Sinusitis

Destruction of medicines. Procedure for destruction of medicines

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.

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ORDER of the Ministry of Health of the Russian Federation dated 12/15/2002 382 (as amended on 02/05/2010) ON APPROVAL OF INSTRUCTIONS ON THE PROCEDURE FOR THE DESTRUCTION OF MEDICINES... Relevant in 2018

INSTRUCTIONS ON THE PROCEDURE FOR THE DESTRUCTION OF MEDICINES THAT HAVE BEEN UNUSED, EXPIRED MEDICINES AND MEDICINES THAT ARE FAKES OR ILLEGAL COPIES OF MEDICINES REGISTERED IN THE RUSSIAN FEDERATION OWN FUNDS

dated 02/05/2010 N 62n)

1. These Instructions have been developed in accordance with the Federal Laws “On Medicines” dated June 22, 1998 N 86-FZ, “On the Sanitary and Epidemiological Welfare of the Population” dated March 30, 1999 N 52-FZ and determines 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.

(as amended by Order of the Ministry of Health and Social Development of the Russian Federation dated 02/05/2010 N 62n)

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.

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 N 62n)

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;

10. Responsibility for the destruction of medicines lies with the subjects of medicines circulation in accordance with the legislation of the Russian Federation.

In this material, we have prepared answers to several questions related to the procedure for destroying expired medicines, as well as narcotic and psychotropic substances, the further use of which for medical purposes is considered inappropriate.

How do you dispose of medications that are past their expiration dates? What legislative acts regulate this procedure? How to store expired medications before disposal.

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Order of the Ministry of Health and Social Development No. 706-dated August 23, 2010 approved the Rules for the storage of medicines.

Clauses 11 and 12 of these Rules state that a medical organization must keep records of medications with a limited shelf life - in electronic form or on paper.

It is necessary to monitor the timely sale of drugs with a limited shelf life. This control is carried out using computer programs, special log books or shelf cards, which indicate: the name of the medicine, its series, expiration date.

What is the procedure for recording discarded medicinal products?

The manager must establish a procedure for accounting for such drugs.

the place of destruction of narcotic drugs is determined (clause 2.1 of the Instructions);
specific methods of disposal are determined;

What else needs to be additionally reflected in the order?

procedural registration of the fact of drug disposal in a medical institution, the form and content of the relevant act, the procedure for its signing and further storage;
rules for working with medical waste that remains after the destruction of drugs in a medical institution. Most of these rules are reflected in SanPiN 2.1.7.2790-10, which is dedicated to the requirements for the management of medical waste;
the procedure for monitoring compliance with the procedure for storing and destroying narcotic and psychotropic substances in a medical organization;
penalties for violating the established procedure for drug disposal in a medical institution.

Lyudmila, good morning.

You need to contact a company licensed to destroy medications.

Federal Law of April 12, 2010 N 61-FZ (as amended on July 13, 2015) “On appeal
medicines" (with amendments and additions, entered into force on July 24, 2015)

Article 59. Grounds and procedure for destruction of medicines

1. Poor quality medicines, falsified
medicines are subject to withdrawal from circulation and destruction in the manner established by the Government of the Russian Federation. The basis for
destruction of medicines is the decision of the owner
medicines, the decision of the relevant authorized
federal executive authority or court decision.

Decree of the Government of the Russian Federation dated 09/03/2010 N 674 (as amended on 09/04/2012) “On
approval of the Rules for the destruction of substandard medicinal products
drugs, counterfeit medicines and counterfeit
medicines"

10.Owner of substandard medicines and (or)
counterfeit medicines, who made a decision on their
seizure, destruction and export, transfers the specified medicines
organization carrying out the destruction of medicines, on
based on the relevant agreement.
11. The organization carrying out the destruction of medicines,
draws up an act on the destruction of medicines, in which
are indicated:
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 destroyed medicines (name,
dosage form, dosage, units of measurement, series) and their
quantity, as well as container or packaging;
e) name of the manufacturer of medicines;
f) information about the owner of the medicines;
g) method of destruction of medicines.
12.An act on the destruction of medicines is drawn up on the day
destruction of substandard medicines and (or)
counterfeit medicines. Number of copies of this
act is determined by the number of parties involved in the destruction
of the specified 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 medicinal products
funds.
13.An act on the destruction of medicines or a copy thereof certified in
sent by the owner of the destroyed medicines to the Federal
health care surveillance service.
If the destruction of substandard medicines and
(or) counterfeit medicines were carried out in
absence of the owner of destroyed medicines, act of
destruction of medicines or its copy certified in
in accordance with the established procedure, within 5 working days from the date of its preparation
sent by an organization carrying out the destruction of medicinal products
funds to their owner.

I am attaching an agreement with one of the companies located in Chita, it may be useful to you.

General requirements for the procedure and grounds for the destruction of medicines are established in Article 59 Federal Law of April 12, 2010 No. 61-FZ “On the Circulation of Medicines”; (hereinafter referred to as Federal Law No. 61-FZ).

In accordance with this article, the following types of medicines subject to destruction can be distinguished:

Poor quality medicines,
Falsified medicines;
Counterfeit medicines.

Poor quality, falsified and counterfeit medicines are subject to withdrawal from civil circulation and destruction.

The procedure for the destruction of medicines is regulated by the Rules for the destruction of substandard medicines, counterfeit medicines and counterfeit medicines, approved Decree of the Government of the Russian Federation dated September 3, 2010 No. 674(hereinafter referred to as the Rules for the destruction of medicines).

Requirements for the procedure for the destruction of medicines do not apply to the destruction narcotic drugs and their precursors, psychotropic drugs and radiopharmaceuticals. The procedure for the destruction of narcotic drugs and their precursors, psychotropic drugs and radiopharmaceutical drugs is regulated by law, in particular Art. 29 Federal Law of January 8, 1998 N 3-FZ “On Narcotic Drugs and Psychotropic Substances” and Instructions for the destruction of narcotic drugs and psychotropic substances included in Lists II and III of the List of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation, the further use of which in medical practice is recognized as inappropriate, approved. by order of the Ministry of Health of the Russian Federation dated March 28, 2003 No. 127 and other regulatory legal acts.

It should also be noted that these requirements do not apply to medicines that have expired, since such medicines cannot be classified as substandard medicines (see Letter of the Federal Tax Service of the Russian Federation dated June 16, 2011 N ED-4-3/9486 “On the procedure for performing transactions with medicines whose shelf life has expired"). The obligation to destroy such medicines, provided for by the repealed Federal Law of June 22, 1998 N 86-FZ “On Medicines” and the Instructions on the procedure for the destruction of medicines, approved. By Order of the Ministry of Health of Russia dated December 15, 2002 N 382, it is not available today.

Current legislation provides for the following requirements for expired medicines:

Ban on the sale of expired medicines;
Special rules have been established storage of medicines expired. In accordance with clause 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 No. 706n If medicines that have expired are identified, they must be stored separately from other groups of medicines in a specially designated and designated (quarantine) area.

In accordance with the Rules for the destruction of medicines, substandard medicines and (or) counterfeit medicines are subject to seizure and destruction on one of the following grounds:

The decision of the owner of these medicines,
Decision of the Federal Service for Surveillance in Healthcare (hereinafter -)
Court decision.

Counterfeit medicines are subject to withdrawal from civil circulation and destruction only by court decision.

In addition, the actual basis for the destruction of medicines are information letters from Roszdravnadzor.

Roszdravnadzor regularly posts information about the identification of substandard medicines, the need to withdraw a medicine, the recall of a medicine, etc. on its official website. In such letters, Roszdravnadzor informs about the need to withdraw certain series of medicines from and destroy them in the prescribed manner, and also invites subjects of medicines circulation and medical organizations to check the availability of the specified series of medicines, the results of which to inform the territorial body of Roszdravnadzor. It follows from this that subjects of medicines circulation should organize the destruction of such medicines. Further, they theoretically have the right to file claims against the supplier and demand a refund of the money paid for these drugs, as well as reimbursement of the costs of destroying the drugs.

Roszdravnadzor, in the event of detection of facts of import into the territory of the Russian Federation or facts of circulation in the territory of the Russian Federation of substandard medicines and (or) counterfeit medicines, makes a decision obliging the owner of these medicines to carry out their seizure, destruction and export in full from the territory of the Russian Federation.

This decision must contain:

Information about medicines;
Grounds for seizure and destruction of medicines;
Deadline for seizure and destruction of medicines;
Information about the owner of the medicines;
Information about the manufacturer of medicines.

The owner of substandard medicines and (or) falsified medicines, within a period not exceeding 30 days from the date of Roszdravnadzor’s decision on their seizure, destruction and export, is obliged to comply with this decision or report his disagreement with it.

If the owner of substandard medicines and (or) falsified medicines does not agree with the decision to confiscate, destroy and export these medicines, and also if he has not complied with this decision and has not reported the measures taken, such medicines are confiscated and destroyed based on a court decision.

Substandard medicines and counterfeit medicines that are under the customs regime of destruction are subject to destruction in the manner established by Chapter 42 of the Customs Code of the Customs Union.