At what humidity are medicines stored? Features of storage of finished medicines

This document obliges to ensure the implementation of a set of measures aimed at creating a system for ensuring the quality of storage and transportation of medicines. What this system is and how it should be implemented in a pharmacy organization, she told NataliaZolotareva, Ph.D., Associate Professor of the Department of Management and Economics of Pharmacy, St. Petersburg State Chemical Pharmaceutical Academy.

In accordance with the current legislation, namely the Federal Law "On the Circulation of Medicines", pharmaceutical activities include wholesale and retail trade in medicines, storage , transportation, dispensing and manufacturing of medicines (PM). In Decree of the Government of the Russian Federation of December 22, 2011 No. 1081, for the first time, a set of works and services was specified by law, which includes pharmaceutical activities. Also, in accordance with the current regulation on licensing pharmaceutical activities, a certain set of requirements and conditions has been established that pharmaceutical organizations must comply with without fail when applying for a license or having one and carrying out relevant activities.

I would like to draw attention to one of the subparagraphs of paragraph 5 concerning licensing requirements and conditions for the storage of drugs in a pharmacy organization. Subparagraph h states that a licensee storing drugs for medical use must comply with the relevant storage rules. This subparagraph is included in the range of license requirements and conditions, the violation of which is considered gross and liability for which is established by applicable law.

TERMINOLOGY

One of the articles of the State Pharmacopoeia of the 12th edition is dedicated to the process of storing drugs, and it clearly states that this is a separate process that is an integral part of the circulation of drugs and is associated with the storage of drugs until they are used within the established expiration date.

The process of storing medicines involves solving several global problems, incl. and in connection with the introduction of new regulatory documents, therefore, organizing the storage process, it is necessary to create a quality assurance system that will allow the storage process to be carried out in accordance with the requirements of regulatory documents. It is also necessary, when organizing storage, to ensure the physical safety of the goods. And an important point is related to the fact that drugs are a product, most of which require special storage conditions. In this regard, another important task arises - the creation of conditions that ensure the stability of those properties of the goods that are declared by the manufacturer. In order to solve these problems, three areas of activity of those who are directly involved in the storage process emerge.

First- taking into account the requirements of new regulatory documents, develop a quality assurance system, and it involves a number of instructions and provisions, the so-called SOPs, and the documents provide a specific list of standard procedures that need to be developed at the organization level and approved.

Second- provide the storage process with the necessary premises, equipment that must meet the requirements established for them.

Third - creation of the necessary storage mode and organization of the placement of goods during storage (systematization).

LEGISLATION ON THE PROCESS OF STORAGE OF MEDICINES

Let's start with the regulatory framework of federal significance, with the Decree of the Government of the Russian Federation No. 1148 of December 31, 2009 "On the procedure for storing narcotic drugs and psychotropic substances." This document has been repeatedly supplemented and updated.

Of course, attention is drawn to the "Rules of good practice for the storage and transportation of drugs for medical use", approved by order of the Ministry of Health of Russia dated August 31, 2016 No. 646n and entered into force on March 1, 2017.

Also among the documents is the current order of the Ministry of Health of Russia dated August 23, 2010 No. 706n "On approval of the rules for storing medicines"; order of the Ministry of Health of July 24, 2015 No. 484n concerning the organization of storage and the creation of special regimes for narcotic drugs and psychotropic substances; the order of transportation and storage of immunobiological drugs of 2016 is determined by the relevant resolution of the Chief State Sanitary Doctor of the Russian Federation of February 17, 2016 No. 19; order of the Ministry of Health of the Russian Federation of October 21, 1997 No. 309 approves the instructions for the sanitary regime of pharmacy organizations (it received a second life in connection with the entry into force of the Rules of Good Pharmacy Practice, where special attention is paid to the procedure for cleaning premises, for which appropriate standard procedures should be developed). How to write them? The answer is obvious: based on the requirements of regulatory documents. In addition to Order No. 309, it is hardly possible to name instructions at the level of the Ministry of Health of the Russian Federation that would answer the question of how the sanitary regime should be properly organized.

Regulatory documents related to pharmacy organizations, wholesalers, and healthcare institutions are:

• order of the Ministry of Health and Social Development of Russia dated 09.01.07 No. 2 "On approval of the norms of natural loss during storage of medicines in pharmacy organizations, drug wholesalers and healthcare institutions". This document is relevant only for those organizations that are related to substances. Natural loss implies the presence of the corresponding type of work;
• order of the Ministry of Health of Russia dated 11/13/96 No. 377 "On approval of instructions for organizing storage in pharmacy organizations of various groups of drugs and medical devices";
• order of the Ministry of Health of Russia dated July 16, 1997 No. 214 of Russia "On quality control of medicines manufactured in pharmacies";
• general pharmacopoeial article OFS.1.1.0010.15 "On the storage of medicines".

QUALITY ASSURANCE SYSTEM

Let's start with document No. 646n, which entered into force on March 1, 2017. It contains certain innovations that require clarification. This document applies to a fairly large number of participants in the field of drug circulation. The first paragraph of the document states that the executors of this order are manufacturers, drug wholesalers, pharmacy organizations, individual entrepreneurs engaged in pharmaceutical activities, as well as medical organizations, including FAPs, outpatient clinics, centers of various kinds located in those settlements. points where there are no pharmacy organizations, and which are endowed with FZ-61 in 2010 with part of the authority to carry out a separate type of work and services of pharmaceutical activities.

The second section of this document attracts special attention - this is a system for ensuring the quality of storage and transportation of medicines. Speaking about the organization of storage, I would like to start with the requirements that are imposed today in terms of creating a quality assurance system.

The document clearly states that this is a wide range of responsibilities. The quality assurance system requires a very serious resource in terms of time, money, and personnel, because SOPs will have to be written by process owners, i.e. those who directly carry out certain processes of storing, receiving, dispensing medicines. At the same time, no one relieves the manager of responsibility for organizing a whole range of measures, which will maintain the appropriate quality of drugs in connection with their storage.

The quality assurance system is a set of measures that is associated with the development and approval of a number of issues. First, you must clearly state in a separate local regulatory act of the organization how you work with suppliers, according to what criteria they are selected, since this is an outpost of the procurement process and the related receipt and storage of medicines.

Order No. 646n says that standard operating procedures, the so-called SOPs, should be developed for the process of receiving, transporting, and placing medicines. This can either be a document that sets out all of these processes as a whole, or a document that can describe individual standard operating procedures. As you wish. Today, regulatory documents do not describe in any way whether you should issue everything together or separately. The forms of documents in which you record the progress of the processes should be prescribed. You must record all this in your instructions and provisions related to the drug storage process. It should also be clearly spelled out how counterfeit, substandard, counterfeit drugs are detected. Maintenance and checks of measuring instruments and equipment that should be in the storage of medicines are carried out, and it is important how to monitor compliance with standard operating procedures. They are not created in order to write and forget once on paper. There is a certain positive moment in the standard operating procedures. This is a document that, to a certain extent, formalizes the procedure for personnel actions, excluding the subjective factor, errors in the reception, transportation, placement and any other process related to pharmaceutical activities. The regulatory document suggests that standard operating procedures should live the life of a pharmacy organization, should change when there are objective reasons. The reason for making a change in the standard operating procedure may be control activities, internal audits, which should also be clearly spelled out at the organization level. All activities related to the functioning of quality assurance, storage and transportation systems are carried out by a responsible person - a quality representative. All processes must be systematized, documented, familiarized with employees and calmly work according to the developed documents.

SOP - STANDARD OPERATING PROCEDURE

SOP is an algorithm of certain actions for different processes, a document that describes step by step the set of actions that an employee of a pharmacy organization must perform in order to perform a particular procedure.

In terms of the type of standard operating procedures, there are two important regulatory documents - orders No. 646n and No. 647n. They specify verbatim what specific standard operating procedures are to be developed. But there is no clear classification of SOPs, and each organization systematizes them independently. Large companies, as a rule, allocate everything related to equipment, its verification into separate groups of SOPs, SOPs related to cleaning the premises, risk management, and even SOPs for managing SOPs can be allocated as a separate block. This is the document that will describe who is involved in the development of documents, what kind of documents they participate in, how many copies and copies of these documents, where they will be stored, updated and agreed upon. This is a huge piece of work. Therefore, where there are many standard operating procedures, SOPs are needed to manage SOPs.

SOPs are not the only document that forms the quality system documentation. The main document is the quality manual. Order No. 647n says that such a document should be developed, it provides the tactics of the organization in terms of ensuring the quality of the relevant goods, meeting consumer requirements in the implementation and implementation of one or another type of work or service. The documents of the second level are SOPs, which indicate who, what, when, with the help of what resources carries out job descriptions, etc. (including quality records).

Unfortunately, today there are no clear instructions on how this document should be drawn up, in what format. But, one way or another, when describing the process, you must answer at least a few questions: who carries out this process, with what equipment, what resources are involved, what procedures are used, what methods and how this process can be evaluated or measured . There is nothing complicated, it is only necessary to systematize a huge amount of documents and present them in a logical sequence.

Process description scheme, i.e. a standard operating procedure should typically include the following sections: the purpose of the process, its scope, responsibility, references to the documents you used to develop it, terminology if necessary, and a key section - the algorithm of actions itself and quality records.

Order No. 646n requires the development of a number of standard operating procedures, incl. to receive goods.

EXAMPLE OF SOP - RECEPTION OF MEDICINES BY A PHARMACY ORGANIZATION

It is good practice to start the SOP with an SOP identifier, which should indicate the type of document or number the procedures. According to the normative documents of the quality assurance system, you must continuously improve, take corrective and preventive measures and actions. How do you prove that they were carried out? Including changing the standard operating procedure. The second improved version will be reflected in the identifier. This will show the reviewer that your versions are working and they are changing.

1. Preparatory measures - preparation of places for the receipt of drugs (refrigeration equipment, safes, cabinets, racks, depending on the type of drugs).
2. Unloading. Upon receipt of drugs, the correctness of transportation is checked.
3. Placement of drugs. Narcotic drugs require instant transfer to safes and metal cabinets. At the next stage, the person responsible for receiving checks the accompanying documents, then the consignment note is filled in, the acceptance stamp is put, the documents are transferred to the supplier.
4. Acceptance control. There are two possible scenarios for the development of events: if everything suits the acceptance control or there are questions in terms of quality and quantity during acceptance, and then certain actions are required on the part of the responsible person. In the first case, if you agree with the delivery, a corresponding entry is made in the accompanying documents (invoice, acceptance stamp, pharmacy seal, full name and signature of the responsible person on the approval protocol) and then the process of registering the received goods in the acceptance control log, the form of which is not determined by the current regulations. It is determined by the head of the pharmacy organization. If subject-quantitative medications are received, entries are made in the appropriate journal.

In the second case, if you do not agree, either in terms of quantity or quality of medicines. In this case, the responsible officer draws up a letter of claim, the commission, on the basis of it, draws up an act on identifying discrepancies in quantity and quality upon acceptance of drugs. Such goods must be placed in a quarantine zone until the circumstances are clarified. Completion of the SOP - if the acceptance control does not reveal non-compliance with the quality requirements, the preparations should be placed at the storage sites, taking into account a separate SOP. Next, we deal with the reusable returnable packaging and transfer it to the designated area, prescribe responsibility. The document should include such positions as how and who developed (direct participant and controller), who agreed. The manager approves the standard procedure.

The golden rule of GMP: what is not documented does not exist.

REQUIREMENTS FOR PREMISES

Premises requirements are very important in terms of storage organization. They are determined by two regulatory documents: orders of the Ministry of Health No. 706n and No. 646n. The device, composition, operation and equipment of premises for storing medicines must correspond to the volume and type of work performed and, of course, ensure the safety of medicines. For pharmacy organizations, there are no requirements for the composition of premises, areas, unlike manufacturers and wholesalers. Only wet cleaning of the premises is allowed, and in accordance with the requirements of Order No. 646n, the cleaning procedure must be recorded in the SOP.

Traditionally, storage rooms should be provided with equipment in the form of racks, cabinets, pallets, and they should be identified and marked. Storage rooms are fixed and must be maintained at a certain temperature and humidity. The premises are equipped with devices for recording temperature and humidity parameters. Instruments must be maintained in good condition. A separate document should record the process of putting the equipment into operation, its verification. This may be a separate SOP.

Order No. 706n speaks of the need to account for drugs with a limited shelf life.

A pharmacy organization must have quarantine zones: one for drugs for which a decision has been made to suspend sales, another for counterfeit products, drugs with an expired shelf life, and another zone for other pharmacy products. Each pharmacological group of drugs is stored in accordance with its specifics: for example, drugs subject to subject-quantitative accounting require separate storage, etc.

Based on materials from an online seminar organized by the St. Petersburg Union of Doctors

In accordance with Article 58 of the Federal Law of April 12, 2010 "On the Circulation of Medicines" (Sobraniye Zakonodatelstva Rossiyskoy Federatsii, 2010, N 16, Art. 1815; N 31, Art. 4161) I order:

1. Approve the Rules for the storage of medicinal products in accordance with the appendix.

2. Recognize as invalid:

sections 1 and 2, paragraphs 3.1 - 3.4, 3.6 and 3.7 of section 3, sections 4 - 7, 12 and 13 Instructions for organizing storage in pharmacies of various groups of medicines and medical devices, approved by order of the Ministry of Health of the Russian Federation of November 13, 1996 g. N 377 "On approval of requirements for the organization of storage in pharmacies of various groups of medicines and medical products" (registered by the Ministry of Justice of Russia on November 22, 1996 N 1202).

Minister T. Golikova

Application

Rules for the storage of medicines

I. General provisions

1. These Rules establish requirements for storage facilities for medicinal products for medical use (hereinafter referred to as medicinal products), regulate the storage conditions for these medicinal products and apply to drug manufacturers, drug wholesalers, pharmacies, medical and other organizations that carry out activities in the circulation of medicines, individual entrepreneurs holding a license for pharmaceutical activity or a license for medical activity (hereinafter, respectively - organizations, individual entrepreneurs).

II. General device requirements

and operation of premises

storage of medicines

2. The device, composition, size of areas (for drug wholesalers), operation and equipment of premises for storing drugs should ensure their safety.

3. Premises for the storage of medicinal products must be maintained at a certain temperature and humidity to ensure the storage of medicinal products in accordance with the requirements of the medicinal product manufacturers indicated on the primary and secondary (consumer) packaging.

4. Premises for the storage of medicines must be equipped with air conditioners and other equipment to ensure the storage of medicines in accordance with the requirements of manufacturers of medicines indicated on the primary and secondary (consumer) packaging, or it is recommended that the premises be equipped with vents, transoms, second lattice doors.

5. Premises for the storage of medicines should be provided with racks, cabinets, pallets, and storage boxes.

6. Finishing of premises for storing medicines (internal surfaces of walls, ceilings) should be smooth and allow for wet cleaning.

III. General requirements for premises

for the storage of medicines

and organization of their storage

7. Premises for the storage of medicines must be equipped with devices for recording air parameters (thermometers, hygrometers (electronic hygrometers) or psychrometers). The measuring parts of these devices must be placed at a distance of at least 3 m from doors, windows and heating devices. Devices and (or) parts of devices from which visual readings are taken should be located in a place accessible to personnel at a height of 1.5-1.7 m from the floor.

The readings of these devices must be recorded daily in a special log (card) of registration on paper or in electronic form with archiving (for electronic hygrometers), which is maintained by a responsible person. The log (card) of registration is stored for one year, not counting the current one. Control devices must be certified, calibrated and verified in the prescribed manner.

8. Medicinal products are placed in the storage rooms in accordance with the requirements of the regulatory documentation indicated on the packaging of the medicinal product, taking into account:

physico-chemical properties of medicines;

pharmacological groups (for pharmacy and medical organizations);

method of application (internal, external);

aggregate state of pharmaceutical substances (liquid, bulk, gaseous).

When placing medicines, it is allowed to use computer technologies (alphabetically, by codes).

9. Separately, in technically reinforced premises that meet the requirements of the Federal Law of January 8, 1998 N 3-FZ "On Narcotic Drugs and Psychotropic Substances" (Sobranie Zakonodatelstva Rossiyskoy Federatsii, 1998, N 2, Art. 219; 2002, N 30 , Article 3033, 2003, No. 2, Article 167, No. 27 (part I), Article 2700; 2005, No. 19, Article 1752; 2006, No. 43, Article 4412; 2007, No. 30, Article 3748, N 31, item 4011; 2008, N 52 (part 1), item 6233; 2009, N 29, item 3614; 2010, N 21, item 2525, N 31, item 4192) are stored :

narcotic and psychotropic drugs;

potent and poisonous medicines, which are controlled in accordance with international legal norms.

10. Shelves (cabinets) for storing medicines in the premises for storing medicines should be installed in such a way as to ensure access to medicines, free passage of personnel and, if necessary, loading devices, as well as accessibility of shelves, walls, floors for cleaning .

Racks, cabinets, shelves intended for storing medicines must be numbered.

Stored medicinal products must also be identified using a shelf card containing information about the stored medicinal product (name, form of release and dosage, batch number, expiration date, manufacturer of the medicinal product). When using computer technology, identification using codes and electronic devices is allowed.

11. In organizations and individual entrepreneurs, it is necessary to keep records of medicines with a limited shelf life on paper or in electronic form with archiving. Control over the timely sale of medicinal products with a limited shelf life should be carried out using computer technology, rack cards indicating the name of the medicinal product, series, expiration date or expiration date registers. The procedure for keeping records of these medicines is established by the head of the organization or individual entrepreneur.

12. If expired medicinal products are identified, they must be stored separately from other groups of medicinal products in a specially designated and designated (quarantine) area.

IV. Requirements for premises

for storage of flammable

and explosive drugs

and organization of their storage

13. Premises for the storage of flammable and explosive medicines must fully comply with current regulations.

14. In order to ensure the storage of flammable and explosive medicines according to the principle of uniformity in accordance with their physical and chemical, fire hazardous properties and the nature of the packaging, the storage rooms of drug wholesalers and drug manufacturers (hereinafter referred to as storage rooms) are divided into separate rooms (compartments) with a fire resistance limit of building structures of at least 1 hour.

15. The quantity of flammable medicinal products required for packaging and manufacturing of medicinal products for medical use per one work shift may be kept in production and other premises. The remaining amount of flammable drugs at the end of work at the end of the shift is transferred to the next shift or returned to the main storage place.

16. The floors of storage rooms and unloading areas should have a hard, even surface. It is forbidden to use boards and iron sheets to level the floors. Floors must provide convenient and safe movement of people, goods and vehicles, have sufficient strength and withstand loads from stored materials, ensure simplicity and ease of cleaning the warehouse.

17. Warehouses for the storage of flammable and explosive medicines must be equipped with fireproof and stable racks and pallets designed for the appropriate load. The racks are installed at a distance of 0.25 m from the floor and walls, the width of the racks should not exceed 1 m and, in the case of storing pharmaceutical substances, have flanges of at least 0.25 m. Longitudinal aisles between the racks should be at least 1.35 m.

18. For the storage of flammable and explosive medicines in pharmacies and individual entrepreneurs, isolated rooms equipped with automatic fire protection and alarm systems (hereinafter referred to as rooms for storing flammable and explosive medicines) are allocated.

19. In pharmacies and individual entrepreneurs, it is allowed to store pharmaceutical substances with flammable and combustible properties in a volume of up to 10 kg outside the premises for storing flammable and explosive medicines in built-in fireproof cabinets. Cabinets must be removed from heat-removing surfaces and passages, with doors not less than 0.7 m wide and not less than 1.2 m high. Free access must be organized to them.

It is allowed to store explosive medicinal products for medical use (in secondary (consumer) packaging) for use for one work shift in metal cabinets outside the premises for storing flammable and explosive medicinal products.

20. The amount of flammable medicines allowed for storage in storage rooms for flammable and explosive medicines located in buildings for other purposes should not exceed 100 kg in bulk.

Premises for the storage of flammable and explosive medicinal products used for the storage of flammable pharmaceutical substances in quantities over 100 kg must be located in a separate building, and the storage itself must be carried out in glass or metal containers isolated from the premises for the storage of flammable medicinal products of other groups.

21. It is forbidden to enter the premises for the storage of flammable and explosive medicines with open sources of fire.

V. Features of the organization of storage of medicines

in warehouses

22. Medicinal products stored in warehouses should be placed on racks or on undercarriages (pallets). It is not allowed to place medicines on the floor without a pallet.

Pallets can be placed on the floor in one row or on racks in several tiers, depending on the height of the rack. It is not allowed to place pallets with medicines in several rows in height without the use of racks.

23. With the manual method of unloading and loading operations, the height of the stacking of medicines should not exceed 1.5 m.

When using mechanized devices for unloading and loading operations, medicinal products should be stored in several tiers. At the same time, the total height of placing medicines on the racks should not exceed the capabilities of mechanized handling equipment (lifts, trucks, hoists).

VI. Features of storage of certain groups of medicines depending on

on physical and physico-chemical properties, exposure to various environmental factors

Storage of medicines requiring protection from light

24. Medicines that require protection from the action of light are stored in rooms or specially equipped places that provide protection from natural and artificial lighting.

25. Pharmaceutical substances that require protection from light should be stored in containers made of light-protective materials (orange glass glass containers, metal containers, packaging made of aluminum foil or polymeric materials painted black, brown or orange), in a dark room or cabinets. .

For the storage of pharmaceutical substances that are especially sensitive to light (silver nitrate, prozerin), glass containers are pasted over with black opaque paper.

26. Medicinal products for medical use that require protection from the action of light, packed in primary and secondary (consumer) packaging, should be stored in cabinets or on shelves, provided that measures are taken to prevent direct sunlight or other bright directional light from reaching these medicinal products (use of reflective film, blinds, visors, etc.).

Storage of medicinal products requiring protection from moisture

27. Pharmaceutical substances that require protection from moisture should be stored in a cool place at temperatures up to + 15 degrees. C (hereinafter referred to as a cool place), in a tightly closed container made of materials impervious to water vapor (glass, metal, aluminum foil, thick-walled plastic containers) or in the manufacturer's primary and secondary (consumer) packaging.

28. Pharmaceutical substances with pronounced hygroscopic properties should be stored in a glass container with a hermetic seal, filled with paraffin on top.

29. In order to avoid damage and loss of quality, storage of medicinal products should be organized in accordance with the requirements indicated in the form of warning labels on the secondary (consumer) packaging of the medicinal product.

Storage of medicines requiring protection

from volatilization and drying

30. Pharmaceutical substances that require protection from volatilization and drying (actually volatile drugs; drugs containing a volatile solvent (alcohol tinctures, liquid alcohol concentrates, thick extracts); solutions and mixtures of volatile substances (essential oils, solutions of ammonia, formaldehyde, chloride hydrogen over 13%, carbolic acid, ethyl alcohol of various concentrations, etc.); medicinal plant materials containing essential oils; medicinal products containing crystallization water - crystalline hydrates; medicinal products that decompose with the formation of volatile products (iodoform, hydrogen peroxide, sodium bicarbonate ); drugs with a certain lower limit of moisture content (magnesium sulfate, sodium paraaminosalicylate, sodium sulfate) should be stored in a cool place, in a hermetically sealed container made of materials impervious to volatile substances (glass, metal, aluminum foil) or in primary and secondary (consumer) packaging of the manufacturer. The use of polymer containers, packaging and capping is allowed in accordance with the requirements of the State Pharmacopoeia and regulatory documentation.

31. Pharmaceutical substances - crystalline hydrates should be stored in hermetically sealed glass, metal and thick-walled plastic containers or in the manufacturer's primary and secondary (consumer) packaging under conditions that comply with the requirements of regulatory documentation for these medicinal products.

Storage of medicines requiring protection from exposure to elevated temperatures

32. Organizations and individual entrepreneurs should store medicinal products that require protection from exposure to elevated temperatures (thermolabile medicinal products) in accordance with the temperature regime indicated on the primary and secondary (consumer) packaging of the medicinal product in accordance with the requirements of regulatory documentation.

Storage of medicines requiring protection from exposure to low temperatures

33. Storage of medicines that require protection from exposure to low temperatures (medicines whose physical and chemical state changes after freezing and is not restored upon subsequent warming to room temperature (40% formaldehyde solution, insulin solutions) organizations and individual entrepreneurs must carry out in accordance with the temperature regime indicated on the primary and secondary (consumer) packaging of the medicinal product in accordance with the requirements of regulatory documentation.

34. Freezing of insulin preparations is not allowed.

Storage of medicinal products requiring protection from environmental gases

35. Pharmaceutical substances that require protection from exposure to gases (substances that react with atmospheric oxygen: various aliphatic compounds with unsaturated intercarbon bonds, cyclic compounds with side aliphatic groups with unsaturated intercarbon bonds, phenolic and polyphenolic, morphine and its derivatives with unsubstituted hydroxyl groups; sulfur-containing heterogeneous and heterocyclic compounds, enzymes and organic preparations; substances that react with atmospheric carbon dioxide: alkali metal salts and weak organic acids (sodium barbital, hexenal), drugs containing polyhydric amines (eufillin), magnesium oxide and peroxide, sodium hydroxide, caustic potash) should be stored in a hermetically sealed container made of materials impervious to gases, if possible filled to the top.

Storage of odorous and coloring medicines

36. Odorous medicinal products (pharmaceutical substances, both volatile and practically non-volatile, but with a strong odor) should be stored in a hermetically sealed container, impervious to odor.

37. Coloring medicinal products (pharmaceutical substances that leave a colored mark that is not washed off by ordinary sanitary and hygienic treatment on containers, closures, equipment and inventory (brilliant green, methylene blue, indigo carmine) should be stored in a special cabinet in a tightly closed container.

38. To work with coloring medicines, it is necessary to allocate special scales, a mortar, a spatula and other necessary equipment for each item.

Storage of disinfectants

39. Disinfectant medicines should be stored in hermetically sealed containers in an isolated room away from the storage of plastic, rubber and metal products and rooms for obtaining distilled water.

Storage of medicines

for medical use

40. Storage of medicinal products for medical use is carried out in accordance with the requirements of the state pharmacopoeia and regulatory documentation, as well as taking into account the properties of the substances that make up them.

41. When stored in cabinets, on racks or shelves, medicinal products for medical use in secondary (consumer) packaging must be placed with the label (marking) outward.

42. Organizations and individual entrepreneurs must store medicinal products for medical use in accordance with the requirements for their storage indicated on the secondary (consumer) packaging of the specified medicinal product.

Medicinal storage

vegetable raw materials

43. Bulk medicinal plant materials should be stored in a dry (no more than 50% humidity), well-ventilated area in a tightly closed container.

44. Bulk medicinal plant materials containing essential oils are stored in isolation in a well-closed container.

45. Bulk medicinal plant materials must be subject to periodic control in accordance with the requirements of the state pharmacopoeia. Grass, roots, rhizomes, seeds, fruits that have lost their normal color, smell and the required amount of active substances, as well as those affected by mold, barn pests, are rejected.

46. ​​Storage of medicinal plant materials containing cardiac glycosides is carried out in compliance with the requirements of the State Pharmacopoeia, in particular, the requirement for repeated control for biological activity.

47. Bulk medicinal plant materials included in the lists of potent and toxic substances approved by Decree of the Government of the Russian Federation of December 29, 2007 N 964 "On approval of the lists of potent and toxic substances for the purposes of Article 234 and other articles of the Criminal Code of the Russian Federation, as well as large size of potent substances for the purposes of Article 234 of the Criminal Code of the Russian Federation" (Sobranie Zakonodatelstva Rossiyskoy Federatsii, 2008, No. 2, Art. 89; 2010, No. 28, Art. 3703), is stored in a separate room or in a separate cabinet under lock and key.

48. Packaged medicinal herbal raw materials are stored on racks or in cabinets.

Storage of medicinal leeches

49. Storage of medical leeches is carried out in a bright room without the smell of medicines, for which a constant temperature regime is established.

Storage of flammable

medicines

51. Storage of flammable medicines (medicines with flammable properties (alcohol and alcohol solutions, alcohol and ether tinctures, alcohol and ether extracts, ether, turpentine, lactic acid, chloroethyl, collodion, cleol, Novikov liquid, organic oils); drugs with flammable properties (sulfur, glycerin, vegetable oils, medicinal plant materials) should be carried out separately from other drugs.

52. Flammable medicines are stored in tightly sealed strong glass or metal containers to prevent the evaporation of liquids from the vessels.

53. Bottles, cylinders and other large containers with flammable and easily combustible medicines should be stored on the shelves of racks in one row in height. It is forbidden to store them in several rows in height using different cushioning materials.

It is not allowed to store these medicines near heating devices. The distance from the rack or stack to the heating element must be at least 1 m.

54. Storage of bottles with flammable and highly combustible pharmaceutical substances should be carried out in containers that protect against impacts, or in cylinder-tilters in one row.

55. At the workplaces of industrial premises allocated in pharmacy organizations and individual entrepreneurs, flammable and easily combustible medicines can be stored in quantities not exceeding the shift requirement. At the same time, the containers in which they are stored must be tightly closed.

56. It is not allowed to store flammable and easily combustible medicines in fully filled containers. The degree of filling should be no more than 90% of the volume. Alcohols in large quantities are stored in metal containers, filled no more than 75% of the volume.

57. Joint storage of flammable medicines with mineral acids (especially sulfuric and nitric acids), compressed and liquefied gases, flammable substances (vegetable oils, sulfur, dressings), alkalis, as well as with inorganic salts that give explosive explosives with organic substances is not allowed. mixtures (potassium chlorate, potassium permanganate, potassium chromate, etc.).

58. Medical ether and ether for anesthesia are stored in industrial packaging, in a cool, dark place, away from fire and heating devices.

Storage of explosive

medicines

59. When storing explosive drugs (drugs with explosive properties (nitroglycerin); drugs with explosive properties (potassium permanganate, silver nitrate), measures should be taken to prevent contamination with dust.

60. Containers with explosive drugs (barrels, tin drums, bottles, etc.) must be tightly closed to prevent vapors of these drugs from getting into the air.

61. Storage of bulk potassium permanganate is allowed in a special compartment of storage facilities (where it is stored in tin drums), in barbells with ground stoppers separately from other organic substances - in pharmacies and individual entrepreneurs.

62. Bulk solution of nitroglycerin is stored in small, well-closed bottles or metal containers in a cool, dark place, taking fire precautions. Move dishes with nitroglycerin and weigh this drug should be in conditions that exclude the spill and evaporation of nitroglycerin, as well as its contact with the skin.

63. When working with diethyl ether, shaking, shock, friction are not allowed.

Storage of narcotic

and psychotropic drugs

65. Narcotic and psychotropic drugs are stored in organizations in isolated rooms specially equipped with engineering and technical security equipment, and in places of temporary storage, subject to the requirements in accordance with the Rules for the Storage of Narcotic Drugs and Psychotropic Substances established by Decree of the Government of the Russian Federation dated December 31, 2009 No. N 1148 (Sobraniye zakonodatelstva Rossiyskoy Federatsii, 2010, N 4, art. 394; N 25, art. 3178).

Storage of potent and poisonous medicines,

medicines subject to

subject-quantitative accounting

66. In accordance with Decree of the Government of the Russian Federation of December 29, 2007 N 964 "On approval of the lists of potent and toxic substances for the purposes of Article 234 and other articles of the Criminal Code of the Russian Federation, as well as large quantities of potent substances for the purposes of Article 234 of the Criminal Code of the Russian Federation" potent and toxic drugs include drugs containing potent and toxic substances included in the lists of potent and toxic substances.

67. Storage of potent and poisonous drugs under control in accordance with international legal norms (hereinafter referred to as potent and toxic drugs under international control) is carried out in premises equipped with engineering and technical security equipment similar to those provided for the storage of narcotic and psychotropic drugs.

68. Potent and poisonous medicines under international control and narcotic and psychotropic medicines may be stored in one technically fortified room.

At the same time, the storage of potent and poisonous medicines should be carried out (depending on the volume of stocks) on different shelves of the safe (metal cabinet) or in different safes (metal cabinets).

69. Storage of potent and poisonous medicines not under international control is carried out in metal cabinets sealed or sealed at the end of the working day.

70. Medicines subject to subject-quantitative accounting in accordance with the order of the Ministry of Health and Social Development of the Russian Federation of December 14, 2005 N 785 "On the procedure for dispensing medicines" (registered with the Ministry of Justice of the Russian Federation on January 16, 2006 N 7353 ), with the exception of narcotic, psychotropic, potent and poisonous medicines, are stored in metal or wooden cabinets, sealed or sealed at the end of the working day.

Order N 646n in paragraph 3 gives the head of the subject of medicines circulation (hereinafter referred to as the MD) the obligation to ensure a set of measures for employees to comply with the rules for storing and (or) transporting the MD. In this case, the subject of treatment means any of the organizations that are subject to the said order, including a medical organization and its separate divisions (outpatient clinics, feldsher and feldsher-obstetric stations, centers (departments) of general medical (family) practice) located in rural areas. settlements in which there are no pharmacy organizations. It follows from the above that every medical organization involved in the storage of medicines must comply with the “new” rules of good practice for their storage from 2017.

A set of measures for the head of a medical organization is called a quality system and includes a wide variety of actions to ensure compliance with the Storage and Transportation Rules. In particular, for the implementation of a quality system for the storage of medicinal products of a medical organization, it is required:

1. Approve the regulations for employees to take actions during the storage and transportation of medicines.
2. Approve the procedures for servicing and checking measuring instruments and equipment.
3. Approve the order of keeping records in journals, reporting procedures.
4. Ensure compliance with standard operating procedures.

At the same time, the new rules for the storage and transportation of medicines require the head of a medical organization to additionally approve documents regulating the procedure for receiving, transporting, and placing medicines. These actions are referred to as standard operating procedures.

Approval of regulations (standard operating procedures) for employees to take actions during storage and transportation of medicines

To introduce a quality system and perform standard operating procedures, the head of the medical organization issues an order and instructs the responsible person to develop and submit for approval the regulations (instructions) for performing various actions during the storage of the medicinal product. A specific list of such instructions has not been established by the Rules of Good Storage Practice. Taking into account the “breakdown” of standard operating procedures for the reception, transportation and placement of medicines, it is advisable to divide the process of storing medicines in a medical organization into the same stages and detail each stage in the instructions, for example, approve the following documents:

1. Instructions for accepting medicines from the carrier

The instruction on the procedure for taking medicines from the carrier (transport organization) should fix the list of actions of an employee of a medical organization upon receipt of a batch of medicines and contain instructions on what circumstances the employee should find out when drawing up documents for each batch of medicines. Thus, the employee should be aware that, in accordance with the Good Practices for Storage and Transportation, drugs with a shorter expiration date are first dispensed for transportation. The remaining shelf life is agreed with the recipient of the medicinal product in preparation for transportation. If the residual shelf life of the medicinal product is short, it is better for the medical organization, when agreeing to receive the medicinal product, to refuse such a supply in order to avoid the subsequent write-off of the entire received batch.

When accepting a medicinal product, the employee must check the compliance of the received drug with the accompanying documentation for the assortment, quantity and quality (checks the name, quantity of drugs with the consignment note or consignment note and invoice, checks the appearance of the container).

As part of the standard operating procedures, a medical organization, before taking medicines, must plan the transportation of medicines with an analysis and assessment of possible risks. In particular, before delivery, the carrier finds out if the medicinal product has special storage conditions and whether the carrier will be able to provide them during transportation. Despite the fact that this is the responsibility of the carrier, and not the medical organization, the latter also has an interest in the knowledge of the transport company about the conditions for transporting a particular drug in order to get it suitable for use. In this connection, it is recommended, at the request of the carrier, to provide full information about the qualitative features of medicinal products, the conditions for their storage and transportation, including temperature, illumination, requirements for containers and packaging.

Separately, it is worth dwelling on the packaging. An employee who takes medicines should pay attention to the quality of the packaging, as well as the presence on the packaging of information about the name, series of transported drugs, their release date, number of packages, name and location of the drug manufacturer, their expiration date and storage conditions, transportation . The absence of this information may indirectly indicate possible violations of the conditions of transportation or even counterfeit goods. If discrepancies are found, or damage to the container, the drugs should not be taken - they must be returned to the supplier with the preparation of an appropriate act and the implementation of the return procedure provided for by the contract. An employee of a medical organization must be instructed on the procedure for processing the procedure for returning such goods.

According to the new Rules of Good Practice for Storage and Transportation, carrier employees sent on a flight are instructed on the procedure for preparing insulated containers for the transportation of medicines (taking into account seasonal characteristics), as well as on the possibility of reusing ice packs. In addition to the new transport regulations, they must take into account the instructions for the preparations, as well as the transport conditions mentioned in other regulations. For example, the conditions for the transportation of immunobiological medicinal products are contained in SP 3.3.2.3332-16, approved. Decree of the Chief State Sanitary Doctor of the Russian Federation of February 17, 2016 N 19, which, among other things, categorically prohibits the use of cold chain equipment for the joint transportation of these drugs and food, other medicines, raw materials, materials, equipment and items that may affect the quality of the transported drugs or damage their packaging. When transporting the ILS, the readings of each thermoindicator should be monitored when loading and unloading preparations, the readings are recorded in a special log of the movement of the ILS twice a day - at the first, second and third levels of the "cold chain", and once a day on working days - at fourth level. Also, the journal should record the facts of planned or emergency shutdown of refrigeration equipment, breakdowns and violations of the temperature regime.

In real life, of course, one cannot rely on the carrier's strict observance of the specified obligations to instruct its employees, as well as on the responsible attitude of such employees to the performance of their labor functions. During transportation, it is difficult to exclude the human factor that leads to a violation of the conditions of transportation - in order to save money, faulty ice packs are used several times, food and other raw materials are placed along with medicines, the temperature is entered in the journal "as you like", usually right before arriving at the recipient of the medicine. There are cases when the carrier's refrigeration equipment is not equipped with thermometers at all or they do not work, always showing the same value. It happens that the arrived car, due to technical characteristics or due to the laid route, obviously could not meet the requirements of the temperature regime, but was released by the transport company on a flight.

Although the rules of transportation require that information be communicated to the sender and recipient of medicinal products about cases of violation of the temperature regime of storage and damage to the package detected during the transportation of the medicinal product, in practice, of course, this requirement is not always observed. Carriers are unwilling to accept the risk of compensation for damages due to non-compliance with the rules of carriage and may seek to conceal this information.

All these points must be taken into account when accepting the medicinal product and noted in the instructions of the employee of the medical organization that, if there are reasonable doubts about the observance of the temperature regime and other conditions during transportation, the identified circumstances should be reflected in documentary form and reported to the management. The new storage rules give the medical organization the right to send a request to the supplier with a request to confirm the fact that the conditions for transporting a particular drug have been met. If such confirmation is not received, the organization has the right to refuse to accept medicinal products delivered in violation of the conditions of transportation.

2. Instructions on the placement (transportation) of medicinal products in the storage area

The instructions should reflect that when an employee accepts medicines, the transport container is cleaned of visual contamination - it is wiped, dust, stains, etc. are removed, and only after that it is brought into the premises or storage area of ​​the medicinal product, and further storage of the medicinal product is carried out taking into account the requirements registration dossier for medicinal products, instructions for medical use, information on packages, on transport containers.

The instructions should describe the rules for the placement of medicinal products, taking into account the Rules of Good Storage Practice. It is worth noting, and conveying to the employee, what should not be done: for example, place medicines on the floor without a pallet, place pallets on the floor in several rows, store food products, tobacco products with medicines, etc.

Since, in accordance with the Rules of Good Storage Practice, shelves (cabinets) for storing medicinal products must be labeled, must have shelf cards located in a visible zone, and ensure the identification of medicinal products in accordance with the accounting system used by the Subject of Medicines Circulation, in the instructions for storage drugs and the employee's job description should reflect the obligation to label racks (cabinets) and fill out rack cards.

If a medical organization uses an electronic data processing system instead of rack cards, it is the responsibility of the employee to fill in the data in such a system. New storage rules allow the identification of drugs in such a system using codes. This means that there is no need to enter the full names of the types of drugs or their locations each time - it is enough to assign a code for one or another value and approve the code correspondence table, which greatly simplifies office work.

Because storage conditions and humidity must be maintained in rooms and areas that correspond to the storage conditions specified in the registration dossier of the medicinal product, the instructions for medical use and on the packaging, the instructions for the placement of medicinal products should mention the placement of drugs in accordance with the indicated modes and the obligation track changes in temperature and humidity by an employee.

In the same instruction, it is permissible to reflect the procedures for cleaning the premises (zones) for storing medicines - they are carried out in accordance with standard operating procedures that are the same for all subjects of medicines storage. In this case, standard operating procedures mean the measures described in Section 11 SanPin 2.1.3.2630-10 "Sanitary and epidemiological requirements for organizations engaged in medical activities" - these measures are the same in relation to all premises of a medical organization (with some exceptions): at least 2 times a day, general cleaning at least once a month, window washing at least 2 times a year, etc. In the instructions for storage, you can simply make a reference to the instructions for wet cleaning of the premises of a medical organization, so as not to clutter up the document with unnecessary information.

An employee of a medical organization must be instructed that persons who do not have access rights defined by standard operating procedures are not allowed into the premises (zones) for storing medicines, i.e. persons whose official duties are not related to the reception, transportation, placement and use of medicines.

3. Instructions on the storage of medicinal products requiring special storage conditions

This document should analyze the points of storage of various categories of drugs, for example, note that the storage of flammable and explosive drugs is carried out away from fire and heating devices, and workers need to exclude mechanical impact on such drugs. It should be fixed in the instruction that medicinal products subject to quantitative accounting, with the exception of narcotic, psychotropic, potent and poisonous drugs, are stored in metal or wooden cabinets, sealed or sealed at the end of the working day. The list of such drugs is established by Order of the Ministry of Health of Russia dated April 22, 2014 N 183n, an employee of a medical organization must know this list and be able to sort drugs based on the specified list.

Medicinal preparations containing narcotic drugs and psychotropic substances must be stored in accordance with the legislation of the Russian Federation on narcotic drugs and psychotropic substances - first of all, taking into account the requirements of the Order of the Ministry of Health of Russia dated July 24, 2015 N 484n. Thus, this Order prescribes the storage of narcotic and psychotropic medicines in premises belonging to the 4th category, or in places of temporary storage in safes (containers) located in the appropriate premises or places. Therefore, the worker who was given the keys to the safe must be identified. Typically, such an employee is a financially responsible person and receives a key “under signature”. In the instructions, it is worth noting the inadmissibility of handing over the keys to strangers, the procedure for handing over the key to the post and the ban on taking the keys home.

The specified order also indicates that after the end of the working day, narcotic and psychotropic drugs must be returned to the place of main storage of narcotic and psychotropic drugs - the medical worker should be charged with checking compliance with this requirement and reflect the procedure for detecting shortages.

In medical organizations, on the inner sides of the doors of safes or metal cabinets where these medicines are stored, lists of stored medicines should be posted indicating their highest single and highest daily doses. Additionally, tables of antidotes for poisoning with these agents are placed in storage places in medical organizations. It would be correct to assign to a specific employee the obligation to generate these lists and monitor the relevance of the information contained in them.

Medical organizations must store narcotic and psychotropic drugs manufactured by drug manufacturers or a pharmacy organization, therefore, the instructions may indicate the inadmissibility of self-manufacturing of such drugs by an employee. The safe or cabinet with the indicated drugs is sealed or sealed at the end of the working day - the sealing procedure should also be reflected in the instructions.

Storage of medicinal products containing potent and toxic substances, which are under control in accordance with international legal norms, is carried out in premises equipped with engineering and technical security equipment similar to those provided for the storage of narcotic and psychotropic medicinal products. The list of such drugs is contained in Decree of the Government of the Russian Federation of December 29, 2007 N 964. Taking into account these requirements, a medical organization must provide a security alarm, familiarize employees with the principles of its operation, appoint an employee responsible for maintaining this system (personal service or with the help of a third-party contract organizations).

Note: all finished medicinal products must be packed and installed in the original packaging with the label (marking) facing out. On racks, shelves, cabinets, a rack card is attached, which indicates the name of the medicine, series, expiration date, quantity. The card is entered for each newly received series to control its timely implementation.

Features of storage of odorous and coloring medicines

Odorous. Volatile and practically non-volatile drugs with a strong odor: ammonia solution, validol, tar, ichthyol, iodoform, camphor, menthol, phenol, essential oils, etc.

Odorous substances should be stored separately in a hermetically sealed container, impervious to smell, separately by name. drugs and parapharmaceutical products.

Coloring. Substances, solutions and mixtures that leave a coloring mark on containers, closures, equipment that cannot be washed off by conventional processing: brilliant green, potassium permanganate, methylene blue, riboflavin, furacillin, ethacridine lactate, etc.

Coloring substances must be stored in a special cabinet in a tightly closed container, separately by name. To work with dyes, for each item, it is necessary to allocate special scales, a mortar, a spatula, etc.

Features of storage of disinfectants

Disinfectants (chloramine B, etc.) should be stored in a hermetically sealed container, in a cool place protected from light, in an isolated room, away from the storage of plastic, rubber and metal products from the premises for obtaining purified water.

Rules for the storage of medicines within the framework of order 706n

The storage of medicines is regulated by the order of the Ministry of Health and Social Development of the Russian Federation of August 23, 2010 N 706n "On Approval of the Rules for the Storage of Medicines".

Order 706n provides a classification of drugs that require protection from external factors - moisture, light, temperature, and so on. The following groups of medicines are distinguished, each of which has its own storage rules:

1. medicines that require protection from exposure to a humid environment and light;

The room for such drugs should be inaccessible to light and well ventilated, the air in the room should be dry, the permissible humidity should be up to 65%. This group includes, for example, silver nitrate, iodine (react to light) and hygroscopic substances (react to moisture).

1. medicines that, if stored improperly, can dry out and volatilize;

This group includes alcohols, ammonia, ethers and formaldehydes. Preparations of this group require a certain temperature regime - from 8 to 15 ° C.

1. drugs that require a special temperature regime;

Drugs exposed to high or low temperatures are stored strictly in accordance with the recommended temperatures indicated by the manufacturer on the primary or secondary packaging of medicines. Adrenaline, novocaine, antibiotics, hormonal drugs (react to temperatures above 25 ° C) and insulin solution, formaldehydes (react to low temperatures) require a special temperature regime.

1. medicines that are affected by gases contained in the environment.

This group includes organ preparations, morphine and so on. The packaging of drugs should not be damaged, the room should not have intense lighting and extraneous odors. The recommended temperature regime is observed - from 15 to 25 ° С.

Where to store medicines?

Medicines are placed in specially designated places - cabinets, open shelves and refrigerators. If drugs are narcotic or are subject to quantitative accounting, the cabinet in which they are placed is sealed to restrict access to it.

Storage rooms for medicines should have opening windows, refrigerators and air conditioners to ensure the right temperature. A thermometer and a hygrometer are installed to determine the temperature and humidity level in the room where the preparations are stored. These appliances are located away from radiators and windows.

How to decipher the terms of storage of medicines?

The conditions for storing medicines are described on the packaging or shipping container, in the instructions for use. Information about the storage conditions of medicines is also placed on the shipping container in the form of handling and warning signs - "Do not throw", "Protect from sunlight" and the like.

Sometimes it is difficult for health workers to decipher the storage conditions of medicines indicated on the packages. For example, the manufacturer indicated that the medicine should be stored at room temperature or in a cool place. What is room temperature? Cool - how many degrees Celsius?

The State Pharmacopoeia of the Russian Federation gave a breakdown of the recommended storage conditions for medicines:

• 2 - 8 °C - providing a cold place (storage in the refrigerator);
• 8 - 15 °С - cool conditions;
• 15 - 25 °C - room temperature.

Storage in a freezer provides for a temperature regime of medicines from -5 to -18 ° C, storage in deep freezing conditions - a temperature regime below -18 ° C.

Medicines with special storage conditions

Special storage conditions for medicines are observed for the following medicines:

• Explosive and flammable.
• Psychotropic and narcotic drugs.

Explosive medicines must not be shaken or hit when moving. They are stored away from radiators and daylight.

Requirements for the storage of narcotic drugs are specified in the Federal Law "On Narcotic Drugs and Psychotropic Substances". Premises for the storage of such drugs are equipped with additional security measures in accordance with the order of the Ministry of Internal Affairs and the Federal Drug Control Service of the Russian Federation No. 855/370 of September 11, 2012 and the order of the Ministry of Health of the Russian Federation No. 484n of July 24, 2015. The essence of the regulatory requirements is that the premises where psychotropic and narcotic drugs are stored must be additionally strengthened. Medicines are stored in metal cabinets and safes that are subject to sealing. Similar rules have been established for medicines subject to subject-quantitative accounting.

How to control the storage of medicines?

A nurse monitors compliance with the rules for storing medicines. This is stated in the order of the Ministry of Health of the Russian Federation dated July 23, 2010 No. 541n. Nurses on duty and senior nurses once per shift record the temperature and humidity parameters in the rooms where medicines are stored, identify medicines on the shelf card, and keep records of medicines with a limited shelf life. Expired medicines are placed in a quarantine area and stored separately from other medicines, and then they are transferred for disposal.

According to article 14.43 of the Code of Administrative Offenses of the Russian Federation, violation of the requirements for the storage of medicines entails the imposition of an administrative fine:

• for citizens - from 1,000 to 2,000 thousand rubles;
• for officials - from 10,000 to 20,000 thousand rubles;
• for legal entities - from 100,000 to 300,000 thousand rubles.

-Roszdravnadzor reported on law enforcement practice for the second quarter of 2017,- comments medical lawyer Alexei Panov. - About a thousand inspections of compliance with the rules for storing medicines were carried out, in 528 cases violations were committed. Administrative fines imposed on 26 million rubles.

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