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What Are Controlled Substances?

by The GoodRx Pharmacist on December 9, 2016 at 3:19 pm

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.

  • Schedule V: According to the DEA, medications in this schedule have a low potential for abuse relative to those in Schedule IV and consist primarily of preparations containing limited quantities of certain narcotics. There are no special restrictions on refills for Schedule V prescriptions. Examples of this type of drug include Robitussin AC, or other cough medicines with codeine.
  • Schedule IV: Similar to Schedule V, these medications have a low potential for abuse relative to those listed in Schedule III. Schedule IV medications may be refilled if your doctor has authorized it on the prescription. However, each prescription may only be refilled up to five times within six months after the date on which the prescription was issued. After five refills or after six months, whichever occurs first, a new prescription is required. Common Schedule IV medications include benzodiazepine anxiety medications like Xanax or Klonopin.
  • Schedule III: These medications have a lower potential for abuse than substances in Schedules I or II, but abuse may lead to moderate or low physical dependence or high psychological dependence. Refill restrictions for Schedule III are the same as for Schedule IV—you may refill up to five times within six months. Some examples include Suboxone (buprenorphine/naloxone), used to treat opioid dependence, or Tylenol with codeine for pain.
  • Schedule II: These medications have a high potential for abuse, which may lead to severe psychological or physical dependence. There are special restrictions for filling and refilling Schedule II prescriptions. First, they require a written prescription signed by your health care provider—they cannot be sent electronically to your pharmacy. There are also no refills allowed on Schedule II prescriptions; you must get a new prescription each time from your doctor. Many states also limit the amount you are allowed to fill at one time to a 30-day supply. Opioid pain medications like Vicodin or Percocet and ADHD medications like Adderall are classified as Schedule II.
  • Schedule I: According to the DEA, any substances in Schedule I have no currently accepted medical use in the United States and a high potential for abuse, and are not available for use even with a prescription—for example, heroin or cocaine.

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