Pharma Companies Beware: Alameda County, California Will Soon Require You to Foot the Cost of Drug Disposal

On July 24, 2012, California’s Alameda County Board of Supervisors (Board) unanimously passed the Safe Drug Disposal Ordinance (Ordinance), the first of its kind in the country. In general, the new Ordinance requires producers of all prescription and nonprescription drugs sold in the county to “participate in a product stewardship program to collect and dispose of unwanted products from residential generators.” The Ordinance offers two options on how producers may comply with this requirement:
 
1. Producers may operate a product stewardship program approved by the Alameda County Department of Environmental Health (Department)either individually or jointly with other producers; or

2. Producers may enter into an agreement with a stewardship organization, which will operate the approved product stewardship program on the producer’s behalf.

Producers, groups of producers, or stewardship organizations are responsible for paying “all administrative and operational costs associated with their  product stewardship program, including the cost of collecting, transporting, and disposing of unwanted products collected from  residential generators and the recycling or disposal, or both, of packaging collected with the unwanted product.” Further, producers are prohibited from charging a fee to cover the cost of a product stewardship program at the time of sale of the drug or when unwanted products are collected for residential generators or delivered for disposal.

The Ordinance requires that all initial product stewardship plans be submitted to the Department for approval by January 1, 2013.  Additionally, producers, groups of producers, or stewardship organizations are required to update its product stewardship plan and submit it to the Department for review and approval at least every three years. Further, each product stewardship program must promote the program to “residential generators, pharmacists, retailers of covered products, and health care practitioners as to the proper and safe method to dispose of unwanted drugs.”

The Department has been charged with enforcing the provisions of the Ordinance and any implementing regulations. Producers who violate the Ordinance’s provisions would be liable to County for a civil penalty “in an amount not to exceed one thousand dollars ($1,000) per day per violation.”

There are many concerns and oppositions surrounding the passage of the Ordinance.  For example, some argue that there is a lack of evidence indicating that the product stewardship programs will help the environment or stop drug abuse. Although there are convincing arguments for and against product stewardship programs, Alameda County has taken the initial step in relieving itself of a financial burden. According to Nate Riley, President of the Board, Alameda County currently maintains 28 product collection sites that dispose of discarded medications; the cost of operating these sites is approximately $40,000 per year. In comparison, the Board estimates that the projected cost of a comprehensive, producer-funded program would cost about “1 cent for every $33 of pharmaceuticals sold in the County.”

For additional information and to view a copy of the Ordinance, Click Here.