Veterinary drugs as goods. Nuances of trade in veterinary drugs and animal supplements
I. Scope
1. These Vacation Rules medicines(hereinafter - the Rules) in veterinary organizations, in veterinary pharmacy organizations, legal entities (hereinafter - Organizations) and individual entrepreneurs determine the requirements for dispensing medicines and are binding on Organizations and individual entrepreneurs that have a license for pharmaceutical activities carried out in the field of circulation medicines intended for animals. 2. In these Rules, a pharmacy organization means a veterinary pharmacy organization, a pharmacy organization, a structural unit of a veterinary organization, individual entrepreneurs engaged in retail trade in medicines, storage, manufacture and dispensing medicines for veterinary use. 3. These Rules are intended for individual entrepreneurs and legal entities.
When accepting prescriptions, manufacturing and dispensing veterinary dosage forms in pharmacies, they are guided by the instructions of the Global Fund of the Republic of Belarus, which is also mandatory for veterinary institutions.
Prescriptions for veterinary dosage forms are also prescribed for general rules prescribing prescriptions. They are prescribed by veterinarians and veterinarians.
The prescription must contain the following information about the animal:
- - kind of animal,
- - nickname (or number for small animals),
- - for young animals - age,
- - the name of the farm or the surname of the owner who owns the animal.
In veterinary practice, the same medicinal substances are used as in medical practice. At the same time, the veterinary formulation has some features associated with its purpose.
Features of the veterinary formulation include:
- 1) the appointment of some medicinal substances out of use or not used in medical practice (naganin, arecoline, etc.);
- 2) other dosages of medicinal substances, weight and volume of dosage forms;
- 3) more frequent use in comparison with medical practice, substances that correct the taste or smell of medicines;
- 4) the use of some dosage forms that are currently not used in medical practice (for example, boluses, porridges, etc.).
In veterinary practice, in addition to medicinal substances, a number of other substances intended specifically for the treatment of animals (pro usu veterinario) are also used for medical use: arecoline bromide, naganin, spanish fly patch, blister collodion, white hellebore tincture, hellebore rhizome, sabadilla seed, antifebrin, arrenal, atoxil and a number of vaccines and sera.
The dosages of drugs used in veterinary practice differ significantly from the dosages used in medical practice. They are set depending on the type, size and age of the animal, its physiological and morphological features and other factors. It is believed that the horse and ruminants are fully developed in the 3rd-4th year of life, and the pig - in the 2nd-3rd year. The sensitivity of different species of animals to a particular medication can be very different. For example, cats are very sensitive to cardiac glycosides, valerian tincture, phenyl salicylate, phenol and not very sensitive to apomorphine; birds are not very sensitive to strychnine; large cattle very sensitive to calomel, etc.
Legislative requirements in the field of circulation of medicinal products for veterinary use are changing dynamically, which was confirmed at a round table meeting held during the days of the exhibition " gold autumn» with the participation of representatives of the Ministry Agriculture RF and Rosselkhoznadzor. The correspondent of the portal "site" found out what rules were established by the recently adopted regulations, which documents are being worked on, and which issues remain unresolved. It is to be hoped that the new legal norms create favorable conditions for market participants. Is it really? We invite readers of the portal to discuss the accumulated problems in the field of drug circulation. To overcome what difficulties that you have encountered in practice, in your opinion, should the rule-making activities of the relevant departments help.
Per Last year the Federal Law "On the Circulation of Medicines" was amended three times, directly related to veterinary medicine. In particular, cases of changing the documents of the registration dossier for a medicinal product were identified, in which it is not necessary to conduct an examination. For such cases, the amount of state duty is reduced. It is legally established that licenses for the right to carry out pharmaceutical activities do not need to be obtained by individual entrepreneurs and organizations that store medicines only for the purposes of breeding, raising, keeping and treating animals. According to the Deputy Director of the Veterinary Department of the Ministry of Agriculture Russian Federation Polina Smyshlyaeva, these amendments were adopted taking into account the negative law enforcement practice, when veterinary clinics often required obtaining a license for pharmaceutical activities.
In December 2014, on the basis of the Federal Law 429-FZ, the conceptual apparatus was significantly expanded, in particular, the concepts of “holder or owner registration certificate”, “reference drug” and “generic drug”, “manufacturing site”, “pharmacovigilance”. Thus, a production site is a territorially isolated complex of a drug manufacturer, designed to carry out the entire process of manufacturing drugs or a certain stage of it. Pharmacovigilance is understood as a type of activity for monitoring the effectiveness and safety of medicines, aimed at identifying, assessing and preventing undesirable consequences of the use of medicines.
Selective control
The updated system of federal state supervision in the field of drug circulation provides for selective quality control of drugs. As follows from the law, within the framework of such control, the authorized body selects samples of medicines for testing, during which their compliance with established requirements is checked.
Depending on the results of the tests, a decision may be made to transfer the medicinal product to serial random quality control in case of repeated detection of non-compliance. The costs of such control are paid by the manufacturer or the holder (owner) of the registration certificate of the medicinal product. Selective control will be carried out in accordance with the annual plan. It is planned to include medicines in respect of which complaints were received, a discrepancy between their quality and that declared by the manufacturer was recorded.
Eight pharmacovigilance centers are expected to open on the territory of the Russian Federation, which, in particular, will assist citizens in completing applications. Complaint details will be entered into electronic system, thanks to this, the relevant information will be available to the manufacturer. Data on a complaint addressed directly to the manufacturer must also be entered into the electronic system. After processing the complaint, the manufacturer can accompany the relevant information with clarifying information, for example, data on the place of purchase of the medicinal product, indicate whether the drug is counterfeit, etc.
160 days instead of 210, duty and layout
Significant changes have been made to state registration medicines. From 210 to 160 working days, the period for this procedure has been reduced. A state duty has been introduced for the issuance of a registration certificate, its amount is 10 thousand rubles. Details of the document confirming the payment of the fee should be indicated in the application for state registration. Currently, it is possible to obtain a duplicate of the registration certificate in case of its loss or damage.
The list of documents constituting the registration dossier has been legally expanded. Thus, in relation to a medicinal product, information on excipients is required, and in relation to pharmaceutical substances, information on impurities. In both cases, it is necessary to report information on packaging and closures.
The rules for presenting the packaging layout for those dosage forms that are produced in different dosage, have different concentrations or volumes. Now, the application and the registration dossier must be accompanied by a label layout for each dosage, concentration, volume and each number of doses in the package. Previously, one layout could include several different concentrations, dosages, etc.
Experts recommend that market participants pay attention to Article 17 “Submission and consideration of an application for state registration of a medicinal product for veterinary use” of Federal Law 61-FZ. The provisions presented in the updated version of this article will help optimize the work in the preparation and execution of documents.
Federal Law No. 429-FZ provides for mandatory inspections of drug production facilities for their compliance GMP rules. A number of provisions of the document are being introduced gradually. From January 1, 2016, inspection of business entities involved in the circulation of medicines is established when considering an application for state registration, and from January 1, 2017 - inspection when confirming state registration. The procedure for conducting inspections is being developed by the Eurasian Economic Commission and the Ministry of Agriculture.
Storage conditions for medicines and feed
The market participants call the Rules for the storage of medicinal products for veterinary use a long-awaited document. The document was developed for a long time with the participation of representatives of the business community. The Rules establish general requirements for storage facilities and for the organization of storage of medicines; features of the organization of storage in warehouses; requirements for storage facilities for explosive and flammable medicines; storage features individual groups medicines.
Sufficient time has passed since the entry into force of the updated version of the rules to assess whether all stipulated norms and the provisions of the document contribute to the optimization of storage procedures and help in organizing work in this direction. As the first reaction of market participants showed, many provisions require clarification. This is also recognized by the Ministry of Agriculture. Representatives of the ministry confirmed that there are many requests to comment on this or that provision of the rules.
The ministry believes that the most exciting question today is whether it is possible to store medicines together with feed and feed additives? When answering it, the representative of the Ministry referred to paragraph 18 of the Rules, which states that, apart from medicines, store substances, equipment and materials intended for rendering veterinary care, animal care, cleaning of premises, as well as disinfection, disinfestation and deratization. Wherein feed and feed additivesare not listed. "During the development of this document, we assumed that there would be no restrictions on the joint storage of medicines with feed and feed additives. The only condition is that you must follow the instructions for the use of medicines and feed additives, as well as the instructions of animal feed manufacturers,” added the deputy director of the veterinary department of the Ministry of Agriculture.
The relevance of the rules for the storage of medicines is obvious. The Vetbezopasnost Association invites representatives of veterinary departments, companies and organizations involved in the circulation of medicines for veterinary use, to draw the attention of the professional community to problems that have not been resolved, despite the update of the rules. Portal "site" provides various possibilities so that you can convey your point of view and learn the opinions of colleagues. You can make your proposal in the blog http://cw09042.tmweb.ru/blog/. Or connect to a discussion on a topic of interest to you on the forum http://cw09042.tmweb.ru/forum/. Tell us about a problem you have encountered in practice. As experience shows, by joint efforts it is possible to overcome difficulties faster. The portal team is ready to summarize the questions received from you and seek clarifications and comments from experts.
Around the problemketamine
One cannot ignore such a topical topic as the use of narcotic drugs and psychotropic substances in veterinary medicine, in particular, the issue of anesthesia of large animals in zoos. For two years, the discussion of these problems has been going on in the framework of the meetings working group which includes representatives of veterinary clinics.
What has been accomplished in the past year? Firstly, the order of the Ministry of Agriculture of Russia dated May 20, 2015 No. 205 “On approval of standards for calculating the need for narcotic drugs and psychotropic substances for veterinary use” was issued. Secondly, a proposal was sent to the Russian government to increase the quota for carfentanil in order to preserve the life and health of animals kept in Russian zoos. Thirdly, the requirements for the storage of narcotic and psychotropic drugs have been significantly simplified. And finally, a draft federal law “On Amendments to the Federal Law “On Narcotic Drugs and Psychotropic Substances”” has been submitted to the government of the Russian Federation. What role these measures will play remains to be assessed. The Association "Vetbezopasnost" is monitoring the development of the situation.
One of the main problems that remain relevant, the participants of the meeting called the rules for the distribution of ketamine for veterinary clinics. In the past two months, there has been an increase in the number of applications for this drug registered for veterinary use. As shown by the analysis of federal legislation, consultations of representatives of various ministries and departments, no restrictions have been established. Despite this, according to the Ministry of Agriculture, wholesale warehouses, medical pharmacies that have the appropriate licenses are not ready to distribute the drug for use in veterinary medicine.
This problem is especially topical for eight regions of the Russian Federation, where 23 clinics can use ketamine. As announced at the round table meeting, the relevant ministry is preparing an appeal to the governors, which is expected to help resolve the issue. We invite readers of the portal to take part in the discussion of this problem. We will be able to submit all constructive proposals and comments for consideration by the working group operating under the Ministry of Agriculture of the Russian Federation.
Documents under development
Currently, a draft procedure for organizing and conducting inspections of drug manufacturers for compliance with GMP requirements is being developed, and a procedure for issuing relevant conclusions is being determined.
The Ministry of Justice is considering an administrative regulation for the provision of public services for the registration of medicines for veterinary use. According to Polina Smyshlyaeva, the document will make it possible to streamline the work of Rosselkhoznadzor in this direction, since it clearly defines the timing and sequence of the implementation of the relevant procedures.
Work continues on other documents. In particular, the administrative regulations for the provision of public services for licensing pharmaceutical activities and the production of medicines are being updated. In the process of developing the procedure for attestation of authorized persons of drug manufacturers, the relevant work is carried out jointly with representatives of professional associations. As expected, soon the draft document will be posted on the official website. Interested parties will be able to submit their comments and suggestions.
The procedure for maintaining the state register of medicinal products for veterinary use is under development. It is planned to clearly prescribe the terms for entering data into the register. The website www.regulation.gov.ru posted a list of names of dosage forms of drugs for veterinary use. The comments and suggestions received from the professional community served as sufficient grounds for the list to be returned for revision. Currently, employees of the relevant department of the Ministry of Agriculture are engaged in this, which was confirmed by its representative.
Another large document to be adopted in the near future is the Rules for holding clinical trial medicinal product for veterinary use, clinical trial of a medicinal product for veterinary use, bioequivalence study of a medicinal product for veterinary use.
The listed documents are planned to be adopted in the next six months, but, as the representative of the Ministry of Agriculture warned, this period may change, taking into account the passage of the public discussion procedure.
In conclusion, it remains to be noted that representatives of the professional community have real opportunities take part in determining the key provisions of the normative acts being developed. It is enough to take the initiative and remember that making changes to an already approved legal act requires more effort and time than participation in the development of its provisions at the stage of drafting and preparing the document.
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 operate on the basis of a license for pharmaceutical activities issued by the authorized federal body executive power in in due course.
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 the activity, 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, items (means) of hygiene, medicinal 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 medicinal products 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. A 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 retail medicinal preparations and other goods permitted to be dispensed from pharmacies.
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);
Copy or extract from the Terms of Sale certain types goods, a list of durable goods that are not subject to the buyer's requirement to provide him free of charge for the period of repair or replacement of a similar product, 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, dimension, style, color or complete sets 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, Art. 584; 2003, No. 29, item 2998; 2005, No. 7, item 560; 2006, No. 7, item 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. Internal surfaces walls, ceilings should be smooth, allow the possibility of wet cleaning and disinfection. The floors of pharmacy premises must 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, allowing 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 preservation.
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 supervision or guarded around the clock by a security company licensed to this species activities.
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 to the premises for the storage of narcotic drugs, psychotropic substances, poisonous and potent substances must be metal or wooden, upholstered with iron on both sides with a bend of the sheet on the end of the door with an overlap or on 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 in without fail 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 goods of other groups that are allowed to be dispensed 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 drugs should be equipped with equipment that provides the necessary conditions storage;
Premises for the storage of medicines and other goods permitted 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 allowed 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 (medicinal products) 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 you to establish the date of shipment, the name of the medicinal product (including dosage form and dosage), batch and batch number, quantity of goods supplied, price of the dispensed medicinal product, name and address of the supplier and recipient, as well as documents confirming the quality of medicinal products.
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) are used the following ways systematization:
For toxicological and pharmacological groups;
According to the method of application;
In accordance with the positions of computer accounting.
The accepted method of storing medicines (medicines) must be specified in the order for 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 sales (narcotic drugs, psychotropic substances, ethanol 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 for dispensing 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 displayed separately in showcases: medicinal products for internal use and medicinal products for external use. Within groups, drugs are arranged according to their pharmacotherapeutic characteristics.
61. In self-service halls, the visitor first receives all necessary information about 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 controller-cashier with the selected product.
62. Information about the services provided by pharmacy organizations, as well as the drugs sold and other goods 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, dispensed quantity, 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 subject- 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 owner of the animal 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 owner of the animal contacts the pharmacy organization.
70. In a pharmacy organization, the conditions for the preservation of prescriptions for medicines that are subject to subject-quantitative accounting should be ensured.
71. The terms of storage of prescriptions in a pharmacy organization are:
For medicines 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 the 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 medicines are subject to 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 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 open form display of goods and selling goods allowed for dispensing 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 pharmacies, 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.
MINISTRY OF AGRICULTURE OF THE RUSSIAN FEDERATION
(Ministry of Agriculture of Russia)
ORDER
On approval of the Rules for the storage of medicinal products for veterinary use
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. 5 538; No. 16, 1917; No. 23, 2833; No. 26, 3350; No. 31, 4251, 4262 No. 32, 4330; No. 40, 5068; 2011, No. 6, Article 888, No. 7, Article 983, No. 12, Article 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), p and y in a yu:
1. Approve the attached Rules for the storage of medicines for
veterinary use.
2. This order comes into force on July 1, 2015.
Minister
N.V. Fedorov
REGULATIONS
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 manufacturers of medicinal products, drug wholesalers, veterinary pharmacy organizations, individual entrepreneurs, veterinary organizations and other organizations that circulate 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 should 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, and 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 in 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.
Shelves for storing medicines in rooms with an area of more than 10 m2 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 shelf 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
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 10 m2, the measuring parts of these devices should be located 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 an accessible personnel place 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 the journal (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, the following systematization methods are used:
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 Narcotic Drugs and Psychotropic Substances" (Collected Legislation of the Russian Federation, 1998, No. 2, Art. 219; 2002, No. 30, item 3033; 2003, No. 2, item 167; No. 27, item 2700; 2004, No. 49, item 4845; 2005, No. 19, item 1752; 2006, No. 43, item 4412; No. 44, item 4535; 2007, No. 30, item 3748; No. 31, item 4011; 2008, No. 30, item 3592; No. 48, item 5515; No. 52, item 6233; 2009, No. 29 ,
Art. 3588; Art. 3614; 2010, no. 21, art. 2525; No. 31, Art. 4192; 2011, no. 1, art. 16, Art. 29; No. 15, Art. 2039; No. 25, art. 3532; No. 49, art. 7019; Art. 7061; 2012, no. 10, art. 1166; No. 53, art. 7630; 2013, no. 23, art. 2878, No. 30, Art. 4057, No. 48, Art. 6161, Art. 6165; 2015, no. 1, art. 54; No. 6, Art. 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 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. It is allowed to store substances, equipment and materials intended for the provision of veterinary (medical) care, animal care, cleaning of premises, as well as disinfection, disinfestation and deratization in 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. When manual way unloading and loading operations, the height of placement of medicines should not exceed 1.5 meters.
When 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 fire-dangerous 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 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 prohibited to enter the premises for storage of fire-explosive and flammable medicines with open sources 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 packaging 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 higher than + 15 ° C, in a sealed container made of materials * that are 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, ethyl alcohol of various concentrations); medicinal plant materials containing essential oils; medicinal
products containing crystallization water - 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 medicinal products requiring protection from exposure to elevated temperatures (thermolabile medicinal products) must be carried out 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.
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 (20 ± 2°C), 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 +4 to +12 °C, unless otherwise indicated in the instructions for use of medicinal products, or on the primary packaging of pharmaceutical substances.
44. Loading refrigeration equipment(refrigerators, refrigerated display cases, chambers, rooms) should provide free air circulation in the room for storing medicines.
Storage of medicinal products requiring protection from exposure low temperature
45. Medicinal products requiring protection from exposure to low temperatures include medicinal products whose physicochemical state changes after freezing and., upon subsequent heating to room temperature(20 ± 2°С) not recoverable (40% formaldehyde solution (formalin), ice cold acetic acid, fatty 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 medicines requiring protection from exposure to gases contained in environment
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 of the 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 medicines 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 must be subjected 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 drugs should be stored in
hermetically sealed glass or metal container.
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 medicines 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, giving 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 medicines (drugs with explosive properties (for example, nitroglycerin); medicines with explosive properties (for example, potassium permanganate, silver nitrate), measures should be taken to prevent contamination with dust.
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 storage facilities in tin drums. In veterinary pharmaceutical organizations, in veterinary organizations and in individual entrepreneurs, potassium permanganate should be stored in barbells with ground stoppers, the barbells 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.
66. It is prohibited to store explosive medicines with acids and alkalis.
Storage of narcotic and psychotropic medicines
67. Narcotic and psychotropic drugs are stored in organizations in isolated rooms, specially equipped with engineering and technical means protection, and in places of temporary storage 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 of December 31, 2009 No. 1148 (Collected Legislation of the Russian Federation, 2010, No. 4, Art. 394 ; No. 25, item 3178; 2011, No. 18, item 2649; No. 42, item 5922; No. 51, item 7534; 2012, No. 1, item 130; No. 27, item 3764; No. 37, article 5002, 2013,
No. 8, art. 831; 2014, no. 15, art. 1752).
Storage of potent and poisonous medicines
68. Potent and poisonous medicines containing potent and toxic substances included in the list of 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 government decree of the Russian Federation of December 29, 2007 No. 964 (Sobraniye Zakonodatelstva Rossiyskoy Federatsii, 2008, No. 2, Art. 89; 2010, No. 28, Art. 3703; 2012, No. 10, Art. 1232; No. 41, Art. 5625; No. 2013, No. b, item 558; No. 9, item 953; No. 45, item 5831), are stored in accordance with paragraphs 69 - 79 of these Rules.
69. The head of the organization or individual entrepreneur, or a person appointed by him from among those working in this organization or with an 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 are equipped with an entrance metal door, wooden door, reinforced on both sides with sheet iron, or a door made of other material, which has a class of protection against destructive influences 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 outside the doors of the safe (cabinet, drawer) for storing potent and poisonous drugs must 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 medicines 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.
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 medicinal products for veterinary use.
| Minister | N.V. Fedorov |
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 should 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, and 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 the primary packaging of 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 shelf 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 medicines requiring protection from exposure to elevated temperatures "should 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 the journal (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, the following systematization methods 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, 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 Narcotic Drugs and Psychotropic Substances" (Collected Legislation of the Russian Federation, 1998, No. 2, Art. 219; 2002, No. 30, item 3033; 2003, No. 2, item 167; No. 27, item 2700; 2004, No. 49, item 4845; 2005, No. 19, item 1752; 2006, No. 43, item 4412; No. 44, item 4535; 2007, No. 30, item 3748; No. 31, item 4011; 2008, No. 30, item 3592; No. 48, item 5515; No. 52, item 6233; 2009, No. 29 , item 3588; item 3614; 2010, No. 21, item 2525; No. 31, item 4192; 2011, No. 1, item 16, item 29; No. 15, item 2039; No. 25, item 3532; No. 49, item 7019; Item 7061; 2012, No. 10, item 1166; No. 53, item 7630; 2013, No. 23, item 2878, No. 30, item 4057, No. 48, item 6161, article 6165; 2015, No. 1, article 54; No. 6, article 885), 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 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 storing medicines are subject to mandatory daily washing with the use of detergents.
18. It is allowed to store substances, equipment and materials intended for the provision of veterinary (medical) care, animal care, cleaning of premises, as well as disinfection, disinfestation and deratization in 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.
When 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 medicinal products with flammable and combustible properties in a volume of up to 10 kg outside the premises for storing fire-explosive and flammable medicinal products 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 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 packaging or dark-colored polymeric materials).
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 light, packed in primary and secondary (consumer) packaging, should be stored in cabinets or on shelves, provided that measures are taken to prevent direct sunlight or other bright directional light from falling on these medicinal products (use of reflective films, 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 (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, chloride hydrogen over 13%, carbolic acid, ethyl alcohol of various concentrations); medicinal plant materials containing essential oils; drugs containing crystallization water - crystalline hydrates; drugs that decompose to form volatile products; drugs with a certain lower limit of moisture content) should store in a room with an air temperature not higher than +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 medicinal preparations atov, on the 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 medicinal products requiring protection from exposure to elevated temperatures (thermolabile medicinal products) must be carried out 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.
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. Medicinal products that require protection from exposure to low temperatures include drugs whose physicochemical state changes after freezing and is not restored upon subsequent heating to room temperature (*) (40% formaldehyde solution (formalin), glacial acetic acid, fatty oils, insulin solutions, etc.).
Storage of medicines requiring protection from exposure to low temperatures is carried out in accordance with the temperature regime specified in the instructions for use of medicines, on the secondary (consumer) packaging - for medicines, 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 oxygen in the air; substances that react with carbon dioxide in the air) should be stored in hermetically sealed containers made of materials that are 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 medicines 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 for 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 medicines 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 that give explosive mixtures with organic substances is not allowed.
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 medicines (drugs with explosive properties (for example, nitroglycerin); medicines with explosive properties (for example, potassium permanganate, silver nitrate), measures should be taken to prevent contamination with dust.
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 barbells with ground stoppers, the barbells 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 premises, 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 poisonous medicines containing potent and toxic substances included in the list of 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 government decree of the Russian Federation of December 29, 2007 No. 964 (Sobraniye Zakonodatelstva Rossiyskoy Federatsii, 2008, No. 2, Art. 89; 2010, No. 28, Art. 3703; 2012, No. 10, Art. 1232; No. 41, Art. 5625; No. 2013, No. 6, Art. 558; No. 9, Art. 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 distribution of potent and poisonous medicines is the head of the organization or an individual entrepreneur, or a person appointed by him from among the veterinarians (pharmacists) working in this organization or with an individual entrepreneur, and in the absence of veterinarians - veterinary paramedics (pharmacists) with secondary vocational 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". A list of potent and poisonous medicines stored in it must be attached to the inside of the door of the safe (cabinet, box).
75. Potent and poisonous medicines 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 pharmaceutical 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.
