Pharmacy Audits and Inspections

Pharmacies play a vital role in healthcare by providing essential medication to patients. However, pharmacies are 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. Safe Harbor Group 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, which includes the purpose of the inspection and the area of the pharmacy that will 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, who 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 provide guidance on how to remedy any deficiencies before the DEA or state board inspector arrives.

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 of the pharmacy and providing valuable guidance to help pharmacies 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!

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