Compliance with the Drug Enforcement Agency’s regulatory and reporting requirements for controlled substances is crucial for avoiding significant penalties. Whether used for sedation, anesthesia, euthanasia, or treating chronic medical conditions, controlled substances are part of most practitioners’ daily lives. Because they are so ubiquitous, it is easy to become casual about their use. As a result, few veterinary practices are fully compliant with DEA regulations.
These are the 10 most common ways practices fail to comply with DEA regulations:
- Not understanding the laws.
Veterinarians can access Title 21 USC Controlled Substances Act 801-890 and the Code of Federal Regulations Title 21 Parts 1300 to 1316 online. In addition, many states require continuing education credits in controlled substance handling. State veterinary medical associations often offer courses to meet this requirement.
- Failing to have a separate registration for each physical location.
According to the Drug Enforcement Administration Diversion Control Division Guidance Document, “DEA regulations require a separate registration for each principal place of business or professional practice at one general physical location where controlled substances are manufactured, distributed, imported, exported, or dispensed by a person (1301.12a). DEA regulations do not prohibit individual and mid-level practitioners from using their home address.”
- Not understanding the security requirements for controlled substances.
Section 1301.71 of CFR Title 21 states, “All applicants and registrants shall provide effective controls and procedures to guard against theft and diversion of controlled substances. In order to determine whether a registrant has provided effective controls against diversion, the Administrator shall use the security requirements set forth in §§ 1301.72-1301.76 as standards for the physical security controls and operating procedures necessary to prevent diversion.”
- Not storing records and controlled substances separately when ordered from different DEA registrations.
Each registrant must maintain separate records, storage, and accountability of controlled substances. Some states require individual DEA registration. Multiple DEA registrations require multiple record-keeping sites with strict attention to prevent comingling of controlled substances or controlled substance records.
- Failing to conduct background checks on employees who might have access to controlled substances.
Section 1301.76 of Title 21 states, “The registrant shall not employ, as an agent or employee who has access to controlled substances, any person who has been convicted of a felony offense relating to controlled substances or who, at any time, had an application for registration with the DEA denied, had a DEA registration revoked or has surrendered a DEA registration for cause. For purposes of this subsection, the term ‘for cause’ means a surrender in lieu of, or as a consequence of, any federal or state administrative, civil, or criminal action resulting from an investigation of the individual’s handling of controlled substances.” In addition, the DEA expects employers to screen nonpractitioners who could have access to controlled substances for criminal convictions and unauthorized use of controlled substances during the hiring process.
- Failing to train employees of their responsibility to report drug diversion.
Your practice’s controlled substance security program must require all employees to report any controlled substance theft or diversion in the workplace by any team member. Employees should acknowledge in writing the obligation to report such information.
- Failure to store records properly.
Practices must maintain inventories and records of Schedule II substances separately from all other records maintained by the registrant. Likewise, inventories and records of controlled substances in Schedules III, IV, and V must be maintained separately or in a form that is readily retrievable from the practitioner’s ordinary business records. Regulations also state that controlled substance invoices must be kept in a separate file from other invoices.
- Failure to keep proper records of controlled substance use.
All registrants must keep detailed records of controlled substances administered or dispensed to patients in the lawful course of professional practice. The term “readily retrievable” means the record is kept or maintained in such a manner that it can be separated out from all other records in a reasonable time. All records related to controlled substances must be maintained and be available for inspection for a minimum of two years. Practices must file a Form 106 online for all thefts, as well as any “significant” losses within 24 hours of their discovery.
- Failure to conduct a biennial inventory.
Each registrant must maintain a complete and accurate inventory of the controlled substances ordered under their registration. Registrants must record the biennial inventory record in a specific manner and maintain it at the registered location for at least two years from the date the inventory was conducted and available for inspection. After taking an initial inventory, the registrant must take a new inventory of all controlled substances on hand at least every two years.
- Failure to handle expired and defective controlled substances properly.
Practices should request assistance in disposing of expired or defective controlled substances from the Special Agent in Charge of the Administration in the area where the practitioner is located by submitting one copy of the DEA Form 41. On the form, the registrant should list the controlled substance or substances they wish to dispose of. The Special Agent in Charge shall instruct the registrant to dispose of the controlled substance in one of the following manners:
- By transfer to a registrant authorized to transport or destroy the substance.
- By delivery to an agent of the Administration or to the nearest office of the Administration.
- By destruction in the presence of an agent of the Administration or other authorized person.
It is important to comply with DEA controlled substance requirements both to protect your ability to order and use these substances in the future and to increase the value of your practice by mitigating risk. The simplest way to drive compliance is by thoroughly understanding your responsibilities and preparing standard operating procedures in a controlled substance manual for your practice.
Related Reading
- Business Briefs: 10 Common OSHA Violations in Equine Practice
- Legal Aspects of Telemedicine in Equine Veterinary Practice
- Staying Ahead of the Curve: Navigating Legislation Affecting the Veterinary Profession
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