What are the Federal Laws on CII Drugs?

You've heard a lot about the opioid crisis in this country—in 2017, over 147,000 Americans died of opioid overdose—and an estimated 1.7 million struggled with opioid abuse. Most of them started with prescription medication. Prescription opioids are already controlled substances in the U.S., and their prescription and distribution are subject to "severe restriction" under federal law. It's important to understand the existing laws and regulations that apply to this problem, especially for those in the health care field.  Below, we'll review where things currently stand.

What is the Controlled Substances Act?

The Controlled Substances Act (CSA) was passed in 1970 to establish federal U.S. drug policy and regulate the importation, possession, use, and distribution of certain substances. It created five "schedules," or classifications, by which to define substances.  Substances are added or removed from the schedules according to the following criteria:

1. How likely is the drug to be abused?
2. Does this drug have an accepted medical use?
3. How likely is the drug to cause addiction, and what kind?
4. How does this drug have to be regulated to comply with international treaties?

Schedule I substances are federally illegal.  Schedule II substances are legal but "severely restricted," and the danger for addiction and level of restriction decrease from there.

What are Schedule II Substances?

Referred to in shorthand as C2 or CII drugs, Schedule II substances are drugs that:

• Have acceptable medical uses according to the U.S. federal government
• Have a high potential for abuse
• Can cause severe psychological or physical dependence if abused

Three categories of drugs are included on Schedule II: opioids (sometimes referred to as "narcotics"), stimulants, and central nervous system (CNS) depressants.  All three categories act directly on the CNS, which consists of the brain and spinal cord. Opioids reduce pain perception; this is their primary medical use.  They also induce euphoria, which makes them highly addictive, and suppress the breathing reflex, which makes them incredibly dangerous.  All opioids are controlled substances—heroin is Schedule I, and most others are Schedule II.  CII examples include:

• morphine
• opium
• codeine
• hydromorphone (Dilaudid)
• methadone (Dolophine)
• meperidine (Demerol)
• oxycodone (OxyContin, Percocet)
• fentanyl (Sublimaze, Duragesic)

Stimulants increase CNS activity, inducing alertness and increasing attention and energy; they also increase blood pressure, heart rate, and respiration.  Stimulants are prescribed to treat ADHD, narcolepsy, and treatment-resistant depression.  Not all stimulants are controlled substances, but CII examples include:

• amphetamine (Dexedrine, Adderall)
• methamphetamine (Desoxyn)
• methylphenidate (Ritalin)

CNS depressants, sometimes referred to as sedatives or tranquilizers, slow down brain activity.  This makes them useful for treating sleep disorders and anxiety.  CII examples include:

• amobarbital
• glutethimide
• pentobarbital

What are the Restrictions on CII Drugs?

All controlled substances:

• Require registration with the DEA. Practitioners who intend to prescribe controlled substances have to register with the DEA, along with any entity that is involved in controlled substance transactions.  They are then assigned a "DEA number" for tracking the drugs' movement from manufacturing or importation up until the drugs are dispensed.
• Must be issued with a complete prescription. This includes:
  • Patient's full name and address
  • Medication name, strength, form, quantity prescribed, and directions for use
  • Prescriber's full name, address, and DEA registration number
  • Prescriber's signature, written in ink on the date that it's issued

All other information may be typewritten or written in ink.

• Must be authenticated by the pharmacist. Pharmacists have a responsibility to use their professional judgment to verify that controlled substance prescriptions were issued for a legitimate medical purpose.  They're also obligated to consult their state prescription drug monitoring program (PDMP) for additional restrictions or procedures.

In addition, CII drugs also:

• Cannot be refilled. Patients must visit the doctor and receive a new prescription if they need one. However, prescribers can decide to issue multiple prescriptions totaling a 90-day supply if there is a necessary medical purpose, if there is no additional risk of diversion or abuse, and if no state law prohibits it.
• Must be issued in writing. In other words, prescribers can't "call it in." Verbally-issued prescriptions are limited to emergency situations only.  The quantity is limited to the amount needed to treat the patient during the emergency, and the pharmacist must document the oral prescription and verify the identity of the prescriber. If prescribers don't deliver a written prescription within 7 days, the pharmacist has to notify the DEA.

Federally, there aren't limits on the length of a single CII prescription or requirements for an expiration date, but many states do have time restrictions (often, 30 days, and this is where the federal exception for multiple prescriptions come in).  If no time restrictions apply, a pharmacist's professional judgment becomes especially critical.

What's Your Role?

As we struggle to control the abuse of opioids and other prescription medications, everyone entering the health care industry has a responsibility to understand and comply with controlled substance regulations.  From pharmacy technicians to veterinary technicians, every health care worker has to be vigilant to ensure that prescription drugs only help, never hurt.