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The Controlled Substances Act and it's Implications for Community Pharmacies

Maintaining records for Controlled Substance Act compliance is an important part of running a successful pharmacy. Failure to ensure practices are compliant with the Control Substance Act’s requirements can result in legal and financial penalties.


What Is the Controlled Substance Act?

The Control Substance Act sets the regulations for the handling, storage, and distribution of controlled substances that pass-through pharmacy. Enforced by the Drug Enforcement Administration (DEA), these regulations include transfer and disposal, security related to theft or loss, record keeping, inventory management, prescription validity, ordering, and dispensing requirements.


What Are Schedule 2 Drugs?

Schedule 2 substances, also known as C2 drugs, are those drugs that require additional care because of the increased potential for patients to be harmed by or abuse the drug. Because of that added risk, C2 drugs have more stringent regulations, procedures, and laws surrounding them. It is best practice, however, to treat all controlled substances with the same care.


Record Keeping: A Common Control Substance Act Compliance Oversight in Pharmacies

Pharmacies are responsible for maintaining accurate records when it comes to controlled substances. Unfortunately, record-keeping violations are not uncommon. Whether it’s due to negligence or a lack of proper training, many pharmacies find themselves facing legal action as a result of failing to comply with the Controlled Substances Act record-keeping requirements.


As we know, Control Substance Act regulations require that pharmacies keep detailed records of every controlled substance transaction. These include inventory tracking, dispensing, and destruction of these substances. While the importance of maintaining these records cannot be overstated, below are some reasons why pharmacies fall short in their efforts to comply with Control substance act record-keeping requirements.


Changing Regulations

One reason may be the complexity of the regulations. Control Substance Act record-keeping requirements are detailed and can be difficult to understand, especially for those who are new to the industry. Furthermore, these requirements are subject to change over time and vary by state, making it difficult for pharmacies to keep up with the latest guidelines.




Inadequate Training

Another contributing factor to record-keeping violations may be a lack of proper training. Pharmacy owners and staff who are responsible for maintaining these records, may not have received adequate training on the specific requirements and protocols for doing so. In some cases, training is only implemented following an audit as part of a corrective action plan.


Staffing & Workflow Challenges

Many pharmacies are short-staffed, forcing them to prioritize patient care over administrative duties. Most have workflows that aren’t streamlined to handle both patient care and administrative requirements because their systems aren’t integrated.


Regardless of the cause, record-keeping violations can have serious consequences for pharmacies. In addition to the legal ramifications, pharmacies can suffer damage to their reputation and loss of business. Pharmacies must identify efficiencies in their workflows or incorporate compliance tools to improve. Additionally, they must ensure staff are properly trained and aware of the proper protocol for handling-controlled substances. Any discrepancies in records must be addressed immediately, and corrective measures must be taken to ensure compliance.


two pharmacists check records

Current Practices and their Limitations – Paper Logbooks and Excel Documents

Current practices for maintaining records of controlled substances include handwritten logs or digital systems like Excel documents or Google Sheets.


Handwritten logs have been a traditional method of record-keeping for many years. These logs are typically kept in notebooks or 3-ringed binders, and entries are made by hand. Although this method can be reliable and straightforward, it has limitations. For example, it can be time-consuming to update and difficult to track changes and revisions. Handwritten logs may also be difficult to read, and the records can be easily forged.


Additionally, keeping paper records for the federal minimum-required two years often results in the papers falling out of the binders or tearing up in certain areas. Lastly, the binders take up limited counter space in pharmacies.


Excel and Google Sheets also have their share of limitations. Records can be easily changed, increasing diversion risk and compromising data integrity. New sheets need to be created every time a new drug is purchased, which can lead to additional confusion. Neither Excel nor Google Sheets utilizes safety features like barcode scanners. And both are standalone systems that lack the data-sharing capabilities today’s workers crave.


Control Substance Act Compliant Records: Best Practices

To ensure your pharmacy is compliant with Control Substance Act record-keeping requirements, it’s important to establish best practices. Remember redundancy is everything when it comes to record keeping. Here are some tips to help you.


1. Keep All Records for a minimum of Two Years

This is a federal standard requirement under the Control Substance Act. Be sure to keep all records, including prescription orders, inventories, and dispensing records, for at least two years. Some states require longer periods.


2. Keep Accurate and Complete Records

Your records must be complete and accurate, allowing you to tell a full and complete story of your inventory activities. Document all relevant information in a neat and easily retrievable format that cannot be easily forged.


3. Segregate Records

Keep your Schedule 2 controlled substance records separate from other prescription records to make sure they are easily accessible in case of a regulatory audit.


4. Train Staff

Ensure all staff members understand the importance of accurate record-keeping and their role in maintaining compliant Control Substance Act records.


5. Review Records Regularly

It’s important to review your records regularly to ensure accuracy and completeness and make any necessary updates or corrections.


6. Use Integrated Solutions

Replace stand-alone solutions with solutions that integrate with your wholesalers and pharmacy management systems. This improves efficiency and reduces the risk of errors in records.


TabulaRx’s Controlled Substances Inventory Management and Compliance Solution

Given the limitations of hand-written and other electronic C2-log systems, it’s clear that pharmacies need a more reliable and affordable solution for staying compliant with Control Substance Act record-keeping requirements. One such solution is TabulaRx.


TabulaRx is a fully integrated Control Substance Act compliance and Inventory Management solution helping pharmacies avoid civil penalties for violating the Control Substance Act. Pharmacies can use it to track their controlled substances inventory activity and reduce the risk of errors and diversion. TabulaRx offers an easy path for pharmacies to follow the aforementioned best practices for recordkeeping.


Keep your controlled substances records organized and up-to-date to keep your pharmacy running smoothly. Contact us to learn more about how we can help you avoid fines while reclaiming compliance and reduce sales reduce activities.

We hope this audio provided every pharmacist an overview of the law.





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