What are controlled substances?

Controlled substances are drugs that are particularly prone to abuse and addiction.

Oversight falls under the Drug Enforcement Administration (DEA), which oversees and enforces the federal controlled substance laws. These laws impact pharmacies that handle controlled substances. Many states have their own laws regarding controlled substances, and some require separate registration.

How are controlled substances categorized in law?

Controlled substances are categorized into five schedules. Some states include a sixth schedule with drugs that are not listed on the federal schedules. The DEA produces a list of federally controlled substances and their chemicals. Each schedule is subject to different regulatory requirements in the areas of transfer, refill etc.

What should pharmacists know about controlled substances?

There are several provisions of the controlled substance laws that are important to practicing pharmacists. On this page, we have highlighted some of the most important and widely asked questions, however, it should be noted that there may be additional state and federal requirements, based upon the location and nature of your pharmacy.

For more information on controlled substance laws as they pertains to your state, visit Bula Law, your Health Mart regulatory compliance resource, and search the Current Laws module, filter by your jurisdiction.

Is there a comprehensive guide for pharmacists regarding the controlled substance schedules?

The DEA compiles federal controlled substance laws and regulations, producing a pharmacist-friendly publication called the Pharmacist’s Manual, which provides more in-depth, specific guidance. 

Are there requirements for pharmacists to conduct inventories?

Federal law states that pharmacies must conduct a physical count of all controlled substances every other year (biennially) and the law outlines the specific times for those inventories.

• States may have additional inventory requirements. An example of this would be when the pharmacist-in-charge changes.
• Here is an example of a Controlled Substance Inventory Log.

How do pharmacies order controlled substances?

Dependent upon the schedule of the drug, the ordering process may differ:

• Schedule II drugs must be ordered with an official DEA form 222, or the electronic equivalent – the Controlled Substance Ordering System ().
• Schedule III, IV and V drugs follow a separate protocol, and may be ordered directly from drug wholesalers.
  • Pharmacies may designate one or more individuals to handle this process using DEA forms 222 and/or the CSOS
  • Power of Attorney is granted to each individual who completes this process.
  • CSOS activities must be reported to a CSOS coordinator who monitor ensure compliance.

Health Mart stores can also order through 

How should a pharmacy handle disposal and loss of controlled substances?

State and Federal regulations must be followed when handling and disposing of damaged, expired, unwanted, unusable or non-returnable controlled substances.

• Pharmacies must keep disposal and loss records.
• A DEA-registered reverse distributer may be used for destruction. If a reverse distributor is used for a Schedule II drug, the DEA form 222 must be used.
• For schedule III-V drugs, the pharmacy must maintain a record of distribution or transfer to a reverse distributor which indicates the drug’s name, dosage form, strength, quantity, and the date transferred.
  • The reverse distributor is responsible for submitting a record of destroyed controlled substances.
  • Additional state regulations may apply. 

Are there specific requirements for pharmacies to handle breakage or spills?

Breakage, spills, or other events where controlled substances become lost or destroyed must be accounted for.

• Substances should be placed in the disposal/destruction waste stream if they are contaminated and recovered after a spill or other mishap.
• If a substance is not recoverable, two witnesses must document the incident in the inventory records, and must sign the inventory.
• Additional state regulations may apply.

What is the protocol for theft or significant loss of controlled substances?

Within one business day of any significant theft or loss incident, the nearest DEA Field Division Office must be notified in writing. The pharmacy must also complete and submit a DEA Form 106, outlining the incident. Reportable incidents include, but are not limited to:

• Employee theft
• Customer theft
• Armed robbery
• Significant dispensing errors
• Losses in-transit

*Additional state requirements may apply, and legal advice should be sought to ensure compliance with all applicable state and federal laws.

NOTE:  Each pharmacy must work with its own attorney to identify the scheduled drugs in its state, to determine whether state controlled-substance registration is required in addition to the federal registration, and to ensure compliance with the relevant legal requirements.

Federal Resources:

Here is a list of important online resources regarding the handling, distribution, and disposal of controlled substances.

• DEA, Drug Disposal Resources
• DEA, Federal Controlled Substances Schedules
• DEA, Theft or Loss of Controlled Substances
• Office of National Drug Control Policy

Additional Resources:

• National Association of State Controlled Substance Authorities (NASCSA)
• McKesson's Controlled Substance Ordering System (CSOS) — available through McKesson Connect^SM
• The Pharmacist's Role in Preventing Prescription Drug Abuse