Labeling Dispensed Controlled Substances in Veterinary Medicine

The dispensing of controlled substances in veterinary medicine is subject to stringent regulations by the Drug Enforcement Administration (DEA) to prevent drug abuse. Labeling dispensed controlled substances is an important part of those regulations to prevent misuse and ensure the well-being of clients and patients.


In this article, we will delve into the specific requirements imposed by the DEA on labeling dispensed controlled substances in veterinary practice.


First of all, we should remember that while dealing with controlled substances, veterinarians should ensure compliance with relevant regulations of their State Board of Pharmacy and State Board of Veterinary Medicine, and federal regulations (CFR Title 21 Chapter II).


To ensure proper labeling of a controlled substance, it is important to understand the specific requirements based on its schedule. Additionally, different schedules may have varying supply policies. Therefore, it is crucial to be aware of the dispensed drug’s schedule to comply with the specific labeling requirements. 

The mandatory labeling components include:

Drug Name: The name of the drug should be clearly displayed on the label, including the generic name, brand name, or trade name, and any additional identifying information such as the strength or dosage form


Prescription Serial Number: A number specific to the drug being dispensed. Commonly this is known as a prescription number or Rx#


Date Filled: The date the drug was filled/dispensed


Expiration Date: The drug’s expiration date should be clearly displayed on the label


Quantity: The quantity of the drug being dispensed as well as what form it is (mL, tablet, etc)


Patient Information: Patient name and species


Prescribing Veterinarian Information: The prescribing veterinarian’s name and address


Directions of Use and Cautionary Statements


To verify the specific labeling requirements for different drug schedules, please follow this link


Also, it is important to educate animal owners about safe and responsible use of medication. So labels may include information on potential side effects, proper storage guidelines, and the importance of adhering to prescribed doses.


And remember, veterinarians are required to maintain proper recordkeeping for their controlled substances, and some states require PMP reporting for practitioners dispensing controlled substancesIt is vital to label controlled drugs correctly before dispensing to ensure patient safety, prevent misuse, and comply with regulatory requirements. Veterinary professionals should follow guidelines strictly to create clear, informative, and accurate labels. By doing so, we contribute to a healthcare system that prioritizes patient well-being and responsible medication use.