Protect Your Veterinary Practice: Ensure Controlled Substances Act Compliance
Think veterinarians are given more latitude within the strict federal laws governing the storage, dispensing and prescribing of controlled substances? Think again! If you don’t put controls in place, you put your practice at risk.
The Controlled Substances Act (CSA) is one of the prime means by which the United States government controls the supply of drugs to prevent abuse and addiction. While the CSA may appear to be aimed primarily at medical professionals who practice in human health, the law does not exempt those practicing in animal health. The CSA applies equally to all medical professionals, regardless of practice type. Often, veterinarians don’t realize that they are subject to the CSA, and thus, they fail to meet all its obligations.
The risks of non-compliance are substantial: Federal or state criminal charges, civil liability, and loss of medical licenses. So how can you protect your veterinary practice and avoid the most common gaps in CSA compliance? Let’s start with an overview of the requirements.
The registration process is a threshold requirement for compliance with the CSA. If you are not a registrant, you cannot legally dispense any controlled substance. To become a registrant, you need to apply with the Drug Enforcement Administration (DEA).
Once approved, you’re given a registrant number that allows you to dispense substances under the CSA. This registrant number is used to track prescriptions and your use of controlled substances as part of your practice. Any unusual prescribing practices or heavy use of controlled substances can trigger the DEA’s scrutiny.
Physical Security and Handling of Controlled Substances
All too often, registrants implement no or very few physical security controls or operating procedures. To be compliant, it’s essential that you store controlled substances in a secure location, limit access, and log their prescription and use.
If you transfer a controlled substance to an administrator or technician, the CSA requires that you document the transfer, including:
- information about the person to whom it was transferred
- type of substance transferred
- the amount of substance transferred
The CSA also requires that registrants perform reasonable diligence that the administrator/technician is unlikely to divert the substance to a recipient other than the patient.
One Illinois disciplinary case provides an example of such a violation.1 A veterinarian stored and dispensed controlled substances from an office desk drawer. He also failed to account for these substances in pertinent logs, and several controlled substances went unaccounted for. As a result, state regulatory bodies placed his professional license on probation. Under this scenario, a registrant might face criminal liability as well.
To prevent theft or diversion:
- Store controlled substances in a secure location. Ensure that only you or other authorized personnel/registrants have access to the secure storage area.
- Consider an automated dispensing cabinet. These devices automatically log who has access and what they remove. If your budget allows, the investment in this technology can help you minimize potential issues with the CSA.
- If you cannot afford a pricey automated system, limit access to the keys to your secure locations as much as possible.
- Enforce clear, written policies for logging access to controlled substances.
- Perform background checks on employees to ensure that there is nothing in their history that would make them likely to divert any controlled substances.
Prescribing Within the Legitimate Practice of Medicine
Under the CSA, controlled substances can only be prescribed for a legitimate medical purpose by a licensed professional acting within the usual course of professional practice. State law defines what constitutes the legitimate practice of medicine, so the CSA piggybacks off the state regulations for professional conduct. As a result, it is possible for some variability in the way the law is enforced. Be sure to find out your state’s specific obligations regarding relevant standards of conduct, ethics and professional practice.
A common issue that can occur is prescribing for purposes outside the scope of the registrant’s professional license. For example, a veterinarian registrant who otherwise does not have a medical license cannot prescribe controlled substances to people.
This scenario is highlighted in the Illinois case mentioned above, where a veterinarian provided Tramadol to his mother for her own personal use. Such a prescription is outside the scope of the veterinarian’s professional license. These actions led to discipline from Illinois regulatory agencies and represented a potential violation of the CSA, risking both the registrant/practitioner’s professional license and criminal liability.
To avoid acting outside of the scope of your professional license, refer to relevant sources of ethical standards, codes of conducts, guidelines, etc. Be sure to fall well within these standards of conduct to avoid liability under the CSA.
Protect Your Practice with a Compliance Plan
Failure to abide by the CSA can lead to significant repercussions. We have only scratched the surface of plans, policies, and procedures to help you maintain compliance. See our Controlled Substances Checklist for additional tips and keep in mind that an experienced, specialized healthcare attorney is your best bet to help you navigate the CSA as well as the state regulations that shape its enforcement.
Ready to learn more? Contact Jackson LLP’s experienced veterinary attorneys for guidance.
Jackson LLP’s attorneys have experience with the complex issues facing veterinary practitioners and practice owners. To protect your practice against liability for controlled substances misuse, and to educate yourself about the legal requirements, schedule a complimentary consultation with an attorney by calling (312) 985-6484 or clicking the button below.
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- Department of Financial and Professional Regulation of the State of Illinois v. [omitted], D.V.M., Case No. 2013-09344, State of Illinois, Department of Financial and Professional Regulation, Division of Professional Regulation.