Health RX Compliance has 40+ years of experience to help build and manage your compliance program

The Risk

The stakes have never been higher for those responsible for controlled substance compliance as the opioid crisis continues to worsen.

Recent record-setting legal judgments and settlements are likely just the start of what is to come. Drug companies and their executives are now facing fines, civil suits, and criminal charges with the possibility of time in prison.

Supply Chain Accountability

All parties, from the manufacturer to the pharmacist filling the prescription, are responsible for ensuring that controlled substances are for legitimate medical use. If you are responsible for a controlled substance compliance program, you need to be sure you are working with someone who can see the complete compliance picture and provide guidance to ensure the company is in compliance with both the rules and regulations. You can’t afford not to do so.

Why Choose Us

Unique Solutions

Unlike other controlled substance compliance consultants, Health Rx Compliance provides compliance solutions and advice that works in conjunction with our client’s practice.

Some of the clients include:

Hospital, Medical, Clinical, and Pharmacy Operations
Drug Manufacturer and Distributor Corporate Compliance
Retail and chain pharmacies

We can help you develop a data driven compliance program that meets the needs, realities, drivers, and pressures that exist in your organization.

Vast Experience

Our team has 40 years of combined experience in law enforcement and with government drug enforcement agencies. Our experience as both investigators and regulators gives us a unique perspective to help our clients with their compliance programs.
We have experience developing and running corporate compliance programs for drug manufacturers and distributors. We also understand the pressures and challenges that corporate compliance teams face every day. We know how to effectively maintain controlled substance records, monitor for suspicious orders, and prevent diversion.

Health Rx Compliance is able to offer controlled substance compliance solutions that are legally compliant, realistic, and that seamlessly integrate within your entity’s operations.

Meet The Team

Our team has experience on both sides of the pharmaceutical industry with over 40 years of combined experience. We provide data driven compliance programs with proven results to ensure our clients are in compliance with DEA and other state regulatory agencies. We offer various training opportunities for industry leaders and partners involved in the distribution chain.

President

Kaushik Kotecha, RPH, MSJ

Kaushik Kotecha is the President of HealthRx Compliance. Prior to establishing HealthRx, he was the Chief Compliance Officer for J M Smith Corporation. After retiring from J M Smith in 2019, he wanted to continue helping DEA registrants with their compliance, which led to the creation of HealthRx. The fundamental goal of HealthRx Compliance is to assist clients with the implementation and improvement of their compliance programs. With almost 30 years of experience in the field, Kaushik is able to use his expertise for the benefit of DEA registrants.

His vast knowledge of compliance led him to create a Suspicious Order Monitoring (SOM) program, which helps enhance clients due diligence and identifies orders that need to be reviewed or reported. Kaushik also provides continuing education for pharmacists and technicians to help them identify orders that have a potential risk of diversion.

Kaushik earned his pharmacy degree from the University of South Carolina, and later worked for SC Department of Health and Environmental Control (DHEC) in the Bureau of Drug Control (BDC) division. He was promoted to Piedmont District Director and retired from DHEC in 2012 and then began working for J M Smith. Over the years he has served as an expert witness in court cases for compliance.

During his time with J M Smith, Kaushik chaired their compliance committee and was able to effectively implement a data driven compliance program with protocols for receiving, storage, and distribution of controlled substances.

Through his years of experience, Kaushik has gained invaluable knowledge of controlled substance compliance. He continues to use his experience to guide HealthRx clients through best practices for DEA compliance.

Healthcare Compliance

Debbie K. Black

Debbie joined HealthRx Compliance in 2021 and assists DEA registrants with reviewing their compliance programs, which includes both record keeping and Suspicious Order Monitoring (SOM) programs. Debbie works closely with various DEA registrants to identify and correct potential violations, and effectively prevents the loss of millions of dollars in penalties for HealthRx Compliance clients.

Before joining the HealthRx Compliance team, Debbie worked as a DEA Group Supervisor (G/S) for the Columbia, South Carolina office. She joined DEA in 1999 as a Diversion Investigator (D/I) and was later promoted to a supervisor. While working as D/I, she ensured DEA registrants complied with Title 21 United States Code (USC) and the Code of Federal Regulations (CFR). She conducted administrative reviews and investigated manufacturers, distributors, researchers, importers/exporters, and narcotic drug treatment facilities. During her tenure at DEA, she worked closely with various stakeholders to prevent drug diversion. Her years of hands-on experience make her a great consultant for controlled substance compliance. Debbie retired from DEA in 2020 as a Group Supervisor before joining Kaushik in 2021 to continue her work in the pharmaceutical industry.

Services

Continuing Education

Audits & Preregistration

Policies & Procedures

Investigation

Expert Analysis:

Analysis of distribution data to identify potential risks
Prepare questionnaire forms for various types of practices to analyze the downstream
Use the acquired information to justify distribution of controlled substances
Train compliance staff on how to review and properly document due diligence
Create a best practice list to ensure all information is reviewed
Properly record and maintain customers’ due diligence files

Suspicious Order Monitoring (SOM):

Assist our clients in establishing data-driven SOM systems
Establish or enhance clients’ suspicious order monitoring system
Review the existing SOM system to ensure it meets the current standards
Provide guidance based on guidance provided by the regulatory agencies and court rulings

Education/Train:

Train compliance team to conduct mock accountability audit and/or inspection
Conduct internal inspections
Creating P&P for daily, weekly, monthly, and annual controlled substance inventories
Train compliance to review the customers' customers, as articulated in DEA’s guidance letters
Completing various DEA forms (DEA 106 & 41)
Establish checks and balances to ensure controlled substance records meet the CFR and U.S.A requirements
Provide training for the clients’; leadership about the company’s corresponding responsibility

Suspicious Order Review:

Review distributors and manufacturers daily flagged controlled substance orders and adjudicated the orders (release or report)
Report or prepare reports for our clients to electronically report suspicious orders to DEA (SORS)
Guide our clients during and after administrative inspections or audits conducted by the government’s regulatory agency

Due Diligence:

Prepare on-site review form for documentation
Review and document due diligence
Perform on-site visits on our client’s behalf

Other Services:

Perform accountability audits and conduct inspections for Narcotic Treatment Program (NTP), retail and hospital pharmacies, surgery centers, and other facilities that dispense or distribute controlled substances.

Call us or email us if your company requires other controlled substances-related expert analysis.