Industry standards approved by the Ministry of Health. Legislative framework of the Russian Federation

legislation of the Russian Federation, 29.06.98, N 26, art. 3006; 10.01.2000, N 2, Art. 126; 07.01.2002, N 1 (1), Art. 2), the Regulation on the Ministry of Health of the Russian Federation, approved by the Decree of the Government of the Russian Federation of April 29, 2002 N 284 (Collected Legislation of the Russian Federation, 06.05.2002, N 18, Art. 1771).

1.2. This OST is mandatory for all pharmacy organizations, regardless of their organizational and legal form and form of ownership, that carry out retail trade in medicines.

This standard does not apply to:

For the operation of pharmacies of medical and preventive institutions and interhospital pharmacies;

For activities on the distribution of samples of medicinal products by representatives of manufacturing enterprises for advertising purposes;

For activities related to the distribution of state standard samples of medicinal products;

For activities related to the circulation of blood and its components used in transfusiology;

For activities related to the sale of raw materials of animal origin and bulk medicinal plant materials subject to further industrial processing for the manufacture of medicines.

II. General Provisions

2.1. A pharmacy organization operates on the basis of a pharmaceutical license issued in established order.

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 referred to as narcotic drugs and psychotropic substances), should be carried out only with a license for activities related to the circulation of narcotic drugs and psychotropic substances.

2.2. The procedure, conditions for granting and renewing a license for pharmaceutical activities, conditions for refusing to grant a license, suspending or revoking a license are established by legislative and regulatory legal acts Russian Federation.

2.3. Pharmacy organizations in their work must be guided by certain requirements established state standards, sanitary, fire safety rules and other regulatory documents(hereinafter referred to as standards), occupational health and safety regulations.

2.4. By the nature of their activities, pharmacy organizations are subdivided into:

Manufacturing medicinal products according to the prescriptions of doctors, the requirements of health care institutions, standard prescriptions, with their subsequent implementation within legal entity prescription and over-the-counter; carrying out the sale of finished medicinal products and other goods permitted for dispensing from pharmacy organizations, to the public on prescription or without a prescription from a doctor and to health care and education institutions, social security and others according to requirements or applications (a pharmacy with a production department, a pharmacy with the right to manufacture medicinal products);

Realizing the sale of finished medicines and other goods allowed for dispensing from pharmacy organizations, to the public on prescription or without a doctor's prescription and to health care institutions on demand or request (a pharmacy of ready-made forms, a pharmacy without the right to manufacture medicines, a pharmacy kiosk, a pharmacy store).

2.5. Pharmacy organizations can be represented by pharmacies, pharmacy points, pharmacy kiosks, pharmacy stores.

Pharmacy organizations can perform the following functions:

Selling ready-made medicinal products (including homeopathic preparations) to the public by prescription and without a doctor's prescription, to healthcare institutions upon request or request;

Manufacturing of medicinal products according to the prescriptions of doctors and the requirements of healthcare institutions, the manufacture of intra-pharmaceutical preparations in accordance with the approved prescriptions and the packaging of medicinal products and medicinal plants with their subsequent sale;

Dispensing drugs free of charge or at a discount to certain groups of the population in accordance with the current legislation of the Russian Federation and on the basis of contracts concluded with territorial bodies management of health care, medical institutions and insurance companies;

Sale of medicinal plant materials in their original packaging; medical products (in particular, patient care items, medical equipment, including prophylactic products, diagnostic tools, therapeutic and prophylactic linen, hosiery, bandages, childcare items, first aid kits medical care and others); disinfectants; personal hygiene items (products) (in particular, skin care products, hair care products, aromatic oils and others); optics (in particular, ready-made glasses, glasses care products and others); mineral waters(natural and artificial); medical, children's and dietary food (in particular, food additives for therapeutic and prophylactic purposes, and others); cosmetic and perfumery products (hereinafter referred to as goods allowed for dispensing from pharmacy organizations);

Dispensing items through the rental point in accordance with established order;

Providing advice to ensure responsible self-medication;

Providing medical professionals health care institutions, education, social security and other necessary information about the drugs available in the pharmacy, as well as about new drugs;

First aid;

Providing advice to ensure responsible self-medication.

Pharmacy:

The sale of medicinal products to the population according to doctor's prescriptions (except for narcotic drugs, psychotropic, potent and poisonous substances) and without a doctor's prescription; sale of prepackaged medicinal plant materials in factory packaging, medical products, personal hygiene items (means);

Manufacturing of medicinal products according to doctor's prescriptions, manufacturing of intra-pharmacy blanks in accordance with approved prescriptions and packaging of medicinal products with their subsequent sale;

Vacation medicines free of charge or at a discount to certain groups of the population in accordance with the current legislation of the Russian Federation and on the basis of contracts concluded with territorial health authorities, medical institutions and insurance companies;

Providing medical workers of health care institutions, education, social security with the necessary information about the drugs available in the pharmacy, as well as about new drugs;

Pharmacy kiosk:

Providing the population with the necessary information on the proper use and storage of medicines at home;

First aid.

Pharmacy store:

Selling drugs to the public without a doctor's prescription; sale of prepackaged medicinal plant materials in factory packaging, medical products, personal hygiene items (means);

Providing the population with the necessary information on the proper use and storage of medicines at home;

First aid.

2.6. The pharmacy organization sells medicinal products registered in established by law Of the Russian Federation in the order or manufactured in a pharmacy organization according to prescriptions of doctors or the requirements of health care institutions (pharmacy, pharmacy).

2.7. It is not allowed to sell medicinal products and other goods that have become unusable, expired, illegal copies of medicinal products.

2.8. The pharmacy organization must have the necessary premises, equipment and inventory that ensure, in accordance with the requirements of the standards, the preservation of the quality and safety of medicinal products during storage and sale, appropriate conditions for the retail sale of medicinal products and other goods allowed for dispensing from pharmacies.

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

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

Information about phone numbers and addresses of healthcare and pharmaceutical authorities;

Book of reviews and suggestions;

Information about population groups entitled to free and preferential provision and extraordinary services, in accordance with the current legislation of the Russian Federation;

Information about the person responsible for drug supply disabled people of the Great Patriotic War and categories of the population equated to them on benefits (for pharmacy organizations that carry out preferential dispensing of medicines);

Information about phone numbers and operating hours of the pharmaceutical inquiry service;

Information on the names of departments or zones of release of the corresponding groups of goods;

Information about the shelf life of medicinal products manufactured in a pharmacy (pharmacy);

Price tags for offered non-prescription drugs and other goods allowed for dispensing from pharmacy organizations;

Information about the employees of the pharmacy organization who directly serve the population (plates, badges and others indicating the 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 (except for the pharmacy kiosk);

If there is a rental point, information on the list of rental items;

Copy or extract from the Federal Law "On Protection of Consumer Rights"<*>;

<*>Law of the Russian Federation of February 7, 1992 N 2300-1 "On Protection of Consumer Rights" (Bulletin of the Congress of People's Deputies of the Russian Federation and the Supreme Council of the Russian Federation, 09.04.1992, N 15, Art. 766; Collected Legislation of the Russian Federation, 1996, N 3, Art.140; 20.12.1999, No. 51, Art.6287).

Copy or extract from the "Rules of Sale certain types goods, a list of durable goods that are not subject to the buyer's requirement to provide him with a free-of-charge for the period of repair or replacement of similar goods, and a list of non-food goods proper quality that cannot be returned or exchanged for similar product other size, shape, dimension, style, color or configuration ", approved in accordance with the established procedure<*>;

<*>dated January 19, 1998 N 55 "On approval of the Rules for the sale of certain types of goods, the list of durable goods, which are not subject to the buyer's requirement to provide him with a free provision of similar goods for the period of repair or replacement, and a list of non-food goods of good quality that cannot be returned, or exchange for a similar product of a different size, shape, dimension, style, color or configuration "(Collected Legislation of the Russian Federation, 01.16.1998, N 4, Art. 482; 10.26.1998, N 43, Art. 5357; 11.10.1999, N 41, Art.4923; 11.02.2002, N 6, Art.584).

The list of medicines dispensed without a doctor's prescription, approved in accordance with the established procedure<*>.

<*>Order of the Ministry of Health of Russia of July 19, 1999 N 287 "On approval of the List of medicines sold without a doctor's prescription" (registration with the Ministry of Justice of Russia on August 23, 1999 N 1875).

2.10. In the course of their activities, specialists of a pharmacy organization are obliged to comply with the norms of pharmaceutical deontology and ethics.

III. Premises and equipment of pharmacy organizations

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

The pharmacy organization should provide for the possibility of entry (exit) for people with disabilities of the musculoskeletal system.

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

3.3. A pharmacy organization must have a sign indicating the type of organization (in accordance with a license for pharmaceutical activities) in Russian and national languages: "Pharmacy", "Pharmacy point", "Pharmacy booth", "Pharmacy store"; organizational and legal form and form of ownership; company name of the organization; location (in accordance with the constituent documents), as well as the operating mode of the organization, addresses and phone numbers of nearby and duty pharmacies.

The name of the type of pharmacy organization should be executed in a font, the size of which makes it possible to clearly distinguish the inscription at any time of the day from a distance of at least 25 meters. When placing a pharmacy organization inside a building, the sign should be on the outer wall of the building.

A pharmacy organization that provides drug assistance at night must have an illuminated sign with information about work at night, indicating the hours of work, a call to call an employee of the pharmacy organization by a visitor.

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

3.5. The composition, dimensions of premises and equipment of the pharmacy organization must correspond to the volume and nature of the carried out pharmaceutical activities, activities related to the circulation of narcotic drugs and psychotropic substances, and the current regulations ensuring the quality and safety of drugs and other goods allowed for dispensing from a pharmacy organization (annex to this standard).

3.6. 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 accordance with the established procedure.

3.7. Premises of pharmacy organizations must meet technical, sanitary, fire-prevention and other licensing requirements and conditions.

3.8. Pharmacy organizations must have centralized systems of power supply, heating, water supply, supply and exhaust ventilation, sewerage.

When organizing pharmacies at medical institutions, they can be equipped with an air conditioning system; administrative premises can be shared. In pharmacy organizations located outside cities, it is possible to have autonomous heating, sewerage and water supply.

3.9. The inner surfaces of walls and ceilings should be smooth and allow for wet cleaning. The floors of industrial premises and material rooms should have a dust-free coating that is resistant to the effects of mechanization and wet cleaning using disinfectants. The finishing materials of the premises must comply with the requirements of the relevant regulatory documents.

The decoration of the administrative premises allows the use of wallpaper, carpets, parquet, oil paints, etc.

3.10. Premises for storing medicines (medicines) in pharmacies should be equipped with special equipment to ensure their storage, taking into account the physicochemical, pharmacological and toxicological properties, as well as the requirements of quality standards for medicines and State Pharmacopoeia Of the Russian Federation and their proper preservation.

Premises of pharmacy organizations located in the city must be equipped with systems burglar alarm connected to a remote control with round-the-clock centralized supervision or guarded round-the-clock by a security company licensed to given view activities.

3.11. Premises for storing narcotic drugs, psychotropic substances, poisonous and potent substances in mandatory must be equipped with multi-line security alarm systems with connection of each line to separate numbers of centralized monitoring consoles, while:

Additional alarm lines protect the internal volumes and areas of premises, safes (metal cabinets) used for storing narcotic drugs, psychotropic, poisonous and potent substances;

Workplaces of personnel carrying out operations with narcotic drugs, psychotropic, poisonous and potent substances, as well as premises for their storage, are equipped with an alarm, which is intended to transmit alarm signals to the duty units of the internal affairs bodies.

3.12. The entrance door to the premises for storing narcotic drugs, psychotropic substances, poisonous and potent substances must be metal or wooden, upholstered with iron on both sides with a sheet folded over the end of the door or on the inner surface of the door, at least 40 mm thick; the frame of the doorway must be made of a steel profile, inside - a lattice metal door.

3.13. Premises for storing narcotic drugs, psychotropic substances, poisonous and potent substances must be equipped with an internal lattice on window openings (or a lattice between frames), made of a steel rod with a diameter of at least 16 mm. The rods should be welded at each node and form meshes of no more than 150 x 150 mm.

3.14. Access to production facilities, storage facilities for goods have persons authorized in accordance with the established procedure. Access of unauthorized persons to these premises is excluded.

3.15. The pharmacy organization must be equipped with an appropriate light, sound and fire alarm, which provides all the conditions for the safety of inventories and compliance with fire safety.

3.16. In pharmacy organizations, a special room (cabinet) should be allocated for storing detergents and disinfectants, inventory and materials used for cleaning premises and processing equipment.

3.17. The total area of administrative and amenity premises of pharmacy organizations depends on the number of personnel and is calculated according to current regulations and rules.

3.18. In the dressing room, outerwear and shoes should be stored separately from sanitary clothes and shoes.

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

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

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

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

The trading floor should be equipped with showcases that provide an overview and safety of medicines and goods of other groups that are allowed to be dispensed from pharmacy organizations, as well as provide convenience in work for the staff of the pharmacy organization. Possible open display of non-prescription drugs and other goods allowed for dispensing from pharmacy organizations;

Premises for storing medicines and other goods permitted for dispensing from pharmacy organizations must be equipped with cabinets, racks, pallets, and items for storing them; storage rooms for thermolabile medicinal products should be equipped with equipment that provides the necessary conditions storage;

Premises for storing medicines and other goods permitted for dispensing 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 the doors. The readings of these devices must be recorded daily in a special log (map), which is kept responsible person during the year and is stored for a year, not counting the past. Control devices must be certified, calibrated and verified in accordance with the established procedure;

Cabinets for storing outer and sanitary clothes, shoes in the dressing room;

Detergents and disinfectants, household tools used for cleaning premises and processing equipment.

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

3.20. Racks and cabinets for storing medicines and other goods approved for dispensing from pharmacy organizations in material rooms should be installed as follows:

The distance to the outer walls is not less than 0.6 - 0.7 m;

The distance to the ceiling is not less than 0.5 m;

Distance from the floor not less than 0.25 m;

Aisles between racks are not less than 0.75 m;

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

IV. Requirements for the organization of acceptance of medicinal products in pharmacy organizations

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

4.2. Medicines and other goods approved 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.

For medicinal products (medicinal products) in damaged packaging that do not have certificates and / or the necessary accompanying documentation, rejected when receiving or dispensing to the patient, not corresponding to the order or with an 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 destroyed in accordance with the established procedure.

4.3. Poisonous and potent substances, narcotic drugs, psychotropic substances, thermolabile medicinal products must be immediately placed in storage areas in accordance with the requirements of this OST.

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

4.5. All deliveries of goods must be accompanied by documents allowing to establish the date of shipment, the name of the drug (including the dosage form and dosage), the batch and batch number, the quantity of the delivered goods, the price of the dispensed drug, the name and address of the supplier and recipient, as well as documents confirming the quality medicines.

4.6. Accepted medicinal products and other goods allowed for dispensing from pharmacy organizations are credited within the time allotted for the acceptance of the goods by the number of commodity units and completeness in the prescribed manner.

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

5.1. Pharmacy organizations should take measures to prevent damage (spillage, scattering, breakage), to prevent contamination of medicines (medicines).

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

By toxicological and pharmacological groups; by the method of application;

In alphabet order;

In accordance with the positions of computer accounting.

The accepted method of storing medicinal products (medicines) must be stipulated in the order for the pharmacy organization and communicated to the personnel of the pharmacy organization.

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

5.4. Medicinal products (medicines) should be stored separately, taking into account their physical and physicochemical properties, the impact on them of various factors external environment in accordance with established requirements <*>.

<*>Order of the Ministry of Health of Russia dated November 13, 1996 N 377 "On approval of instructions for organizing storage in pharmacies different groups medicines and medical products "(registration in the Ministry of Justice of Russia on November 22, 1996, N 1202).

5.5. The storage of narcotic drugs and psychotropic substances, potent and poisonous substances must be carried out in accordance with applicable regulatory requirements <*>.

5.6. Special requirements are imposed on the storage of medicinal products (medicinal products) of lists "A" and "B", in particular:

Medicines (medicines) belonging to lists "A" and "B" (regardless of the dosage form) are stored in isolation, in lockable metal cabinets under lock (list "A") and in wooden cabinets under lock (list "B" );

On the inner side of the cabinet doors, in which drugs (drugs) of the "A" list are stored, there should be the inscriptions "A", "Venena", and on the inside of the cabinet doors, in which drugs (drugs) of the "B" list are stored "- inscriptions" B "," Heroica "and lists of drugs of lists" A "and" B "indicating the highest single and daily doses;

The inscriptions on the bars in which the drugs of the "A" list are stored must be white on a black background, and on the bars containing the drugs of the "B" list, in red on a white background; in both cases, the highest single and daily doses should be indicated on the bars;

IN work time the keys to the metal cabinet with drugs (drugs) of the "A" list, located in the assistant's room, must be kept by an authorized employee of the pharmacy organization. After the end of the working day, the cabinets are sealed or sealed, and the keys to them, the seal and the sealant must be kept by the head of the pharmacy organization or by persons authorized by the order of the pharmacy organization;

Wooden cabinets for storing medicines (drugs) of the "B" list after the end of the working day should be locked;

In pharmacies on duty, medicines of lists "A" and "B" are left at night, which are kept by the duty employee of the pharmacy in a separate locker, in quantities and assortments necessary for the provision of emergency medical care. After the end of the watch, this cabinet is sealed or sealed;

Reagents containing medicines of lists "A" and "B", and being on the table of a pharmacist-analyst or a pharmacist-technologist during work, after the end of work should be stored in a cabinet under lock and key;

The list of medicinal products (medicinal products) assigned to lists "A" and "B" is determined in accordance with the current regulatory documents.

Vi. Requirements for the dispensing (sale) of medicinal products in pharmacies

6.1. Dispensing (sale) of medicinal products is carried out by prescription and without a doctor's prescription, as well as according to the requirements of healthcare institutions on the basis of an agreement.

6.2. Upon receipt of the prescriptions and requirements of the established samples at the pharmacy organization, the specialist of the pharmacy organization evaluates their compliance with certain requirements and, in accordance with the tariffs, determines the cost of the dispensed drug.

6.3. If a prescription drug is replaced by its synonym (generic form), with the consent of the buyer or in agreement with the doctor, the trade name of the dispensed drug should be indicated on the back of the prescription, the signature and the date of dispensing should be signed.

6.4. Dispensing of medicinal products with special conditions sales (narcotic drugs, psychotropic, potent and poisonous substances, ethyl alcohol and others), carried out in compliance with the requirements of the current regulatory documents<*>and these Rules.

<*>Order of the Ministry of Health of Russia dated August 23, 1999 N 328 "On the rational prescription of drugs, the rules for prescribing them and the procedure for their dispensing by pharmacies (organizations)" (registration with the Ministry of Justice of Russia dated October 21, 1999 N 1944). Order of the Ministry of Health of Russia dated November 12, 1997 N 330.

6.5. Dispensing (selling) of medicinal products under free and preferential prescriptions is carried out from pharmacy organizations on the basis of an agreement with organizations that finance preferential dispensing of medicinal products to the population.

6.6. Benefits in servicing certain groups of the population are provided in accordance with legislative and regulations Of the Russian Federation, as well as on the basis of decisions of the state power subjects of the Russian Federation.

6.7. Medicines sold from pharmacy organizations must have information in accordance with the state information standard of the medicinal product.

The buyer, at his request, may be provided with additional information about the purchased medicinal product, about the synonyms (generic forms) of the purchased medicinal product available in the pharmacy organization and their prices.

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

6.9. When dispensing medicinal products, violation of the secondary packaging is allowed, with the obligatory indication of the series and expiration date of medicinal products on the pharmaceutical packaging and the provision of the necessary information. Violation of the primary packaging of the medicinal product is not allowed.

6.10. At the buyer's request, an authorized employee of a pharmacy organization provides information on documents on prices and shelf life of medicines and other goods allowed for dispensing from pharmacy organizations and on documents confirming their quality.

6.11. For information about medicines and other goods allowed for dispensing from pharmacy organizations, various types of showcases can be used, where medicines sold without a doctor's prescription and samples of available goods are displayed.

Medicines are placed separately on display cases: medicines for internal use and medicines for external use. Within the groups, drugs are arranged according to the pharmacotherapeutic principle.

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

6.13. Information about the services provided by pharmacy organizations, as well as sold medicinal products and other goods allowed for dispensing from pharmacy organizations, must be carried out in accordance with the requirements current legislation.

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

6.15. The buyer has the right to return or replace goods of inadequate quality purchased from a pharmacy organization (except for those goods that are included in the list of non-food goods of good quality that cannot be returned or exchanged for similar goods of other size, shape, dimension, style, color or configuration in accordance with with the current procedure<*>).

Vii. Accounting and reporting in pharmacy organizations

7.1. Pharmacy organizations maintain operational and accounting records of inventories in accordance with established forms in accordance with the current legislation of the Russian Federation.

7.2. The accounting of 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 the given enterprise (individual, natural-cost, cost).

7.3. Subject-quantitative accounting is subject to narcotic drugs, psychotropic, poisonous and potent substances, ethyl alcohol and other drugs in accordance with the current regulatory documents <*>.

<*>Resolution of the Government of the Russian Federation of November 9, 2001 N 782 "On government regulation prices for medicines "(Collected Legislation of the Russian Federation, 19.11.2001, N 47, Art. 4448).

VIII. Requirements for the personnel of pharmacy organizations

8.1. Pharmaceutical positions in pharmacy organizations are held by specialists - pharmacists or pharmacists in accordance with the established procedure.

8.2. The management of the pharmacy organization is carried out by a pharmacist who has a certificate of a specialist and work experience in the specialty for at least 3 years. In pharmacy organizations located outside the city, the management of the pharmacy organization can be carried out by a pharmacist who has a specialist certificate.

8.3. In departments of pharmacy organizations with an open form of displaying goods and selling goods allowed for dispensing from pharmacy organizations, it is allowed to attract persons with secondary or secondary medical education or higher medical education as consultants.

8.4. Pharmacy specialists must improve their qualifications in accordance with current requirements.

8.5. Pharmacy staff must follow the rules of personal hygiene, including the use of special clothing.

8.6. In order to ensure sanitary requirements employees of pharmacy organizations must pass medical examination according to established order.

8.7. Persons with signs of illness, open wounds are not allowed to work, as long as their state of health may cause the risk of contamination of goods sold in a pharmacy organization.

8.8. Not allowed in production premises, as well as at workplaces in the trading floor, smoking, eating, storing personal medicines, food, drinks, tobacco products.

8.9. In their production activities, employees of pharmacy organizations are guided by the current documents in the field of pharmaceutical activities, the rules of internal work schedule, safety requirements and this OST.

IX. Quality assurance of medicines (medicines) in pharmacy organizations

9.1. The pharmacy organization should have a quality management system for the pharmacy organization.

9.2. Each pharmacy organization must have internal labor regulations approved by the head of the organization, with a mark on familiarization of employees. The revision of the rules and repeated familiarization with them by the employees of the pharmacy organization is carried out annually.

9.3. The pharmacy organization must regularly conduct internal checks for compliance with the requirements of this OST.

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

9.4. Inspections can be carried out both by employees of the pharmacy organization, independent of the persons directly carrying out the activity being inspected, and by independent experts.

9.5. The frequency of checks is determined by the pharmacy organization itself.

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

9.7. During subsequent checks, the implementation of the recommendations and their effectiveness are monitored.

9.8. Each employee of a pharmacy organization must be familiar with this OST, the procedure for performing the duties assigned to him, regulatory legal acts and standards related to the activities of the organization. Pharmacy organizations should have for each employee job descriptions approved in the appropriate order.

Pharmacy organizations should provide for a system of continuous improvement vocational education employees on the current legislation, the use of medicines, etc. The plan and topics of classes are approved by the head of the pharmacy organization.

9.9. The head of the pharmacy organization appoints a quality representative from the management personnel.

9.10. The pharmacy organization ensures the maintenance of documentation in accordance with the legislative and regulatory legal acts of the Russian Federation.

Application
to the industry standard
"Vacation (implementation) rules
medicines
in pharmacy organizations.
Basic provisions ",
approved by the Order
Ministry of Health of Russia
dated 04.03.2003 N 80

INDUSTRY STANDARD Appendix

1. Minimum standards for the area of pharmacies of finished dosage forms located in cities, m2

N N	Pharmacy organization type	General	Shopping room			Staff premises		Head office	Wardrobe	Bathroom
1.	Pharmacy	90	42	20	4	8	2	8	4	2

N N	Pharmacy organization type	General	Shopping room	Storage rooms (material rooms)	Premises for acceptance, unpacking	Staff premises	Storage rooms for households. inventory (closet)	Head office	Wardrobe	Bathroom
1.	Pharmacy	66	18	22	4	6	2	8	4	2

3. Minimum standards for the area of pharmacies manufacturing pharmaceuticals and located in cities, m2

MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

Abolished from January 10, 2004 on the basis of
Order of the Ministry of Health of Russia dated December 17, 2003 N 598
____________________________________________________________________

In order to bring regulatory legal acts in line with the current antimonopoly legislation of the Russian Federation

I order:

1. To amend the order of the Ministry of Health of Russia dated March 4, 2003 N 80 "On Approval of the Industry Standard" Rules for the Dispensing (Sale) of Medicines in Pharmacy Organizations. Basic Provisions "(registered with the Ministry of Justice of Russia on March 17, 2003, registration N 4272):

1.1. Appendix to the order:

1.1.1. In the seventh paragraph of clause 2.5, the words "(in particular, patient care items, medical equipment, including prophylactic drugs, diagnostic tools, therapeutic and prophylactic linen, hosiery, bandages, childcare items, first aid kits and others) "to exclude;

1.1.2. In the ninth paragraph of clause 2.5, the words "provision of counseling for the purpose of responsible self-medication" shall be deleted;

1.1.3. In paragraph fourteen of clause 2.5, the words "(except for narcotic drugs, psychotropic, potent and poisonous substances)" shall be replaced with the words "(except for narcotic drugs and psychotropic substances)";

1.1.4. In paragraphs fourteen, twenty-one and twenty-fifth of clause 2.5, after the word "hygiene" add the words "and others *";

________________

* (Collected Legislation of the Russian Federation, 1998, No. 26, Article 3006; 2000, No. 2, Article 126; 2002, No. 1, Article 2).

1.1.5. Clause 6.9 shall be amended as follows:

"6.9. In order to ensure the protection of medicines from the effects of adverse conditions the environment, guarantees of maintaining the quality of medicines for the deadline expiration date, when dispensing medicinal products, violation of secondary packaging is not allowed.

Medicines coming into circulation must meet the requirements of state quality standards for medicines * ";

________________

* Order of the Ministry of Health of Russia of November 1, 2001 N 388 "On state standards for the quality of medicines" (registered by the Ministry of Justice of Russia on November 16, 2001, registration N 3041).

1.1.6. In clause 6.15, the words "(except for those goods that are included in the" list of non-food products that are not subject to return or exchange for a similar product of other size, shape, dimension, style, color or configuration in accordance with the current procedure) "shall be replaced by the words" list non-food products of good quality, not subject to return or exchange, is determined by the current regulatory legal document) ";

1.2. The appendix to the industry standard "Rules for the dispensing (sale) of medicinal products in pharmacy organizations. Basic provisions" shall be stated in the edition of the appendix to this order.

2. Control over the implementation of this order shall be entrusted to the Deputy Minister A.V.Katlinsky.

The minister
Yu.L. Shevchenko

Registered
at the Ministry of Justice
Russian Federation
October 7, 2003
registration N 5159

Application. Appendix to the industry standard "Rules for the dispensing (sale) of medicinal products in pharmacy organizations. Basic provisions"

Application

1. The minimum standards for the area of pharmacies of finished dosage forms located in settlements with a population of more than 1 million people, sq. m *

________________

pp 2.5, 2.9,.


Pharmacy organization type	Total area**	Manufacturing bathroom *	Admin- strativally economic new premises	Sanitary household premises
________________

Self
Structural subdivision*
________________

Self
Structural subdivision*
________________ * For pharmacies that are structural divisions, the absence of a separate room for the archive is allowed.

2. Minimum standards for the area of pharmacies of finished dosage forms located in settlements with a population of 500 thousand to 1 million people inclusive, sq. M *

________________

* Obligatory availability of premises: production (trading floor, premises for receiving and unpacking goods, storage rooms); administrative and economic (separate place for the manager and accountant, dressing room or closet, staff room, archive); sanitary facilities (lavatory with an airlock, storage area for cleaning equipment). At the same time, these premises must comply with the requirements for pharmacies in accordance with clauses 2.5, 2.9, sections III-VI of this industry standard.


Pharmacy organization type	Total area**	Manufacturing bathroom *	Admin- strativally economic new premises	Sanitary household premises
________________ * The production premises of pharmacies with the right to manufacture medicines (without aseptic means) are increased by 25 sq. M, pharmacies with the right to manufacture medicines (with aseptic means) are increased by 48 sq. M. *
Pharmacy with the right to work with narcotic drugs, psychotropic, potent and poisonous substances:
Self
Structural subdivision*
________________ * For pharmacies that are structural divisions, the absence of a separate room for the archive is allowed.
Pharmacy without the right to work with narcotic drugs, psychotropic, potent and poisonous substances:
Self
Structural subdivision*
________________ * For pharmacies that are structural divisions, the absence of a separate room for the archive is allowed.

3. Minimum standards for the area of pharmacies of finished dosage forms located in settlements with a population of 100 thousand to 500 thousand people inclusive, sq. M *

________________


Pharmacy organization type	Total area**	Manufacturing bathroom *	Admin- strativally economic new premises	Sanitary household premises
________________ * The production premises of pharmacies with the right to manufacture medicines (without aseptic means) are increased by 25 sq. M, pharmacies with the right to manufacture medicines (with aseptic means) are increased by 48 sq. M. ** The total area does not include areas of vestibules, corridors and other auxiliary premises.
Pharmacy with the right to work with narcotic drugs, psychotropic, potent and poisonous substances:
Self
Structural subdivision*
________________ * For pharmacies that are structural divisions, the absence of a separate room for the archive is allowed.
Pharmacy without the right to work with narcotic drugs, psychotropic, potent and poisonous substances:
Self
Structural subdivision*
________________ * For pharmacies that are structural divisions, the absence of a separate room for the archive is allowed.

4. Minimum standards for the area of finished dosage forms pharmacies located in settlements with a population of 10 thousand to 100 thousand people inclusive, sq. M *

________________


Pharmacy organization type	Total area**	Manufacturing bathroom *	Admin- strativally economic new premises	Sanitary household premises
________________ * The production premises of pharmacies with the right to manufacture medicines (without aseptic means) are increased by 25 sq. M, pharmacies with the right to manufacture medicines (with aseptic means) are increased by 48 sq. M. ** The total area does not include areas of vestibules, corridors and other auxiliary premises.
Pharmacy with the right to work with narcotic drugs, psychotropic, potent and poisonous substances:
Self
Structural subdivision*
________________ * For pharmacies that are structural divisions, the absence of a separate room for the archive is allowed.
Pharmacy without the right to work with narcotic drugs, psychotropic, potent and poisonous substances:
Self
Structural subdivision*
________________ * For pharmacies that are structural divisions, the absence of a separate room for the archive is allowed.

5. Minimum standards for the area of pharmacies of finished dosage forms located in settlements with a population of less than 10 thousand people, sq. M *

________________


Pharmacy organization type	Total area**	Manufacturing bathroom *	Admin- strativally economic new premises	Sanitary household premises
________________ * The production premises of pharmacies with the right to manufacture medicines (without aseptic means) are increased by 25 sq. M, pharmacies with the right to manufacture medicines (with aseptic means) are increased by 48 sq. M. ** The total area does not include areas of vestibules, corridors and other auxiliary premises.
Pharmacy with the right to work with narcotic drugs, psychotropic, potent and poisonous substances:
Self
Structural subdivision*
________________ * For pharmacies that are structural divisions, the absence of a separate room for the archive is allowed.
Pharmacy without the right to work with narcotic drugs, psychotropic, potent and poisonous substances:
Self
Structural subdivision*
________________ * For pharmacies that are structural divisions, the absence of a separate room for the archive is allowed.

6. Minimum standards for the area of pharmacies without the right to manufacture medicines and located in settlements with a population of more than 10 thousand people, sq. M *

________________


Pharmacy organization type	Total area**	Manufacturing bathroom *	Admin- strativally economic new premises	Sanitary household premises
________________ ** The total area does not include areas of vestibules, corridors and other auxiliary premises.

________________
Independent
Structural subdivision*
________________

________________ * For pharmacies located in medical institutions, it is allowed to organize administrative and economic and sanitary facilities, combined with the corresponding premises of the medical and preventive institution.
Independent
Structural subdivision*
________________ * For pharmacies that are structural subdivisions, the absence of premises for the archive is allowed.

7. Minimum standards for the area of pharmacies without the right to manufacture medicines and located in settlements with a population of less than 10 thousand people, sq. M *

________________


Pharmacy organization type	Total area**	Manufacturing bathroom *	Admin- strativally economic new premises	Sanitary household premises
________________ * The production premises of pharmacies with the right to manufacture medicines are increased by 25 sq.m. ** The total area does not include areas of vestibules, corridors and other auxiliary premises.
Pharmacy point with the right to work with potent and toxic substances *:
________________ * For pharmacies located in medical institutions, it is allowed to organize administrative and economic and sanitary facilities, combined with the corresponding premises of the medical and preventive institution.
Independent
Structural subdivision*
________________ * For pharmacies that are structural subdivisions, the absence of premises for the archive is allowed.
Pharmacy point without the right to work with potent and poisonous substances *:
________________ * For pharmacies located in medical institutions, it is allowed to organize administrative and economic and sanitary facilities, combined with the corresponding premises of the medical and preventive institution.
Independent
Structural subdivision*
________________ * For pharmacies that are structural subdivisions, the absence of premises for the archive is allowed.

8. Minimum standards for the area of pharmacy kiosks located in settlements with a population of more than 10 thousand people, sq. M *

________________

* Obligatory availability of premises: production (trading floor, premises for receiving and unpacking goods, storage rooms); administrative and economic (separate place for the manager and accountant, dressing room or closet, staff room, archive); sanitary facilities (lavatory with an airlock, storage area for cleaning equipment). At the same time, these premises must meet the requirements for pharmacies in accordance with clause 2.5 of the Administrative
strativally
economic
new premises

Sanitary
household premises

________________
* The total area does not include areas of vestibules, corridors and other auxiliary premises.

________________

9. Minimum standards for the area of pharmacy kiosks located in settlements with a population of less than 10 thousand people, sq. M *

________________

* Obligatory availability of premises: production (trading floor, premises for receiving and unpacking goods, storage rooms); administrative and economic (separate place for the manager and accountant, dressing room or closet, staff room, archive); sanitary facilities (lavatory with an airlock, storage place for cleaning equipment). In this case, these premises must comply with the requirements for pharmacies in accordance with clause 2.5, new premises

Sanitary
household premises

________________
* The total area does not include areas of vestibules, corridors and other auxiliary premises.

Pharmacy kiosk (independent)

Pharmacy kiosk (structural unit) *

________________
* For pharmacy kiosks that are structural divisions, the absence of an archive room is allowed.

10. Minimum standards for the area of pharmacy stores, sq. M *

________________


Pharmacy organization type	Total area*	Manufacturing bathroom	Admin- strativally economic new premises	Sanitary household premises
________________ * The total area does not include areas of vestibules, corridors and other auxiliary premises.
Pharmacy store

Marat Milushin - candidate legal sciences, director of a law firm"Uniko-94"

What changes will the cancellation bring Industry standard "Rules dispensing (selling) medicinal funds in pharmacy organizations. The main provisions "?
We also heard that instead of the canceled OST new sanitary facilities are at registration rules (SanPiN). Are they accepted?

Approved by the Order of the Ministry of Health of the Russian Federation dated 04.03.2003 No. 80 Industry standard "Rules for the dispensing (sale) of medicinal
funds in pharmacy organizations. Basic provisions "OST 91500.05.0007-2003 established a number of legal regulations,
regulating the activities of pharmacy organizations.
In clause 2.5 of the Standard, the permitted functions of pharmacy organizations were defined in detail. Clause 2.9 was established
list of information for buyers, which is located in the trading floor of the pharmacy.
Sections 3, 4, 8 and 9 determined, respectively: general requirements for premises and equipment of pharmacy organizations; requirements for the organization of drug acceptance; clearer requirements for the personnel of pharmacy organizations
(clauses 8.1 - 8.3, 8.7 - 8.8); requirements for quality assurance of medicines in pharmacy organizations.
The norms of most of the above paragraphs of the Standard are not established by other regulatory legal acts and,
accordingly, in connection with the cancellation of the OST from March 2, 2014 by the Order of the Ministry of Health of the Russian Federation dated January 09, 2014 No. 1n, they are not mandatory.
The Ministry of Health of the Russian Federation has prepared a draft Order approving the "Rules for the dispensing of drugs for medical use by pharmacy organizations, individual entrepreneurs licensed for pharmaceutical activities ", however, this project is, in fact, a modernized version of the Order of the Ministry of Health and Social Development of the Russian Federation of December 14, 2005 No. 785" Procedure for dispensing medicines "and in no way replaces the canceled Industry Standard.
According to our information, the RF Ministry of Health does not plan to issue a regulatory legal act to replace the above Industry Standard. Any information about the preparation by Rospotrebnadzor Sanitary regulations that set standards for pharmacy organizations are not yet available.

In connection with the cancellation of order No. 80 from 03/04/2003 a number of questions arise.
1. Should there be a form in the pharmacy a quality management system has been established, which is it regulated by the document now? If the post of Commissioner for quality, how to deal with the system of government quality?
2. Should internal checks structural units pharmacy networks?
3. Should there be continuous training continued professional development employee education with plan and topics?
What document should you focus on?

Section 9 approved by the Order of the Ministry of Health of the Russian Federation dated 04.03.2003 No. 80 of the Industry Standard
(sale) of medicines in pharmacy organizations. Basic Provisions ”OST 91500.05.0007-2003 established requirements for quality assurance of medicines in pharmacy organizations. In connection with the cancellation of the Industry Standard by Order of the Ministry of Health of the Russian Federation dated 01/09/2014 No. 1n, these requirements have ceased to be valid.
Thus, today the issues of managing the quality system of medicines in a pharmacy organization, conducting internal
On-site inspections of units and occupations with personnel are not regulated by the current legislation. Accordingly, the implementation of these measures in a pharmacy organization is not considered mandatory.

Than now, in connection with the cancellation of the OST, pharmacies will differ from pharmacies points? Is it possible to all pharmacy pun who can re-license to pharmacies?

In accordance with part 2 of Article 55 of the Federal Law of the Russian Federation of 12.04.2010 No. 61-FZ "On the Circulation of Medicines" (as amended on 25.11.2013), the types of pharmacy organizations are approved by the authorized federal body executive power... By order of the Ministry of Health and Social Development of the Russian Federation of July 27, 2010 No. 553n, the following types of pharmacy organizations were approved:
1. pharmacy: finished dosage forms; production; production facility with the right to manufacture aseptic medicinal products;
2. pharmacy;
3. pharmacy kiosk.
No official documents that define the difference between the above types of pharmacy organizations do not exist.
Neither Federal law RF dated 4.05.2011 No. 99-FZ "On licensing certain types of activities" (as amended on 02.07.2013), nor by the Resolution of the Government of the Russian Federation dated 22.12.2011 No. 1081 "On licensing pharmaceutical activities" (as amended by from 04/15/2013) renewal of a license for pharmaceutical activities in connection with a change in the type of pharmacy organization
not provided.

As now, in connection with the cancellation of the OST 91500.05007-2003 from 02.03.2014, the requirements for equipment are regulated downgrade and p Premises of pharmacy organizations? Where can I get information about registration changing the operating modes of the pharmacy (regime), signage?

Section 3 of the Industry Standard “Rules for the Dispensing (Sale) of Medicines in Pharmacy Organizations. Basic Provisions ”OST 91500.05.0007-2003 determined the general requirements for premises and equipment of pharmacy organizations.
In particular, clause 3.3 of the Standard contained requirements for the sign of a pharmacy organization. With the withdrawal of the Standard, these requirements
have lost their force.
Currently, special requirements are established only for premises for storing medicines. They are approved by the Order of the Ministry of Health and Social Development of the Russian Federation of 23.08.2010 No. 706n "Rules for storing medicines" (as amended on 28.12.2010).
The sign should be guided by general requirements to the design of signs of trade organizations, which are established by clause 10 of the "Rules for the sale of certain types of goods", approved by the Decree of the Government of the Russian Federation of 01.19.98, No. 55 (as amended on 04.10.2012).

Dear leaders, you can send questions to the editorial office about legal regulation pharmacy activities. A professional lawyer will answer them.

In order to develop a system of standardization in healthcare and improve the functioning of the sphere of circulation of medicines, I order:

Industry standard OST 91500.05.0007-2003
Rules for dispensing (selling) medicinal products in pharmacy organizations. Basic Provisions
(approved by order of the Ministry of Health of the Russian Federation of March 4, 2003 N 80)

1.1. Industry standard 91500.05.0007-2003 "Rules for the dispensing (sale) of medicines in pharmacy organizations. Basic provisions" (hereinafter - OST) was developed in accordance with the Law of the Russian Federation of June 10, 1993 N 5154-1 "On standardization" (Bulletin of the Supreme Council of the Russian Federation, 1993, No. 25, Article 917; Collected Legislation of the Russian Federation, 1996, No. 1, Article 4; 2002, No. 28, Article 2791; 2002, No. 30, Article 3033), dated June 22, 1998 Year N 86-FZ "On Medicines" (Collected Legislation of the Russian Federation, 1998, N 26, Art. 3006; 2000, N 2, Art. 126; 2002, N 1 (Part I), Art. 2), on the Ministry Healthcare of the Russian Federation, approved by the Government of the Russian Federation of April 29, 2002 N 284 (Collected Legislation of the Russian Federation, 2002, N 18, Art. 1771).

1.2. This OST is mandatory for all pharmacy organizations, regardless of their organizational and legal form and form of ownership, that carry out retail trade in medicines.

For activities related to the sale of raw materials of animal origin and bulk medicinal plant materials subject to further industrial processing for the manufacture of medicines.

2.1. A pharmacy organization operates on the basis of a pharmaceutical license issued in accordance with the established procedure.

The acquisition, storage and sale of narcotic drugs and psychotropic substances included in narcotic drugs, psychotropic substances and their precursors, subject to control in the Russian Federation in accordance with the established procedure (hereinafter referred to as narcotic drugs and psychotropic substances), must be carried out only with a license for the types of activity, related to the circulation of narcotic drugs and psychotropic substances.

2.2. , the conditions for granting and renewing a license for pharmaceutical activities, conditions for refusing to grant a license, suspending or canceling a license are established by legislative and regulatory legal acts of the Russian Federation.

2.3. Pharmacy organizations in their work must be guided by certain requirements established by state standards, sanitary, fire safety rules and other regulatory documents (hereinafter referred to as standards), labor protection and safety rules.

Manufacturing medicinal products according to the prescriptions of doctors, the requirements of healthcare institutions, standard prescriptions, with their subsequent sale within the legal entity on prescriptions and without prescriptions from a doctor; selling finished medicinal products and other goods permitted for dispensing from pharmacy organizations, to the public on prescription or without a prescription from a doctor and to health care, education, social security institutions and others upon requirements or requests (pharmacy with a production department, pharmacy with the right to manufacture medicinal products );

Selling ready-made medicinal products (including homeopathic preparations) to the public by prescription and without a doctor's prescription, to healthcare institutions upon request or request;

Dispensing drugs free of charge or at a discount to certain groups of the population in accordance with the current legislation of the Russian Federation and on the basis of contracts concluded with territorial health authorities, medical institutions and insurance companies;

Sale of medicinal plant materials in their original packaging; medical products (in particular, patient care items, medical equipment, including prophylactic products, diagnostic tools, therapeutic and prophylactic linen, hosiery, bandages, childcare items, first aid kits and others); disinfectants; personal hygiene items (products) (in particular, skin care products, hair care products, aromatic oils and others); optics (in particular, ready-made glasses, glasses care products and others); mineral waters (natural and artificial); medical, children's and dietary food (in particular, food additives for therapeutic and prophylactic purposes, and others); cosmetic and perfumery products (hereinafter referred to as goods allowed for dispensing from pharmacy organizations);

Providing the population with the necessary information on the proper use and storage of medicines at home; providing advice to ensure responsible self-medication;

Providing medical workers of health care institutions, education, social security and other necessary information about the drugs available in the pharmacy, as well as about new drugs;

Order of the Ministry of Health of the Russian Federation of March 4, 2003 N 80
"On Approval of the Industry Standard" Rules for the Dispensing (Sale) of Medicines in Pharmacy Organizations. Basic provisions "

In order to develop a system of standardization in healthcare and improve the functioning of the sphere of circulation of medicines, I order:

To approve and put into effect from March 30, 2003 the Industry standard OST 91500.05.0007-2003 "Rules for the dispensing (sale) of medicinal products in pharmacy organizations. Basic provisions" (Appendix).

Yu.L. Shevchenko

Industry standard OST 91500.05.0007-2003
Rules for dispensing (selling) medicinal products in pharmacy organizations. Basic Provisions
(approved by order of the Ministry of Health of the Russian Federation of March 4, 2003 N 80)

With changes and additions from:

September 23, December 17, 2003, January 30, August 29, 2004, September 13, 2005, April 18, 2007

I. Introduction

1.1. Industry standard 91500.05.0007-2003 "Rules for the release (sale) of medicines in pharmacy organizations. Basic provisions" (hereinafter - OST) was developed in accordance with the Law of the Russian Federation of June 10, 1993 N 5154-1 "On standardization" (Bulletin of the Supreme Council of the Russian Federation, 1993, No. 25, Article 917; Collected Legislation of the Russian Federation, 1996, No. 1, Article 4; 2002, No. 28, Article 2791; 2002, No. 30, Article 3033), Federal Law of 22 June 1998 N 86-FZ "On Medicines" (Collected Legislation of the Russian Federation, 1998, N 26, Art. 3006; 2000, N 2, Art. 126; 2002, N 1 (Part I), Art. 2), Regulations on the Ministry of Health of the Russian Federation, approved by Decree of the Government of the Russian Federation of April 29, 2002 N 284 (Collected Legislation of the Russian Federation, 2002, N 18, Article 1771).

II. General Provisions

2.1. A pharmacy organization operates on the basis of a pharmaceutical license issued in accordance with the established procedure.

The 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 referred to as narcotic drugs and psychotropic substances), must be carried out only with a license for activities connected with the circulation of narcotic drugs and psychotropic substances.

2.5. Pharmacy organizations can be represented by pharmacies, pharmacy points, pharmacy kiosks, pharmacy stores.

Pharmacy organizations can perform the following functions:

Selling ready-made medicinal products (including homeopathic preparations) to the public by prescription and without a doctor's prescription, to healthcare institutions upon request or request;

Dispensing drugs free of charge or at a discount to certain groups of the population in accordance with the current legislation of the Russian Federation and on the basis of contracts concluded with territorial health authorities, medical institutions and insurance companies;

Sale of medicinal plant materials in their original packaging; medical products (in particular, patient care items, medical equipment, including prophylactic products, diagnostic tools, therapeutic and prophylactic linen, hosiery, bandages, childcare items, first aid kits and others); disinfectants; personal hygiene items (products) (in particular, skin care products, hair care products, aromatic oils and others); optics (in particular, ready-made glasses, glasses care products and others); mineral waters (natural and artificial); medical, children's and dietary food (in particular, food additives for therapeutic and prophylactic purposes, and others); cosmetic and perfumery products (hereinafter referred to as goods allowed for dispensing from pharmacy organizations);

Leaving items through the rental point in accordance with the established procedure;

Providing the population with the necessary information on the proper use and storage of medicines at home; providing advice to ensure responsible self-medication;

Providing medical workers of health care institutions, education, social security and other necessary information about the drugs available in the pharmacy, as well as about new drugs;

First aid;

Providing advice to ensure responsible self-medication.

2.10. In the course of their activities, specialists of a pharmacy organization are obliged to comply with the norms of pharmaceutical deontology and ethics.

III. Premises and equipment of pharmacy organizations

The pharmacy organization should provide for the possibility of entry (exit) for people with disabilities of the musculoskeletal system.

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

3.4. When a pharmacy organization is closed for sanitary work, repairs, re-equipment or in connection with its liquidation, the population is notified of this by an announcement posted at the front door 5 days before the closure of the pharmacy organization. The ad contains the address of the nearest pharmacy organizations. When a pharmacy organization is closed in connection with repairs or its liquidation, the head of the pharmacy organization notifies the licensing authority that issued the license.

Information about changes:

3.5. The composition, dimensions of premises and equipment of the pharmacy organization are determined by the current sanitary and hygienic, construction and other norms and rules.

3.7. Premises of pharmacy organizations must meet technical, sanitary, fire-prevention and other licensing requirements and conditions.

3.8 Pharmacy organizations should have centralized systems of power supply, heating, water supply, supply and exhaust ventilation, sewerage.

The decoration of the administrative premises allows the use of wallpaper, carpets, parquet, oil paints, etc.

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

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 round-the-clock by a security company licensed for this type of activity.

Information about changes:

3.11. Premises for storing narcotic drugs, psychotropic substances, poisonous and potent substances must be equipped with multi-border security alarm systems with each line connected to separate numbers of centralized monitoring consoles, while:

Additional alarm lines protect the internal volumes and areas of premises, safes (metal cabinets) used for storing narcotic drugs, psychotropic, poisonous and potent substances;

Workplaces of personnel performing operations with narcotic drugs, psychotropic, poisonous and potent substances, as well as premises for their storage, are equipped with alarms.

3.13. Premises for storing narcotic drugs, psychotropic substances, poisonous and potent substances must be equipped with an internal lattice on window openings (or a lattice between frames), made of a steel rod with a diameter of at least 16 mm. The rods must be welded at each knot and form meshes of no more than 150x150 mm.

3.14. Access to production facilities, storage facilities for goods have persons authorized in accordance with the established procedure. Access of unauthorized persons to these premises is excluded.

3.15. The pharmacy organization must be equipped with an appropriate light, sound and fire alarm, which provides all the conditions for the safety of inventories and compliance with fire safety.

3.16. In pharmacy organizations, a special room (cabinet) should be allocated for storing detergents and disinfectants, inventory and materials used for cleaning premises and processing equipment.

3.17. The total area of administrative and amenity premises of pharmacy organizations depends on the number of personnel and is calculated in accordance with applicable rules and regulations.

3.18. In the dressing room, outerwear and shoes should be stored separately from sanitary clothes and shoes.

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

All devices, apparatus used in a pharmacy organization must have technical passports, which are preserved during the entire period of operation. It is necessary to regularly check the instruments, devices used in the pharmacy organization, in accordance with the requirements of regulatory documents;

Premises for storing medicines and other goods permitted for dispensing from pharmacy organizations 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 the doors. The readings of these devices must be recorded daily in a special journal (card), which is kept by the responsible person for a year and stored for a year, not counting the past. Control devices must be certified, calibrated and verified in accordance with the established procedure;

Cabinets for storing outer and sanitary clothes, shoes in the dressing room;

Detergents and disinfectants, household tools used for cleaning premises and processing equipment.

All equipment and external decoration of premises in pharmacy organizations must meet sanitary and hygienic, fire safety and health and safety requirements.

3.20. Racks and cabinets for storing medicines and other goods approved for dispensing from pharmacy organizations in material rooms should be installed as follows:

The distance to the outer walls is at least 0.6-0.7 m;

The distance to the ceiling is not less than 0.5 m;

Distance from the floor not less than 0.25 m;

Aisles between racks are not less than 0.75 m;

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

IV. Requirements for the organization of acceptance of medicinal products in pharmacy organizations

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

For medicinal products (medicinal products) in damaged packaging that do not have certificates and / or the necessary accompanying documentation, rejected during acceptance or dispensing to the patient, not corresponding to the order or with an 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 destroyed in accordance with the established procedure.

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

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

5.1. Pharmacy organizations should take measures to prevent damage (spillage, scattering, breakage), to prevent contamination of medicines (medicines).

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

By toxicological and pharmacological groups;

By the method of application;

In alphabet order;

In accordance with the positions of computer accounting.

The accepted method of storing medicinal products (medicines) must be stipulated in the order for the pharmacy organization and communicated to the personnel of the pharmacy organization.

5.3. A pharmacy organization must keep records of medicines (medicines) 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.

5.4. Medicinal products (medicines) should be stored separately, taking into account their physical and physicochemical properties, the impact on them of various environmental factors in accordance with the established requirements * (4).

5.5. The storage of narcotic drugs and psychotropic substances, potent and poisonous substances should be carried out in accordance with the current regulatory requirements * (5).

5.6. Special requirements are imposed on the storage of medicinal products (medicinal products) of lists "A" and "B", in particular:

The inscriptions on the bars in which the drugs of the "A" list are stored must be white on a black background, and on the bars containing the drugs - in red on a white background; in both cases, the highest single and daily doses should be indicated on the bars;

During working hours, the keys to the metal cabinet with drugs (drugs) of the "A" list, located in the assistant's room, must be kept by an authorized employee of the pharmacy organization. After the end of the working day, the cabinets are sealed or sealed, and the keys to them, the seal and the sealant must be kept by the head of the pharmacy organization or by persons authorized by the order of the pharmacy organization;

Wooden cabinets for storing medicines (drugs) of the "B" list after the end of the working day should be locked;

Reagents containing medicinal products and, and which are during work on the table of a pharmacist-analyst or a pharmacist-technologist, after the end of work should be stored in a cabinet under lock and key;

The list of medicinal products (medicinal products) referred to lists "A" and "B" is determined in accordance with the current regulatory documents.

Vi. Requirements for the dispensing (sale) of medicinal products in pharmacies

Information about changes:

6.4. Dispensing of medicinal products with special conditions of sale (narcotic drugs, psychotropic substances, ethyl alcohol and others) is carried out in compliance with the requirements of the current regulatory documents * (6) and these Rules.

6.5. Dispensing (sale) of medicinal products under free and preferential prescriptions is carried out from pharmacy organizations, on the basis of an agreement with organizations that finance preferential dispensing of medicinal products to the population.

6.6. Benefits in servicing certain groups of the population are provided in accordance with the legislative and regulatory acts of the Russian Federation, as well as on the basis of decisions of state authorities of the constituent entities of the Russian Federation.

6.7. Medicines sold from pharmacy organizations must have information in accordance with the state information standard of the medicinal product.

Medicines are placed separately on display cases: medicines for internal use and medicines for external use. Within the groups, drugs are arranged according to the pharmacotherapeutic principle.

6.13. Information about the services provided by the pharmacy organizations, as well as the drugs sold and other goods allowed for dispensing from the pharmacy organizations should be carried out in accordance with the requirements of the current legislation.

6.14. Cash registers of a pharmacy organization must be registered with the tax authorities at the location of the pharmacy organization in accordance with the established procedure.

At the same time, the buyer, to whom the goods of inadequate quality have been sold, have the right, at their choice, to demand the free elimination of defects in the goods or reimbursement of the costs of correcting them by the consumer or a third party, a commensurate reduction in the purchase price, replacement with a product of a similar brand (model, article), replacement with the same goods of another brand (model, article) with the appropriate recalculation of the purchase price, termination of the purchase and sale agreement in the manner determined by the legislative and regulatory legal acts of the Russian Federation * (8).

Vii. Accounting and reporting in pharmacy organizations

7.1. Pharmacy organizations maintain operational and accounting records of inventories in accordance with established forms in accordance with the current legislation of the Russian Federation.

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7.3. Subject-quantitative accounting is subject to narcotic drugs, psychotropic substances, ethyl alcohol and other drugs in accordance with the current regulatory documentation * (9).

7.4. The procedure for the formation of retail prices for medicines (medicines) for a pharmacy organization, regardless of the organizational and legal form and forms of ownership, is established in accordance with the requirements of regulatory legal acts approved by the Government of the Russian Federation and the executive authorities of the constituent entities of the Russian Federation * (10).

VIII. Requirements for the personnel of pharmacy organizations

8.1. Pharmaceutical positions in pharmacy organizations are held by specialists - pharmacists or pharmacists in accordance with the established procedure.

8.4. Pharmacy specialists must improve their qualifications in accordance with current requirements.

8.5. Pharmacy staff must follow the rules of personal hygiene, including the use of special clothing.

8.6. In order to ensure sanitary requirements, employees of pharmacy organizations must undergo a medical examination in the prescribed manner.

8.7. Persons with signs of illness, open wounds are not allowed to work, as long as their state of health may cause the risk of contamination of goods sold in a pharmacy organization.

8.8. Smoking, eating, storing personal medicines, food, drinks, tobacco products is not allowed in production facilities, as well as at workplaces in the trading floor.

8.9. In their production activities, employees of pharmacy organizations are guided by the current documents in the field of pharmaceutical activities, internal labor regulations, safety requirements and this OST.

IX. Quality assurance of medicines (medicines) in pharmacy organizations

9.1. The pharmacy organization should have a quality management system for the pharmacy organization.

9.3. The pharmacy organization must regularly conduct internal checks for compliance with the requirements of this OST.

9.4. Inspections can be carried out both by employees of the pharmacy organization, independent of the persons directly carrying out the activity being inspected, and by independent experts.

9.5. The frequency of checks is determined by the pharmacy organization itself.

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

9.7. During subsequent checks, the implementation of the recommendations and their effectiveness are monitored.

9.8. Each employee of a pharmacy organization must be familiar with this OST, the procedure for performing the duties assigned to him, regulatory legal acts and standards related to the activities of the organization. Pharmacy organizations must have job descriptions for each employee, approved in the appropriate order.

Pharmacy organizations should provide for a system of continuous professional development of employees on the current legislation, the use of medicines, etc. The plan and topics of classes are approved by the head of the pharmacy organization.

9.9. The head of the pharmacy organization appoints a quality representative from the management personnel.

9.10. The pharmacy organization ensures the maintenance of documentation in accordance with the legislative and regulatory legal acts of the Russian Federation.

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Industry standards approved by the Ministry of Health. Legislative framework of the Russian Federation

Application. Appendix to the industry standard "Rules for the dispensing (sale) of medicinal products in pharmacy organizations. Basic provisions"

Industry standard OST 91500.05.0007-2003 Rules for dispensing (selling) medicinal products in pharmacy organizations. Basic Provisions (approved by order of the Ministry of Health of the Russian Federation of March 4, 2003 N 80)

With changes and additions from:

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Industry standard OST 91500.05.0007-2003
Rules for dispensing (selling) medicinal products in pharmacy organizations. Basic Provisions
(approved by order of the Ministry of Health of the Russian Federation of March 4, 2003 N 80)