What Are Controlled Substances?

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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Does your medication need a prescription, or can you just buy it at the pharmacy? Is it a controlled substance, with restrictions on how and when it can be refilled? Drug categorization can be a confusing topic, especially if you don’t have a medical background—but it can have a big effect on how easily you’re able to get the medicine you need.

What are prescription vs OTC drugs?

Medications can ultimately be broken down into the following 2 categories: prescription drugs, and over-the-counter drugs that you can walk into any pharmacy and purchase.

Prescription medications require a prescription from a health care provider. They are typically filled by your pharmacist, but can also be given to you as a sample from your doctor’s office.

OTC medications have been found to be safe and appropriate for use without the supervision of a health care professional, and can be purchased off-the-shelf in any store without a prescription.

The division of the FDA known as the Center for Drug Evaluation and Research (CDER) is responsible for classifying prescription drugs, generic drugs, and over-the-counter or OTC drugs.

What are controlled vs non-controlled medications?

Prescription medications can further be broken down into two sub-categories: controlled and non-controlled.

Most prescriptions for infections or for chronic conditions are non-controlled. For example, most blood pressure and cholesterol medications, diabetes medications (including insulin), asthma inhalers, and antibiotics are all non-controlled medications.

Controlled substances are medications that can cause physical and mental dependence, and have restrictions on how they can be filled and refilled. They are regulated and classified by the DEA (Drug Enforcement Administration) based on how likely they are to cause dependence.

Some examples of controlled substances include opioid pain medications like Vicodin, or ADHD medications like Adderall.

How are controlled substances classified?

Controlled medications are broken down into more specific categories, which have different restrictions on how and when they can be filled or refilled.

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