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Pharma: Controlled or Not Controlled, That is the Question

Kevin Webber - Nov 7, 2019, 6:52:05 AM

There are a lot of pharmaceuticals on the market today, which can certainly make it difficult to be sure your facility is managing pharmaceutical waste properly. Perhaps the most important thing to be clear on when it comes to pharma waste is the difference between how controlled pharmaceutical drugs and non-controlled ones must be handled as they become waste products. Here we’ll outline the basics on this topic, as well as the potential consequences – including the legal, environmental and public safety implications – of handling them improperly.

Pharma-controlled or not controlled substancesControlled or non-controlled? Identifying your waste

When it comes to pharmaceutical waste, knowing whether or not a waste product is a controlled substance is essential to a safe and compliant waste management process. Controlled and non-controlled pharmaceuticals require very different collection, handling and disposal methods, and are governed by very different regulations.

About controlled pharmaceuticals

Controlled pharmaceutical drugs and products are regulated by the Drug Enforcement Agency (DEA). They are classified into 5 distinct categories, called schedules, according to factors that include the acceptable medical use of each substance, its dependency potential and its abuse rate. These are:

  • Schedule I – Drugs that have no accepted medical use and a high rate of abuse. Examples include heroin, cocaine and ecstasy.

  • Schedule II – Drugs that have a high potential for abuse, are considered dangerous, and can lead to severe dependence in users. Examples include Vicodin, Demerol, methadone and oxycodone.

  • Schedule III – Drugs that have a moderate to low potential for abuse and/or dependence. Anabolic steroids, testosterone and acetaminophen with codeine products are examples of Schedule III drugs.

  • Schedule IV – Drugs that have a low abuse potential and dependence risk. Examples include Tramadol, Valium, Xanax and Ambien.

  • Schedule V – Drugs that have a lower potential for abuse or dependence than Schedule IV substances. They include products with low levels of certain narcotics, and examples include cough medicines with small doses of codeine, Lyrica and Lomotil.

The DEA website offers a complete alphabetical list of controlled substances to help you identify any that may find their way into your facility’s pharmaceutical waste. Waste products that are on the controlled substances list must be separated from all other pharmaceutical waste and sent to a DEA-registered reverse distributor – unless your facility is a DEA registrant that is allowed to destroy controlled substances onsite.

About non-controlled pharmaceuticals

Non-controlled pharmaceutical drugs are products that do not appear on the DEA controlled substances schedules and are not regulated by the agency. However, once they become waste products, they are regulated by the Environmental Protection Agency (EPA) under the Resource Conservation and Recovery Act (RCRA) program. Under RCRA, these products are separated into two basic categories; Hazardous and non-hazardous pharmaceutical waste.

The hazardous pharmaceutical waste category includes RCRA listed wastes, which are products that have, as the primary active ingredient, substances that appear on any of the RCRA’s four hazardous waste lists. It also includes bulk chemotherapy waste, which are waste products that contain more than 3 percent of a listed chemotherapy product, and characteristic pharmaceutical wastes, which are products that display one or more of the following EPA-defined properties; ignitability, corrosivity, reactivity or toxicity. Waste products in this category must be segregated in approved RCRA hazardous containers and sent to an approved hazardous waste facility for treatment and/or disposal.

Pharmaceutical waste that falls under the RCRA’s non-hazardous waste category are products that are not listed wastes or do not carry the properties of characteristic wastes. While these products may not fall under the hazardous category, most are not harmless, and can not be mixed with general waste. They must, according to state and federal regulations, be segregated into approved containers that are marked as non-hazardous pharmaceutical waste and sent to approved waste facilities for treatment and disposal.

Why getting it right is essential

Making sure that your facility is disposing of pharmaceutical waste properly is important for many reasons. The most obvious of these, from a business standpoint, is regulatory compliance. Compliance mistakes can lead to fines, lawsuits and other legal hassles. Then there is the potential human costs of waste handling mistakes, such as accidental poisonings or diversion of controlled substance wastes. Finally, there is the potential of environmental harm, as mishandled pharmaceutical wastes often find their way into the nation’s soil and waterways.

If you still aren’t clear on all the details of proper pharmaceutical waste management, you aren’t alone. It is a very complex topic, and the many regulations that govern it can be confusing. A solid, full-service medical waste service company can help clear that confusion, putting their expertise to work for you as you build a safe, efficient and compliant waste management process.

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Topics: Pharma Waste

Kevin Webber

Kevin Webber

Kevin Webber is a partner at TriHaz Solutions and actively involved in the day-to-day business from a strategic and operational standpoint. He has a successful background in business/investment management and entrepreneurship, including recognition by Inc. Magazine’s 5000 list of fastest-growing private companies.

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