As a pharmacist, facing a board of pharmacy investigation can be extremely risky. While losing your professional license might seem like the greatest risk, this isn’t necessarily the case. Increasingly, boards of pharmacy are working with pharmacy benefit managers (PBMs), state attorneys general, and the Drug Enforcement Administration (DEA) to conduct wide-ranging investigations; as a result, in addition to facing professional discipline, pharmacists can face both civil and criminal liability as well.
With this in mind, pharmacists must take a proactive and comprehensive approach to their defense when facing board of pharmacy investigations. Targeted pharmacists must quickly identify the allegations against them and then use the facts at hand to defend themselves by all means available. Pharmacists facing board scrutiny must also consider the possibility that they may be facing scrutiny from other entities, and they must ensure that the defenses they present to the board do not create exposure in other areas.
“Defending against a pharmacy board investigation is becoming an increasingly difficult—and increasingly risky—task. Targeted pharmacists need to work with experienced defense counsel who can help limit the scope of their investigations, evaluate all possible defense strategies, and help protect their careers to the fullest extent possible.” – Dr. Nick Oberheiden, Founding Attorney of Oberheiden P.C.
Responding Effectively to a Pharmacy Board Investigation
So, what does it take to survive a board of pharmacy investigation in 2025? Here are 12 keys to executing an effective defense:
1. Figure Out What Triggered the Board’s Investigation
A critical early step in defending against a board of pharmacy investigation is determining what triggered the inquiry. There are several possibilities, and different triggers can signal that different allegations are at issue. For example, if the pharmacy board is acting on information supplied by the DEA, this likely indicates that the investigation pertains to drug-related issues instead of billing issues or a patient’s allegations of pharmacy malpractice.
With that said, the board of pharmacy investigations can—and often do—target a wide range of violations. As a result, it is critical not to make any assumptions at this stage. Even if you think you know why the board might be investigating, you should not ignore the possibility that you may need to defend against different allegations.
2. Figure Out if the Board of Pharmacy is the Only Entity Investigating
In addition to determining the investigation’s trigger, it is also critical to determine whether the pharmacy board is the only entity investigating. If you are also facing scrutiny from the DEA, another federal agency, your PBM, or a private insurer, this can significantly alter the dynamics (and risks) of your situation. As noted above, pharmacy boards are increasingly collaborating with these other entities, and targeted pharmacists are increasingly facing civil liability and criminal prosecution in addition to professional disciplinary action.
3. Engage Defense Counsel to Intervene in the Investigation(s)
Once you learn you are facing scrutiny, you should immediately engage a pharmacy investigation lawyer. Your lawyer will be able to take the preliminary steps we just discussed and will be able to help you chart your steps while the board’s investigation is pending. If necessary, your legal counsel can intervene in any other investigations as well. Due to the unique factual and legal issues involved in pharmacy-related matters, it is critical to choose a lawyer with specific experience representing pharmacists.
4. Identify the Allegations At Issue in the Investigation(s)
Your pharmacy investigation attorney will also be able to identify the specific allegations that are at issue. Numerous possibilities and issues present different risks and require different defenses. Some examples of common issues in the board of pharmacy investigations include:
- Controlled Substances Ordering and Verification Issues (DSCSA Violations)
- Drug Inventory Discrepancies
- Electronic Prescription and Recordkeeping Violations
- Patient and Prescription Verification Issues
- Staffing Issues (i.e. Inadequate Staffing Ratios and Hiring Unlicensed Personnel)
- Inadequate Supervision
- Aiding and Abetting Unlicensed Practice
- Failure to Confirm Medical Necessity
- Inadequate Physical or Digital Security
- Patient Privacy Violations (HIPAA Violations)
- Patient, Prescriber, and Payor Complaints
- Failure to Disclose Required Information to the Board of Pharmacy
These can all be issues in investigations conducted by other state licensing boards as well. To identify the allegations you need to defend against, your pharmacy investigation attorney should intervene in the investigation(s) and directly communicate with the pharmacy board (and any other investigating entities). Your lawyer should also work with you to conduct an internal compliance assessment. This assessment, which will be protected under the attorney-client privilege, should be designed to uncover any and all issues that have the potential to trigger allegations. By analyzing the information gathered during this assessment in light of the circumstances at hand, your attorney should be able to determine both (i) what laws, rules, or regulations you are alleged to have violated and (ii) what defenses you have available.
5. Be Prepared to Affirmatively Demonstrate Compliance
In many cases, affirmatively demonstrating compliance can be both a highly effective and highly efficient defense strategy during a pharmacy board investigation. If your internal compliance assessment reveals that the investigation is misguided, then using the compliance documentation you have on hand to prove it could bring a swift end to the inquiry.
But, when relying on your compliance documentation during a board of pharmacy investigation, you must be certain that the documentation is adequate. If there are deficiencies in your pharmacy’s compliance program, or if your pharmacy’s inventory, billing, and patient records do not adequately confirm compliance, then attempting to rely on these records could do more harm than good. Your lawyer will be able to assist with conducting this analysis as well.
6. Be Prepared to Challenge Misguided Allegations and Faulty Assumptions
Frequently, pharmacy boards do not have the full story when they initiate an investigation. They can only act on the information they have, and frequently, this information is incomplete—if not inaccurate or misleading.
Given that this is the case, targeted pharmacists need to be prepared to challenge misguided allegations and faulty assumptions as part of their pharmacy board investigation defense. Pharmacists must not assume that the board’s allegations are valid or that the board’s information will dictate the outcome of the investigation. Instead, they must make informed decisions based on the advice of counsel, and they must be able to rely on their counsel to present a fair and accurate picture of the true facts at hand.
7. Proactively Address Any Identified Violations
If you are aware of any violations or learn of any violations when conducting a privileged internal compliance audit, you will need to address these violations proactively. But what this means will depend on the specific issues and circumstances involved.
For example, if a member of your pharmacy’s billing team was incorrectly billing Medicaid even though you had comprehensive billing policies and procedures, then acknowledging the issue and working with the pharmacy board (and CMS) to reach an amicable resolution might be the best approach. On the other hand, if you were knowingly dispensing opioids to patients without valid prescriptions, this is a different matter entirely. In this scenario, proactively addressing the violation might mean ceasing the prohibited practice and formulating a defense strategy focused on settlement or preventing the pharmacy board (and potentially the U.S. Department of Justice (DOJ)) from meeting its burden of proof.
8. Implement (or Establish) Internal Investigation Response Procedures
During the board of pharmacy investigations, targeted pharmacists must ensure that they (and their counsel) maintain control over all information and records in their possession. To do this, pharmacists should implement (or, if necessary, establish) internal investigation response procedures. This includes but is not limited to, procedures regarding record collection and disclosure and internal and external communications.
9. Be Concise and Do Not Speculate
When communicating with pharmacy board investigators, it is important to be concise and avoid speculation. Sharing more information than is necessary can be risky, and speculating as to what a drug supplier or pharmacy technician may have done (or why) isn’t beneficial for anyone. Instead, targeted pharmacists should focus on specifically answering the questions asked (assuming it is in their best interests to answer), and they should not hesitate to say, “I don’t know,” when this is the true answer.
In this regard, relying on the advice of experienced counsel can be extremely helpful. A lawyer who has experience representing pharmacists during board investigations should be able to help you understand what to say (and what not to say), what records you need to disclose, and how you should handle questions when either (i) you aren’t entirely sure of the answer, or (ii) answering the question truthfully could have adverse consequences.
10. Identify and Target a Specific Favorable Resolution
Part of executing an effective defense strategy during a board of pharmacy investigation is having a specific goal in mind. An experienced pharmacy investigation lawyer will be able to assist with evaluating your options, prioritizing these options, and then developing and executing a strategy focused on achieving a specific favorable result. Depending on the circumstances, a favorable result could range from terminating the investigation without further action to negotiating a settlement that protects your license and reputation.
11. Be Prepared for Circumstances to Change
While it is critical to have a strategy in place, it is equally important for pharmacists targeted in the board of pharmacy investigations to be prepared for circumstances to change. As new facts come to light and additional entities get involved, the investigation dynamics could shift drastically. Acknowledging that this is a possibility and having contingency plans will help ensure that unexpected events do not derail your defense. This is another area where conducting a comprehensive and unbiased internal compliance assessment can prove invaluable. If you are aware of all of the issues that have the potential to come to light during the board’s investigation (or during an ensuing state or federal investigation), you will be able to plan accordingly—even if you don’t need to defend against certain allegations immediately.
12. Identify and Preserve Issues for Appeal
Finally, as the outcome of a board of pharmacy investigation is inherently unpredictable, targeted pharmacists and their defense lawyers should identify and preserve issues for appeal throughout the process. If the circumstances are such that it is not possible to terminate the investigation without consequences or negotiate a favorable outcome, then appealing the board’s decision could prove critical for protecting your pharmacy license and your career.
First Steps When Facing a Pharmacy Board Investigation
With all of this in mind, if you are facing a pharmacy board investigation in 2025, what are your first steps? While the first step in building your defense strategy may be to figure out what triggered the board’s investigation, there are some steps you need to take before you get to this stage. If you are facing scrutiny from your board of pharmacy, you should:
- Preserve All Potentially Relevant Documentation – Destroying or deleting potentially relevant documentation will only raise additional questions. It can also lead to additional allegations (potentially additional penalties) for interfering with the board’s investigation. Even if you have concerns about the contents of the records you have on hand, the best course of action is to keep them and discuss their potential implications with your lawyer.
- Cease Any Violative (or Potentially Violative) Practices – If you think you may know why your pharmacy board is investigating, you should cease any practices that could be continuing to increase your exposure. With that said, as we discussed above, you should not make any assumptions; and, when in doubt, you should seek legal advice promptly.
- Engage a Pharmacy Investigation Defense Lawyer – Protecting your license, reputation, and career will require an informed, strategic, and proactive defense. This means you need an experienced lawyer on your side to prevent criminal convictions. The sooner you engage a lawyer to represent you, the sooner your lawyer can intervene in the investigation and build your defense.
