| Chapter 402 |
| 2022 -- H 7133 SUBSTITUTE B Enacted 06/30/2022 |
| 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 |
| It is enacted by the General Assembly as follows: |
| SECTION 1. Title 23 of the General Laws entitled "HEALTH AND SAFETY" is hereby |
| amended by adding thereto the following chapter: |
| CHAPTER 25.6 |
| PHARMACEUTICAL REDISTRIBUTION PROGRAM ACT |
| 23-25.6-1. Short title. |
| This act shall be known and may be cited as the "Pharmaceutical Redistribution Program |
| Act." |
| 23-25.6-2. Definitions. |
| (a) As used in this chapter, the following words shall have the following meanings: |
| (1) "Cancer drug" means a prescription drug that is used to treat cancer, the side effects of |
| cancer, or the side effects from a cancer medication. A cancer drug must be deemed a non-harmful |
| substance by the Federal Drug Administration (FDA) and shall only be administered by a licensed |
| professional of the state. |
| (2) "Controlled substance" means a drug, substance, immediate precursor, or synthetic drug |
| in schedules I-V of chapter 28 of title 21 with high risk of dependency and addiction. Controlled |
| substances include certain depressants, stimulants, narcotics, hallucinogens, and anabolic steroids. |
| Controlled substances are regulated by the Drug Enforcement Agency under the Controlled |
| Substances Act. "Controlled substance" does not include distilled spirits, wine, or malt beverages, |
| as those terms are defined or used in chapter 1 of title 3, nor tobacco. |
| (3) "Distributor" means a person defined in § 21-28-1.02. |
| (4) "Department" means the Rhode Island department of health. |
| (5) "Donor" means any person or institution who or that is authorized to possess |
| prescription drugs and who is willing to provide them to a redistributor once they are recommended |
| to be discontinued by a physician. "Donor" includes, but is not limited to, any patient in legal |
| possession of a prescribed drug, a health care healthcare proxy, and any licensed health care |
| healthcare facility or health care healthcare provider such as a hospital, pharmacy, or long-term- |
| care facility, or a state or federal prison. |
| (6) "Most in need" means priority provided to a person in need of a drug based on the |
| person's ability to pay. |
| (7) "Non-controlled substance prescription drugs" means any non-controlled substance |
| drug meant for human use pursuant to a prescription administered by a prescriber. |
| (8) "Out-of-state redistributor" means a redistributor that is based outside of this state. An |
| out-of-state redistributor shall abide by this state's laws in addition to the laws of their its own state. |
| Out-of-state redistributors must be licensed by the department as distributors in accordance with |
| the provisions of chapter 28 of title 21. |
| (9) "Pharmaceutical redistribution program" means the program established pursuant |
| to the provisions of this chapter for the redistribution of unused prescription drugs and shall |
| include any facility that may accept the return of unused non-controlled substance prescription |
| drugs and orchestrate their redistribution to aid persons of this state who have difficulty |
| affording or accessing the non-controlled substance drugs. This program shall prevent the |
| waste of unused non-controlled substance prescription drugs through the preservation and |
| redistribution to persons or licensed facilities based on their lack of access or ability to pay for |
| the drugs at full market value. |
| (10) "Prescriber" means any person who has occupational licensing by relevant boards to |
| prescribe a drug. Prescribers include, but are not limited to, doctors, physicians, or any other person |
| legally permitted by this state. |
| (11) "Receiver" means any person or institution who or that receives a donated drug, |
| including, but not limited to,: a wholesaler, a drug manufacturer, a repackager, a returns processor, |
| a third-party logistics provider, a health care healthcare facility, a pharmacy, a hospital, or a |
| patient. Donated medications shall be obtained legally, with informed consent of the donor, and |
| without coercion. |
| (12) "Redistributor" means any person or institution partaking in the redistribution of non- |
| controlled substance prescription drugs pursuant to the provisions of this chapter. The entities a |
| redistributor may donate drugs to include, but are not limited to, patients, institutions, hospitals, |
| and health care healthcare providers. Redistributors shall also include out-of-state redistributors |
| engaged in redistribution pursuant to the provisions of this chapter. Redistributors must be licensed |
| by the department as distributors in accordance with the provisions of chapter 28 of title 21. |
| (13) "Tamper-evident packaging" means a package that has an outer or secondary seal that |
| must be broken to access the inner package and shall include clear messaging that the package had |
| previously been opened after its seal date. Tamper-evident packaging includes, but is not limited |
| to, blister packs and seal manufactured bottles. |
| (14) "Temperature-sensitive medication" means prescription medications that are unstable |
| at room temperature, or approximately 70 ± 15°F. Unstable medications may begin to decompose, |
| outside of this temperature range, affecting drug potency and thus efficacy. Temperature ranges |
| tolerable for a medication's storage are determined by the manufacturer. Common examples of |
| temperature-sensitive medications include drugs that must be refrigerated, such as biologics or |
| insulin. |
| (15) "Transaction date" means the date on which the drug was transferred from the donor |
| to the pharmaceutical redistribution program or to the redistributor. All available information |
| surrounding the transaction date shall be logged and recorded, such as the date when the medication |
| left the donor, and the date when the medication was received by the redistributor. |
| (16) "Underinsured" means any person who does not have adequate insurance coverage |
| and access to basic health care, or any person who spends more than ten percent (10%) of their |
| household income on out-of-pocket health care healthcare costs or more than five percent (5%) of |
| their income on their health care healthcare deductible. |
| 23-25.6-3. Eligibility criteria. |
| (a) Eligibility criteria for the reception of donated drugs shall prioritize individuals who are |
| most in need, do not have insurance, are underinsured, or are reliant on public health programs. |
| Redistributors should ensure adequate allocation of donated medications for those in prioritized |
| populations. Once the need for these drugs amongst these prioritized people is fulfilled, the |
| redistributor can dispense medication to other populations reporting financial burden. Redistributed |
| drugs shall not be sold for an amount in excess of the price authorized pursuant to § 23-25.6-5(c). |
| (b) Donated drugs may be transferred from in-state redistributors to other in-state |
| redistributors or out-of-state redistributors, assuming this transaction is legal in the state of origin |
| and the state of transfer. The donation and redistribution of drugs is not categorized as wholesale |
| distribution and does not warrant licensing as a wholesaler. |
| 23-25.6-4. Voluntary participation and donation conditions. |
| (a) All participation in the donation program shall be voluntary. No health professional, |
| insurer, agency, or entity shall force any person to participate in the pharmaceutical distribution |
| program. |
| (b) The following conditions shall be met for the donation of a prescription drug to occur.: |
| (1) All of the donated drugs shall pass inspection by a licensed pharmacist. |
| (2) The donated drugs shall be received in an intact, tamper-evident package with a clearly |
| displayed expiration date with no less than three (3) months until the expiration date. |
| (3) The donated drugs shall not be temperature-sensitive medications or a controlled |
| substance. |
| (4) The donated drugs shall be provided to the recipient in accordance with state law. The |
| drugs shall have been prescribed legally by a licensed health care healthcare professional after |
| having been properly transferred to and processed by an authorized pharmaceutical redistribution |
| program or redistributor. |
| (5) An authorized and properly licensed health care healthcare pharmacist shall deem the |
| drug has not been tampered with upon arrival and is properly labeled. If labels have degraded but |
| drug identity can be verified, new labels may be created. If the drugs have been combined in one |
| package, the information about all included drugs shall be labeled clearly. If the drugs have been |
| donated from out-of-state out of state, this donation must abide by all of the laws of both states. |
| (6) The donated drugs shall have all prior patient information redacted in compliance with |
| HIPAA regulations or the pills shall be transferred to a new container. |
| (7) If the drugs donated have been combined, the closest expiration date for any drugs shall |
| be used for the entire package. |
| (c) If any one of the conditions contained in subsection (b) of this section is not satisfied, |
| the donated drugs shall not be distributed pursuant to the provisions of this program and may be |
| destroyed pursuant to department of health regulations. |
| 23-25.6-5. Redistribution of donated medications. |
| (a) A redistributor may dispense prescription drugs to eligible persons as long as they abide |
| by the provisions of this chapter. |
| (b) A redistributor may repackage drugs prior to redistribution. Repackaged drugs shall be |
| labeled thoroughly and labels shall include the drug name, expiration date, and kept separately from |
| other drugs until brought up for inspection. If multiple drugs are packaged together, the closest |
| expiration date shall be used pursuant to the requirements contained in § 23-25.6-4(b). |
| (c) A redistributor's compensation from an institution will not constitute the resale of drugs. |
| The distributor shall make a record of that charge and provide it upon request to the supervising |
| government agency. This sale price shall reflect an incentive to offer the drugs at a price that is |
| affordable and reasonable for people who do not have the means to pay for such the drugs at market |
| price. The price incurred by the patient shall not exceed the usual and customary dispensing fee |
| determined by the this state's Medicaid program. |
| (d) Donated drugs that cannot be utilized by the redistributor shall be destroyed through |
| lawful methods, or transferred to a returns processor. Redistributors shall keep a record of disposed |
| drugs, the quantity of drug, its name, and strength. |
| (e) An authorized redistributor of drugs shall store the drugs legally, separate from other |
| non-donated drugs, and shall meet the requirements of the United States Pharmacopoeia (USP) |
| standards. The drugs shall be stored in a way which that does not impair the quality and safety of |
| the drug. The drug shall be stored legally according to the methods described in this chapter. The |
| facilities and storage shall be subject to investigation and approval from the department of health |
| or a third party approved by the department of health. All records required pursuant to the |
| provisions of this chapter shall be retained in physical or electronic format for a period of two (2) |
| years. The drugs shall be labeled properly with a serial number or other effective label. |
| Redistributors shall keep records by either electronic or non-electronic means for the full two (2) |
| years. |
| 23-25.6-6. Civil and criminal immunity. |
| Any person, except a person licensed from the Rhode Island department of health or any |
| other similar license from another jurisdiction involved in a drug donation, who acts reasonably |
| and in good faith shall be immune from criminal and civil liability for any persons who are harmed |
| from the reception of a donated drug. Liability shall be absolved for any act associated, but not |
| limited to, the transfer of the donated drugs from one party to another, transportation, repackaging, |
| or dispensing of donated drugs. Any person involved in drug donation who acts reasonably and in |
| good faith shall be protected from any disciplinary action from their employers. "Good faith", as |
| used in this section, may be defined as the intent to help people, the adoption of honest and altruistic |
| intentions, and the preservation of moral and ethical values. |
| 23-25.6-7. Rules and regulations. |
| (a) The department shall collaborate with the board of pharmacy to promulgate rules and |
| regulations necessary to regulate a program consistent with the public health and safety, through |
| which unused prescription drugs are donated pursuant to this chapter, to become operational on |
| January 1, 2023. |
| (b) The department shall collaborate with the board of pharmacy to promulgate rules and |
| regulations necessary to regulate the program established pursuant to this chapter, on or before |
| January 1, 2023. |
| SECTION 2. This act shall take effect upon passage. |
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| LC003452/SUB B |
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