Working within the healthcare industry generally means dealing with prescription medications, and doing so, like all things healthcare, means complying with regulations that govern these drugs. Among the most important of these is the Controlled Substances Act (CSA), which gives the federal government the authority to single out certain drugs or substances to be much more tightly regulated than others. Drugs that are designated by the CSA as controlled substances must be treated differently than other medications, with restrictions placed on how they can be manufactured, prescribed, used, handled, stored, distributed and disposed of once they become pharmaceutical waste. Here, we’ll get into the details you need to know about controlled substances.
What is a controlled substance?
A controlled substance is a drug or other substance that has been deemed by the federal government to be likely to be abused and/or cause physical or psychological addiction. They are tightly regulated under federal law, and classified by the Drug Enforcement Administration (DEA) into 5 separate categories, or schedules, according to their potential for abuse and/or addiction. Substances listed in these schedules include opioids, depressants, stimulants, anabolic steroids and hallucinogens, among others.
Why is it managed differently?
A controlled substance is managed differently than other drugs and substances because it has become or has the potential to become a public health threat. While many controlled substances have medical uses and can be very beneficial to patients when used properly, they can also be dangerous when mishandled. For this reason, controlled substances that are used medicinally are managed according to strict rules, imposed by the DEA, meant to ensure that they are managed appropriately to avoid harm to patients and that they are not diverted for illicit use.
Where do they come from?
Controlled substances may come from a number of sources, depending upon the particular type. Drugs or substances classified as Schedule 1 are those that do not, according to the DEA, have any accepted medical uses and carry a high potential for abuse. They are not available to medical institutions or the public. Rather, they are typically procured for illicit use via the black market.
Controlled substances that do have accepted medical uses, which are classified under Schedules 2 through 5, are produced by pharmaceutical companies. They are prescribed by qualified physicians for their patients and dispensed to those patients by pharmacies.
How are they disposed of?
Controlled substances are strictly regulated by the DEA even during disposal. Facilities must handle controlled substance pharmaceutical waste differently than they would wasted non-controlled drugs.
Controlled substance pharmaceutical waste generally consists of unused, partially used,expired, damaged, unwanted or otherwise unusable controlled drugs. These waste products must be segregated into approved containers, separate from all other pharmaceutical waste. That’s because disposing of these drugs in compliance with DEA regulations means ensuring that they are rendered non-retrievable – or, simply stated, completely destroyed. Incineration is the preferred method of destruction.
If your facility is registered with the DEA for controlled substance disposal, these products can then be destroyed onsite in compliance with DEA rules. If not, your facility’s controlled substance waste must be transferred to a DEA registrant, also known as Authorized Reverse Distributors, for disposal.
Failing to comply with DEA regulations on the proper handling and disposal of controlled substance pharmaceutical waste – and/or DEA documentation/record-keeping rules regarding this process – can lead to legal consequences, including civil penalties and fines. For this reason, many facilities seek the expertise of solid, full-service medical waste service providers to help ensure that their procedures for disposal of controlled substance and other regulated wastes remain in full compliance with all regulations set forth by the DEA and all other federal, state and local authorities.