1. Main stock narcotic drugs and psychotropic substances should be stored in safes, on the inside doors of which there should be lists of the highest single and daily doses. Narcotic drugs and psychotropic substances issued from the main storage location for current work (assistant, prescription department) are stored in safes in these premises during working hours.

(as amended by Order of the Ministry of Health of the Russian Federation dated May 16, 2003 N 205)

2. B working hours The key to the safe with narcotic drugs and psychotropic substances located in the assistant room in the prescription department must be with the pharmacist-technologist. After the end of the working day, safes are sealed or sealed, and the keys to them, the seal and the seal must be kept by the financially responsible person authorized to do so by order of the pharmacy.

(as amended by Order of the Ministry of Health of the Russian Federation dated May 16, 2003 N 205)

The windows of material rooms in which narcotic drugs and psychotropic substances are stored must have metal bars, and the doors must be lined with iron. After completion of work, these rooms are locked and sealed by the financially responsible person.

(as amended by Order of the Ministry of Health of the Russian Federation dated May 16, 2003 N 205)

3. Material rooms and safes in which narcotic drugs and psychotropic substances are stored must have a security light and sound alarm.

(as amended by Order of the Ministry of Health of the Russian Federation dated May 16, 2003 N 205)

Access to the room where stocks of narcotic drugs and psychotropic substances are stored is permitted to persons directly working with them, which is formalized by permission from the Internal Affairs Directorate and an order from the pharmacy. Admission is issued a second time when one of the employees changes.

(as amended by Order of the Ministry of Health of the Russian Federation dated May 16, 2003 N 205)

4. The issuance of narcotic drugs and psychotropic substances to the assistant’s room for current work must be carried out from the material room only by a financially responsible person authorized to do so.

(as amended by Order of the Ministry of Health of the Russian Federation dated May 16, 2003 N 205)

5. The stock of narcotic drugs and psychotropic substances in pharmacies, regardless of the organizational and legal form, form of ownership and departmental subordination, should not exceed the monthly requirement. For pharmacies remote from supply bases, the stock of these products is established by the governing bodies of pharmaceutical (pharmacy) organizations in the constituent entities Russian Federation.

(as amended by Order of the Ministry of Health of the Russian Federation dated May 16, 2003 N 205)

6. In the assistant room of pharmacies, stocks of narcotic drugs and psychotropic substances should not exceed the five-day requirement.

(as amended by Order of the Ministry of Health of the Russian Federation dated May 16, 2003 N 205)

7. In on-duty pharmacies during night duty, the pharmacist, if necessary, uses narcotic drugs and psychotropic substances, which are kept in a sealed safe. After completing his duty, he reports to the financially responsible person responsible for accounting and storage of narcotic drugs and psychotropic substances.

(as amended by Order of the Ministry of Health of the Russian Federation dated May 16, 2003 N 205)

8. Narcotic drugs and psychotropic substances are subject to subject-quantitative accounting in a special logbook for registering transactions related to the circulation of narcotic drugs and psychotropic substances (hereinafter referred to as the logbook), numbered, bound and certified by the signature of the head of the pharmacy and sealed with the seal of the pharmacy.

The form of the registration log is approved by the head of the pharmacy and must comply with the Rules for maintaining and storing special logs of transactions related to the circulation of narcotic drugs and psychotropic substances, approved in the prescribed manner<*>.

<*>Decree of the Government of the Russian Federation of July 28, 2000 N 577 “On the procedure for submitting information on activities related to the trafficking of narcotic drugs and psychotropic substances, and registering transactions related to these activities” (Collected Legislation of the Russian Federation, 08.14.2000, N 33, Art. 3397)

(as amended by Order of the Ministry of Health of the Russian Federation dated May 16, 2003 N 205)

The law is simple: Due to the loss of force of Decree of the Government of the Russian Federation of July 28, 2000 N 577, one should be guided by the Decree of the Government of the Russian Federation of November 4, 2006 N 644 adopted in its place

9. At least once a month, the authorized person who is entrusted with control over the maintenance and storage of the registration log checks the entries in the log, checks the actual presence of narcotic drugs and psychotropic substances with their book balances, as indicated on the next line after the last one at the time of inspection makes a note in the registration log indicating the date of inspection and certifies it with his signature.

When inventorying the inventory of a pharmacy (pharmacy department), the actual balances of narcotic drugs and psychotropic substances are established, for which a separate inventory is drawn up. If deviations are identified when removing actual balances from book data, the pharmacy manager is obliged to immediately notify the health care or pharmaceutical management body of a constituent entity of the Russian Federation about this in writing, which must conduct an internal investigation within 3-5 days.

Used prescription forms for narcotic drugs and psychotropic substances included in List II of the List of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation, must be stored in a safe, filed, sealed, laced by month and year for five years.

(as amended by Order of the Ministry of Health of the Russian Federation dated May 16, 2003 N 205)

10. Narcotic drugs and psychotropic substances with an expired shelf life, waste, marriage, handed over by relatives of deceased patients are subject to write-off in accordance with the regulations on the write-off of narcotic drugs and special recipes unused by cancer patients and destruction in the prescribed manner (Appendix 6).

Before destruction, these narcotic drugs and psychotropic substances must be stored on a separate shelf or in a separate compartment of the safe.

(as amended by Order of the Ministry of Health of the Russian Federation dated May 16, 2003 N 205)

Boss
Support Department
medicine organizations
and medical equipment
T.G. KIRSANOVA

Chairman
Standing Committee
drug control
E.A. BABAYAN

APPROVED
By order of the Ministry
health
Russian Federation
dated November 12, 1997 N 330

Zakharochkina Elena Revovna
Associate Professor, Department of Economic Economics, Faculty of Pharmacy, First Moscow State Medical University. THEM. Sechenova, Ph.D.

SECURITY OF PREMISES AND APPOINTMENT OF PERSONS RESPONSIBLE FOR STORAGE

At the same time, the security of premises belonging to the 1st and 2nd categories is carried out on a contractual basis:

• private security units under the internal affairs bodies of the Russian Federation;
• an organization subordinate to the Ministry of Internal Affairs of the Russian Federation, or
• departmental security of federal executive authorities.

Security of premises belonging to the 3rd and 4th categories is carried out on a contractual basis by involving the specified security organizations or legal entities licensed to carry out non-state (private) security activities.

When concluding an agreement with a security organization, the level of engineering and technical strength of the premises, the types of technical security equipment and the class of resistance of safes to burglary are determined.

By order of the head of the legal entity:

• Persons responsible for storage and authorized to work with narcotic drugs, psychotropic substances and precursors are appointed.
• The procedure for storing keys to safes, metal cabinets and premises, as well as seals and sealing devices used for sealing is established.

The order of the head of the legal entity also approves the list of persons entitled to access the premises.

After the end of the working day, safes, metal cabinets and premises are sealed (sealed) and handed over to guards. Premises that operate 24 hours a day are not subject to security guarding.

NS and PW stored in premises of all categories and in places of temporary storage are subject to accounting in accordance with the Rules for maintaining and storing special logs of transactions related to the circulation of narcotic drugs and psychotropic substances, approved by Decree of the Government of the Russian Federation dated November 4, 2006 No. 644 .

Precursors stored in premises of the 1st and 3rd categories are subject to accounting in accordance with the Rules for maintaining and storing special logs of transactions related to the circulation of precursors of narcotic drugs and psychotropic substances, approved by Decree of the Government of the Russian Federation dated 06/09/10 No. 419 .

Responsibility for organizing the storage of narcotic drugs, psychotropic substances and precursors lies with the head of the legal entity or an official authorized by him.

Special requirements for storage conditions of narcotic and psychotropic drugs for medical use in pharmacies, medical institutions, research, educational organizations and wholesale trade organizations are established by the Ministry of Health and social development Russian Federation (see below - order of the Ministry of Health and Social Development of the Russian Federation No. 397n dated May 16, 2011).

STORAGE FEATURES

Special requirements for storage conditions of narcotic drugs and psychotropic substances intended for veterinary use in pharmacies and veterinary organizations are established by the Ministry of Agriculture of the Russian Federation.

Decree of the Government of the Russian Federation dated December 31, 2009 No. 1148 “On the procedure for storing narcotic drugs, psychotropic substances and their precursors” also determines that the features of storage of narcotic drugs and psychotropic substances intended to ensure activity in the organ system federal service security (FSB) and the federal executive body in the field of internal affairs, as well as in the Armed Forces of the Russian Federation, are established by the relevant federal executive bodies.

Order of the Ministry of Health and Social Development of the Russian Federation dated May 16, 2011 No. 397n “On approval of special requirements for the storage conditions of narcotic drugs and psychotropic substances registered in the prescribed manner in the Russian Federation as medicines intended for medical use in pharmacies, medical institutions, scientific- research, educational organizations and wholesale trade organizations of medicines" (registered with the Ministry of Justice of the Russian Federation on 02.06.11 No. 20923) approved the corresponding special requirements, which define storage features.

Order of the Ministry of Health and Social Development of the Russian Federation dated 02.08.10 No. 590n was declared invalid.

Storage areas for NLS and PLS that require protection from elevated temperatures (refrigerator compartment, refrigerator, thermal container) must be equipped with temperature metering devices.

STORAGE OF PRECURSORS

Storage of NS and PD precursors included in List I of the List of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation, approved by Decree of the Government of the Russian Federation dated June 30, 1998 No. 681, is regulated by Decree of the Government of the Russian Federation dated December 31, 2009 No. 1148 “On the procedure for storage narcotic drugs, psychotropic substances and their precursors" (see MA No. 01/12. - Ed.).

Storage of precursors included in Tables I, II, III of List IV is regulated by Decree of the Government of the Russian Federation dated August 18, 2010 No. 640 “On approval of the Rules for the production, processing, storage, sale, acquisition, use, transportation and destruction of precursors of narcotic drugs and psychotropic substances” (as amended by the Decree of the Government of the Russian Federation dated December 8, 2011 No. 1023 “On amendments to certain acts of the Government of the Russian Federation in connection with improving control over the circulation of precursors of narcotic drugs and psychotropic substances”).

Precursors are stored in isolated rooms, which are sealed (sealed) after the end of the working day (RF PP No. 640 as amended by RF PP No. 1023). It is important to note that in new edition There is no requirement for storage on racks (pallets) in unopened (undamaged) or sealed (sealed) packaging or in shipping containers.

Head of a legal entity (individual entrepreneur):

• appoints persons responsible for the storage of precursors (for precursors included in Table I of List IV of the list - from among those admitted to work with precursors);
• establishes the procedure for storing keys to premises, as well as seals (sealing devices).

Legal entities and individual entrepreneurs may store and use precursors in quantities not exceeding their production needs.

It should also be noted that the order of the Ministry of Health and Social Development of the Russian Federation dated August 23, 2010 No. 706n “On approval of the Rules for the storage of medicines” (registered with the Ministry of Justice of the Russian Federation on October 4, 2010 No. 18608) (as amended by the order of the Ministry of Health and Social Development of the Russian Federation dated December 28, 2010 No. 1221n) approved the Rules storage of medicines, establishing requirements for premises for storing medicines (medicines) for medical use and regulating the storage conditions of these medicines, which apply to manufacturers of medicines, wholesale trade organizations of medicines, pharmacies, medical and other organizations operating in the circulation of medicines, individual entrepreneurs having a license for pharmaceutical activities or a license to practice medicine.

Rules for storing drugs include the following sections:

I. General provisions.

II. General requirements for the design and operation of drug storage premises.

III. General requirements for premises for storing medicines and organizing their storage.

IV. Requirements for premises for storing flammable and explosive medicines and organizing their storage.

V. Features of organizing the storage of medicines in warehouses.

VI. Storage Features separate groups medicines depending on their physical and physico-chemical properties, the impact of various environmental factors on them.

In particular, they installed storage features:

√ Medicines

• requiring protection from light;
• requiring protection from moisture;
• requiring protection from volatilization and drying out;
• requiring protection from exposure to elevated temperatures;
• requiring protection from exposure to low temperatures;
• requiring protection from exposure to gases contained in the environment;
• odorous and coloring;
• disinfectants;
• flammable;
• explosive;
• narcotic and psychotropic drugs;
• potent and poisonous, and subject to subject-quantitative accounting;

√ Medicines for medical use

√ Medicinal plant raw materials.

Thus, when storing narcotic drugs, psychotropic substances and precursors, it is also necessary to take into account their physical and physical and chemical properties, the impact on them of various environmental factors.

1. Premises for storing narcotic drugs and psychotropic substances (hereinafter PS and PP) and their precursors are divided into 4 categories; for each category, requirements for storage conditions are established.

3. Category 2 includes premises of pharmacy organizations intended for storing a 3-month or 6-month supply (for pharmacy organizations located in rural settlements and remote from settlements localities) NS and PV, as well as premises of veterinary pharmacies intended for storing a 3-month supply of NS and PV.

4. The 3rd category includes premises of medical and veterinary organizations intended for storing a 15-day supply of NS and PV included in List II of the post list. No. 681, and a month's supply of PV included in List III of the post list. No. 681, premises of medical organizations or separate divisions of medical organizations, premises of legal entities intended for storage of NS and PV, their precursors used for scientific, educational and expert purposes.

5. The 4th category includes premises of pharmacy, medical and veterinary organizations intended for storing a daily supply of NS and PV included in List II of the list, and a three-day supply of PV included in List III of the List, as well as premises of medical organizations intended for storage of unused drugs received from relatives of deceased patients.

6. Temporary storage places for NS and PV are provided, which include packing, kits, kits for the provision of primary health care, emergency and specialized medical care, which include NS and PV.

7. The decision on the need to organize temporary storage places is made by the head of the legal entity

8. For premises of each category, basic requirements for their equipment with engineering and technical means security, as well as the conditions for storing narcotic drugs and psychotropic substances in them.

9. In premises belonging to the 2nd category, NS and PV are stored in locked safes or metal cabinets. The room is equipped with a metal entrance door, a wooden door reinforced on 2 sides with sheet iron, or a door made of another material with a protection class from destructive influences of at least 3. Entrance door has at least 2 locking devices of the 3rd class of protection against destructive influences

10. In a room belonging to the 3rd category, NS and PP and precursors are stored in locked bulk or attached to the floor (wall) safes of at least 3rd class of burglary resistance. A safe weighing less than 1000 kilograms is attached to the floor or wall or built into the wall using an anchor.

11. In a room belonging to the 4th category, NS and PV are stored in locked bulk or attached to the floor (wall) safes of at least 3rd class of burglary resistance. A safe weighing less than 1000 kilograms is attached to the floor or wall or built into the wall using an anchor.

12. In places of temporary storage, NS and PV are stored in locked safes of at least 1st class of burglary resistance or metal or containers made of other high-strength materials.

13. NS and PW stored in premises of all categories and in places of temporary storage are subject to accounting in accordance with the Rules for maintaining and storing special logs of transactions related to the circulation of narcotic drugs and psychotropic substances, approved by the RF Government of November 4, 2006 . N 644.

14. Precursors stored in premises of the 1st and 3rd categories are subject to accounting in accordance with the Rules for maintaining and storing special logs of transactions related to the circulation of precursors of narcotic drugs and psychotropic substances, approved by the RF Government of June 9, 2010 . N 419.

15. In order to ensure the safety of NS and PP, their precursors, the premises are subject to protection.

16. Security of premises belonging to the 1st and 2nd categories is carried out on a contractual basis by private police security units.

17. Security of premises belonging to the 3rd and 4th categories is also carried out by involving legal entities licensed to carry out private security activities.

18. In the absence of private police security units in rural settlements or areas remote from settlements, it is allowed to protect premises belonging to the 2nd category by involving legal entities licensed to carry out private security activities with the right to provide security services objects by taking appropriate measures to respond to signal information from technical security equipment installed at protected objects.

19. The level of engineering and technical equipment of the premises, types of technical security equipment and the class of safes’ resistance to burglary are determined when concluding an agreement with a security organization.

20. After the end of the working day, safes, metal cabinets and premises are sealed (sealed) and handed over to guards. Premises that operate 24 hours a day are not subject to security guarding.

21. By order of the head of a legal entity, persons are appointed responsible for the storage of narcotic drugs, psychotropic substances and precursors, authorized to work with NS and PW, their precursors, and establishes the procedure for storing keys to safes, metal cabinets and premises, as well as those used for sealing ( sealing) seals and sealing devices.

22. The list of persons entitled to access the premises is approved by order of the head of the legal entity.

23. Responsibility for organizing the storage of narcotic drugs, psychotropic substances and precursors lies with the head of the legal entity or an official authorized by him.

24. Stocks of NS and PV intended for medical use are determined legal entities based on standards for calculating the need for these medicines intended for medical use.

25. In pharmacies and medical organizations at internal sides On the doors of safes or metal cabinets in which NS and PV are stored, lists of stored narcotic and psychotropic medications should be posted indicating their highest single and highest daily doses.

26. Additionally, in medical organizations, in places where NS and PV are stored, tables of antidotes for poisoning with these drugs are posted.

27. The storage of pharmaceutical substances of narcotic and psychotropic drugs in pharmacies should be carried out in bars indicating the highest single and highest daily doses.

28. Storage of NS and PV used during the working day in assistant rooms and prescription departments of pharmacies, in classrooms of educational organizations, as well as in laboratories of research organizations is carried out in safes (containers) of these premises or departments.

29. At the end of the working day, NS and PV must be returned to the place of their main storage.

30. In medical organizations, NS and PV should be stored only in the form of ready-made dosage forms, manufactured by drug manufacturing organizations or pharmaceutical establishments.

31. It is prohibited to store in medical organizations NS and PV manufactured pharmacy organizations, in the absence of a label with the inscription “Poison” in black paint and containing: the designations “Internal”, “External”, “Eye drops”, etc.; name or number pharmacy establishment, who manufactured medicine; name of the department (office) of the medical organization; the composition of the medicinal product in accordance with the prescription specified in the requirement; date of manufacture, analysis number, expiration date; signatures of the persons: those who manufactured, checked and dispensed the medicinal product from the pharmacy organization.

32. It is allowed to store NS and PP that require protection from elevated temperatures in pharmacies, medical, research, educational organizations and wholesale trade organizations medicines:

· in premises of the 1st and 2nd categories, specially equipped with engineering and technical security means - in lockable refrigerators (refrigerators) or in a special area for placing refrigerators (refrigerators), separated from the main storage area by a metal grill with a lockable lattice door;

· in premises of the 3rd category, specially equipped with engineering and technical security means - in a special area for placing refrigerators (refrigeration chambers), separated from the main storage area by a metal grill with a lockable grill door;

· in places of temporary storage - in thermal containers placed in safes, or in metal or other high-strength materials containers placed in thermal containers.

33. Storage places for NS and PV that require protection from elevated temperatures (refrigerator compartment, refrigerator, thermal container) must be equipped with temperature metering devices.

34. Poor-quality NS and PV identified in a pharmacy, medical or wholesale trade organization of medicines, as well as NS and PV handed over by relatives of deceased patients to a medical institution, are subject to storage in specially equipped temporary storage areas until they are written off and destroyed.