Pharmacy/DEA Inspections

Owning or supervising a pharmacy requires meticulous detail to everything. When you are facing an investigation or are subject disciplinary action for alleged violations related to a pharmacy inspection, you need attorneys who are just as diligent as you are.

We at Chapman Law Group assist pharmacy owners and supervising pharmacists (i.e., consulting pharmacists, pharmacists in charge and prescription department managers) who are under investigation. Our entire legal team is dedicated to defending licensed professionals like you, and we work regularly with DOH, LARA, BOP and DEA to resolve licensure matters.

Pharmacy Compliance Audit

The practice of pharmacy is highly regulated by a vast body of state and federal laws and regulations that are ever growing and changing. Pharmacy owners and managers are expected to stay compliant with these laws and regulations, and they are subject to routine compliance inspections. Failure to comply can result in discipline — including revocation of permits and/or DEA registrations — and even criminal charges.

That’s why it is important for pharmacy owners and managers to take proactive steps. Our seasoned team of compliance and health care defense attorneys will work with you to ensure compliance before your pharmacy is subject to a state or DEA pharmacy inspection. 

Board of Pharmacy Inspections

The Board of Pharmacy can inspect a pharmacy for several reasons. These include inspections prior to permitting/licensing; inspections after receipt of an application for change of location or change of ownership; routine inspections to ensure compliance; and enforcement inspections.

Licensing/permitting inspections and routine pharmacy inspections focus on compliance with state statutes and regulations. The main areas of inspection include:

• • Proper supervision of pharmacy staff
  • Security and storage of pharmacy area, medications and records
  • Appropriate work space, including the size of an area, access to sinks and temperature of the refrigeration system
  • Sterile and hygiene practices (for compounding pharmacies)
  • Proper labeling of dispensed medications
  • Removal of expired medications from shelves
  • Date of filling and initials of dispensing pharmacist on original prescriptions
  • Pharmacist offering to counsel patients with new or refill prescriptions
  • Unit dose records
  • Proper destruction of medications, especially controlled substances
  • Records, including prescription, patient, controlled substances and logbook records
  • Proper permits and DEA registration
  • DEA Form 222 records (complete and incomplete forms)
  • Invoices and receipts for controlled substances
  • Copies of required inventory — Florida requires a biennial inventory of controlled substances, while Michigan requires an annual inventory of controlled substances. Both states require a complete inventory of controlled substances on the day of transfer/change of ownership.
  • Policy and procedures manual — Florida specifically looks for policies and procedures to minimize dispensing of a controlled substance based on fraud or invalid physician-patient relationship; description of a continuous quality improvement program; and evidence that pharmacy technicians have reviewed the manual. Michigan specifically looks for theft and diversion policies.

Our pharmacy law attorneys assist pharmacy owners and managers prior to inspections to ensure compliance; during inspections to answer the inspector’s questions; and after inspections to address any deficiencies and defend administrative actions.

Disciplinary Action for Deficiencies

If the investigator finds deficiencies during the pharmacy inspection, they will issue an investigative report that outlines the alleged violations. The report is forwarded to the Department’s attorney for possible disciplinary action. Disciplinary action is usually initiated by an administrative complaint; however, the Department may issue an emergency suspension of a pharmacy’s license if they believe the conduct jeopardizes the health, safety or welfare of the public.

Possible sanctions for deficiencies include:

• • • Suspension
    • Revocation
    • Correct deficiencies
    • Fines
    • Reimbursement of prosecution costs
    • Sister state action
    • Report to NPDB
    • Probation/monitoring (requiring additional inspections)
    • Require additional continuing education

Authorization for State Inspection

In Florida, the Department can conduct routine compliance and investigative inspections. Applicants for pharmacy permits consent to inspections prior to issuance of a permit. Obstruction during these pharmacy inspections are grounds for discipline.

In Michigan, the Board cannot conduct a pharmacy inspection without consent or an administrative search warrant. If the Board of Pharmacy asks for your consent to inspect, we advise that you contact our attorneys immediately to determine whether consent should be given. Only in emergency circumstances can the Board of Pharmacy inspect without consent or a warrant. Similar to Florida, applicants for pharmacy permits are subject to permitting inspections prior to issuance of a permit.

State Enforcement Investigation

While most pharmacy inspections are routine compliance inspections, some aim to investigate things such as patient complaints, suspected diversion and fraud. Inspections led by complaints and suspected violations can quickly result in disciplinary action. Therefore, we strongly advise you to contact our attorneys immediately if you believe you are under investigation or subject to a pharmacy inspection.

Enforcement investigations can be difficult to distinguish from a routine inspection. Key things to look for are the presence of law enforcement, including DEA and OIG, together with state investigators (BOP/DOH); an administrative warrant authorizing the seizure of property; and investigators seeking to take statements from staff.

Our attorneys can help to:

• ensure the investigators/law enforcement do not exceed the scope of their warrant or investigative authority set by statute;
• determine if/when to withdraw consent to search;
• ensure pharmacy owners, managers and staff do not make incriminating statements; and
• respond to the investigator’s questions.

Most importantly, if arrests are made, we can make sure your rights are protected and that you do not provide information that may be harmful later.

DEA Inspections

Similar to state inspections, the DEA conducts pharmacy inspections for various reasons, including investigation of a complaint and random inspections to ensure compliance. Compliance-driven pharmacy inspections generally target such matters as:

• • Records (prescription and dispensing records and logbooks)
  • DEA registration certificates for that particular location
  • Purchase records for controlled substances
  • Transfer records for controlled substances
  • DEA Form 222
  • Theft reports
  • Security of controlled substances
  • Inventory

The DEA has the authority to bring criminal charges if they discover diversion or other serious violations during a “routine” inspection. Just as with state enforcement agencies, it’s crucial that you contact our attorneys immediately should the DEA arrive to inspect your pharmacy.

The DEA must have consent or an administrative search warrant to inspect a pharmacy. Our lawyers can help you determine whether to give consent; provide onsite representation to answer the investigator’s questions; be sure that pharmacy staff do not make incriminating statements to investigators; and monitor the situation so that the DEA does not exceed the scope of the search authorized by statute or a search warrant.