2022 -- H 7133 SUBSTITUTE A

========

LC003452/SUB A

========

     STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 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

     Referred To: House Health & Human Services

     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 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 proxy, and any licensed health care facility or health care 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 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 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 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

LC003452/SUB A - Page 2 of 7

health care 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 costs or more than five percent (5%) of their income

on their health care 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,

LC003452/SUB A - Page 3 of 7

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 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 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, 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

LC003452/SUB A - Page 4 of 7

affordable and reasonable for people who do not have the means to pay for such 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 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 or institution involved in a drug donation, including, but not limited to,

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

agencies, contract carriers, or hospitals, who act 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

LC003452/SUB A - Page 5 of 7

January 1, 2023.

     SECTION 2. This act shall take effect upon passage.

========

LC003452/SUB A

========

LC003452/SUB A - Page 6 of 7

EXPLANATION

BY THE LEGISLATIVE COUNCIL

OF

A N   A C T

RELATING TO HEALTH AND SAFETY -- PHARMACEUTICAL REDISTRIBUTION

PROGRAM ACT

***

     This act would authorize the creation and implementation of a pharmaceutical

redistribution program, with rules and regulations to be promulgated by the department of health

in collaboration with the board of pharmacy, and to commence operations on January 1, 2023. This

program would provide for the redistribution of donated and unused non-controlled substance

prescription drugs from facilities to aid persons of this state who have difficulty affording or

accessing those drugs. The program would be voluntary and establish the conditions for donations

and redistribution with civil and criminal immunity for persons or institutions acting in good faith.

     This act would take effect upon passage.

========

LC003452/SUB A

========

LC003452/SUB A - Page 7 of 7