What are the rules for controlled substance prescription refills?

In general, schedule II controlled substance prescriptions cannot be refilled and expire after 6 months. Schedule III or IV prescriptions may not be filled or refilled more than 6 months after the written date OR refilled more than 5 times, whichever comes first. Schedule V controlled substances may be refilled as authorized. Laws may vary by state.

Key Points

Rules and regulations for controlled substances vary by state and federal law in the U.S. In general,

• Schedule II prescriptions cannot be refilled and expire after 6 months, but this can vary by state. For example, CII prescriptions are only valid for 30 days after being written in Massachusetts, but are valid for 6 months in North Carolina.
• Schedule III or IV prescriptions may not be filled or refilled more than 6 months after the written date OR refilled more than 5 times, whichever comes first.
• Schedule V controlled substances may be refilled as authorized and may not be subject to the 6 month, 5 refill limit.
• Always check directly with your local pharmacist for the most up-to-date rules specific to controlled substances.

Note: Rules for controlled substance medications must comply with both state and federal rules and regulations. For activities regulated by both state and federal agencies, the more stringent rule must be followed.

Do I need to see my doctor to get a new CII prescription every 30 days?

No, your doctor may elect to write sequential prescriptions for CII medicines that indicate a “Do Not Fill Until” date on the prescription AND for sequential prescriptions that authorize no more than a 90-day supply, if allowed by state law.

What is a Controlled Substance?

The U.S. Drug Enforcement Agency (DEA) determines which medications fall under the category of "controlled substance". In the U.S., there are five controlled substance schedules at the federal level (Schedules CI-V) that are used to classify drugs based upon the:

• abuse potential
• accepted medical use
• safety and potential for addiction

Individuals who work with controlled substances, such as those who order, handle, store, and distribute these substances must be registered with the DEA to perform these functions. They are required to maintain accurate inventories, records and security of the controlled substances.

The abuse potential of a drug is a strong factor in determining the schedule for a drug.

• For example, Schedule I drugs (such as heroin) have a high potential for abuse and the potential to create severe psychological and / or physical dependence.
• As the Schedule changes, from Schedule II to Schedule V, the abuse potential declines. Schedule V drugs have the least potential for abuse.

Do not give or sell a prescription controlled substance to anyone else. Selling or giving to others may harm them and is against the law

According to the DEA, a substance need not be listed as a controlled substance to be treated as a Schedule I substance for criminal prosecution (for example, controlled substance analogues structurally or pharmacologically substantially similar to or is represented as being similar to a Schedule I or Schedule II substance).

What is the Federal Controlled Substance Act?

The Federal Controlled Substance Act (CSA) is the principal federal law regulating the manufacture, distribution, dispensing and delivery of medications which have the potential for abuse or dependence.

The Controlled Substances Act (CSA) schedule information displayed applies to substances regulated under federal law. There may be variations in CSA schedules between individual states and federal law.

Examples of Controlled Substances

• Schedule I (no recognized medical use in the U.S.) - heroin, lysergic acid diethylamide (LSD), marijuana (cannabis) at the Federal level, 3,4-methylenedioxymethamphetamine (Ecstasy), methaqualone, and peyote.
• Schedule II - morphine, codeine, opium, hydrocodone, hydromorphone (Dilaudid) methadone (Dolophine), meperidine (Demerol), oxycodone (OxyContin, Percocet), and fentanyl (Sublimaze, Duragesic). Schedule II stimulants include amphetamine (Dexedrine, Adderall), methamphetamine (Desoxyn), and methylphenidate (Ritalin) methamphetamine, methylphenidate, and lisdexamfetamine. Other schedule II substances include: cocaine, amobarbital, pentobarbital and glutethimide.
• Schedule III - products containing not more than 90 milligrams of codeine per dosage unit (Tylenol with Codeine), combination products containing not more than 50 milligrams of morphine per 100 milliliters or per 100 grams; and buprenorphine products used to treat addiction (Suboxone). Schedule III non-narcotics include benzphetamine (Didrex), phendimetrazine, ketamine, and anabolic steroids such as oxandrolone (Oxandrin) or testosterone (Depo-Testosterone).
• Schedule IV - tramadol (Ultram), alprazolam (Xanax), clonazepam (Klonopin), clorazepate (Tranxene), diazepam (Valium), lorazepam (Ativan), midazolam (Versed), temazepam (Restoril), and triazolam (Halcion).
• Schedule V - cough preparations containing not more than 200 milligrams of codeine per 100 milliliters or per 100 grams (Robitussin AC and Phenergan with Codeine).

Some states have a controlled substance Schedule VI designation, but the definition can vary.

• For example, in Massachusetts a Schedule VI designation includes all prescription drugs which are not included in Schedules II through V, for example, maintenance medications such as blood pressure, cholesterol or diabetes drugs, or other short-term use medicines like antibiotics.
• But in the state of North Carolina a Schedule VI drug includes drugs such as marijuana, hashish and other tetrahydrocannabinols (THC) products.

Contact the State Board of Pharmacy if you questions about controlled substance classifications in your state.

Related: Definitions and Lists of Controlled Substances (in more detail)

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Can I get a Schedule II controlled substance in an emergency?

Yes, in an emergency situation, your pharmacist may be able to fill a prescription for a Schedule II controlled substance medicine if given an oral authorization by your doctor. The amount dispensed is limited to the amount needed for treatment during the emergency period.

In addition, the prescribing healthcare provider shall mail or deliver a written Rx for the emergency quantity prescribed within 7 days of authorizing an emergency CII prescription.

As always, this rule can vary by state, so check with your pharmacist.

Can I just fill part of my controlled substance prescription?

If state law does not prohibit partial filling of CII prescriptions, you may be able to get a partial fill of a CII prescription. Ask your local pharmacist. In general, the total quantity dispensed of a CII medication can be filled no later than 30 days from the original date the prescription was written (but can vary by state). The total quantity of medicine cannot exceed the original amount prescribed.

Can my doctor just email my controlledsubstance prescription to the pharmacist?

No, according to DEA federal law, electronic prescribing (e-prescribing) of controlled substances must be created and transmitted using an electronic application that meets the DEA requirements. Emailing is not allowed. These systems must be able to:

• link to registered prescribers
• store and transmit information consistently and accurately
• allow digital signature functionality, with user permission
• have the ability to accept two-factor authentication for security purposes.

What information should be included on a controlled substance prescription?

Prescriptions written for controlled substance prescriptions must contain specific information as required by law such as:

• prescriber’s name, address, signature and DEA registration number
• date prescription written
• patient’s full name and address
• medication name, strength, quantity and dosage form
• directions for use
• number of refills authorized (if any, and if allowed by law)

Health care providers should consult their state rules to determine what specific prescription requirements exist.