Health Rx Compliance

Holistic Controlled Substance Compliance Consulting

Holistic Controlled Substance Compliance Consulting

THE STAKES...

THE STAKES...

Can your controlled substance compliance consultant see the complete picture? The stakes have never been higher for those responsible for controlled substance compliance.

THE OPIOD CRISIS...

THE OPIOD CRISIS...

continues to worsen, claiming countless lives and ruining families and even entire communities.

SOCIETY...

SOCIETY...

is starting to push back…HARD

RECORD-SETTING JUDGEMENTS...

RECORD-SETTING JUDGEMENTS...

Recent record-setting legal judgments and settlements are likely just the start of what is to come. Some drug company executives are now facing criminal charges and the possibility of time in prison for their failed compliance programs.

ACCOUNTABILITY...

ACCOUNTABILITY...

Companies that manufacture, distribute, and administer these controlled substances are starting to be held strictly accountable for their diversion and misuse. It is more imperative than ever that these companies have a rigorous and impeccable compliance program in place that will have measures in place that satisfy governmental agencies (both regulatory and law enforcement) and that will survive the scrutiny of both judge and jury.

SUPPLY CHAIN COMPLIANCE...

SUPPLY CHAIN COMPLIANCE...

All parties in the controlled substance supply chain have a responsibility for compliance from the manufacturer to the pharmacist filling out the prescription.  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 give you advice that both complies with the law and works well for your company. 

You can’t afford not to do so. 

Health Rx Compliance is your best and safest choice. 

Why Us?

HEALTH RX COMPLIANCE ADVANTAGE

Unique Solutions

UNIQUE SOLUTIONS

Unlike other controlled substance compliance consultants, Health Rx Compliance provides compliance solutions and advice that match the realities of the three key areas of controlled substance compliance:

  • Governmental Regulatory and Enforcement Agencies
  • Hospital, Medical, Clinical, and Pharmacy Operations
  • Drug Manufacturer and Distributor Corporate Compliance
 

In addition, our principal has a Master of Science in Jurisprudence degree from Seton Hall University, so we have a more in-depth legal understanding than the typical controlled substance compliance consultant.

We can see the complete compliance picture.

And we can help you and your staff, sales team, and board members to see it too.

More importantly, we can help you to develop a compliance program that meets the needs, realities, drivers, and pressures that exist in your organization. 

Vast Experience

Vast Experience

We have extensive direct experience in each of the key controlled substance compliance areas.

  • Our principal has deep experience in law enforcement and with a government drug enforcement agency. We have years of experience investigating and enforcing controlled substance laws. We understand how government agencies think, how they conduct their regulatory duties, and what they look for when evaluating a company’s compliance program.
 
  • We have experience in practicing in a pharmacy as a licensed pharmacist, so we understand and appreciate how compliance policies and procedures can directly affect the efficiency of pharmacy and clinical operations. We know and understand how compliance policies and procedures will be received by staff. We can design workable processes and draft policies and procedures that meet compliance requirements without unnecessarily disrupting medical operations. 
 
  • We have experience developing and running an award winning and state-of-the-art corporate compliance program for a large drug distributor. We know how to develop such programs. We also understand the pressures and challenges that corporate compliance teams face every day. We know how to maintain effective controls against drug diversion, monitor for suspicious orders, and what a distributor must have in its “Know Your Customer” files.
 

Unique Value

Unique Value

How many other controlled substance consultants have that depth of experience in these three main areas of controlled substance compliance?

Zero other consultants.

And if your compliance consultant only has experience in one of the three key areas of controlled substance compliance, it is very likely that you will get advice that is one-dimensional.

For example, if your consultant is an investigator, chances are that consultant may only be able identify issues that revolve around criminal violations and overlook the importance of the controlled substance regulations. The recommendations that consultant gives might satisfy law enforcement, but might not work within the political climate of the corporate world.

You will likewise receive incomplete advice if your compliance consultant only has experience in medicine or only has experience within corporate compliance.

But we understand the pressures, incentives, concerns, and motives that exist in each sector of the compliance world.

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

About Us

Health Rx Compliance is headed by Kaushik Kotecha. It is Mr. Kotecha’s variety of experience in the controlled substance compliance space that makes Health Rx Compliance so different from other compliance consultants. Read more

Services

What We Can Do for You

Data-driven compliance

DATA-DRIVEN COMPLIANCE

Assist hospitals and long-term care facilities with dispensing and disposal protocols, staff hiring and background screening, and training in spotting potential diversion of controlled substances. 

Protocols, Hiring & Screening

Protocols, Hiring & Screening

Assist hospitals and long-term care facilities with dispensing and disposal protocols, staff hiring and background screening, and training in spotting potential diversion of controlled substances.

policies and procedures

POLICIES AND PROCEDURES

Assist hospitals, pharmacies, long term care facilities, and other providers in developing compliant policies and procedures, and provide staff training

Expert Analysis & Witnesses

EXPERT ANALYSIS & WITNESSES​

Review complex distribution data and provide expert analysis and expert witness services to attorneys.

Unique Needs

UNIQUE NEEDS​

We can also assist you with many other services to help you with your controlled substance compliance needs.

Executive Training

EXECUTIVE TRAINING​

Train executive teams, sales teams, and other staff on their compliance obligations under the Controlled Substance Act.

audits & pre-registration

AUDITS & PRE-REGISTRATION

Prepare organizations for controlled substance accountability audits, pre-registration review before registration with the Drug Enforcement Administration, or a Verified Accredited Wholesale Distributors (VAWD) inspection.

compliance due diligence

Compliance due diligence

Perform controlled substance compliance due diligence on behalf of entities looking to acquire an existing distributor, pharmacy, or other provider.

Investigations & Theft

Investigations & Theft

Conduct internal investigations and assist with controlled substance theft reports.

Assure compliance with the company’s CID

Assure compliance with the company’s CID

If you have received a CID, talk to us first before responding.

TAILORED SERVICES

TAILORED SERVICES​

Please contact us directly to discuss your particular situation.

Contact

Let's talk

About Us

Our History

Health Rx Compliance is headed by Kaushik Kotecha, an experienced veteran in the controlled substance compliance space that differentiates Health Rx Compliance from all other compliance consultants.

Mr. Kotecha started his career as a uniformed police officer. He attended the University of South Carolina and earned a degree in pharmacy. He has experience in a variety of areas of pharmacy practice including retail pharmacies and hospital pharmacies, including managing an oncology pharmacy within an oncology clinic.

He was hired by the South Carolina Department of Health and Environmental Control in its Bureau of Drug Control as a Piedmont Inspector. In that role, he ensured that registrants complied with South Carolina controlled substance laws and regulations. His regulatory duties included conducting routine inspections and both routine and investigative accountability audits. He also performed routine inspections and provided guidance to DHEC registrants. His enforcement duties included investigating for criminal violations such as forged prescriptions, employee thefts, unlawful distribution by both doctors and other individuals, and executing search and arrest warrants.

In 1999, he was promoted to Piedmont Director in which he continued to supervise inspectors and oversee major investigations.

During his tenure at the Bureau of Drug Control, he participated in several training sessions, the most notable being:

  • South Carolina Criminal Justice Academy
  • Drug Enforcement Basic Training
  • Advance Video and Surveillance Training for law enforcement
  • Reed Interview and interrogation training (Basic to Advanced)
  • IC3, Internet Crime Complaint Center training for law enforcement
  • Computer fraud training (sponsored by the United States Secret Service)


Mr. Kotecha has also been qualified as an expert witness on controlled substance compliance matters in state court.

In 2012, he retired from the Bureau of Drug Control and became a Compliance Director with Smith Drug Company. During his tenure at Smith Drug, he established a state-of-the-art compliance department. Smith’s compliance department has received many accolades from various regulatory agencies. He established data driven processes to identify risks and educate both the in-house staff and customer pharmacists regarding their obligation under the Controlled Substances Act.

Mr. Kotecha was promoted to Sr. Vice President at Smith Drug and retired as the Chief Corporate Chief Compliance Officer, reporting directly to the CEO.

In addition, Mr. Kotecha has also received graduate degrees from Seton Hall in the areas of jurisprudence, pharmaceuticals & medical devices, and hospital and patient care.

Please fill out the contact form on the main page of this website so Mr. Kotecha’s Health Rx Compliance can help you develop a compliance program that meets your company’s unique needs.