On the approval of the rules for the storage of medicines 706. Storage of medicinal leeches. Storage of medicines requiring protection from moisture
The minister
T. Golikova
Registered
at the Ministry of Justice
Russian Federation
October 4, 2010
registration N 18608
Application. Storage rules for medicines
Application
to the order of the Ministry
health and social
development of the Russian Federation
dated August 23, 2010 N 706n
I. General Provisions
1. These Rules establish the requirements for storage facilities medicines for medical use(hereinafter - medicines), regulate the storage conditions of these medicines and apply to manufacturers of medicines, drug wholesalers, pharmacy organizations, medical and other organizations operating in the circulation of medicines, individual entrepreneurs licensed to pharmaceutical activities or a license for medical activity (hereinafter referred to as organizations, individual entrepreneurs).
II. General requirements for the design and operation of premises for storing medicines
2. The device, composition, size of areas (for manufacturers of medicines, wholesalers of medicines), operation and equipment of premises for storing medicines must ensure their safety (paragraph as amended, entered into force on February 22, 2011.
3. Premises for storing medicinal products must maintain a certain temperature and humidity of the air to ensure the storage of medicinal products in accordance with the requirements of manufacturers of medicinal products specified on the primary and secondary (consumer) packaging.
4. Premises for storing medicinal products must be equipped with air conditioners and other equipment to ensure the storage of medicinal products in accordance with the requirements of manufacturers of medicinal products specified 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 storing medicines should be provided with racks, cabinets, pallets, and supplies.
6. Finishing of premises for storing medicines ( inner surfaces walls, ceilings) must be smooth and allow for wet cleaning.
III. General requirements for premises for storing medicines and organizing their storage
7. Premises for storing medicines should be equipped with devices for recording air parameters (thermometers, hygrometers (electronic hygrometers) or psychrometers). The measuring parts of these devices must be located at a distance of at least 3 m from doors, windows and heating devices. The devices and (or) parts of the devices from which the readings are visually read should be located in an accessible place for personnel at a height of 1.5-1.7 m from the floor.
The readings of these instruments should be recorded daily in special magazine(card) registration on paper or in in electronic format with archiving (for electronic hygrometers), which is maintained by the responsible person. The log (card) of registration is kept for one year, not counting the current one. Control devices must be certified, calibrated and verified in accordance with the established procedure.
8. Medicines are placed in 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 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 technology(alphabetically, by codes).
9. Separately, in technically fortified 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, N 2, Article 219; 2002, N 30, Art 3033, 2003, No. 2, Art. 167, No. 27 (part I), Art. 2700; 2005, No. 19, Art. 1752; 2006, No. 43, Art. 4412; 2007, No. 30, Art. 3748, No. 31, Article 4011; 2008, No. 52 (part 1), Article 6233; 2009, No. 29, Article 3614; 2010, No. 21,
Article 2525, No. 31, Article 4192) are stored:
narcotic and psychotropic drugs;
potent and poisonous medicines controlled in accordance with international legal regulations.
10. Racks (cabinets) for storing medicines in rooms for storing medicines should be installed in such a way as to provide access to medicines, free passage of personnel and, if necessary, loading devices, as well as accessibility of racks, walls, floor for cleaning ...
Racks, cabinets, shelves intended for storing medicines must be identified (paragraph as amended, entered into force on February 22, 2011 by order of the Ministry of Health and Social Development of Russia dated December 28, 2010 N 1221n.
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 by means of 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, shelf cards indicating the name of the medicinal product, batch, expiration date or shelf life logs. The procedure for keeping records of these medicines is established by the head of the organization or an individual entrepreneur.
12. If medicines with an expired shelf life are identified, they should be stored separately from other groups of medicines in a specially designated and designated (quarantine) zone.
IV. Requirements for premises for storing flammable and explosive medicinal products and organizing their storage
13. Premises for storing flammable and explosive drugs must fully comply with current regulations.
14. Premises for storing medicinal products in drug wholesalers and drug manufacturers (hereinafter - warehouse premises) are divided into separate premises (compartments) with a fire resistance limit of building structures of at least 1 hour in order to ensure the storage of flammable and explosive medicinal products according to the principle of homogeneity in accordance with their physicochemical, fire hazard properties and the nature of the packaging
15. Necessary for packing and manufacturing drugs for medical use, the amount of flammable drugs may be kept in production and other premises per work shift. 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 site.
16. Floors storage facilities and unloading areas must have a firm, level surface. It is forbidden to use boards and iron sheets for leveling the floors. Floors must provide a comfortable and safe movement people, cargo and vehicles, have sufficient strength and withstand the loads from the stored materials, ensure the simplicity and ease of cleaning the warehouse.
17. Warehouses for storing flammable and explosive drugs should be equipped with non-combustible 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 have, in the case of storing pharmaceutical substances, flanges of at least 0.25 m. Longitudinal aisles between the racks should be at least 1.35 m.
18.In pharmacy organizations and individual entrepreneurs are allocated isolated rooms equipped with automatic fire protection and alarms for storing flammable pharmaceutical substances and explosive drugs (paragraph as amended, entered into force on February 22, 2011 by order of the Ministry of Health and Social Development of Russia dated December 28, 2010 N 1221n.
19. Pharmacy organizations and individual entrepreneurs are allowed to store pharmaceutical substances with flammable and combustible properties in a volume of up to 10 kg outside the premises for storing flammable pharmaceutical substances and explosive medicines in built-in fireproof cabinets. Cabinets must be removed from heat-dissipating surfaces and passages, with doors at least 0.7 m wide and at least 1.2 m high.Free access to them must be organized (the paragraph was supplemented from February 22, 2011 by order of the Ministry of Health and Social Development of Russia dated December 28, 2010 year N 1221n.
It is allowed to store explosive medicinal products for medical use (in secondary (consumer) packaging) for use per one work shift in metal cabinets outside the premises for storing flammable pharmaceutical substances and explosive medicinal products (the paragraph was supplemented from February 22, 2011 by order of the Ministry of Health and Social Development of Russia dated December 28 2010 N 1221n.
20. The amount of flammable pharmaceutical substances allowed for storage in rooms for storing flammable pharmaceutical substances and explosive drugs located in buildings for other purposes should not exceed 100 kg in bulk.
Premises for storing flammable pharmaceutical substances and explosive drugs used for storing flammable pharmaceutical substances in amounts exceeding 100 kg should be located in a separate building, and storage itself should be carried out in glass or metal containers, isolated from premises for storing other groups of flammable pharmaceutical substances ...
(Clause as amended, entered into force on February 22, 2011 by order of the Ministry of Health and Social Development of Russia dated December 28, 2010 N 1221n.
21. It is prohibited to enter the premises for storing flammable pharmaceutical substances and explosive medicines with open sources of fire (clause supplemented from February 22, 2011 by order of the Ministry of Health and Social Development of Russia dated December 28, 2010 N 1221n.
V. Peculiarities of organizing the storage of medicines in warehouses
22. Medicines stored in warehouses should be placed on racks or on pallets. It is not allowed to place medicines on the floor without a pallet.
Pallets can be located 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 using racks.
23. When manual way for 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, medicines should be stored in several tiers. Wherein total height placing medicines on racks should not exceed the capabilities of mechanized loading and unloading facilities (lifts, autocars, hoists).
23_1. The area of storage facilities must correspond to the volume of stored medicines, but be at least 150 sq. M, including:
drug acceptance area;
area for the main storage of medicines;
expedition area;
premises for medicines requiring special storage conditions.
(The item is additionally included from February 22, 2011 by order of the Ministry of Health and Social Development of Russia dated December 28, 2010 N 1221n)
Vi. Features of storage of certain groups of medicines, depending on the physical and physicochemical properties, the impact on them of various environmental factors
Storage of medicines requiring protection from light
24. Medicines requiring protection from light are stored in rooms or specially equipped places that provide protection from natural and artificial light.
25. Pharmaceutical substances requiring protection from light should be stored in containers made of light-protective materials ( glass containers orange glass, metal containers, packaging from aluminum foil or polymer materials colored black, brown or orange colors), v dark room or closets.
For storage of pharmaceutical substances that are especially sensitive to light (silver nitrate, proserin), 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 direct sunlight or other strong directed light from falling on the specified medicinal products. (use of reflective film, blinds, visors, etc.).
Storage of medicines requiring protection from moisture
27. Pharmaceutical substances requiring protection from moisture should be stored in a cool place at temperatures up to + 15 degrees. С (hereinafter referred to as a cool place), in a tightly sealed container made of materials impermeable 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 an airtight seal, filled with paraffin on top.
29. In order to avoid spoilage and loss of quality, storage of medicinal products should be organized in accordance with the requirements applied 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 requiring protection against volatilization and drying out (volatile medicinal products themselves; medicinal products containing volatile solvent ( alcoholic tinctures, liquid alcohol concentrates, thick extracts); solutions and mixtures volatile matter (essential oils, solutions of ammonia, formaldehyde, hydrogen chloride over 13%, carbolic acid, ethanol 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 materials impermeable to volatile substances (glass, metal, aluminum foil) or in primary and secondary (consumer) manufacturer's packaging. The use of polymer containers, packaging and closures is allowed in accordance with the requirements of the state pharmacopoeia and regulatory documents.
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 meet the requirements of regulatory documents for these medicinal products.
Storage of medicines requiring protection from exposure to high temperatures
32. Storage of medicinal products requiring protection from exposure elevated temperature(thermolabile medicines), organizations and individual entrepreneurs should carry out in accordance with temperature regime indicated on the primary and secondary (consumer) packaging of the medicinal product in accordance with the requirements of regulatory documents.
Storage of medicines requiring protection from exposure to low temperatures
33. Storage of medicinal products requiring protection from exposure low temperature(medicines, the physicochemical state of which after freezing changes and upon subsequent warming up to room temperature not recoverable (40% formaldehyde solution, insulin solutions) organizations and individual entrepreneurs should 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 documents.
34. Freezing of insulin preparations is not allowed.
Storage of medicines requiring protection from exposure to gases contained in the environment
35. Pharmaceutical substances requiring protection from the effects of gases (substances that react with atmospheric 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 organopreparations; substances that react with carbon dioxide in the air: salts of alkali metals and weak organic acids (sodium barbital, hexenal), drugs containing polyatomic amines (aminophylline), magnesium oxide and peroxide, sodium hydroxide, caustic potassium), should be stored in a hermetically sealed container made of materials impermeable 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 possessing strong smell) should be stored in a hermetically sealed, odor-proof container.
37. Coloring drugs (pharmaceutical substances that leave a colored mark that cannot be washed off by ordinary sanitary and hygienic processing on containers, closures, equipment and inventory (brilliant green, methylene blue, indigo carmine) should be stored in a special cabinet in a tightly sealed container.
38. To work with coloring drugs for each item, it is necessary to allocate special scales, a mortar, a spatula and other necessary equipment.
Storage of disinfectants
39. Disinfectant medicines should be stored in a hermetically sealed container in an isolated room away from the storage rooms for plastic, rubber and metal products and the 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 documents, as well as taking into account the properties of the substances included in their composition.
41. When stored in cabinets, on racks or shelves, medicinal products for medical use in secondary (consumer) packaging must be placed outside with the label (marking).
42. Organizations and individual entrepreneurs must store medicinal products for medical use in accordance with the storage requirements specified on the secondary (consumer) packaging of the said medicinal product.
Storage of medicinal plant materials
43. Bulk medicinal plant materials should be stored in a dry (no more than 50% humidity), well-ventilated room in a tightly closed container.
44. Bulk medicinal herbal raw materials containing essential oils are stored isolated in a well-closed container.
45. Bulk medicinal plant raw materials should 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 ingredients, 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 raw 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 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 potent substances for the purposes of Article 234 of the Criminal Code of the Russian Federation "(Collected Legislation of the Russian Federation, 2008, No. 2, Article 89; 2010, No. 28, Article 3703), is stored in a separate room or in a separate cabinet under lock and key.
48. Packaged medicinal plant materials are stored on racks or in cabinets.
Storage of medicinal leeches
49. Storage of medicinal leeches is carried out in a light, odorless room 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's liquid, organic oils); medicines with flammable properties (sulfur, glycerin, vegetable oils, bulk medicinal herbal raw materials) should be carried out separately from other medicines (paragraph as amended, put into effect on February 22, 2011 by order of the Ministry of Health and Social Development of Russia dated December 28, 2010 N 1221n.
52. Flammable medicines are stored in tightly sealed strong, glass or metal containers to prevent evaporation of liquids from the vessels.
53. Bottles, cylinders and other large containers with flammable and flammable drugs should be stored on the shelves in one row in height. It is forbidden to store them in several rows in height using various cushioning materials.
The storage of the indicated medicinal products near heating devices is not allowed. The distance from the rack or stack to the heating element must be at least 1 m.
54. The storage of bottles with flammable and flammable pharmaceutical substances should be carried out in containers that protect against impacts, or in balloon tilters in one row.
55. At the workplaces of production facilities allocated in pharmacy organizations and individual entrepreneurs, flammable and flammable medicines can be stored in quantities that do not exceed the replacement requirement. In this case, the containers in which they are stored must be tightly closed.
56. It is not allowed to store flammable and flammable medicines in a fully filled container. The filling degree should be no more than 90% of the volume. Large quantities of alcohols are stored in metal containers filled to no more than 75% of their volume.
57. Joint storage of flammable medicines with mineral acids (especially sulfuric and nitric acids), compressed and liquefied gases, flammable substances ( vegetable oils, gray, dressings), alkalis, as well as 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 medicinal products
59. When storing explosive medicinal products (medicinal products with explosive properties (nitroglycerin); medicinal products with explosive properties (potassium permanganate, silver nitrate), measures should be taken against their contamination with dust.
60. Containers with explosive drugs (barbells, tin drums, flasks, etc.) must be tightly closed to prevent vapors of these agents from entering 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 bars with ground-in corks separately from other organic substances - in pharmacies and individual entrepreneurs.
62. Bulk nitroglycerin solution is stored in small well-sealed vials or metal containers in a cool, dark place, taking precautions against fire. Moving dishes with nitroglycerin and weighing this drug should be in conditions that exclude the spilling and evaporation of nitroglycerin, as well as contact with the skin.
63. When working with diethyl ether, shaking, impacts, friction are not allowed.
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 means of 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, Art. 3178).
Storage of potent and poisonous medicines, medicines subject to quantitative accounting
66. In accordance with the decree of the Government of the Russian Federation of December 29, 2007 N 964 "On approval of lists of potent and poisonous 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 "potent and poisonous medicines include medicines containing potent and toxic substances included in the lists of potent substances and toxic substances.
67. The storage of potent and poisonous medicines under control in accordance with international legal norms (hereinafter referred to as potent and poisonous medicines under international control) is carried out in premises equipped with engineering and technical means of protection, similar to those provided for the storage of narcotic and psychotropic medicines.
68. It is allowed to store in one technically fortified room strong and poisonous medicines under international control and narcotic and psychotropic medicines.
In this case, the storage of potent and poisonous drugs should be carried out (depending on the volume of reserves) on different shelves of the safe (metal cabinet) or in different safes (metal cabinets).
69. The storage of strong 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 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, they are stored in metal or wooden cabinets, sealed or sealed at the end of the working day.
Document revision taking into account
changes and additions prepared
JSC "Codex"
1. These Rules establish requirements for premises for storing medicinal products for medical use (hereinafter referred to as medicinal products), regulate the storage conditions for these medicinal products and apply to manufacturers of medicinal products, drug wholesalers, pharmacy organizations, medical and other organizations carrying out activity in the circulation of medicines, individual entrepreneurs with a license for pharmaceutical activity or a license for medical activity (hereinafter, respectively, organizations, individual entrepreneurs).
Judicial practice and legislation - Order of the Ministry of Health and Social Development of the Russian Federation of 08/23/2010 N 706n (as amended on 12/28/2010) On approval of the Rules for the storage of medicines
The storage of medicines is carried out in accordance with the Rules for the storage of medicines, approved by the order of the Ministry of Health and social development Of the Russian Federation dated August 23, 2010 N 706n (hereinafter - the Order).
System classification example
Medical supplies
Systemic classification of neurosurgical instruments
1. Cutting
a) Scissors
- Neurosurgical
- Vascular
2. Sawing
- Wire saw Jigli (2 handles + guide)
3. Biting
a) Nippers
- For opening the skull according to Dahlgren
- Egorova-Freidina
- For laminectomy
4. Drilling
- Bracket with a set of cutters and drills
5. Stitching
- Cannulas for puncturing the ventricles of the brain are blunt, etc.
Approximate scheme commodity analysis
Medical and pharmaceutical products
1. Title.
2. Classification group.
3. Appointment.
4. Commercial types, standard sizes.
6. Design features.
7. Technical requirements (quality control methods).
8. Packaging.
9. Marking.
10. Storage, transportation.
11. Sterilization, disinfection.
QUESTIONS TO CREDIT
1. Subject and tasks of medical and pharmaceutical commodity science. Significance in the system of training pharmacists.
2. A brief historical overview of the emergence and development of the production of medical technology.
3. Standardization and its significance. Types of normative and technical documentation.
4. Indicators of the quality of medical and pharmaceutical products. Methods for determining quality.
5. Basic concepts of plastics. Classification of plastics. Disinfection, storage of plastic products.
6. Metallic materials used for the manufacture of medical equipment (cast iron, steel). Carbon steel grades.
7. Alloyed steels. Characteristics of stainless steels.
8. Characteristics of non-ferrous metals and products from them.
9. Basics of the technological process of manufacturing medical products from metal.
10. Corrosion of surgical instruments, anti-corrosion measures.
11. Glass. The technological process of obtaining glass products. Classification of types of glass and characteristics of medical glass products.
12. Composition and technological process of obtaining porcelain and earthenware products. Vices ceramic products, the difference between porcelain and earthenware. Packing and storing them.
13. Characteristics of medical equipment: medical instruments, apparatus, devices, equipment.
14. Container, packaging, packaging materials, closures. Packing functions.
15. The role of packaging as a marketing tool.
16. Classification of packaging and basic requirements for it.
17. Classification of containers. Requirements for packaging.
18. Marking of goods. Information signs. Trademarks.
19. Equipment for physiotherapy: electrotherapy, light therapy. Hydrotherapy equipment. Ultrasound therapy devices. Equipment for aerosol therapy.
20. Characterization of absorbable suture materials. Packaging, storage, sterilization.
21. Characteristics of non-absorbable suture materials. Packaging, storage, sterilization.
22. Classification of surgical needles by design features. Requirements, methods for determining quality, storage conditions.
23. Characteristics of special-purpose syringes.
24. Characteristics of general-purpose syringes.
25. Characteristics of tubular needles. Design, material, assortment, methods of quality determination.
26. Characteristics of equipment for transfusion, injection and suction.
27. Classification of surgical instruments.
28. Classification of cutting (scissors) general surgical instruments. Design, methods for determining quality.
29. Classification of cutting (knives) general surgical instruments. Technical requirements for them.
30. Characteristics of sawing and gouging general surgical instruments. Requirements for them.
31. Characteristics of biting and scraping general surgical instruments.
32. Characteristics of hemostatic and gastrointestinal clamping instruments for general surgical purposes.
33. Characteristics of needle holders, linen and auxiliary general surgical instruments.
34. Characteristics of expanding and pushing back surgical instruments.
35. Characteristics of cutting ophthalmic instruments.
36. Characteristics of clamping, expanding and pushing back ophthalmic instruments.
37. Characteristics of cutting otorhinolaryngological instruments.
38. Characteristics of dilating, probing and auxiliary instruments used in otorhinolaryngology.
39. Characteristics of the instruments used in urology.
40. Characteristics of instruments used in obstetric practice.
41. Characteristics of gynecological instruments.
42. Dental equipment.
43. Characteristics of products for therapeutic dentistry.
44. Characteristics of instruments for dental surgery.
45. Characteristics of instruments for orthopedic dentistry, dental work.
46. Characteristics of medical diagnostic devices for measurement blood pressure, anthropometry, spirometry.
47. Characteristics of medical diagnostic partings for auscultation, percussion, study of tendon reflexes.
48. Instruments and devices for laboratory research.
49. Medical plaster. Tools and devices used when working with plaster.
50. Means of transport and medical immobilization. Devices, requirements for them. Kits and instruments used for osteosynthesis.
51. Endoscopic devices, their characteristics (cystoscopes, urethrocystoscopes).
52. Endoscopic devices, their characteristics (gastroscope, thorascope, bronchoesophagoscope).
53. Endoscopic devices, their characteristics (urethroscope, rectoscope, cystolithotripter).
54. Safety regulations for the operation of medical equipment.
55. Mineral waters. Classification of medicinal mineral waters... Storage procedure, transportation.
56. General requirements to the organization of storage of medicines and products medical purpose.
57. Requirements for the arrangement and operation of storage facilities in pharmacies.
58. Features of storage of medicines requiring protection from light.
59. Features of storage of medicines requiring protection from moisture.
60. Peculiarities of storage of medicinal products requiring protection from volatilization.
61. Features of storage of medicines requiring protection from exposure to high and low temperatures.
62. Features of storage of medicines requiring protection from exposure to gases.
63. Features of storage of odorous and coloring medicines.
64. Features of storage of medicinal plant materials.
65. Storage of rubber products.
66. Storage of dressings, auxiliary materials.
67. Storage of medical equipment.
68. Requirements for storage rooms for flammable and explosive materials.
69. Storage of flammable substances.
70. Storage of explosive substances.
71. Ingredients that make up the rubber compound. Technological processes manufacturing of rubber products. Natural process aging of rubber, factors that accelerate this process.
72. Methods of shaping rubber products. Curing. Indicators of the quality of rubber products.
73. Characteristics of rubber products obtained by the dipping method. Quality control methods.
74. Characteristics of rubber products obtained by manual gluing. Methods for determining quality.
75. Characteristics of molded rubber products. Methods for determining quality.
76. Methods for obtaining tubular rubber products. Description of the assortment. Methods for determining quality.
77. Characteristics of medical cotton wool. Quality indicators of medical absorbent cotton wool.
78. Characteristics of gauze and alignin. Quality indicators. Sterilization and storage.
79. Classification of ready-made dressings, their characteristics.
80. Equipment for grinding and weighing. Devices for dispensing liquids and bulk solids. Filtration equipment.
81. Characteristics of the means of small-scale mechanization of pharmacies.
82. Steam sterilizers different types... Device, principle of operation, technical data.
83. Apparatus for distillation. The device, the principle of operation.
84. Medical oxygen. Ways to get it.
85. Cylinders for compressed gases, their design, color, storage, operation. Transportation.
86. The main units of the oxygen-breathing apparatus. Oxygen inhalers.
87. Classification of spectacle lenses by optical properties, by shape. Requirements for the quality of spectacle lenses.
88. Optical properties of the eye. Refraction of the eye and its abnormalities.
89. Spectacle frames, classification, individual selection. Special glasses.
90. Characteristics of a device for the study of visual acuity, for measuring intraocular pressure.
LITERATURE
Main literature:
1. Dremova, N.B. Medical and pharmaceutical commodity science: tutorial for students studying in the specialty 040500 "Pharmacy" / NB Dremova. - Kursk: KSMU, 2005 .-- 520 p.
2. Medical and pharmaceutical commodity science: a textbook for students medical universities/ S.Z. Umarov [and others]. - M .: GEOTAR-MED, 2003 .-- 368 p.
Order of the Ministry of Health and Social Development of the Russian Federation of 08.23.2010 N 706n
Note to the document
Comes into force 10 days after the day of official publication.
Document's name
Order of the Ministry of Health and Social Development of the Russian Federation of 08.23.2010 N 706n
"On approval of the Rules for the storage of medicines"
(Registered in the Ministry of Justice of the Russian Federation on 04.10.2010 N 18608)
MINISTRY OF HEALTH AND SOCIAL DEVELOPMENT
RUSSIAN FEDERATION
ON THE APPROVAL OF THE STORAGE RULES OF MEDICINAL PRODUCTS
Pursuant to article 58 Federal law of April 12, 2010 N 61-FZ "On the Circulation of Medicines" (Collected Legislation of the Russian Federation, 2010, N 16, Art. 1815; N 31, Art. 4161) I order:
1. To approve the Rules for the storage of medicinal products in accordance with the appendix.
2. To declare 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 different groups medicines and medical products, approved by 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).
T.A. GOLIKOVA
Application
to the Order
Ministry of Health
and social development
Russian Federation
STORAGE RULES FOR MEDICINES
1. These Rules establish requirements for premises for storing medicinal products for medical use (hereinafter referred to as medicinal products), regulate the storage conditions for these medicinal products and apply to manufacturers of medicinal products, drug wholesalers, pharmacy organizations, medical and other organizations carrying out activity in the circulation of medicines, individual entrepreneurs with 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 premises
storage of medicines
2. The arrangement, composition, dimensions of areas (for organizations of wholesale trade in medicinal products), operation and equipment of premises for storing medicinal products must ensure their safety.
3. Premises for storing medicinal products must maintain a certain temperature and humidity of the air to ensure the storage of medicinal products in accordance with the requirements of manufacturers of medicinal products specified on the primary and secondary (consumer) packaging.
4. Premises for storing medicinal products must be equipped with air conditioners and other equipment to ensure the storage of medicinal products in accordance with the requirements of manufacturers of medicinal products specified 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 storing medicines should be provided with racks, cabinets, pallets, and supplies.
6. Finishing of premises for storing medicines (inner surfaces of walls, ceilings) should be smooth and allow for wet cleaning.
III. General requirements for storage rooms
medicines and the organization of their storage
7. Premises for storing medicines should be equipped with devices for recording air parameters (thermometers, hygrometers (electronic hygrometers) or psychrometers). The measuring parts of these devices must be located at a distance of at least 3 m from doors, windows and heating devices. Devices and (or) parts of devices from which the readings are visually read should be located in an accessible place for personnel at a height of 1.5 - 1.7 m from the floor.
The readings of these devices must be recorded on a daily basis in a special register (card) on paper or in electronic form with archiving (for electronic hygrometers), which is maintained by the responsible person. The log (card) of registration is kept for one year, not counting the current one. Control devices must be certified, calibrated and verified in accordance with the established procedure.
8. Medicines are placed in storage rooms in accordance with the requirements of the regulatory documentation indicated on the packaging of the medicinal product, taking into account:
physicochemical 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 fortified premises that meet the requirements of the Federal Law of January 8, 1998 N 3-FZ "On Narcotic Drugs and psychotropic substances ah "(Collected Legislation of the Russian Federation, 1998, N 2, Art. 219; 2002, N 30, Art. 3033; 2003, N 2, Art. 167, N 27 (Part I), Art. 2700; 2005, N 19, art. 1752; 2006, N 43, art. 4412; 2007, N 30, art. 3748, N 31, art. 4011; 2008, N 52 (part I), art. 6233; 2009, N 29, Art.3614; 2010, N 21, Art. 2525, N 31, Art.4192), stored:
narcotic and psychotropic drugs;
potent and poisonous medicines controlled in accordance with international legal standards.
10. Racks (cabinets) for storing medicines in rooms for storing medicines should be installed in such a way as to provide access to medicines, free passage of personnel and, if necessary, loading devices, as well as accessibility of racks, walls, floor for cleaning ...
Racks, cabinets, shelves for storing medicines should 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 by means of 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, shelf cards indicating the name of the medicinal product, batch, expiration date or shelf life logs. The procedure for keeping records of these medicines is established by the head of the organization or an individual entrepreneur.
12. If medicines with an expired shelf life are identified, they should be stored separately from other groups of medicines in a specially designated and designated (quarantine) zone.
IV. Requirements for storage rooms for flammable
and explosive drugs
and organizing their storage
13. Premises for storing flammable and explosive drugs must fully comply with current regulations.
14.In order to ensure the storage of flammable and explosive drugs according to the principle of homogeneity in accordance with their physicochemical, fire hazard properties and the nature of the packaging, premises for storage of drug wholesalers and drug manufacturers (hereinafter - warehouse premises) are divided into separate rooms (compartments) with a fire resistance of building structures of at least 1 hour.
15. The amount of flammable medicinal products required for packaging and manufacturing of medicinal products for medical use per 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 site.
16. The floors of warehouses and unloading areas should have a hard, even surface. It is forbidden to use boards and iron sheets for leveling the floors. The floors should provide convenient and safe movement of people, goods and vehicles, have sufficient strength and withstand the loads from the stored materials, provide simplicity and ease of cleaning the warehouse.
17. Warehouses for storing flammable and explosive drugs should be equipped with non-combustible 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 have, in the case of storing pharmaceutical substances, 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 drugs in pharmacy organizations and individual entrepreneurs, isolated rooms are allocated, equipped with automatic fire protection and alarms (hereinafter - rooms for storing flammable and explosive drugs).
19. Pharmacy organizations and individual entrepreneurs are 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 drugs in built-in non-combustible cabinets. Cabinets must be removed from heat-dissipating surfaces and passages, with doors at least 0.7 m wide and at least 1.2 m high. Free access to them must be organized.
It is allowed to store explosive medicinal products for medical use (in secondary (consumer) packaging) for use per 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 rooms for storing flammable and explosive medicines located in buildings for other purposes should not exceed 100 kg in bulk.
Premises for storing flammable and explosive medicinal products used for storing flammable pharmaceutical substances in an amount over 100 kg should be located in a separate building, and storage itself should be carried out in glass or metal containers, isolated from premises for storing flammable medicinal products of other groups.
21. It is prohibited to enter premises for storing flammable and explosive medicinal products 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 racks or on pallets. It is not allowed to place medicines on the floor without a pallet.
Pallets can be located 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 using racks.
23. In the case of a manual method of unloading and loading, the height of placing medicinal products should not exceed 1.5 m.
When using mechanized devices for unloading and loading operations, medicines 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 loading and unloading facilities (lifts, autocars, hoists).
Vi. Features of storage of certain groups of medicinal
funds depending on physical and physical-chemical
properties, the impact on them of various
factors external environment
from the action of light
24. Medicines requiring protection from light are stored in rooms or specially equipped places that provide protection from natural and artificial light.
25. Pharmaceutical substances requiring protection from light should be stored in containers made of light-shielding materials (glass containers of orange glass, metal containers, packaging made of aluminum foil or polymer materials painted in black, brown or orange colors), in a dark room or closets ...
For storage of pharmaceutical substances that are especially sensitive to light (silver nitrate, proserin), 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 direct sunlight or other strong directed light from falling on the specified medicinal products. (use of reflective film, blinds, visors, etc.).
Storage of medicines requiring protection
from moisture
27. Pharmaceutical substances requiring 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 sealed 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 an airtight seal, filled with paraffin on top.
29. In order to avoid spoilage and loss of quality, storage of medicinal products should be organized in accordance with the requirements applied 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 requiring protection against volatilization and drying out (volatile medicinal products themselves; medicinal products 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 raw materials containing essential oils; medicinal products containing crystallization water - crystalline hydrates; medicinal products that decompose with the formation of volatile products (iodoform, hydrogen peroxide, bicarbonate sodium); medicinal products 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 impermeable to volatile substances (glass, metal, aluminum foil) or in primary and secondary (consumer) packaging of the manufacturer. The use of polymer containers, packaging and closures is allowed in accordance with the requirements of the state pharmacopoeia and regulatory documents.
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 meet the requirements of regulatory documents for these medicinal products.
Storage of medicines requiring protection
from exposure to high temperatures
32. Organizations and individual entrepreneurs should store medicinal products requiring 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 documents.
Storage of medicines requiring protection
from exposure to low temperatures
33. Storage of medicines requiring protection from exposure to low temperatures (medicines, the physical and chemical state of which after freezing changes and upon subsequent warming to room temperature is not restored (40% formaldehyde solution, insulin solutions)), organizations and individual entrepreneurs should 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 documents.
34. Freezing of insulin preparations is not allowed.
Storage of medicines requiring protection
from exposure to gases contained in environment
35. Pharmaceutical substances requiring protection from the effects of gases (substances that react with atmospheric 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 organopreparations; substances that react with carbon dioxide in the air: salts of alkali metals and weak organic acids (sodium barbital, hexenal), drugs containing polyatomic amines (aminophylline), magnesium oxide and peroxide, sodium hydroxide, caustic potassium) should be stored in a hermetically sealed container made of materials impermeable to gases, filled to the top if possible.
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 drugs (pharmaceutical substances that leave a colored mark that cannot be washed off by ordinary sanitary and hygienic processing on containers, closures, equipment and inventory (brilliant green, methylene blue, indigo carmine)) should be stored in a special cabinet in a tightly sealed container ...
38. To work with coloring drugs for each item, it is necessary to allocate special scales, a mortar, a spatula and other necessary equipment.
Storage of disinfectants
39. Disinfectant medicines should be stored in a hermetically sealed container in an isolated room away from the storage rooms for plastic, rubber and metal products and the 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 documents, as well as taking into account the properties of the substances included in their composition.
41. When stored in cabinets, on racks or shelves, medicinal products for medical use in secondary (consumer) packaging must be placed outside with the label (marking).
42. Organizations and individual entrepreneurs must store medicinal products for medical use in accordance with the storage requirements specified on the secondary (consumer) packaging of the said medicinal product.
Storage of medicinal plant materials
43. Bulk medicinal plant materials should be stored in a dry (no more than 50% humidity), well-ventilated room in a tightly closed container.
44. Bulk medicinal herbal raw materials containing essential oils are stored isolated in a well-closed container.
45. Bulk medicinal plant raw materials should 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, granary 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 raw 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 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 "(Collected Legislation of the Russian Federation, 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 plant materials are stored on racks or in cabinets.
Storage of medicinal leeches
49. Storage of medicinal leeches is carried out in a light, odorless room 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 ethereal tinctures, alcohol and ether extracts, ether, turpentine, lactic acid, chloroethyl, collodion, cleol, Novikov's liquid, organic oils); medicinal means with flammable properties (sulfur, glycerin, vegetable oils, medicinal plant raw materials)) should be carried out separately from other medicines.
52. Flammable medicines are stored in tightly sealed strong, glass or metal containers to prevent evaporation of liquids from the vessels.
53. Bottles, cylinders and other large containers with flammable and flammable drugs should be stored on the shelves in one row in height. It is forbidden to store them in several rows in height using various cushioning materials.
The storage of the indicated medicinal products near heating devices is not allowed. The distance from the rack or stack to the heating element must be at least 1 m.
54. The storage of bottles with flammable and flammable pharmaceutical substances should be carried out in containers that protect against impacts, or in balloon tilters in one row.
55. At the workplaces of industrial premises allocated in pharmacy organizations and individual entrepreneurs, flammable and flammable medicines can be stored in quantities that do not exceed the replacement requirement. In this case, the containers in which they are stored must be tightly closed.
56. It is not allowed to store flammable and flammable medicines in a fully filled container. The filling degree should be no more than 90% of the volume. Large quantities of alcohols are stored in metal containers filled to no more than 75% of their 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 inorganic salts that give 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 medicinal products
59. When storing explosive medicinal products (medicinal products with explosive properties (nitroglycerin); medicinal products with explosive properties (potassium permanganate, silver nitrate)), measures should be taken against their contamination with dust.
60. Containers with explosive drugs (barbells, tin drums, flasks, etc.) must be tightly closed to prevent vapors of these agents from entering 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 bars with ground-in corks separately from other organic substances - in pharmacies and individual entrepreneurs.
62. Bulk nitroglycerin solution is stored in small well-sealed vials or metal containers in a cool, dark place, taking precautions against fire. Moving dishes with nitroglycerin and weighing this drug should be in conditions that exclude the spilling and evaporation of nitroglycerin, as well as contact with the skin.
63. When working with diethyl ether, shaking, impacts, friction are not allowed.
Storage of narcotic and psychotropic medicines
65. Narcotic and psychotropic drugs are stored in organizations in isolated rooms specially equipped with engineering and technical means of 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 the Decree of the Government of the Russian Federation of December 31, 2009 No. N 1148 (Collected Legislation of the Russian Federation, 2010, N 4, Art. 394; N 25, Art. 3178).
Storage of potent and poisonous medicinal
funds, medicines subject to
subject-quantitative accounting
66. In accordance with the Decree of the Government of the Russian Federation of December 29, 2007 N 964 "On the approval of lists of potent and poisonous 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 Federation "potent and poisonous medicines include medicines containing potent and poisonous substances included in the lists of potent substances and poisonous substances.
67. The storage of potent and poisonous medicines under control in accordance with international legal norms (hereinafter referred to as potent and poisonous medicines under international control) is carried out in premises equipped with engineering and technical means of protection, similar to those provided for the storage of narcotic and psychotropic medicines.
68. It is allowed to store in one technically fortified room strong and poisonous medicines under international control and narcotic and psychotropic medicines.
In this case, the storage of potent and poisonous drugs should be carried out (depending on the volume of reserves) on different shelves of the safe (metal cabinet) or in different safes (metal cabinets).
69. The storage of strong 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 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 of the Ministry of Health of the Russian Federation of November 13, 1996 N 377 "On approval of instructions for organizing storage of various groups of medicines and medical products in pharmacies" (with amendments and additions)
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· Order of the Ministry of Health of the Russian Federation of November 13, 1996 N 377 "On approval of instructions for organizing storage of various groups of medicines and medical products in pharmacies" (with amendments and additions)
· Application. Instructions for organizing storage of various groups of medicines and medical products in pharmacies
Order of the Ministry of Health of the Russian Federation of November 13, 1996 N 377
"On approval of instructions for organizing storage in pharmacies of various groups of medicines and medical products"
In order to ensure High Quality and safety of medicines and medical products in pharmacies, creating safe environment labor when working with them
I. I approve
1.1. Instructions for organizing storage of various groups of medicines and medical products in pharmacies (Appendix).
II. I order
2.1. The pharmaceutical management bodies of the constituent entities of the Russian Federation shall organize the storage of medicines and medical products in pharmacies and work with them in accordance with the instructions approved by this order.
2.2. Consider as invalid on the territory of the Russian Federation Appendix 1 to Order of the Ministry of Health of the USSR N 520 dated May 15, 1981 "On approval of the" Instructions for organizing storage of various groups of medicines and medical products in pharmacies "and" Temporary instructions on the procedure for storage and handling in pharmacies with drugs and medical products with flammable and explosive properties. "
2.3. Control over the implementation of this order shall be entrusted to Deputy Minister A.E. Vilken.
| The minister | T.B.Dmitrieva |
Registration N 1202
Instructions
on the organization of storage in pharmacies of various groups of medicines and medical products
With changes and additions from:
GUARANTEE:
See the Rules for the storage of medicines approved by order of the Ministry of Health and Social Development of Russia dated August 23, 2010 N 706n
On compliance with the rules for storing medicines, see the letter of Roszdravnadzor dated July 23, 2010 N 04I-722/10
On clarification of individual requirements of this Instruction see the letter of the Pharmacy Committee of the Moscow Government dated April 13, 1998 N 1-05 / 1151
1. Introductory part
Abolished.
Information about changes:
See text in section 1
2. Requirements for the design and operation of storage facilities
Abolished.
Information about changes:
See text in section 2
3. General requirements for the organization of storage of medicines and medical devices
3.1. Abolished.
Information about changes:
See text in clause 3.1
3.2. Abolished.
Information about changes:
See the text of paragraph 3.2
3.3. Abolished.
Information about changes:
See the text of clause 3.3
3.4. Abolished.
Information about changes:
See the text of clause 3.4
3.5. Medical devices should be stored separately in groups:
Plastic products;
Dressings and auxiliary materials;
Medical equipment products.
3.6. Abolished.
Information about changes:
See text in clause 3.6
3.7. Abolished.
Information about changes:
See text in clause 3.7
4. Requirements for the storage of various groups of medicines and medical devices
Abolished.
Information about changes:
See text in section 4
5. Features of storage of medicinal plant materials
Abolished.
Information about changes:
See text in section 5
Abolished.
Information about changes:
See text in section 6
7. General rules preparation of medicines and medical devices for use after storage
Abolished.
Information about changes:
See text in section 7
8. Storage of medical devices
8.1. Rubber products
8.1.1. For best preservation rubber products in storage rooms, it is necessary to create:
Protection from light, especially direct sun rays, high (more than 20 ° C) and low (below 0 °) air temperatures; flowing air (drafts, mechanical ventilation); mechanical damage(squeezing, bending, twisting, stretching, etc.);
To prevent drying, deformation and loss of their elasticity, the relative humidity is not less than 65%;
Isolation from aggressive substances (iodine, chloroform, ammonium chloride, lysol, formalin, acids, organic solvents, lubricating oils and alkalis, chloramine B, naphthalene);
Storage conditions away from heating devices (at least 1 m).
8.1.2. Storage rooms for rubber products should not be located on the sunny side, preferably in semi-basement dark or darkened rooms. To maintain high humidity in dry rooms, it is recommended to place vessels with 2% aqueous solution carbolic acid.
8.1.4. For storage of rubber products, storage rooms are equipped with cabinets, drawers, shelves, racks, hanging blocks, racks and others. necessary inventory, subject to free access.
8.1.5. When placing rubber products in storage rooms, it is necessary to fully use its entire volume. This prevents bad influence excess oxygen in the air. However, rubber products (except for corks) should not be stacked in several layers, as objects in the lower layers are compressed and caked.
Cabinets for storing medical rubber products and parapharmaceutical products of this group must have tightly closing doors. The inside of the cabinets must have a perfectly smooth surface.
The internal arrangement of cabinets depends on the type of rubber products stored in them. Cabinets designed for:
Storage of rubber products in a recumbent position (bougie, catheters, ice bladders, gloves, etc.) are equipped with drawers in such a way that objects can be placed in them to the full length, freely, preventing them from bending, flattening, twisting, etc.;
Storage of products in a suspended state (bundles, probes, irrigation tube), are equipped with hangers located under the cabinet lid. The hangers should be removable so that they can be taken out with suspended objects. To strengthen the hangers, grooved pads are installed.
8.1.6. Rubber products are placed in storages by name and expiration date. A label is attached to each batch of rubber products indicating the name, expiration date.
8.1.7. Special attention should be given to the storage of certain types of rubber products requiring special conditions storage:
Backing discs, rubber heating pads, ice bubbles are recommended to be kept slightly inflated, rubber tubes stored with plugs inserted at the ends;
Removable rubber parts of appliances should be kept separate from parts made of other material;
Products that are especially sensitive to atmospheric factors - elastic catheters, bougie, gloves, fingertips, rubber bandages, etc. stored in tightly closed boxes, densely sprinkled with talcum powder. Rubber bandages are stored rolled up sprinkled with talcum powder along their entire length;
Rubberized fabric (one-sided and two-sided) is stored isolated from the substances specified in paragraph 8.1.1., In horizontal position in rolls, suspended on special racks. It is allowed to store the rubberized fabric stacked in no more than 5 rows on smoothly cut off shelves;
Elastic varnish products - catheters, bougie, probes (on ethylcellulose or copal varnish), in contrast to rubber, are stored in a dry room. Some softening, stickiness of the surface is a sign of aging. Such products are rejected.
8.1.8. Rubber stoppers must be stored packed in accordance with the requirements of the current specifications.
8.1.9. Rubber products should be inspected periodically. Items that begin to lose elasticity must be restored in a timely manner in accordance with the requirements of the NTD.
8.1.10. Rubber gloves are recommended, if they have hardened, stick together and become brittle, put without straightening, for 15 minutes in a warm 5% ammonia solution, then knead the gloves and immerse them for 15 minutes in warm (40 - 50 ° C) water with 5% glycerin ... The gloves become elastic again.
9. Plastic products
Store plastic products in a ventilated dark room, at least 1 m away from heating systems. There should be no open flames or volatile matter vapors in the room. Electrical appliances, fittings and switches must be manufactured in anti-spark (fire-prevention) design. In the room where cellophane, celluloid, aminoplastic products are stored, the relative humidity should be maintained no higher than 65%.
10. Dressings and auxiliary material
10.1. Dressings are stored in a dry ventilated room in cabinets, boxes, on racks and pallets, which must be painted from the inside with a light oil paint and kept clean. Cabinets containing dressings are periodically wiped with a 0.2% chloramine solution or other approved disinfectants.
10.2. Sterile dressings (bandages, gauze napkins, cotton wool) are stored in their original packaging. It is forbidden to store them in the primary opened packaging.
10.3. Non-sterile dressings (cotton wool, gauze) are stored packed in thick paper or in bales (bags) on racks or pallets.
10.4. Auxiliary material (filter paper, paper capsules, etc.) must be stored in industrial packaging in dry and ventilated rooms in separate cabinets in strictly hygienic conditions... After opening the industrial packaging, it is recommended to store the packaged or the remaining amount of auxiliary material in polyethylene, paper bags or in kraft bags.
11. Products of medical equipment
11.1. Surgical instruments and other metal products should be stored in dry, heated rooms at room temperature. The temperature and relative humidity in storage rooms should not fluctuate sharply. The relative humidity should not exceed 60%. In climatic zones with high humidity, the relative humidity in the storage room is allowed up to 70%. In this case, control over the quality of medical devices should be carried out at least once a month.
11.2. Surgical instruments and other metal products obtained without anti-corrosion grease are lubricated thin layer petroleum jelly that meets the requirements of the State Pharmacopoeia. Surgical instruments are carefully inspected and wiped with gauze or a clean, soft cloth before lubrication. Lubricated instruments are stored wrapped in thin waxed paper.
11.3. To avoid corrosion on surgical instruments, do not touch them with unprotected and damp hands when examining, wiping, lubricating, and reading them. All work must be carried out holding the tool with a gauze napkin, tweezers.
11.4. It is advisable to store cutting objects (scalpels, knives) laid in special slots of drawers or pencil cases to avoid the formation of chipping and bluntness.
11.5. Surgical instruments should be stored by name in boxes, cabinets, boxes with lids, with the designation of the name of the instruments stored in them.
11.6. Tools, especially those stored without packaging, must be protected from mechanical damage, and sharp-cutting parts, even wrapped in paper, must be protected from contact with neighboring objects.
11.7. When moving surgical instruments and other metal products from a cold place to a warm treatment (wiping, lubricating) and storing them, they should be done only after the instrument's “sweating” has stopped.
11.8. Storage of metal products (made of cast iron, iron, tin, copper, brass, etc.) should be carried out in dry and heated rooms. Under these conditions, copper (brass) nickel silver and tin objects do not require lubrication.
11.9. When rust appears on painted iron products, it is removed and the product is again covered with paint.
11.10. Silver and nickel silver instruments should not be stored together with rubber, sulfur and sulfur-containing compounds due to the blackening of the surface of the instruments.
12. Medicinal leeches
Abolished.
Information about changes:
See text in section 12
13. Requirements for containers for medicines and medical devices
Abolished.
Information about changes:
MINISTRY OF HEALTH AND SOCIAL DEVELOPMENT
RUSSIAN FEDERATION
ON THE APPROVAL OF THE STORAGE RULES OF MEDICINAL PRODUCTS
In accordance with Article 58 of the Federal Law of April 12, 2010 N 61-FZ "On the Circulation of Medicines" (Collected Legislation of the Russian Federation, 2010, N 16, Art. 1815; N 31, Art. 4161) I order:
1. To approve the Rules for the storage of medicinal products in accordance with the appendix.
2. To declare invalid:
sections 1 and 2, clauses 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 products, approved by the Order of the Ministry of Health of the Russian Federation dated 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).
The minister
T.A. GOLIKOVA
Application
to the Order
Ministry of Health
and social development
Russian Federation
dated August 23, 2010 N 706n
STORAGE RULES FOR MEDICINES
I. General Provisions
1. These Rules establish requirements for premises for storing medicinal products for medical use (hereinafter referred to as medicinal products), regulate the storage conditions for these medicinal products and apply to manufacturers of medicinal products, drug wholesalers, pharmacy organizations, medical and other organizations carrying out activity in the circulation of medicines, individual entrepreneurs with 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 premises
storage of medicines
2. The arrangement, composition, dimensions of areas (for organizations of wholesale trade in medicinal products), operation and equipment of premises for storing medicinal products must ensure their safety.
3. Premises for storing medicinal products must maintain a certain temperature and humidity of the air to ensure the storage of medicinal products in accordance with the requirements of manufacturers of medicinal products specified on the primary and secondary (consumer) packaging.
4. Premises for storing medicinal products must be equipped with air conditioners and other equipment to ensure the storage of medicinal products in accordance with the requirements of manufacturers of medicinal products specified 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 storing medicines should be provided with racks, cabinets, pallets, and supplies.
6. Finishing of premises for storing medicines (inner surfaces of walls, ceilings) should be smooth and allow for wet cleaning.
III. General requirements for storage rooms
medicines and the organization of their storage
7. Premises for storing medicines should be equipped with devices for recording air parameters (thermometers, hygrometers (electronic hygrometers) or psychrometers). The measuring parts of these devices must be located at a distance of at least 3 m from doors, windows and heating devices. Devices and (or) parts of devices from which the readings are visually read should be located in an accessible place for personnel at a height of 1.5 - 1.7 m from the floor.
The readings of these devices must be recorded on a daily basis in a special register (card) on paper or in electronic form with archiving (for electronic hygrometers), which is maintained by the responsible person. The log (card) of registration is kept for one year, not counting the current one. Control devices must be certified, calibrated and verified in accordance with the established procedure.
8. Medicines are placed in storage rooms in accordance with the requirements of the regulatory documentation indicated on the packaging of the medicinal product, taking into account:
physicochemical 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 fortified premises that meet the requirements of the Federal Law of January 8, 1998 N 3-ФЗ "On Narcotic Drugs and Psychotropic Substances" (Collected Legislation of the Russian Federation, 1998, N 2, Art. 219; 2002, N 30 , Art.3033; 2003, No. 2, Art. 167, No. 27 (Part I), Art. 2700; 2005, No. 19, Art. 1752; 2006, No. 43, Art. 4412; 2007, No. 30, Art. 3748, N 31, Art. 4011; 2008, N 52 (part I), Art. 6233; 2009, N 29, Art. 3614; 2010, N 21, Art. 2525, N 31, Art. 4192), stored:
narcotic and psychotropic drugs;
potent and poisonous medicines controlled in accordance with international legal standards.
10. Racks (cabinets) for storing medicines in rooms for storing medicines should be installed in such a way as to provide access to medicines, free passage of personnel and, if necessary, loading devices, as well as accessibility of racks, walls, floor for cleaning ...
Racks, cabinets, shelves for storing medicines should 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 by means of 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, shelf cards indicating the name of the medicinal product, batch, expiration date or shelf life logs. The procedure for keeping records of these medicines is established by the head of the organization or an individual entrepreneur.
12. If medicines with an expired shelf life are identified, they should be stored separately from other groups of medicines in a specially designated and designated (quarantine) zone.
IV. Requirements for storage rooms for flammable
and explosive drugs
and organizing their storage
13. Premises for storing flammable and explosive drugs must fully comply with current regulations.
14.In order to ensure the storage of flammable and explosive drugs according to the principle of homogeneity in accordance with their physicochemical, fire hazard properties and the nature of the packaging, premises for storage of drug wholesalers and drug manufacturers (hereinafter - warehouse premises) are divided into separate rooms (compartments) with a fire resistance of building structures of at least 1 hour.
15. The amount of flammable medicinal products required for packaging and manufacturing of medicinal products for medical use per 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 site.
16. The floors of warehouses and unloading areas should have a hard, even surface. It is forbidden to use boards and iron sheets for leveling the floors. The floors should provide convenient and safe movement of people, goods and vehicles, have sufficient strength and withstand the loads from the stored materials, provide simplicity and ease of cleaning the warehouse.
17. Warehouses for storing flammable and explosive drugs should be equipped with non-combustible 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 have, in the case of storing pharmaceutical substances, 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 drugs in pharmacy organizations and individual entrepreneurs, isolated rooms are allocated, equipped with automatic fire protection and alarms (hereinafter - rooms for storing flammable and explosive drugs).
19. Pharmacy organizations and individual entrepreneurs are 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 drugs in built-in non-combustible cabinets. Cabinets must be removed from heat-dissipating surfaces and passages, with doors at least 0.7 m wide and at least 1.2 m high. Free access to them must be organized.
It is allowed to store explosive medicinal products for medical use (in secondary (consumer) packaging) for use per 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 rooms for storing flammable and explosive medicines located in buildings for other purposes should not exceed 100 kg in bulk.
Premises for storing flammable and explosive medicinal products used for storing flammable pharmaceutical substances in an amount over 100 kg should be located in a separate building, and storage itself should be carried out in glass or metal containers, isolated from premises for storing flammable medicinal products of other groups.
21. It is prohibited to enter premises for storing flammable and explosive medicinal products 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 racks or on pallets. It is not allowed to place medicines on the floor without a pallet.
Pallets can be located 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 using racks.
23. In the case of a manual method of unloading and loading, the height of placing medicinal products should not exceed 1.5 m.
When using mechanized devices for unloading and loading operations, medicines 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 loading and unloading facilities (lifts, autocars, hoists).
Vi. Features of storage of certain groups of medicinal
funds depending on physical and physical-chemical
properties, the impact on them of various
environmental factors
from the action of light
24. Medicines requiring protection from light are stored in rooms or specially equipped places that provide protection from natural and artificial light.
25. Pharmaceutical substances requiring protection from light should be stored in containers made of light-shielding materials (glass containers of orange glass, metal containers, packaging made of aluminum foil or polymer materials painted in black, brown or orange colors), in a dark room or closets ...
For storage of pharmaceutical substances that are especially sensitive to light (silver nitrate, proserin), 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 direct sunlight or other strong directed light from falling on the specified medicinal products. (use of reflective film, blinds, visors, etc.).
Storage of medicines requiring protection
from moisture
27. Pharmaceutical substances requiring 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 sealed 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 an airtight seal, filled with paraffin on top.
29. In order to avoid spoilage and loss of quality, storage of medicinal products should be organized in accordance with the requirements applied 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 requiring protection against volatilization and drying out (volatile medicinal products themselves; medicinal products 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 raw materials containing essential oils; medicinal products containing crystallization water - crystalline hydrates; medicinal products that decompose with the formation of volatile products (iodoform, hydrogen peroxide, bicarbonate sodium); medicinal products 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 impermeable to volatile substances (glass, metal, aluminum foil) or in primary and secondary (consumer) packaging of the manufacturer. The use of polymer containers, packaging and closures is allowed in accordance with the requirements of the state pharmacopoeia and regulatory documents.
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 meet the requirements of regulatory documents for these medicinal products.
Storage of medicines requiring protection
from exposure to high temperatures
32. Organizations and individual entrepreneurs should store medicinal products requiring 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 documents.
Storage of medicines requiring protection
from exposure to low temperatures
33. Storage of medicines requiring protection from exposure to low temperatures (medicines, the physical and chemical state of which after freezing changes and upon subsequent warming to room temperature is not restored (40% formaldehyde solution, insulin solutions)), organizations and individual entrepreneurs should 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 documents.
34. Freezing of insulin preparations is not allowed.
Storage of medicines requiring protection
from exposure to gases contained in the environment
35. Pharmaceutical substances requiring protection from the effects of gases (substances that react with atmospheric 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 organopreparations; substances that react with carbon dioxide in the air: salts of alkali metals and weak organic acids (sodium barbital, hexenal), drugs containing polyatomic amines (aminophylline), magnesium oxide and peroxide, sodium hydroxide, caustic potassium) should be stored in a hermetically sealed container made of materials impermeable to gases, filled to the top if possible.
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 drugs (pharmaceutical substances that leave a colored mark that cannot be washed off by ordinary sanitary and hygienic processing on containers, closures, equipment and inventory (brilliant green, methylene blue, indigo carmine)) should be stored in a special cabinet in a tightly sealed container ...
38. To work with coloring drugs for each item, it is necessary to allocate special scales, a mortar, a spatula and other necessary equipment.
Storage of disinfectants
39. Disinfectant medicines should be stored in a hermetically sealed container in an isolated room away from the storage rooms for plastic, rubber and metal products and the 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 documents, as well as taking into account the properties of the substances included in their composition.
41. When stored in cabinets, on racks or shelves, medicinal products for medical use in secondary (consumer) packaging must be placed outside with the label (marking).
42. Organizations and individual entrepreneurs must store medicinal products for medical use in accordance with the storage requirements specified on the secondary (consumer) packaging of the said medicinal product.
Storage of medicinal plant materials
43. Bulk medicinal plant materials should be stored in a dry (no more than 50% humidity), well-ventilated room in a tightly closed container.
44. Bulk medicinal herbal raw materials containing essential oils are stored isolated in a well-closed container.
45. Bulk medicinal plant raw materials should 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, granary 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 raw 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 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 "(Collected Legislation of the Russian Federation, 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 plant materials are stored on racks or in cabinets.
Storage of medicinal leeches
49. Storage of medicinal leeches is carried out in a light, odorless room 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 ethereal tinctures, alcohol and ether extracts, ether, turpentine, lactic acid, chloroethyl, collodion, cleol, Novikov's liquid, organic oils); medicinal means with flammable properties (sulfur, glycerin, vegetable oils, medicinal plant raw materials)) should be carried out separately from other medicines.
52. Flammable medicines are stored in tightly sealed strong, glass or metal containers to prevent evaporation of liquids from the vessels.
53. Bottles, cylinders and other large containers with flammable and flammable drugs should be stored on the shelves in one row in height. It is forbidden to store them in several rows in height using various cushioning materials.
The storage of the indicated medicinal products near heating devices is not allowed. The distance from the rack or stack to the heating element must be at least 1 m.
54. The storage of bottles with flammable and flammable pharmaceutical substances should be carried out in containers that protect against impacts, or in balloon tilters in one row.
55. At the workplaces of industrial premises allocated in pharmacy organizations and individual entrepreneurs, flammable and flammable medicines can be stored in quantities that do not exceed the replacement requirement. In this case, the containers in which they are stored must be tightly closed.
56. It is not allowed to store flammable and flammable medicines in a fully filled container. The filling degree should be no more than 90% of the volume. Large quantities of alcohols are stored in metal containers filled to no more than 75% of their 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 inorganic salts that give 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 medicinal products
59. When storing explosive medicinal products (medicinal products with explosive properties (nitroglycerin); medicinal products with explosive properties (potassium permanganate, silver nitrate)), measures should be taken against their contamination with dust.
60. Containers with explosive drugs (barbells, tin drums, flasks, etc.) must be tightly closed to prevent vapors of these agents from entering 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 bars with ground-in corks separately from other organic substances - in pharmacies and individual entrepreneurs.
62. Bulk nitroglycerin solution is stored in small well-sealed vials or metal containers in a cool, dark place, taking precautions against fire. Moving dishes with nitroglycerin and weighing this drug should be in conditions that exclude the spilling and evaporation of nitroglycerin, as well as contact with the skin.
63. When working with diethyl ether, shaking, impacts, friction are not allowed.
Storage of narcotic and psychotropic medicines
65. Narcotic and psychotropic drugs are stored in organizations in isolated rooms specially equipped with engineering and technical means of 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 the Decree of the Government of the Russian Federation of December 31, 2009 No. N 1148 (Collected Legislation of the Russian Federation, 2010, N 4, Art. 394; N 25, Art. 3178).
Storage of potent and poisonous medicinal
funds, medicines subject to
subject-quantitative accounting
66. In accordance with the Decree of the Government of the Russian Federation of December 29, 2007 N 964 "On the approval of lists of potent and poisonous 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 Federation "potent and poisonous medicines include medicines containing potent and poisonous substances included in the lists of potent substances and poisonous substances.
67. The storage of potent and poisonous medicines under control in accordance with international legal norms (hereinafter referred to as potent and poisonous medicines under international control) is carried out in premises equipped with engineering and technical means of protection, similar to those provided for the storage of narcotic and psychotropic medicines.
68. It is allowed to store in one technically fortified room strong and poisonous medicines under international control and narcotic and psychotropic medicines.
In this case, the storage of potent and poisonous drugs should be carried out (depending on the volume of reserves) on different shelves of the safe (metal cabinet) or in different safes (metal cabinets).
69. The storage of strong 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 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.