Pharmacies play a vital role in healthcare by providing essential medication to patients. However, because they deal with controlled substances, pharmacies are also subject to frequent inspections by the Drug Enforcement Administration (DEA) and state boards of pharmacy to ensure compliance with laws and regulations. These inspections can be stressful and time-consuming, but they are necessary to maintain a safe and legal pharmacy operation. The Safe Harbor Group team — which has prevented over $550 million in government overpayments, fines, and forfeitures — can help pharmacies prepare for DEA audits and inspections.
DEA Inspections: What to Expect
DEA inspections are typically unannounced and can occur at any time during regular business hours. The DEA agent will present a notice of inspection that includes the purpose of the inspection and the area of the pharmacy to be inspected. The agent will then conduct a comprehensive review of the pharmacy’s controlled substance records, policies, and procedures. The agent will also evaluate the pharmacy’s compliance with state and federal laws, including the proper storage, handling, and dispensing of controlled substances.
State Board of Pharmacy Inspections
In addition to DEA inspections, pharmacies are also subject to inspections by state boards of pharmacy. These inspections are conducted to ensure that the pharmacy is operating in compliance with state pharmacy laws and regulations. The state board inspector will review the pharmacy’s policies and procedures, controlled substance records, and medication storage practices. The state board inspector will also evaluate the pharmacy’s compliance with state and federal laws, including proper handling and dispensing of medication.
Safe Harbor Group Can Help You Prepare for Inspections
Pharmacies must be prepared for inspections to avoid penalties for noncompliance. Penalties for noncompliance can include suspension or revocation of the pharmacy’s license, fines, and even criminal charges. Additionally, improper storage of controlled substances or loss of controlled substances can result in significant penalties.
The Safe Harbor Group team includes a former DEA diversion investigator and a former board of medicine inspector, both of whom can conduct a front-to-back inspection of the pharmacy. Our investigators can evaluate the pharmacy’s policies and procedures, controlled substance records, medication storage practices, and compliance with state and federal laws. Our team can also identify potential issues and guide the remedying of any deficiencies before the DEA or state board inspector arrives.
Why Consult Safe Harbor Group for Pharmacy Audits and Inspections in Detroit?
Working with Safe Harbor Group gives pharmacies access to professionals who understand the pressure of strict oversight. Their team brings deep knowledge of compliance audits, fraud prevention, and risk management, helping organizations navigate regulatory challenges with clarity and confidence. Led by Ronald W. Chapman II — whose nationally recognized record in high-stakes healthcare fraud cases has safeguarded providers from hundreds of millions in potential losses — SHG offers guidance backed by proven results. With this level of insight and support, pharmacies can manage audits more efficiently, address risks proactively, and maintain compliance with far greater peace of mind.
Speak With an Expert Today
Pharmacy inspections can be stressful, but they are necessary to ensure compliance with laws and regulations. Safe Harbor Group helps pharmacies prepare for DEA audits and inspections by conducting a comprehensive front-to-back inspection and providing guidance to help them avoid penalties for noncompliance.
To ensure that your pharmacy is ready for a DEA or state board of pharmacy inspection, contact Safe Harbor Group today!
