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  • jwgilbreath

Pharmaceutical and Sharps Waste

Hello all!

Something a little new to discuss....I am not completely versed in these regs but thought they were interesting. Sort of a bit overwhelming too. This is prime example of bureaucracy in action though (but I didn't say it...😜)

California's requirements for CalRecycle.

So in California some very strict requirements have been established about handling of pharmaceutical and Sharps waste. The state expects that each manufacturer that sells in the state has created a stewardship program or worked with a group to be a part of a larger stewardship program.

There are layers to this reg....

Wholesalers and pharmacies must use the CalRecycle site to check to see if the medications they are purchasing are "covered products". This is a list of products sent to the state of California from "Cover Entities" (I.e., generally manufacturers). I realize that is a simplified way to put it but these regs are complicate! Once the pharmacy (focusing on us since that is what affects us directly) decides to purchase a product they must review the list to ensure it is "covered" and the covered entity has a "stewsardship program" to handle the waste. This is for pharmaceuticals and sharps btw!

The pharmacy can register to take in the product and handle for people as waste or help inform patients how to get a product (such as a take back bag) to handle the waste. As an example, there are approved stewardship programs such as Med-Project that many manufacturers work through. The pharmacy could share a brochure with the patient from Med-Project to help the patient in handling the waste. So, not only does the pharmacy have to ensure that the product is a "Covered Product" sold by a "Covered Entity" they also have to ensure that the stewardship program meets the requirements for the CalRecycle processes. You may ask where a pharmacy can find this info...well the CalRecycle site has information on it available to inform the pharmacy. In fact, it is written into the regulations that the pharmacy MUST assess the site to determine the info. They also have a form you can use to document the reviews. They do not state how often to review in the regs but I assume fairly regularly (especially if purchasing a new item). If while reviewing the product or entity---The distributor or wholesaler and the pharmacy or other retailer shall notify the department if it determines that a covered product that it sells or offers for sale is from a covered entity that is not listed on the department's Internet Web site.

Btw you can face steep fines (~$50,000 per day) for each day out of compliance....ex. If not doing the reviews, if not reporting products determined not to be covered, etc. A special California governmental body called the Department of Resources Recycling and Recovery is the regulatory body related to this regulation.

As you can assume this is especially impacting retail pharmacies. Have any of you had to deal with this? How are you handling the review processes that are required? These regs feel daunting....especially if the pharmacy is just a small mom and pop type of store.

Thanks everybody!


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