Order for writing off alcohol 378 n. Subject quantitative accounting. Rules for registration of transactions related to the circulation of medicines for medical use included in the list of medicines for medical use subject to registration

Clause 4 of Appendix 1 of Order 378n: registration of transactions related to the circulation of medicines is carried out for each trade name (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.

Example of violation 3.
According to the journal of the wholesale sales department for a medicinal product with the international nonproprietary name “Ethanol (Ethyl Alcohol) 95%” at the time of inspection, the actual balance as of the 1st day of the month (December 1, 2017) for the trade name “Ethanol (Ethyl Alcohol) 95% - 100 ml” was 0 pack, in fact there were packages in stock (14 pack). The available packaging, as explained by the person in charge, was taken into account in the section of the magazine “Ethanol (Ethyl Alcohol) 95%, gr” - angro.

Representatives of the organization, in support of their position, explained that in the wholesale sales department “Ethanol” (Ethyl Alcohol), 95% is sold at the request of a medical organization and for the manufacture of extemporaneous dosage forms, and this drug is accounted for in various units of measurement. For dispensing according to the requirements of the medical organization, it is taken into account in bottles indicating the number of bottles. For the manufacture of extemporaneous dosage forms, accounting is kept in grams (receipt according to invoices from suppliers and consumption according to the requirements of invoices of a medical organization and prescriptions are converted from milliliters to grams in accordance with Appendix No. 9, Table No. 1 of Order No. 751n. 100 ml of the drug “Ethanol ( Ethyl alcohol) 95% corresponds to 81.14 grams. Separate pages are allocated for the medicinal product with the international nonproprietary name “Ethanol (Ethyl Alcohol) 95%” in the register of the wholesale sales department.

Based on the above, the company believes that there were no violations of clause 4 of the Rules for registering transactions, and clause 7 of the Rules for maintaining and storing special transaction logs (Appendices 1 and 2 of Order 378n).

The court, having assessed the totality and interrelation of the submitted inspection materials and the parties’ arguments, found that the accounting of the same type of product with the international nonproprietary name “Ethanol (Ethyl Alcohol) 95%” was carried out both in bottles and in grams on separate sheets of the journal . At the same time, the court, when resolving the dispute in this part, comes to the conclusion that this accounting procedure does not comply with the current Registration Rules.

According to clause 4 of the Rules for Registration of Transactions, 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 electronic form. In this case, the unit of measurement is indicated in the journal.

The accounting procedure that an organization maintains (in different units of measurement on separate sheets of the accounting journal for the same batch of a medicinal product) can lead to discrepancies and discrepancies in accounting. According to the records kept in milliliters (bottles), the drug is not available (according to the journal as of 12/01/2017 - 0 packages), while in fact the drug, if taken into account in grams, is not consumed (available) 2084.45 g per 12/01/2017, which is reflected in the journal.

Example of violation 4.
According to the journal of the wholesale sales department for a medicinal product with the international non-proprietary name “Ethanol (Ethyl Alcohol) 70%-100 ml”, a joint summary record was kept for several incoming trade names.

The receipt of various trade names is confirmed by a delivery note dated 10/09/2017 (trade name “Ethyl alcohol solution for external use 70% 100 ml, manufacturer Rosbio LLC, Russia”), a delivery note dated 10/09/2017 (trade name “Ethyl alcohol solution for external use 70% 100 ml, manufacturer LLC "Rosbio", Russia), invoice dated July 28, 2017 (trade name "Ethyl alcohol solution for external use and preparation of dosage forms 70% 100 ml, manufacturer OJSC PCPK "Medkhimprom", Russia"), delivery note dated June 30, 2017 (trade name "Ethyl alcohol solution for external use and preparation of dosage forms 70% 100 ml, manufacturer "Hippocrates" LLC, Russia").

The organization, without disputing this fact, at the same time believes that since the medicinal product has one trade name, one dosage form, one dosage, registration of transactions on one separate, expanded sheet of the accounting journal does not indicate a violation of paragraph 4 of the Rules for registering transactions related to circulation medicines for medical use.

When resolving a dispute in this part, the court recognizes the company’s objections as justified. It follows from the content of paragraph 4 of the Registration Rules that registration is carried out for each trade name of the medicinal product (for each individual dosage and dosage form). Since we are talking about one trade name “Ethyl alcohol solution for external use and preparation of dosage form 70% 100 ml,” there is no reason to believe that records were kept for several trade names. The fact that the goods were supplied by different manufacturers does not indicate different trade names of the goods supplied.

Clause 5 of Appendix 1 of Order No. 378n, registration of transactions related to the circulation of medicines is carried out by persons authorized by the head of the legal entity (not the head of the pharmacy, but the head of the legal entity!) for maintaining and storing accounting logs, or an individual entrepreneur with a license for pharmaceutical activities or medical activities.

Order of the Ministry of Health of the Russian Federation (Ministry of Health of Russia) dated June 17, 2013 N 378n, Moscow “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 logs of transactions related to the circulation of medicines for medical use, and rules for maintaining and storing special logs of operations related to the circulation of medicines for medical use"

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 transactions 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 medicinal products for medical use, included in the list of medicinal products for medical use, subject to subject-quantitative accounting 1 (hereinafter referred to as medicinal products), 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, Art. 663, Art. 4666; 2007, Art. 3439; Art. 3183, Art. 6572; 3, Art. 314, Art. 2100, Art. 3035, Art. 3703, Art. 4271, Art. 5864, Art. 6720; 2011, Art. 1390, Art. 1635, Art. 4473, Art. 5921, Art. 1232, No. 1295, No. 2400, No. 2864, No. 5002, No. 6686, No. 6861 .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.

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 medicines, 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 with an indication of 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, Art. 7351; 26, Art. 7587;

Registration N 29404

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 V. Skvortsova

Appendix No. 1 to the Order

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.

Appendix No. 2 to the Order

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

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).

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, Art. 3439; , N 28, Art. 3703, Art. 4271, Art. 5864, Art. 6720; 29, art. 4473, no. 5921, no. 7534; 2012, no. 1232, no. Art. 2864, No. 37, No. 48, No. 6686, No. 6861;

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.

V.I. 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.