Dealing with pharmaceutical waste properly is very important, since getting it wrong can cause harm to people, animals and the environment, and can also have legal consequences for your facility. However, proper management of pharma waste can also be a very complicated and confusing process, given the number and complexity of state and federal regulations that apply to it. So what do you need to know to help ensure that you’re dealing with waste in a safe and compliant manner?
What Constitutes Pharmaceutical Waste?
Pharmaceutical waste is a term used to describe drugs and other pharmaceutical products that are slated for disposal. This may include medications that have not been used before their expiration dates, discontinued medications, unused prescription or over-the-counter medications, and partially used medications. It may also include devices, like syringes, used to administer medications and, in some cases, vials and other containers or packaging materials that once held pharmaceutical products.
Additionally, beginning in August, 2019, the Environmental Protection Agency (EPA) rules on when medications that are placed into the reverse distribution chain will be considered to be pharmaceutical waste will change. Products in the reverse distribution chain are ones that are not immediately designated for disposal. Rather, they may be returned to manufacturers, for example, or sent to specific facilities for recycling and/or redistribution.
Historically, these products, which may be prescription or over-the-counter products, have not been considered “discarded” by the EPA as they made their way through the reverse distribution chain. That meant that they were not regulated as pharmaceutical waste until they arrived at their destination and were then slated for disposal. Even when they were finally designated as waste, standards for disposal were not as strict for these products as they were for those that were classified as pharmaceutical waste at the point of generation. However, under the new rule, products that cannot reasonably be expected to be recycled or redistributed – such as those returned to manufacturers for disposal – will be deemed pharmaceutical waste and subject to Resource Conservation and Recovery Act (RCRA) waste handling regulations.
Types of Pharmaceutical Waste
Pharmaceutical waste is divided into two broad categories; Hazardous and non-hazardous underRCRA. Hazardous waste products are tightly regulated by RCRA, and must be handled and disposed of in very specific ways. Non-hazardous pharmaceutical waste, despite its RCRA designation, is not harmless, and must be handled with care as well.
Hazardous pharmaceutical waste
Hazardous pharmaceutical waste typically makes up about 5 to 10 percent of overall pharmaceutical waste. Hazardous waste is further divided into three general categories, which are:
RCRA listed pharmaceutical waste – These are waste products that contain, as the primary active ingredient, substances that appear on one of RCRA’s four hazardous waste lists, typically the P or U lists. P-listed pharmaceuticals are considered acutely toxic, which means that they can cause death or irreversible health affects with exposure to small doses. U-listed pharmaceuticals are considered toxic, but not as hazardous as P-listed materials. Containers and other packaging that once contained listed materials and devices used to administer them may also be classified as listed pharmaceutical waste. This applies to P-list substances unless containers or devices have been triple rinsed with approved solvents, and to U-listed substances unless containers hold no more than 3 percent of the U-listed product.
Bulk chemotherapy waste – This category includes any pharmaceutical waste product that still contains more than 3 percent of a listed chemotherapy product. This may include used IV bags and other drug containers, for example, or materials used to clean up spilled chemotherapy drugs.
Controlled substances – These are drugs that are tightly regulated by the Drug Enforcement Administration (DEA), typically due to their potential for abuse or addiction. While some may be considered listed pharmaceutical waste under RCRA, they cannot be placed in RCRA hazardous containers. Rather, they must be segregated and disposed of (destroyed) according to DEA regulations.
Non-Hazardous pharmaceutical waste
Pharmaceutical waste that is classified as non-hazardous under RCRA is not regulated by its standards. However, that does not mean that it is harmless, nor does it mean that it is unregulated. Other state and federal environmental regulations do apply, and this type of waste must also be disposed of properly. This category of waste includes:
Drugs that contain P or U-listed substances as secondary or inactive ingredients.
Products deemed hazardous by the Occupational Safety and Health Administration (OSHA)
Products that have been categorized as carcinogenic by the US Department of Health.