Veterinary drugs as commodities

Approved by the educational and methodological commission of the faculty of veterinary medicine (protocol No. dated_2014)

Reviewers:

N.M. Vasilevsky,

Doctor of Veterinary Sciences, Professor, Head of the Department of Organization and Economics of Veterinary Affairs, FGBOU VPO MGAVMiB;

L.A. Gnezdilova,

Doctor of Veterinary Sciences, Professor of the Department of Diagnosis of Diseases and Animal Therapy.

1. Regulatory framework for state registration of medicinal products for veterinary use

Medicines - these are substances or their combinations that come into contact with the human or animal body, penetrate into the organs, tissues of the human or animal body, used for a human or animal for the purpose of:

Prevention;

diagnostics;

Treatment of the disease;

rehabilitation;

Preservation, prevention or termination of pregnancy.

They can be obtained: from blood, blood plasma, from organs, tissues of the human or animal body, plants, minerals by synthesis methods or using biological technologies. Medicinal products include pharmaceutical substances and drugs.

In accordance with the Federal Law of April 12, 2010 No. 61-FZ "On the Circulation of Medicines", medicines are introduced into civil circulation in the territory Russian Federation if they are registered by the relevant authorized federal body executive power.

Registration is the official procedure for the admission of a drug into circulation by evaluating and approving the data contained in the registration dossier on its safety and efficacy, as well as on the conditions of its production and quality control. It ends with the issuance of a registration certificate and the entry of the medicinal product into the State Register of Animal Medicines.

The following are subject to state registration:

original medicines;

Generic drugs;

New combinations of previously registered medicines;

Medicinal products registered earlier, but produced in other dosage forms, in new dosage. State registration of medicinal products is carried out by the relevant authorized federal executive body within a period not exceeding 210 working days from the date of acceptance of the application for state registration of the medicinal product. The period of state registration of a medicinal product is calculated from the date of acceptance by the relevant authorized federal executive body of an application for state registration of a medicinal product with the attachment of the necessary documents until the date of issue registration certificate medicinal product.

The following are not subject to state registration:

medicinal products manufactured by veterinary pharmacy organizations, individual entrepreneurs who have a license for pharmaceutical activities, according to prescriptions for medicinal products and the requirements of veterinary organizations;

Medicinal plant materials;

Medicinal products intended for export;

Radiopharmaceutical medicinal products manufactured directly in medical organizations in the manner prescribed by the authorized federal executive body.

The use of unregistered medicinal products is allowed in preclinical studies, evaluation of their effectiveness, as well as for the treatment of specific animals in zoos and circuses.

State registration is not allowed:

Different medicinal products under the same trade name;

One medicinal product manufactured by the manufacturer under different trade names and submitted for state registration in the form of two or more medicinal products.

In order to implement the requirements of the Law of the Russian Federation "On Veterinary Medicine", federal law"On the circulation of medicines" Ministry of Agriculture of the Russian

The Federation issued an order dated April 1, 2005 “On approval of the rules for state registration of medicines and feed additives”, which approved the Rules for the State Registration of Medicines for the Treatment of Animals.

According to the Rules, the Rosselkhoznadzor is responsible for state registration veterinary drugs.

For the state registration of a medicinal product, the Applicant submits the following registration documents and data to Rosselkhoznadzor:

Application for state registration of a medicinal product;

Legal address of the organization - the manufacturer of the medicinal product;

The name of the medicinal product, including the international generic name, the scientific name for Latin, main synonyms;

The original name of the medicinal product, if it is registered as a trademark in accordance with the legislation of the Russian Federation on trademarks, service marks and appellations of origin;

The list of components that make up the medicinal product, their quantity;

Instructions for use of the medicinal product, drawn up in accordance with the requirements of the Federal Law "On the Circulation of Medicines";

Medicinal product quality certificate;

Data on the production of the medicinal product;

Medicinal product quality control methods;

Results of preclinical studies of the medicinal product;

Results of clinical trials of the medicinal product;

The results of the veterinary and sanitary examination of livestock products after the use of the medicinal product;

Medicinal product samples for examination of its quality;

Proposals for the price of the medicinal product;

documents confirming the registration of the medicinal product, if it is registered outside the Russian Federation.

2. Significance of preclinical and subsequent clinical study of the medicinal product

Most unwanted side effects medicines should be detected when they are preclinical toxicological study in experiments on laboratory animals. In this regard, in last years the role of preclinical study of the safety of drugs under development has sharply increased. Toxicological research has expanded significantly, become complex and expensive; their volume, the adequacy of the methods and biological models used, as well as the quality of the studies carried out, are strictly regulated and controlled by the health authorities of most countries.

Toxicity - the property or ability of chemicals, acting on biological systems in a non-mechanical way, to cause their damage or death. Toxicity is also the property of a drug to cause undesirable biological effects in doses exceeding the therapeutic ones. In other words, toxicity is the property of a substance, when it enters the human body, animals or plants in certain quantities, to cause their poisoning or death.

Judgments about the toxicity of a substance to humans (in the absence of accurate clinical data) are based on the results of animal experiments, the variety and number of which in some cases should be increased. It is generally accepted to divide toxicological studies into:

Study of general toxic action;

Study specific species toxicity (allergenicity, immunotoxicity, reproductive toxicity, carcinogenicity).

The study of the general toxic effect allows you to determine the tolerable and toxic doses pharmacological substance and identify the most sensitive to the studied pharmacological substance organs and systems of the body, the nature and extent of pathological changes in them, as well as to investigate the reversibility of the damage caused.

The study of general toxic action is divided into the study of:

Acute toxicity ( toxic effect a substance administered in a single dose or in multiple doses over a period of not more than 24 hours, which may present as a disorder physiological functions or in violation of the morphology of the organs of experimental animals, as well as the death of the animal);

Subacute/subchronic toxicity (a set of functional and (or) morphological disorders of organs and systems of an experimental animal after reintroduction within 2-12 weeks);

Chronic toxicity (a set of functional and (or) morphological disorders of the organs and systems of the experimental animal after repeated administration for 36-12-18 months).

The duration of drug administration in the study of chronic toxicity is determined by the intended course clinical application. As a classic example of conducting preclinical studies of drugs, one can cite the methodological approaches to the study of general toxicity, set out in the Guidelines for the study of the general toxic effect of pharmacological substances.

The organization, planning and conduct of preclinical studies of medicinal products is carried out in accredited institutions in accordance with the principles of good laboratory practice (GLP).

Clinical study of drugs is carried out in accordance with the instructions, which set out modern approaches to the study of drugs from various clinical and pharmacological groups for various diseases.

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Veterinary medicine is advancing by leaps and bounds, there are many, biologically active additives and vaccines, to improve the condition, and others, increase their survival and increase the body's resistance. However, in veterinary medicine, a drug that can replace a good half of modern drugs has been used for a long time and very successfully, it is called Dorogov's antiseptic stimulator (ASD). Today we will get acquainted with fraction 2, its instructions and application features.

Description, composition and form of release

Dorogov's antiseptic stimulator is made from meat and bone by sublimation of organic raw materials at high temperature.

Part medicinal solution includes amide derivatives, aliphatic and cyclic hydrocarbons, choline, carboxylic acids, ammonium salts, other compounds and water.

Externally, the drug is a liquid solution, the color of which varies from yellow to brown with a red impurity. The liquid quickly dissolves in water with the formation of a slight fine sediment.

The sterile preparation is packaged in glass bottles with a capacity of 20 ml and 100 ml.

Biological properties

Due to its composition, ASD faction 2 known for extensive pharmacological properties which explains its successful use in veterinary medicine.

• Stimulates the central and peripheral nervous system.
• Improves intestinal motility and function gastrointestinal tract in general, by accelerating the production of enzymes.
• Stimulates endocrine system body, which, in turn, has a beneficial effect on metabolism.
• It is an antiseptic, promotes the rapid restoration of damaged tissues.

Did you know? A.V. Dorogov invented this remedy in 1947 and positioned it as a medicine that can be used, among other things, to treat people from cancer. His archival records contain information that it was the ASD who helped save the mother of Lavrenty Beria from cancer.

Indications for use

Fraction 2 ASD is used, according to the instructions for the treatment and prevention of farm animals, and other poultry, can be used for.

• For injury and disease internal organs in particular the gastrointestinal tract.
• With diseases of the genital area, therapy of vaginitis, endometritis and other pathologies in.
• In order to stimulate metabolic processes and accelerating the growth of poultry offspring.
• As a stimulator of one's own immunity during rehabilitation after illnesses.
• To normalize the functioning of the central nervous system.
• Can be applied when various injuries providing antiseptic and healing action.

Dosage and administration

For the correct dosing of the drug, you must strictly follow the instructions in the instructions, since the dosage for different animals is very different.

Important! When used orally, the drug should be consumed by the animal before or during the morning meal.

Horses

When calculating the norm for, one should follow the general rule age dosage.

• If the age of the animal is less than 12 months, then 5 ml of the drug is diluted in 100 ml boiled water or compound feed.
• In the period from 12 to 36 months, the dosage is doubled and is 10-15 ml of the product per 200-400 ml of the solvent.
• For horses over 3 years of age, the dose increases slightly, up to 20 ml of medication and up to 600 ml of liquid.

cattle

For the treatment of ASD, it is prescribed orally, while it is recommended to adhere to following scheme:

• animals up to 12 months - 5-7 ml of the drug, diluted in 40-100 ml of water;
• at the age of 12-36 months - 10-15 ml per 100-400 ml of feed or water;
• older than 36 months should receive 20-30 ml of the drug in 200-400 ml of liquid.

The drug is also used topically to treat gynecological complications in women using the douching method. The dosage is selected according to the diagnosis and instructions in each individual case.

For washing infected wounds, a 15-20% ASD solution is used.

Sheep

Sheep get the most weak dose of all pets:

• up to 6 months only 0.5-2 ml per 10-40 ml of water;
• from six months to a year - 1-3 ml per 20-80 ml of liquid;
• older than 12 months - 2-5 ml of the drug is diluted in 40-100 ml of water.

Pigs

Application possible with 2 months.

• from 2 months to six months, the dose is 1-3 ml of the drug to 20-80 ml of water;
• after six months - 2-5 ml per 40-100 ml of water;
• after 1 year - 5-10 ml per 100-200 ml of liquid.

Chickens, turkeys, geese, ducks

For the treatment of poultry according to ASD instructions fraction 2 assumes the following order of application: for adults, 35 ml of the drug is taken per 100 liters of water or 100 kg; for young individuals, in order to strengthen the body, a dosage is taken at the rate of 0.1 ml of solution per 1 kg of live weight of an individual.

For poultry, the drug is used not only inside, but is sprayed in the habitat of birds in the form of a 10% aqueous solution (5 ml of solution per 1 cubic meter of room). This is done for 15 minutes on the first, twenty-eighth and thirty-eighth days of the life of the young to accelerate growth. This method also makes it possible to cure young livestock from apteriosis, in which they are weakly feathered.

Dogs

When preparing an ASD-2 solution for dogs, it must be borne in mind that it can be taken by an animal older than six months and in such a dosage as 2 ml of the drug per 40 ml of water.

Precautions and special instructions

Since the drug is included in the group moderately hazardous substances, it is recommended to work with him exclusively in rubber gloves to prevent contact with the skin. After finishing work, hands are washed with concentrated warm soapy water then rinsed with running water.

In order to implement Article 58 of the Federal Law of April 12, 2010 No. 61-FZ “On the Circulation of Medicines” (Collected Legislation of the Russian Federation, 2010, No. 16, Art. 1815; No. 31, Art. 4161; No. 42, Art. 5293; No. 49, item 6409; 2011, No. 50, item 7351; 2012, No. 26, item 3446; No. 53, item 7587; 2013, No. 27, item 3477; No. 48, item 6165; 2014, No. 11, Article 1098; No. 43, Article 5797; 2015, No. 10, Article 1404) and in accordance with subparagraph 5.2.25(43) of the Regulations on the Ministry of Agriculture of the Russian Federation, approved by the Decree of the Government of the Russian Federation June 12, 2008 No. 450 (Collected Legislation of the Russian Federation, 2008, No. 25, Art. 2983; No. 32, Art. 3791; No. 42, Art. 4825; No. 46, Art. 5337; 2009, No. 1, Art. 150; No. 3, item 378; No. 6, item 738; No. 9, item 1119, item 1121; No. 27, item 3364; No. 33, item 4088; 2010, No. 4, item 394; No. 5, item 538; No. 16, item 1917; No. 23, item 2833; No. 26, item 3350; No. 31, item 4251, 4262; No. 32, item 4330; No. 40, item 5068 ; 2011, No. 6, item 888; No. 7, item 983; No. 12, item 1652; No. 14, art. 1935; No. 18, art. 2649; No. 22, art. 3179; No. 36, Art. 5154; 2012, no. 28, art. 3900; No. 32, Art. 4561; No. 37, art. 5001; 2013, no. 10, art. 1038; No. 29, Art. 3969; No. 33, art. 4386; No. 45, Art. 5822; 2014, no. 4, art. 382; No. 10, Art. 1035; No. 12, art. 1297; No. 28, Art. 4068; 2015, no. 2, art. 491; No. 11, Art. 1611), I order:

1. Approve the attached Rules for the storage of medicines for veterinary use.

Rules
storage of medicinal products for veterinary use

I. General provisions

1. These Rules establish requirements for storage facilities for medicinal products for veterinary use (hereinafter referred to as medicinal products), determine the storage conditions for medicinal products and apply to drug manufacturers, drug wholesalers, veterinary pharmacy organizations, individual entrepreneurs, veterinary organizations and other organizations circulating medicines for veterinary use (hereinafter, respectively - organizations, individual entrepreneurs).

II. General requirements for premises for the storage of medicines and organization of storage of medicines

2. The device, composition, size of areas, operation and equipment of premises for the storage of medicines must ensure their safety, taking into account the physicochemical, pharmacological and toxicological properties, as well as the requirements of regulatory documents for medicines established by manufacturers of medicines, and / or general pharmacopoeial articles, and/or pharmacopoeial articles.

3. The internal surfaces of the enclosing structures (walls, partitions, ceilings) in the premises for storing medicines must be smooth and allow for wet cleaning. The floors in the premises for the storage of medicines should be solid, hard and even, have a dust-free coating that is resistant to mechanical and wet cleaning using disinfectants, should not have unpainted wooden surfaces.

4. Premises for the storage of medicines must be equipped with equipment that allows to ensure the temperature and humidity conditions for storing medicines in accordance with the storage conditions provided for by the instructions for the use of medicinal products for veterinary use (hereinafter referred to as medicinal products), or the storage conditions indicated on primary packaging pharmaceutical substances.

5. Premises for the storage of medicinal products must have power supply, heating systems, be equipped with a forced or natural ventilation system. It is not allowed to heat the premises with gas appliances with an open flame or electric heaters with an open electric coil.

6. Premises for the storage of medicines must be equipped with racks, cabinets, pallets (stands). It is not allowed to store medicines on the floor without a pallet.

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

7. In the premises for storing medicines, racks (cabinets) should be installed in such a way as to ensure free access to medicines for personnel and, if necessary, loading devices, as well as the availability of racks (cabinets), walls, floors for cleaning. Shelving for storing medicines in rooms with an area of ​​​​more than * should be installed as follows:

distance to external walls - not less than 0.6 m;

distance to the ceiling - at least 0.5 m;

distance from the floor - not less than 0.25 m;

passages between racks - not less than 0.75 m.

8. Racks, cabinets and shelves in them intended for storing medicines must be numbered and marked. Pallets (pedestals) intended for storage of medicines must be marked.

On racks and cabinets, a rack card should be attached indicating the names of medicines, batch number, expiration date, number of storage units. When using computer technologies, the absence of rack cards is allowed, provided that the stored medicines are identified using codes and electronic devices.

When storing medicines in veterinary organizations and organizations engaged in breeding, raising and keeping animals, the groups of medicines systematized by the methods listed in paragraph 13 of these Rules are indicated in the rack cards.

9. Medicinal products in secondary (consumer) packaging, pharmaceutical substances in primary packaging should be stored in cabinets, on racks or shelves with the label (marking) facing out.

10. Premises for the storage of medicinal products requiring protection from exposure elevated temperature» must be equipped with refrigeration equipment equipped with thermometers (thermographs, temperature recorders).

11. Premises for the storage of medicines must be equipped with devices for recording air parameters (thermometers, hygrometers (electronic hygrometers) or psychrometers). In premises for storing medicines with an area of ​​more than *, the measuring parts of these devices should be placed at a distance of at least 3 m from doors, windows and heating devices.

Devices and (or) parts of devices from which visual readings are taken should be located in a place accessible to personnel at a height of 1.5 - 1.7 m from the floor.

12. The readings of instruments for recording air parameters (thermometers, hygrometers (electronic hygrometers) or psychrometers) must be recorded 2 times a day in a log (map) for recording air parameters on paper or in electronic form with archiving (for electronic hygrometers), which is maintained the person responsible for the storage of medicines. The journal (card) of registration is started for one calendar year. The log (card) of registration is kept for one calendar year following the year of keeping the log (card) of registration. Devices for recording air parameters must be certified, calibrated and verified in the prescribed manner.

13. When storing medicines are used the following ways systematization:

by pharmacological groups;

according to the method of application (internal, external);

In alphabet order;

taking into account state of aggregation pharmaceutical substances (liquid, bulk, gaseous).

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

The method of organizing the storage of medicines is approved by order of the head of the organization or an individual entrepreneur and brought to the attention of the staff.

14. Separately from other groups of medicines, in accordance with the requirements of the Federal Law of January 8, 1998 No. 3-FZ "On drugs and psychotropic substances” (Sobraniye zakonodatelstva Rossiyskoy Federatsii, 1998, No. 2, Art. 219; 2002, No. 30, Art. 3033; 2003, No. 2, Art. 167; No. 27, Art. 2700; 2004, No. 49, 4845; 2005, No. 19, 1752; 2006, No. 43, 4412; No. 44, 4535; 2007, No. 30, 3748; No. 31, 4011; 2008, No. 30, 3592; No. 48, 5515; No. 52, 6233; 2009, No. 29, 3588; 3614; 2010, No. 21, 2525; No. 31, 4192; 2011, No. 1, Article 16, Article 29; No. 15, Article 2039; No. 25, Article 3532; No. 49, Article 7019; Article 7061; 2012, No. 10, Article 1166; No. 53, Article 7630 ; 2013, No. 23, item 2878, No. 30, item 4057, No. 48, item 6161, item 6165; 2015, No. 1, item 54; No. 6, item 885), are stored:

narcotic and psychotropic drugs, precursors;

potent and poisonous drugs that are controlled in accordance with international legal norms.

15. 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 and / or rack cards indicating the name of the medicine, series, expiration date or expiration date registers. The procedure for keeping records of these medicines is established by the head of the organization or individual entrepreneur.

16. If expired medicinal products, in damaged packaging, substandard, falsified or counterfeit medicinal products are detected, they must be stored separately from other groups of medicinal products in a specially allocated and marked (quarantine) area or in a special container for no more than 3 months in order to destruction of such medicines in accordance with the Rules for the destruction of substandard medicines, counterfeit medicines and counterfeit medicines, approved by the Decree of the Government of the Russian Federation of September 3, 2010 No. 674 (Collected Legislation of the Russian Federation, 2010, No. 37, Art. 4689; 2012 , No. 37, item 5002).

17. Premises and equipment for the storage of medicines are subject to mandatory daily washing using detergents.

18. Storage of substances, equipment and materials intended for the provision of veterinary (medical) care, animal care, cleaning of premises, as well as disinfection, disinfestation and deratization is allowed in the premises for the storage of medicines. These substances, equipment and materials should be stored separately from the places of storage of medicines.

19. Access of unauthorized persons to the places of storage of medicines is not allowed.

20. When storing medicinal products, the requirements of the legislation of the Russian Federation in the field of circulation of medicinal products and the field of fire safety are taken into account.

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

21. Storage of medicines is carried out in accordance with the requirements of these Rules, taking into account the following features of the organization of storage of medicines in warehouses.

22. Medicinal products stored in warehouses should be placed on racks or on undercarriages (pallets).

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

Using mechanized devices for carrying out unloading and loading operations, the total height of the placement of medicines on the racks should ensure the possibility of carrying out these works.

IV. Requirements for premises for the storage of fire-explosive and flammable medicines and the organization of their storage

24. Storage of fire and explosion hazardous and flammable medicinal products should be carried out taking into account their physical and chemical properties(for example, the ability to oxidize, self-heat and ignite when exposed to moisture, contact with air).

25. Isolated rooms should be allocated for the storage of fire and explosion hazardous and flammable medicines.

The locations of isolated rooms in buildings (structures), space-planning solutions aimed at limiting the spread of fire, as well as methods of fire protection should be determined on the basis of the legislation of the Russian Federation in the field of circulation of medicines and the field of fire safety, taking into account the category of premises for explosion and fire danger.

26. Warehouses must be equipped with fireproof cabinets, racks and pallets designed for the appropriate load. The racks are installed at a distance of 0.25 m from the floor and 0.6 m from the 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

27. In the premises for the manufacture of medicinal products, it is allowed to store fire-explosive and flammable medicinal products in the amount necessary for packaging and manufacturing of medicinal products during one work shift. At the same time, the containers in which they are stored must be tightly closed. The remaining amount of fire and explosion hazardous and flammable medicines at the end of work at the end of the shift is transferred to the next shift or returned to the main storage place.

28. In veterinary pharmacy organizations and individual entrepreneurs, it is allowed to store medicines with flammable and combustible properties in a volume of up to 10 kg outside the premises for storing fire-explosive and flammable medicines in built-in fireproof cabinets. Cabinets must be removed from heat-removing surfaces and passages, have doors at least 0.7 m wide and at least 1.2 m high. Free access must be organized to them.

It is allowed to store fire and explosion hazardous medicines for use for one work shift in metal cabinets outside the premises for storing fire and explosion hazardous and fire hazardous medicines.

29. The amount of flammable medicines allowed for storage in storage rooms for fire and explosion hazard and flammable medicines located in warehouse buildings should not exceed 100 kg in bulk.

30. Premises for the storage of fire-explosive and flammable medicines in excess of 100 kg should be located in a separate building, while pharmaceutical substances should be stored in glass or metal containers isolated from other groups of medicines.

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

V. Features of storage of certain groups of medicines depending on the physical and physico-chemical properties, the impact on them of various environmental factors

Storage of medicines requiring protection from light

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

33. Pharmaceutical substances that require protection from light should be stored in containers made of light-protective materials (dark glass containers, metal containers, aluminum foil or polymer materials dark-colored).

34. Pharmaceutical substances that are particularly sensitive to light should be stored in a black light-tight container.

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

Storage of medicinal products requiring protection from moisture

36. Medicines that require protection from moisture should be stored in a room with an air temperature not exceeding +15 ° C, in a sealed container made of materials impervious to water vapor.

Pharmaceutical substances with pronounced hygroscopic properties should be stored in glass containers with airtight lids.

To avoid deterioration and loss of quality, storage of medicinal products requiring protection from moisture should be organized in accordance with the storage conditions provided for in the instructions for use of medicinal products, or the storage conditions indicated on the primary packaging of pharmaceutical substances.

Storage of medicinal products requiring protection from volatilization and drying out

37. Medicines that require protection from volatilization and drying out (actually volatile medicines; medicines containing a volatile solvent ( alcohol tinctures, liquid alcohol concentrates, thick extracts); solutions and mixtures of volatile substances ( essential oils, solutions of ammonia, formaldehyde, hydrogen chloride over 13%, carbolic acid, ethanol various concentrations); medicinal plant materials containing essential oils; medicines containing water of crystallization - crystalline hydrates; drugs that decompose with the formation of volatile products; medicinal products with a certain lower limit of moisture content) should be stored in a room with an air temperature not exceeding +15 ° C, in a sealed container made of materials impervious to volatile substances in accordance with the instructions for use of medicinal products, and the conditions indicated on the secondary (consumer) packaging - for medicines, on primary packaging - for pharmaceutical substances.

38. Pharmaceutical substances containing water of crystallization should be stored in a room with an air temperature not exceeding +15°C at a relative humidity of 50-65%.

Storage of medicines requiring protection from exposure to elevated temperatures

39. Storage of medicines that require protection from exposure to elevated temperatures (thermolabile medicines) must be carried out in accordance with the storage conditions provided for in the instructions for the use of medicines, or the storage conditions indicated on the primary packaging of pharmaceutical substances.

40. Biological medicinal products of the same name should be stored in batches, taking into account their expiration date. Do not store biologics on the refrigerator door panel.

41. Antibiotics should be stored in industrial packaging at room temperature (*), unless otherwise indicated in the instructions for use of medicinal products, or on the primary packaging of pharmaceutical substances.

42. Organic preparations should be stored in a dark, dry place at a temperature of 0 to +15°C, unless otherwise indicated in the instructions for use of the medicinal product.

43. Oils should be stored at a temperature of 44 to +12°C, unless otherwise indicated in the instructions for use of medicinal products, or on the primary packaging of pharmaceutical substances.

44. Loading of refrigeration equipment (refrigerators, refrigerated display cases, chambers, rooms) should ensure free air circulation in the premises for storing medicines.

Storage of medicines requiring protection from exposure to low temperatures

45. Medicines that require protection from exposure to low temperatures include medicines whose physicochemical state changes after freezing and when heated to room temperature(*) not recoverable (40% formaldehyde solution (formalin), ice cold acetic acid, fixed oils, insulin solutions, etc.).

Storage of medicines requiring protection from exposure to low temperatures is carried out in accordance with temperature regime specified in the instructions for use of medicinal products, on the secondary (consumer) packaging - for medicinal products, on the primary packaging - for pharmaceutical substances.

Freezing of preparations requiring protection from exposure to low temperatures is not allowed.

Storage of medicinal products requiring protection from environmental gases

46. ​​Medicines that require protection from the effects of gases in the environment (substances that react with atmospheric oxygen; substances that react with carbon dioxide air), should be stored in hermetically sealed containers made of materials impervious to gases, if possible filled to the top.

Storage of odorous and coloring medicines

47. Odorous medicines should be stored in hermetically sealed containers, impervious to smell, separately by name.

48. Coloring medicines (leaving a colored mark that is not washed off by ordinary sanitary and hygienic treatment on containers, closures, equipment and inventory) should be stored in a special cabinet in a tightly closed container, separately by name.

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

Storage of antiseptic medicines

49. Antiseptic drugs should be stored in sealed containers isolated from places where plastic, rubber and metal products are stored and places where distilled water is obtained.

Storage of medicinal plant materials

50. Medicinal plant materials (previously dried) should be stored in a dry, well-ventilated area, in a hermetically sealed container.

51. Medicinal plant materials containing essential oils must be stored in isolation in a hermetically sealed container.

52. Medicinal plant materials should be subject to periodic control in the form of an assessment of organoleptic indicators. Grass, roots, rhizomes, seeds, fruits that have lost their color, smell, and also affected by mold, pests, are not allowed to further storage and use.

Storage of flammable medicines

53. Storage of flammable medicines (medicines with flammable properties; medicines with flammable properties) should be carried out separately from other medicines.

54. In order to prevent the evaporation of liquids from vessels, flammable medicinal products should be stored in hermetically sealed glass or metal containers.

55. Containers with a volume of more than 5 liters with flammable and easily combustible medicines should be stored on the shelves of racks in one row in height. It is forbidden to store them in several rows in height using different cushioning materials.

56. It is not allowed to store flammable medicines at a distance of less than 1 meter from heating devices.

57. Storage of bottles with flammable and flammable drugs should be carried out in containers that protect against impacts, or in cylinder tippers in one row.

58. It is not allowed to store flammable and easily combustible medicines in fully filled containers. The filling of containers should not exceed 90% of the volume. Alcohols in a volume of more than 5 liters are stored in metal containers filled with no more than 75% of the volume.

59. Joint storage of flammable medicinal products with mineral acids, compressed and liquefied gases, flammable substances, alkalis, as well as with inorganic salts, which give explosive mixtures with organic substances.

60. Medical ether and ether for anesthesia should be stored in industrial packaging, in a room with an air temperature not exceeding +15 ° C in a place protected from light, at a distance of at least 1 meter from heating devices.

Storage of flammable and explosive medicines

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

62. Containers with flammable and explosive drugs must be tightly closed to prevent vapors of these drugs from getting into the air.

63. Storage of bulk potassium permanganate is allowed in a special compartment of storage facilities in tin drums. In veterinary pharmaceutical organizations, in veterinary organizations and in individual entrepreneurs, potassium permanganate should be stored in stem-glasses with ground-in stoppers, the stem-glasses should be located separately from other substances.

64. Bulk solution of nitroglycerin should be stored in a hermetically sealed glass or metal container, in a room with an air temperature not exceeding +15 ° C in a place protected from light, subject to fire precautions. The container with nitroglycerin should be moved and the drug should be weighed in conditions that exclude spillage and evaporation of nitroglycerin, as well as its contact with the skin.

65. When working with diethyl alcohol, shaking, shock, friction is not allowed.

Storage of narcotic and psychotropic medicines

67. Narcotic and psychotropic medicines are stored in organizations in isolated rooms, specially equipped with engineering and technical security equipment, and in places of temporary storage in compliance with the requirements established by the Rules for the Storage of Narcotic Drugs, Psychotropic Substances and Their Precursors, approved by Decree of the Government of the Russian Federation dated 31 December 2009 No. 1148 (Collected Legislation of the Russian Federation, 2010, No. 4, Art. 394; No. 25, Art. 3178; 2011, No. 18, Art. 2649; No. 42, Art. 5922; No. 51, Art. 7534 ; 2012, No. 1, item 130; No. 27, item 3764; No. 37, item 5002; 2013, No. 8, item 831; 2014, No. 15, item 1752).

Storage of potent and poisonous medicines

68. Potent and toxic drugs containing potent and toxic substances included in the list potent substances for the purposes of Article 234 and other articles of the Criminal Code of the Russian Federation and in the list of toxic substances for the purposes of Article 234 and other articles of the Criminal Code of the Russian Federation, approved by Decree of the Government of the Russian Federation of December 29, 2007 No. 964 (Collected Legislation of the Russian Federation, 2008, No. 2, Article 89; 2010, No. 28, Article 3703; 2012, No. 10, Article 1232; No. 41, Article 5625; No. 2013, No. 6, Article 558; No. 9, Article 953; No. 45 , Art. 5831), are stored in accordance with paragraphs 69 - 79 of these Rules.

69. The person responsible for the storage, accounting and dispensing of potent and poisonous medicines is the head of an organization or an individual entrepreneur, or a person appointed by him from among those working in this organization or at individual entrepreneur veterinarians (pharmacists), and in the absence of veterinarians - veterinary paramedics (pharmacists) with a secondary professional education.

70. The head of the organization, an individual entrepreneur is obliged to familiarize the persons responsible for the storage, accounting and dispensing of potent and poisonous medicines, against receipt, with the rules for handling these drugs.

71. Premises intended for the storage of potent and poisonous medicines shall be equipped with an entrance metal door, a wooden door reinforced on both sides with sheet iron, or a door made of other material with a class of protection against destructive effects not lower than the third.

72. Storage of poisonous medicines is allowed only in a separate room.

73. Potent medicinal products may be stored in the same room with other (not potent) medicinal products, but always in separate cabinets and under lock and key.

74. Potent and poisonous medicinal products shall be stored in safes specially allocated for this purpose, metal or iron-covered wooden cabinets or locked boxes. On the outer side of the door of the safe (cabinet, drawer) for storing potent and poisonous drugs, it is necessary to have the appropriate inscription "Strong/poisonous drugs". On the inside the door of the safe (cabinet, drawer) must be affixed with a list of potent and poisonous medicines stored in it.

75. Potent and poisonous drugs in large containers (for example, containers, barrels, cans, bags) should be stored in warehouses equipped with supply and exhaust ventilation, fire extinguishing equipment and alarms.

76. Strong and poisonous medicines should be stored separately in groups on separate shelves of cabinets (safes) depending on the method of their use.

77. Cabinets, safes and boxes in which poisonous medicines are stored, after the end of the working day, are locked and sealed or sealed. Premises and warehouses are locked, sealed or sealed.

78. Keys, a seal for sealing, a sealer are kept by the person responsible for storage, accounting and dispensing of potent and poisonous medicines.

79. Access to the premises for the storage of potent and toxic substances is allowed only to those responsible for the storage, accounting and dispensing of potent and toxic drugs to persons directly working with them, specified in the order of the head of the organization, individual entrepreneur.

Document overview

The Rules for the storage of medicinal products for veterinary use have been approved. They establish requirements for storage facilities and define storage conditions.

The rules apply to manufacturers, wholesalers, veterinary pharmacy organizations, individual entrepreneurs, veterinary organizations and other organizations that circulate medicines.

When storing medicines, 4 methods of systematization are used: by pharmacological groups; according to the method of application (internal, external); In alphabet order; taking into account the state of aggregation of pharmaceutical substances (liquid, bulk, gaseous).

When placing medicines, the use of computer technologies (by codes) is allowed.

The method of organizing storage is approved by order of the head of the organization or individual entrepreneur and brought to the attention of the staff.

Narcotic and psychotropic drugs, precursors are stored separately; strong and poisonous medicines controlled in accordance with international legal norms.

Accounting for medicines with a limited shelf life should be kept on paper or in electronic form with archiving. Control over the timely sale of such medicines is organized using computer technology and / or rack cards indicating the name of the medicine, series, expiration date or expiration date registers. The accounting procedure is established by the head of the organization or individual entrepreneur.

Application

to the order of the Ministry of Agriculture of Russia

RULES FOR DISPENSING MEDICINES FOR VETERINARY USE

I. Scope

1. These Rules for dispensing medicinal products (hereinafter referred to as the Rules) in veterinary organizations, veterinary pharmacy organizations, legal entities (hereinafter referred to as Organizations) and individual entrepreneurs determine the requirements for the dispensing of medicinal products and are binding on Organizations and individual entrepreneurs licensed for pharmaceutical activities carried out in the field of circulation of medicines intended for animals.

2. In these Rules, a pharmacy organization means a veterinary pharmacy organization, a pharmacy organization, a structural subdivision of a veterinary organization, individual entrepreneurs engaged in retail trade in medicinal products, storage, manufacture and dispensing of medicinal products for veterinary use.

3. These Rules are intended for individual entrepreneurs and legal entities.

II. General provisions

4. Pharmacy organizations carry out their activities on the basis of a license for pharmaceutical activities issued by the authorized federal executive body in the prescribed manner.

5. Acquisition, storage and sale of narcotic drugs and psychotropic substances included in the List of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation in accordance with the established procedure (hereinafter - narcotic drugs and psychotropic substances) must be carried out only if there is a license for activities related to the circulation of narcotic drugs and psychotropic substances.

7. By the nature of their activities, veterinary pharmacy organizations and individual entrepreneurs are divided into:

Manufacture medicines according to prescriptions with their subsequent implementation; selling finished medicinal products;

Carrying out the sale of finished medicinal products without the right to manufacture medicinal products.

8. Veterinary pharmacy organizations can be represented by veterinary pharmacies (hereinafter - Pharmacy), veterinary pharmacy stores (hereinafter - Pharmacy stores), veterinary pharmacy kiosks (hereinafter - Pharmacy kiosks).

9. Pharmacy organizations can perform the following functions:

9.1. Pharmacy:

Sale of finished medicinal products by prescription and without prescriptions;

Manufacture of medicines according to prescriptions of doctors with their subsequent implementation;

Realization of medicinal plant raw materials in the original packaging; animal care items, disinfectants and detergents, hygiene items (means), medicinal feed and feed additives (therapeutic and prophylactic purposes), cosmetic and perfumery products;

9.2. Pharmacy Store and Pharmacy Kiosk:

Sale of finished medicinal products without prescriptions;

Realization of medicinal plant raw materials in the original packaging; animal care items, disinfectants and detergents, hygiene items (means), medicated feed and feed additives (therapeutic and prophylactic purposes), cosmetic and perfumery products;

providing the necessary information on the proper use and storage of medicines at home;

provision of advisory assistance in order to ensure responsible self-treatment.

10. The pharmacy sells medicines registered in accordance with the procedure established by the legislation of the Russian Federation or manufactured in a pharmacy organization according to prescriptions.

11. It is not allowed to sell medicines and other goods that have become unusable, expired, illegal copies of medicines and without documents certifying their quality.

12. pharmacy organization must have the necessary premises, equipment and inventory to ensure, in accordance with the requirements of the standards, the preservation of the quality and safety of medicinal products during their storage and sale, appropriate conditions for retail trade in medicinal products and other goods permitted for dispensing from pharmacy organizations.

13. In a pharmacy organization, in convenient places for familiarization on the trading floor, the following should be placed:

Copies of licenses for pharmaceutical activities and other activities in accordance with the legislation of the Russian Federation;

Book of reviews and suggestions;

Information on telephone numbers and working hours of the federal executive body exercising the functions of control and supervision in the field of veterinary medicine, and bodies state power subjects of the Russian Federation in the field of veterinary medicine;

information on the names of departments or distribution zones of the corresponding groups of goods;

Information on the shelf life of medicinal products manufactured in the Pharmacy;

Price tags for medicines and other goods allowed to be dispensed without a prescription;

Information about employees directly serving the population (tablets, badges and others indicating full name and position);

Information about the administrator on duty (full name, position) and the location of the alarm call button for the administrator on duty (with the exception of the Pharmacy Kiosk);

A copy or extract from the Law of the Russian Federation -1 "On the Protection of Consumer Rights" (Collected Legislation of the Russian Federation, 1996, No. 3, Art. 140; 1999, No. 51, Art. 6287; 2002, No. 1 (part 1), Art. 2; 2004, No. 35, article 3607; No. 45, article 4377; No. 52 (part 1), article 5275; 2006, no.), art. 3439; No. 43, Art. 4412, No. 48, Art. 4943; 2007, no. 44, art. 5282; 2008, no.> 30 (part 2), Art. 3616; 2009, no. 23, art. 2776; No. 48, Art. 5711);

A copy or extract from 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 similar product free of charge for the period of repair or replacement, and a list of non-food products of good quality that cannot be returned or exchanged for a similar product of a different size , shape, size, style, color or configuration approved by the Decree of the Government of the Russian Federation (Collected Legislation of the Russian Federation, 1998, No. 4, Art. 482, No. 43, Art. 5357; 1999, No. 41, Art. 4923; 2002, No. 6, article 584; 2003, No. 29, article 2998; 2005, No. 7, article 560; 2006, No. 7, article 790, no.), art. 5588; 2007, no. 14, art. 1697; 2009, no. 5, art. 622).

III. Premises and equipment of pharmacy organizations

14. All premises of the pharmacy organization must be located in the building (building) and functionally combined into a single block, isolated from other organizations. Entrance (exit) to the pharmacy organization through the premises of another organization is allowed.

15. A pharmacy organization should provide for the possibility of entry (exit) for people with impaired functions of the musculoskeletal system.

16. On the premises of pharmacy organizations, it is not allowed to place units that are not functionally related to the types of activities specified in the licenses.

17. A pharmacy organization must have a sign indicating the type of organization (in accordance with the license for pharmaceutical activities) in Russian and national languages: "Veterinary Pharmacy", "Veterinary Pharmacy Store", "Veterinary Pharmacy Kiosk"; Name legal entity indicating the legal form; TIN, OGRN, company name of the organization; location (in accordance with the constituent documents), as well as the operating hours of the organization, addresses and telephone numbers of nearby pharmacies.

18. When placing a pharmacy organization inside the building, the sign must be on the outer wall of the building.

19. A pharmacy organization that sells medicines at night must have an illuminated sign with information about work at night, indicating hours of operation, a call for a visitor to call an employee of a pharmacy organization.

20. When closing a pharmacy organization for holding sanitary works, repair, re-equipment or in connection with its liquidation, the population is notified of this by an announcement posted on the front door 5 days before the closing of the pharmacy organization. The ad contains the address of the nearest pharmacy organizations. When a pharmacy organization is closed due to repairs or its liquidation, the head of the pharmacy organization notifies the licensing authority that issued the license.

21. The composition, dimensions of the premises and equipment of the pharmacy organization must meet the technical, sanitary, fire and other licensing requirements and conditions.

22. The total area of ​​administrative and amenity premises of pharmacy organizations depends on the number of employees and is calculated in accordance with the current rules and regulations. The internal surfaces of walls and ceilings must be smooth, allow for wet cleaning and disinfection. The floors of pharmacy premises should have a dust-free coating that is resistant to the effects of mechanization and wet cleaning using disinfectants. Interior decoration materials must comply with the requirements of the relevant regulatory documents, while the use of unpainted wooden surfaces is not allowed.

23. Finishing of administrative and amenity premises allows the use of wallpaper, carpeting, parquet, oil paints, etc.

24. Pharmacy organizations must have centralized systems of power supply, heating, water supply, supply and exhaust ventilation, sewerage. In pharmacy organizations located outside cities, it is possible to have autonomous heating, sewerage and water supply.

25. When organizing pharmacy points, they can be equipped with an air conditioning system; administrative and amenity premises may be shared.

26. It is not allowed to heat the premises with gas appliances with an open flame or electric heaters with an open electric coil.

27. In pharmacy organizations, conditions must be created for observing the rules of personal hygiene of employees.

28. Premises for the storage of medicines (drugs) in pharmacy organizations must be equipped with special equipment to ensure their storage, taking into account the physicochemical, pharmacological and toxicological properties, as well as the requirements of the quality standards of medicines and the State Pharmacopoeia of the Russian Federation and their proper safety.

29. The premises of pharmacy organizations located in the city must be equipped with security alarm systems connected to a remote control with round-the-clock centralized surveillance or guarded around the clock by a security company licensed for this type of activity.

30. When changing the layout of the premises of pharmacy organizations during the validity of the license, the licensee informs the licensing authority about this in the prescribed manner.

31. Entrance door in premises for the storage of narcotic drugs, psychotropic substances, poisonous and potent substances, it must be metal or wooden, upholstered with iron on both sides with a sheet folded onto the end of the door with an overlap or onto the inner surface of the door, with a thickness of at least 40 mm; the framing of the doorway should be made of a steel profile, inside - a lattice metal door.

32. Premises for the storage of narcotic drugs, psychotropic substances, poisonous and potent substances must be equipped with an internal grate on window openings (or a grate between frames) made of a steel bar with a diameter of at least 16 millimeters. The rods must be welded at each node and form cells no larger than 150 x 150 millimeters.

33. Access to the production premises, premises for the storage of goods shall have persons authorized in the prescribed manner. Access of unauthorized persons to these premises is excluded.

34. A pharmacy organization must be equipped with appropriate light and sound and fire alarms that provide all the conditions for the safety of inventory and compliance with fire safety.

35. In pharmacy organizations, a special room (cabinet) should be allocated for storing detergents and disinfectants, inventory and materials used in cleaning rooms and processing equipment. Cleaning equipment must be marked in accordance with its purpose.

36. In the dressing room (in a special closet, labeled in accordance with its purpose) outerwear and footwear should be stored separately from sanitary clothing and footwear.

37. A pharmacy organization must be equipped with equipment and inventory in accordance with the functions performed:

Production facilities must be equipped with pharmacy furniture, technological and other equipment permitted for use, inventory in accordance with current regulations, taking into account the volume and nature of the pharmacy organization;

All devices, devices used in a pharmacy organization must have technical passports that remain throughout the entire period of operation. It is necessary to regularly calibrate instruments, apparatus used in a pharmacy organization in accordance with the requirements of regulatory documents;

For the storage of narcotic drugs, psychotropic substances, if you have a license for the right to work with these groups, you must have safes; for the storage of potent and toxic substances - metal cabinets;

The trading floor should be equipped with showcases that provide the opportunity to review and preserve medicines and other groups of goods allowed for dispensing from pharmacy organizations, as well as provide convenience for the staff of the pharmacy organization. It is possible to open display of non-prescription drugs and other goods allowed to be dispensed in pharmacies;

Premises for the storage of medicines and other goods allowed to be dispensed from pharmacies must be equipped with cabinets, racks, pallets, and underwares for their storage; premises for the storage of thermolabile medicinal products should be equipped with equipment that provides the necessary storage conditions;

Premises for the storage of medicines and other goods allowed to be dispensed from pharmacies must be equipped with devices for recording air parameters (thermometers, hygrometers or psychrometers), which are placed on the inner wall of the room, away from heating devices at a height of 1.5 - 1 .7 m from the floor and at least 3 m from doors. The readings of these devices must be recorded twice a day in a special journal (map), which is maintained by a responsible person during the year and is stored for a year, not counting the past. Control devices must be certified, calibrated and verified in the prescribed manner;

Cabinets for storing outerwear and sanitary clothing, shoes in the dressing room;

Detergents and disinfectants, household equipment used in cleaning rooms and processing equipment.

All equipment and external design premises in pharmacy organizations must meet sanitary and hygienic, fire safety requirements and the requirements of safety and labor protection.

38. Racks and cabinets for storing medicines and other goods allowed to be dispensed from pharmacy organizations should be installed as follows:

Distance to external walls - not less than 0.6 - 0.7 m;

Distance to the ceiling - at least 0.5 m;

Distance from the floor - not less than 0.25 m;

Passages between racks - not less than 0.75 m;

On all racks, cabinets, shelves, a rack card is attached indicating the name of the medicinal product, series, expiration date, number of storage units.

IV. Requirements for the organization of acceptance of medicines in pharmacy organizations

39. When carrying out loading and unloading operations during the acceptance or shipment of medicines and other goods allowed for dispensing from pharmacy organizations, incoming medicines must be protected from precipitation, exposure to low and high temperatures.

40. Medicinal products and other goods permitted for sale from pharmacy organizations with expired shelf life, not meeting quality requirements, standards and without documents certifying their quality are not subject to acceptance.

41. For medicinal products (medicines) in damaged packaging, without certificates and / or necessary accompanying documentation, rejected upon acceptance or dispensing, not in accordance with the order or with expired shelf life, an act is drawn up; they must be appropriately labeled and placed in a designated area separate from other medicinal products until they are identified, returned to the supplier, or disposed of in the prescribed manner.

42. Medicinal products requiring special storage conditions must be immediately placed in storage areas in accordance with the requirements of these Rules.

43. The number of drugs taken that require special storage conditions must correspond to the available capacity of special equipment.

44. All shipments of goods must be accompanied by documents that allow to establish the date of shipment, the name of the medicinal product (including dosage form and dosage), batch and lot number, the quantity of goods supplied, the price of the dispensed medicinal product, the name and address of the supplier and recipient, as well as documents confirming the quality of drugs.

45. The supply of medicines can only be carried out from wholesale trade organizations that have a license for pharmaceutical activities.

46. ​​To carry out pre-sale preparation of medicinal products prior to submission to the trading floor (unpacking, sorting, inspecting goods, checking the quality of goods according to outward signs and the availability of the necessary information about the product and its manufacturer or supplier), it is necessary to equip a special place with the appropriate marking.

47. Accepted medicinal products and other goods allowed for dispensing from pharmacy organizations are received within the time limits allotted for the acceptance of goods in terms of the number of trade units and completeness in the prescribed manner.

V. Requirements for the organization of storage of medicines (medicines) in pharmacy organizations

48. Pharmacy organizations should take measures to prevent damage (spill, spillage, breakage), to prevent contamination of medicines (drugs).

49. When storing medicines (medicines), the following systematization methods are used:

By toxicological and pharmacological groups;

According to the method of application;

In accordance with the positions of computer accounting.

The accepted method of storing medicines (drugs) must be specified in the order of the pharmacy organization and brought to the attention of the pharmacy organization personnel.

50. A pharmacy organization must keep records of medicines (drugs) with a limited shelf life on paper or in electronic form with archiving on hard media. The archiving mode is set by the head of the pharmacy organization.

51. Medicines (drugs) should be stored separately, taking into account their physical and physico-chemical properties, exposure to them various factors external environment in accordance with established requirements.

52. Storage of narcotic drugs and psychotropic substances, potent and poisonous substances must be carried out in accordance with applicable regulatory requirements.

VL Requirements for dispensing (sales) of medicinal products in pharmacies

53. Dispensing (sale) of medicinal products is carried out by prescription and without a prescription from a veterinarian.

54. When prescriptions are received by a pharmacy organization, a specialist of the pharmacy organization assesses their compliance with certain requirements and, in accordance with the tariffs, determines the cost of the manufactured and dispensed medicinal product.

55. Dispensing of medicinal products with special conditions sale (narcotic drugs, psychotropic substances, ethyl alcohol and others) is carried out in compliance with the requirements of the current regulatory documents and these Rules.

56. Medicinal products sold from pharmacy organizations must have information in accordance with the state information standard for the medicinal product.

57. When dispensing medicinal products, an authorized employee of the pharmacy organization informs the buyer about the rules for using the medicinal product for the treatment and prevention of animal diseases: the mode of administration, single and daily dose, method of intake (taking into account the intake of food, etc.), storage rules, etc .; draws the attention of the buyer to the need to carefully read the information about the medicinal product. The answers of the employee must be professional, competent, in compliance with the requirements of ethics.

58. In exceptional cases, when dispensing medicinal products, violation of the secondary factory packaging is allowed. At the same time, the medicinal product must be dispensed in a pharmacy package with the obligatory indication of the name, manufacturer's series, expiration date of the medicinal product, series and date according to the laboratory packing journal and other necessary information (instruction, leaflet, etc.).

Violation of the primary factory packaging of medicines is not allowed.

59. At the request of the buyer, an authorized employee of the pharmacy organization provides information on documents on prices and expiration dates of medicines and other goods allowed to be dispensed from pharmacy organizations, and on documents confirming their quality.

60. For information about medicines and other goods allowed to be dispensed from pharmacies, various types of showcases can be used, where medicines sold without a doctor's prescription and samples of available goods are displayed.

Medicinal products are placed separately on showcases: medicinal products for internal use and drugs for external use. Within groups, drugs are arranged according to their pharmacotherapeutic characteristics.

61. In self-service halls, the visitor first receives all the necessary information about the non-prescription drugs of interest to him, other goods allowed for dispensing from pharmacy organizations, from a consultant working in the hall, then he turns to the cashier controller with the selected product.

62. Information about the services provided by pharmacy organizations, as well as the drugs sold and other goods that are allowed to be dispensed from pharmacy organizations, must be carried out in accordance with the requirements of the legislation of the Russian Federation.

63. Cash registers of a pharmacy organization must be registered with the tax authorities at the location of the pharmacy organization in the prescribed manner.

64. The buyer has the right to return or replace goods of inadequate quality purchased at a pharmacy organization (with the exception of those goods that are included in the list of non-food products of good quality that cannot be returned or exchanged for a similar product of a different size, shape, size, style, color or configuration in accordance with current regulations).

65. When dispensing medicinal products according to a prescription issued by a veterinary worker who has the right to do so, the Pharmacy employee makes a note on the prescription for the dispensing of the medicinal product (name or number of the veterinary pharmacy organization, name and dosage of the medicinal product, quantity dispensed, signature of the dispenser and date of dispensing ).

66. When dispensing medicinal products under prescriptions valid for one year, the prescription is returned with the name or number of the veterinary pharmacy organization, the signature of the employee of the veterinary pharmacy organization, the amount of the drug dispensed and the date of issue on the back. At the next appeal to the veterinary pharmacy organization, the notes on the previous receipt of the medicinal product are taken into account. Upon expiration of the prescription, the prescription is canceled with the stamp “Recipe invalid” and left at the veterinary pharmacy organization.

67. In exceptional cases, veterinary specialists and pharmaceutical workers of a pharmacy organization are allowed to make a one-time dispensing of a medicinal product prescribed by a veterinarian according to prescriptions valid for one year, in the amount necessary for the treatment of animals for two months, with the exception of medicinal products subject to quantitative accounting. If the pharmacy organization does not have a medicine prescribed by a veterinarian, with the exception of a medicine included in the List of medicines dispensed by prescription of a doctor (paramedic), as well as another medicine dispensed free of charge or at a discount, an employee of the pharmacy organization may carry out its synonymous replacement with the consent of the owner of the animal.

68. Prescriptions for medicines marked “statim” (immediately) are served within a period not exceeding one working day from the moment the animal owner contacts the pharmacy organization.

69. Prescriptions for medicines marked “cito” (urgently) are served within a period not exceeding two working days from the moment the animal owner contacts the pharmacy organization.

70. In a pharmacy organization, conditions must be provided for the preservation of prescriptions for medicines left for storage, subject to subject-quantitative accounting.

71. The terms of storage of prescriptions in a pharmacy organization are:

For medicinal products dispensed by prescription of a veterinarian (paramedic) - five years;

For narcotic drugs and psychotropic substances included in the List of narcotic drugs and psychotropic substances used in veterinary medicine - ten years;

for other medicinal products subject to subject - quantitative accounting, with the exception of narcotic drugs and psychotropic substances included in the List of the List of narcotic drugs and psychotropic substances used in veterinary medicine; anabolic steroid- three years.

72. After the expiration of the storage period, prescriptions are subject to destruction in the presence of the commission, about which acts are drawn up.

73. Medicines of good quality purchased by citizens (owners of animals) are not subject to return or exchange in accordance with the List of non-food products of good quality that are not subject to return or exchange for a similar product of a different size, shape, size, style, color or configuration, approved by a government decree of the Russian Federation dated 01.01.01 No. 55 (Sobraniye Zakonodatelstva Rossiyskoy Federatsii, 1998, No. 4, Art. 482; No. 43, Art. 5357; 1999, No. 41, Art. 4923; 2002, No. 6, Art. 584; 2003, No. 29, article 2998; 2005, No. 7, article 560; 2006, No. 7, article 790; 2006, no.), article. 5588; 2007, no. 14, art. 1697; 2009, no. 5, art. 622).

74. It is not allowed to re-dispense (sale) medicines recognized as goods of inadequate quality and returned by citizens for this reason.

75. Incorrectly issued prescriptions are canceled with the stamp “Recipe invalid” and recorded in the journal. Information about all incorrectly written prescriptions is brought to the attention of the head of the relevant veterinary medical institution.

VII. Accounting and reporting in pharmacy organizations

76. Pharmacy organizations maintain operational and accounting records of inventory items in accordance with established forms in accordance with the legislation of the Russian Federation.

77. Accounting for goods in pharmacy organizations is carried out by name, series, expiration date, purchase and (or) selling prices according to schemes that are most appropriate in the conditions of this organization (individual, in-kind value, value).

78. Narcotic drugs, psychotropic substances, ethyl alcohol and other drugs are subject to subject-quantitative accounting in accordance with regulatory documentation.

79. The procedure for the formation of retail prices for medicines (medicines) for a pharmacy organization, regardless of the legal form and form of ownership, is established in accordance with the requirements of regulatory legal acts approved by the Government of the Russian Federation and executive authorities of the constituent entities of the Russian Federation.

IV. Control over the dispensing of medicinal products by pharmacies

80. Internal control over compliance by employees of a pharmacy organization with the procedure for dispensing medicines (including those subject to subject-quantitative accounting; medicines included in the List of medicines dispensed by prescription of a doctor (paramedic), as well as other medicines dispensed free of charge or with discount), carried out by the head (deputy head) of the pharmacy organization or a veterinary (pharmaceutical) employee of the pharmacy organization authorized by him.

81. External control over compliance by pharmacy organizations with the procedure for dispensing medicines is carried out by the Federal Service for Veterinary and phytosanitary supervision and bodies for control over the circulation of narcotic drugs and psychotropic substances within their competence.

VIII. Requirements for the personnel of pharmaceutical organizations

82. An individual entrepreneur has a higher or secondary pharmaceutical or veterinary education and a specialist certificate.

83. The presence of employees whose activities are related to the manufacture, receipt, storage, dispensing and sale of medicines, higher or secondary pharmaceutical or veterinary education and specialist certificates.

84. The presence of the head of the organization, whose activities are directly related to the receipt, storage, dispensing, manufacture and destruction of medicines, higher pharmaceutical or veterinary education, work experience in the specialty for at least 3 years and a specialist certificate.

85. In pharmacy organizations located outside the city, the management of a pharmacy organization may be carried out by a veterinary assistant or a pharmacist who has a specialist certificate.

86. In the departments of pharmacy organizations with an open form for displaying goods and selling goods that are allowed to be dispensed from pharmacy organizations, it is allowed to involve persons with higher or secondary pharmaceutical or veterinary education as consultants.

87. Specialists of pharmacy organizations must improve their qualifications in accordance with the legislation of the Russian Federation.

88. The personnel of pharmacy organizations must observe the rules of personal hygiene, including the use of special clothing.

89. Smoking, eating, storage of personal medicines, food, drinks, tobacco products is not allowed in production premises, as well as at workplaces in the trading floor.

90. In their production activities, employees of pharmacy organizations are guided by the legislation of the Russian Federation in the field of pharmaceutical activity, internal labor regulations, safety requirements and these Rules.

IX. Ensuring the quality of medicines (medicines) in pharmacy organizations

91. A pharmacy organization's quality management system should be formed in a pharmacy organization.

92. Each pharmacy organization must have internal labor regulations approved by the head of the organization, with a mark on familiarization of employees. Revision of the rules and re-familiarization of the employees of the pharmacy organization with them are carried out annually.

93. A pharmacy organization should regularly conduct internal audits for compliance with the requirements of these rules.

When conducting inspections, attention should be paid to the presence in the pharmacy organization of relevant documents for the premises occupied, job descriptions of employees, standards, and other necessary documents.

94. Inspections can be carried out both by employees of the pharmacy organization, independent of the persons directly involved in the audited activity, and by independent experts.

95. The frequency of inspections is determined by the pharmacy organization itself.

96. The results of inspections are recorded and brought to the attention of the personnel responsible for the area of ​​work being inspected and the management of the pharmacy organization.

97. Follow-up reviews monitor the implementation of recommendations and their effectiveness.

98. Each employee of the pharmacy organization must be familiar with these Rules, the procedure for fulfilling the duties assigned to him, regulatory legal acts and standards related to the activities of the organization. In pharmacy organizations, each employee must have job descriptions approved in the appropriate manner.

Pharmacies should have a system continuous improvement professional education of employees on the legislation of the Russian Federation, the use of medicines and more. The plan and topics of classes are approved by the head of the pharmacy organization.

99. The head of the pharmacy organization appoints the authorized person for the quality of medicines from the management staff.

100. The pharmacy organization ensures the maintenance of documentation in accordance with the legislation of the Russian Federation.

Retailers of pet products offer their customers a diverse range of products, ranging from feed to various supplements and veterinary drugs. The wider the assortment, the more revenue the store can count on, but sometimes, in the pursuit of profit, sellers get so carried away that they forget about certain established restrictions and pay fines from the profits received. One of these restrictions concerns the trade in animal medicines, which is discussed in this note.

What are the requirements for veterinary drugs?

Retailers selling veterinary drugs and supplements need to be aware that the main document regulating relations for the sale of medicinal products, including those intended for animals, isLawabout medicines. It gives the concept of medicines, which include substances used for the prevention, diagnosis, treatment of diseases in humans and animals. Medicines also include substances of plant, animal or synthetic origin intended for the production and manufacture of medicines (pharmaceutical substances). As you can see, it is easy to include veterinary drugs sold in stores into these categories. The All-Russian classifier of products speaks in favor of this.OK 005-93*(2), in it, veterinary drugs are included in the group "Medicines, chemical-pharmaceutical products and medical products".

There are a number of requirements for medicines intended for the treatment of animals. They must have the inscription "For animals" (paragraph 5 of Art. 16 drug law) and are subject to state registration body of executive power, whose competence includes the exercise of control and supervision in the field of circulation of medicines (par. 3 p. 1 art. 19drug law). SeparateRulesstate registration of medicines for animals and feed additives*(3) . Attempts to challenge this normative act has already taken the union of pet business organizations in court, but to no avail (Determination of the Supreme Court of the Russian Federation of 21.11.2 005 N GKPI 2005-1431). The use of unregistered medicinal products is allowed only in clinical trials of medicinal products or trials of medicinal products intended for the treatment of animals. In all other cases, only registered medicinal products can be used. The next requirement is that the retail sale of medicinal products for animals is carried out in a pharmacy, veterinary pharmacy or veterinarian (paragraph 6 of Art. 32 Law on Medicines).

The most important thing for merchants It is concluded that the activities for the sale of veterinary drugs are related to the pharmaceutical industry and, by virtue ofpp. 47 paragraph 1 of Art. 17 Law on Licensing and certain types of activities*(4) subject to compulsory licensing. A license to carry out pharmaceutical activities is issued for five years and, as a rule, pharmacies (veterinary pharmacies) are among the licensees, which receive a license in the manner prescribed inRegulations on the licensing of pharmaceutical activities*(5) . In the field of medicine circulation natural products intended for animals, licenses are issued by the Federal Service for Veterinary and Phytosanitary Surveillance. This is where the organization involved in the sale of veterinary drugs and supplements for animals should contact. But, as practice shows, the owners of stores selling goods for animals believe that the listed requirements do not apply to them.

What is the opinion of the judiciary?

The conclusions of the majority of court instances are reduced to the fact that the retail sale of medicinal products intended for animals is a pharmaceutical activity and is subject to licensing. Let's highlight the most common pet products in stores, the sale of which, according to inspectors and courts, requires a license:

— ear drops for the treatment of cats and dogs, which are antibacterial mi medicines (resolutions of FAS POdated 19.02.2008 N A55-15396/2007 , FAS ZSOdated 05/22/2007 N F04-2264 / 2007 (33 437-A81-7) , dated 04/02/2007 N F04-1048 / 2007 (32 057-A81-43)) ;

- drugs intended for the treatment of animals, such as stressmix, madikoks, mastometrin, enroflon, estrofan (Decree of the Arbitration Court of the Kirov Region dated February 20, 2009 N A28-1128 / 2009-30 / 14);

- insectoacaricidal drops, anthelmintic drugs, means for regulating the sexual activity of cats and dogs (decisions of the FAS VVOdated 04/28/2008 N A28-10474 / 2007-5 05/27 , Arbitration Court of the Chelyabinsk region. dated February 12, 2009 N A76-1435 / 2009-56 -120);

Implementation of any of the above these types of goods obliges the seller to take care of the availability of a license. If a veterinary drugs are registered and included in the state register of medicines for animals and feed additives, then, as the above decisions show, there is practically no chance of escaping liability from a seller who does not have a license. But that doesn't stop everyone.

What is the responsibility for violations and can it be avoided?

The absence of a license required for a certain type of activity is sufficient serious violation. This is evidenced by the fact that for the implementation of activities without a license (if a license is required), the current legislation provides for administrative and civil liability. ATparagraph 2 of Art. 14.1The Code of Administrative Offenses of the Russian Federation provides for an administrative fine in the amount of 40,000 to 50,000 rubles. Civil law provides for the liquidation of a legal entity by a court decision as one of the penalties (paragraph 2 of Art. 61Civil Code of the Russian Federation)*(6) .

But sometimes sellers sell drugs without a license, knowing full well that they can be fined. They rely on the insignificance of the offense, which may be the basis for exemption from liability (Art. 2.9Code of Administrative Offenses of the Russian Federation,Decrees e FAS UO dated 09/24/2008 N F09-6673 / 08-C1). When qualifying an offense as not insignificant, the courts proceed from an assessment of the specific circumstances of its commission. The insignificance of the offense takes place in the absence of a significant threat to protected public relations. Circumstances such as personality and the property status of the person called to account, voluntary elimination of the consequences of the violation, compensation for damage caused, are not facts evidencing mi about insignificant these violations (18 Decree of the Plenum of the Supreme Arbitration Court of the Russian Federation dated 02.06.2004 N 10). At the same time, the court may take into account extenuating circumstances and impose a penalty in the form of a fine in the minimum amount provided for by the Code of Administrative Offenses of the Russian Federation (Decree FAS VBO dated April 28, 2008 N A28-10474 / 2007-5 05/27).

Penalties can be avoided if the deadline for bringing to administrative responsibility is missed. AT retail, as a rule, the rights of the consumer are violated, for which the period for bringing to responsibility is set within a year. However, if a pet store sells products for cats and dogs, in this case, the consumer of the drug is (attention!) Animals, so there is no reason to believe that the rights of the consumer (citizen) have been violated. This means that the term for bringing to responsibility is not a year, but only two months (Art. 4.5 Code of Administrative Offenses of the Russian Federation), the expiration of which is a circumstance excluding liability. Of course, these arguments could be taken as an April Fool's joke, but this is not a hoax, dear reader, but the conclusions made in the Resolution of the Seventeenth Arbitration Court of Appeal of November 17, 2008 N 17AP-8424 / 2008-A K in case N A50-10625 / 2008.

Despite the fact that there is a shorter period of prosecution for violating animal rights, you should not violate them and hope that the inspectors will miss it. Everything that depends on must be taken t organization of measures to comply with established rules and regulations. This can be done by a pharmacy or wholesaler, who must comply with the establishedregulations wholesale trade in medicinesDecree FAS UO dated 01/14/2009 N F09-10219 / 08-C1) . Retail store it is problematic to obtain a license to sell veterinary drugs. Therefore, store owners can be recommended another solution to the issue - the exclusion from the range of products offered for animals of veterinary drugs, for the implementation of which one cannot do without a license (Decree FAS PO dated March 27, 2008 N A55-17560/2007).

S.V. Bulaev,

expert of the magazine "Trade: accounting and taxation"

"Trade: accounting and taxation", N 3, March 2009