Background:

Consumers have unused medicines in their homes for a variety of reasons. These medicines can pose risks and, if not disposed of properly, can contribute to the contamination of the water supply, resulting in accidental poisoning and drug abuse. Consumers may dispose of drugs by throwing them in the garbage, flushing them down the toilet or sink, or returning them to their pharmacy. Guidance to consumers on how to properly dispose of unused medications is inconsistent.

A variety of medicine-return programs are appearing throughout the country. They use methods that allow consumers to return unused and unwanted drugs such as permanent return locations, one-day return opportunities, and mail-back or ship-back of drugs.

The Department of Ecology (DOE) and local governments implement solid waste disposal and hazardous waste disposal programs. The State Board of Pharmacy licenses health care professionals who are authorized to prescribe and administer drugs.

Summary of Bill:

A program that allows consumers to return unwanted legend and non-legend drugs is established. By January 1, 2012, all drug producers of drugs sold in the state of Washington must participate in a drug return program. Producers of the drugs are responsible for planning and administering the program.

Product Stewardship Program. The elements of a producer administered program include:

Payment of all costs for collecting, transporting, and disposing of unwanted drugs.
No fee may be imposed by the program on the consumer either when the drugs are purchased or when they are delivered for collection.
A program must allow collection of drugs regardless of whether the producer is a participant in the program.
A producer program must develop a plan that is approved by the DOE.
A program may include one or more producers or may be an organization that manages the program for producers.

Product Stewardship Plan. The plan must contain provisions for:

a collection system;
a transportation and drug disposal system;
the secure tracking and handling of the drugs;
public education and outreach efforts of the program; and
how packaging collected with the drugs will be recycled.

A product stewardship plan must be approved by the DOE. The initial plans must be completed by January 1, 2011. The plan must be updated at least every four years. Any changes to the plan must obtain prior approval with limited exceptions.

Annual Report. Beginning in 2013, each program must submit an annual report to the DOE. The report includes:

information on the amount of product collected and processed through a disposal facility; and
penalties or violations received by participating transporters and disposal facilities.

Promotion of the program. The program must make the public aware of the efforts to collect unwanted residential drugs through web sites, toll-free telephone numbers, and promotional materials located in pharmacies and other appropriate locations.

Disposal of unwanted drugs. All unwanted drugs must be disposed of at a hazardous waste facility.

Changes to the plan by the government agency. If the DOE determines that there is imminent danger to the public because of operation or provisions of the product stewardship plan, it may amend, suspend or cancel approval of a plan.

Enforcement - Producers . Enforcement begins with written warnings prior to imposing any monetary penalty. The DOE may waive or reduce the penalty. Penalties include:

Producer not participating in an approved program. After receiving a written warning, if the violation continues, the DOE may impose a monetary penalty of $10,000 for each calendar day the violation continues.
Producer fails to implement its approved plan. After receiving a written warning, if the violation continues, the DOE may impose a monetary penalty of $5,000. After 30 days and for each 30 day period the violation continues, the monetary penalty increases to $10,000.
Failure to update a plan, submit a required report, or provide the required notification. After a written warning, a monetary penalty of $5,000 may be imposed. After 30 days and for each 30 day period the violation continues, the monetary penalty increases to $10,000.

Enforcement - Wholesalers. Enforcement begins with written warnings prior to imposing any monetary penalty. Wholesalers who sells drugs from a producer not participating in a product stewardship program or whose program is not in compliance with the law are subject to a monetary penalty of $10,000. The DOE must maintain a website indicating whether a producer is in compliance.

Rule-making and reporting to the Legislature. The DOE may adopt rules to implement the law and must consult with the State Board of Pharmacy on rules dealing with the secure collection, tracking, and handling of drugs collected under the program. The DOE may establish performance standards for the product stewardship program. By December 31, 2014, the DOE must report to the Legislature on the implementation of this law.

Funding. The DOE may establish fees for administering the program to fully recover but not exceed the expenses incurred. The Pharmaceutical Product Stewardship Program Account is established. All fees and penalties are deposited into the account. Money may be loaned from the State Toxics Control Account to pay initial administrative costs but must be repaid with interest within two years of a loan of funds.