Animal Health Solutions

47 Q4 2021 | Animal Health Solutions So, your answer is "Yes". An individual practitioner is a physician, dentist, veterinarian, or other individual licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which he/she practices, to dispense a controlled substance in the course of professional practice, but does not include a pharmacist, a pharmacy, institutional practitioner, or mid-level practitioner. See 21 CFR 1300.01(b). In addition, individual practitioners must also follow applicable state, local, or tribal laws. 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. 21 CFR 1301.12(a). DEA regulations do not prohibit individual practitioners from using their home address. If an individual practitioner does choose to use their home address as a principal place of business or professional practice, the location becomes a "controlled premises" and is subject to unannounced inspections and administrative warrants under existing DEA regulations. See 21 CFR 1316.01–1316.13. An individual practitioner whose DEA-registered location is a home must comply with the established recordkeeping requirements (see 21 CFR 1304 and 1305) and security requirements. See 21 CFR 1301.71, 1301.75–1301.76. Reporting controlled substance breakage, spillage, and/or damage to the DEA One of the most common questions I get asked is "What do we do about the bottle of Fentanyl I just dropped, I have to report this to the DEA within 24 hours?" Well, you don't, and you never had to in the first place. The brand-new DEA information page has some great reference tools that address most your requirements as a DEA registrant. While neither the Controlled Substances Act nor DEA's regulations specifically address reporting the breakage and/ or spillage of a controlled substance, on August 12, 2005, DEA published in the Federal Register (FR) a Final Rule, Reports by Registrants of Theft or Significant Loss of Controlled Substances, 70 FR 47094. In that rule, DEA remarked that previous guidance on the topic, given in a July 8, 2003 Notice of Proposed Rulemaking and Guidance Document, Reports by Registrants of Theft or Significant Loss of Controlled Substances, 68 FR 40576, was adequate and sufficiently clear: the witnessed breakage or spillage of a controlled substance does not constitute a loss of controlled substances because the registrant can account for the controlled substances; these types of incidents do not require notification to DEA. 70 FR 47096; see also 68 FR 40578. DEA also stated that registrants "should continue to employ common sense, good faith approaches to their reporting and recordkeeping obligations in the case of breakage and spillage." 70 FR 47096. DEA registrants are also reminded of their recordkeeping obligations with respect to controlled substances that are disposed of by destruction. See 21 CFR 1304.22(a) (2)(ix). But be very careful to track how often "spills or broken bottles" occur. We have seen on more than one occasion where the nurse of veterinary technician filled an empty bottle of fentanyl with water and dropped it on the floor to simulate the actual breaking of a bottle filled with the controlled substance. If you have robust surveillance cameras, review the incident to ensure that drug diversion is not occurring, if they get away with it once, they will continue to steal your inventory. About the author Jack has more than three decades of continuous leadership expertise in government, security, law enforcement and private industry. For 26 years, he worked for the Department of Justice/Drug Enforcement Administration as a Special Agent and Supervisory Special Agent, gaining extensive experience in all facets of complex criminal drug conspiracy investigations. He received numerous awards and commendations. After retiring from the DEA, Jack directed executive protection for a major hedge fund company. Jack is joined by a vast network of leading investigators worldwide, who ensure that our clients receive the highest quality support and services. TITAN Group is a full-service controlled substance risk management firm that provides DEA compliance, state regulatory compliance, drug security and anti-diversion solutions. Titan's team of former Drug Enforcement Administration (DEA) Special Agents, Diversion and State Investigators works with healthcare and veterinary professionals that handle controlled substances to ensure operations are fully compliant. We can help provide you with the best course of action based on your needs.

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