Controlled Substances are useful drugs, but they are subject to a host of rules and regulations due to their inherent potential for misuse and abuse. The implementation and monitoring is done by the DEA.

Medical science has made rapid progress over the decades and there is a plethora of drugs for treating varied health conditions. These range from mild and regular ones for headache, nausea, cold and cough to more strong and sophisticated medications.

Now, while the job of a medicine is to heal, it can beget many other complications as well. Let us take controlled substances for instance. Like it is always said, these drugs are controlled and require controlled substance license registration for good reason.

Getting into the whys and wherefores!

Controlled substances form a class of essential drugs that serve well in treating chronic pain, extreme pain, anxiety, insomnia, attention disorders and more. They include opioids, stimulants, depressants, hallucinogens, and anabolic steroids. This included drugs with no known medical use, such as morphine, Valium and Ritalin as well as those that are considered illegal outright. The latter two categories may be used for research purposes.

The problem here is that, while most of the controlled substances yield effective results, they also hold the scope for abuse which can even lead to addiction. This is what leads to misuse, diversion and even trafficking of these substances!

All controlled substances are regulated by the Controlled Substances in the United States. The Act divides these medical drugs into five distinct schedules based on certain factors. The Drug Enforcement Administration (DEA) is responsible for implementing the Act. Accordingly, it maintain strict control over the use of controlled substances.

What does it entail?

The regulations cover everything from how they are made, stored and handled to how they are prescribed and used. The guidelines include registration, mandatory safety protocols, recordkeeping, reporting and even disposal.

To start with, every manufacturer, service provider, healthcare professional, hospital, pharmacist or researcher that intends to prescribe, administer, dispense or otherwise handle a controlled substance has to first apply for DEA new registration. Specific classifications, guidelines and other regulations are applicable here. DEA registration renewal is required at regular intervals.

The DEA will screen the applicant and, if approved, will assign a DEA license with a unique number. This works like a stamp of authority and has to be quoted on all applications, prescriptions, receipts and the like.

The law also stipulates clear safeguards for storing the controlled substances so as to warrant their safety and security. Then there is the mandate to record all entries related to the controlled substances. These have to be maintained for a couple of years and be accessible at any time.

Apart from this, the DEA also subjects registered entities to surprise audits to check that all the regulations are being followed to the letter. It can also conduct an investigation in case of any complaint or suspicion of misuse/diversion.

Given what’s at stake here, it is advisable to engage the services of a DEA compliance professional from the word go!