Legal Matters: Successful DEA Inspections Require Knowing Your Compliance Obligations

By Jake Kathleen Marcus, JD, PGDip

Of 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.

DEA Inspections

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.

• 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.

Preparation for a DEA Inspection

• 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.

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.

Prescription Regulations

Controlled substances are classified into five schedules (I–V) based on their potential for abuse, medical use and safety. Dentists who sedate patients for procedures often employ Schedule II–V drugs, such as opioids (e.g., hydrocodone, oxycodone) and benzodiazepines (e.g., diazepam).

DEA regulations stipulate specific requirements for writing prescriptions for controlled substances. Prescriptions must include:

• the patient’s full name and address;

• the practitioner’s full name and address;

• the practitioner’s DEA registration number; and

• the drug name, strength, dosage form, quantity prescribed, directions for use and the number of refills (if any).

Dentists can — and in some states must — use electronic prescribing of controlled substances (EPCS) systems, which must meet DEA requirements to ensure security and authenticity.(3)

What dentists cannot do is prescribe drugs for use in a dental procedure. Prescriptions can only be written for medications for home use. Medications to be used in the dental office must be purchased directly from DEA-registered distributors. Of particular importance is that destruction of expired or damaged controlled substances must be done by a DEA-registered reverse distributor.(4)

DEA Recordkeeping and Inventory

Dentists must maintain accurate records of all controlled substances they receive, dispense and prescribe.(5) Records must be kept for at least two years and be readily available for inspection by the DEA. In addition, dentists must conduct an initial inventory of all controlled substances on hand when they first register with the DEA. They must also conduct a biennial inventory thereafter.

After a DEA Inspection

A DEA inspection may result in:

• Corrective actions: If any deficiencies are identified during the inspection, take immediate corrective actions to address them prior to any subsequent inspection or by a date specified by the inspector. This may include updating records, enhancing security measures or providing additional staff training.

• Follow-up: In some cases, the DEA may conduct follow-up inspections to ensure that corrective actions have been implemented.

Overview of the MATE Act

Effective June 27, 2023, the Medication Access and Training Expansion (MATE) Act mandates that all healthcare providers who are registered with the DEA to prescribe controlled substances must complete a one-time training related to opioid and other substance use disorders. Here are the key aspects of the mandatory training for DEA registration:

• Training: The MATE Act requires healthcare providers to complete at least eight hours of training. The training must cover topics such as:

  • Safe prescribing practices: Education on the proper prescribing of opioids and other controlled substances to prevent misuse and abuse.

  • Substance use disorders: Training on identifying and managing patients with substance use disorders.

  • Pain management: Best practices for pain management that minimize the risk of addiction and abuse.

  The training must be completed through an accredited provider. These programs are often available online or through professional organizations such as the American Dental Association. (Editor’s note: While AGD PACE–approved programs are not currently considered authorized providers of this training, AGD has compiled a list of CE providers that meet the statute requirement in order to ensure AGD members have access to required training and options: agd.org/education/learn/medication-access-and-training-expansion-(mate). Additionally, AGD has been working diligently with legislators on a resolution to include AGD as an accredited provider, and movement is expected in 2025.)

• Submit documentation: Keep the certificate or proof of completion for your records. You may need to provide this documentation when applying for or renewing your DEA registration.

• State-specific regulations: Understand and comply with any state-specific requirements and guidelines for prescribing controlled substances.

The key to a successful DEA inspection — as well as a mandated state dental board inspection — is knowing and complying with the application regulation. Following the steps above can both reduce the anxiety associated with inspections and keep your dental office in line with best practices. A compliant dental office is also less likely to experience theft of controlled substances and is better able to detect employee misconduct. All of this results in better patient care and a more productive business.

Jake Kathleen Marcus, JD, PGDip, has been a regulatory lawyer primarily in the healthcare space for over 35 years. They were recently awarded a postgraduate diploma in technology, media and telecommunications by Queen Mary University of London School of Law. To comment on this article, email impact@agd.org.

References

1. “Registration.” Drug Enforcement Agency Diversion Control Division, U.S. Department of Justice, deadiversion.usdoj.gov/drugreg/registration.html. Accessed 11 July 2024.

2. “21 CFR Part 1301 - PART 1301—Registration of Manufacturers, Distributors, and Dispensers of Controlled Substances.” Cornell Law School Legal Information Institute, Cornell University, law.cornell.edu/cfr/text/21/ part-1301. Accessed 11 July 2024.

3. Drug Enforcement Administration, Department of Justice. “21 CFR Parts 1300, 1304, 1306, and 1311: Electronic Prescriptions for Controlled Substances.” Federal Register, vol. 75, no. 61, 31 March 2010, pp. 16236-16319, govinfo.gov/content/pkg/FR-2010-03-31/pdf/2010-6687.pdf.

4. “21 CFR 1317.55 Reverse Distributor and Distributor Acquisition of Controlled Substances from Collectors or Law Enforcement.” Code of Federal Regulations, National Archives, ecfr.gov/current/title-21/chapter-II/ part-1317/subpart-B/section-1317.55. Last amended 5 July 2024. Accessed 11 July 2024.

5. “21 CFR Part 1304 Records and Reports of Registrants.” Code of Federal Regulations, National Archives, ecfr.gov/current/title-21/chapter-II/part-1304. Last amended 5 July 2024. Accessed 11 July 2024.