With changes and additions from. Legislative framework of the Russian Federation New order on alcohol 378 n

In the material we will consider the features of subject-quantitative accounting in medical institutions, PKU journals, order 378n, and also cover in detail the issues and subtleties of filling out documentation on PKU.

Subject-quantitative recording of individual medications is mandatory in all medical institutions. The rules for maintaining medicines registers were approved by order of the Ministry of Health of the Russian Federation No. 378n dated June 17, 2013.

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Let's take a closer look at the intricacies of filling out PKU logs.

From the article you will learn:

Order 378n: subject-quantitative accounting of drugs

According to Order 378n, subject-quantitative records of medicines are carried out both in medical institutions and in pharmacies. However, filling out the PKU log in a healthcare institution has its own nuances.

First of all, the manager issues an internal order for the institution, by which he appoints an employee responsible for implementing PCU and recording the receipt and consumption of drugs in accounting and reporting documentation.

The PKU log form is the same for all medical organizations, so the responsible employee must strictly follow the rules for maintaining it.

Drug circulation in medical organizations: what the chief nurse needs to know

Draw up local regulations on those responsible for working with medicines and where medicines are stored.
Don't complicate your drug accounting process by requiring unnecessary forms to be filled out.
Clean up medication storage areas and instruct staff on how to avoid mistakes when handling medications.
A complete algorithm of actions, as well as ready-to-download journal forms and a memo for health workers on storing medications in departments, are available to clients of the “Chief Nurse” magazine.

The PKU journal is opened for a period of 1 year. It ends at the end of December, and a new document is started in January. It is acceptable to keep a journal both on paper and in electronic format.

There are two options for maintaining a paper PKU journal:

Order and buy a ready-made document from a printing house;
Type, print and sew a journal yourself from separate sheets of paper, which are then numbered and sealed with the seal of the institution and the signature of the head physician.

The electronic accounting journal is maintained differently - accounting is carried out on electronic media, and the completed pages of the journal are printed and stapled every month. When the calendar year comes to an end, the bound sheets are numbered and filed in a journal, which is then sealed and certified by the signatures of the person in charge, the head physician and the seal of the medical institution.

The person responsible for accounting for medications:

every day records in the journal all incoming and outgoing transactions with them;
daily records the consumption of medicines;
When new medications arrive at the department, he makes entries in the journal for each of them in accordance with the invoices (the invoice number and the date of receipt of the drugs are indicated).

How to make corrections to the journal and make reconciliations

It was already mentioned above that the regulatory document regulating the maintenance of PKU journals is order No. 378n dated June 17, 2013. According to it, at the end of each calendar month, all records of remaining medications are verified with their actual number in the PKU journal, information about the reconciliation is entered into the journal . If there is an error in the log, the person in charge must make corrections.

This is done as follows:

an incorrect entry is carefully crossed out;
The correct entry is written next to it;
the correction is certified with the mark “corrected believe” and the signature of the responsible employee.

Uncertified corrections and erasures in the document are unacceptable.

How to store the PKU log

The current subject-quantitative accounting journal is stored in a safe or metal cabinet, the keys to which are kept by an authorized person. Originals and copies of invoices should be kept in the same place with it - they are stitched together in chronological order.

After a year, the completed PKU journal is transferred to the institution’s archive - here it is stored for 3 years.

How to record the dispensing of drugs to inpatients in a journal

Information about the medicine prescribed to the patient is noted in his chart.

It states:

Name of the medicine.
At what time or at intervals of how many hours should you take the drug.
Dosage.
How long does the patient need to take this drug?

Information about medications dispensed to patients is also entered into the PKU journal - the date of prescription, the patient’s surname and initials, his medical card number, and the amount of medication dispensed. If medications are given to patients daily, then records should also be made every day.

How to correctly record a reconciliation act in the PKU journal

All transactions with medicines are recorded for each individual item, including the receipt and consumption of individual medications and dosages.

If the PCU journal is maintained in electronic format and reconciliation data is entered at the end of each month, the journal sheets will be maintained incorrectly.

It is more correct to do the following:

on the last day of the month, drug balances are reconciled based on accounting documents and the actual number of drugs;
the reconciliation record is entered in the PKU journal itself - it will be the next one after the last record of incoming and outgoing transactions with the drug (including dosage and dosage form).

If there were no transactions for any drug during the month, then the reconciliation record in the printed electronic journal at the end of the month will be the only one.

Entering reconciliation notes into the journal after the last entry greatly simplifies the order of document maintenance, while entering such notes at the end of the journal makes the procedure more complex.

Registration N 29404

In accordance with paragraph 5.2.171(3) of the Regulations on the Ministry of Health of the Russian Federation, approved by Decree of the Government of the Russian Federation of June 19, 2012 N 608 (Collected Legislation of the Russian Federation, 2012, N 26, Art. 3526; 2013, N 16, Art. 1970), I order:

Approve:

rules for registering transactions related to the circulation of medicinal products for medical use, included in the list of medicinal products for medical use, subject to subject-quantitative accounting, in special journals for recording operations related to the circulation of medicinal products for medical use, in accordance with Appendix No. 1;

rules for maintaining and storing special logs of transactions related to the circulation of medicines for medical use, in accordance with Appendix No. 2.

Minister V. Skvortsova

Appendix No. 1 to the Order

Rules for registering transactions related to the circulation of medicinal products for medical use, included in the list of medicinal products for medical use, subject to subject-quantitative accounting, in special journals for recording transactions related to the circulation of medicinal products for medical use

1. These Rules establish requirements for registration of transactions related to the circulation of medicines for medical use, included in the list of medicines for medical use, subject to subject-quantitative accounting 1 (hereinafter referred to as medicines), as a result of which their quantity and (or) changes ) state.

2. Registration of transactions related to the circulation of medicinal products that are narcotic drugs, psychotropic substances or their precursors included in lists II, III, IV of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation 2 is carried out by the subjects of drug circulation funds in special journals in the forms provided for in Appendix No. 1 to the Rules for maintaining and storing special journals for recording transactions related to the circulation of narcotic drugs and psychotropic substances, approved by Decree of the Government of the Russian Federation of November 4, 2006 N 644 3, and the appendix to the Rules for maintaining and storage of special logs of registration of transactions related to the circulation of precursors of narcotic drugs and psychotropic substances, approved by Decree of the Government of the Russian Federation of June 9, 2010 N 419 4.

3. Registration of transactions related to the circulation of medicines (with the exception of medicines specified in paragraph 2 of these Rules) is carried out in special journals for recording operations related to the circulation of medicines (hereinafter referred to as the log books):

1) manufacturers of medicines and wholesale trade organizations of medicines in the form in accordance with Appendix No. 1 to these Rules;

2) pharmacy organizations and individual entrepreneurs with a license for pharmaceutical activities, in the form in accordance with Appendix No. 2 to these Rules;

3) medical organizations and individual entrepreneurs with a license for medical activities, in the form in accordance with Appendix No. 3 to these Rules.

4. Registration of transactions related to the circulation of medicinal products is carried out for each trade name of the medicinal product (for each individual dosage and dosage form) on a separate expanded sheet of the accounting journal or in a separate accounting journal on paper or in electronic form.

5. Registration of transactions related to the circulation of medicines is carried out by persons authorized by the head of a legal entity to maintain and store accounting logs, or by an individual entrepreneur who has a license for pharmaceutical activities or medical activities.

2 Decree of the Government of the Russian Federation of June 30, 1998 N 681 “On approval of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation” (Collected Legislation of the Russian Federation, 1998, N 27, Art. 3198; 2004, N 8, Article 663, No. 47, Article 4666; 2006, No. 29, Article 3253; 2007, No. 28, Article 3439; 2009, No. 26, Article 3183, No. 52, Article 6572; 2010, N 3, Article 314, No. 17, Article 2100, No. 24, Article 3035, No. 28, Article 3703, No. 31, Article 4271, No. 45, Article 5864, No. 50, Art. 6720; 2011, No. 10, Article 1390, No. 12, Article 1635, No. 29, Article 4466, No. 4473, No. 42, Article 5921, No. 51, Article 7534; 2012, No. 10, Art. 1232, N 11, Art. 1295, N 19, Art. 2400, N 22, Art. 2864, N 37, Art. 5002, N 48, Art. 6686, N 49, Art. 6861; 2013, N 9, Art. 953).

Appendix No. 2 to the Order

Rules for maintaining and storing special logs of transactions related to the circulation of medicines for medical use

1. These Rules establish requirements for maintaining and storing special logs of transactions related to the circulation of medicines for medical use, included in the list of medicines for medical use, subject to subject-quantitative accounting 1 (hereinafter referred to as log books, medicines).

2. These Rules do not apply to the maintenance and storage of special logs of transactions related to the circulation of medicines that are narcotic drugs, psychotropic substances and their precursors included in lists II, III, IV of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation 2.

3. The introduction and storage of special logs of transactions related to the circulation of medicinal products, specified in paragraph 2 of these Rules, is carried out in accordance with the Rules for the maintenance and storage of special logs of transactions related to the circulation of narcotic drugs and psychotropic substances, approved by decree of the Government of the Russian Federation dated November 4, 2006 N 644 3, and the Rules for maintaining and storing special logs of transactions related to the circulation of precursors of narcotic drugs and psychotropic substances, approved by Decree of the Government of the Russian Federation dated June 9, 2010 N 419 4.

4. Accounting books filled out on paper are bound, numbered and sealed with the signature of the head of the legal entity (individual entrepreneur) and the seal of the legal entity (individual entrepreneur) before they begin to be maintained.

Accounting logs are prepared for the calendar year.

5. Sheets of accounting logs filled out electronically are printed out monthly, numbered, signed by a person authorized to maintain and store accounting logs, and bookleted by name of the medicinal product, dosage, and dosage form.

At the end of the calendar year, the bound sheets are drawn up in a journal, sealed indicating the number of sheets and certified by the signature of the person authorized to maintain and store accounting journals, the head of the legal entity (individual entrepreneur) and the seal of the legal entity (individual entrepreneur).

6. Entries in the accounting journals are made by a person authorized to maintain and store the accounting journal, with a ballpoint pen (ink) at the end of the working day on the basis of documents confirming the completion of incoming and outgoing transactions with the medicinal product.

7. The receipt of the medicine is reflected in the accounting journal for each receipt document separately, indicating the number and date. Drug consumption is recorded daily. Pharmacy organizations and individual entrepreneurs with licenses for pharmaceutical activities record the daily consumption of the drug, indicating separately the prescriptions issued to medical workers and the requirements of medical organizations.

8. Corrections in the accounting journals are certified by the signature of the person authorized to maintain and store the accounting journals. Erasures and uncertified corrections in accounting journals are not permitted.

9. On the last day of each month, the person authorized to maintain and store accounting journals checks the actual availability of medicines with their balance in the accounting journal and makes appropriate entries in the accounting journal.

10. The accounting journal is stored in a metal cabinet (safe), the keys to which are kept by the person authorized to maintain and store the accounting journal.

Receipt and expense documents (their copies) are filed in the order of their receipt by date and stored together with the accounting journal.

11. Completed accounting logs are stored in the archives of a legal entity (individual entrepreneur).

1 Article 58.1 of the Federal Law of April 12, 2010 N 61-FZ “On the Circulation of Medicines” (Collected Legislation of the Russian Federation, 2010, N 16, Art. 1815, N 31, Art. 4161, N 42, Art. 5293, N 49, Art. 6409; 2011, N 50, Art. 7351; 2012, N 26, Art. 3446; N 53, Art. 7587).

2 Decree of the Government of the Russian Federation of June 30, 1998 N 681 (Collection of Legislation of the Russian Federation, 1998, N 27, Art. 3198; 2004, N 8, Art. 663, N 47, Art. 4666; 2006, N 29, Art. 3253; 2007, N 28, Art. 3439; 2009, N 26, Art. 3183, N 52, Art. 6572; 2010, N 3, Art. 314, N 17, Art. 2100, N 24, Art. 3035 , N 28, Art. 3703, N 31, Art. 4271, N 45, Art. 5864, N 50, Art. 6696, Art. 6720; 2011, N 10, Art. 1390, N 12, Art. 1635, N 29, Article 4466, Article 4473, No. 42, Article 5921, No. 51, Article 7534; 2012, No. 10, Article 1232, No. 11, Article 1295, No. 19, Article 2400, No. 22, Article 2864, No. 37, Article 5002, No. 48, Article 6686, No. 49, Article 6861; 2013, No. 9, Article 953).

3 Collection of Legislation of the Russian Federation, 2006, No. 46, Art. 4795; 2008, N 50, art. 5946; 2010, N 25, art. 3178; 2012, N 37, art. 5002.

4 Collection of Legislation of the Russian Federation, 2010, No. 25, Art. 3178; 2011, N 51, art. 7534; 2012, N 1, art. 130, N 41, art. 5623, N 51, art. 7235.

Order of the Ministry of Health of the Russian Federation dated June 17, 2013 N 378n "On approval of the rules for registering transactions related to the circulation of medicines for medical use, included in the list of medicines for medical use, subject to subject-quantitative accounting, in special journals for recording transactions related with the circulation of medicines for medical use, and the rules for maintaining and storing special logs of transactions related to the circulation of medicines for medical use" (with amendments and additions)

Order of the Ministry of Health of the Russian Federation dated June 17, 2013 N 378n
"On approval of the rules for registering transactions related to the circulation of medicinal products for medical use, included in the list of medicinal products for medical use, subject to subject-quantitative accounting, in special journals for recording operations related to the circulation of medicinal products for medical use, and the rules for maintaining and storage of special logs of transactions related to the circulation of medicines for medical use"

With changes and additions from:

rules for maintaining and storing special logs of transactions related to the circulation of medicines for medical use, in accordance with Appendix No. 2.

IN AND. Skvortsova

Registration N 29404

The rules for registration in special journals of transactions related to the circulation of drugs included in the list of drugs for medical use, subject to subject-quantitative recording, have been approved.

Here are the requirements for registration of operations that are related to the circulation of medicines and as a result of which their quantity and (or) condition changes.

These operations are registered by manufacturers of medicines and wholesale trade organizations, pharmacy/medical organizations and individual entrepreneurs with a license for pharmaceutical/medical activities. The forms of the corresponding journals are given.

Registration is carried out for each trade name of the medicinal product (for each individual dosage and dosage form) on a separate expanded sheet of the accounting journal or in a separate journal on paper or in electronic form.

Registration is carried out by persons authorized by the head of the legal entity to maintain and store accounting logs, or individual entrepreneurs who have a license for pharmaceutical/medical activities.

In addition, the rules for maintaining and storing special logs of transactions related to the circulation of medicines for medical use are established.

Special attention is paid to the registration of transactions related to the circulation of drugs that are included in lists II, III, IV of the list of narcotic drugs, psychotropic substances and their precursors subject to control in our country.

Letter from the Ministry of Health of the Republic of Tatarstan
dated October 21, 2013 N 09-01/11725

Heads of medical organizations independently
from the organizational and legal form, form
property and departmental affiliation
Republic of Tatarstan
Heads of Health Departments
by years Kazan, Naberezhnye Chelny,
Nizhnekamsk, Almetyevsk MZ RT
Heads of pharmaceutical organizations

The Ministry of Health of the Republic of Tatarstan sends you for guidance in your work the order of the Ministry of Health of the Republic of Tatarstan dated June 17, 2013 N 378n “On approval of the rules for registering transactions related to the circulation of medicines for medical use, subject to subject-quantitative accounting, in special journals for recording transactions related with the circulation of medicines for medical use, and the rules for maintaining and storing special logs of transactions related to the circulation of medicines for medical use" (hereinafter referred to as Order No. 378n). The order came into force on September 8, 2013.
In accordance with the written explanation of the Ministry of Health of the Russian Federation, medical and pharmacy organizations, wholesale trade organizations of medicines, individual entrepreneurs with a license for pharmaceutical activities or a license for medical activities are required to comply with the requirements of this order.
In connection with incoming requests from medical organizations about the procedure for registering and maintaining new logs of operations related to the circulation of medicines for medical use, subject to subject-quantitative accounting (hereinafter referred to as PKU), we inform you as follows.
The list of medicines subject to PCU was approved by order of the Ministry of Health and Social Development of the Russian Federation dated December 14, 2005 N 785 “On the procedure for dispensing medicines”.
Please note that from this list the drugs Butorphanol, Teaneptine and 21 potent substances have been transferred to List III of psychotropic substances, diethyl ether has been transferred to List IV of precursors of the List of narcotic drugs, psychotropic substances and their precursors, approved by the Decree of the Government of the Russian Federation of June 30, 1998 N 681 and require accounting procedures approved for narcotic drugs, psychotropic substances and their precursors.
When drawing up new-style accounting journals approved by Order N 378n, it is necessary to take into account:
- the transfer of the accounting balance of medicinal products subject to PCU from the “old” accounting journals to the new ones is carried out according to an act by a commission, the composition of which is approved by order of the head of the legal entity;
- in the “old” accounting logs the following entry is made: “The log is completed due to the entry into force of the order of the Ministry of Health of the Russian Federation dated June 17, 2013 N 378n”);
- unused sheets of “old” accounting journals are crossed out.
Registration of transactions is carried out for each trade name of the medicinal product (for each individual dosage and dosage form) on a separate expanded sheet of the accounting journal or in a separate accounting journal on paper or in electronic form.
Registration of transactions in accounting journals is carried out by persons authorized by order of the head of the legal entity to maintain and store accounting journals.
Journals filled out on paper are bound, numbered and sealed with the signature of the head of the legal entity and the seal of the legal entity before they begin to be maintained.
It is allowed to keep a logbook in electronic form. In this case, the sheets filled out electronically must:
- print monthly;
- number;
- pamphlets by name of the drug, dosage, dosage form;
- after the end of the calendar year, the bound sheets are drawn up in a journal, which is sealed indicating the number of sheets and certified by the signatures of the person authorized to maintain and store journals, the head of the legal entity and the seal of the legal entity.
Entries in the accounting journals are made by an authorized person with a ballpoint pen at the end of the working day on the basis of documents confirming the completion of incoming and outgoing transactions with medicines.
The receipt of a medicinal product is reflected in the accounting journal for each receipt document, indicating the number and date of the document; recording each expense transaction in the accounting journal is not required; in medical organizations, consumption is recorded daily. Pharmacy organizations and individual entrepreneurs also record daily consumption, but separately indicate the prescriptions of doctors and the requirements of medical organizations.
Corrections in the accounting journals are certified by the signature of the person authorized to maintain and store the accounting journals. Erasures and uncertified corrections in accounting journals are not permitted.
On the last day of each month, the person authorized to maintain and store accounting journals checks the actual availability of medicines with their balance in the accounting journal and makes appropriate entries in the accounting journal (columns 12 and 13 are filled in).
The accounting journal is stored in a metal cabinet (safe), the keys to which are kept by the person authorized to maintain and store the accounting journal.
Receipt and expense documents (their copies) are filed in the order of their receipt by date and stored together with the accounting journal.
Completed accounting logs are stored in the archives of the legal entity.
Accounting logs are prepared for the calendar year. As of December 31, 2013, the accounting journal must be completed, with the balance transferred to the accounting journal for 2014.
In order to tighten the accounting or adapt the accounting to the treatment process, additional columns or lines may be added to the forms of journals for recording medicines subject to PCU, approved by Order N 378n. All additions must be approved by order of the head of the legal entity. It is not allowed to exclude columns of accounting journals approved by Order N 378n.
Taking into account the proposals of medical organizations, we recommend logbook forms for use in the offices of senior nurses and treatment rooms of departments of medical organizations (Appendices No. 1 and No. 2, additions to the logbook forms are highlighted in bold).
In accordance with paragraph 5 of Art. 58.1 of the Federal Law of April 12, 2010 N 61-FZ (as amended on July 2, 2013) “On the Circulation of Medicines” control over compliance with the rules for registering operations related to the circulation of medicines for medical use included in the list of medicines subject to subject-matter quantitative accounting, in special journals, as well as compliance with the rules for maintaining and storing special journals is carried out within the framework of licensing control.

Appendix No. 1

Journal of transactions related to the circulation of medicines for medical use (office of the head nurse ____________________________________) name of the department

Balance on the 1st of the month

Total consumption per month

Signature of the authorized person

Received from:

N and document date

Quantity (batch)

date of issue

N of the medical document (full name of the patient, requirement of the treatment room)

Quantity

March, etc.

Appendix No. 2

(name of medical organization)

Journal of transactions related to the circulation of medicines for medical use (treatment room ____________________________) department name

Balance on the 1st of the month

Just a month upon arrival with the balance

Total consumption per month

Journal balance at the end of the month

Actual balance at the end of the month

Signature of the authorized person

Balance at the end of the work shift

Received from:

N and document date

Quantity (batch)

date of issue

N of the medical document (full name of the patient,

Quantity

has not entered into force Editorial from 17.06.2013

Name of document	ORDER of the Ministry of Health of the Russian Federation dated June 17, 2013 N 378n "ON APPROVAL OF THE RULES FOR REGISTRATION OF OPERATIONS RELATED TO THE CIRCUIT OF MEDICINES FOR MEDICAL USE INCLUDED IN THE LIST OF MEDICINES FOR MEDICAL USE SUBJECT TO PRODUCTION ETHNO-QUANTITATIVE ACCOUNTING, IN SPECIAL JOURNALS FOR ACCOUNTING OF OPERATIONS RELATED TO THE CIRCULATION OF MEDICINES DRUGS FOR MEDICAL USE, AND RULES FOR MAINTENANCE AND STORAGE OF SPECIAL JOURNALS FOR RECORDING OPERATIONS RELATED TO THE CIRCULATION OF MEDICINES FOR MEDICAL USE"
Document type	order
Receiving authority	Ministry of Health of the Russian Federation
Document Number	378N
Acceptance date	01.01.1970
Revision date	17.06.2013
Registration number in the Ministry of Justice	29404
Date of registration with the Ministry of Justice	15.08.2013
Status	has not entered into force
Publication	At the time of inclusion in the database, the document was not published
Navigator	Notes

ORDER of the Ministry of Health of the Russian Federation dated June 17, 2013 N 378n "ON APPROVAL OF THE RULES FOR REGISTRATION OF OPERATIONS RELATED TO THE CIRCUIT OF MEDICINES FOR MEDICAL USE INCLUDED IN THE LIST OF MEDICINES FOR MEDICAL USE SUBJECT TO PRODUCTION ETHNO-QUANTITATIVE ACCOUNTING, IN SPECIAL JOURNALS FOR ACCOUNTING OF OPERATIONS RELATED TO THE CIRCULATION OF MEDICINES DRUGS FOR MEDICAL USE, AND RULES FOR MAINTENANCE AND STORAGE OF SPECIAL JOURNALS FOR RECORDING OPERATIONS RELATED TO THE CIRCULATION OF MEDICINES FOR MEDICAL USE"

This document comes into force 10 days after the day of its official publication (clause 12 of Decree of the President of the Russian Federation dated May 23, 1996 N 763)

Order

Approve:

rules for maintaining and storing special logs of transactions related to the circulation of medicines for medical use, in accordance with Appendix No. 2.

Minister
IN AND. SKVORTSOVA

Applications

Appendix No. 1

Russian Federation
dated June 17, 2013 N 378n

Appendix 1. RULES FOR REGISTRATION OF OPERATIONS RELATED TO THE CIRCULATION OF MEDICINES FOR MEDICAL USE INCLUDED IN THE LIST OF MEDICINES FOR MEDICAL USE SUBJECT TO SUBJECT-QUANTITATIVE ACCOUNTING IN SPECIAL EDUCATIONAL JOURNALS TA OF OPERATIONS RELATED TO THE CIRCULATION OF MEDICINES FOR MEDICAL USE

1. These Rules establish requirements for registration of transactions related to the circulation of medicines for medical use, included in the list of medicines for medical use, subject to subject-quantitative accounting<1>(hereinafter referred to as medicines), as a result of which their quantity and (or) condition changes.

2. Registration of operations related to the circulation of medicines that are narcotic drugs, psychotropic substances or their precursors included in lists III of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation<2>, is carried out by subjects of circulation of medicines in special journals according to the forms provided for in Appendix No. 1 to the Rules for maintaining and storing special journals for recording transactions related to the circulation of narcotic drugs and psychotropic substances, approved by Decree of the Government of the Russian Federation of November 4, 2006 N 644<3>, and an appendix to the Rules for maintaining and storing special logs of transactions related to the circulation of precursors of narcotic drugs and psychotropic substances, approved by Decree of the Government of the Russian Federation of June 9, 2010 N 419<4>.

<2>Decree of the Government of the Russian Federation of June 30, 1998 N 681 “On approval of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation” (Collected Legislation of the Russian Federation, 1998, N 27, Art. 3198; 2004, N 8 , Article 663, No. 47, Article 4666; 2006, No. 29, Article 3253; 2007, No. 28, Article 3439; 2009, No. 26, Article 3183, No. 52, Article 6572; 2010, No. 3 , Article 314, No. 17, Article 2100, No. 24, Article 3035, No. 28, Article 3703, No. 31, Article 4271, No. 45, Article 5864, No. 50, Article 6696, Article 6720 ; 2011, N 10, article 1390, N 12, article 1635, N 29, article 4466, article 4473, N 42, article 5921, N 51, article 7534; 2012, N 10, article 1232 , No. 11, Article 1295, No. 19, Article 2400, No. 22, Article 2864, No. 37, Article 5002, No. 48, Article 6686, No. 49, Article 6861; 2013, No. 9, Art. 953).

<3>Collection of legislation of the Russian Federation, 2006, N 46, art. 4795; 2008, N 50, art. 5946; 2010, N 25, art. 3178; 2012, N37, art. 5002.

<4>Collection of legislation of the Russian Federation, 2010, N 25, art. 3178; 2011, N 51, art. 7534; 2012, N 1, art. 130, N 41, art. 5623, N 51, art. 7235.

1) manufacturers of medicines and wholesale trade organizations of medicines in the form in accordance with Appendix No. 1 to these Rules;

2) pharmacy organizations and individual entrepreneurs with a license for pharmaceutical activities, in the form in accordance with Appendix No. 2 to these Rules;

3) medical organizations and individual entrepreneurs with a license for medical activities, in the form in accordance with Appendix No. 3 to these Rules.

APPENDICES TO THE RULES

Appendix No. 1

medicines for medical use,

Russian Federation
dated June 17, 2013 N 378n

Appendix 1. JOURNAL OF OPERATIONS RELATED TO THE CIRCULATION OF MEDICINES FOR MEDICAL USE

Month

Balance on the 1st of the month

Coming

Consumption

Total consumption per month

Signature of the authorized person

Received from:

N and document date

Quantity

To whom it was released

N and document date

Quantity

January

February

March

April

May

June, etc.

Appendix No. 2
to the Rules for registering transactions related to circulation
medicines for medical use,
included in the list of medicines for medical
applications subject to subject-quantitative accounting,
in special journals for recording transactions related to circulation
medicines for medical use,
approved by order of the Ministry of Health
Russian Federation
dated June 17, 2013 N 378n

Appendix 2. JOURNAL OF OPERATIONS RELATED TO THE CIRCULATION OF MEDICINES FOR MEDICAL USE

Month	Balance on the 1st of the month	Coming		Just a month upon arrival with the balance	Types of consumption	Consumption					Monthly expenses for each type separately	Just a month for all types of expenses	Remainder according to the accounting journal at the end of the month	Actual balance at the end of the month	Signature of the authorized person
Month	Balance on the 1st of the month	Supplier, N and document date	Quantity	Just a month upon arrival with the balance	Types of consumption	1	2	3	4	5, etc.	Monthly expenses for each type separately	Just a month for all types of expenses		Actual balance at the end of the month	Signature of the authorized person
1	2	3	4	5	6	7	8	9	10	11	12	13	14	15	16
January					according to prescriptions
January					according to requirements
February etc.					according to prescriptions
February etc.					according to requirements

Appendix No. 3
to the Rules for registering transactions related to circulation
medicines for medical use,
included in the list of medicines for medical
applications subject to subject-quantitative accounting,
in special journals for recording transactions related to circulation
medicines for medical use,
approved by order of the Ministry of Health
Russian Federation
dated June 17, 2013 N 378n

Appendix 3. JOURNAL OF OPERATIONS RELATED TO THE CIRCULATION OF MEDICINES FOR MEDICAL USE

Month

Balance on the 1st of the month

Coming

Just a month upon arrival with the balance

Consumption

Total consumption per month

Balance of the accounting journal at the end of the month

Actual balance at the end of the month

Signature of the authorized person

Received from:

N and document date

Quantity

date of issue

N of the medical document (full name of the patient)

Quantity

January

February

March

April

May

June, etc.

Appendix No. 2
to the order of the Ministry of Health
Russian Federation
dated June 17, 2013 N 378n

Appendix 2. RULES FOR MAINTAINING AND STORING SPECIAL JOURNALS FOR RECORDING OPERATIONS RELATED TO THE CIRCULATION OF MEDICINES FOR MEDICAL USE

1. These Rules establish requirements for maintaining and storing special logs of transactions related to the circulation of medicines for medical use, included in the list of medicines for medical use, subject to subject-quantitative accounting<1>(hereinafter referred to as log books, medicines).

<1>Federal Law of April 12, 2010 N 61-FZ “On the Circulation of Medicines” (Collected Legislation of the Russian Federation, 2010, N 16, Art. 1815, N 31, Art. 4161, N 42, Art. 5293, N 49, Art. 6409; 2011, N 50, Art. 7351; 2012, N 26, Art. 3446; N 53, Art. 7587).

3. The introduction and storage of special logs of transactions related to the circulation of medicinal products, specified in paragraph 2 of these Rules, is carried out in accordance with the Rules for the maintenance and storage of special logs of transactions related to the circulation of narcotic drugs and psychotropic substances, approved by decree of the Government of the Russian Federation dated November 4, 2006 N 644<3>, and the Rules for maintaining and storing special logs of transactions related to the circulation of precursors of narcotic drugs and psychotropic substances, approved by Decree of the Government of the Russian Federation of June 9, 2010 N 419<4>.

<3>Collection of legislation of the Russian Federation, 2006, N 46, art. 4795; 2008, N 50, art. 5946; 2010, N 25, art. 3178; 2012, N 37, art. 5002.

<4>Collection of legislation of the Russian Federation, 2010, N 25, art. 3178; 2011, N 51, art. 7534; 2012, N 1, art. 130, N 41, art. 5623, N 51, art. 7235.

Accounting logs are prepared for the calendar year.

10. The accounting journal is stored in a metal cabinet (safe), the keys to which are kept by the person authorized to maintain and store the accounting journal.

Receipt and expense documents (their copies) are filed in the order of their receipt by date and stored together with the accounting journal.

11. Completed accounting logs are stored in the archives of a legal entity (individual entrepreneur).

The Zakonbase website contains ORDER of the Ministry of Health of the Russian Federation dated June 17, 2013 N 378n "ON APPROVAL OF RULES FOR REGISTRATION OF OPERATIONS RELATED TO THE CHANGE OF MEDICINES FOR MEDICAL USE INCLUDED IN THE LIST OF MEDICINES FOR MEDICAL USE SUBJECT TO SUBJECT-QUANTITATIVE ACCOUNTING IN SPECIAL ACCOUNTING JOURNALS OPERATIONS RELATED TO THE CIRCULATION OF MEDICINES FOR MEDICAL USE, AND RULES FOR MAINTENANCE AND STORAGE OF SPECIAL RECORDINGS OF OPERATIONS RELATED TO THE CIRCULATION OF MEDICINES FOR MEDICAL USE" in the latest edition. It is easy to comply with all legal requirements if you read the relevant sections, chapters and articles of this document for 2014. To find the necessary legislative acts on a topic of interest, you should use convenient navigation or advanced search.

On the Zakonbase website you will find ORDER of the Ministry of Health of the Russian Federation dated June 17, 2013 N 378n "ON APPROVAL OF RULES FOR REGISTRATION OF OPERATIONS RELATED TO THE CHANGE OF MEDICINES FOR MEDICAL USE INCLUDED IN THE LIST OF MEDICINES FOR MEDICAL USE ENTITIES SUBJECT TO SUBJECT-QUANTITATIVE ACCOUNTING IN SPECIAL MAGAZINES Accounting for operations related to the treatment of drugs for medical use, and the rules for maintaining and storage of special journals for accounting for operations related to the treatment of drugs for medical use "in the fresh and full version, in which all changes and amendments are made. This guarantees the relevance and reliability of the information.

At the same time, download the ORDER of the Ministry of Health of the Russian Federation dated June 17, 2013 N 378n “ON APPROVAL OF THE RULES FOR REGISTRATION OF OPERATIONS RELATED TO THE CIRCULATION OF MEDICINES FOR MEDICAL USE, INCLUDED IN THE LIST OF MEDICINES FOR MEDICAL USE, SUBJECT X SUBJECT-QUANTITATIVE ACCOUNTING, IN SPECIAL JOURNALS FOR ACCOUNTING OPERATIONS RELATED “CYCLING OF MEDICINES FOR MEDICAL USE, AND RULES FOR MAINTENANCE AND STORAGE OF SPECIAL JOURNALS FOR RECORDING OPERATIONS RELATED TO THE CIRCULATION OF MEDICINES FOR MEDICAL USE” is available completely free of charge, both in full and in separate chapters.