Controlled substance FAQs
What are controlled substances?
Controlled substances are drugs or other substances that are tightly controlled by the government because they may be abused or cause addiction.”Controlled” applies to the way the substance is made, used, handled, stored, and distributed. Controlled substances include opioids, stimulants, depressants, hallucinogens, and anabolic steroids. Examples of drugs that are controlled substances are Fentanyl, Methadone, Ketamine, and Diazepam.
What are controlled substance schedules?
Drugs and other substances that are considered controlled substances under the Controlled Substances Act (CSA) are divided into five schedules. An updated and complete list of the schedules is published annually in Title 21 Code of Federal Regulations (CFR) §§1308.11 through 1308.15. Substances are placed in their respective schedules based on whether they have a currently accepted medical use in the United States, their relative abuse potential, and likelihood of causing dependence when abused.
What is the fine for each individual regulatory compliance infraction?
Can a veterinarian prescribe opioids legally without a valid veterinarian-client-patient relationship (VCPR)?
No. Establishing a valid veterinarian-client-patient relationship is the core obligation for legal and ethical use of drugs, both legal and controlled. When dispensing or prescribing any drug, veterinarians should ensure they act within the framework of a valid relationship as defined by the state in which the veterinary practice is located.
Are prescription limits for opioids the same in every state?
No. Prescribing restrictions vary by state.
What is “drug diversion”?
Any theft or removal of controlled substances for nonapproved purposes is considered diversion.
What is the core mission of the Drug Enforcement Administration (DEA)?
To prevent, detect, and investigate the diversion of controlled pharmaceuticals and listed chemicals from legitimate sources while ensuring an adequate and uninterrupted supply for legitimate medical, commercial, and scientific needs.
How and when should I report the theft or loss of controlled substances to the DEA?
Federal regulations require that registrants notify the Field Division Office of the Administration in his/her area, in writing, of the theft or significant loss of any controlled substance, disposal receptacles, or listed chemicals within one business day of discovery of such loss or theft. The registrant shall also complete the and submit to the Field Division Office in his/her area, DEA Form-106 regarding the loss or theft.
Can I employ a convicted felon for a position that works or interacts with controlled substances?
No. According to according to Title 21 CFR 1301.76(a): “The registrant shall not employ, as an agent or employee who has access to controlled substances, any person who has been convicted of a felony offense relating to controlled substances or who, at any time, had an application for registration with the DEA denied, had a DEA registration revoked or has surrendered a DEA registration for cause.”
If federal regulations differ from my state’s regulations, which should I follow?
Veterinarians must follow whichever is more stringent.
What is a DEA registration number?
A DEA registration number provides veterinarians a license to prescribe, administer, or dispense controlled substances classified as Schedule II or higher.
How often do I need to renew my DEA registration?
DEA registration must be renewed every three years with the submission of a registration renewal application (DEA Form-224a) and fee.
What happens if I miss the DEA registration-renewal deadline?
Your DEA number is removed and cannot be retrieved; you will have to obtain an entirely new DEA registration number.
Can I have just one DEA registration even if I prescribe controlled substances at separate hospital locations?
No. Veterinarians who practice at multiple hospitals/offices and have supplies of controlled substances to administer or dispense at all of the locations need a separate DEA registration for each location.
How long am I required to maintain records concerning controlled substances?
The DEA requires that records concerning controlled substances be maintained for at least two years for inspection and copying by duly authorized DEA officials. However, this period is longer in some states and can be upwards of five years or more. You must follow whichever regulation is more stringent. If you have the storage space, we recommend keeping all records as long as you would keep tax records in calendar year increments.
Do records for Schedule II drugs need to be kept separately from Schedule III, IV, and V drugs?
Yes. Failing to separate records for Schedule II drugs from Schedule III, IV, and V drugs is considered cross-contamination of DEA required paperwork.
Can records concerning controlled substances be kept with all other business records?
No. All records and inventories of Schedules III, IV, and V controlled substances must be maintained either separately from all other records or in such a form that the information required is readily retrievable from the ordinary business records.
What does “records concerning controlled substances need to be ready and retrievable” entail?
Per the DEA, readily retrievable means the record is kept or maintained in such a manner that it can be separated out from all other records in a reasonable time or that it is identified by an asterisk, redline, or some other identifiable manner such that it is easily distinguishable from all other records.
How often should I reconcile logbooks?
As frequently as possible. If you don’t review your logbooks daily, it gets more difficult to reconcile issues as additional days, weeks, or months go by. A best practice for all facilities is to routinely conduct audits of controlled drugs at the end of each shift.
What logbooks should I use to track controlled substance inventory?
At a minimum, the following logs should be instituted for daily use: one for each Schedule II–V drug in your facility, an Authorized Personnel Log, an Unopened Container Log, an Opened Container Log, and a Biennial Inventory Logbook.
Where should I store controlled substance logbooks?
Federal law requires controlled substance logbooks to be kept within close proximity to the controlled substance safe.
Why does weighing controlled substances matter?
Weighing controlled substances increases accuracy and serves as an excellent early warning system for the doctor to detect if drug diversion is taking place. Furthermore, every bottle and vial of liquid sold by a manufacturer is over- or underfilled. Weighing assures that the precise amount of controlled substances has been logged.
How often should I weigh controlled substances?
Under the best possible practice protocols, staff would weigh each bottle when it is received and when the bottle goes from the unopened to the opened container when the seal is removed. At a minimum, the bottle should be weighed each time liquid is extracted for dosing.
What is a Registrant “Near Miss” Incident Notification Log?
The purpose of this log is for practitioners to document any irregularities as they pertain to controlled substances in the facility. This log is to be used to record any interactions with your controlled substances that do not have a logical explanation. A “near miss” is an unplanned event that has the potential to cause, but does not actually result in, an interruption to normal operations.
Why is it important to use a Registrant “Near Miss” Incident Notification Log?
Recognizing and reporting “near miss” incidents can make a major difference within your organization since these events are sometimes predictors of loss-producing events.
Do I need to account for hub loss?
Yes. Failing to account for hub loss tells the DEA that you have failed to properly account for your controlled substance inventory.
What is an acceptable method of destruction for controlled substance waste disposal?
The only acceptable method of destruction for controlled substance waste disposal is incineration through a licensed reverse distributor.
Will I be notified by the DEA prior to inspections?
The DEA holds the legal authority to conduct unannounced inspections to ensure that registrants actively comply with laws related to the dispensing, prescribing, sale, destruction, recordkeeping, etc. of controlled substances.