care proxy, and any licensed health care facility or health care provider

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such as a hospital, pharmacy, or long-term care facility, or a state or federal prison.

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     (4) "Most in need" means priority provided to a person in need of a drug based on the

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person's ability to pay.

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     (5) "Non-controlled substance prescription drugs" means any non-controlled substance

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drug meant for human use pursuant to a prescription administered by a prescriber.

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     (6) "Out-of-state redistributor" means a redistributor that is based outside of this state. An

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out-of-state redistributor shall abide by this state's laws in addition to the laws of their own state.

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     (7) "Pharmaceutical redistribution program" means the program established pursuant

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to the provisions of this chapter for the redistribution of unused prescription drugs and shall

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include any facility that may accept the return of unused non-controlled substance prescription

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drugs and orchestrate their redistribution to aid persons of this state who have difficulty

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affording or accessing the non-controlled substance drugs. This program shall prevent the

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waste of unused non-controlled substance prescription drugs through the preservation and

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redistribution to persons or licensed facilities based on their lack of access or ability to pay for

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the drugs at full market value.

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     (8) "Prescriber" means any person who has occupational licensing by relevant boards to

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prescribe a drug. Prescribers include, but are not limited to, doctors, physicians, or any other person

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legally permitted by this state.

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     (9) "Receiver" means any person or institution who receives a donated drug, including, but

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not limited to, a wholesaler, a drug manufacturer, a repackager, a returns processor, a third-party

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logistics provider, a health care facility, a pharmacy, a hospital, or a patient. Donated medications

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shall be obtained legally, with informed consent of the donor, and without coercion.

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     (10) "Redistributor" means any person or institution partaking in the redistribution of non-

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controlled substance prescription drugs pursuant to the provisions of this chapter. The entities a

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redistributor may donate drugs to include, but are not limited to, patients, institutions, hospitals and

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health care providers. Redistributors shall also include out-of-state redistributors engaged in

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redistribution pursuant to the provisions of this chapter.

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     (11) "Tamper-evident packaging" means a package that has an outer or secondary seal that

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must be broken to access the inner package and shall include clear messaging that the package had

 

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previously been opened after its seal date. Tamper-evident packaging includes, but is not limited

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to, blister packs and seal manufactured bottles.

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     (12) "Temperature-sensitive medication" means prescription medications that are unstable

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at room temperature, or approximately 70 ± 15°F. Unstable medications may begin to decompose,

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outside of this temperature range, affecting drug potency and thus efficacy. Temperature ranges

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tolerable for a medication's storage are determined by the manufacturer. Common examples of

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temperature-sensitive medications include drugs that must be refrigerated, such as biologics or

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insulin.

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     (13) "Transaction date" means the date on which the drug was transferred from the donor

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to the pharmaceutical redistribution program or to the redistributor. All available information

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surrounding the transaction date shall be logged and recorded, such as the date when the medication

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left the donor, and the date when the medication was received by the redistributor.

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     (14) "Underinsured" means any person who does not have adequate insurance coverage

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and access to basic health care, or any person who spends more than ten percent (10%) of their

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household income on out-of-pocket health care costs or more than five percent (5%) of their income

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on their health care deductible.

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     23-25.6-3. Eligibility criteria.

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     (a) Eligibility criteria for the reception of donated drugs shall prioritize individuals who are

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most in need, do not have insurance, are underinsured, or are reliant on public health programs.

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Redistributors should ensure adequate allocation of donated medications for those in prioritized

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populations. Once the need for these drugs amongst these prioritized people is fulfilled, the

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redistributor can dispense medication to other populations reporting financial burden. Redistributed

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drugs shall not be sold for an amount in excess of the price authorized pursuant to § 23-25.6-5(c).

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     (b) Donated drugs may be transferred from in-state redistributors to other in-state

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redistributors or out-of-state redistributors, assuming this transaction is legal in the state of origin

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and the state of transfer. The donation and redistribution of drugs is not categorized as wholesale

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distribution and does not warrant licensing as a wholesaler.

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     23-25.6-4. Voluntary participation and donation conditions.

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     (a) All participation in the donation program shall be voluntary. No health professional,

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insurer, agency or entity shall force any person to participate in the pharmaceutical distribution

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program.

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     (b) The following conditions shall be met for the donation of a prescription drug to occur.

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     (1) All of the donated drugs shall pass inspection by a licensed pharmacist.

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     (2) The donated drugs shall be received in an intact, tamper-evident package with a clearly

 

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displayed expiration date with no less than three (3) months until the expiration date.

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     (3) The donated drugs shall not be temperature-sensitive medications or a controlled

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substance.

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     (4) The donated drugs shall be provided to the recipient in accordance with state law. The

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drugs shall have been prescribed legally by a licensed health care professional after having been

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properly transferred to and processed by an authorized pharmaceutical redistribution program or

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redistributor.

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     (5) An authorized and properly licensed health care pharmacist shall deem the drug has not

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been tampered with upon arrival and is properly labeled. If labels have degraded but drug identity

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can be verified, new labels may be created. If the drugs have been combined in one package, the

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information about all included drugs shall be labeled clearly. If the drugs have been donated from

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out-of-state, this donation must abide by all of the laws of both states.

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     (6) The donated drugs shall have all prior patient information redacted in compliance with

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HIPAA regulations or the pills shall be transferred to a new container.

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     (7) If the drugs donated have been combined, the closest expiration date for any drugs shall

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be used for the entire package.

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     (c) If any one of the conditions contained in subsection (b) of this section is not satisfied,

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the donated drugs shall not be distributed pursuant to the provisions of this program and may be

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destroyed pursuant to department of health regulations.

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     23-25.6-5. Redistribution of donated medications.

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     (a) A redistributor may dispense prescription drugs to eligible persons as long as they abide

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by the provisions of this chapter.

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     (b) A redistributor may repackage drugs prior to redistribution. Repackaged drugs shall be

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labeled thoroughly and labels shall include the drug name, expiration date and kept separately from

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other drugs until brought up for inspection. If multiple drugs are packaged together, the closest

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expiration date shall be used pursuant to the requirements contained in § 23-25.6-4(b).

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     (c) A redistributor's compensation from an institution will not constitute the resale of drugs.

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The distributor shall make a record of that charge and provide it upon request to the supervising

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government agency. This sale price shall reflect an incentive to offer the drugs at a price that is

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affordable and reasonable for people who do not have the means to pay for such drugs at market

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price. The price incurred by the patient shall not exceed the usual and customary dispensing fee

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determined by the this state's Medicaid program.

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     (d) Donated drugs that cannot be utilized by the redistributor shall be destroyed through

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lawful methods, or transferred to a returns processor. Redistributors shall keep a record of disposed

 

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drugs, the quantity of drug, its name, and strength.

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     (e) An authorized redistributor of drugs shall store the drugs legally, separate from other

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non-donated drugs, and shall meet the requirements of the United States Pharmacopoeia (USP)

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standards. The drugs shall be stored in a way which does not impair the quality and safety of the

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drug. The drug shall be stored legally according to the methods described in this chapter. The

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facilities and storage shall be subject to investigation and approval from the department of health

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or a third party approved by the department of health. All records required pursuant to the

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provisions of this chapter shall be retained in physical or electronic format for a period of two (2)

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years. The drugs shall be labeled properly with a serial number or other effective label.

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Redistributors shall keep records by either electronic or non-electronic means for the full two (2)

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years.

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     23-25.6-6. Civil and criminal immunity.

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     Any person or institution involved in a drug donation, including, but not limited to,

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pharmacists, manufacturers, wholesalers, redistributors, health care providers, government

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agencies, contract carriers, or hospitals, who act reasonably and in good faith shall be immune from

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criminal and civil liability for any persons who are harmed from the reception of a donated drug.

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Liability shall be absolved for any act associated, but not limited to, the transfer of the donated

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drugs from one party to another, transportation, repackaging, or dispensing of donated drugs. Any

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person involved in drug donation who acts reasonably and in good faith shall be protected from

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any disciplinary action from their employers. "Good faith", as used in this section, may be defined

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as the intent to help people, the adoption of honest and altruistic intentions and the preservation of

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moral and ethical values.

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     23-25.6-7. Rules and regulations.

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     (a) The department of health and the board of pharmacy shall jointly develop and

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implement a program consistent with the public health and safety, through which unused

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prescription drugs are donated pursuant to this chapter, to become operational on January 1, 2023.

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     (b) The department and the board shall promulgate rules and regulations necessary to

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implement the program established pursuant to this chapter, on or before January 1, 2023.

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     SECTION 2. This act shall take effect upon passage.

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EXPLANATION

BY THE LEGISLATIVE COUNCIL

OF

A N   A C T

RELATING TO HEALTH AND SAFETY -- PHARMACEUTICAL REDISTRIBUTION

PROGRAM ACT

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     This act would authorize the creation and implementation of a pharmaceutical

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redistribution program by the department of health (DOH) and the board of pharmacy to commence

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operations on January 1, 2023. This program would provide for the redistribution of donated and

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unused non-controlled substance prescription drugs from facilities to aid persons of this state who

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have difficulty affording or accessing those drugs. The program would be voluntary and establish

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the conditions for donations and redistribution with civil and criminal immunity for persons or

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institutions acting in good faith.

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     This act would take effect upon passage.

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