Order 706 n on approval. General rules for storing medicinal substances
MINISTRY OF HEALTH AND SOCIAL DEVELOPMENT
RUSSIAN FEDERATION
ORDER
ON APPROVAL OF RULES FOR STORAGE OF MEDICINES
List of changing documents
In accordance with Article 58 of the Federal Law of April 12, 2010 N 61-FZ “On the Circulation of Medicines” (Collection of Legislation of the Russian Federation, 2010, N 16, Art. 1815; N 31, Art. 4161) I order:
1. Approve the Rules for the storage of medicines in accordance with the appendix.
2. To recognize as 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 Order of the Ministry of Health of the Russian Federation of November 13, 1996 N 377 “On approval of requirements for organizing 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
RULES FOR STORING MEDICINES
List of changing documents
(as amended by Order of the Ministry of Health and Social Development of the Russian Federation dated December 28, 2010 N 1221n)
I. General provisions
1. These Rules establish requirements for premises for storing medicines for medical use (hereinafter referred to as medicines), regulate the storage conditions of these medicines and apply to manufacturers of medicines, wholesale trade organizations of medicines, pharmacies, medical and other organizations carrying out activities in the circulation of medicines, individual entrepreneurs with a license for pharmaceutical activities or a license for medical activities (hereinafter referred to as organizations, individual entrepreneurs, respectively).
II. General requirements for the design and operation of premises
storage of medicines
2. The design, composition, size of areas (for manufacturers of medicines, wholesale trade organizations of medicines), operation and equipment of premises for storing medicines must ensure their safety.
(clause 2 as amended by Order of the Ministry of Health and Social Development of the Russian Federation dated December 28, 2010 N 1221n)
3. In the premises for storing medicines, certain temperatures and air humidity must be maintained to ensure the storage of medicines in accordance with the requirements of the manufacturers of medicines specified on the primary and secondary (consumer) packaging.
4. Premises for storing medicines must be equipped with air conditioners and other equipment that allows for storage of medicines in accordance with the requirements of the manufacturers of medicines specified on primary and secondary (consumer) packaging, or it is recommended to equip the premises with windows, transoms, and second lattice doors.
5. Premises for storing medicines must be provided with racks, cabinets, pallets, and stockpiles.
6. The finishing of premises for storing medicines (internal surfaces of walls, ceilings) must be smooth and allow for the possibility of wet cleaning.
III. General requirements for storage facilities
medicines and organization of their storage
7. Premises for storing medicines must be equipped with instruments 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 readings are visually read must be located in a place accessible to personnel at a height of 1.5 - 1.7 m from the floor.
The readings of these devices must be recorded daily in a special logbook (card) on paper or in electronic form with archiving (for electronic hygrometers), which is maintained by a responsible person. The registration log (card) is stored 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);
state of aggregation of pharmaceutical substances (liquid, bulk, gaseous).
When placing medicines, the use of computer technologies is allowed (alphabetically, by code).
9. Separately, in technically fortified premises that meet the requirements of Federal Law No. 3-FZ of January 8, 1998 “On Narcotic Drugs and Psychotropic Substances” (Collected Legislation of the Russian Federation, 1998, No. 2, Art. 219; 2002, No. 30 , art. 3033, art. 167, no. 2700; 2005, no. 1752; 3748, No. 4011, No. 52, Article 6233; 2010, No. 2525, Article 4192), stored:
narcotic and psychotropic drugs;
potent and poisonous medicines controlled in accordance with international legal standards.
10. Shelving (cabinets) for storing medicines in medicine storage rooms must be installed in such a way as to ensure access to medicines, free passage of personnel and, if necessary, loading devices, as well as accessibility of shelving, walls, and floors for cleaning .
Racks, cabinets, and shelves intended for storing medicines must be identified.
(as amended by Order of the Ministry of Health and Social Development of the Russian Federation 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, release form and dosage, batch number, expiration date, manufacturer of the medicinal product). When using computer technology, identification using codes and electronic devices is allowed.
11. Organizations and individual entrepreneurs must keep records of medicines with a limited shelf life on paper or in electronic form with archiving. Control over the timely sale of medicines with a limited shelf life should be carried out using computer technology, rack cards indicating the name of the medicine, series, expiration date or expiration date logs. The procedure for maintaining records of these medicines is established by the head of the organization or individual entrepreneur.
12. If expired medicines are identified, they must be stored separately from other groups of medicines in a specially designated and designated (quarantine) area.
IV. Requirements for premises for storing flammable materials
and explosive drugs
and organizing their storage
13. Premises for storing flammable and explosive medicines must fully comply with current regulatory documents.
14. Premises for storing medicines in wholesale trade organizations of medicines and manufacturers of medicines (hereinafter referred to as warehouses) are divided into separate rooms (compartments) with a fire resistance limit of building structures of at least 1 hour in order to ensure the storage of flammable and explosive medicines according to the principle of uniformity in accordance with their physicochemical, fire hazard properties and the nature of the packaging.
(clause 14 as amended by Order of the Ministry of Health and Social Development of the Russian Federation dated December 28, 2010 N 1221n)
15. The amount of flammable medicines necessary for packaging and manufacturing medicines for medical use for one work shift may be kept in production and other premises. The remaining amount of flammable drugs at the end of the shift is transferred to the next shift or returned to the main storage location.
16. The floors of warehouses and unloading areas must have a hard, even surface. It is prohibited to use boards and iron sheets to level floors. Floors must ensure convenient and safe movement of people, cargo and vehicles, have sufficient strength to withstand the loads of stored materials, and ensure simplicity and ease of cleaning the warehouse.
17. Warehouses for storing flammable and explosive medicines must be equipped with fireproof and stable racks and pallets designed for the appropriate load. The racks are installed at a distance of 0.25 m from the floor and walls, the width of the racks should not exceed 1 m and, in the case of storing pharmaceutical substances, have flanges of at least 0.25 m. Longitudinal passages between the racks should be at least 1.35 m.
18. Pharmacy organizations and individual entrepreneurs are allocated isolated premises, equipped with automatic fire protection and alarm systems, for storing flammable pharmaceutical substances and explosive medicines.
(clause 18 as amended by Order of the Ministry of Health and Social Development of the Russian Federation dated December 28, 2010 N 1221n)
19. Pharmacy organizations and individual entrepreneurs are allowed to store pharmaceutical substances with flammable and combustible properties in an amount of up to 10 kg outside the premises for storing flammable pharmaceutical substances and explosive drugs in built-in fireproof cabinets. Cabinets must be located away 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 provided.
(as amended by Order of the Ministry of Health and Social Development of the Russian Federation dated December 28, 2010 N 1221n)
It is allowed to store explosive medicinal products for medical use (in secondary (consumer) packaging) for use for one work shift in metal cabinets outside the premises for storing flammable pharmaceutical substances and explosive medicinal products.
(as amended by Order of the Ministry of Health and Social Development of the Russian Federation dated December 28, 2010 N 1221n)
20. The amount of flammable pharmaceutical substances allowed for storage in premises for storing flammable pharmaceutical substances and explosive drugs located in buildings for other purposes must not exceed 100 kg in bulk form.
Premises for storing flammable pharmaceutical substances and explosive drugs used for storing flammable pharmaceutical substances in quantities over 100 kg must be located in a separate building, and the storage itself must be carried out in glass or metal containers isolated from premises for storing other groups of flammable pharmaceutical substances .
(clause 20 as amended by Order of the Ministry of Health and Social Development of the Russian Federation dated December 28, 2010 N 1221n)
21. It is prohibited to enter premises for storing flammable pharmaceutical substances and explosive medicines with open sources of fire.
(as amended by Order of the Ministry of Health and Social Development of the Russian Federation dated December 28, 2010 N 1221n)
V. Features of organizing storage of medicines
in warehouses
22. Medicines stored in warehouses must be placed on racks or on racks (pallets). It is not allowed to place medicines on the floor without a tray.
Pallets can be placed on the floor in one row or on racks in several tiers, depending on the height of the rack. It is not allowed to place pallets with medicines in several rows in height without the use of racks.
23. When unloading and loading operations are carried out manually, the height of 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. At the same time, the total height of placement of medicines on the racks should not exceed the capabilities of mechanized loading and unloading equipment (lifts, trucks, hoists).
23.1. The area of warehouse premises must correspond to the volume of stored medicines, but be at least 150 square meters. m, including:
medicine reception area;
area for the main storage of medicines;
expedition zone;
premises for medicines requiring special storage conditions.
(clause 23.1 introduced by Order of the Ministry of Health and Social Development of the Russian Federation dated December 28, 2010 N 1221n)
VI. Features of storage of certain groups of drugs
means depending on physical and physico-chemical
properties, effects on them of various
environmental factors
from the action of light
24. Medicines that require protection from light are stored in rooms or specially equipped places that provide protection from natural and artificial light.
25. Pharmaceutical substances that require protection from light should be stored in containers made of light-protective materials (orange glass containers, metal containers, packaging made of aluminum foil or polymer materials painted black, brown or orange), in a dark room or cabinets .
To store pharmaceutical substances that are particularly sensitive to light (silver nitrate, proserine), glass containers are covered with black light-proof paper.
26. Medicines for medical use that require protection from light, packaged in primary and secondary (consumer) packaging, should be stored in cabinets or on shelves, provided that measures are taken to prevent these medicines from being exposed to direct sunlight or other bright directional light (use of reflective film, blinds, visors, etc.).
Storage of medicines requiring protection
from exposure to moisture
27. Pharmaceutical substances that require protection from moisture should be stored in a cool place at temperatures up to +15 degrees. C (hereinafter referred to as a cool place), in a tightly closed container made of materials 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 glass containers with an airtight seal, filled with paraffin on top.
29. To avoid spoilage and loss of quality, storage of medicines should be organized in accordance with the requirements printed in the form of warning notices on the secondary (consumer) packaging of the medicine.
Storage of medicines requiring protection
from volatilization and drying out
30. Pharmaceutical substances that require protection from volatilization and drying (volatile drugs themselves; drugs containing a volatile solvent (alcohol tinctures, liquid alcohol concentrates, thick extracts); solutions and mixtures of volatile substances (essential oils, solutions of ammonia, formaldehyde, chloride hydrogen over 13%, carbolic acid, ethyl alcohol of various concentrations, etc.); medicinal plant materials containing essential oils; medicines containing crystallization water - crystalline hydrates; medicines that decompose with the formation of volatile products (iodoform, hydrogen peroxide, hydrogen carbonate). sodium); medicines with a certain lower limit of moisture content (magnesium sulfate, sodium para-aminosalicylate, sodium sulfate)) should be stored in a cool place, in hermetically sealed containers made of materials impenetrable to volatile substances (glass, metal, aluminum foil) or in primary and manufacturer's secondary (consumer) packaging. The use of polymer containers, packaging and closures is permitted in accordance with the requirements of the state pharmacopoeia and regulatory documentation.
31. Pharmaceutical substances - crystalline hydrates should be stored in hermetically sealed glass, metal and thick-walled plastic containers or in the manufacturer’s primary and secondary (consumer) packaging under conditions that meet the requirements of regulatory documentation for these medicines.
Storage of medicines requiring protection
from exposure to elevated temperatures
32. Organizations and individual entrepreneurs must store medicines that require protection from exposure to elevated temperatures (heat-labile medicines) in accordance with the temperature conditions indicated on the primary and secondary (consumer) packaging of the medicine in accordance with the requirements of regulatory documentation.
Storage of medicines requiring protection
from exposure to low temperature
33. Storage of medicines that require protection from exposure to low temperatures (medicines whose physical and chemical state changes after freezing and is not restored upon subsequent warming to room temperature (40% formaldehyde solution, insulin solutions)), organizations and individual entrepreneurs must carry out in accordance with the temperature conditions indicated on the primary and secondary (consumer) packaging of the medicinal product in accordance with the requirements of regulatory documentation.
34. Freezing of insulin preparations is not allowed.
Storage of medicines requiring protection
from exposure to gases contained in the environment
35. Pharmaceutical substances that require protection from gases (substances that react with atmospheric oxygen: various aliphatic compounds with unsaturated intercarbon bonds, cyclic compounds with side aliphatic groups with unsaturated intercarbon bonds, phenolic and polyphenolic, morphine and its derivatives with unsubstituted hydroxyl groups; sulfur-containing heterogeneous and heterocyclic compounds, enzymes and organic preparations; substances that react with carbon dioxide in the air: salts of alkali metals and weak organic acids (sodium barbital, hexenal), drugs containing polyhydric amines (aminophylline), magnesium oxide and peroxide, sodium hydroxide, caustic potassium), should be stored in hermetically sealed containers made of materials impermeable to gases, filled to the top if possible.
Storage of odorous and coloring medicines
36. Odorous medicines (pharmaceutical substances, both volatile and practically non-volatile, but with a strong odor) should be stored in hermetically sealed containers that are impenetrable to odor.
37. Coloring medicinal products (pharmaceutical substances that leave a colored mark that is not washed off by normal sanitary and hygienic treatment on containers, closures, equipment and supplies (diamond green, methylene blue, indigo carmine)) should be stored in a special cabinet in a tightly closed container .
38. To work with coloring medicines, it is necessary to allocate special scales, a mortar, a spatula and other necessary equipment for each item.
Storage of disinfectant medicines
39. Disinfectant medicines should be stored in hermetically sealed containers in an isolated room away from storage areas for plastic, rubber and metal products and premises for obtaining distilled water.
Storage of medicines
for medical use
40. Storage of medicinal products for medical use is carried out in accordance with the requirements of the state pharmacopoeia and regulatory documentation, as well as taking into account the properties of the substances 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 with the label (marking) facing out.
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 specified 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 area in a tightly closed container.
44. Bulk medicinal plant materials containing essential oils are stored separately in a well-closed container.
45. Bulk medicinal plant materials must be subject to periodic monitoring 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 ingredients, as well as those affected by mold and 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 monitoring of biological activity.
47. Bulk medicinal plant materials included in the lists of potent and toxic substances approved by Decree of the Government of the Russian Federation of December 29, 2007 N 964 “On approval of 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-sized 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, Art. 89; 2010, No. 28, Art. 3703), stored in a separate room or in a separate cabinet under lock and key.
48. Packaged medicinal plant materials are stored on shelves or in cabinets.
Storage of medicinal leeches
49. Storage of medicinal leeches is carried out in a bright room without the smell of medicine, for which a constant temperature regime is established.
Storage of flammable drugs
51. Storage of flammable medicines (medicines with flammable properties (alcohol and alcohol solutions, alcohol and ether tinctures, alcohol and ether extracts, ether, turpentine, lactic acid, chloroethyl, collodion, cleol, Novikov liquid, organic oils); medicinal products with flammable properties (sulfur, glycerin, vegetable oils, bulk medicinal plant materials)) should be carried separately from other drugs.
(as amended by Order of the Ministry of Health and Social Development of the Russian Federation dated December 28, 2010 N 1221n)
52. Flammable medications are stored in tightly closed, durable glass or metal containers to prevent evaporation of liquids from the vessels.
53. Bottles, cylinders and other large containers with flammable and highly combustible medicines should be stored on shelves in one row in height. It is prohibited to store them in several rows in height using different cushioning materials.
Storing these medications near heating appliances is not allowed. The distance from the rack or stack to the heating element must be at least 1 m.
54. Storage of bottles with flammable and highly combustible pharmaceutical substances should be carried out in impact-resistant containers or in one-row tipper containers.
55. At workplaces of production premises allocated in pharmacies and individual entrepreneurs, flammable and combustible medicines can be stored in quantities not exceeding shift requirements. In this case, the containers in which they are stored must be tightly closed.
56. It is not allowed to store flammable and highly combustible medicines in completely filled containers. The degree of filling should be no more than 90% of the volume. Alcohols in large quantities are stored in metal containers filled to no more than 75% of the volume.
57. It is not allowed to store flammable medicines together with mineral acids (especially sulfuric and nitric acids), compressed and liquefied gases, flammable substances (vegetable oils, sulfur, dressings), alkalis, as well as with inorganic salts that produce explosive compounds with organic substances. mixtures (potassium chlorate, potassium permanganate, potassium chromate, etc.).
58. Medical ether and ether for anesthesia are stored in industrial packaging, in a cool place, protected from light, away from fire and heating devices.
Storage of explosive drugs
59. When storing explosive medicines (medicines with explosive properties (nitroglycerin); medicines with explosive properties (potassium permanganate, silver nitrate)), measures should be taken to prevent contamination with dust.
60. Containers with explosive drugs (barbells, tin drums, bottles, etc.) must be tightly closed to prevent vapors of these drugs from entering the air.
61. Storage of bulk potassium permanganate is allowed in a special compartment of warehouse premises (where it is stored in tin drums), in rods with ground-in stoppers, separately from other organic substances - in pharmacy organizations and individual entrepreneurs.
62. Bulk nitroglycerin solution is stored in small well-closed flasks or metal vessels in a cool place, protected from light, taking precautions against fire. Move the container with nitroglycerin and weigh out this drug under conditions that prevent spillage and evaporation of nitroglycerin, as well as contact with the skin.
In order for an enterprise to bring only profit, you need to be on guard in literally everything. Otherwise, the pharmacy will face either serious fines, confiscation of goods, suspension of activities for three months, or closure...
READ THE INSTRUCTIONS!
So, in order for the pharmacy to operate quietly, without wasting money on fines, and for the business to be profitable, front desk workers must strictly comply with all the rules and regulations prescribed for pharmacy personnel. The same can be said about pharmacy equipment. Meanwhile, not everything and not everywhere goes as it should. And representatives of regulatory authorities come with inspections at this time. And what happens? Here is just one real example from practice. Once in Moscow, near the Paveletsky railway station, a young entrepreneur opened a pharmacy. And the process, as they say, began. But only until the first check. The group of inspectors who came to him first of all inquired about the presence and performance of thermometers and hygrometers. To which the owner of the pharmacy business asked, not without surprise: “Why are they? We have air conditioners. The climate is comfortable. Everything is fine!” The entrepreneur had nothing to prove that everything was really good in the pharmacy. As a result, this pharmacy was sealed and closed within an hour, and the inventory amounted to 9 million rubles. confiscated and destroyed.
Of course, the example described is almost a rarity. But more local troubles happen almost regularly. What's happening? The fact is that the staff of any pharmacy works with people, most of them work in a state of stress, because pharmacy visitors are most often sick people who already carry negativity in their communication. Imagine that the employee of the first table must take leave, listen carefully to the buyer, give a qualified answer, while not forgetting about goodwill. And also (a modern pharmacy is still a business) you want to sell and resell, there are also deadlines and goods of the day. But at the same time, the pharmacy worker must accept, disassemble, and arrange goods that arrive at the pharmacy once or twice daily...
What is the result? Time passes, and the carts with goods keep growing and growing. The work of arranging goods becomes automatic - they don’t think, don’t look, don’t read, just pushing the received goods, while also keeping in mind the fear of some kind of unscheduled inspection (pharmacies know about comprehensive inspections).
After all, inspectors can come to a pharmacy, take a photo, ask an unexpected, sometimes tricky question, open any cabinet and refrigerator, and check the appliances. Fear of them literally paralyzes the worker at the first desk, and even experienced managers sometimes cannot say their name for several minutes. This is what the pharmaceutical inspector of the Association of Pharmacy Institutions "SoyuzPharma" says Olga Afanasyevna Pozdnyakova:
— I go to the pharmacy, take a package of drug N and ask the pharmacist: “What is this?” The pharmacist begins to retell all the instructions literally by heart, like an excellent schoolgirl. After listening carefully, I say: “Fine: 40 thousand.” She says: “Why? I told you everything!” Yes, I just forgot about the storage conditions! This is perhaps the most important information that drug manufacturers or dietary supplements want to convey to pharmacies. After all, what is a drug is a substance, a chemical, molecular compound, obtained under certain conditions and influences, tested, dated and studied. The manufacturer guarantees the stability of this substance if it is stored in pharmacies under certain conditions specified by him. Often, deviations from the required temperature, humidity level or other factors lead to the fact that the medicine, at best, will not have the desired effect, and at worst, will cause irreparable harm to the health of the consumer.
Pharmacy managers and front desk workers are required to know the standards regarding the storage of medications. You can get acquainted with them by reading the State Pharmacopoeia of the XIII edition (Article 1.1.10 OFS 1.1.0010.15), the pharmacopoeial article describes in detail that when storing medicines that require protection from the influence of environmental factors (light, temperature, atmospheric composition of air and etc.), it is necessary to ensure the storage regime specified in the pharmacopoeial monograph or regulatory documentation.
This pharmacopoeial article establishes general requirements for the storage of pharmaceutical substances, excipients and medicinal products and applies to all organizations in which drugs are stored, taking into account the type of activity of the organization.
Let's get back to the checks. The pharmaceutical inspector checks the refrigerator, and the temperature there does not correspond to the concept of a “cool place,” i.e. 8-15°C! Can the stability of substances be guaranteed if they are stored incorrectly? The required parameters of humidity, temperature, and illumination are not observed. But people trust pharmacies. But, unfortunately, we have to admit that the storage of medicines is the weakest point in our pharmacies. Inspectors know about this and fine heavily.
EVERYONE HAS HIS OWN PLACE!
What should a pharmacy worker's attention be paid to first when he picks up a package? For distribution by pharmaceutical groups - external and internal drugs separately! “I open the cabinets. And what do I see? Medicines, dietary supplements, ointments, cosmetics, massagers... Everything is in one box. To my question I hear the answer: “It’s so convenient for us!” - Olga Pozdnyakova gives an example from her practice. But the State Pharmacopoeia with this disagrees: “All medicines – storage and display – are separated into pharmaceutical groups, taking into account their external or internal use.”
Some companies produce both medicines and dietary supplements (dietary supplements), and pharmacy workers display them in one line on the display window. As a result, fines amount to 40 thousand rubles. for every (!) violation. If the inspector gets into the hands of a package that does not have the inscription " Medicine" or " Dietary supplement", then the internal filling can be considered a food product; it is generally prohibited for sale through a pharmacy. Again a fine! Let's remember display of the medicinal product and dietary supplement cannot be together.
"Store in a place protected from light at a temperature not exceeding 25°C!", i.e. secondary packaging cannot serve as protection from light, even if there is dark glass in the cabinet or darkening packaging. The requirements of both Roszdravnadzor and Rospotrebnadzor confirm that it is necessary to put the drug with the specified information on the primary packaging in a cabinet without a glass door; otherwise, the pharmacy will again receive the same 40 thousand rubles. fine
Some manufacturers write that their secondary packaging serves as protection from light. Then it's a different matter. But it happens that inspectors, examining the cabinet doors from the inside, notice that there is no dark coating on the glass, and issue a fine for the violation, and this is already wrong. According to the new requirements, darkening the inside of the door must be done only for substances, and not for finished dosage forms. In general, light can be either natural (sunlight) or artificial; pharmacy workers sometimes consider only the first “forbidden”. In fact, we are talking about any lighting.
There are also contradictions. For example, it may be written on the packaging (in the instructions) " store in a cool place at a temperature not exceeding 6° WITH", You need to rely on this information from the manufacturer, even if it does not correspond to those specified in the Pharmacopoeia for a “cool place” of 8-15°C.
By the way, standards have not yet been developed for dietary supplements that determine what is considered a cool storage place and what is considered a cold place.
Be sure to read the instructions, paying attention to the following.
- What's in the package? Medicine, dietary supplement, medical product, hygiene product, etc. Lay everything out separately.
- Aggregate state of the drug. Coloring drugs, volatile, liquid must have a separate storage place; flammable - in a metal cabinet. Explosive, radiopharmaceutical, caustic, corrosive, liquefied and other drugs with hazardous properties must be stored in a specially designed room equipped with additional safety and security equipment.
FILL OUT THE JOURNAL CORRECTLY!
It is also important who and how in the pharmacy fills out the mandatory accounting (control) logs. Everything can be very beautiful, but it is not always right. The inspector, together with the council, opens the refrigerator, and instead of 2-8°C, all three thermometers show 15°C. They check it with the log, and there is a morning entry - +6°C. All violations are immediately photographed and recorded. The inspector's verdict was a refrigerator full of drugs for immediate destruction and license suspension for 90 days. We must remember that proper storage of medicines means the life and health of their consumers. You must approach filling out the journal extremely responsibly. Sometimes, especially on New Year's holidays, the pharmacy employee who keeps the log combines several days with one curly bracket and sets, for example, 12°C. All. Fine. Each day must be filled out on a separate line. If a pharmacy employee gives an incorrect or even simply inaccurate answer to the inspector’s question, this is a fine. It also happens that they open a storage place, but in the refrigerator it’s -6°C, everything is frozen! Sometimes the magazine says - in the morning +4°C, and in the evening +8°C. This is an unacceptable temperature fluctuation. According to standards, it can only be 1°C! Otherwise, this means that the refrigerator requires repair and cannot be used.
Now there are so-called pharmaceutical refrigerators, in which the entire cooling element runs throughout the entire chamber. In such a refrigerator, the same temperature is ensured in all its places. At the same time, there is no official term “pharmaceutical refrigerator” yet, but I know that in Voronezh, for example, pharmacies are licensed only if they have such a refrigerator. But this is a “local” exception. Pharmacies usually have household refrigerators. They often have glass doors, which is already a violation for medications that are prescribed to be stored in a place protected from light. The cooling element is either only at the top or only halfway up the refrigerator. Naturally, the temperature in different parts of such a refrigerator is different. Closer to the cooling element - lower. In other zones it is higher. Therefore, three thermometers must be installed in such refrigerators. If we are talking about storing insulin and other biological drugs, then in this case you need your own thermometer on each shelf of the refrigerator.
Important! Let's turn again to the pharmacopoeial article: “The temperature regime on the shelves of the refrigerator is different: the temperature is lower near the freezer, higher near the door panel that opens.
Providing a cold place means storing drugs in a refrigerator at a temperature of 2 to 8 ° C, avoiding freezing. Cool storage means storing drugs in the refrigerator at a temperature of 8 to 15°C. In this case, it is allowed to store drugs in the refrigerator, with the exception of drugs that, when stored at a refrigerator temperature below 8°C, can change their physicochemical characteristics, for example, tinctures, liquid extracts, etc.
It is not allowed to freeze drugs that have the appropriate requirements in the pharmacopoeial monograph or regulatory documentation and are indicated on the primary or secondary packaging, incl. insulin preparations, adsorbing immunobiological preparations, etc.
It is not allowed to freeze drugs placed in packaging that can be destroyed by freezing, for example, drugs in ampoules, glass bottles, etc."
"DRY" HOW IS THIS?
Now about humidity. Pharmacies are literally in full swing. Sometimes it is very difficult for staff to find time to take hygrometer readings. And this must be done daily, before 10 am, with an entry in the journal. It happens that a certain employee is responsible for this procedure and works on a “two days in two” schedule. As a result, she writes the hygrometer readings "forward". All inspectors know about this and... fine. You must remember exactly the procedure for working with a hygrometer. The algorithm is as follows:
- Take readings from the “dry” and “wet” thermometers.
- Calculate the temperature difference between the “dry” and “wet” thermometers.
- Determine the relative humidity using the psychrometric table. The desired relative humidity will be at the intersection of the dry-bulb temperature lines and the difference in dry-bulb and wet-bulb temperatures.
- Places where medicines are stored for more than 4 hours must be equipped with hygrometers (Order of the Ministry of Health of the Russian Federation No. 377 dated November 13, 1996 “On approval of requirements for organizing storage in pharmacies of various groups of medicines and medical products”).
- Storage of medicines is carried out at a relative humidity of no more than 60 ± 5%, depending on the relevant climatic zone (I, II, III, IVA, IVB), unless special storage conditions are specified in the regulatory documentation.
- Humidity during storage in a cool, dry place should be 50%. We don't have more humidity. But we have unconfigured hygrometers. And that's the problem. If it is dry, it is considered inoperative and its performance is not taken into account.
A pharmacy worker must be responsible for the quality of products and medications that he dispenses to the consumer, and the quality primarily depends on the storage conditions of the drug. If a pharmacy does everything correctly and works honestly, then it won’t be afraid of fines!
Based on materials from the training seminar of AAU "SoyuzPharma"
Samvel Grigoryan on whether it is possible to place medicines and dietary supplements on the same display shelf
Employees of pharmacy organizations often have questions regarding the display of medicines and other pharmacy products in display cases. Many of these questions relate to the rules for storing dietary supplements in pharmacies. “Explain, is it possible to put dietary supplements along with medications on the same shelf?” - such a laconic letter from a pharmacist from Bryansk was found in the editorial mail of Katren-Style. It would seem, well, what could be super complicated in arranging display cases. However, the problem is that this topic is not properly regulated.
After the Industry Standard “Rules for the dispensing (sale) of medicines in pharmacies became invalid on March 2, 2014. Basic provisions (Order of the Ministry of Health of the Russian Federation No. 80 of 04.03.2003),” which contained very vague, but at least some regulation of display window placement - on this topic, if not a vacuum, then a very rarefied space was formed in the legislation. As a result, pharmacy workers do not have clear rules from the regulator on how to lay out items correctly, while inspectors, on the contrary, have the opportunity to pardon or punish at their own discretion. And yet we will try to cover this topic.
A showcase is also storage
Any product accepted by a pharmacy can have only two states - it is either stored or dispensed. And the presence of packaging on a pharmacy display - be it an over-the-counter medicine or a dietary supplement - is one of the storage options, during which consumers are informed about this product, its availability in the pharmacy, price, dosage, dosage form, etc. Maybe exactly Therefore, regulators do not consider it necessary or urgent to separately regulate the display issue - after all, the topic of storage is regulated in the relevant regulatory act.
Meaning Order of the Ministry of Health and Social Development of the Russian Federation dated August 23, 2010 No. 706n “On approval of the Rules for the storage of medicines”. As for “Instructions for organizing storage in pharmacies of various groups of medicines and medical products” (Order of the Ministry of Health of the Russian Federation dated November 13, 1996 No. 377), then most of its articles have become invalid. Only its norms apply to medical products and medical equipment, dressings and auxiliary materials, plastic and rubber products.
In Order No. 706n, even the words “showcase” and “display” are absent. But, probably, there is not a single pharmacy or pharmacy that does not have some of its medicinal products stored in the front and display areas of the pharmacy hall. Thus, Rules for storing medicines Order No. 706n naturally applies to the pharmacy hall.
What follows from Order No. 706n
Pay attention to the title of the order - it really concerns almost exclusively medicines. Clause 8 of Section III of the order determines that they are placed in storage rooms - we have already mentioned above that these also include the front and display areas of pharmacy halls - taking into account:
- pharmacological groups;
- physical and chemical properties;
- method of application (internal, external);
- state of aggregation of pharmaceutical substances (liquid, bulk, gaseous);
and also in accordance with the requirements of the regulatory and technical documentation indicated on the packaging of the medicinal product.
Order No. 706n does not contain any separate instructions on how to store dietary supplements, medical products, personal hygiene products, mineral water, cosmetics, etc. regarding medicinal products in a pharmacy - including on the display case. There are none in “Hygienic requirements for the organization of production and circulation of biologically active food additives” (SanPiN 2.3.2. 1290–03). Therefore, from a formal point of view, some interpret this in such a way that dietary supplements can be placed with medications “of the same type” on the same display shelf.
However, such a conclusion seems doubtful. Firstly, dietary supplements essentially cannot be combined with drugs of the “same focus”, because they are not drugs (the effect on the same body systems does not mean anything).
Secondly, “targeting” does not mean belonging to one pharmacological group, which, by the way, cannot contain both drugs and non-medicines, that is, dietary supplements. And since Order No. 706n and its paragraph cited above talk about regulating the storage of medicines and specifically by pharmacological groups, it is obvious that in none of the storage places - including on the display case - medicines can be placed together with dietary supplements .
In order not to be misleading
There is another side to the topic. We should not forget about Article 10 of the Law “On the Protection of Consumer Rights” (dated 02/07/1992 No. 2300–1), which prescribes providing customers with the necessary and reliable information about goods, ensuring the possibility of their correct choice.
Imagine, a consumer approaches a display window where not only medications of the same pharmacological group are displayed, but also dietary supplements “of the same type.” The phrase “Not a medicine”, of course, according to clause 4.4 of SanPiN 2.3.2. 1290–03, is present on the packaging of dietary supplements, but, as a rule, it is printed in small print and is not noticeable from afar.
Therefore, when looking at a shop window, it’s easy to miss such a phrase. In addition, when displayed, it may end up on the inaccessible side of the package. As a result, the buyer may automatically assume that this product, like the drugs located around it, is a medicine, although, we emphasize, this can hardly be called deliberate misleading on the part of the pharmacy. However, the consumer may decide to purchase this particular name, believing it to be medicinal. And only at home, after taking a closer look at the packaging or instructions, will you discover that it is not such.
Thus, the joint display of medicines and dietary supplements on the same display shelf creates the risk of unconsciously misinforming the consumer and violating his rights as defined in Article 10 of the Law “On Protection of Consumer Rights”. And therefore it should also be avoided.
The conclusions are as follows. It is not recommended to place medications and any dietary supplements on one display shelf. To store dietary supplements in a pharmacy, it is better to provide separate display spaces, which should be accompanied by the inscription “Dietary active food supplements.” On the ordering of various dietary supplements within such a SanPiN showcase 2.3.2. 1290–03 says nothing. It only contains an indication that dietary supplements should be stored taking into account their physical and chemical properties, under the conditions specified by the manufacturer, observing temperature, humidity and light conditions.
Chapter 1. General requirements for storage organization
Regulatory framework governing the storage of pharmaceutical products
Organization of proper storage of medicines and other pharmaceutical products is subject to licensing requirements and is carried out strictly in accordance with regulatory documents. The list of regulatory documents is given in Table 1.
Table 1
Regulatory documents regulating the storage of medicines and other pharmaceutical products
| № | Document title |
| N 706n order of the Ministry of Health of the Russian Federation | dated 08/23/2010. "On approval of the Rules for the storage of medicines" |
| N 397n order of the Ministry of Health of the Russian Federation | dated 16.05.2011 "On approval of special requirements for storage conditions of narcotic drugs and psychotropic substances registered in the prescribed manner in the Russian Federation as medicines intended for medical use in pharmacies, medical institutions, research, educational organizations and organizations for the wholesale trade of medicines." |
| N 1148 order of the Ministry of Health of the Russian Federation | dated December 31, 2009 “On the procedure for storing narcotic drugs and psychotropic substances.” |
| No. 377 order of the Ministry of Health of the Russian Federation | dated November 13, 1996 “On approval of instructions for organizing storage in pharmacies of various groups of medicines and medical products” |
| No. 214 order of the Ministry of Health of the Russian Federation | dated July 16, 1997 “On quality control of drugs manufactured in pharmacy organizations (pharmacies).” |
| FZ-61 | dated 04/12/2010 “On the circulation of medicines” |
| No. 183n order of the Ministry of Health of the Russian Federation | dated 04/22/2014 "On approval of the list of medicines for medical use, subject to subject-quantitative accounting." |
| No. 55 RF PP | dated 01/19/1998 "On approval of the Rules for the sale of certain types of goods, a list of durable goods that are not subject to the buyer's requirement to provide him with a gratuitous supply for the period of repair or replacement of a similar product, and a list of non-food products of proper quality that cannot be returned or exchanged for a similar one goods of a different size, shape, dimension, style, color or configuration.” |
| No. 681 RF PP | dated June 30, 1998 “On approval of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation.” |
| N 964 PP RF | dated 12/29/2007 "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 quantities of potent substances for the purposes of Article 234 of the Criminal Code of the Russian Federation." |
| N 644 PP RF | dated 04.11.2006 "On the procedure for submitting information on activities related to the trafficking of narcotic drugs and psychotropic substances, and registration of transactions related to the trafficking of narcotic drugs and psychotropic substances." |
| No. 640 RF PP | dated 08/18/2010 "On approval of the Rules for the production, processing, storage, sale, acquisition, use, transportation and destruction of precursors of narcotic drugs and psychotropic substances." |
| No. 970 order of the Ministry of Health of the Russian Federation | dated September 25, 2012 “On approval of the Regulations on state control over the circulation of medical products.” |
| No. 674 RF PP | dated 09/03/2010 "On approval of the Rules for the destruction of substandard medicines, counterfeit medicines and counterfeit medicines." |
| No. 309 order of the Ministry of Health of the Russian Federation | dated 10/21/1997 "On approval of the Instructions on the sanitary regime of pharmacy organizations (pharmacies)". |
| No. 1081 RF PP | dated December 22, 2011 “On licensing of pharmaceutical activities.” |
| No. 1085 RF PP | dated December 22, 2011 “On licensing activities related to the trafficking of narcotic drugs, psychotropic substances and their precursors, and the cultivation of narcotic plants.” |
Characteristics of storage requirements
Medicines, medical products and other pharmaceutical products
Storage mode is a set of climatic and sanitary-hygienic requirements that ensure the safety of goods.
Climatic requirements for storage conditions include the following parameters:
Storage temperature
Relative humidity
Air exchange
Gas composition
· Illumination.
Storage temperature
Air temperature in the storage room. One of the most significant indicators of storage mode. With increasing temperature, chemical, physicochemical, biochemical and microbiological processes intensify. Measured in degrees Celsius.
Commodity research provides for several storage modes (C 0):
· Frozen – no higher than -20;
· In the refrigerator compartment – from 0 to +4;
· At cool temperatures – from +12 to +15;
· At room temperature – from +18 to +20;
· Cold chain temperature – from 0 to +8.
The storage temperature is determined by the manufacturer based on the results of testing the stability of the product. Storage conditions must comply with the instructions contained on the label.
The temperature regime for storing medicines is organized in accordance with the instructions of the State Pharmacopoeia of the XII edition (Table 2).
Table 2
Temperature conditions for storing medicines according to the State Fund XII
| Terms | Temperature limits |
| Store at a temperature not exceeding 30 0 C | from +2 to +30 0 С |
| Store at a temperature not exceeding 25 0 C | from + 2 to + 25 0 C |
| Store at a temperature not exceeding 15 0 C | from + 2 to + 15 0 C |
| Store at a temperature not exceeding 8 0 C | from + 2 to + 8 0 C |
| Store at a temperature not lower than 8 0 C | from +8 to +25 0 C |
In addition to the specific indication of temperature, the following terms with temperature limits can also be used:
The distance from the storage location to heating devices must be more than 1 m.
Storage of medicines in a medical institution must comply with the general requirements of the Ministry of Health.
However, in practice they are often violated. Let us recall the basic rules for storing medications of different groups, and consider the typical mistakes of medical institutions when organizing storage processes. R
Let's find out who is responsible for improper storage of medications.
From the article you will learn:
- Rules for storing medicines
- Rules for storing drug groups
- Requirements for storage conditions of drugs
Rules for storing medicines
Storage of medicines is one of the basic processes of circulation of medicines. Order of the Ministry of Health and Social Development of the Russian Federation No. 706n dated August 23, 2010 approved a list of rules according to which the storage of medicines is organized in medical institutions of the Russian Federation. Order "On approval of the Rules for the storage of medicines"
This document provides a classification of medicines that require protection from environmental factors - light, temperature, moisture, etc. The following groups of drugs have been identified, for each of which there are different storage rules: a group of products that require protection from exposure to a humid environment and light; medicines that, if stored improperly, can dry out and evaporate; medications that should be stored at a certain temperature; drugs that can deteriorate when exposed to gases contained in the environment.
What documents approve the rules for storing medicines?
As mentioned above, the rules for storing medicines were approved by Order No. 706n.
In addition, there are other documents that establish additional storage conditions for medicines:
1. Order of the Ministry of Health No. 771 of October 29, 2015 (list of pharmacopoeial articles).
2. Order of the Ministry of Health No. 676n dated August 31, 2016 (description of good practices for storing and transporting medicines);
3. Order of the Ministry of Health No. 770 of October 28, 2015 (changes to the list of pharmacopoeial monographs).
Rules for storing medicines are also fixed in the local documentation of the medical organization. Such documents include SOPs - standard operating procedures that describe in detail the storage conditions of medicines, the actions of medical staff, etc. The content of such standard documents includes the following sections: requirements for the transportation of medicines; measures to protect drugs from environmental influences; rules for admitting health workers to rooms to place medications; rules for cleaning these premises; the procedure for conducting audits of compliance with procedures and the results of these audits; responsibility of health workers who violated standard procedures.
Rules for storing drug groups
The rules for storing medicines must be observed taking into account the group of belonging of a particular medicine.
Medicines must be placed in specially designated areas. These are cabinets, open shelves,...
If the drugs are classified as narcotic drugs or are subject to PCU, the cabinet in which they are placed must be sealed. It is advisable to use a refrigerator safe with a burglary resistance class.
Other drugs can be stored on shelves so that their consumer packaging is visible.
Storage conditions for medicines include equipping storage areas with opening windows, pharmaceutical refrigerators and air conditioners.
This allows you to ensure a suitable temperature regime.
Storage conditions for medicines
Let's look at some rules for storing medications from different groups.
1. Medicines that should be protected from light. The group's medicinal products are stored in places where light access is limited. To do this, reflective film is applied to the windows or they are covered with blinds, etc. Pharmaceutical refrigerators must have special glass in the door that does not allow ultraviolet rays to pass through, or the door must be solid.
2. Medicines that need to be protected from moisture. The room for such drugs should be well ventilated. The air in it must be dry, the permissible humidity is up to 65%.
3. Medicines that are prone to drying out and volatilization. Special storage conditions are ensured by maintaining optimal air temperature - from 8 to 15C. Hydrogen peroxide, iodine, etc. are prone to volatilization.
4. Storage of medications under special temperature conditions. There are drugs that can deteriorate in high or low temperatures. Recommendations for the storage temperature of a particular drug are indicated by the manufacturer on the primary or secondary packaging.
5. Drugs that may deteriorate due to exposure to gases in the air. The packaging of the drugs should not be damaged, there should be no intense lighting or foreign odors in the room. The recommended temperature in the office is observed.
The conditions under which medications must be stored are usually described: on the packaging or shipping container of the medications; in the instructions for medical use of the drug; in the state register of medicines. These terms and conditions must be clearly legible. The language of instructions is Russian. Information about the storage conditions of medicines is also placed on the shipping container in the form of handling and warning signs. For example: “Do not throw”, “Keep away from sunlight”, etc.
Requirements for storage conditions of drugs
Storage of drugs belonging to the group of poisonous and potent drugs is carried out in special premises. They must be equipped with security engineering and technical devices. In additionally reinforced premises, both narcotic and other potent drugs can be stored simultaneously.
Depending on the available supply of drugs, they are stored on separate shelves or in different sections of the cabinet. Drug storage regulations require that potent drugs not under international control be stored in metal cabinets, which are sealed at the end of the day by a responsible health professional. It is important to use, which provides protection against unauthorized access and allows you to set the exact temperature conditions for storing medicines.
What kind of premises should be used for storing medicines?
A medical organization must comply with the requirements for premises that are planned to be used for storing medicines. Let us highlight a few general rules: it is important that the room has sufficient capacity for convenient and separate storage of drugs from different groups; zoning of the premises involves the allocation of a common zone, a special zone and a quarantine zone. Drugs whose expiration dates have expired are stored separately; storage areas should be well lit; household premises are separated from areas in which medicines are stored; personal belongings of healthcare workers, drinks and food should not be stored together with medications; the optimal temperature for certain groups of drugs is ensured in the room; equipment for routine and general cleaning of the premises is stored in separate cabinets; the room must be free from the possibility of animals, rodents and insects entering it; Shelf maps are placed next to the shelves for medicines, which allow you to quickly find the right drug; the premises must be equipped with a security system; the operational rules for the use of refrigerators, air conditioners and other premises systems (fire safety, security, etc.) are observed; preparations for recording temperature and other air parameters must undergo periodic verification and calibration.
Medicines with special storage conditions
Special storage conditions for medicines are observed for the following medicines: 1. Psychotropic and narcotic medicines. 2. Explosive and flammable. 3. Drugs whose properties are affected by environmental conditions.
For example, explosive medications should not be shaken or struck when moving. They are stored away from heating radiators and daylight.
It is prohibited to store photosensitive drugs in the primary packaging. They are placed in secondary packaging that has light-protective properties. For drugs that are sensitive to high and low temperatures, it is necessary to comply with the temperature regime recommended by their manufacturer.
Storage of immunobiological drugs requires special attention. We are talking about the “cold chain” principle, which ensures the maintenance of optimal temperature to preserve the beneficial properties of the drug at all stages of its transportation and movement. Spoiled drugs are stored separately from other drugs and will be destroyed later. Requirements for the storage of narcotic drugs are specified in the Federal Law “On Narcotic Drugs and Psychotropic Substances”. Premises for their storage are equipped with additional protection measures in accordance with the requirements of Order No. 370 of the Federal Drug Control Service of Russia dated September 11, 2012. Special requirements for the storage of such drugs are also contained in the departmental order of the Ministry of Health of the Russian Federation No. 484n dated July 24, 2015.
The essence of these requirements is that the premises for storing narcotic drugs must be further strengthened. Medicines are placed in metal cabinets, pharmaceutical refrigerators, and refrigerator safes, which are subject to sealing at the end of the work shift by the responsible health workers. Similar rules have been established for medications that are subject to subject-quantitative accounting.
Errors when storing medicines
The rules for storing medicines discussed above are often violated in practice in medical institutions.
Common mistakes include the following:
- medicines are stored in violation of the requirements specified on their packaging from the manufacturer;
- regular medications are stored together with medications whose expiration dates have expired;
- in a medical institution, the expiration dates of medications are not taken into account in a special journal;
- There are no devices in medical institutions to monitor temperature indicators in medicine storage rooms.
Who is responsible for improper storage of medications?
Accounting, storage and use of medications are the duties of a nurse.
This is indicated in the order of the Ministry of Health and Social Development of Russia dated July 23, 2010 No. 541n. According to Part 1 of Article 14.43 of the Code of the Russian Federation on Administrative Offenses, violation of the requirements for the circulation of medicines is an administrative offense.
In this case, the nurse will face a fine - from 1000 to 2000 rubles.
A medical institution may be fined from 100,000 to 300,000 rubles.
Examples of violations and subsequent punishments
Temperature violation- Resolution of the Supreme Court of the Russian Federation of December 8, 2014 No. 307-AD14-700
100,000 rub.
There are no instruments in the treatment rooms certified by metrological control bodies - Resolution of the Supreme Court of the Russian Federation of February 3, 2016 No. 305-AD1518634
100,000 rub.
There is no daily recording of air temperature and humidity; there is no device for recording air humidity parameters (hygrometer); there is no specially designated and designated (quarantine) zone; no records are kept of medicines with a limited shelf life - Resolution of the Supreme Court of the Russian Federation of January 19, 2015 No. 306-AD144327
100,000 rub.
