- The Problem
- The Law
- Criteria and Procedures
- Stakeholder Concerns
- Ongoing Actions
- For More Information
The U.S. Geological Survey conducted a study in 2002 sampling 139 streams across 30 states and found that 80 percent had measurable concentrations of prescription and nonprescription drugs, steroids, and reproductive hormones. Studies show exposure even to low levels of drugs has negative effects on fish and other aquatic species and may have negative effects on human health.
In order to reduce the likelihood of improper disposal of drugs, Senate Bill (SB) 966 (Simitian, Chapter 542, Statutes of 2007) was enacted to develop criteria and procedures for programs through which the public may return and ensure the safe and environmentally sound disposal of drugs and may do so in a way that is convenient for consumers.
Criteria and Procedures
As part of SB 966 requirements, the CIWMB (now known as the Department of Resources Recycling and Recovery or CalRecycle) adopted criteria and procedures for pharmaceutical waste collection model programs.
As part of SB 966, the CIWMB was required to address home-generated pharmaceutical disposal. SB 966 directed the CIWMB to develop criteria and procedures for model programs that collect these unused or expired medications from consumers. CalRecycle was required to report to the Legislature by Dec. 1, 2010 on its evaluation of the efficacy, safety, statewide accessibility, and cost effectiveness of participating model programs, as well as provide recommendations for potential implementation of a statewide program and statutory changes.
Uses for the Criteria and Procedures
The criteria and procedures can help determine if an existing collection program meets the minimum criteria of a model program. They may also be used as guidelines to implement a new model program. Local jurisdictions are not required to adopt them in the development of their programs, but they must meet all CalRecycle-approved criteria and procedures in order to be considered a “model program.” This must be a self-certifying process since SB 966 did not mandate that CalRecycle certify programs after analyzing programs for the Report to the Legislature. Programs can determine whether they are consistent with those voluntary guidelines with the help of the "model program consistency" questions in the survey forms that were made available for the Pharmaceutical Drug Waste Disposal Program Workshop.
The CIWMB went through an extensive process in developing the criteria and procedures for model programs. This process involved evaluating existing medication collection and disposal programs being run by local jurisdictions within California, other states, and other countries to determine their compatibility with the minimum criteria listed in SB 966. As directed by SB 966, the CIWMB formed a working group that consisted of representatives from the Pharmacy Board, State Water Resources Control Board, California Department of Public Health, and the Department of Toxic Substances Control. CIWMB staff convened the working group and conducted four workshops during 2008 to facilitate comments and suggestions from stakeholders representing local government, pharmaceutical companies, medical and hazardous waste haulers, for-profit and non-profit health care providers, and other interested parties.(See the Medication Waste Management Plan for more details.)
The original criteria and procedures were approved on Nov. 13, 2008. As directed, staff held another workshop on Dec. 19, 2008 and received additional comments on the adopted criteria. The revised criteria and procedures were adopted on Feb. 24, 2009.
Some remaining stakeholder concerns require changes to the statutes or regulations that govern pharmaceutical waste collection and disposal if they are to be addressed. The stakeholder concerns, which are currently beyond the purview of the criteria and procedures, are described below.
Stakeholders have expressed concerns about the following requirements for home-generated medication collection and disposal:
- The current permitting approach is considered too cumbersome; addressing this concern would require revising Department of Public Health-enforced statutes.
- Current Medical Waste Management Act standards require tracking that is considered too meticulous; addressing this concern would also require revising Department of Public Health-enforced statutes.
- “Incineration only” signage at facilities is considered unnecessary, as it is only needed for containers to transport the waste for disposal; addressing this concern would require revising Department of Public Health regulations.
- Signed inventories accompanying home-generated pharmaceutical waste are considered burdensome; addressing this concern would require revising current Drug Enforcement Agency law.
Flexibility and Cost
Stakeholders stated that the following current requirements are impeding their ability to be flexible and cost efficient with their collection programs:
- Common carriers are not allowed to collect and transport pharmaceutical waste; addressing this concern would require revising Department of Public Health-enforced statutes.
- Pharmaceutical waste may not be managed by standards other than the Medical Waste Management Act; addressing this concern would require revising Department of Public Health-enforced statutes.
- Controlled substances currently must only be collected in the presence of law enforcement; addressing this concern would require revising federal law.
Stakeholders have been concerned about the following responsibility and authority issues related to medication waste generation:
- The definition of who is responsible for pharmaceutical waste generation is unclear for those who actually generate, own, and are ultimately responsible for the storage, transport, and disposal of pharmaceutical waste.
- Collection sites currently contribute to their waste generator status by collecting home-generated pharmaceutical waste and potentially increase their associated fees; addressing this concern would require revising Department of Public Health-enforced statutes and providing a generator exemption for these collection sites under Medical Waste Management Act standards.
- The authority of the Department of Public Health and the Pharmacy Board is unclear as it relates to adopting and enforcing standards to allow pharmacies and other locations to collect home-generated medication waste.
CalRecycle evaluated existing medication collection programs to determine if they met the model program criteria and procedures, collected input from stakeholders regarding the criteria, and continues to track any potential legislation that may impact the model criteria and procedures.
CalRecycle collected statistical data from participating model programs in order to evaluate and report these findings to the Legislature by Dec. 1, 2010.
At the July 20, 2010, SB 966 Pharmaceutical Drug Waste Disposal Program Workshop, CalRecycle staff received stakeholder input regarding survey results, analysis methodology, initial findings and additional information on effective programs in California that collect and dispose of home-generated medication waste. These findings and stakeholder input are addressed in the final report Recommendations for Home-Generated Pharmaceutical Collection Programs in California, which was due to the California Legislature by Dec. 2010. The report analyzes the programs for effectiveness, cost, accessibility and safety.
For More Information
Stay informed about CalRecycle’s latest developments to promote safe medication disposal.
- Listserv: To receive periodic information about medication waste, subscribe to the Sharps and Medication Disposal Listserv.
- Contact: Please contact firstname.lastname@example.org for questions or more information.