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How is Pharmaceutical Waste Regulated?

How is Pharmaceutical Waste Regulated?

Pharmaceutical wastes are classified as non-hazardous, hazardous, and medical wastes. To determine which category a pharmaceutical waste falls into, its chemical, physical, and toxicological characteristics are assessed and classified. For example, if a pharmaceutical company generates highly reactive waste (e.g. perchlorates, diazo and azo compounds), it is classified as hazardous waste and requires specific handling such as lab pack services. In order to ensure compliance with federal regulations, therefore, generators need to know what category their waste falls into.

Hazardous Pharmaceutical Wastes

An expired or discarded pharmaceutical may be considered hazardous waste in California if it exhibits one of the four following hazardous characteristics: ignitability, corrosivity, reactivity or toxicity. RCRA listed wastes are also considered hazardous. Unused commercial chemicals in pharmaceuticals are categorized under the P and U lists. This includes chemicals that are no longer needed, are expired or off-specification, or spill residues. Listed hazardous pharmaceutical wastes include nicotine, epinephrine, nitroglycerin, and more. For a waste to be listed, it must meet the following criteria: 

  • The waste must contain one of the chemicals on the P List or U list
  • The chemical in the waste must be unused
  • The chemical in the waste must be in the form of a commercial chemical product

 

 

 

 

pharmaceutical waste

Medical Wastes

In California, medical waste is defined as “any biohazardous, pathological, pharmaceutical, or trace chemotherapy waste not regulated by the federal Resource Conservation and Recovery Act (RCRA) of 1976.”

The Medical Waste Management Act applies to pharmaceutical wastes that are qualified as hazardous in California but not by the RCRA’s definition. However, household pharmaceutical waste is not regulated as hazardous or medical waste. There are various factors that determine if a generator is regulated under the Medical Waste Management Act. For more information on compliance with the Medical Waste Management Act, you should contact the California Department of Public Health.

Non-Hazardous Pharmaceutical Wastes

Pharmaceutical wastes from households and certain very small-quantity generators, known as Conditionally Exempt Small Quantity Generators (CESQGs), are qualified as non-hazardous.

How do Large Quantity Generators Comply

Businesses generating over 100 kg per month of RCRA regulated hazardous pharmaceutical waste are required to manage it as hazardous waste. Generators are responsible in determining whether their pharmaceutical wastes are considered to be RCRA hazardous wastes. Because these various hazardous waste regulations can be difficult to keep up with, it is helpful to consult with hazardous waste specialists who can evaluate your existing waste and disposal operations. As a trusted waste disposal provider for businesses throughout Southern California, HTS can help you make sure your waste is disposed of properly and prevent costly fines. Contact us here or call us at (562) 906-2633 for more information.

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