Welcome to the Department of Toxic Substances Control

Regulatory Issues for Waste Pharmaceutical and Personal Care Products Management

Note: The discussion of the regulatory topics, below, is limited to pharmaceutical waste; it does not cover personal care products.

How are unwanted pharmaceuticals regulated?

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Some pharmaceutical wastes are classified as hazardous wastes.  Others are medical waste, and still others are nonhazardous wastes.  Which category a discarded pharmaceutical falls into depends on its chemical, physical, and toxicological properties and who generates the waste. 

Hazardous Properties of Pharmaceutical Wastes and Personal Care Products

A discarded pharmaceutical may be identified as a hazardous waste in California if it appears on a regulatory list of hazardous wastes or exhibits one of four hazardous characteristics. Listed hazardous wastes include epinephrine, nitroglycerin, and many chemotherapy agents (40CFR Part 261). Characteristics that make a waste a hazardous waste include:

  • Ignitability (examples include formulations with more than 24% alcohol, collodion, and oxidizers such as potassium permanganate and silver nitrate),
  • Corrosivity (having a pH less than 2 or greater than 12.5),
  • Reactivity  (one example is nitroglycerin, which is generally exempt from federal hazardous waste regulations, but not California hazardous waste regulations), and
  • Toxicity (containing a regulated substance at a concentration above the limit for that substance, as determined by a laboratory procedure known as the Toxicity Characteristic Leaching Procedure (TCLP).  One example would be zinc in some shampoos).

Pharmaceuticals that are Regulated as Hazardous Waste
In California, the Department of Toxic Substances Control (DTSC) is the agency authorized to regulate pharmaceutical wastes to the extent they are regulated as hazardous waste under the federal Resource Conservation and Recovery Act (RCRA).  California’s hazardous waste laws govern  the management of waste pharmaceuticals that meet the federal definition of hazardous waste found in Title 40 Code of Federal Regulation (40CFR) 261.3.  However, pharmaceutical wastes produced households and certain small, non-household generators known as Conditionally Exempt Small Quantity Generators (CESQGs), are not regulated as hazardous waste. 

Pharmaceuticals that are Regulated as Medical Waste
Some wastes that are not regulated under RCRA – such as wastes that contain zinc and wastes produced by generators who are exempt from RCRA (such as Conditionally Exempt Small Quantity Generators) – are nevertheless identified as hazardous waste in California. Besides the chemical and physical properties mentioned above, a number of additional factors can cause a waste to exhibit the characteristic of toxicity under California standards.  If the waste contains a substance listed in the California Code of Regulations Sections 66261.24(a)(1) and 66261.24(a)(2) at a concentration above the specified limit, the waste would be identified as a hazardous waste in California.  In addition, a waste that is toxic when inhaled, or that is fatal to certain types of fish in laboratory tests, is considered a hazardous waste in California.

Pharmaceutical wastes that meet California’s definition of hazardous waste but not RCRA’s definition, as well as pharmaceutical wastes generated by people who are not regulated under RCRA, are subject to the Medical Waste Management Act (Division 104, Part 14 California Health and Safety Code).  (However, pharmaceutical waste produced by a household is not regulated as hazardous waste or medical waste.)

Whether or not a specific generator or activity is regulated under the Medical Waste Management Act may depend on a number of factors. If you have questions about how a specific pharmaceutical waste is regulated, or about how to comply with the Medical Waste Management Act, you should contact the California Department of Health Services’ Medical Waste Management Branch.  More information on Pharmaceuticals as Medical Waste can be found at the California Department of Health Services web page.




What does this mean to a household?

Pharmaceutical waste produced by a household is exempt from classification as hazardous waste or medical waste.  This means that a household may legally dispose of their waste pharmaceuticals and personal care products in the solid waste stream or into the sanitary sewer (“down the drain”). While these practices are legal, they may not be the environmentally preferred ways for a household to dispose of unwanted pharmaceuticals.  Some local government agencies such as Household Hazardous Waste (HHW) Programs partner with pharmacies or hold their own pharmaceutical collection events.  Call before taking the pharmaceuticals to an HHW facility.




What does this mean to a very small quantity generator (e.g., doctors’ offices, pharmacies, and small clinics)?

 

medical devices

Hazardous waste pharmaceuticals produced by a business that meets the regulatory definition of a Conditionally Exempt Small Quantity Generator (CESQG)17 are exempt from regulation under RCRA.  A CESQG may dispose of their hazardous waste pharmaceuticals at a Household Hazardous Waste (HHW) Collection program that accepts business waste and pharmaceuticals.  Not all HHW programs accept business waste or pharmaceuticals, so it is important to call first.


The management and disposal of pharmaceutical waste generated by a CESQG may be regulated under the California Medical Waste Management Act.  The Medical Waste Management act governs the management of pharmaceutical waste generated by a CESQG that meets the definition of hazardous waste under  Title 22 of the California Code of Regulations, Section 66261.3.





What does this mean to larger generators (e.g. clinics, hospitals, research)?

Businesses that generate more than 100kg per month of RCRA regulated hazardous waste must manage their RCRA regulated pharmaceutical waste as hazardous waste. Generators are responsible for determining whether their waste pharmaceuticals are RCRA hazardous wastes.

The Florida Department of Environmental Protection working with United States Environmental Protection Agency (U.S. EPA) has developed a list of pharmaceuticals that may meet the definition of RCRA hazardous waste.

Further the U.S. EPA has issued guidance letters for generators of waste pharmaceuticals such as doctor’s offices, clinics and hospitals utilizing reverse distribution programs for waste pharmaceuticals.

Certain pharmaceuticals generated by Small and Large Quantity Generators of RCRA waste that do not meet the Federal definition of hazardous waste may be regulated under the California Medical Waste Management Act.

The pharmaceutical wastes from business generators that would be regulated as hazardous waste or medical waste in California are those wastes that meet the definition of hazardous under California Code of Regulations, Sections 66261.3 and 66261.4.




Treatment Storage and Disposal Facilities

In California, facilities that receive RCRA regulated waste pharmaceuticals for treatment, storage and disposal need to have a hazardous waste permit from DTSC.  These facilities must maintain compliance with applicable sections of the California Health and Safety Code and California Code of Regulations.

Facilities that receive non-RCRA regulated pharmaceutical waste for treatment, storage or disposal need a permit from the California Department of Health Services for medical waste management.

Pharmaceutical waste programs operated by local governmental agencies, pharmacies and hospitals may accept waste pharmaceuticals from residents.  After collection, the collected pharmaceuticals may be sent to a RCRA incinerator for total destruction.  However, because of regulatory issues surrounding the collection of controlled substances, please check with your local federal Drug Enforcement Agency before establishing a residential pharmaceutical collection program.

For business-generated waste pharmaceuticals, many pharmaceutical suppliers will make arrangements for the return of unsold, unopened pharmaceuticals.  Businesses may choose to utilize reverse distribution service companies to help manage these unsold or unopened pharmaceuticals.





 
 
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