The Controlled Substances Act (CSA) is a federal law in the United States that regulates the manufacture, import, possession, use, and distribution of certain substances. It also creates a unified legal framework to regulate certain drugs that are deemed to pose a risk of abuse and dependence.
Pharmacies are critical in ensuring that these controlled substances are dispensed appropriately and in accordance with the law. Non-compliance with CSA regulations can significantly impact pharmacies, ranging from loss of licenses to potential closure of the business. Read on to learn more.
Consequences of CSA Non-Compliance on Pharmacies
Loss of Licenses
The Drug Enforcement Administration (DEA) has the authority to revoke a pharmacy’s DEA registration if it determines that the pharmacy has committed violations demonstrating a lack of control over its controlled substance inventory. Losing a pharmacy DEA license can have severe consequences for the pharmacy, including loss of revenue, reputation, and the potential closure of the business.
In today’s age of social media and instant news, word of a pharmacy’s non-compliance can quickly spread, damaging the pharmacy’s reputation. The negative publicity can lead to a loss of customers, decreased revenue, and potential legal action.
Firing/Hiring New Staff
Pharmacies found to be non-compliant with CSA regulations may need to fire current staff and hire new staff to comply with the rules. This can be a costly and time-consuming process, as new staff members will need to be trained and licensed to handle controlled substances. In addition, the loss of experienced staff can lead to decreased productivity and potential errors in dispensing medications.
Implementation of a Corrective Action Plan
Pharmacies may need to implement a corrective action plan if found to be CSA non-compliant. The plan outlines the steps the pharmacy will take to address the violations and prevent future non-compliance. It can include additional staff training, policy and procedure changes, and increased monitoring of controlled substance inventories. Implementing a corrective action plan can be costly and time-consuming, and failure to comply with the plan can lead to further sanctions.
Legal fees can include the cost of hiring an attorney to represent your pharmacy and any fines or penalties due to the non-compliance. It can be a significant burden for pharmacies, particularly small independent pharmacies.
The DEA decides the fine amount depending on the severity of the violation and the history of the pharmacy. Fines can go up to hundreds of thousands of dollars, posing a burden for independent pharmacies.
Pharmacy Business Bottom Line Impact
The costs associated with fines, legal fees, and corrective action plans can add up quickly and hurt the pharmacy’s revenue. In addition, negative publicity and the resulting loss of customers can further impact the pharmacy’s revenue. The impact on the bottom line can be particularly severe for small independent pharmacies, which may not have the financial resources to absorb the costs of non-compliance.
Potential Closure and Elimination of Access to Drugs for the Community
The DEA’s revocation of a pharmacy’s registration could have significant consequences for the community, particularly in areas with limited access to medication options. The closure of a pharmacy could result in residents being unable to obtain essential medications and receive counseling, which could lead to health complications and reduced quality of life.
Letter of Admonishment
Sometimes, after the DEA audit, the errors identified might not be severe enough to revoke registration or take legal action. In such cases, the DEA may issue a Letter of Admonishment to highlight the areas that require attention and place the DEA registrant on probation.
If a pharmacy or pharmacist receives this letter, the DEA will probably conduct a follow-up inspection within one or two years. If a future inspection reveals that your pharmacy’s compliance program has not improved or that there are more errors, the DEA is likely to revoke your pharmacy’s registration.
Referral for Civil Investigation
In rare cases, the investigators from the DEA may refer your pharmacy to the U.S. Department of Justice (DOJ) for civil prosecution. This action can only be taken if the investigators determine that your pharmacy does not pose a threat to public safety but still requires significant enforcement action. If the DEA refers a case for civil prosecution, pharmacies may face substantial financial liability in civil enforcement cases, as each compliance deficiency may be considered a separate violation.
How to Avoid These Outcomes If the DEA is Auditing Your Pharmacy?
To avoid negative outcomes during a DEA audit of your pharmacy, it is important to have a thorough understanding of the DEA’s regulations and requirements for controlled substances. Here are some steps you can take to minimize the risk of negative outcomes:
Establish a Compliance Culture
Ensure all employees know the DEA regulations and the importance of complying with them. Provide regular training to ensure that everyone is up to date on the latest rules and procedures.
Maintain Accurate Records
Keep detailed records of all controlled substance transactions, including dispensing and inventory records. Ensure that records are up to date, stored securely, and easily accessed.
Monitor Your Inventory
Keep a close eye on your inventory and ensure it matches your records. Conduct regular audits to identify any discrepancies or potential issues.
Respond Promptly to Any DEA Inquiries:
If the DEA contacts you for information or to schedule an audit, be prepared to provide any information or documents requested.
Consult with Legal Counsel
Consider consulting with legal counsel if you have concerns about your compliance program or receive a letter of admonishment or other negative outcomes from the DEA.
Pharmacies must take steps to ensure compliance with CSA regulations to avoid the negative consequences that can result from non-compliance.
Using C2 Keep’s efficient compliance platform is one of the most effective ways to easily track your pharmacy’s controlled substance activities. It helps organize your controlled substance records, statements, activities, and insights all in one place and ensures you are more CSA-compliant and audit prepared.
Schedule a demo today and take a step closer to experiencing the peace of mind you deserve.