Rules for storing narcotic drugs in the hospital. Нс, пв and their precursors: protection of premises

1. Storage rooms drugs and psychotropic substances (hereinafter PS and PS) and their precursors are divided into 4 categories, with respect to each of the categories, requirements for storage conditions are established.

3. The 2nd category includes the premises of pharmacy organizations intended for storing a 3-month or 6-month stock (for pharmacy organizations located in rural settlements and distant from settlements) NS and PV, as well as premises of veterinary pharmacy organizations , intended for storage of a 3-month supply of HC and PV.

4. The 3rd category includes the premises of medical and veterinary organizations intended for storing a 15-day supply of NS and PV, included in list II of the list of posts. No. 681, and a monthly supply of PV, included in the list III of the list of post. No. 681, premises of medical organizations or separate subdivisions of medical organizations, premises of legal entities intended for storing 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 list, as well as premises of medical organizations intended for storage of unused drugs taken from relatives of deceased patients.



6. The places for temporary storage of 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 legal entity

8. In relation to the premises of each of the categories, basic requirements to their equipment with engineering and technical means of protection, as well as to the conditions for storing narcotic drugs and psychotropic substances in them.

9. In a room belonging to the 2nd category, NS and PV are stored in lockable safes or metal cabinets. The room is equipped with an entrance metal door, a wooden door reinforced with sheet metal on 2 sides, or a door made of another material with a protection class against destructive influences not lower than 3. Entrance door has at least 2 locking devices of the 3rd class of protection against destructive effects

10. In a room belonging to the 3rd category, HC and PV and precursors are stored in lockable bulk safes or safes attached to the floor (wall), not lower than 3rd class of burglary resistance. A safe weighing less than 1000 kilograms can be attached to the floor or wall, or built into the wall using an anchorage.

11. In a room belonging to the 4th category, NS and PV are stored in lockable bulk safes or safes attached to the floor (wall), not lower than 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 lockable safes of at least 1 class of resistance to burglary or metal containers or containers made of other high-strength materials.

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

14. Precursors stored in rooms of the 1st and 3rd categories are subject to accounting in accordance with the Rules for maintaining and storing special logs for registering operations related to the circulation of precursors of narcotic drugs and psychotropic substances, approved by the RF Government dated June 9, 2010 No. 419.

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

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

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

18. In the absence of non-departmental police security units in rural settlements or distant from settlements, it is allowed to guard premises belonging to the 2nd category by attracting legal entities licensed to carry out private security activities with the right to provide security services facilities by taking appropriate response measures to signal information of technical security equipment installed at protected facilities.

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

20. After the end of the working day, safes, metal cabinets and rooms are sealed (sealed) and handed over under protection. Premises with round-the-clock operation are not subject to surrender.

21. The order of the head of the legal entity appoints persons responsible for the storage of narcotic drugs, psychotropic substances and precursors, admitted to work with NS and PV, their precursors, and establishes the procedure for storing keys from safes, metal cabinets and premises, as well as used for sealing ( sealing) seals and sealing devices.

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

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

24. Stocks of HC and PS intended for medical use, are determined by legal entities on the basis of standards for calculating the need for the specified medicinesah, intended for medical use.

25. In pharmacies and medical organizations, on the inner sides of the doors of safes or metal cabinets in which NS and PV are stored, lists of stored narcotic and psychotropic drugs with an indication of their higher single and higher daily doses must be posted.

26. Additionally, in medical organizations in the places of storage of NS and PV, tables of antidotes for poisoning with these drugs are placed.

27. The storage of pharmaceutical substances of narcotic and psychotropic drugs in pharmacies should be carried out in bars with an indication of the higher single and higher daily doses.

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

29. Upon the expiration of a working day, NS and PO 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 formsmanufactured by organizations - manufacturers of medicines or a pharmacy.

31. It is prohibited to store NS and PV in medical organizations, manufactured by pharmacy organizations, in the absence of a label with the inscription in black paint "Poison" and containing: the designations "Internal", "External", "Eye drops", etc .; name or number pharmacythe manufacturer of the medicinal product; the name of the department (office) 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 persons: who manufactured, checked and dispensed the drug from the pharmacy organization.

32. It is allowed to store NS and PV that require protection from elevated temperature, in pharmacies, medical, research, educational institutions and drug wholesalers:

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

In rooms of the 3rd category, specially equipped with engineering and technical means of protection, - in a special area for placing refrigerators (refrigerating chambers), separated from the main storage area by a metal grill with a lockable lattice door;

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

33. Places of storage of HC and HP, requiring protection from elevated temperature (cold chamber, refrigerator, thermal container), must be equipped with temperature metering devices.

34. Poor quality NS and PV identified in a pharmacy, medical or drug wholesaler, as well as NS and PV, handed over by relatives of deceased patients to a medical institution, until they are written off and destroyed, must be stored in specially equipped temporary storage facilities.

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

(as amended by the Order of the Ministry of Health of the Russian Federation of 05.16.2003 N 205)

2.In work time The key to the safe with narcotic drugs and psychotropic substances, located in the assistant room of the prescription department, must be in the possession of 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 in the possession of the financially responsible person authorized to do so by the order of the pharmacy.

(as amended by the Order of the Ministry of Health of the Russian Federation of 05.16.2003 N 205)

There should be metal bars on the windows of the material rooms in which narcotic drugs and psychotropic substances are stored, and the doors should be upholstered with iron. After finishing work, these rooms are locked and sealed by the financially responsible person.

(as amended by the Order of the Ministry of Health of the Russian Federation of 05.16.2003 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 the Order of the Ministry of Health of the Russian Federation of 05.16.2003 N 205)

Access to the room where stocks of narcotic drugs and psychotropic substances are stored is allowed to persons directly working with them, which is formalized with an admission from the ATC authorities and an order for a pharmacy. The admission is issued a second time when one of the employees changes.

(as amended by the Order of the Ministry of Health of the Russian Federation of 05.16.2003 N 205)

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

(as amended by the Order of the Ministry of Health of the Russian Federation of 05.16.2003 N 205)

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

(as amended by the Order of the Ministry of Health of the Russian Federation of 05.16.2003 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 the Order of the Ministry of Health of the Russian Federation of 05.16.2003 N 205)

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

(as amended by the Order of the Ministry of Health of the Russian Federation of 05.16.2003 N 205)

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

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

<*> Resolution of the Government of the Russian Federation of July 28, 2000 N 577 "On the procedure for submitting information on activities related to the circulation of narcotic drugs and psychotropic substances, and registration of transactions associated with this activity" (Collected Legislation of the Russian Federation, 08.14.2000, N 33, Article 3397)

(as amended by the Order of the Ministry of Health of the Russian Federation of 05.16.2003 N 205)

The law is simple: In connection with the loss of force of the Decree of the Government of the Russian Federation of July 28, 2000 N 577, one should be guided by the adopted instead of the Decree of the Government of the Russian Federation of 04.11.2006 N 644

9. At least once a month authorized person, which is entrusted with control over the maintenance and storage of the registration journal, checks the entries in the journal, compares the actual presence of narcotic drugs and psychotropic substances with their book remains, about which on the next line after the last entry in the registration journal at the time of checking, makes a note indicating the date of verification and certifies it with his signature.

During the inventory of the inventory of the pharmacy (department of the pharmacy), the actual balances of narcotic drugs and psychotropic substances are established, for which a separate inventory list is drawn up. In the event of deviations in the removal of actual balances from book data, the head of the pharmacy is obliged to immediately notify the healthcare or pharmaceutical management body of the constituent entity of the Russian Federation about this in writing, which must conduct an official investigation within 3 to 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 in a filed, sealed, laced for months and years for five years.

(as amended by the Order of the Ministry of Health of the Russian Federation of 05.16.2003 N 205)

10. Expired narcotic drugs and psychotropic substances, battle, marriage, surrendered by relatives of deceased patients are subject to write-off in accordance with the regulation on the write-off of narcotic drugs and special prescriptions unused by cancer patients and destruction in accordance with the established procedure (Appendix 6).

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

(as amended by the Order of the Ministry of Health of the Russian Federation of 05.16.2003 N 205)

Chief
Provision Office
drug organization
and medical technology
T.G. KIRSANOVA

Chairperson
The Standing Committee
drug control
E.A. BABAYAN

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

Zakharochkina Elena Revovna
Associate Professor of the UEF Department of the Faculty of Pharmacy of the First Moscow State Medical University. THEM. Sechenov, Ph.D.

SECURITY OF THE PREMISES AND APPOINTMENT OF PERSONS RESPONSIBLE FOR STORAGE

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

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

The protection 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 a contract with a security organization, the level of engineering and technical strength of the premises, the types of technical means of protection 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 is established for storing keys from safes, metal cabinets and premises, as well as seals and sealing devices used for sealing (sealing).

By order of the head of the legal entity, the list of persons entitled to access the premises is also approved.

After the end of the working day, safes, metal cabinets and rooms are sealed (sealed) and handed over under protection. Premises with round-the-clock operation are not subject to surrender.

NS and PV 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 for registering transactions related to the circulation of narcotic drugs and psychotropic substances, approved by the Government of the Russian Federation dated 04.11.06 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 for registering operations related to the circulation of precursors of narcotic drugs and psychotropic substances, approved by the Government of the Russian Federation dated 09.06.10 No. 419 ...

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

Special requirements for the storage conditions of narcotic and psychotropic medicines for medical use in pharmacies, medical institutions, research, educational organizations and wholesale trade organizations are established by the Ministry of Health and social development Of the Russian Federation (see below - the order of the Ministry of Health and Social Development of the Russian Federation No. 397n dated 05.16.11).

STORAGE FEATURES

Special requirements for the storage conditions of narcotic drugs and psychotropic substances intended for veterinary use in pharmacy and veterinary organizations are established by the Ministry agriculture RF.

Decree of the Government of the Russian Federation of December 31, 2009 No. 1148 "On the procedure for storing narcotic drugs, psychotropic substances and their precursors" also determines that the peculiarities of storing narcotic drugs and psychotropic substances intended to ensure activities in the system of organs 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 of May 16, 2011 No. 397n "On the 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 organizations of wholesale trade in medicines "(registered with the Ministry of Justice of the Russian Federation on 02.06.11 No. 20923) approved the relevant special requirements, which define the storage characteristics.

The 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 PLCs requiring protection from elevated temperatures (cold room, refrigerator, thermal container) must be equipped with temperature meters.

STORAGE OF PRECURSORS

The storage of NS and PV 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 of 06/30/98 No. 681, is regulated by Decree of the Government of the Russian Federation No. 1148 dated December 31, 2009 "On the storage procedure narcotic drugs, psychotropic substances and their precursors ”(see MA No. 01/12. - Ed. note).

Storage of precursors listed in Tables I, II, III List IV, is regulated by the Decree of the Government of the Russian Federation of 18.08.10 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 of 08.12.11 No. 1023 "On amendments to some acts of the Government of the Russian Federation in connection with the improvement of control over the circulation of precursors of narcotic drugs and psychotropic substances").

Storage of precursors is carried out 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 allowed to work with precursors);
  • establishes the procedure for storing keys from the premises, as well as seals (sealing devices).

Legal entities and individual entrepreneurs can store and use precursors in quantities that do not exceed their production needs.

It should also be noted that the order of the Ministry of Health and Social Development of the Russian Federation dated 23.08.10 No. 706n "On approval of the Rules for the storage of medicines" (registered in the Ministry of Justice of the Russian Federation on 04.10.10 No. 18608) (as amended by the order of the Ministry of Health and Social Development of the Russian Federation dated 28.12.10 No. 1221n) approved the Rules storage of medicines, establishing requirements for rooms for storing medicines (MPs) for medical use and regulating storage conditions for these drugs, which apply to drug manufacturers, drug wholesalers, pharmacy organizations, medical and other organizations involved in drug circulation, individual entrepreneurslicensed to pharmaceutical activities or a license to practice medicine.

The storage rules for drugs include the following sections:

I. General Provisions.

II. General requirements to the arrangement and operation of premises for storing medicines.

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

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

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

Vi. Features of storage of certain groups of medicines, depending on the physical and physicochemical properties, impact on them various factors external environment.

In particular, the storage features:

√ Medicines

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

Medicines for medical use

√ Medicinal herbal raw materials.

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