HealthRx Compliance Inc offers controlled substance compliance services to DEA Registrants.  The Registrants include independent pharmacies, LTCF, drug distributors, drug manufacturers, and other Registrants.  Our team has a combined experience of over 50 years.  

Kaushik Kotecha is a pharmacist who practiced in hospital, retail, and oncology pharmacist manager.   He then went to work for the South Carolina Department of Health and Environment Control (SCDHEC) in 1993.  He started his career with SCDHEC as an inspector and then was promoted to Piedmont District Director.   During his time at SCDHEC, Kaushik worked on complex criminal cases involving the violation of the SC Code of Laws and SC Controlled Substance Regulations.  Kaushik is familiar with performing criminal investigations and administrative actions taken by the State.  After he retired from SCDHEC, Kaushik went to work for Smith Drug Company (wholesale drug distributor) as Director of Controlled Substance Director.  He retired from J M Smith Corporation as a Chief Compliance Officer.  He started Health Rx Compliance to assist DEA Registrants in compliance with the controlled substance rules and regulations.  Kaushik is a licensed pharmacist, and he obtained his Master of Jurisprudence (MSJ) from Seton Hall.  Kaushik’s MSJ is in Pharmaceutical & Medical Devices and Hospital & Patients Care.  

Debra K. Black began her career with the Drug Enforcement Administration (DEA) as a Diversion Investigator (D/I).  She is familiar with the United States Code of Federal Regulations (CFR).  Debra has been involved in many federal investigations and involved with various administrative actions taken by the DEA.   Debra comes to us with a wealth of knowledge regarding the CFR.  

Together Debra and Kaushik together have over 50 years of experience regarding the rules and regulations related to the controlled substances.  

SERVICES HEALTHRX COMPLIANCE PROVIDES 

Pharmacy (Retail, LTCF or Specialty) 

  • Establishing controlled substance Policy and Procedures specific to the client’s practice
  • Pre-registration Inspection 
  • Quarterly or annual Inspection 
  • Conduct controlled substance accountability audits
  • Review security procedures
  • Review pharmacy’s dispensing data to evaluate the risks (identify high risk prescribers)
  • Review client’s controlled substance records to ensure the records are properly documented and filed. 

NARCOTIC DRUG TREATMENT PROGRAM (NDTP)

  • Evaluate NDTP’s policy, and procedures
  • Conduct accountability audits
  • Review security procedures 

Drug Distribution (Wholesalers) 

  • Evaluate and make recommendations of the controlled substance distributors policy and procedures. 
  • Review customers’ due diligence files
  • Review or assist with establishing a Suspicious Order Monitoring (SOM) system and adequately document the flagged order’s follow-up investigation. 
  • Test the vault and the cage’s alarm systems. 
  • Conduct a controlled substance accountability audit
  • Ensure that the distributor is complying with the DEA’s rules and regulations. 
  • Review customers’ data to evaluate high-risk customers
  • Ensure that all the controlled substance records are complete and in proper order. 
  • Conduct on-site visit of high-risk customers

Manufacturers 

  • Evaluate and make a recommendation 
  • Review and conduct accountability audit of the manufacturing facility
  • Conduct on-site visits of the customer and/or downstream customers 
  • Assist with the company’s SOM program
  • Ensure proper documentation 
  • Assist with import and export policy and procedures 

Additional Services

  • Conduct internal investigation involving controlled substance violations
  • Review Registrant’s governmental agreements to ensure compliance