Title 23
Health and Safety

Chapter 25.6
Pharmaceutical Redistribution Program Act

§ 23-25.6-2. Definitions.

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) “Department” means the Rhode Island department of health.

(4) “Distributor” means a person defined in § 21-28-1.02.

(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 healthcare proxy, and any licensed healthcare facility or 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 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 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 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 healthcare costs or more than five percent (5%) of their income on their healthcare deductible.