Rules for the destruction of expired medicines. Procedure for destroying expired medications. How to get rid of medications correctly
Ekaterina Filippova on how low-quality medicines are eliminated
Diagnosis - “illiquid”
“The concept of low-quality medicine is defined in 61-FZ “On the Circulation of Medicines.” According to the norms of Russian legislation, this includes falsified, counterfeit and low-quality drugs,” recalls RAAS Executive Director Nelly Ignatieva. “In pharmacies, acceptance control is mandatory; the basis for accepting a medicine is the presence of documents confirming the quality of the drug - this is a declaration of quality conformity,” continues Nelly. “If drugs are received of inadequate quality, the pharmacy will issue a refund.”
Our experts:
David Melik-Guseinov (Moscow),
Director of the non-profit partnership “Center for Social Economy”, member of the Coordination Council of the State Duma of the Russian Federation on issues of innovative development of the medical and pharmaceutical industry
Nelly Ignatieva (Moscow),
Executive Director of the Russian Association of Pharmacy Chains (RAAS), member of the Scientific Society of Pharmacists of Moscow, Ph.D. n.
Dmitry Parkhomenko (Moscow),
Deputy Head of the Federal Service for Surveillance in Healthcare
David Melik-Huseinov notes that those drugs that have lost their properties due to incorrect transportation, logistics, and storage (incorrect temperature, humidity, etc.) can be considered low-quality. “Identification of such drugs is extremely difficult: in the same series there may be both high-quality and low-quality drugs,” complains David Melik-Huseinov.
Medicines are classified as low-quality even if there was a defect at the manufacturing plant. “Here the situation is simpler,” the whole series echoes, says David Melik-Guseinov. - Roszdravnadzor usually receives such information from factories, but sometimes it independently encounters the fact of illiquid products. In this case, letters about the found defect are sent to all organizations that could receive these drugs.” Typically, notification occurs in a fan-based manner: Federal Roszdravnadzor sends a message to regional authorities, and they, in turn, send messages to those enterprises where defective drugs were supplied.
Search for the enemy
The Federal Service for Surveillance in Healthcare is engaged in the search for low-quality drugs. “In cases where Roszdravnadzor of the Russian Federation identifies drugs that do not meet quality standards, their sale in pharmacies is stopped, and the drugs themselves must be returned and disposed of,” says Nelly Ignatieva, executive director of the RAAS.
The organization and conduct of control activities are regulated by the provisions of the Federal Law of December 26, 2008 No. 294-FZ “On the protection of the rights of legal entities and individual entrepreneurs in the exercise of state control (supervision) and municipal control.” The control activities of Roszdravnadzor are accompanied by the selection of drug samples for further testing on the basis of the laboratory complexes of the Federal State Budgetary Institution “Information and Methodological Center for Expertise, Accounting and Analysis of the Circulation of Medical Products” of Roszdravnadzor.
Nelly Ignatieva
Executive Director of RAAS:
The figures for low-quality drugs in Russia are lower than in other countries, but some experts claim higher figures. I consider it appropriate to say that the lack of therapeutic effectiveness when taking medications is not always a consequence of their low quality. The result of the “work” of the drug is influenced, first of all, by its compliance with the causative agent of the disease, as well as by the correctness of taking and storing the medicine at home. Let me give you a classic example: simultaneous use of a contraceptive with a decoction of St. John's wort will not have the desired result. Antibacterial agents will not cure a viral infection, and vice versa, but will cause a mutation of the pathogen. The fact is that our citizens often prefer self-medication to visiting a doctor. And the failure of self-medication is then explained by the low quality of the drugs.
“Roszdravnadzor has created a system of state control of the quality of medicines,” reports Dmitry Parkhomenko. “It includes the central office, territorial bodies of Roszdravnadzor in the constituent entities of the Russian Federation, laboratory complexes for drug quality control, and the information system of Roszdravnadzor.”
Laboratory complexes have been created in each federal district where drug quality tests are carried out using pharmacopoeial methods. Mobile laboratories of Roszdravnadzor also operate for the express analysis of drugs: according to Dmitry Parkhomenko, they screen the quality of drugs using non-destructive spectral analysis methods and check the compliance of drugs with the requirements of regulatory documentation in terms of “description”, “packaging”, “labeling”.
Generalized information about activities for state quality control of drugs is posted on the official website of Roszdravnadzor www.roszdravnadzor.ru. In 2014, a search section appeared on the portal concerning information about drugs withdrawn from circulation. It is posted in the “Medicines” section in the “Drug Quality Control” section in the “Search for Drugs Withdrawn from Circulation” subsection or in the “Electronic Services” section of the website.
Can't be sold, can't be destroyed
“The disposal of drugs is carried out in accordance with sanitary standards, the standards for the destruction of substandard, falsified and counterfeit drugs are determined by the Government Decree (as amended by the Decree of the Government of the Russian Federation of September 4, 2012 No. 882),” says Nelly Ignatieva.
Disposal of expired, substandard, falsified and counterfeit medicines is carried out by an organization licensed to collect, use, neutralize, transport and dispose of waste of hazard classes I–IV, at specially equipped sites, landfills and in specially equipped premises in compliance with environmental protection requirements environment in accordance with the legislation of the Russian Federation.
“Of course, low-quality medicines cannot simply be thrown into a landfill, like expired food products, because they contain certain chemical components or even entire mixtures of them,” says David Melik-Huseinov. - Each drug has its own destruction procedures, depending on the composition and form of the drug. The main methods for disposing of expired or low-quality medicines can be identified, including incineration, burial and various technologies that neutralize chemicals.” Liquid preparations (potions, drops, injections in ampoules, etc.) are eliminated by significantly diluting the contents of bottles, ampoules and etc. Medicines are diluted with water in a ratio of 1:100, and the resulting “weak solution” is washed down the drain. Residues from ampoules and other “containers” are disposed of in a landfill as ordinary industrial waste. Solid medications (all kinds of tablets, powders, etc.) are disposed of depending on whether they are soluble in water. The order of the Ministry of Health of the Russian Federation dated December 15, 2002 No. 382 states: “Solid dosage forms containing water-soluble drug substances, after crushing to a powder state, must be diluted with water in a ratio of 1:100 and the resulting suspension (or solution) must be drained into an industrial sewer.”
Solid dosage forms that are insoluble in water, as well as soft dosage forms (ointments, suppositories, etc.) are burned. Explosive drugs and medicinal plant materials with a high content of radionuclides are destroyed using special technologies owned by licensed “liquidation organizations.”
Medicines and expired medicines, which contain narcotic and psychotropic substances, are disposed of in a special manner. The most difficult category to eliminate is drugs intended for cancer patients. While mildly toxic drugs can simply be rendered unmarketable or mixed with sand and taken to a household landfill, special landfills have been created for highly potent drugs.
However, no matter what the medicine is—highly toxic or relatively “harmless”—in case of violation of quality indicators, an act is drawn up according to which it is necessary to stop the circulation of this drug. The fact of its destruction must also be documented.
In the name of quality
Roszdravnadzor annually publishes on its website lists of unscrupulous pharmaceutical companies whose products cause numerous complaints. When compiling the blacklist, complaints from distributors, pharmacy organizations and data from scheduled inspections of Roszdravnadzor itself are taken into account. The main participants in the “hit parade” are small companies whose specialization is inexpensive and generic products. The production capacity of such companies leaves much to be desired, so there is no need to talk about the presence of modern quality control systems. Naturally, such enterprises do not use GMP standards.
Meanwhile, David Melik-Huseinov believes that the total introduction of GMP standards could largely solve the problem with low-quality products: “In my opinion, it is necessary to consistently apply GMP standards throughout the entire pharmaceutical chain - both for production and distribution, and for pharmacy retail. It is through such an integrated approach that real order can be established.”
Non-compliance of a drug with the stated standards (for example, the presence of foreign impurities in its composition) can make the drug not only useless, but also dangerous. If such indicators as the rate of dissolution, absorption, and disintegration are not met to the standard level, it is likely that the consumer will not experience a positive effect from the treatment.
A simple discrepancy between the actual weight of the tablet and what is indicated on the packaging can also devalue the therapy. Still, experts note some positive dynamics in the topic of low-quality drugs. “Over the past few years, there has been a trend towards a decrease in the circulation of drugs that pose a threat of harm to the life and health of citizens,” says Roszdravnadzor representative Dmitry Parkhomenko. - A significant factor influencing the improvement of drug quality is increased responsibility for the release of products that do not meet established requirements. On January 23, 2015, Federal Law No. 532-F3 of December 31, 2014 came into force, which introduced direct rules of administrative and criminal liability for the production, import and sale of substandard, falsified and unregistered drugs.”
In addition, Dmitry Parkhomenko emphasizes the importance of such innovation as selective control. Let us recall that this innovation was announced in December 2014, when Federal Law No. 429 “On Amendments to the Federal Law “On the Circulation of Medicines” was adopted. According to Dmitry Parkhomenko, the new type of state supervision will make it possible to introduce a more effective approach to testing the quality of drugs entering public circulation.
The activities of some organizations, for example, pharmacies, clinics, private medical offices, etc., are related to the use and sale of medicines. Like any product, they must be sold or used on time; the manufacturer indicates an acceptable expiration date for this. However, situations are inevitable in which some drugs will remain on the shelves or in the warehouse after this period has expired. How to act correctly in such cases, how to formalize their write-off and what to do with expired drugs later, we will understand in this article.
Expired means poor quality
The number on the packaging of medications indicating the end date for its use is very important. Even if in fact nothing happens to the contents of the bottle or box in the extra few days after the specified date, such medicines can no longer be sold or taken.
Art. 59 of the Law “On the Circulation of Medicines” equates drugs with an expired shelf life to poor quality, removing them from the regulations of the pharmacopoeia. 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 a product subject to disposal that has lost its consumer properties. How to proceed with them is stated in the Instructions approved by Order of the Russian Ministry of Health 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;
- counterfeits;
- counterfeit medicinal products;
- counterfeits of officially registered medicinal brands in the Russian Federation.
The regulations regarding the destruction of such drugs are approved by the legislation of the Russian Federation:
- in Decree of the Government of the Russian Federation of September 3, 2010 No. 674 - for most medications;
- in Order of the Ministry of Health of the Russian Federation of November 12, 1997 No. 330 - if the medications are classified as psychotropic drugs or narcotic drugs.
Responsibilities of owners of substandard medicines
Those legal entities or individual entrepreneurs who own or manage medicines, in accordance with paragraph 2 of the above-mentioned Instructions, must necessarily carry out the following operations with them:
- Conduct a timely inventory and identify medicines that are losing their consumer qualities or do not initially meet them.
- Immediately withdraw such drugs from circulation and document this in accordance with the established documentary procedure.
- Send seized drugs for disposal in full to special enterprises licensed to destroy them.
- Be present in person or send your representative to the drug destruction procedure (as part of a specially created commission).
NOTE! Disposal of expired drugs can be initiated not only by the good will of the owner, but also by instructions from regulatory authorities or a court decision.
How to write off medications correctly
The procedure for write-off and subsequent disposal of medicines is associated with fairly extensive documentary support. The main document is the Write-off Certificate, which will become the basis for transferring spoiled or expired medicines for destruction. The process of identifying and writing off such medicines involves several important steps:
- 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 this data in accounting documentation.
To record data on drug damage, the following forms can be used:
- No. TORG-15 and No. TORG-16, approved by Resolution of the State Statistics Committee of Russia No. 132 of December 25, 1998 “On approval of unified forms of primary accounting documentation for recording trade operations”;
- forms from the Methodological Recommendations for practical and scientific workers, approved by Order of the Ministry of Health of Russia No. 98/124 of May 14, 1998.
IMPORTANT! The write-off act is the main document when disposing of spoiled or expired medicines. On its basis, they are transferred to special organizations for destruction.
Lawful destruction of medicines
Medicines that have become of poor quality cannot simply be thrown into the trash. They must be handed over for legally regulated destruction to special companies that have permission to do so.
Financial accounting of drug disposal
The owner enters into a service agreement with such an organization - it will serve as a document confirming expenses.
ATTENTION! Disposal costs depend not only on the company’s tariffs, but also on the features of disposal of certain medications: for example, tablets are much easier to destroy than medications in aerosol form, hence the higher cost of disposal of the latter. The cost of destruction is also affected by the packaging of drugs, their weight, and volume.
After direct destruction, the executing company issues an invoice to the customer for services, after which an Acceptance Certificate for the work performed is issued (it is usually standard).
The Tax Code requires 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 the independent disposal of medicines by their owners, subject to the following conditions:
- the owner is not the manufacturer of the drug;
- The batch to be disposed of is small in volume.
Most often this situation occurs in pharmacies.
Medicines must be disposed of in the order established by the Instructions, defined for each type of medicine being destroyed:
- liquid medications must be diluted strongly with water (not less than 1:100) and poured into the sewer;
- tablets that dissolve in water must be ground into powder, which is also dissolved in water and poured out;
- ointments and insoluble dosage forms must be burned;
- fragments of ampoules, boxes, currency, bottles, etc. are disposed of as household waste (thrown away)
FOR YOUR INFORMATION! If the substances being destroyed are explosive or flammable, their independent disposal is prohibited.
Destruction Act
After disposal, members of the commission fill out a special act. It needs to reflect 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;
- list of medications to be destroyed (name, number of units, packaging features, containers);
- name of the owner of the assets being disposed of (company or individual entrepreneur) and his data;
- justification for the disposal method (for each drug on the list).
ATTENTION! The act of destruction must be signed by all members of the commission and sealed 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 the arsenal of an organization or individual entrepreneur does not dispose of out-of-standard medicines 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 an official convicted of selling overdue medications - a fine of 4,000 to 5,000 rubles.
A “bonus” will be the loss of the institution’s reputation and, as a result, a drop in demand and respect among clients.
In order to implement the Federal Law of June 22, 1998 No. 86-FZ “On Medicines” (Collected Legislation of the Russian Federation, 1998, No. 26, Art. 3006; 2000, No. 2, Art. 126; 2002, No. 1 (ch I), Art. 2) I order:
Approve the Instructions on the procedure for the destruction of medicinal products that have become unusable, expired medicinal products and medicinal products that are counterfeits or illegal copies of medicinal products registered in the Russian Federation (Appendix).
Yu. Shevchenko
Application
Approved
By order
Ministry of Health
Russian Federation
dated December 15, 2002 No. 382
INSTRUCTIONS
ABOUT THE PROCEDURE FOR DESTROYING MEDICINES,
OUT OF USEFUL MEDICINES
EXPIRED DRUGS AND MEDICINES,
THAT ARE FAKE OR ILLEGAL COPIES
REGISTERED IN THE RUSSIAN FEDERATION
MEDICINES
1. These Instructions have been developed in accordance with Federal Laws dated 06.22.98 No. 86-FZ “On Medicines”, dated 03.30.99 No. 52-FZ “On the Sanitary and Epidemiological Welfare of the Population” and determine the procedure for the destruction of medicines that have become unusable , expired medicines and medicines that are counterfeits or illegal copies of medicines registered in the Russian Federation.
2. Medicines that have become unusable and medicines that have expired are subject to withdrawal from circulation and subsequent destruction in full. The sale of these medicines is prohibited.
3. Medicines that are counterfeits or illegal copies of medicines registered in the Russian Federation, discovered and confiscated by the customs authorities of the Russian Federation when imported into the territory of the Russian Federation, are subject to destruction.
4. The medicines specified in paragraphs 2 and 3 of this Instruction are confiscated and withdrawn from circulation by the customs authorities of the Russian Federation, legal entities and individual entrepreneurs who are the owners or possessors of these medicines.
5. The transfer of medicines by the customs authorities of the Russian Federation, legal entities and individual entrepreneurs who are the owners or possessors of medicines to enterprises that have the appropriate license, and their subsequent destruction is carried out on a contractual basis.
6. The destruction of medicines is carried out in compliance with the mandatory requirements of regulatory documents on environmental protection and is carried out in the presence of the owner or possessor of the medicines to be destroyed.
(clause 6 as amended by Order of the Ministry of Health and Social Development of the Russian Federation dated 02/05/2010 No. 62n)
7. The destruction of medicines confiscated by the customs authorities of the Russian Federation is carried out by enterprises that have the appropriate license at specially equipped sites, training grounds and premises in accordance with the requirements stipulated by the legislation of the Russian Federation.
8. Features of the destruction of medicines:
Liquid dosage forms (injection solutions in ampoules, bags and bottles, aerosol cans, medicines, drops, etc.) are destroyed by crushing (ampoules) followed by diluting the contents of ampoules, bags and bottles 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 bottles are removed in the usual manner, as industrial or household waste;
Solid dosage forms (powders, tablets, capsules, etc.) containing water-soluble drug substances must, after crushing to a powder state, be diluted with water in a ratio of 1:100 and the resulting suspension (or solution) drained into an industrial sewer;
Solid dosage forms (powders, tablets, capsules, etc.) containing drug substances insoluble in water, soft dosage forms (ointments, suppositories, etc.), transdermal forms of drugs, as well as pharmaceutical substances are destroyed by burning;
Narcotic drugs and psychotropic substances included in lists II and III of the List of narcotic drugs, psychotropic substances and their precursors, the further use of which in medical practice is recognized as inappropriate, are destroyed in accordance with the legislation of the Russian Federation;
Flammable and explosive medicines, radiopharmaceuticals, as well as medicinal plant materials with a high content of radionuclides are destroyed under special conditions using special technology available to the destruction organization, in accordance with the license.
9. When destroying medicines, an act is drawn up, which indicates:
(as amended by Order of the Ministry of Health and Social Development of the Russian Federation dated 02/05/2010 No. 62n)
Date, place of destruction;
Place of work, position, last name, first name, patronymic of the persons who took part in the destruction;
Reason for destruction;
Information about the name (indicating the dosage form, dosage, unit of measurement, series) and quantity of the medicinal product being destroyed, as well as about the container or packaging;
Name of the manufacturer of the medicinal product;
Name of the owner or proprietor of the medicinal product;
Method of destruction.
The act of destruction of medicinal products is signed by the persons who took part in the destruction of medicinal products and is sealed with the seal of the organization that carried out the destruction of the medicinal product.
(as amended by Order of the Ministry of Health and Social Development of the Russian Federation dated 02/05/2010 No. 62n)
10. Responsibility for the destruction of medicines lies with the subjects of medicines circulation in accordance with the legislation of the Russian Federation.
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 from pharmaceutical products, their production and preparation
- Cytostatics
Medical waste class G-
Class D includes toxicologically hazardous waste (class 1-4) - these are:
- mercury-containing devices, items and equipment;
- waste of raw materials and products from pharmaceutical industries;
- expired medications, as well as disinfectants and diagnostic agents that cannot be used;
- waste from the operation of vehicles, equipment, lighting systems, etc.
Collection and disposal of medicinal products of group G is carried out taking into account the degree of toxicity of each type of waste, in accordance with methodological recommendations for determining the level of toxicity, classifier and other current regulatory documents.
Removal of Group G waste for disposal or neutralization must be carried out by organizations that have the appropriate licenses. Negligence in this matter is unacceptable. The infection rate of medical waste is thousands of times higher than that of ordinary household waste. Improper disposal of medicines and other medical products leads to the spread of pathogenic viruses, highly toxic compounds, and radioactive substances. The soil, nearby bodies of water, and air become infected, which has a detrimental effect on the health of each of us.
Payment
We work only with legal entities by bank transfer.
Minimum cost 6000
Legal methods of work
All waste is neutralized without harming the environment.
We provide environmental documents
Upon completion of work we provide environmental certificates
We work in Moscow and the Central Federal District
Order of interaction
Disposal of expired medications (which cannot be used) by our company’s specialists involves the following course of action:
- Collection of information on the composition and quantity of recycled waste, conditions and place of its storage.
- Analysis of collected data to determine optimal methods of transportation, disposal and processing.
- Drawing up a complete list of necessary work, determining the cost of services.
- Signing a drug disposal agreement.
- Collection and transportation of medications - according to schedule or request. We replace unusable waste containers with new ones.
- Drawing up a waste acceptance report indicating the necessary information.
- Issuance of a coupon or disposal certificate upon completion of all work.
Disposal methods
Disposal of medicines is carried out using various methods, the most common of which are:
- Chemical disinfection. It is carried out using chlorine-containing substances. It is often combined with grinding, dissolving and other mechanical processes to ensure complete penetration of chemicals.
- Sterilization with water steam in autoclaves at temperatures above 100 degrees Celsius, under high pressure.
- Combustion using incinerator furnaces. In this case, sorting before disposal of low-quality medicines is not necessary - all waste is completely destroyed.
- Processing using microwaves.
What regulatory documents regulate the destruction of medicines and the placement of medicines in the quarantine zone? What is the algorithm of actions? In what cases should the pharmacy destroy the drugs itself, and in what cases can it return them to the supplier? How can you minimize pharmacy disposal costs? In what form should acts of destruction and placement in a quarantine zone be drawn up? How can you force an organization that destroys medicines to draw up a report and provide it to the pharmacy?
May 23, 2013 11432
Please pay attention to the date of the response - the situation may have changed.
Substandard medicines are destroyed in accordance with the “Rules for the destruction of substandard medicines, counterfeit medicines and counterfeit medicines”, approved by Decree of the Government of the Russian Federation of 09/03/2010 No. 674 (as amended on 09/04/2012).
The concept of a designated quarantine zone for organizations operating in the field of circulation of medicines is not clearly defined by current legislation.
In accordance with paragraph 12 of the “Rules for the storage of medicines” approved by Order of the Ministry of Health and Social Development of the Russian Federation dated August 23, 2010 (as amended on December 28, 2010), if medicines with an expired expiration date are identified, they must be stored separately from other groups of medicines funds in a specially designated and designated (quarantine) area.
According to clause 4.2 of the Industry Standard “Rules for the dispensing (sale) of medicines in pharmacies. Basic Provisions", approved by Order of the Ministry of Health of the Russian Federation dated 04.03.2003 No. 80 (as amended on 18.04.2007), for medicinal products (medicines) in damaged packaging, without certificates and/or the necessary accompanying documentation, rejected When receiving or dispensing to a patient that does not correspond to the order or has expired, a report is drawn up. Such medications must be properly labeled and placed in a designated area separate from other medications until they are identified, returned to the supplier, or disposed of as required.
The Standard does not establish requirements for the form and content of the act.
Thus, the act on identifying medicines to be placed in the 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, falsified medicines and counterfeit medicines”, substandard medicines and (or) counterfeit medicines are subject to seizure and destruction by decision of the owner of these medicines, the 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 the Federal Service for Surveillance in Healthcare and Social Development made a decision on their seizure, destruction and export, is obliged to execute this decision or report your disagreement with him.
The current civil legislation of the Russian Federation does not define the concept of “owner”, however, within the meaning of civil law norms, the owner of a product is a person who owns it on any legal basis, in particular, the owner of a product is its owner if he has not transferred the right of ownership 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 provisions 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 compensation for expenses and losses incurred if he proves that the goods supplied to him were of poor quality at the time of delivery or that the goods were damaged due to the fault of the supplier, for example, due to violations of transportation conditions, etc.
According to paragraph 8 of the Rules, the destruction of medicines is carried out by an organization that has a license to collect, use, neutralize, transport and dispose of waste of I-IV hazard classes.
In accordance with paragraph 11 of these Rules, the organization carrying out the destruction of 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 who took part in the destruction of medicines, their place of work and position;
c) justification for the destruction of medicines;
d) information about the destroyed medicines (name, dosage form, dosage, units of measurement, series) and their quantity, as well as about the container or packaging;
e) name of the manufacturer of medicines;
f) information about the owner of the medicines;
g) method of destruction of medicines.
An act on the 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 who took part in the destruction of these medicines, signed by all persons who took part in the destruction of these medicines, and certified by the seal of the organization carrying out the destruction of medicines (clause 12 of the Rules).
As can be seen from the legislative norms listed above, the need to draw up an act is established by law, but the strict form of the act on the destruction of medicines has not been established, and a clear composition of persons taking part in the destruction of medicines has not been established.
Thus, the form of the act can be arbitrary, provided it reflects all the positions specified in paragraph 11 of the Rules.
For the destruction of medicines, the organization carrying out the destruction may create an appropriate commission. 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 act of destruction of medicines or its copy, certified in the prescribed manner, is 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 will be used to close the contract.