STATE Bill #; Year DESCRIPTION; HISTORY

ARIZONA AZ Rev Stat § 32-1909 Program Status: Enacted law; Pilot. Accepted by: Physician office, pharmacy, hospital, or healthcare institution. Who can donate: Person, manufacturer or healthcare institution. Program eligible patients: Only state residents who meet eligibility standards set by Board. Rx: Accepted only in original sealed & tamper-evident unit dose packaging. Restrictions: Expiration must be more than 6 months from donation date. Recipient must sign waiver form about the program. Legislative History: Final regulations promulgated, effective 6/6/08; HB 2382 (2006).

CALIFORNIA CA Health and Safety Code §§150200-150208 Program Status: Enacted law; Operational. Accepted by: County-owned pharmacy, pharmacy that contracts with the county and certain primary care clinics. Who can donate: Skilled Nursing Facility (SNF), a SNF designated as an institution for mental disease (IMD), general acute care hospital, psychiatric hospital, intermediate care facility, correctional treatment center, chemical dependency recovery hospital, psychiatric health facility, residential care facility for the elderly, mental health rehabilitation center, some pharmacies, wholesalers and manufacturers. Program eligible patients: Medically indigent persons, free of charge. Rx: Drugs that are received and maintained in their unopened, tamper-evident packaging. Restrictions: Must be ensured that drugs received have not been in the possession of any individual member of the public. Operated by: SIRUM Legislative History: Signed into law by governor as Chapter 444, 9/30/05. In September 2012, California passed and signed SB 1329, which significantly expanded the prescription drug donation and distribution law enacted by SB 798 in 2005. It adds primary care clinics and pharmacies to those who can participate in the program. California amended the bill authorizing pharmacies to repackage donated medicine in preparation for redistribution A 1069, 9/13/16.

COLORADO CO Rev Stat § 12-42.5-133 Program Status: Enacted law; Operational. Accepted by: A nonprofit entity that has the legal authority to possess the materials or to a practitioner authorized by law to dispense. Who can donate: A patient, patient's next of kin, hospital, community mental health center, hospice, nursing care facility, assisted living residence, correctional facility, pharmacy and other licensed facilities. Program eligible patients: Uninsured and underinsured patients. Rx: Unused medications or medical supplies, and used or unused medical devices. Restrictions: Medications that require refrigeration, freezing or special storage are not allowed. Operated by: SIRUM Legislative History: The act took effect 8/8/07, SB 07-231 (2007). The law was revised in 2015 to remove the 6-month expiration date for donations and change the definition of a “licensed facility;” HB 1039.

FLORIDA FL Stat §499.029 FL Admin. Code R. 61N-1.026 Program Status: Enacted law; Operational. ** Accepted by: A physician's office, pharmacy, hospital, hospice, or health care clinic that participates in the program.

Who can donate: A person, health care facility, hospital, pharmacy, drug manufacturer, medical device manufacturer or supplier, wholesaler of drugs or supplies, or any other entity may donate.

Program eligible patients: Residents, except those Medicaid-eligible or under any other prescription drug program funded in whole or in part by the state are ineligible to participate. Rx: Unused cancer drugs or supplies in its original, unopened, sealed and tamper-evident unit dose packaging.

Restrictions: All drugs submitted to the program will be administered by a pharmacist to determine the drugs and supplies are not adulterated or misbranded. Additionally, a cancer drug may not be accepted or dispensed under the program if such drug bears an expiration date that is less than six months after the date the drug was donated.

Legislative History: SB22A (2003). HB 371 (2006) took effect July 1, 2006. The state has a webpage that provides further information about their Cancer Drug Donation Program.

GEORGIA O.C.G.A. § 31-8-301 Program Status: Enacted law; Operational.

Accepted by: Any pharmacy, hospital, federally qualified health center, or nonprofit clinic that participates in the drug repository program and meets criteria for participation in the program. Who can donate: Any person, including a drug manufacturer, wholesaler, reverse distributor pharmacy, third-party logistics provider, government entity, hospital, or health care facility. Program eligible patients: Medically indigent person, uninsured, underinsured, or enrolled in a public assistance health benefits program. Rx: Over-the-counter and unused prescription drugs.

Restrictions: Only drugs in their original sealed and tamper-evident unit dose packaging may be accepted and dispensed. For prescription drugs must not expire before the completion of the medication by the eligible patient based on the prescribing health care professional's directions. For over-the-counter drugs, they must not expire before use by the eligible patient based on the directions for use on the manufacturer's label. Controlled substances are not accepted.

Legislative History: The state-wide program required by this Code section was to be implemented no later than January 1, 2007; HB 430 (2006). HB 897 was signed by the governor 4/27/16; effective date 7/1/16.

IOWA IA Code §§ 135M.1—7 641 IAC 109.1 Program Status: Enacted law; Operational. Accepted by: Medical facilities or pharmacies that elect to participate in the program and meet the requirements established by the department. Who can donate: Any person or organization may donate prescription drugs and supplies. Program eligible patients: Drugs may be donated to individuals or may be distributed to another eligible medical facility or pharmacy for use. Iowans at or below 200% of the federal poverty level as well as individuals who are uninsured or under-insured are eligible to receive donated drugs. Rx: Prescription drugs, over-the-counter drugs, and supplies.

Restrictions: Must be inspected to assure the prescription drug or supplies have not been adulterated or misbranded. The drug must be in its original sealed and tamper-evident packaging. Legislative History: HF 724 (2005) was approved and signed by the governor on May 3, 2005. Dept. of Public Health Regulations ARC 5563B (Chapter 109) effective March 2007. Program is currently Operational serving over 71,000 patients as of 2016. The Department of Public Health has a webpage explaining the inception of the program and further information.

KANSAS Board of Pharmacy Laws and Regulations KS Stat §§ 65-1668 – 1675 KS Stat § 65-1664 Program Status: Enacted law; Operational. Accepted by: A qualifying center or clinic in consultation with a pharmacist. Who can donate: Residents of adult care homes and donating entities that volunteer to participate in the program. Program eligible patients: Medically indigent residents of Kansas. Rx: Unused medications; excludes controlled substances.

Restrictions: The medications must come from a controlled storage unit of a donating entity and be in its original packaging or tamper-evident packaging. Drugs purchased under Medicaid or SCHIP do not apply.

Legislative History: Signed into law by governor on March 20, 2008. The Kansas Department of Health and Environment has a webpage that provides further information about the program.

LOUISIANA LA Rev Stat

§§ 37:1226.2—3

Program Status: Enacted law; Operational. * Accepted by: Charitable pharmacies. Who can donate: Any person, including a drug manufacturer, hospital, health care facility, or governmental entity. Program eligible patients: Appropriately screened and qualified patients free of charge. Rx: Prescription drugs.

Restrictions: Drugs must be in their original sealed and tamper-evident packaging. In addition, donor shall execute a form stating the donation of the drugs. The pharmacy should retain that form along with other acquisition records.

Legislative History: A pilot program began in 1998 without statutory authority.

HB 1402 was signed into law as Act 811 of 2004. Program effective August 15, 2004. SB 19 was signed into law by the governor as Act 643 of 2006, 6/29/06. Amended 6/02/16, H671, to provide for the return of prescription drugs from individuals within the custody of law enforcement.

MARYLAND MD Health-Gen Code § 15– 605

Program Status: Operational.** Accepted by: Board approved drop-off sites, such as licensed pharmacies, and/or repositories which meet specified criteria. Who can donate: Any person. Program eligible patients: A needy patient who is a resident of Maryland, as indicated by the individual’s health care practitioner. Rx: Prescription drugs or medical supplies.

Restrictions: The drugs must be in their original unopened and sealed packaging; or packaged in tamper-evident unit dose packaging and unadulterated. The donor must sign a statement that indicates the donor is the owner of the drugs and are voluntarily offering them to the program. A repository may not establish a waiting list for any prescription drug or medical supply dispensed by the program. Cannot charge a dispense fee that exceeds $10.

Legislative History: Signed by the governor as Chapter 287, 5/2/06. SB 1059 was effective July 1, 2006. Program expanded to include drug disposal locations and broaden citizen knowledge in 2014. The Maryland Board of Pharmacy has a public webpage providing further information about the program. More information can be found in the Annual Board of Pharmacy Prescription Drug Repository Program 2016 report.

MICHIGAN MI Comp L § 333.17775 Program Status: Enacted law; Operational.** Accepted by: A pharmacy, health professional, or charitable clinic that participates in the program. Who can donate: Residents, guardians of residents, manufacturers, pharmacies, and clinics. Program eligible patients: Residents eligible to receive Medicaid or Medicare, or has no health insurance, and otherwise lacks reasonable means to purchase prescription drugs. Rx: Unused prescription drugs and cancer drugs.

Restrictions: Expired prescription drugs and controlled substances are not accepted.

Legislative History: HB 6021 (2004) was signed as Public Act 329, effective September 23, 2004. HB 5672 (2006) created a Cancer Drug Repository program in the state, effective September 29, 2006. HB 5089 (2012) required the Department of Licensing and Regulatory Affairs to establish and maintain the Utilization of Unused Prescription Drugs Program, which was created to dispense unused or donated prescription drugs, effective March 28, 2013. The state has a public webpage that provides further information about their repository programs.

MONTANA MT Code §§ 37-71401—08 Program Status: Enacted law; Operational.**

Accepted by: Provisional community pharmacies. Who can donate: Long-term care facilities.

Program eligible patients: Qualified patients for transfer free of charge or at a reduced charge to those individuals. Rx: Unused prescription drugs, devices, and cancer drugs.

Restrictions: Drugs defined as a dangerous drug or a drug designated as a precursor to a controlled substance cannot be accepted.

Legislative History: This act was effective 10/1/01; SB 288 (2001). It was to be fully implemented by 1/1/05. In 2009, the state also created a cancer drug repository program with HB 409. All participating repository pharmacies can be found on their Cancer Drug Repository Donor Registry Log.

NEBRASKA NE Code §§71-2422—2430 Program Status: Enacted law; Operational.** Accepted by: Any physician's office, pharmacy, hospital, or health clinic that elects to participate in the program and meets criteria established by the department for such participation. Who can donate: Any person or entity, including, but not limited to, a cancer drug manufacturer or health care facility. Program eligible patients: Eligible Nebraska residents. Rx: Cancer drugs and immunosuppressant drugs.

Restrictions: The drug needs to be in its original, unopened, sealed, and tamper-evident unit dose packaging, except that a cancer drug packaged in single unit doses may be accepted and dispensed if the outside packaging is opened but the single-unit-dose packaging is unopened.

Legislative History: The Act, RRS Neb. 71-2424 et seq., became operative on 9/15/03; LB 756 (2003). In addition, LB 1116 of 2006, signed into law 3/13/06, clarified the program, including eliminating a restriction on the number of doses that can be donated; allowing donation of injectable cancer drugs and requiring donation forms to include the name of the original patient. LB 37 (2015) made amendments to the existing drug donation program relating to dispensing and labeling. The Department of Health & Human Services has a program webpage available to the public.

NEW HAMPSHIRE NH Rev Stat § 318.58 Program Status: Enacted law; Operational. Accepted by: Pharmacy, hospital, nursing home, outpatient clinic, veterans home, and correctional facility. Who can donate: Any person or entity. Program eligible patients: Uninsured or underinsured persons. Rx: Unused prescription drugs, including manufacturer's samples that have not reached their expiration date, are contained in unopened unit dose or other tamper-evident packaging, and show no evidence of contamination. Medical devices that have not been opened. Restrictions: Minimum 3 months from expiration date. Unused prescription drugs and medical devices may not be resold, but the facility or service redistributing may charge a handling fee for the service not to exceed $15. All individuals in the program shall be informed that these products have been redispensed. Legislative History: Current program effective as of July 2011. In 2018, legislation established a Commission to review and to study enhancing the program of donating, accepting, and redispensing unused drugs.

NORTH DAKOTA ND Century Code § 43-15.2 Program Status: Enacted law; Operational.** Accepted by: Practitioners or pharmacies that meets the criteria established for participation in the program. Who can donate: Any person or entity. Program eligible patients: Eligible patients who fill out the “Recipient Information Form.” Rx: Legend drugs, devices, or supplies.

Restrictions: A drug donated, prescribed, or dispensed under the program must be in the original, unopened, sealed, and tamper-evident unit dose packaging, except a drug packaged in single-unit doses may be accepted and dispensed if the outside packaging has been opened and the single-unit-dose package is unopened.

Legislative History: Signed into law by governor in April 2007; HB 1256 (2007). Patients may find out more information on the North Dakota Board of Pharmacy’s webpage for the Drug Repository Program.

OHIO OH Rev Code § 3715.87 OAC 4729:5-10 Program Status: Enacted law; Operational. Accepted by: Any pharmacy, hospital, or nonprofit clinic that participates in the program and meets certain eligibility requirements established in rules adopted by the Board. Who can donate: Any person, including a drug manufacturer or health care facility. Program eligible patients: Individuals that meet the economic eligibility standards. Rx: Prescription drugs, including orally administered cancer drugs not in original sealed and tamper-evident packaging. Restrictions: Drugs must be in their original sealed and tamper-evident unit dose packaging. Operated by: SIRUM and local nonprofits. Legislative History: Signed by governor on 1/6/03; HB 221 (2003). Amended in 2009 and 2012.

OKLAHOMA 59 OK Stat §§59-367.1—8 Program Status: Enacted law; Operational. Accepted by: Any pharmacies operated by a county, pharmacy operated by a city-county health department or a pharmacy under contract with a city-county health department, a pharmacy operated by the Department of Mental Health and Substance Abuse Services or a charitable clinic for the purpose of distributing the unused prescription medications.

Who can donate: Drugs may be transferred from residential care homes, nursing facilities, assisted living centers, public intermediate care facilities for people with mental retardation (ICF/MR) or pharmaceutical manufacturers. Program eligible patients: Oklahoma residents who are medically indigent. Rx: Unused prescription drugs. Restrictions: Prescription drugs defined as controlled substances will not be accepted. Legislative History: Became effective on 6/3/04 and includes amendments up to November 2015.Expanded to include orally administered cancer drugs that are not in original sealed and tamper-evident unit dose packaging (2019).

TENNESSEE

Tenn. Code Ann. § 63-10-504 Program Status: Enacted law; starting * Accepted by: Charitable clinic pharmacies. Who can donate: Nursing homes or hospice services programs.

Program eligible patients: Tennessee residents who are indigent.

Rx: Unused prescription medications; controlled substances are excluded.

Restrictions: Drugs in their original sealed and tamper-evident packaging should be accepted.

Legislative History: The act took effect 7/1/06 and began as a pilot program. HB 3560 & SB 3660 (2006). Amended in 2017, S429 & H 137, to replace part 5 of the legislation and reestablish administrative rules for the drug donation program.

TEXAS TX Health and Safety Code §442.001-.058 Texas Administrative Code §95.1-.9 Program Status: Enacted law; Operational. Accepted by: Pharmacies or health care facilities that provides health care services to patients and maintains a pharmacy in the facility including hospitals, convalescent and nursing facilities and related institutions, and ambulatory surgical centers. Who can donate: Anyone. Program eligible patients: Any individual. Rx: Unused prescription drugs packaged into original sealed, unit-dose packages such as blister cards. Restrictions: No refrigerated drugs and no REM drugs. Legislative History: Original program was signed into law in 2007, SB 1896 (2007). A pilot program, SB 1243 (2015), was signed into law 6/19/15 and has been operational since 9/1/15.A permanent program was created by HB 2561 (2017) with rules promulgated in 2018. The Department of State Health Services maintains information here.

VIRGINIA VA Code § 54.1-3411.1 Program Status: Enacted law; Operational.** Accepted by: Hospitals and on-site hospital pharmacies. Who can donate: Hospitals are authorized to donate drugs that were originally dispensed to hospital patients, but have been returned. The program also accepts donations from individuals, including those residing in nursing homes, assisted living facilities, or intermediate care facilities, or from those pursuant to a power of attorney, a decedent's personal representative, a legal guardian of an incapacitated person, or a guardian ad litem on behalf of the represented individual. Program eligible patients: Indigent patients. Rx: Prescription drugs.

Restrictions: The pharmacist-in-charge at the pharmacy shall be responsible for determining the suitability of the product for re-dispensing. A re-dispensed prescription shall not be assigned an expiration date beyond the expiration date or beyond-use date on the label from the first dispensing and no product shall be re-dispensed more than one time. No product shall be accepted for re-dispensing by the pharmacist where integrity cannot be assured.

Legislative History: H 154 signed 4/6/02. HB 1854 signed by governor as Chapter 68, 3/24/05. HB 2682 signed as Chapter No. 114, 2/5/09. Amended by S 544 enacted on 3/19/18 to broaden the donor pool. The Board of Pharmacy has a list of donating sites posted online.

WISCONSIN WI Stat §§ 148.01—10



Program Status: Enacted law; Operational.** Accepted by: Medical facilities or pharmacies that elects to participate in the program and meets requirements specified by rule by the department. State prison pharmacies. Who can donate: Any person or entity. Program eligible patients: Residents who have a valid prescription, have cancer, and do not have the means to pay for the medication. Rx: Prescription drugs, cancer drugs or supplies. Includes supplies for other chronic diseases.

Restrictions: The prescription drug should never have been in the possession of the patient to whom it was originally prescribed. The prescription drug is returned in its original container. A pharmacist determines that the prescription drug has not been adulterated or misbranded. The cancer drug or supplies needed to administer a cancer drug must be in its original, unopened, sealed, and tamper-evident unit dose packaging or, if packaged in single-unit doses, the single-unit-dose packaging must be unopened.

Legislative History: SB 56 approved by governor 8/20/03. AB 845 enacted April 6, 2004. AB 197 signed into law by governor as Act 16, 7/5/05. The Department of Health Services has a public webpage displaying information about the current donation program.