Organizational issues of creating a system for ensuring the quality of storage and transportation of medicines in a medical institution. General rules for the storage of medicinal substances
| Terms | Temperature limits |
| Store at a temperature not exceeding 30 0 С | from +2 to +30 0 С |
| Store at a temperature not exceeding 25 0 С | from + 2 to + 25 0 C |
| Store at a temperature not exceeding 15 0 С | from + 2 to + 15 0 С |
| Store at a temperature not exceeding 8 0 С | from + 2 to + 8 0 С |
| Store at a temperature not lower than 8 0 C | from +8 to +25 0 С |
| Store at a temperature from 15 0 to 25 0 С | from +15 to +25 0 С |
| Store at a temperature from 8 0 to 15 0 С | from +8 0 to +15 0 C |
| Store at -5 0 to -18 0 С | from -5 0 to -18 0 C |
| Store at temperatures below -18 0 С | from - 18 0 С |
In addition to the specific indication of temperature, the following terms with temperature limits can also be used:
The distance from the storage place to the heating devices must be more than 1m.
Relative humidity
An indicator characterizing the degree of saturation of air with water vapor and is measured in%.
High humidity contributes to the occurrence of microbiological spoilage, corrosion of metal surfaces.
Relative humidity in the storage room medicines should not exceed 60% + 5% depending on the relevant climate zone, unless special conditions are specified in the normative documentation.
The “Store in a dry place” parameters correspond to humidity not higher than 50% and room temperature from +15 to +25 0 С
Checking temperature and humidity is carried out daily, at least once a day. Instrument readings are recorded in a special log (map) by a responsible person. Registration records should demonstrate the temperature and humidity regimes established for the premises, and, if they do not comply, corrective actions. An exemplary sample log is presented in Appendix 1.
Air exchange
Mode indicator characterizing the intensity and frequency of air exchange in the environment surrounding the goods. In the process of air exchange, a uniform temperature and humidity regime is created, and gaseous substances emitted by stored goods, containers, equipment, etc. are removed. Air currents can be natural (drafts) and artificial, caused by the operation of supply and exhaust ventilation, air conditioners and other equipment
Gas composition
Mode indicator characterizing the composition of air in the environment - oxygen, carbon dioxide, which can have Negative influence on the quality of medicines in case of violation of the storage regime.
illumination
Storage mode indicator characterizing the intensity of artificial and natural light in the storage room. The influence of light energy can manifest itself in the action of direct sun rays, scattered light in the visible region of the light spectrum and radiation in the ultraviolet region.
When creating storage conditions for a single medicinal product, it is necessary to be guided by the requirements specified in pharmacopoeial article or regulatory documentation for this medicinal product, established by the manufacturer or developer on the basis of the results of a stability study in accordance with the General Pharmacopoeia Monograph "Shelf life of medicinal products"
1.3. General requirements to the device and operation
Storage space
For creating optimal mode storage it is necessary that the storage room meets the license requirements and conditions:
1. Storage of medicines should be carried out in the premises intended for this purpose.
2. The device, composition, operation and equipment of premises for the storage of medicines must ensure proper storage conditions for various groups of medicines. For manufacturers of medicines, for organizations wholesale of medicines, the size of the area is also taken into account.
3. The complex of premises should include:
Premises (zone) of acceptance, designed for unpacking and acceptance of goods with a preliminary inspection
Room (area) for sampling medicines in accordance with the requirements of the General Pharmacopoeia Monograph "Sampling"
Premises (area) for quarantine storage of medicines
Room for medicines requiring special storage conditions
A room (area) for storing rejected, returned, recalled and medicinal products with expired validity. These medicinal products and their places of storage must be clearly marked.
4. The storage room must be isolated from other premises of the unit. In the absence of an isolated room, a storage area is allocated in the common room.
5. The inner surfaces of walls and ceilings must be smooth, allowing the possibility of wet cleaning.
6. The floor of the room must have a dust-free coating that is resistant to the effects of mechanization and wet cleaning using disinfectants, such as ceramic tiles. The use of wooden unpainted surfaces is not allowed. Materials for interior decoration must meet the requirements of the relevant regulatory documents.
7. Indoor storage medicines a certain temperature and humidity of the air must be maintained to ensure their storage in accordance with the requirements of drug manufacturers indicated on the primary and secondary (consumer) packaging.
In accordance with Article 58 of the Federal Law of April 12, 2010 "On the Circulation of Medicines" (Collection of Legislation Russian Federation, 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 products medical purpose, approved by the order of the Ministry of Health of the Russian Federation of November 13, 1996 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 premises for the storage of medicines for medical use(hereinafter - medicinal products), regulate the storage conditions of these medicinal products and apply to manufacturers of medicinal products, drug wholesalers, pharmacy organizations, medical and other organizations engaged in activities in the circulation of medicinal products, individual entrepreneurs licensed for pharmaceutical activity or a license to 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 air 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 to equip the premises 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 storage of medicines ( internal surfaces walls, ceilings) must 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:
physical and chemical properties medicines;
pharmacological groups(for pharmacies 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 drugs and psychotropic substances" (Sobraniye zakonodatelstva Rossiyskoy Federatsii, 1998, N 2, art. 219; 2002, N 30, art. 3033, 2003, N 2, art. 167, N 27 (part I), art. 2700; 2005 , N 19, item 1752; 2006, N 43, item 4412; 2007, N 30, item 3748, N 31, item 4011; 2008, N 52 (part 1), item 6233; 2009, N 29, article 3614; 2010, N 21, article 2525, N 31, article 4192) are stored:
narcotic and psychotropic drugs;
potent and poisonous drugs under control in accordance with international legal regulations.
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 rack 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 medicines with a limited shelf life should be carried out using computer technology, rack cards indicating the name of the medicine, 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 medicinal products according to the principle of uniformity in accordance with their physical and chemical, flammable properties and the nature of the packaging, the premises for the storage of drug wholesalers and drug manufacturers (hereinafter referred to as warehouse premises) are divided into separate premises (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 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 should provide convenient and safe movement of people, goods and Vehicle, 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. 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 are allocated, equipped with automatic fire protection and alarm systems (hereinafter referred to as rooms for storing flammable and explosive medicines).
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 medicines for medical use (in secondary (consumer) packaging) for use for one work shift in metal cabinets outside the premises for storing flammable and explosive medicines.
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 exceeding 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. When manual way 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 racks, 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, hydrogen chloride over 13%, carbolic acid, ethyl alcohol of various concentrations, etc.); medicinal plant materials containing essential oils; medicines containing crystallization water - crystalline hydrates; drugs that decompose with the formation of volatile products (iodoform, hydrogen peroxide, sodium bicarbonate); medicines 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 impermeable materials for volatile substances (glass, metal, aluminum foil) or in primary and secondary (consumer) manufacturer's packaging. 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 medicinal products requiring protection from exposure elevated temperature
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 medicinal products requiring protection from exposure low temperature
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: salts of alkali metals and weak organic acids(sodium barbital, hexenal), drugs containing polyhydric amines (eufillin), magnesium oxide and peroxide, caustic sodium, caustic potash) should be stored in hermetically sealed containers 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. Disinfectants should be stored in hermetically sealed containers in an isolated room away from plastic, rubber and metal storage facilities and distilled water production facilities.
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 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" (Sobraniye Zakonodatelstva Rossiyskoy Federatsii, 2008, N 2, Art. 89; 2010, N 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 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, alcoholic 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 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 drugs 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 medicinal products with mineral acids (especially sulfuric and nitric acids), compressed and liquefied gases, flammable substances ( vegetable oils, sulfur, dressing material), alkalis, as well as with inorganic salts, giving explosive mixtures with organic substances (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 others. organic matter- 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 spillage 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 means protection, 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 of December 31, 2009 N 1148 (Collected Legislation of the Russian Federation, 2010, N 4, Art. 394; N 25, article 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 medicines under control in accordance with international legal norms (hereinafter referred to as potent and toxic medicines 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 dated 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.
The room for the storage of basic stocks of medicines and medical products at the head nurse of the health facility unit must meet the technical, sanitary, fire and other licensing requirements and conditions, be isolated from other premises of the unit. The internal surfaces of walls and ceilings must be smooth, allowing the possibility of wet cleaning. The floor of the room must have a dust-free coating that is resistant to the effects of mechanization and wet cleaning using disinfectants. The use of wooden unpainted surfaces is not allowed. Materials for interior decoration must meet the requirements of the relevant regulatory documents.
The storage room for medicines and medical products must be equipped with special equipment to ensure their storage and proper preservation, taking into account the physicochemical, pharmacological and toxicological properties, as well as the requirements of quality standards for medicines and the State Pharmacopoeia of the Russian Federation, namely:
· Cabinets, racks, trays for storing medicines and medical products, as well as lockable metal cabinets and safes for storing certain groups of medicines;
Refrigerators for storage of thermolabile medicines;
· Devices for recording air parameters (thermometers, hygrometers or psychrometers), which are placed on the inner wall of the room away from heating devices at a height of 1.5-1.7 m from the floor and at a distance of at least 3 m from the doors;
· Detergents and disinfectants to ensure sanitary conditions.
The equipment must be resistant to the effects of wet cleaning with the use of disinfectants and meet the sanitary and hygienic, fire safety and labor protection requirements.
General requirements for the storage of medicines and medical devices
Medicines and medical devices in the departments should be stored in lockable cabinets, with the obligatory division into groups: “External”, “Internal”, “Injection”, “ Eye drops”, etc. In addition, in each compartment of the cabinet (for example, “Internal”) there should be a division of medicines into tablets, potions, etc .; powders and tablets are stored, as a rule, on the top shelf, and solutions - on the bottom.
Storage of finished medicinal products should be carried out in compliance with external conditions(modes of temperature, humidity, illumination) specified by the manufacturer in the instructions for the preparation, and general requirements. All finished medicinal products must be packed and installed in the original industrial or pharmacy packaging with the label (marking) facing out.
Tablets and dragees are stored separately from other medicines in a dry and, if necessary, protected from light place.
Dosage forms for injection should be stored in a cool, dark place in a separate cabinet (or cabinet compartment).
Liquid dosage forms(syrups, tinctures) should be stored in a dark place.
Plasma-substituting solutions are stored in isolation in a cool, dark place. Ointments, liniments are stored in a cool, dark place, in a tightly closed container. Preparations containing volatile and thermolabile substances are stored at a temperature not exceeding +10 C.
Suppositories are stored in a dry, cool, dark place.
Storage of most medicines in aerosol packages should be carried out at a temperature of +3 to +20 C in a dry, dark place, away from heating devices. Aerosol packages should be protected from shock and mechanical damage.
Infusions, decoctions, emulsions, serums, vaccines, organ preparations, solutions containing benzylpenicillin, glucose, etc., are stored only in refrigerators (+2 - +10 C).
Immunobiological preparations should be stored separately by name at the temperature indicated for each name on the label or in the instructions for use. Immunobiological preparations of the same name are stored in batches, taking into account the expiration date.
Medicinal plant materials should be stored in a dry, well-ventilated area.
Medicines with a strong odor (iodoform, lysol, ammonia, etc.) and flammable (ether, ethyl alcohol) are stored in a separate cabinet. Coloring medicines (iodine, brilliant green, etc.) are also stored separately.
Storage of medicines in the operating room, dressing room, procedural room is organized in glassed instrument cabinets or on surgical tables. Each vial, jar, package containing a medicinal product must have an appropriate label.
Narcotic drugs and psychotropic substances, potent and poisonous substances must be kept in safes. It is allowed to store narcotic drugs and psychotropic substances in metal cabinets in technically fortified premises. Safes (metal cabinets) must be kept closed. After the end of the working day, they must be sealed or sealed. Keys to safes, seals and ice-cream should be kept by financially responsible persons authorized to do so by order of the head physician of the healthcare institution.
Narcotic drugs and psychotropic substances, potent and poisonous substances obtained by medical staff, must be stored in a closed and sealed safe attached to the floor or wall in a specially designated room. On the inside the safe door contains a list of narcotic drugs and psychotropic substances, indicating the highest single and daily doses. Narcotic drugs and psychotropic substances for parenteral, internal and external use should be stored separately.
Responsible for organizing the storage and issuance of narcotic drugs and psychotropic substances to patients are the head of the health facility or his deputies, as well as persons authorized to do so by order of the health facility.
Units of healthcare facilities should have tables of higher single and daily doses of narcotic drugs and psychotropic substances, as well as tables of antidotes for poisoning by them, in places of storage and at the posts of doctors and nurses on duty. Medical products should be stored separately from medicines and in groups: rubber products, plastic products, dressings and auxiliary materials, medical equipment products.
"On approval of the Rules for the storage of medicines"
Published on October 13, 2010 Effective October 24, 2010 Registered with the Ministry of Justice of the Russian Federation on October 4, 2010 Registration No. 18608Rules 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,
- organization of wholesale trade in medicines,
- pharmacy organizations,
- medical and other organizations carrying out activities in the circulation of medicines,
- individual entrepreneurs who have a license for pharmaceutical activity or a license for medical activity (hereinafter, respectively - organizations, individual entrepreneurs).
II. General requirements for the arrangement and operation of storage facilities for medicines
2. The device, composition, size of areas (for wholesale trade organizations of medicinal products), operation and equipment of premises for the storage of medicinal products should ensure their safety.3. In the premises for the storage of medicines, certain temperature and air humidity, allowing to ensure the storage of medicines in accordance with the requirements of medicine manufacturers indicated on the primary and secondary (consumer) packaging.
4. Premises for the storage of medicines must be equipped air conditioners and other equipment to ensure the storage of medicines in accordance with the requirements of medicine manufacturers indicated on the primary and secondary (consumer) packaging, or it is recommended to equip the premises with vents, transoms, and second lattice doors.
5. Premises for the storage of medicines must be provided racks, cabinets, pallets.
6. Finishing of premises for storing medicines (internal surfaces of walls, ceilings) should be smooth and allow the possibility of wet cleaning.
III. General requirements for premises for the storage of medicinal products and the organization of their storage
7. Premises for storing medicines should be equipped with devices for registration of 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 instruments must be recorded daily in a special magazine (map) 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).
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"(Collected Legislation of the Russian Federation, 1998, No. 2, Art. 219; 2002, No. 30, Art. 3033, 2003, No. 2, Art. 167, No. 27 (part I), Art. 2700; 2005, No. 19, 1752; 2006, N 43, item 4412; 2007, N 30, item 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 drugs that are controlled in accordance with international legal norms.
Racks, cabinets, shelves intended for storage of medicines should be numbered.
Stored medicinal products must also be identified by rack 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 maintain accounting for medicines with a limited expiration date on paper or in electronic form with archiving. Control over the timely sale of medicines with a limited shelf life should be carried out using computer technology, rack cards indicating the name of the medicine, 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. When identifying drugs with expired they must be kept separately from other groups of medicines in a specially allocated and designated (quarantine) zone.
IV. Requirements for premises for the storage of flammable and explosive medicines and the organization of their storage
13. Storage rooms flammable and explosive medicines must comply with current regulations.14. In order to ensure the storage of flammable and explosive medicinal products according to the principle of uniformity in accordance with their physical and chemical, flammable properties and the nature of the packaging, the premises for the storage of drug wholesalers and drug manufacturers (hereinafter referred to as warehouse premises) are divided into separate premises (compartments) with fire resistance limit building structures for at least 1 hour.
15. Necessary for packaging and manufacturing of medicinal products for medical use on one work shift the number of flammable medicines is allowed to be kept in production and other premises. The remaining amount of flammable drugs 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 hard, even finish. 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, be of sufficient strength and withstand loads from stored materials, and ensure simplicity and ease of cleaning the warehouse.
17. Warehouses for the storage of flammable and explosive medicines must be equipped fireproof and resistant shelving and pallets, designed for the appropriate load. 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 pharmacy organizations and individual entrepreneurs, isolated premises, equipped with automatic fire protection and alarm systems (hereinafter referred to as rooms for storing flammable and explosive medicines).
19. In pharmacy organizations and individual entrepreneurs, it is allowed to store pharmaceutical substances that have flammable and combustible properties, in a volume of up to 10 kg outdoors 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 on one work shift in metal cabinets outdoors for storing flammable and explosive medicines.
20. The number 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 bulk.
Premises for the storage of flammable and explosive medicinal products used for the storage of flammable pharmaceutical substances in excess of 100 kg must be located in separate building, and the storage itself should be carried out in a glass or metal container isolated from the premises for storing flammable drugs 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. Medicines stored in warehouses should be placed on shelving or at peddlers(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 the physical and physico-chemical properties, the impact on them of 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-shielding materials(orange glass glass containers, metal containers, packaging made of aluminum foil or plastic 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 requiring protection from light, packed in primary and secondary (consumer) packaging, should be stored in cabinets or on racks, provided that measures are taken to prevent hit for these drugs direct sunlight or otherwise bright directional light(use of reflective film, blinds, visors, etc.).
Storage of medicinal products requiring protection from moisture
27. Pharmaceutical substances requiring protection against exposure to moisture should be stored in a cool place at temperatures up to + 15 deg. FROM(hereinafter - 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 glass container with hermetic closure, 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 medicinal products requiring protection from volatilization and drying out
30. Pharmaceutical substances that require protection from volatilization and drying:- actually volatile drugs;
- medicinal products containing a volatile solvent
- alcohol tinctures,
- liquid alcohol concentrates,
- thick extracts;
- solutions and mixtures of volatile substances
- essential oils,
- ammonia solutions,
- formaldehyde solutions,
- solutions of hydrogen chloride over 13%,
- solutions of carbolic acid,
- ethyl alcohol of various concentrations, etc.;
- medicinal plant materials containing essential oils;
- medicines containing crystallization water - crystalline hydrates;
- drugs that decompose to form volatile products
- iodoform,
- hydrogen peroxide,
- sodium bicarbonate;
- medicinal products with a defined lower moisture content limit
- magnesium sulfate,
- sodium paraaminosalicylate,
- sodium sulfate,
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. Storage of medicinal products requiring protection from exposure elevated temperature(thermolabile medicinal products), 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.Storage of medicines requiring protection from exposure to low temperatures
33. Storage of medicinal products requiring protection from exposure low temperature(drugs 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 drugs insulin not allowed.
Storage of medicinal products requiring protection from environmental gases
35. Pharmaceutical substances requiring protection against exposure to gases- substances that react with air oxygen:
- various compounds of the aliphatic series with unsaturated intercarbon bonds,
- cyclic 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 organ preparations;
- substances that react with carbon dioxide in the air:
- salts of alkali metals and weak organic acids (sodium barbital, hexenal),
- drugs containing polyhydric amines (eufillin), magnesium oxide and peroxide, caustic sodium, caustic potassium,
Storage of odorous and coloring medicines
36. odorous medicines (pharmaceutical substances, both volatile and practically non-volatile, but possessing strong smell) should be stored in a hermetically sealed, odor-tight container.37. Coloring medicines (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
38. To work with coloring drugs for each item, it is necessary to allocate special scales, mortar, spatula and other necessary equipment.
Storage of disinfectants
39. Disinfectants Medicinal products should be stored in a hermetically sealed container in an isolated room away from plastic, rubber and metal storage facilities and distilled water facilities.Storage of medicinal products for medical use
40. Storage of medicinal products for medical use is carried out in accordance with the requirements state pharmacopoeia and normative documentation, and also taking into account properties substances included in their composition.41. When stored in cabinets, on racks or shelves, medicinal products for medical use in secondary (consumer) packaging should be placed label(marking) outside.
42. Organizations and individual entrepreneurs must store medicinal products for medical use in accordance with requirements for their storage indicated on the secondary (consumer) packaging of the specified medicinal product.
Storage of medicinal plant materials
43. Bulk Medicinal plant materials should be stored in dry(no more than 50% humidity), well-ventilated area in a tightly closed container.44. Bulk medicinal herbal raw materials containing essential oils stored separately 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 affected by mold, barn pests, reject.
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 herbal raw materials included in the lists potent and poisonous substances approved by Decree of the Government of the Russian Federation of December 29, 2007 N 964 "On approval of 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 amounts of potent substances for the purposes of Article 234 of the Criminal Code of the Russian Federation" (Sobraniye zakonodatelstva Rossiyskoy Federatsii, 2008, N 2, Art. 89; 2010, N 28, Art. 3703), is stored in a separate room or in a separate closet under lock and key.
48. prepackaged Medicinal plant materials are stored on shelves 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.50. The content of leeches is carried out in the prescribed manner.
Storage of flammable medicines
51. Storage of flammable medicines- medicines that have flammable properties
- alcohol and alcohol solutions,
- alcohol and ether tinctures,
- alcohol and essential extracts,
- ether,
- turpentine,
- lactic acid,
- chloroethyl,
- collodion,
- cleol,
- novikov liquid,
- organic oils
- medicines that have flammable properties
- sulfur,
- glycerol,
- vegetable oils,
- medicinal herbs)
52. Flammable medicines are stored in tightly closed strong glass or metal containers to prevent evaporation fluids from vessels.
53. Bottles, cylinders and other large containers with flammable and flammable medicines should be stored on shelves 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 medicinal products in heating appliances. 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 interchangeable need. 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 not exceed 90% volume. Alcohols in large quantities are stored in metal containers, filled no more than 75% of the volume.
57. Joint storage of flammable medicinal products 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, giving explosive mixtures with organic substances
- potassium chlorate,
- potassium permanganate,
- potassium chromate, etc.
Storage of explosive medicines
59. Storage explosive drugs (drugs with explosive properties (nitroglycerin); drugs with explosive properties (potassium permanganate, silver nitrate) should be protected from dust contamination.60. Containers with explosive medicines (barrels, tin drums, bottles, etc.) must be close tight to avoid getting the vapors of these products into the air.
61. Bulk storage potassium permanganate 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 nitro glycerin stored in small well-closed bottles or metal containers in a cool, dark place, taking precautions against fire. Move dishes with nitroglycerin and weigh this drug should be in conditions that exclude spillage and evaporation of nitroglycerin, as well as its contact with the skin.
63. When working with diethyl ether shaking, blows, friction are not allowed.
64. It is prohibited to store explosive medicines with acids and alkalis.
Storage of narcotic and psychotropic medicines
65. Narcotic and psychotropic medicinal products 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 of December 31, 2009 N 1148 (Collection of Legislation Russian Federation, 2010, N 4, item 394; N 25, item 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 medicines under control in accordance with international legal norms (hereinafter referred to as potent and toxic medicines 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.
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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 exposure external factors- moisture, light, temperature and so on. The following groups of medicines are distinguished, each of which has its own storage rules:
- 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).
- 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.
- 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. Special temperature conditions require adrenaline, novocaine, antibiotics, hormonal preparations(react to temperatures above 25 ° C) and insulin solution, formaldehydes (react to low temperatures).
- 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 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?
Monitors compliance with the rules for the storage of medicines nurse. 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 temperature and air humidity parameters in the premises where medicines are stored, identify medicines on a 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;
- on the officials- from 10,000 to 20,000 thousand rubles;
- on the 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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