Animal Health Solutions

Q3 2019 | Animal Health Solutions | 27 More at: northamerica.covetrus.com/publications Registration responsibilities What happens if the DEA registered practitioner/registrant leaves? This can happen through selling of a clinic, change in employment, or death of registrant. The Covetrus North America Regulatory Team routinely fields questions about DEA compliance. Below are some frequently addressed situations, but we encourage you to reach out to your legal advisors and/or DEA contact for questions specific to your practice. When the DEA registrant is selling or leaving a clinic, the registrant is responsible for the controlled substances purchased using their DEA registration. The options for the remaining controlled substances in inventory are: • Take the drugs with them to the new registered location; • Have the drugs destroyed; or • Transfer the drugs to the new owner, who also must have a valid DEA registration, or registrant. The transfer must include the DEA registration number, name and address of the person transferring the drugs and the person receiving the controlled substance. The transfer must also include name, amount, strength, and quantity of the controlled substance. A final inventory must also be taken by the leaving registrant and an initial inventory must be taken by the new registrant. Notification to your supplier is needed as well so their records indicate that they are distributing to the correct DEA registration. Inventory and recordkeeping responsibilities Every registrant is required to keep records and inventories of controlled substances. This means that if a clinic orders controlled substances using different DEA registration numbers, each registration is required to have separate recordkeeping and inventories. Typically, practices utilize one registration. Accurate records are important to track each controlled substance from the time that the drug is received from the supplier until it is administered or disposed of properly. Examples of records that are to be kept by the registrant? • Receiving records from suppliers; • Administration and dispensing records to patients; and • Movement of controlled substance items to other stocking locations. Inventories should be taken frequently to account for controlled substances on hand. The DEA requires that an inventory is taken at least once every two years, known as a biennial inventory. Designated biennial inventories shall include: • Name of the substance; • Finished form of the substance (example: 2mg/mL); • The number units or volume of each finished form; (100 tablet bottle, or 10mL vial); and • The number of commercial containers of each such finished form (5-100 count bottles). DEA and state regulatory agency audits of veterinary practices are increasing. Protect yourself and your practice by remaining vigilant and adhering to state and federal regulations. 1. 21 CFR §1301.11(a) 2. 21 CFR §1301.74(a) Security requirements generally 3. 21 CFR §1301.75 Physical security controls for practitioners 4. 21 CFR §1301.76 Other security controls for practitioners What if the registrant passes away? In the event that a registrant passes away, those closest to them must notify the DEA as soon as possible. Drugs cannot be purchased using the deceased practitioner's DEA registration. The remaining drugs can be transferred to another registered location or the DEA will pick up the drugs upon request. The supplier is to be notified as soon as possible to ensure they are not further distributing controlled substances to the deceased registrant. Security responsibilities All registrants shall provide effective controls and procedures to guard against theft and diversion. 2 A common action against practitioner DEA registrations is "failure to prevent theft and diversion." The registrant is responsible for the security and record keeping of the controlled substances at all times. Physical security Controlled substances listed in Schedule II, III, IV, and V shall be stored in a securely locked, substantially constructed cabinet. 3 For example, an unlocked filing cabinet does not meet the physical security requirements for controlled substances. Staffing In addition, 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. Background checks can usually detect any such offenses. Local companies are available to facilitate in conducting background checks.

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