Be Prepared: The Value of a Mock Inspection by Ret. New Jersey Board of Pharmacy Investigator Charles Harris

The State Board of Pharmacy has the legal authority to conduct inspections of pharmacies, with or without prior notice. Without preparation, unannounced inspections by the Board of Pharmacy can disrupt business operations, and in some instances, expose compliance deficiencies that come with increasingly high monetary fines and other penalties. Satish V. Poondi, Esq., partner, registered pharmacist, and co-chair of the firm’s Health Law and Pharmacy Law Practice Group, says, “Preparing for an inspection is critical. Pharmacists should not only have all policies and procedures up to date, but should also be sure they and their teams are meeting all standards of operation and practice.”

Earlier this year, Poondi welcomed Charles Harris to the firm, noting that his 29-year role with the State of New Jersey Department of Law and Public Safety included researching and preparing Reports of Investigation, testifying before Licensing Boards and Superior court, and checking for compliance with New Jersey Laws, Rules and Regulations for the Division of Consumer Affairs Professional Licensing Boards.

Poondi and Harris recommend that pharmacies prepare for inspections through a Mock Inspection process, led by Harris, whose experience includes conducting statewide inspections and investigations of all pharmacies, including compounding pharmacies on behalf of the New Jersey Board of Pharmacy, as well as facilities ranging from offices of doctors, dentists and other health care professionals.

Harris points out that inspections by the Board of Pharmacy can reveal any number of deficiencies, many of which have historically resulted in significant fines, such as:

• Outdated, misbranded, improperly stored, over-filled and return to stock (RTS) medication found in the active drug stock inventory: $25-$50 per container
• Failure to monitor the pharmacy’s refrigerator, freezer and permitted area temperature: $10,000
• Failure to develop and maintain policies and procedures for the monitoring and control of the pharmacy’s temperature: $5,000
• Failure to ensure proper security of the pharmacy: $10,000
• Failure to properly secure the pharmacy’s dispensing area with a registered pharmacist on duty at all times that the pharmacy is opened for operation: $10,000
• Non-compliance with the standards and practices with UPS 800: $10,000
• Failure to notify the Board of Pharmacy of any temperature excursions of twenty-four (24) hours: $5,000
• Failure to conduct the required biennial CDS inventory: $1,000
• Failure to notify the Board of Pharmacy of the ‘Change of RPIC’: $1,000
• Failure to a current reference for the General Practice of Pharmacy: $200
• Failure to provide immediate supervision to pharmacy technicians: $500

Poondi adds, “I have known Charles for many years, and have respected his diligence, professionalism, and thorough inspection reports. His mock inspection process is comprehensive and provides independent pharmacies, pharmacists, pharmacy technicians, retail chains, wholesalers, hospitals, and compounding pharmacies with peace of mind. His knowledge of compliance with state statutes and regulations is an advantage to pharmacies who want to stay ahead of unannounced inspections.”

Please contact Satish V. Poondi for more information.
spoondi@tisslaw.com
973-533-1000