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H.711

Introduced by   Representatives Canfield of Fair Haven, Acinapura of Brandon, Allaire of Rutland City, Baker of West Rutland, Barnard of Richmond, Branagan of Georgia, Condon of Colchester, Donaghy of Poultney, Dostis of Waterbury, Dowland of Holland, Dunsmore of Georgia, Endres of Milton, Evans of Essex, Flory of Pittsford, Helm of Castleton, Klein of East Montpelier, Koch of Barre Town, Komline of Dorset, Krawczyk of Bennington, Larrabee of Danville, LaVoie of Swanton, Livingston of Manchester, Malcolm of Pawlet, Marcotte of Coventry, Martin of Springfield, Masland of Thetford, McFaun of Barre Town, Mook of Bennington, Morley of Barton, Morrissey of Bennington, Parent of St. Albans City, Pillsbury of Brattleboro, Potter of Clarendon, Pugh of S. Burlington, Randall of Troy and Tracy of Burlington

Referred to Committee on

Date:

Subject:  Health; unused prescription drugs and medical supplies 

Statement of purpose:  This bill proposes to create a drug repository program through which licensed facilities, wholesale drug distributors, and drug manufacturers can donate unused, unopened prescription drugs and medical supplies to pharmacies, hospitals, and clinics in order to dispense such drugs and supplies, for only a handling fee, to persons who are income eligible and uninsured, or both.

AN ACT RELATING TO A PRESCRIPTION DRUG AND MEDICAL SUPPLY REPOSITORY PROGRAM

It is hereby enacted by the General Assembly of the State of Vermont:

Sec. 1.  26 V.S.A. chapter 36, subchapter 7 is added to read:

Subchapter 7.  Unused Prescription Drug and Medical Supply Repository Program

§ 2078a.  DEFINITIONS

As used in this subchapter:

(1)  “Drug manufacturer” has the same meaning as “manufacturer” in section 2022 of this title.

(2)  “Health care facility” has the same meaning as in section 9402 of Title 18. 

(3)  “Hospital” has the same meaning as in section 9402 of Title 18.

(4)  “Nonprofit clinic” means a charitable nonprofit corporation organized and operated pursuant to Title 11B or any charitable organization not organized and not operated for profit that provides health care services to indigent and uninsured persons.  “Nonprofit clinic” does not include a health care facility, as defined in section 9402 of Title 18, or a hospital.  

(5)  “Prescription drug” has the same meaning as in section 2022 of this title.

(6)  “Wholesale drug distributor” has the same meaning as in section 2022 of this title.

§ 2078b.  CREATION; UNUSED PRESCRIPTION DRUG AND MEDICAL

                SUPPLY PROGRAM

(a)  The board of pharmacy shall establish a program to accept and dispense donated prescription drugs and medical supplies to Vermont residents who meet the eligibility standards established by rules adopted by the board pursuant to section 2078d of this title.

(b)  The board of pharmacy shall allow only drugs or medical supplies in their original sealed and tamper-evident unit dose packaging to be accepted and dispensed, except for drugs packaged in single unit doses when the outside packaging is opened if the single unit dose packaging is undisturbed.  The board of pharmacy shall allow donation of only those drugs bearing an expiration date that is less than six months beyond the date the drug is donated and shall allow drugs to be dispensed only when the expiration date is more than one month from the date of dispensing.  The board of pharmacy shall prohibit accepting or dispensing a drug when there is reason to believe that it is adulterated. 

(c)  Each health care facility and wholesale drug distributor, in accordance with the rules adopted by the board of pharmacy under section 2078d of this title, shall do one of the following:

(1)  Give to the participating pharmacy, hospital, or nonprofit clinic any unsold or unused prescription drugs and medical supplies that the facility or distributor cannot sell or otherwise use that meets the requirements of this subchapter;

(2)  For each unsold or unused prescription drug and medical supply that a facility or distributor does not donate through the program, submit to the board of pharmacy a statement as to why the distributor will not give the drug to the program. 

(d)  A drug manufacturer or any health care facility as defined in section 9402 of Title 18 may donate prescription drugs or medical supplies to the drug repository program.  The drugs or medical supplies must be donated at a pharmacy, hospital, or nonprofit clinic which meets criteria for participation in the program established by rules adopted by the board of pharmacy under section 2078d of this title.  Nothing in this or any other section requires a pharmacy, hospital, or nonprofit clinic to participate in the program. 

(e)  A participating pharmacy, hospital, or nonprofit clinic shall dispense drugs and medical supplies accepted under this section to individuals who are residents of this state and meet the eligibility standards established in rules adopted by the board under section 2078d of this title.  A drug may be dispensed only pursuant to a prescription issued by a licensed health professional authorized by law to prescribe drugs.  A pharmacy, hospital, or nonprofit clinic that accepts drugs under the program shall comply with all applicable federal and state laws concerning storage and distribution of drugs and shall inspect all drugs prior to dispensing them to determine that they are not adulterated.   

(f)  The pharmacy, hospital, or nonprofit clinic may charge individuals receiving drugs or medical supplies under the program a handling fee established in accordance with rules adopted by the board under section 2078d of this title.  Drugs and medical supplies accepted by the repository shall not be resold.

§ 2078c.  LIMITATION OF LIABILITY; IMMUNITY

(a)  The following persons and entities shall not, in the absence of bad faith, be subject to criminal prosecution, professional disciplinary action, or liability in tort or other civil action for injury, death, or loss to person or property, resulting from the drugs or medical supplies accepted or dispensed under the program:

(1)  Individuals authorized under chapter 23 of this title to practice medicine and surgery;

(2)  Individuals authorized under chapter 33 of this title to practice osteopathic medicine and surgery;

(3)  Individuals authorized under chapter 26 of this title to practice podiatric medicine and surgery;

(4)  Registered nurses and licensed practical nurses practicing pursuant to chapter 28 of this title;

(5)  Physician assistants practicing pursuant to chapter 31 of this title;

(6)  Dentists and dental hygienists practicing pursuant to chapter 13 of this title;

(7)  Optometrists practicing pursuant to chapter 30 of this title;

(8)  Pharmacists practicing pursuant to this chapter;

(9)  The board of pharmacy;

(10)  A drug manufacturer;

(11)  A wholesale drug distributor;

(12)  A health care facility; and

(13)  Any other state governmental agency.

(b)  A drug or medical supply manufacturer shall not, in the absence of bad faith, be subject to criminal prosecution or liability in tort or other civil action for injury, death, or loss to person or property for matters related to the donation, acceptance, or dispensing of a drug or medical supply made by that manufacturer that is donated by any person under the program, including liability for failure to transfer or communicate product or consumer information or the expiration date of the donated drug or medical supply. 

§ 2078d.  RULES

The board of pharmacy, in consultation with the office of Vermont health access, the department of health, the department of disabilities, aging, and independent living, and the board of medical practice, shall adopt rules necessary to implement the requirements of this subchapter.  The rules shall include:

(1)  Standards and procedures for health care facilities, wholesale drug distributors, and drug manufacturers to give drugs and medical supplies to the repository program, including a procedure whereby a health care facility or wholesale drug distributor may submit a statement as to why it will not give a particular drug to the program.  

(2)  Eligibility criteria for pharmacies, hospitals, and nonprofit clinics to receive and dispense drugs or medical supplies accepted under the program.

(3)  Standards and procedures for accepting, safely storing, and dispensing donated drugs and medical supplies.

(4)  Standards and procedures for inspecting donated drugs and medical supplies to determine that the original unit dose packaging is sealed and tamper-evident and that the drugs and medical supplies are unadulterated, safe, and suitable for dispensing.

(5)  Eligibility standards for uninsured Vermont residents to receive drugs or medical supplies, defining eligibility to include individuals who:

(A)  Have a family income below 400 percent of the federal poverty level and are uninsured;

(B)  Have a family income below 400 percent of the federal poverty level and are insured but have deductibles or co-payments for prescription drugs that are substantial and cannot be met by current sources or savings; or

(C)  Receive Medicare, regardless of whether Medicaid is also received.   

(6)  A formula to determine the amount of a handling fee that pharmacies, hospitals, and nonprofit clinics may charge to recipients to cover restocking and dispensing costs.

(7)  Procedures for handling of drugs and medical supplies donated to the repository which shall include:

(A)  A list of drugs, by drug class or by individual drug, that the repository will accept;

(B)  A list of drugs, by drug class or by individual drug, that the repository will not accept, including why the drug is ineligible for donation.

(C)  A list of medical supplies that the repository will accept;

(D)  A list of medical supplies that the repository will not accept, including why the medical supplies are ineligible for donation.

(8)  Any other standards and procedures necessary for the development and implementation of the program. 

§ 2078e.  FORMS

The board of pharmacy, in consultation with the office of Vermont health access, the department of health, the department of disabilities, aging, and independent living, and the board of medical practice, shall create forms necessary to implement the requirements of this subchapter.  The forms shall include:

(1)  A form that an individual receiving a drug or medical supply from the repository must sign before receiving the drug or medical supply to confirm that the individual understands the immunity provisions of the program.

(2)  A form each donor must sign stating that the donor is the owner of the drugs or medical supplies and intends to donate them voluntarily to the repository.

(3)  A form, such as an identification card, which an individual who is eligible to receive donated drugs or medical supplies may use to demonstrate eligibility.



Published by:

The Vermont General Assembly
115 State Street
Montpelier, Vermont


www.leg.state.vt.us