The procedure for the destruction of expired medicinal products. Disposal of expired medicines

The activities of some organizations, such as pharmacies, clinics, private medical offices etc., associated with the use and implementation medicines(LS). Like any product, they must be sold or used on time, the manufacturer indicates a valid expiration date for this. However, situations are inevitable in which part of the drugs will remain on the shelves or in the warehouse after this period has expired. How to act correctly in such cases, how to write them off and what to do with expired drugs later, we understand in this article.

Expired means poor quality.

The number on the package medicines, indicating the end date for its application, is very important. Even if, in fact, nothing happens to the contents of the vial or box in the extra few days after the specified date, it is no longer possible to sell or take such medicines.

Art. 59 of the Law "On the Circulation of Medicines" equates drugs with an expired shelf life to substandard ones, removing them from the pharmacopeia regulations. In Art. 31 of Federal Law No. 86-FZ of July 22, 1998, their sale is directly and categorically prohibited.

From the designated date, they cease to be medicines, but are considered to be recyclable goods that have lost their consumer properties. How to deal with them further is stated in the Instruction approved by the Order of the Ministry of Health of Russia No. 382 of December 15, 2002. It is valid for the following medicines:

• whose expiration date has expired;
• which for any reason have become unusable;
• falsifications;
• counterfeit medicinal products;
• fakes officially registered in the Russian Federation medicinal trademarks.

The regulation on the destruction of such drugs is approved by the legislation of the Russian Federation:

• in Decree of the Government of the Russian Federation of September 03, 2010 No. 674 - for most medications;
• in the Order of the Ministry of Health of the Russian Federation of November 12, 1997 No. 330 - if the drugs are psychotropic or narcotic drugs.

Responsibilities of Owners of Substandard Medicinal Products

Those legal entities or individual entrepreneurs who own or manage medicinal products, in accordance with paragraph 2 of the above Instruction, must perform the following operations with them without fail:

1. Timely conduct an inventory and identify drugs that lose their consumer qualities or do not meet them initially.
2. Immediately withdraw such drugs from circulation and formalize this in accordance with the established documentary procedure.
3. Send the withdrawn medicines for disposal in full to special enterprises licensed for their destruction.
4. Be present in person or send your representative to the procedure for the destruction of drugs (as part of a specially created commission).

NOTE! Disposal of expired drugs can be initiated not only by the goodwill of the owner, but also by instructions from regulatory authorities or a court decision.

How to write off medicines correctly

The procedure for write-off and subsequent disposal of medicinal products is associated with a fairly extensive documentary support. The main paper is the Write-off Act, which will become the basis for the transfer of spoiled or expired medicines for destruction. The process of identifying and writing off such medicines involves several important steps:

1. Inventory:
   • identification and fixation of substandard drugs;
   • entering information into inventory sheets (with signatures of members of the inventory commission and persons with financial responsibility);
   • reflection of these data in the accounting documentation.

The following forms can be used to record data on damage to drugs:

• No. TORG-15 and No. TORG-16, approved by the Decree of the State Statistics Committee of Russia No. 132 of December 25, 1998 "On approval of unified forms of primary accounting documentation for accounting for trade operations";
• forms from the Guidelines for practitioners and researchers, approved by the Order of the Ministry of Health of Russia No. 98/124 dated May 14, 1998.

IMPORTANT! The write-off act is the main document for the disposal of spoiled or expired medicines. On its basis, they are transferred to special organizations for destruction.

Lawful destruction of medicines

Medications that have become substandard cannot simply be thrown into the trash. They must be handed over for legally regulated destruction to special firms that have permission to do so.

Financial accounting for the disposal of medicines

The owner concludes a service agreement with such an organization - it will serve as a document confirming the costs.

ATTENTION! Disposal costs depend not only on the company's tariffs, but also on the specifics of the disposal of certain drugs: for example, tablets are much easier to destroy than aerosol drugs, hence the higher cost of disposal of the latter. The cost of destruction also affects the packaging of medicines, their weight, volume.

After direct destruction, the contractor issues an invoice for services to the customer, after which an Acceptance Certificate for the work performed is issued (it is usually standard).

The Tax Code prescribes that these expenses be taken into account when calculating income tax (clause 1, article 264 of the Tax Code of the Russian Federation).

Is it possible to destroy medicines yourself

The law allows self-disposal of medicinal products by their owners, subject to the following conditions:

• the owner is not a drug manufacturer;
• the batch to be disposed of is small in volume.

Most often this situation occurs in pharmacies.

It is necessary to dispose of medicinal products in the order established by the Instruction, determined for each type of destroyed medicinal products:

• liquid medicines must be strongly diluted with water (not less than 1:100) and poured into sewers;
• tablets that dissolve in water must be ground into powder, which is also dissolved in water and poured;
• ointments and insoluble dosage forms must be burned;
• fragments of ampoules, boxes, convoys, vials, etc. are disposed of as household waste (thrown away)

NOTE! If the substances to be destroyed are explosive or flammable, their self-disposal is prohibited.

Destruction act

After disposal, members of the commission fill out a special act. It should include the following information:

• date of disposal;
• the place where it happened;
• data of all members of the destruction commission (name, position, place of work);
• reasons why drugs are sent for disposal;
• a list of destroyed medicines (name, number of units, features of packaging, containers);
• the name of the owner of the assets being disposed of (company or individual entrepreneur) and his data;
• rationale for the method of disposal (for each medicine from the list).

ATTENTION! The act of destruction must be signed by all members of the commission and affixed with the seal of the liquidation enterprise.

After drawing up, within 5 days, this document or its certified copy is sent to the Federal Service for Surveillance in Healthcare and social development.

What threatens negligent drug owners

If in the arsenal of an organization or an individual entrepreneur, medicines that have lost their condition are not disposed of on time, for unscrupulous owners of Art. 14.1 of the Code of Administrative Offenses of the Russian Federation provides for serious liability:

• for an organization - a fine in the amount of 40,000 to 50,000 rubles;
• it is possible to suspend core activities for up to 3 months;
• for official caught in the sale of medicinal "delay" - a fine of 4,000 to 5,000 rubles.

The "bonus" will be the loss of the institution's reputation and, as a result, a drop in demand and respect from customers.

EXPIRED MEDICINES AND PHARMACEUTICAL WASTE ARE CLASS G MEDICAL WASTE IN ACCORDANCE WITH SanPiN 2.1.7.2790-10, these wastes include:

• Expired medicines, waste from medicines and diagnostics
• Medicines that have lost their consumer properties
• Waste of pharmaceutical products, their production and preparation
• Cytostatics

Class G medical waste

Class G includes toxicologically hazardous waste (classes 1-4) - these are:

• mercury-containing devices, objects and equipment;
• waste of raw materials and products of pharmaceutical industries;
• expired medicines, as well as disinfectants and diagnostics that are not to be used;
• waste from the operation of vehicles, equipment, lighting systems, etc.

Collection and disposal of drugs of group D is carried out taking into account the degree of toxicity of each type of waste, according to guidelines to determine the level of toxicity, the classifier and other applicable regulatory documents.

The removal of group G waste for disposal or neutralization must be carried out by organizations that have the appropriate licenses. negligent attitude in this issue unacceptable. The infection rate of medical waste is thousands of times higher than that of ordinary household waste. Improper disposal of medicines and other products medical activities leads to the spread of pathogenic viruses, highly toxic compounds, and radioactive substances. Soil, nearby water bodies, air are exposed to infection, which adversely affects the health of each of us.

Payment

We work only with legal entities by bank transfer.
Minimum cost 6000

Legal practices

All waste is neutralized without harming the environment.

We provide environmental documents

Upon completion of work, we provide environmental acts

We work in Moscow and the Central Federal District

Order of interaction

Disposal of expired medicines (not to be used) by the specialists of our company involves the following scheme of actions:

1. Collection of information on the composition and amount of recycled waste, conditions and place of their storage.
2. Analysis of the collected data to determine the best methods of transportation, disposal and processing.
3. Compilation of a complete list necessary work, determination of the cost of services.
4. Signing a contract for the disposal of medicines.
5. Collection and transportation of medicines - according to the schedule or application. Instead of unusable waste containers, we leave new ones.
6. Drawing up an act of acceptance and delivery of waste indicating the necessary information.
7. Issuance of a coupon or act of disposal upon completion of all work.

Disposal methods

Disposal of medicinal products is carried out using various methods among which the most common are:

• Chemical disinfection. It is carried out with the use of chlorine-containing substances. Often combined with grinding, dissolving and other mechanical processes - to ensure complete penetration of chemicals.
• Steam sterilization in autoclaves at temperatures above 100 degrees Celsius, under high pressure.
• Incineration using incinerators. In this case, sorting before disposal of substandard medicines is not mandatory - all waste is completely destroyed.
• Processing using microwaves.

What to do with medicines that have become unusable? Most people just throw expired pills in the trash. But medicines are chemical compounds that can harm the natural balance of the natural environment. Therefore, handling them requires compliance with certain rules.

The procedure for getting rid of unnecessary medicines is regulated by SANPiN - “Sanitary rules and norms”. This regulatory document in the instructions "Sanitary and epidemiological requirements for the treatment of medical waste" establishes their classification from 5 groups, from "A" to "D".

Additional Information! In the current classification of waste from medical institutions, the corresponding letter indicates the degree of danger of "garbage" for humans and the natural environment:

• - do not actually pose a danger;
• - dangerous, possibly infected;
• - carriers serious illnesses;
• - toxic;
• "D" - containing radioactive components.

The toxic waste materials of group "G" include:

• medicines, diagnostic and disinfection means, the use of which is no longer possible;
• waste from industries and pharmaceutical enterprises (laboratories, factories, pharmacies, etc.).

These are the majority of tablets, ointments, gels, syrups, solutions and emulsions that can no longer be used for their intended purpose. When getting rid of them, you must be guided by the rules for waste group "G".

However, there are exceptions to be considered. For example, drug ampoules should be disposed of depending on their contents. So there is a separately developed regulation - "Procedure for the destruction of unusable vaccines and toxoids." He explains that inactivated vaccines are Class A, meaning non-hazardous waste. But “live” vaccines are already class “B”, and they must be decontaminated before being destroyed.

In general, medicines should be discarded if they have:

• the expiration date has expired: the dates of release of the product and the expiration date of the possible use are indicated on the packaging without fail;
• the recommended storage regime was significantly violated: a number of drugs can be stored only with strict observance of the “cold chain”, some solutions must be used immediately after opening the ampoule, and unnecessary residues should be discarded, etc.;

• the packaging is damaged: if the integrity of the paper or plastic shell is broken, then those pills that are “in the public domain” cannot be used, as they could become contaminated, change their properties under the influence of air, etc .;
• on the packaging, the labeling, data on the name and permissible periods of use of the product are erased or unclear;
• the appearance of the medicine does not match the description in the instructions: the tablets or ointment have changed color and consistency, a precipitate or flakes have appeared at the bottom of the emulsion bottle, the possibility of which is not indicated by the manufacturer, etc.

Note! Many medicines are classified as hazardous toxic waste. This means that when they get into the natural environment, they will destroy the soil, poison the water, can cause the death of plants, animals and birds, and as a result, harm the health of people. Therefore, they cannot simply be thrown away with ordinary garbage or flushed down the drain.

How drugs are disposed of

AT medical institutions and in the pharmaceutical industry, medicines are disposed of together with other waste, in accordance with applicable laws and regulations.

Equipment for the disposal of expired medicines today is already in many medical institutions (HCIs). This allows you to get rid of most of the waste in the health facility on your own.

However, not all institutions can solve such a problem without outside help. For example, there are constantly working first-aid posts in every preschool educational institution (DOE). But kindergartens do not provide for the use of equipment for the disposal of medicines.

In this case, it is necessary to conclude an agreement with a company that provides services for the disposal of expired medicines. Then in the preschool educational institution it will only be necessary to collect them in special containers, and specialists will carry out the removal, disinfection, destruction of pharmaceutical waste or their shipment for disposal at the landfill. Upon completion of work, the customer must be provided with an act on the disposal of medicines.

Businesses offering medical waste disposal services must be licensed.

How to properly dispose of medications at home

Unfortunately, in Russia today there is no practice of taking obsolete medicines among the population. So if you are worried about possible harm from the medicines you throw away in a regular trash can, you can use the following simple tips:

1. Carefully read the instructions for the drug, perhaps the manufacturer has indicated how it can be thrown away.
2. Do not pour or dispose of residues down the drain unless directed to do so by the instructions for use.
3. Remove the paper or plastic shells from the tablets and mix them with inedible waste. This must be done so that the chemical does not get into the food of an animal or person. A good solution would be to use a resealable jar or a tight box for disposal, in which the preparations can be poured with sand or earth. Tear up pill packs as finely as possible. In the absence of a solid container, put the garbage in a bag and tie it tightly.
4. Remove dangerous trash from your home immediately so that it does not become “prey” for curious children and pets.

Important! Remember to regularly review your first aid kit. It is necessary to get rid of all expired medicines in time, as well as those that were stored incorrectly. Remember that the use of a pill that has become unusable will not only not solve your problem, but can also cause additional harm to health.

Myths about home drug disposal

There are widespread misconceptions about the safest way to get rid of pharmaceutical "garbage" at home.

For example, it is not uncommon to come across advice to crush the pills and tablets themselves before throwing them away in order to prevent their reuse by the people who found them. But in reality, it is dangerous to do this, since you yourself can undergo a serious “chemical” attack from careless inhalation of the resulting powder, getting it on your skin or eyes.

The advice to mix discarded pharmaceuticals with loose products in order to visually “hide” it from prying eyes. In this case, the possibility of getting it into someone's food only increases, since both people and animals picking up food in garbage cans are by no means squeamish.

Take back program

In some countries, a community drug program is already in place. Its name, "Take back", is translated from English as "take back".

Unsuitable drugs can be handed over to special collection points located in pharmacies or medical institutions. A similar experience is successfully practiced in Canada and the EU countries.

The pharmacist tells how to properly dispose of expired medicines in the next video.

Today, the practice of drug disposal in Russia still leaves much to be desired. Not only ordinary citizens, for lack of an affordable alternative, continue to throw all kinds of pills into ordinary garbage. Unfortunately, there are frequent violations of the rules for disposal of medical waste among medical institutions and pharmaceutical companies. As a result, a huge amount of dangerous medicines in our country still ends up in ordinary open landfills.

What normative documents regulated the destruction of medicines, the placement of medicines in a quarantine zone? What is the algorithm of actions? In what cases does the pharmacy have to destroy the medicines itself, and in what cases can they return them to the supplier? How can the destruction costs of the pharmacy be minimized? In what form should acts for destruction and placement in a quarantine zone be drawn up? How can you force an organization that destroys medicines to draw up an act and provide it to a pharmacy?

Please pay attention to the date of the answer - the situation may have changed.

Substandard medicines are destroyed in accordance with the "Rules for the destruction of substandard medicines, falsified medicines and counterfeit medicines", approved by Decree of the Government of the Russian Federation of September 3, 2010 No. 674 (as amended on September 4, 2012).
The concept of a dedicated quarantine zone for organizations operating in the field of circulation of medicines is not clearly defined by the current legislation.
In accordance with paragraph 12 approved by the Order of the Ministry of Health and Social Development of the Russian Federation dated August 23, 2010 No. 706n "Rules for the storage of medicines" (as amended on December 28, 2010), when medicines with an expired shelf life are identified, they must be stored separately from other groups of medicines. funds in a specially allocated and designated (quarantine) zone.
According to clause 4.2 of the Industry Standard “Rules for the Dispensing (Sale) of Medicinal Products in Pharmacy Organizations. Basic Provisions”, approved by the Order of the Ministry of Health of the Russian Federation of 04.03.2003 No. 80 (as amended on 18.04.2007), for medicinal products (drugs) in damaged packaging, without certificates and / or necessary accompanying documentation, rejected when accepting or dispensing to a patient that does not correspond to the order or expired, an act is drawn up. Such medicines must be appropriately labeled and placed in a designated area separate from other medicines until they are identified, returned to the supplier, or disposed of in the prescribed manner.
Requirements for the form and content of the act are not established by the Standard.
Thus, an act on the identification of medicinal products to be placed in a quarantine zone, and on their movement to and from the quarantine zone can be drawn up in any form.
In accordance with paragraph 2 of the "Rules for the destruction of substandard medicines, counterfeit medicines and counterfeit medicines", substandard medicines and (or) counterfeit medicines are subject to seizure and destruction by decision of the owner of these medicines, by decision of the Federal Service for Surveillance in Healthcare and social development or court decision.
According to paragraph 4 of these Rules, the owner of substandard medicines and (or) counterfeit medicines, within a period not exceeding 30 days from the date of the decision by the Federal Service for Supervision in Health and Social Development of the decision to withdraw, destroy and export them, is obliged to execute this decision or express your disagreement with it.
The current civil legislation of the Russian Federation does not define the concept of "owner", however, according to the civil law norms, the owner of the goods is the person who owns them on any legal grounds, in particular, the owner of the goods is its owner, if he has not transferred ownership rights to another person, for example , did not transfer the goods for commission or the item for rent.
Thus, according to the above Rules, the destruction of substandard medicines must be ensured by their owner, i.e. in this case, a pharmacy organization.
At the same time, in accordance with the norms of Articles 475-477 of the Civil Code of the Russian Federation, the seller (pharmacy) has the right to make claims to the supplier (manufacturer) demanding reimbursement of expenses incurred and losses if he proves that the goods delivered to him were of poor quality at the time of delivery or that damage to the goods occurred due to the fault of the supplier, for example, due to violations of the conditions of transportation, etc.
According to paragraph 8 of the Rules, the destruction of medicines is carried out by an organization licensed to collect, use, neutralize, transport and dispose of waste of hazard class I-IV.
In accordance with paragraph 11 of these Rules, the organization that destroys medicines draws up an act on the destruction of medicines, which indicates:
a) date and place of destruction of medicines;
b) last name, first name, patronymic of the persons involved in the destruction of medicines, their place of work and position;
c) justification for the destruction of medicines;
d) information about destroyed medicinal products (name, dosage form, dosage, units of measure, series) and their quantity, as well as container or packaging;
e) name of the drug manufacturer;
f) information about the owner of medicines;
g) method of destruction of medicines.
The act of destruction of medicines is drawn up on the day of destruction of substandard medicines and (or) counterfeit medicines. The number of copies of this act is determined by the number of parties involved in the destruction of these medicinal products, signed by all persons involved in the destruction of these medicinal products, and certified by the seal of the organization that destroys the medicinal products (paragraph 12 of the Rules).
As can be seen from the norms of legislation listed above, the need to draw up an act has been legally established, but a strict form of an act on the destruction of medicines has not been established, and a clear composition of persons involved in the destruction of medicines has not been established.
Thus, the form of the act can be arbitrary, provided that it reflects all the positions specified in paragraph 11 of the Rules.
An appropriate commission may be created by the destruction organization for the destruction of medicines. At the same time, as follows from paragraph 13 of the Rules, participation in the process of destruction of medicines by their owner is not mandatory. In this case, the certificate of destruction of medicines or its copy, certified in accordance with the established procedure, shall be sent to the owner of the destroyed medicines within 5 working days from the date of its preparation.
When concluding a contract for the destruction of medicines, you can additionally specify a list of documents that close the contract.

The procedure for the destruction of drugs in cases established by law is determined by the “Instruction on the procedure for the destruction of medicines that have become unusable, medicines with an expired shelf life and medicines that are counterfeits or illegal copies registered in Russian Federation medicines”, approved by order of the Ministry of Health of Russia dated December 15, 2002 No. 382.

In accordance with the instructions, drugs are subject to withdrawal from circulation and destruction in full:

fallen into disrepair;

expired;

which are fakes or illegal copies of drugs registered in the Russian Federation, discovered and confiscated, including by customs authorities when imported into the Russian Federation.

The destruction of medicinal products is carried out in compliance with the mandatory requirements for the protection environment. For the destruction of drugs, a special commission is created by the executive authority of the subject of the Federation. Drugs are destroyed in the presence of the owner or owner of drugs. Medicines confiscated by the customs authorities are destroyed only by licensed enterprises at specially equipped sites and landfills.

Liquid dosage forms (solutions for injection in ampoules, in bags and vials, in aerosol cans, medicines, drops, etc.) are destroyed by crushing (ampoules) followed by dilution of the contents of ampoules, bags and vials with water in a ratio of 1: 100 and draining the resulting solution into an industrial sewer (holes are pre-made in aerosol cans).

The remains of ampoules, aerosol cans, bags and vials are taken out in the usual manner as industrial or household waste.

Solid dosage forms (powders, tablets, capsules, etc.) containing water-soluble drug substances, after crushing to a powdery state, are diluted with water in a ratio of 1: 100. The resulting suspension (or solution) is drained into an industrial sewer.

Solid dosage forms (powders, tablets, capsules, etc.) containing drug substances that are insoluble in water, soft dosage forms (ointments, suppositories, etc.), transdermal forms of drugs, as well as pharmaceutical substances are destroyed by incineration.

Flammable, explosive drugs, radiopharmaceuticals, as well as medicinal products with a high content of radionuclides are destroyed under special conditions using a special technology available to the destruction organization in accordance with the license.

When drugs are destroyed, an act is drawn up by the commission for the destruction of drugs. which indicates: date, place of destruction; place of work, position, surname, name, patronymic of the persons who took part in the destruction; grounds for destruction; name information (indicating dosage form, dosages, units of measurement, series) and the quantity of the destroyed drugs, as well as containers or packaging; name of the drug manufacturer; name of the owner or owner of the drug; way of destruction. Act on

quercetin, kaempferol, luteolin, etc.; steroidal saponins. found in flowers essential oil containing farnesol.

Standardization. The quality of raw materials is regulated by GF XT.

External signs.Grass: a mixture of whole, rarely broken leaves, inflorescences with peduncles, individual flowers and pieces of peduncles. The color of the leaves is green, less often brownish-green, the flowers are yellowish, the peduncles are light green. Leaves: individual or pairwise connected leaves with a long sheath, sometimes broken. flowers: a mixture of inflorescences with remnants of peduncles up to 20 cm long, flowers and sometimes pieces of peduncles. The smell is weak.

Chopped Herb: a mixture of pieces of leaves, peduncles, flowers passing through a sieve with a hole diameter of 7 mm; crushed leaves: pieces less than 7 mm.

Microscopy. In the microscopic examination of leaves and grass, inclusions of calcium oxalate in the form of thin raphids and large needle-like crystals (styloids) in the mesophyll, as well as “lying” palisade tissue, the cells of which are elongated across the width of the leaf (leaf preparation from the surface), have a diagnostic value.

Microscopic analysis of the perianth shows polygonal epidermal cells slightly elongated along the axis with straight thin walls and delicate cuticle folding. In the mesophyll of the perianth, thin raphids are visible. less common are large styloids.

Storage. Raw materials are stored with care. List B..

Usage. Lily of the valley preparations (tincture, Korglikon) are used as cardiotonic drugs.

Question 4. The prescription is written incorrectly. It must be issued on the form No. 148-1U-88, certified by a personal seal and the signature of a doctor, the seal of the medical institution "For prescriptions"

Doses are not too high.

Prescription validity period - 10 days Shelf life in a pharmacy - a year

For sodium barbital, NEO - 0.6 was established. Prescription-1.0. NEO are overpriced.

The method of application of drugs is indicated in Russian or Russian and national languages indicating the dose, frequency, time of administration and its duration, and for drugs that interact with food, the time of their use relative to food intake (before, during, after a meal).

Storage conditions in the pharmacy: Ready-made products are placed in the package with the label facing out. A rack card is attached to cabinets and shelves, which reflects the name of the medicine, series and expiration date. / //

The medicine is stored for 10 days at t not higher than 25C. 5">^ <■

■j Ticket 14. Bonpocl. ^ \u■^

I Glucose - glucose vKg^ Numerical indicators. Whole raw material. The amount of flavonoids determined by the spectrophotometric method, in terms of avicularin, is not less than 0.5%; (Methods see article GFH1 herb mountaineer bird)

Storage. Raw materials are stored on racks or pallets in a dry, well-ventilated area. Shelf life 3 years.

Usage. An infusion of herbs is used as a hemostatic agent in gynecological practice, it also has a diuretic effect, promotes the discharge of calculi in kidney stones and bladder. The grass is part of the collection of M. N. Zdrenko. Used in homeopathy.

Question 4. The prescription is written incorrectly. Patients with pituitary dwarfism can prescribe anabolic steroids and vitamins free of charge. Recipe, form - f No. 107 / U. certified by the personal seal and signature of the doctor. The prescription is valid for 2 months. The pharmacy does not store a prescription. The expiration date of the solution of glucose 10%-100 ml is 30 days in protection. away from light at T not higher than 25C, if corked “for running in”. Best before date- the period of time during which the quality of the finished drug is guaranteed to comply with the requirements of regulatory documentation. In addition, in accordance with the expiration date, the marking must contain an indication of the expiration date (OST 42-510 - 98).

Expiration dates

Depending on the limits of shelf life, products are divided into perishable (from 6 hours to 96 hours). short-term stored (from 12 hours to 30 days); long-term storage: with a limited shelf life (in the practice of pharmaceutical organizations, a limited shelf life is considered to be up to 2 years); without expiration date limitation (can keep consumer properties for several years without their loss).

set for IMN. During this period, the manufacturer guarantees the compliance of medical devices with the requirements of the standards, subject to the conditions of transportation, storage and operation. In other words, the duration of the use of goods in accordance with the purpose is guaranteed without a significant loss of consumer properties. The warranty period for their operation is three years from the date of sale through a retail pharmacy network, and in medical institutions - 18 months from the date of receipt by the consumer. Extending the expiration date is not allowed.

% expiration date.

When shipping the specified products from the warehouse to the retail network and healthcare facilities, the remaining shelf life must be at least 60%. and for bacterial preparations - at least 40% of the expiration date indicated on the label.

Medical products with a shelf life of more than two years can be shipped to the buyer if the remaining shelf life is at least 18 months. Delivery of products with a shorter shelf life can be made in agreement with the buyer, which is determined by the contractual terms.

Glucose belongs to "Monosaccharides. Monosaccharides, being substances with dual functions, enter into many reactions characteristic of alcohols and carbonyl compounds (aldehydes).

White crystalline powder, odorless, sweet taste. specific

rotation from +52 to +53° (10% aqueous solution), easily soluble in water.

Reaction to reducing sugars. Color reaction with 0.5% triphenyltetrazolium chloride solution in the presence of sodium hydroxide solution with heating. A red precipitate of triphenylformazan precipitates:

When a solution of copper sulfate is added and alkalized, glucose forms a violet-blue complex compound. This reaction simultaneously proves the presence of both hydroxyl and aldehyde groups, which reduce copper (II) to copper oxide (I) on standing. .

The presence of hydroxyl groups can also be proved by an acetylation reaction (formation of pentaacetates with a stable melting point occurs). R-tion on the aldehyde group 1. R-tion of the "silver mirror" Mv,tx ^o

R-tion of condensation with resorcinol.

an indicator of the quality of carbohydrates is the specific rotation of solutions, which characterizes their optical activity. To establish the specific rotation, glucose is preliminarily dried at 100–105 °C to constant weight.

Measurement of the angle of rotation of glucose is carried out using a polarimeter after preliminary addition of two drops of ammonia solution to the test solution. This speeds up the process mutarotation. It is associated with the establishment of equilibrium in the formation of two epigiers: 64% α-O(+)-glucose and 36% p-D(+)-glucose. This creates an average value of the specific rotation of the glucose solution, equal to +52.5° (FS allows 51.5-53.0°).

Under conditions of thermal sterilization of glucose solutions for injection, regardless of the presence of a stabilizer, degradation products are formed: deoxyhexazones, organic acids, formaldehyde, 5-hydroxymethylfurfural.

The quantitative determination of glucose can be performed by various methods.

CH 2 OH (CHOH) 4 C G "b + 3NaOH --> CH 2 OH (CHOH) 4 COONa + 2Nal + 2H 2 O

One of the titrimetric methods for the analysis of monosaccharides is based on the use of Fehling's reagent (2-3 fold excess). It is added to the weighed portion of an accurately measured amount, and then the remainder of the copper (II) cation not consumed for oxidation is determined iodometrically.

The technique is based on the reduction of copper (II) to copper (I) from the tartrate complex with carbohydrates:

An excess of Fehling's reagent containing copper (II) ions is reduced with iodide in an acidic medium, and the released iodine is titrated with sodium thiosulfate:

2Cu 2+ + 5G \u003d 2Cul + I 2

The polarimetric method for determining sugars is based on measuring the angle of rotation of polarized light. Angle of rotation a (in degrees) measured on a polarimeter and specific rotation [a] about are interconnected by the equation: [a]o \u003d 100 a /1*s. Knowing the specific rotation, the length of the tube I and measuring the angle of rotation, we can calculate the mass fraction With(%) according to the formula:

R a* 100 [a] 2V/

The GLC method for the determination of glucose is used after it has been converted into volatile compounds (sorbitol acetates or glucosonic acid nitrile).

Store carbohydrate drugs in a well-closed container at room temperature. Glucose in aqueous solutions is oxidized during storage. The hygroscopicity of glucose should also be taken into account.

Glucose is used for various diseases of the heart, liver, shock, collapse as a source of easily digestible nutrition that improves the functions of various organs. The main pathways of D-glucose metabolism are glycolysis and aerobic oxidation to carbon dioxide, water and ATP. Assign glucose inside (0.5-1.0 g), intravenously up to 20-50 ml of a 40% solution, used in pharmaceutical practice as fillers in the preparation of tablets and powders.

Glucose solution 5, 10, 25 and 40% for injections.

Glucose powder used in technology injection solutions, is analyzed for transparency, color and pH of its solutions, the presence of chloride ions, sulfates, as well as calcium and barium ions. Heavy metals are allowed no more than 0.0005% (in the absence of arsenic).

A solution of glucose for injection is obtained taking into account the content of water of crystallization in it. Before making the solution, the water must be boiled in order to remove oxygen from the air. Purification of colored products of the "decomposition of glucose, pyrogenic substances and impurities of heavy metals (Fe, Cu), accelerating the process of glucose oxidation in solutions, is carried out with activated brightening carbon of grade "A". An important factor determining the stability of glucose in a solution is the pH of the medium. At pH \u003d 1.0-3.0, a heterocyclic aldehyde is formed - hydroxymethylfurfural, which causes staining

gas solution ijiwKUJbi eno they are not suitable for removing pyrogens, therefore, the efficiency of removing pyrogens cannot be explained only by a small pore diameter. It is recommended that the Seitz filter pore diameter not exceed 2.4 µm. The Seitz filter retains pyrogens from solution by 99.5%, even when they are present in significant amounts. The lower the concentration of lyrogenic substances in the solution, the better they are retained on the filter.

Treatment of the solution with activated carbon followed by filtration through a Seitz filter provides a more complete removal of pyrogenic substances.

To remove pyrogenic substances from amino acid solutions used for intravenous infusion, it is proposed to autoclave them at a temperature of 120 ° C for 2 hours in a nitrogen atmosphere.

A decrease in pyrogenic substances occurs during thermal sterilization for 20 minutes at 120 ° C, and at 140 ° C for 20 minutes their inactivation occurs. Complete destruction of pyrogenic substances is achieved by sterilization in an oven at T=200 C for 45 minutes or at 250°C for 30 minutes. At a temperature of 120 °C, pyrogenicity decreases during autoclaving by the following values: within 30 minutes by 25%, 1 hour - by 70%, 2 hours - by 95%, 4 hours - by 100%.

The physical methods for removing pyrogens from solutions include their destruction using ultrasound with a frequency of 2 MHz and an intensity of 2 W/cm 2 for 10 min. In this case, complete destruction of pyrogenic substances is achieved. At the same time, ultrasound at 800 MHz and an intensity of 1 7 5 W/cm 2 for 5-10 minutes slightly reduces the pyrogenicity of water. Under the action of ultrasound, the pH of water changes by ±0.75.

The period of use of water for injection is regulated by 24 hours from the moment of receipt, provided that it is stored under aseptic conditions. With longer storage, water absorbs carbon dioxide and oxygen from the air, can interact with the material of the container used, causing the transition of heavy metal ions, and is a breeding ground for microorganisms. Therefore, it is most preferable to use freshly prepared water, which is sometimes boiled for 30 minutes immediately after distillation.

More reliable storage is guaranteed by special systems made of inert material. The water in them is high temperature and in constant motion.

Stabilization of glucose solutions

Glucose solutions, according to the NTD, are stabilized with the Weibel reagent:

Acids HC1 dil. - 4.4 ml.

Water for injection - up to 1 l

Weibel stabilizer is added to glucose solutions in an amount of 5% by volume, regardless of its concentration.

The introduction of hydrochloric acid to glucose solutions prevents the oxidation of glucose in an alkaline medium. It should be noted that the theoretical issues of the process of glucose stabilization are complex and not yet sufficiently studied. It is currently believed that sodium chloride does not contribute to the cyclization of glucose, and in combination with hydrochloric acid creates a buffer system for glucose, which is unstable in acidic and neutral media.

Features of the manufacture of solutions of glucose in a pharmacy.

In the manufacture of solutions, glucose is taken in a larger amount than indicated in the recipe, taking into account the content of water of crystallization in the glucose molecule. Moisture content of glucose can be 9.8; ten; 10.2; 10.4%.

An additional requirement for the medicinal substance "Glucose for injections" is non-pyrogenicity. A portion of each batch of synthesized glucose in the form of a 5% solution must withstand the test for pyrogenity, a test dose of 10 ml per 1 kg of animal weight (article GF "Testing for pyrogenity").

Store glucose in a sterile, well-closed container.

In the manufacture of glucose solutions, a Weibel stabilizer is used. which contains sodium chloride and 0.1 M solution of hydrochloric acid.

Stabilizer Ingredients:

Sodium chloride (calcined) ............................................... 0.26 g

0.1 M solution of hydrochloric acid ............................... 5 ml / l

It is more convenient to use a freshly prepared, analyzed Weibel solution:

Sodium chloride (calcined) ............................................... 5.2 g

Hydrochloric acid solution (8.3%).................... 4.4 ml

Water for injections............................................... .................1 l

The stabilizer is added in an amount of 5% of the volume of the glucose solution, regardless of concentration. The shelf life of the stabilizer is 1 day.

Important reduce the oxygen content of the solvent by boiling water for injection beforehand.

Stabilized glucose solutions have a very acidic reaction (pH 3.0 - 4.0), so its 5% solution, used in gynecology for intrauterine injections, is made without a stabilizer.

Sodium chloride (Natrii chloridum) - white cubic crystals or white odorless crystalline powder, salty taste - soluble in three parts of water. A 0.9% solution has a pH of 5.0 - 7.0.

Additional requirements to the medicinal substance "Sodium chloride for injection": in order to destroy pyrogenic substances, the powder with a layer of no more than 6 -7 cm is heated at 180 ° C in open glass or porcelain containers in air sterilizers for 2 hours; sterile powder is used within 24 hours.

Hydrochloric acid (Acidum hydrochloricum). To make 1 liter of hydrochloric acid solution, it is necessary to take 4.4 ml of acid diluted (8.3%) with a density of 1.038 - 1.039 g / ml and water for injection to the appropriate volume. Usually, 5 ml of a 0.1 mol/l hydrochloric acid solution (pH 3.0-4.1) is added to 1 liter of the prepared glucose solution of various concentrations.

Herba Polygoni avicularis- grass knotweed (knotweed)

(Polygoni avicularis herba - mountaineer bird (knotweed) grass)

Highlander bird (knotweed) - Polygonum aviculare from the family buckwheat (Polydonaceae); used as a medicine.

Chemical composition. The grass of the highlander bird contains flavonoids (0.2-1%), the main ones are avicularin and quercitrin; tannins (1.8-4.8%); ascorbic acid; phenolic acids; about 1 silicic acid compounds.

R = L-arabinose - avicularin R = L-rhamnose - quercitrin quality reactions. Flavonoids are detected in a 70% alcohol extract by yellow-green staining with aluminum chloride. Numerical indicators.Whole raw material. The sums of flavonoids, determined by the spectrophotometric method, in terms of avicularin. not less than 0.5%; (Methods see article GFH1 herb mountaineer bird)

The whole process of quantitative determination of a in plant raw materials can be divided into three main stages:

1) extraction of flavonoids from raw materials;

2) purification of extracted flavonoids from associated substances

3) quantitative determination of isolated and purified flavonoids by the SPM method at 410 nm.

Storage. Raw materials are stored on racks or pallets in a dry, well-ventilated area. Shelf life 3 years.

Usage. An infusion of herbs is used as a hemostatic agent in gynecological practice, it also has a diuretic effect, promotes the discharge of stones in kidney and bladder stones. The grass is part of the collection of M. N. Zdrenko. Used in homeopathy.

Question 4. The prescription is correct. The prescription is valid for 1 month. The pharmacy keeps the prescription for 5 years. Shelf life of glucose solution 10%-100 ml 30 days in protection. away from light at T not higher than 25C, if sealed “for running in”. Best before date- the period of time during which the quality of the finished drug is guaranteed to comply with the requirements of regulatory documentation. In addition, in accordance with the expiration date, the marking must contain an indication of the expiration date (OST 42-510 - 98).

For most drugs and other goods pharmacy assortment established expiration dates and warranty periods. Expiration dates- these are the maximum allowable periods during which the goods have guaranteed safety.

Depending on the limits of shelf life, products are divided into perishable (from 6 hours to 96 hours), short-term stored (from 12 hours to 30 days); long-term storage: with a limited shelf life (in the practice of pharmaceutical organizations, a shelf life of up to 2 years is considered limited): without a shelf life limit (it can retain consumer properties for several years without losing them).

Warranty periods of storage and operation set for IMN. During this period, the manufacturer guarantees the compliance of medical devices with the requirements of the standards, subject to the conditions of transportation, storage and operation. In other words, the duration of the use of goods in accordance with the purpose is guaranteed without a significant loss of consumer properties. For example, the warranty period for ice packs is three and a half years from the date of manufacture. The warranty period for their operation is three years from the date of sale through a retail pharmacy network, and in medical institutions - 18 months from the date of receipt by the consumer. Extending the expiration date is not allowed.

Special delivery conditions define the remaining expiration dates, according to which drugs must be shipped by the manufacturer in such a way that at the time of their shipment, at least 80% of the expiration date indicated on the label remains, and for bacterial preparations, dental and polymeric materials - at least 50 % expiration date.

When shipping these products from a warehouse to a retail network and healthcare facilities, the remaining shelf life must be at least 60%, and for bacterial preparations - at least 40% of the shelf life indicated on the label.

Medical products with a shelf life of more than two years can be shipped to the buyer if the remaining shelf life is at least 18 months. Delivery of products with a shorter shelf life can be made in agreement with the buyer, which is determined by the contractual terms. yellow. Between pH = 3.0-5.0, all glucose decomposition reactions are somewhat slowed down. With an increase in pH (more than 5.0), the decomposition mechanism becomes even more complicated (breaking the glucose chain and the formation of organic acids). Based on this, a Weibel stabilizer is added to the solution, containing in its composition a 0.1 n solution of hydrochloric acid, which creates optimal pH values, and sodium chloride, which blocks highly reactive glucose groups.

The preparation of a glucose solution consists of the following operations

TP-5.1. Removal of oxygen from the air

TP-5.2. Dissolution of glucose

TP-5.3. Cleaning of colored decomposition products,

impurities of heavy metals and pyrogenic substances

TP-5.4. Pre-filtering

TP-5.5. Stabilization

TP-5.6. final filtration

TP-5.7. Standardization

For glucose in the GF, the requirement of non-pyrogenicity has been introduced. since glucose is good

nutrient medium for microorganisms. If drugs do not respond

requirements of the “for injection” variety, they are subjected to special cleaning from unacceptable

chemical and other impurities.

In the absence of an "injectable" grade of magnesium sulfate that does not contain compounds

manganese and iron, purification from these impurities is carried out with magnesium oxide when heated and

settling followed by their adsorption on activated carbon.

The process of glucose decomposition in solutions is accelerated by traces of heavy metals (iron and

copper). In order to clean the solution from heavy metals and colored decomposition products

glucose, it is pre-treated with activated charcoal and stabilized

hydrochloric acid to pH 3.0-4.0.

In the production of injection solutions, activated carbon grade A is used,

pre-treated with hydrochloric acid solution.

Activated carbon Activated carbon is obtained from the wood of some coniferous and deciduous species.

trees, by roasting and activating coal. The process of obtaining coal goes through two stages:

1. The starting material is heated at temperatures up to 500 °C without air access, and charring and sublimation of volatile substances occur.

2. The resulting raw coal is calcined in a stream of water vapor or carbon dioxide at a temperature of 850--960 ° C, while the remains of resinous substances burn out and the inner surface of the coal is released. It turns out coal, everything internal structure which is a huge number of cracks, empty pores, tubules and passages. Such carbon is called active or activated.

Depending on the purpose, active brightening powdered charcoal is produced in four grades:

OU-A - dry alkaline clarifying coal. Used to purify syrups in the sugar refinery industry, water and solutions in the production of organic acids, oils and fats, medical preparations;

OU-B - brightening coal wet sour. Used to clean medical preparations; solutions in starch-treacle industries and hydrolysis plants;

OU-V - dry alkaline clarifying coal. Designed for cleaning and clarifying various solutions in the food industry;

OU-G - dry alkaline clarifying coal. Used to purify liquids from high-molecular resinous and coloring impurities in organic synthesis.

Activated carbon treatment The remaining shelf life can be determined by the batch number.

Series- a certain amount of a homogeneous finished product, made for

When placing finished medicinal products on storage sites (racks, shelves, cabinets), the following requirements are imposed:

The drugs are stacked and installed in the original packaging with the label (marking) facing out;

a rack card is attached next to the drug, which indicates the name of the drug. series, expiration date, quantity. The map is printed on thick paper. It is started for each newly received series to control its timely implementation.