Many in the pharmaceutical industry that do business or have products that are distributed in the state of California are aware that they like to do things a little differently there. Some of our clients have reached out to ask about a law that is hitting their radar. It is known as the California Pharmaceutical and Sharps Waste Stewardship Law (CAPSWSL). Not the best for creating an acronym, I know, but we can’t all be as creative as the FDA.
In general, CAPSWSL was established to address the proper handling and disposal of home-generated pharmaceutical and sharps waste and provide safe and convenient options to minimize the environmental impact from the disposal of such products. CAPSWSL requires a broad spectrum of companies who sell or distribute drug products doing business in California to develop and submit a “stewardship plan” to CalRecyle (which is a branch of the California Environmental Protection Agency) for the handling and disposal of pharmaceutical and sharps waste. Yes, California has their own EPA so if you get a letter from them, it is real, so pay attention to what they are asking you to do. If they find you are in violation of this law, there are significant fines that can be assessed on a daily basis to any company that is not in compliance, so penalties can add up very quickly!
While we are not a law firm and we cannot provide legal advice, if you sell or distribute pharmaceutical products into the state of California, you may be affected, and you should educate yourself and be aware of this law. To obtain further information about CAPSWSL, you can also go to the Pharmaceutical and Sharps Waste Stewardship – CalRecycle Home Page.
The team at Lachman Consultants is always here to assist clients with their FDA drug and medical device regulatory and compliance needs, whether it be to give direct advice on matters within its expertise or to assist and point you in the right direction to others who may have the expertise you require. So do yourself a favor and educate yourself on this law, if your company sells or distributes drug products in California. If you have any questions about its applicability to your firm, please contact J.Leaming@LachmanConsultants.com.