2019 -- S 0798 SUBSTITUTE A

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LC002256/SUB A/2

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     STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2019

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A N   A C T

RELATING TO FOOD AND DRUGS -- OPIOID STEWARDSHIP ACT

     

     Introduced By: Senators Ruggerio, Coyne, Miller, Sosnowski, and DiPalma

     Date Introduced: April 10, 2019

     Referred To: Senate Finance

     It is enacted by the General Assembly as follows:

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     SECTION 1. Title 21 of the General Laws entitled "FOOD AND DRUGS" is hereby

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amended by adding thereto the following chapter:

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CHAPTER 28.10

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OPIOID STEWARDSHIP ACT

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     21-28.10-1. Definitions.

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     Unless the context otherwise requires, the following terms shall be construed in this

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chapter to have the following meanings:

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     (1) "Department" means the Rhode Island department of health.

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     (2) "Director” means the director of the Rhode Island department of health.

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     (3) "Distribute" means distribute as defined in § 21-28-1.02.

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     (4) "Distributor" means distributor as defined in § 21-28-1.02.

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     (5) "Manufacture" means manufacture as defined in § 21-28-1.02.

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     (6) "Manufacturer" means manufacturer as defined in § 21-28-1.02.

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     (7) "Market share" means the total opioid stewardship fund amount measured as a

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percentage of each manufacturer's, distributor's and wholesaler's gross, in-state, opioid sales in

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dollars from the previous calendar year as reported to the U.S. Drug Enforcement Administration

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(DEA) on its Automation of Reports and Consolidated Orders System (ARCOS) report.

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     (8) "Wholesaler" means wholesaler as defined in § 21-28-1.02.

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     21-28.10-2. Opioid registration fee imposed on manufacturers, distributors, and

 

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wholesalers.

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     All manufacturers, distributors, and wholesalers licensed or registered under this title or

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chapter 19.1 of title 5 (hereinafter referred to as "licensees"), that manufacture or distribute

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opioids shall be required to pay an opioid registration fee. On an annual basis, the director shall

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certify the amount of all revenues collected from opioid registration fees and any penalties

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imposed, to the general treasurer. The amount of revenues so certified shall be deposited quarterly

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into the opioid stewardship fund restricted receipt account established pursuant to § 21-28.10-10.

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     21-28.10-3. Determination of market share and registration fee.

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     (1) The total opioid stewardship fund amount shall be five million dollars ($5,000,000)

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annually, subject to downward adjustments pursuant to § 21-28.10-7.

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     (2) Each manufacturer's, distributor's, and wholesaler's annual opioid registration fee

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shall be based on that licensee's in-state market share.

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     (3) The following sales will not be included when determining a manufacturer's,

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distributor's, or wholesaler's market share:

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     (i) The gross, in-state opioid sales attributed to the sale of buprenorphine or methadone;

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     (ii) The gross, in-state opioid sales sold or distributed directly to opioid treatment

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programs, data-waivered practitioners, or hospice providers licensed pursuant to chapter 17 of

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title 23;

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     (iii) Any sales from those opioids manufactured in Rhode Island, but whose final point of

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delivery or sale is outside of Rhode Island; and

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     (iv) Any sales of anesthesia or epidurals as defined in regulation by the department.

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     (4) The department shall provide to the licensee, in writing, on or before October 15,

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2019, the licensee's market share for the 2018 calendar year. Thereafter, the department shall

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notify the licensee, in writing, on or before October 15 of each year, of its market share for the

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prior calendar year based on the opioids sold or distributed for the prior calendar year.

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     21-28.10-4. Reports and records.

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     (a) Each manufacturer, distributor, and wholesaler licensed to manufacture or distribute

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opioids in the state of Rhode Island shall provide to the director a report detailing all opioids sold

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or distributed by such manufacturer or distributor in the state of Rhode Island. Such report shall

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include:

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     (1) The manufacturer's, distributor's, or wholesaler's name, address, phone number, DEA

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registration number, and controlled substance license number issued by the department;

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     (2) The name, address, and DEA registration number of the entity to whom the opioid

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was sold or distributed;

 

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     (3) The date of the sale or distribution of the opioids;

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     (4) The gross receipt total, in dollars, of all opioids sold or distributed;

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     (5) The name and National Drug Code of the opioids sold or distributed;

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     (6) The number of containers and the strength and metric quantity of controlled substance

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in each container of the opioids sold or distributed; and

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     (7) Any other elements as deemed necessary or advisable by the director.

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     (b) Initial and future reports.

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     Such information shall be reported annually to the department via ARCOS or in such

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other form as defined or approved by the director; provided, however, that the initial report

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provided pursuant to subsection (a) of this section shall consist of all opioids sold or distributed in

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the state of Rhode Island for the 2018 calendar year, and shall be submitted by August 1, 2019.

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Subsequent annual reports shall be submitted by April 1 of each year based on the actual opioid

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sales and distributions of the prior calendar year.

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     21-28.10-5. Payment of market share.

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     The licensee shall make payments quarterly to the department with the first payment of

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its market share due on January 1, 2020; provided, that the amount due on January 1, 2020 shall

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be for the full amount of the payment for the 2018 calendar year, with subsequent payments to be

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due and owing on the first day of every quarter thereafter.

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     21-28.10-6. Rebate of market share.

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     In any year for which the director determines that a licensee failed to report information

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required by this chapter, those licensees complying with this chapter shall receive a reduced

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assessment of their market share in the following year equal to the amount in excess of any

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overpayment in the prior payment period.

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     21-28.10-7. Licensee opportunity to appeal.

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     (a) A licensee shall be afforded an opportunity to submit information to the department

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documenting or evidencing that the market share provided to the licensee (or amounts paid

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thereunder), pursuant to § 21-28.10-3(4), is in error or otherwise not warranted. The department

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may consider and examine such additional information that it determines to be reasonably related

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to resolving the calculation of a licensee's market share, which may require the licensee to

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provide additional materials to the department. If the department determines thereafter that all or

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a portion of such market share, as determined by the director pursuant to § 21-28.10-3(4), is not

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warranted, the department may:

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     (1) Adjust the market share;

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     (2) Adjust the assessment of the market share in the following year equal to the amount in

 

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excess of any overpayment in the prior payment period; or

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     (3) Refund amounts paid in error.

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     (b) Any person aggrieved by a decision of the department relating to the calculation of

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market share may appeal that decision to the superior court, which shall have power to review

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such decision, and the process by which such decision was made, as prescribed in chapter 35 of

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title 42.

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     (c) A licensee shall also have the ability to appeal its assessed opioid registration fee if

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the assessed fee amount exceeds the amount of profit the licensee obtains through sales in the

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state of products described in § 21-28.10-3. The department may, exercising discretion as it

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deems appropriate, waive or decrease fees as assessed pursuant to § 21-28.10-3 if a licensee can

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demonstrate that the correctly assessed payment will pose undue hardship to the licensee's

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continued activities in state. The department shall be allowed to request, and the licensee shall

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furnish to the department, any information or supporting documentation validating the licensee's

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request for waiver or reduction under this subsection. Fees waived under this section shall not be

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reapportioned to other licensees which have payments due under this chapter.

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     21-28.10-8. Departmental annual reporting.

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     By January of each calendar year, the department of behavioral healthcare,

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developmental disabilities and hospitals (BHDDH), the executive office of health and human

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services (EOHHS), the department of children, youth and families (DCYF), the Rhode Island

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department of education (RIDE), the Rhode Island office of veterans' affairs (RIOVA), the

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department of corrections (DOC), and the department of labor and training (DLT) shall report

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annually to the governor, the speaker of the house, and the senate president which programs in

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their respective departments were funded using monies from the opioid stewardship fund and the

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total amount of funds spent on each program.

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     21-28.10-9. Penalties.

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     (a) The department may assess a civil penalty in an amount not to exceed one thousand

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dollars ($1,000) per day against any licensee that fails to comply with this chapter.

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     (b)(1) In addition to any other civil penalty provided by law, where a licensee has failed

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to pay its market share in accordance with § 21-28.10-5, the department may also assess a penalty

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of no less than ten percent (10%) and no greater than three hundred percent (300%) of the market

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share due from such licensee.

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     (2) In addition to any other criminal penalty provided by law, where a licensee has failed

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to pay its market share in accordance with § 21-28.10-5, the department may also assess a penalty

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of no less than ten percent (10%) and no greater than fifty percent (50%) of the market share due

 

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from such licensee.

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     21-28.10-10. Creation of opioid stewardship fund.

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     (a) There is hereby established, in the custody of the department, a restricted receipt

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account to be known as the "opioid stewardship fund."

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     (b) Monies in the opioid stewardship fund shall be kept separate and shall not be

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commingled with any other monies in the custody of the department.

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     (c) The opioid stewardship fund shall consist of monies appropriated for the purpose of

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such account, monies transferred to such account pursuant to law, contributions consisting of

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promises or grants of any money or property of any kind or value, or any other thing of value,

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including grants or other financial assistance from any agency of government and monies

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required by the provisions of this chapter or any other law to be paid into or credited to this

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account.

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     (d) Monies of the opioid stewardship fund shall be available to provide opioid treatment,

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recovery, prevention, education services, and other related programs, subject to appropriation by

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the general assembly.

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     21-28.10-11. Allocation.

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     The monies, when allocated, shall be paid out of the opioid stewardship fund and subject

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to the approval of the director and the approval of the director of the department of behavioral

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healthcare, developmental disabilities and hospitals (BHDDH), pursuant to the provisions of this

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chapter.

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     21-28.10-12. Severability.

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     If any clause, sentence, paragraph, subdivision, or section of this act shall be adjudged by

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any court of competent jurisdiction to be invalid, such judgment shall not affect, impair, or

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invalidate the remainder thereof, but shall be confined in its operation to the clause, sentence,

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paragraph, subdivision, or section directly involved in the controversy in which such judgment

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shall have been rendered. It is hereby declared to be the intent of the legislature that this act

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would have been enacted even if such invalid provisions had not been included herein.

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     21-28.10-13. Rules and regulations.

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     The director may prescribe rules and regulations, not inconsistent with law, to carry into

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effect the provisions of chapter 28.10 of title 21, which rules and regulations, when reasonably

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designed to carry out the intent and purpose of this chapter, are prima facie evidence of its proper

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interpretation. Such rules and regulations may be amended, suspended, or revoked, from time to

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time and in whole or in part, by the director. The director may prescribe, and may furnish, any

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forms necessary or advisable for the administration of this chapter.

 

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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 FOOD AND DRUGS -- OPIOID STEWARDSHIP ACT

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     This act would establish an opioid stewardship payment program requiring manufacturers

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and distributors of opioids to pay an amount, based on the amount of opioids manufactured or

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distributed, into a fund which would be used to support programs operated by the department of

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behavioral healthcare, developmental disabilities and hospitals (BHDDH), the executive office of

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health and human services (EOHHS), the department of children, youth and families (DCYF), the

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Rhode Island department of education (RIDE), the Rhode Island office of veterans' affairs

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(RIOVA), the department of corrections (DOC), the department of labor and training (DLT) or

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agencies certified, authorized, approved or otherwise funded by the Rhode Island department of

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health (DOH) to provide opioid treatment, recovery and prevention and education services.

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     This act would take effect upon passage.

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