CBD: Compliance, Risk Management, and Investigation Defense
Pharmacies and businesses that manufacture, distribute, and sell CBD products are subject to numerous laws and regulations. Our lawyers and former federal agents assist with all aspects of compliance, risk management, and defense.
It is no secret that CBD is now big business in the United States. With more states relaxing their stance on CBD and other cannabis-derived products each year, pharmacies, dispensaries, and CBD product manufacturers have unprecedented opportunities to exploit an entirely new market with extraordinarily high demand.
But, entering the United States’ burgeoning CBD market is not without risk. In addition to the risks that attend to running any type of pharmacy or consumer-oriented business, pharmacies and other businesses that sell CBD products face substantial legal and regulatory risks as well. As a result, compliance needs to be a priority – at both the state and federal levels – and pharmacies and other businesses that sell CBD products need to undertake additional measures to protect themselves against regulatory enforcement actions, civil liability, and even criminal prosecution.
Federal Lawyers and Former Federal Agents for CBD Compliance, Risk Management, and Defense
At Oberheiden P.C., we bring decades of relevant experience to assisting pharmacies and other businesses with all aspects of CBD compliance, risk management, and defense. When you choose our firm, you will work with highly-experienced professionals including:
- Dr. Nick Oberheiden, Founding Attorney – Dr. Nick Oberheiden has been representing pharmacies, health care providers, and other businesses for well over a decade. His experience encompasses all aspects of federal compliance, and he has represented clients in more than 45 states in federal investigations involving the Drug Enforcement Administration (DEA), Food and Drug Administration (FDA), and other agencies.
- Roger Bach, Former DEA Executive Assistant – Roger Bach has more than 30 years of prior experience working inside the federal government. This includes experience as a Special Agent with the U.S. Department of Justice (DOJ) and as an Executive Assistant at the DEA. He offers a wealth of unique insights to companies that manufacture, distribute, and sell CBD products.
- Chris Quick, Former IRS-CI Special Agent – Chris Quick is a former Special Agent with the Federal Bureau of Investigation (FBI) and Internal Revenue Service Criminal Investigations (IRS-CI). He advises companies on all aspects of CBD-related tax compliance and federal risk management.
- Dennis Wichern, Former DEA Special Agent-in-Charge – Prior to joining Oberheiden P.C., Dennis Wichern supervised more than 600 DEA personnel as a Special Agent-in-Charge. He is intimately familiar with the DEA’s operations and enforcement priorities, and he uses this knowledge to help our clients avoid unwanted DEA scrutiny.
CBD compliance has many facets. From complying with state registration and licensing requirements to complying with DEA and FDA regulations, pharmacies and other businesses must ensure that they are doing everything that is necessary to comply with the law. We provide advice and representation for all aspects of CBD compliance, including:
1. DEA Compliance for Pharmacies and CBD Businesses
The DEA has updated its regulations pertaining to CBD several times over the past few years, most recently on August 21, 2020. These updates were made in response to amendments to the Controlled Substances Act (CSA) made by the Agriculture Improvement Act of 2018 (AIA), which specifically addressed CBD and other cannabis-derived products.
The DEA’s regulations strictly control the manufacture, sale, and administration of CBD products and medications. While certain products and medications currently fall under Schedule V (and a very limited number of products have been “decontrolled”), others remain prohibited Schedule I controlled substances under the CSA. As a result, DEA compliance can present particular challenges for pharmacies and other retailers, as it is often necessary to examine individual CBD products in order to determine what compliance measures are necessary.
2. Compliance with the FDA’s CBD Regulations
Alongside the DEA, the FDA shares primary responsibility for enforcing CBD-related compliance. The FDA has published several extensive resources on CBD compliance, and pharmacies and other businesses are expected to know – and follow – the rules, requirements, and prohibitions the FDA has put in place. This includes (but is by no means limited to) rules, requirements, and prohibitions regarding:
- FDA approval requirements and procedures for products containing CBD
- Products containing CBD and THC
- Dietary supplements containing CBD
- Cosmetics containing CBD
- Foods and other edibles containing CBD
Similar to the DEA’s regulations, many of the FDA’s regulations are specific to individual types of CBD products. Pharmacies and other businesses need to keep this in mind when developing their compliance policies and procedures, and they must have systems in place to ensure that only FDA-approved products hit their shelves.
3. State-Level CBD Compliance
In addition to DEA and FDA compliance, pharmacies and other businesses that sell CBD products must contend with state and local regulatory requirements as well. These regulations are often highly-restrictive, yet they also typically offer little guidance with regard to what companies can, and should, be doing to comply. At Oberheiden P.C., we can help your pharmacy or other business cut through the miles of red tape that stand in the way of lawfully selling CBD products, and we can do so in an efficient and timely manner.
CBD Risk Management
When it comes to CBD risk management, federal and state compliance is just one of several layers. From physical security and cybersecurity to electronic prescription compliance for pharmacies, there are numerous other aspects to CBD risk management as well.
If your pharmacy or other business sells (or is planning to sell) CBD products, you need to implement a robust risk management program. This program should thoroughly address all aspects of compliance, and it should provide your executive team and staff members with clear guidance based on your company’s particular risk tolerance and risk profile. Our CBD risk management services include:
- Establishing federal and state CBD compliance policies and procedures
- Adopting measures to ensure continued compliance
- Adopting physical security and cybersecurity protocols
- Evaluating CBD-related insurance needs and coverage options
- Evaluating CBD vendors and CBD products
- Seeking FDA approvals and managing FDA approval requirements
- Managing labeling and other product-related requirements and risks
- Managing patient and customer-related risks
- Federal tax compliance consulting regarding CBD products
- Ongoing evaluation of changes in the legal landscape pertaining to CBD
Preparing for and Defending Against CBD-Related Investigations
Due to the rapidly-evolving nature of CBD regulation and oversight at the federal and state levels, even pharmacies and other businesses that prioritize compliance should expect to receive inquiries from the DEA, FDA, and state regulators. When faced with a CBD-related investigation, being able to affirmatively demonstrate compliance is key, although companies also need to be careful not to share information with federal or state authorities unnecessarily.
In addition to assisting pharmacies and other businesses with CBD compliance and risk management, we also assist with investigation preparation and defense. Our lawyers and former agents have significant experience on both sides of state and federal law enforcement investigations, and we are intimately familiar with DEA, FDA and other agency procedures. As a result, not only can we provide defense representation during CBD-related investigations, but we can also assist with preparing documentation and proactive defense strategies before investigations occur.
Whether you are currently facing a CBD-related investigation or you are seeking to get out in front of any potential DEA, FDA, or state-level scrutiny, our federal lawyers and consultants can help you strategize, and we can help position your pharmacy or other business for a favorable result. Having handled well over 2,000 investigations as defense counsel and as federal agents and prosecutors, we are well-attuned to the challenges, risks, and opportunities that arise during law enforcement investigations.
FAQs: Maintaining a Compliant Pharmacy or CBD Business
When Do I Need to Start Thinking about CBD Compliance?
The ideal time to start thinking about CBD compliance is before your pharmacy or business starts stocking CBD products. Operating without a compliance program presents unnecessary risks, and it could very well lead to a DEA or FDA investigation.
How Can I Assess My Company’s Current CBD Compliance Efforts?
Prior to providing any recommendations, our lawyers and consultants will assess your company’s current CBD-related policies and procedures. Based on this assessment, we will provide custom-tailored recommendations focused on your company’s specific needs.
What Miscues are Likely to Trigger DEA and FDA Investigations?
There are many different types of miscues that can trigger DEA and FDA investigations. In addition to operating without a compliance program (which will usually be readily apparent), selling unapproved products, operating without the requisite licenses and registrations, and other common mistakes can all lead to federal scrutiny.
What are the Risks Associated with Non-Compliance Pertaining to CBD?
Non-compliance with pertinent laws and regulations can have consequences ranging from loss of registration or licensure to federal criminal prosecution. Many CBD products are still considered prohibited controlled substances at the federal level, and even state laws legalizing CBD place strict controls around what pharmacies and other businesses can and cannot sell.
Speak with a Federal Lawyer or Compliance Consultant at Oberheiden P.C.
If you would like more information about our firm’s CBD compliance, risk management, or investigation defense services, we encourage you to get in touch. To speak with one of our senior federal lawyers or former federal agents in confidence, please call 888-680-1745 or request a consultation online today.