Ketamine is a controlled substance in Russia. Here is what a veterinary clinic needs to store it legally
A veterinary clinic can operate on animals under ketamine anesthesia for years and then lose its license during a single inspection if the inspector finds a safe that is not anchored to the floor with bolts. Regulatory risk in this area is rarely tied to the drug itself. It comes from the infrastructure, the staff, and the paperwork around it.
Ketamine remains a psychotropic substance included in List II of the register subject to control in Russia. Only legal entities are entitled to work with it. A veterinarian registered as an individual entrepreneur, even with specialized education and years of experience, will not receive a license for the circulation of psychotropic substances. This rule splits the veterinary surgery market into clinics capable of administering full anesthesia and those operating without it.
The set of rules used today to inspect the storage of psychotropic substances in veterinary medicine was almost completely updated in 2021-2022. A clinic that relies on outdated regulations, or on general requirements written for human medical organizations without adjusting for veterinary specifics, risks receiving a corrective order during its very first inspection by Rosselkhoznadzor.
Prior to 2022, Storage and Clearance Were Regulated by a Different Set of Decrees
The foundation of this regulation did not change for over twenty years. Federal Law No. 3-FZ dated January 8, 1998, «On Narcotic Drugs and Psychotropic Substances» (hereinafter, Law No. 3-FZ), establishes a state monopoly on the circulation of these substances and admits legal entities to it only under a license. Ketamine, as an NMDA receptor antagonist, was included in the list of controlled substances because of the risk of non-medical use, not because of its pharmacological properties alone.
Before the 2021-2022 reform, the storage procedure for narcotic drugs and psychotropic substances was set by Government Decree No. 1148 dated December 31, 2009. Staff clearance to work with them was governed by Decree No. 892 dated August 6, 1998. The use of ketamine and other substances specifically in veterinary medicine was described in a separate Regulation approved by Decree No. 453 dated September 3, 2004. The procedure for issuing the drug under signature, performing injections, and destroying residues in veterinary organizations was detailed by Ministry of Agriculture Order No. 19 dated February 18, 2005.
By the early 2020s, these acts no longer matched the current structure of regulatory authorities. Guarding facilities that hold narcotic drugs and psychotropic substances had long since moved from the Ministry of Internal Affairs’ extra-departmental security service to the National Guard, yet the requirements for the engineering reinforcement of premises were still written around the old departmental structure in a 2018 order. The Government revised the entire block of decrees on the storage, clearance, and accounting of psychotropic substances across 2021 and 2022.
The general storage procedure for veterinary medicines is set by Ministry of Agriculture Order No. 426 dated July 29, 2020. It explicitly carves narcotic and psychotropic drugs out of the general regime: paragraph 48 of the order requires storing them separately from other drugs, in isolated rooms fitted with dedicated engineering and technical security measures, in compliance with the separate rules on storing narcotic drugs and psychotropic substances. For a clinic, this means ketamine cannot go into the same safe used for highly potent and poisonous substances, even if that safe meets the requirements of Order No. 426. A stricter, self-contained set of rules applies to a psychotropic substance.
Since 2022, Storage and Clearance Have Been Inspected Under a New Package of Decrees
On April 30, 2022, the Government approved Decree No. 809, «On the Storage of Narcotic Drugs, Psychotropic Substances, and Their Precursors.» It replaced the 2009 decree and remains in force until September 1, 2028.
Decree No. 809 divides all storage premises for psychotropic substances into five categories. Veterinary organizations almost always fall into the 3rd category, designed for a 15-day supply of List II substances, which includes ketamine, and a monthly supply of List III substances. A clinic with a small volume of surgeries may choose the 4th category, with a three-day supply, but the category chosen sets the entire subsequent list of requirements for the room.
For premises in the 3rd category, the decree requires a safe with a burglary-resistance rating of at least Class 3. If the safe weighs less than 1,000 kilograms, the clinic must secure it to the floor or wall with anchor bolts, or build it into the wall. Inspectors check this requirement first: a freestanding, unanchored safe formally violates the storage rules even if its resistance class is correct.
The engineering reinforcement of the room itself (walls, doors, windows, locks) is governed by a separate document: the joint order of the Federal National Guard Troops Service No. 335 and the Ministry of Internal Affairs No. 677, dated September 15, 2021. It applies the same five categories and assigns a protection class to each structural element. For 3rd-category premises, the entrance door must meet protection class 2, and internal walls and partitions must meet class 1. An additional grated door is left to the clinic director’s discretion rather than being mandatory for this category.
Guarding premises in the 3rd and 4th categories falls to National Guard units or licensed private security companies. The alarm signal from the safe or from a break-in is routed to the monitoring station of whichever organization holds the contract.
Staff clearance since 2022 is governed by Decree No. 911 dated May 20, 2022. The substance of the rules stayed close to the old ones, but the procedure changed. Anyone under 18, or anyone without a medical certificate confirming the absence of drug, toxic, or alcohol dependence and a clearance certificate from the internal affairs bodies confirming no relevant criminal record, is barred from working with psychotropic substances. The clinic director, not the employee, arranges the medical examination and files the request with the Ministry of Internal Affairs; the decree explicitly bars employees from approaching the internal affairs bodies on their own.
Accounting for operations involving ketamine is governed by Decree No. 2117 dated November 30, 2021. It allows both paper and electronic registration logs. The clinic keeps a completed log in its archive for 5 years after the last entry, then destroys it by an act signed by the director.
The use of ketamine specifically in veterinary medicine is described in a separate Regulation approved by Decree No. 1794 dated October 20, 2021. It replaced the 2004 Regulation and remains in force until March 1, 2028. The procedure for issuing the drug under signature, injecting animals, and destroying residues and used ampoules is still detailed by Ministry of Agriculture Order No. 19 of February 18, 2005. A clinic should request the current version of this order from Rosselkhoznadzor before an inspection: the order was issued under the old 2004 Regulation, and clinics sometimes work from copies that were never updated.
The destruction of psychotropic substance residues and empty packaging is generally governed by Ministry of Health Order No. 1004n dated October 22, 2021. In veterinary medicine, it applies alongside the special rules in Order No. 19 and the Regulation approved by Decree No. 1794.
Licensing for the circulation of psychotropic substances itself is set out in Decree No. 1007 dated June 2, 2022. It limits licensees for Lists I-III to legal entities: individual entrepreneurs cannot obtain this license, except for activity involving precursors under Table I of List IV.
Violating the rules on storing, accounting for, and destroying psychotropic substances falls under Article 6.16 of Russia’s Code of Administrative Offenses. The fine for a legal entity runs from 200,000 to 400,000 rubles, and the alternative penalty is suspension of operations for up to 90 days. Losing ketamine through a storage violation, even with no sign of theft, can be grounds for a criminal case under Article 228.2 of Russia’s Criminal Code against the employee responsible for storage.
| Parameter | Before the Reform | Now |
|---|---|---|
| Storage of controlled substances | Decree No. 1148, Dec 31, 2009 | Decree No. 809, Apr 30, 2022 |
| Staff clearance | Decree No. 892, Aug 6, 1998 | Decree No. 911, May 20, 2022 |
| Use in veterinary medicine | Regulation under Decree No. 453, Sep 3, 2004 | Regulation under Decree No. 1794, Oct 20, 2021 |
| Engineering reinforcement of premises | Order of Rosgvardia/MVD No. 1/5, 2018 | Order of Rosgvardia No. 335 / MVD No. 677, Sep 15, 2021 |
| Retention period for registration logs | Former reporting rules | 5 years, under Decree No. 2117, Nov 30, 2021 |
What to Do
Determine the category of your premises and check it against Decree No. 809. Calculate the actual ketamine stock in milligrams for a 15-day period under List II. This calculation confirms or disproves the category stated in your license.
Check the safe’s class and how it is fastened. A safe below Class 3, or one not secured with anchor bolts when it weighs under 1,000 kg, becomes grounds for a corrective order at any inspection.
Check the premises’ engineering reinforcement against the joint order of Rosgvardia No. 335 and MVD No. 677. Check the protection class of the entrance door, the internal partitions, and the locking devices separately for each element: the requirements are not the same across them.
Update the personal files of cleared staff under Decree No. 911. Make sure the file for every veterinary anesthetist holds a current medical certificate and a clearance certificate from the internal affairs bodies, not just a diploma and a five-year-old clearance order.
Move registration logs to a format built for 5-year retention. If the clinic keeps paper logs, assign someone to bind and number them and to move them to the archive on time once their active period ends.
Licensing oversight for the circulation of psychotropic substances in veterinary medicine belongs to Rosselkhoznadzor. Roszdravnadzor oversees human medical organizations and has no authority over veterinary clinics. During a routine or unannounced inspection, an inspector checks the actual premises against the category stated in the license, checks the safe’s certificate and class, pulls the personal files of cleared staff, and reconciles the ketamine balance in the safe against the entries in the registration log for recent operations. A mismatch on any of these points gets recorded as a violation, whether or not the substance was actually lost.
Ketamine remains one of the few drugs that full veterinary surgery is hard to imagine without. The right to use it comes down to how precisely a clinic has met the requirements of five decrees and one joint order. An inspector checks this point by point: whether the safe is bolted down, whether the door meets the required protection class, whether every employee has a current medical certificate, and whether a registration log is kept with a five-year retention period.
Regulatory Framework:
1. Federal Law No. 3-FZ dated January 8, 1998, «On Narcotic Drugs and Psychotropic Substances»
2. Government Decree No. 809 dated April 30, 2022, «On the Storage of Narcotic Drugs, Psychotropic Substances, and Their Precursors»
3. Government Decree No. 911 dated May 20, 2022, «On the Clearance of Persons to Work with Narcotic Drugs and Psychotropic Substances, and with the Circulation of Their Precursors»
4. Government Decree No. 2117 dated November 30, 2021, «On the Procedure for Reporting Activity Related to the Circulation of Narcotic Drugs and Psychotropic Substances, the Cultivation of Controlled Plants, and the Registration of Related Operations»
5. Government Decree No. 1794 dated October 20, 2021, «On the Regulation on the Use of Narcotic Drugs and Psychotropic Substances in Veterinary Medicine»
6. Government Decree No. 1007 dated June 2, 2022, «On Licensing Activity Involving the Circulation of Narcotic Drugs, Psychotropic Substances, and Their Precursors»
7. Order of the Federal National Guard Troops Service No. 335 and the Ministry of Internal Affairs No. 677, dated September 15, 2021, «On Requirements for Equipping Facilities and Premises with Engineering and Technical Security Measures»
8. Ministry of Agriculture Order No. 19 dated February 18, 2005, «On the Procedure for Issuing, Recording, and Injecting Narcotic Drugs and Psychotropic Substances in Veterinary Medicine»
9. Ministry of Health Order No. 1004n dated October 22, 2021, «On the Destruction of Narcotic Drugs, Psychotropic Substances, and Their Precursors»
10. Ministry of Agriculture Order No. 426 dated July 29, 2020, «On the Rules for Storing Medicines for Veterinary Use»
11. Article 6.16 of Russia’s Code of Administrative Offenses
12. Article 228.2 of Russia’s Criminal Code