Legal Matters
Successful DEA Inspections Require Knowing Your Compliance Obligations By Jake Kathleen Marcus, JD, PGDip
O
f concern to most dentists is the possibility of an inspection by the Drug Enforcement Administration (DEA). The DEA regulates the prescribing, distribution and administration of controlled substances, including those used in dental practices, and has the authority to conduct inspections of dental offices to ensure compliance with controlled substances regulations. Inspections may be routine or prompted by reports of irregularities, which may be made by any member of the public.
• Theft and loss reporting: Inspectors will check records to confirm that any thefts or significant losses of controlled substances have been promptly reported using DEA Form 106. • Destruction of controlled substances: Inspectors will review records and procedures for the destruction of controlled substances to ensure they comply with DEA guidelines.
DEA Inspections
• Maintenance of accurate records: Ensure all records of controlled substances — including purchase orders, prescriptions and inventories — are complete, accurate and readily accessible. • Secure storage: Verify that all controlled substances are stored in a secure, locked location that meets DEA standards. • Regular audits: Conduct regular internal audits of controlled substances inventory and records to identify and correct any discrepancies. • Training and education: Ensure that all staff members involved in handling controlled substances are properly trained in DEA regulations and the dental practice’s policies and procedures.
DEA inspections fall into two categories: • Routine inspections: These are conducted periodically, often every few years, to ensure ongoing compliance. • Triggered inspections: Inspections may be triggered by certain events, such as significant losses or thefts of controlled substances, complaints, irregularities in prescribing patterns, or other suspicious activities. While there is no way to avoid an inspection entirely, compliance with DEA regulations is essential to avoid federal sanction in the form of penalties, which can include fines or suspension or revocation of your DEA registration, as well as action by your state dental board.
Areas of Focus During DEA Inspections
• Recordkeeping: Inspectors will review records related to the acquisition, dispensing and prescribing of controlled substances. This includes checking DEA Form 222 (used for ordering Schedule II substances) and inventory records. • Inventory management: Inspectors will verify that initial and biennial (every two years) inventories are accurate and up to date and that they include all required information. • Prescription practices: Inspectors will examine prescription records to ensure that they comply with DEA regulations. This includes verifying that all required information is present on prescriptions for controlled substances. • Security measures: Inspectors will assess the physical security measures in place for storing controlled substances, ensuring they are securely locked and adequately protected against theft and diversion.
10
AGD IMPACT
SEPTEMBER 2024
Preparation for a DEA Inspection
The following are the key points regarding compliance with DEA regulation of dentists.
DEA Registration Dentists must obtain a DEA registration number to prescribe, dispense or administer controlled substances. This number is unique to the practitioner and must be renewed every three years. Dentists apply for DEA registration using DEA Form 224.1 The application can be completed online through the DEA Diversion Control Division’s website.1 It is critical to remember that DEA registration must be renewed, and, to the dismay of dentists who practice in multiple locations, each office in which controlled substances are used must have its own separate DEA registration. In addition to the federal requirement, some states also require registration in order to prescribe controlled substances.2 State dental and pharmacy boards often provide additional guidelines and requirements.