home Drugs Rules for the dispensing of medicinal products for medical use, including immunobiological medicinal products, by pharmacy organizations and individual entrepreneurs with a license for pharmaceutical activities. New rules from

Rules for the dispensing of medicinal products for medical use, including immunobiological medicinal products, by pharmacy organizations and individual entrepreneurs with a license for pharmaceutical activities. New rules from

Samvel Grigoryan talks about the new document regulating the procedure for dispensing medicines and coming into force on September 22

IP and IBLP

In general, in order No. 403n the topic of IBP release is spelled out separately, which is not in order 785. It will be regulated by paragraph 13 of the first mentioned act. This paragraph, in particular, determines that when an IBP is dispensed, the exact time of this same dispensing, in hours and minutes, is indicated on the prescription or prescription counterfoil, which remains with the buyer.

Violation of secondary

With the entry into force of Order No. 403n, new emphasis will appear on the topic of the possibility of violation of secondary (consumer) packaging of medicines. The “retiring” norm of Order No. 785 allows this to be done in exceptional cases, if the pharmacy organization is unable to fulfill the doctor’s prescription.

The order No. 403n that replaced it is in this regard more specific and more in line with modern requirements, medical practice and consumer demands. Paragraph 8 of the order determines that violation of secondary packaging and dispensing of a medicinal product in primary packaging is permitted in cases where the amount of the drug indicated in the prescription or required by the consumer (for over-the-counter dispensing) is less than the amount of the drug contained in the secondary packaging.

In this case, the buyer must be provided with instructions for use or a copy thereof, and tampering with the original packaging is prohibited. By the way, the new order does not contain the rule that in case of violation of the secondary order, the drug must be dispensed in pharmaceutical packaging with the obligatory indication of the name, factory batch, expiration date of the drug, series and date according to the laboratory packaging register, which is determined by order No. 785.

"The medicine has been released"

Clause 4 of Order No. 403n of the Ministry of Health of the Russian Federation regulates the topic of prescription forms and the list of drugs dispensed on them. In particular, narcotic and psychotropic drugs of Schedule II are dispensed using Form No. 107/u-NP, with the exception of narcotic and psychotropic drugs in the form of transdermal therapeutic systems.

The remaining prescription drugs, as is known, are dispensed using forms No. 107-1/u. According to paragraph 22 of the order of the Ministry of Health of the Russian Federation dated December 20, 2012 No. 1175n “On approval of the procedure for prescribing and prescribing medications, as well as forms of prescription forms...”, prescriptions written on the forms of this form are valid for two months from the date of prescription. However, for patients with chronic diseases, it is allowed to set the validity period of the prescription form No. 107-1/u within up to one year and exceed the recommended amount of the drug for prescribing per prescription, established by Appendix No. 2 of this order.

Such a prescription, which also indicates the periods and quantity of the drug dispensed (in each period), is returned to the buyer, of course, with the required notes on the date of dispensing, dosage and quantity of the drug dispensed. This is prescribed by paragraph 10 of order No. 403n. He also determines that the next time the patient comes to the pharmacy with the same prescription, the chief must take into account the notes on the previous dispensing of the drug.

The prescription remains at the pharmacy

There are some changes on the topic indicated in the title of this chapter. Paragraph 14 of the new order establishes that the retail trade entity retains (with the mark “The medicinal product is dispensed”) and stores:

within 5 years prescriptions for:

within 3 years prescriptions for:

within 3 months recipes for:

Order No. 403n of the Russian Ministry of Health did not come without a cherry on the cake, albeit a dubious one. Paragraph 15 of the order states that prescriptions not specified in the previous 14th paragraph (we listed them just above) are marked with the stamp “The drug has been dispensed” and are returned to the indicator. It seems to follow from this that prescriptions of form No. 107-1/y with a two-month validity period become “disposable”. We advise readers to pay special attention to this new norm.

The topic of combating the abuse of alcohol-containing drugs in pharmacies, which was recently trumpeted by the media, is also reflected in the new order on the rules of dispensing. According to the current procedure, prescriptions for such drugs are returned to the patient (with a “dispensed” stamp); under the new order, they must remain in the pharmacy organization.

To avoid getting caught

The procedure for working with incorrectly written prescriptions is now described in a little more detail (clause 15 of order No. 403n). In particular, when they are registered by a pharmacist in a journal, it is necessary to indicate the identified violations in the execution of the prescription, the full name of the health worker who wrote it, the name of the medical organization in which he works, and the measures taken.

Paragraph 17 of Order No. 403n contains the rule that a pharmacist does not have the right to provide false or incomplete information about the availability of drugs in the pharmacy’s assortment - including drugs that have the same INN - and also to hide information about the availability of drugs that have a lower price. Similar provisions are contained in subparagraph 2.4 of Article 74 of the Law of November 21, 2011 No. 323-FZ “On the fundamentals of protecting the health of citizens in the Russian Federation” and paragraph 54 of the Rules of Good Pharmacy Practice (Order of the Ministry of Health of the Russian Federation dated August 21, 2016 No. 647n). The only thing new here is that this rule appears for the first time in the order on vacation rules.

This was a review of the order, so to speak, “on fresh trail.” Readers will probably find in it other points and norms that deserve special attention. Write to the editors of Katren-Style magazine about them, and we will address your questions to leading industry experts. We will also ask them about the problem of “disposable” prescriptions with a two-month validity period, which was mentioned above, as well as the dispensing of ethyl alcohol and alcohol-containing drugs in the light of the provisions of the new order No. 403n.

Materials about the order of the Ministry of Health No. 403n:

What could be more important for a pharmacy organization than the order in which medications are dispensed. Pharmacists barely had time to return from their summer vacation and look around when a new order of the Ministry of Health of the Russian Federation dated July 11, 2017 No. 403n was published with appendices “On approval of the rules for the dispensing of drugs for medical use, including immunobiological drugs, by pharmacy organizations, individual entrepreneurs with license for pharmaceutical activities." Order No. 403n on the vacation procedure was registered with the Ministry of Justice of the Russian Federation on September 8; its validity begins on September 22 of the current year.

The first thing I want to say in this regard is that now forget the number “785”. The new order 403n with amendments and additions invalidates the well-known order of the Ministry of Health and Social Development dated December 14, 2005 No. 785 “On the procedure for dispensing medicines,” as well as the orders of the Ministry of Health and Social Development No. 302, No. 109 and No. 521 that amended it. At the same time, many points of a new regulatory legal act repeat - sometimes almost verbatim - the corresponding fragments of the predecessor order. But there are also differences, new provisions, on which we will focus more, setting out the first observations and notes in the margins of the freshly issued order of the Ministry of Health No. 403n.

IP and IBLP

Order of the Ministry of Health of the Russian Federation No. 403n consists of three appendices. The first approves new rules for the dispensing of medicinal products, including immunobiological medicinal products (IBP); the second is the requirements for the dispensing of narcotic and psychotropic drugs, drugs with anabolic activity, and other drugs subject to subject-quantitative accounting (SQR). The third appendix establishes the rules for the dispensing of medicines according to the invoice requirements of medical organizations, as well as individual entrepreneurs (IP) with a license for medical activities.

Under the new order, the dispensing of over-the-counter drugs will be allowed both to pharmacies and pharmacy points, as well as individual entrepreneurs and pharmacy kiosks. For the rest, if we summarize points 2 and 3 of order No. 403n and the list of drugs, the following picture emerges.

The dispensing of narcotic and psychotropic drugs can only be carried out by pharmacies and pharmacy points that have the appropriate license.
The remaining prescription drugs are dispensed by pharmacies, pharmacy points and individual entrepreneurs (of course, those with a license for pharmaceutical activities - this clarification will be further considered accepted by default and omitted).
The dispensing of immunobiological prescription drugs is carried out by pharmacies and pharmacy points. Individual entrepreneurs are not mentioned in this provision of paragraph 3, which means that they cannot dispense drugs of this group, which we advise you to pay special attention to.

In general, in order No. 403n the procedure for dispensing IBP drugs is prescribed separately, which is not in order 785. It will be regulated by paragraph 13 of the first mentioned act. This paragraph, in particular, determines that when an IBP is dispensed, the exact time of this same dispensing, in hours and minutes, is indicated on the prescription or prescription counterfoil, which remains with the buyer.

IBLP can be released if two conditions are met. Firstly, if the buyer has a special thermal container in which the required mode of transportation and storage of these thermolabile drugs can be observed. The second condition is an explanation (from the pharmacist to the buyer) of the need to deliver this drug to a medical organization, despite the fact that it can be stored in the mentioned container for no more than 48 hours.

Let us recall in this regard that this topic is also regulated by subclause 8.11.5 of the Sanitary and Epidemiological Rules “Conditions for transportation and storage of immunobiological preparations” (SP 3.3.2.3332–16), which were approved by Resolution of the Chief State Sanitary Inspector of the Russian Federation dated February 17, 2016 No. 19 It obliges the pharmacy employee to instruct the buyer on the need to comply with the “cold chain” when transporting biopharmaceutical products.

The fact of this instruction is recorded with a mark on the drug packaging, prescription or other accompanying document. The mark is certified by the signature of the buyer and the chief clerk (or another representative of the pharmacy organization) and also includes the date and time of dispensing. However, the SanPiN does not specify that the time in this case should be indicated in hours and minutes.

Violation of secondary

With the amendments and additions to Order No. 403n, new emphasis will appear on the topic of the possibility of violation of secondary (consumer) packaging of medicines. The “retiring” norm of Order No. 785 allows this to be done in exceptional cases, if the pharmacy organization is unable to fulfill the doctor’s prescription.

The order No. 403n that replaced it with a list of drugs in this regard is more specific and more in line with modern requirements, medical practice and consumer demands. Paragraph 8 of the order determines that violation of secondary packaging and dispensing of a medicinal product in primary packaging is permitted in cases where the amount of the drug indicated in the prescription or required by the consumer (for over-the-counter dispensing) is less than the amount of the drug contained in the secondary packaging.

In this case, the buyer must be provided with instructions for use or a copy thereof, and tampering with the original packaging is prohibited. By the way, in the new order of the Ministry of Health of the Russian Federation No. 403n there is no provision that in case of violation of the secondary drug must be dispensed in pharmaceutical packaging with the obligatory indication of the name, factory series, expiration date of the drug, series and date according to the laboratory packaging register, which is determined by order No. 785.

What does this mean in practice? Let's assume two situations: first - drug X tablets (or dragees) No. 56, primary packaging - blister; the second is drug N tablets No. 56, in a bottle. And in both cases, the question arises about its release to the patient who has presented the chief of staff with a prescription on which, say, 28 tablets or 42 tablets (dragées) are prescribed.

It is clear that in the first case this is acceptable, since it is possible to dispense 28 or 42 tablets without breaking the primary packaging (blister), and in the second case it is unacceptable, since the primary packaging in this situation is a bottle, and breaking it is strictly prohibited. So, our first capital officials do not have the right to count out tablets or dragees from a bottle, as they do in pharmacies in some foreign countries.

"The medicine has been released"

According to form No. 148–1/у-88 the following are issued:

Schedule III psychotropic drugs;
narcotic and psychotropic drugs of Schedule II in the form of transdermal therapeutic systems;
drugs included in the list of drugs subject to PCU, with the exception of those drugs that are dispensed in form No. 107/u-NP;
drugs that have anabolic activity and are classified as anabolic steroids according to the anatomical-therapeutic-chemical classification (ATC) recommended by the World Health Organization (code A14A);
drugs specified in paragraph 5 of the “Procedure for dispensing to individuals medicinal products containing, in addition to small quantities of narcotic drugs, psychotropic substances and their precursors, other pharmacological active substances” (order of the Ministry of Health and Social Development of the Russian Federation dated May 17, 2012 No. 562n);
preparations manufactured according to a prescription for a medicinal product and containing a narcotic drug or psychotropic substance included in Schedule II and other pharmacological active substances in a dose not exceeding the highest single dose, and provided that this combined medicinal product is not a narcotic or psychotropic drug Schedule II drug.

The list of other prescription drugs, as is known, is dispensed on form No. 107-1/u. According to paragraph 22 of the order of the Ministry of Health of the Russian Federation dated December 20, 2012 No. 1175n “On approval of the procedure for prescribing and prescribing medications, as well as forms of prescription forms...”, prescriptions written on the forms of this form are valid for two months from the date of prescription. However, for patients with chronic diseases, it is allowed to set the validity period of the prescription form No. 107-1/u within up to one year and exceed the recommended amount of the drug for prescribing per prescription, established by Appendix No. 2 of this order.

Such a prescription, which also indicates the periods and quantity of the drug dispensed (in each period), is returned to the buyer, of course, with the required notes on the date of dispensing, dosage and quantity of the drug dispensed. This is prescribed by paragraph 10 of order No. 403n. It also determines that the next time the patient comes to the pharmacy with the same prescription for a list of drugs, the chief must take into account the notes on the previous dispensing of the drug.

When the maximum quantity specified in the prescription is purchased, it must be stamped “Dispensed.” And a one-time release of the entire quantity, according to the same paragraph, is allowed only in agreement with the doctor who wrote this prescription.

The prescription remains at the pharmacy

There are some changes on the topic indicated in the title of this chapter. Paragraph 14 of the new order No. 403n of the Ministry of Health establishes that the retail trade entity retains (with the mark “The medicinal product is dispensed”) and stores:

within 5 years prescriptions for:

narcotic and psychotropic drugs of Schedule II, psychotropic drugs of List III (according to the outgoing 785th order, they are stored for 10 years);

within 3 years prescriptions for:

drugs dispensed free of charge or at a discount (according to forms No. 148–1/u-04 (l) or No. 148–1/u-06 (l));
combination drugs containing narcotic drugs or psychotropic substances included in Schedules II and III, manufactured in a pharmacy, drugs with anabolic activity, drugs subject to PCU;

within 3 months recipes for:

drugs in liquid dosage form containing more than 15% ethyl alcohol by volume of the finished product, other drugs classified by ATC as antipsychotics (code N05A), anxiolytics (code N05B), hypnotics and sedatives (code N05C), antidepressants (code N06A ) and not subject to PCU.

Note that Order 785 does not contain this group of recipes for three-month storage.

Order No. 403n of the Ministry of Health did not come without a cherry on the cake, albeit a dubious one. Paragraph 15 of the order states that prescriptions not listed in the previous 14th paragraph (we listed them just above) are marked with the stamp “The drug has been dispensed” and are returned to the indicator. It seems to follow from this that prescriptions of form No. 107-1/y with a two-month validity period become “disposable”. We advise readers to pay special attention to this new norm.

The topic of combating the abuse of alcohol-containing drugs in pharmacies, which was recently trumpeted by the media, is also reflected in the new order on the procedure for dispensing drugs. According to the current procedure, prescriptions for such drugs are returned to the patient (with a “dispensed” stamp); under the new order, they must remain in the pharmacy organization.

To avoid getting caught

The procedure for dispensing incorrectly written prescriptions is now described in a little more detail (clause 15 of order No. 403n). In particular, when they are registered by a pharmacist in a journal, it is necessary to indicate the identified violations in the execution of the prescription, the full name of the health worker who wrote it, the name of the medical organization in which he works, and the measures taken.

According to this clause, when dispensing a drug, the pharmacist informs the buyer not only about the regimen and doses, but also about the rules for storing it at home and interactions with other drugs.

In theory this means the following. The pharmaceutical inspector can approach the first table in the guise of an ordinary buyer - so to speak, make a test purchase. And if the inspector, when dispensing the medicine, does not inform him, for example, that this medicine must be stored at a temperature no higher than 25 ° C, or does not ask whether he is currently taking other medicines, then the inspector can “throw off the mask” and draw up an act of administrative violation. So the norm in paragraph 16 is serious and fraught. And, of course, it requires that the chief captain be thoroughly versed in the complex and voluminous topic of drug interactions.

Paragraph 17 of Order No. 403n, as amended, contains the rule that a pharmacist does not have the right to provide false or incomplete information about the availability of drugs in the pharmacy product range - including drugs that have the same INN - and also to hide information about the availability of drugs that have a lower price . Similar provisions are contained in subparagraph 2.4 of Article 74 of the Law dated November 21, 2011 No. 323 Federal Law “On the fundamentals of protecting the health of citizens in the Russian Federation” and paragraph 54 of the Rules of Good Pharmacy Practice (Order of the Ministry of Health of the Russian Federation dated August 21, 2016 No. 647n). The only thing new here is that this rule appears for the first time in the order on the vacation procedure.

These were explanations of order No. 403n, so to speak, “on a fresh trail.” Readers will probably find in it other points and norms that deserve special attention. Write to the editors of Katren-Style magazine about them, and we will address your questions to leading industry experts. We will also ask them about the problem of “disposable” prescriptions with a two-month validity period, which was mentioned above, as well as the dispensing of ethyl alcohol and alcohol-containing drugs in light of the provisions of the new Order No. 403 of the Ministry of Health.

On October 5, a webinar by Larisa Garbuzova, Ph.D. will be held on our website. D., Associate Professor of the Department of Management and Economics of Pharmacy at Northwestern State Medical University (St. Petersburg), dedicated, and on October 25, Executive Director of the National Pharmaceutical Chamber Elena Nevolina on the same topic. Register for both webinars.

Materials on the order of the Ministry of Health No. 403n.

Application. Rules for the dispensing of medicinal products for medical use, including immunobiological medicinal products, by pharmacy organizations and individual entrepreneurs with a license for pharmaceutical activities

Order of the Ministry of Health of the Russian Federation dated July 11, 2017 N 403n
"On approval of the rules for the dispensing of medicinal products for medical use, including immunobiological medicinal products, by pharmacy organizations and individual entrepreneurs with a license for pharmaceutical activities"

2. To recognize as invalid:

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” (registered by the Ministry of Justice of the Russian Federation on January 16, 2006, registration N 7353);

Order of the Ministry of Health and Social Development of the Russian Federation dated April 24, 2006 N 302 “On amendments to the order of the Ministry of Health and Social Development of the Russian Federation dated December 14, 2005 N 785” (registered by the Ministry of Justice of the Russian Federation on May 16, 2006, registration N 7842);

Order of the Ministry of Health and Social Development of the Russian Federation dated February 12, 2007 N 109 "On amendments to the Procedure for the dispensing of medicines, approved by order of the Ministry of Health and Social Development of the Russian Federation dated December 14, 2005 N 785" (registered by the Ministry of Justice of the Russian Federation March 30, 2007, registration N 9198);

Order of the Ministry of Health and Social Development of the Russian Federation dated August 6, 2007 N 521 "On amendments to the Procedure for the dispensing of medicines, approved by order of the Ministry of Health and Social Development of the Russian Federation dated December 14, 2005 N 785" (registered by the Ministry of Justice of the Russian Federation August 29, 2007, registration N 10063).

IN AND. Skvortsova

New rules for the dispensing of drugs for medical use, including immunobiological ones, by pharmacies and individual entrepreneurs with a pharmaceutical license have been approved.

Medicines are dispensed without a prescription, by prescription and according to the invoice requirements of medical organizations and individual entrepreneurs with a license for medical activities. The rules apply to pharmacies, pharmacy points, pharmacy kiosks and individual entrepreneurs with a license for pharmaceutical activities. Of these, only pharmacies and pharmacy points can dispense prescription drugs, as well as narcotic and psychotropic drugs. To release the latter, you must have an appropriate license.

As before, separate prescription forms are provided for psychotropic drugs; free medicines; for others. It is clarified what drugs are dispensed for them. Prescription service times have been kept the same.

The specifics of dispensing an immunobiological drug have been established. Thus, on the prescription or prescription stub, which remains with the purchaser, the exact time (in hours and minutes) of dispensing is indicated. In this case, the purchaser must have a special thermal container. The first receives clarification on the delivery time of the drug to the medical facility.

The shelf life of recipes has been clarified.

The requirements for the dispensing of narcotic and psychotropic, anabolic drugs, as well as drugs subject to subject-quantitative accounting, have been revised.

The order of the Russian Ministry of Health and Social Development on the procedure for dispensing medicines (taking into account the changes made) has become invalid.

Order of the Ministry of Health of the Russian Federation dated July 11, 2017 N 403n “On approval of the rules for the dispensing of drugs for medical use, including immunobiological drugs, by pharmacy organizations and individual entrepreneurs with a license for pharmaceutical activities”

This order comes into force on September 22, 2017.

Dear Colleagues! We inform you that the Order of the Ministry of Health of Russia dated July 11, 2017 N 403n “On approval of the rules for the dispensing of drugs for medical use, including immunobiological drugs, by pharmacy organizations and individual entrepreneurs with a license for pharmaceutical activities” was issued. Registered with the Ministry of Justice of Russia on September 08. 2017 N 48125. Enters into force on September 22, 2017. The Russian Ministry of Health has updated the procedure for dispensing medicines from pharmacies. New rules for dispensing medicines for medical use, including immunobiological ones, by pharmacies and individual entrepreneurs with a pharmaceutical license have been approved. Medicines are dispensed without a prescription, by prescription and according to the invoice requirements of medical organizations and individual entrepreneurs with a license for medical activities. The rules apply to pharmacies, pharmacy points, pharmacy kiosks and individual entrepreneurs with a license for pharmaceutical activities. Of these, only pharmacies and pharmacy points can dispense prescription drugs, as well as narcotic and psychotropic drugs. To release the latter, you must have an appropriate license. As before, separate prescription forms are provided for psychotropic drugs; free medicines; for others. It is clarified what drugs are dispensed for them. Prescription service times have been kept the same. The specifics of dispensing an immunobiological drug have been established. Thus, on the prescription or prescription stub, which remains with the purchaser, the exact time (in hours and minutes) of dispensing is indicated. In this case, the purchaser must have a special thermal container. The first receives clarification on the delivery time of the drug to the medical facility. The shelf life of recipes has been clarified. The requirements for the dispensing of narcotic and psychotropic, anabolic drugs, as well as drugs subject to subject-quantitative accounting, have been revised. The order of the Russian Ministry of Health and Social Development on the procedure for dispensing medicines (taking into account the changes made) has become invalid. The order, among other things, determines: - types of medications that can be dispensed by pharmacies, pharmacy points, pharmacy kiosks, and individual entrepreneurs with the appropriate license; - features of the dispensing of narcotic drugs, psychotropic drugs, immunobiological drugs; - the period during which medications are dispensed, including those marked in the prescription “statim” (immediately) and “cito” (urgently); - requirements for primary and secondary packaging of a medicinal product dispensed from a pharmacy; - shelf life of prescriptions for dispensed drugs in a pharmacy organization; - responsibilities of a pharmacy employee when identifying prescriptions issued in violation of the rules for their execution; - features of the dispensing of drugs subject to subject-quantitative accounting; - features of the dispensing of drugs according to the invoice requirements of medical organizations and individual entrepreneurs with a license for medical activities. Order of the Ministry of Health and Social Development of Russia dated December 14, 2005 N 785 “On the Procedure for Dispensing Medicines” with the amendments and additions made to it is considered invalid.

MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

ORDER

Additionally, see letter of the Ministry of Health of Russia dated September 27, 2017 N 2853/25-4 "Explanation of the norms of the order dated July 11, 2017 N 403n" On approval of the rules for the dispensing of drugs for medical use, including immunobiological drugs, by pharmacy organizations and individual entrepreneurs who have a license for pharmaceutical activities" and a letter from the Ministry of Health of Russia dated October 24, 2017 N 3095/25-4 "Additional clarifications of the norms of the order dated July 11, 2017 N 403n "On approval of the rules for the dispensing of drugs for medical use, including immunobiological drugs drugs, pharmacy organizations, individual entrepreneurs with a license for pharmaceutical activities." - Database manufacturer's note.
_____________________________________________________________________________________________

In accordance with Article 55 of the Federal Law of April 12, 2010 N 61-FZ “On the Circulation of Medicines” (Collection of Legislation of the Russian Federation, 2010, N 16, Art. 1815; N 31, Art. 4161; 2013; N 48, Art. 6165; 2014, N 52, Art. 7540; 2015, N 29, Art. 4388; 2016, N 27, Art. 4238), paragraph 3 of Article 12 of the Federal Law of September 17, 1998 N 157-FZ "On immunoprophylaxis of infectious diseases" (Collected Legislation of the Russian Federation, 1998, N 38, Art. 4736; 2009, N 1, Art. 21; 2013, N 48, Art. 6165) and subparagraphs 5.2.169, 5.2.183 of the Regulations on the Ministry of Health Russian Federation, approved by Decree of the Government of the Russian Federation of June 19, 2012 N 608 (Collection of Legislation of the Russian Federation, 2012, N 26, Art. 3526; 2013, N 16, Art. 1970; N 20, Art. 2477; N 22, Art. 2812; N 33, Art. 4386; N 45, Art. 5822; 2014, N 12, Art. 1296; N 26, Art. 3577; N 30, Art. 4307; N 37, Art. 4969; 2015, N 2, art. 491; N 12, art. 1763; N 23, art. 3333; 2016, N 2, art. 325; N 9, art. 1268; N 27, art. 4497; N 28, art. 4741; N 34, art. 5255; N 49, art. 6922; 2017, N 7, art. 1066),

I order:

1. Approve the rules for the dispensing of medicinal products for medical use, including immunobiological medicinal products, by pharmacy organizations and individual entrepreneurs with a license for pharmaceutical activities, in accordance with the appendix.

2. To recognize as invalid:

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” (registered by the Ministry of Justice of the Russian Federation on January 16, 2006, registration N 7353);

Order of the Ministry of Health and Social Development of the Russian Federation dated April 24, 2006 N 302 “On amendments to the order of the Ministry of Health and Social Development of the Russian Federation dated December 14, 2005 N 785” (registered by the Ministry of Justice of the Russian Federation on May 16, 2006, registration N 7842);

Order of the Ministry of Health and Social Development of the Russian Federation dated February 12, 2007 N 109 "On amendments to the Procedure for the dispensing of medicines, approved by order of the Ministry of Health and Social Development of the Russian Federation dated December 14, 2005 N 785" (registered by the Ministry of Justice of the Russian Federation March 30, 2007, registration N 9198);

Order of the Ministry of Health and Social Development of the Russian Federation dated August 6, 2007 N 521 "On amendments to the Procedure for the dispensing of medicines, approved by order of the Ministry of Health and Social Development of the Russian Federation dated December 14, 2005 N 785" (registered by the Ministry of Justice of the Russian Federation August 29, 2007, registration N 10063).

Minister
V.I.Skvortsova

Registered
at the Ministry of Justice
Russian Federation
September 8, 2017,
registration N 48125

Application. Rules for the dispensing of medicinal products for medical use, including immunobiological medicinal products, by pharmacy organizations and individual entrepreneurs with a license for pharmaceutical activities

Application
to the order
Ministry of Health
Russian Federation
dated July 11, 2017 N 403n

I. General requirements for the dispensing of medicinal products for medical use

1. These rules determine the procedure for the dispensing of medicinal products for medical use, including immunobiological medicinal products (hereinafter - medicinal products), by pharmacy organizations and individual entrepreneurs with a license for pharmaceutical activities (hereinafter - retail trade entities), without a prescription and (or ) according to a prescription for a medicinal product written out in the prescribed manner by medical workers, as well as according to the requirements-invoices of an organization engaged in medical activities (hereinafter referred to as the medical organization), or an individual entrepreneur who has a license for medical activities (hereinafter referred to as the prescription, the requirement-invoice ).
________________
Subparagraph "h" of paragraph 5 of part 4 of Article 18, subparagraph "k" of paragraph 1 of part 1 of Article 33 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 42, Art. 5293; N 49, Art. 6409; 2014, N 52, Art. 7540).

Orders of the Ministry of Health of the Russian Federation:

(registered by the Ministry of Justice of the Russian Federation on June 25, 2013, registration N 28883), as amended by orders of the Ministry of Health of the Russian Federation dated December 2, 2013 N 886n (registered by the Ministry of Justice of the Russian Federation on December 23, 2013, registration N 30714) , dated June 30, 2015 N 386n (registered by the Ministry of Justice on August 6, 2015, registration N 38379) and dated April 21, 2016 N 254n order N 1175n);

(registered by the Ministry of Justice of the Russian Federation on August 15, 2012, registration N 25190), as amended by orders of the Ministry of Health of the Russian Federation dated June 30, 2015 N 385n (registered by the Ministry of Justice of the Russian Federation on November 27, 2015, registration N 39868) and dated April 21, 2016 N 254n (registered by the Ministry of Justice of the Russian Federation on July 18, 2016, registration N 42887) (hereinafter referred to as Order N 54n).

2. Dispensing of medications without prescriptions is carried out:

pharmacies;

pharmacy points;

pharmacy kiosks;

individual entrepreneurs with a license for pharmaceutical activities (hereinafter referred to as individual entrepreneurs).

3. Dispensing of prescription drugs is carried out:

pharmacies;

pharmacy points;

individual entrepreneurs (with the exception of the sale of narcotic drugs and psychotropic substances included in the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation, approved by Decree of the Government of the Russian Federation of June 30, 1998 N 681 (hereinafter referred to as the List, respectively) .
________________
Collection of Legislation of the Russian Federation, 1998, No. 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, 6720; 2011, N 10, art. 1390; N 12, art. 1635; N 29, art. 4466, 4473; N 42, art. 5921; N 51, art. 7534; 2012, N 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; N 25, art. 3159; N 29, art. 3962; N 37, art. 4706; N 46, art. 5943; N 51, art. 6869; 2014, N 14, art. 1626; N 23, art. 2987; N 27, art. 3763; N 44, art. 6068; N 51, art. 7430; 2015, N 11, art. 1593; N 16, art. 2368; N 20, art. 2914; N 28, art. 4232; N 42, art. 5805; 2016, N 15, art. 2088; 2017, N 4, art. 671; N 10, art. 1481.

The dispensing of narcotic and psychotropic drugs according to prescriptions is carried out by pharmacies and pharmacy points that have a license to operate in the circulation of narcotic drugs, psychotropic substances and their precursors, and the cultivation of narcotic plants.

Immunobiological drugs are dispensed according to prescriptions by pharmacies and pharmacy points.

4. Form N 107/u-NP, narcotic and psychotropic drugs included in the List of Narcotic Drugs and Psychotropic Substances, the circulation of which is limited in the Russian Federation and in respect of which control measures are established in accordance with the legislation of the Russian Federation and international treaties of the Russian Federation, are dispensed. (list II), List (hereinafter referred to as narcotic and psychotropic drugs of list II), with the exception of narcotic and psychotropic drugs in the form of transdermal therapeutic systems.
________________
Appendices No. 1 and 2 to order No. 54n.

According to prescriptions written out on prescription forms N 148-1/у-88, the following are dispensed:
________________
Clause 9 of the procedure for prescribing and prescribing medications, approved by Order N 1175n.

psychotropic medicinal products included in the List of psychotropic substances, the circulation of which is limited in the Russian Federation and in respect of which certain control measures may be excluded in accordance with the legislation of the Russian Federation and international treaties of the Russian Federation (List III), the List (hereinafter referred to as psychotropic medicinal products of List III );

narcotic and psychotropic drugs of list II in the form of transdermal therapeutic systems;

medicines included in the list of medicines for medical use subject to subject-quantitative registration, with the exception of medicines specified in paragraphs one and three of this paragraph, and medicines sold without a prescription (hereinafter referred to as medicines subject to subject-quantitative registration );
________________
Order of the Ministry of Health of the Russian Federation dated April 22, 2014 N 183n “On approval of the list of medicines for medical use subject to subject-quantitative registration” (registered by the Ministry of Justice of the Russian Federation on July 22, 2014, registration N 33210) as amended by the order Ministry of Health of the Russian Federation dated September 10, 2015 N 634n

drugs with anabolic activity (in accordance with the main pharmacological action) and classified according to the anatomical-therapeutic-chemical classification recommended by the World Health Organization (hereinafter - ATC) as anabolic steroids (code A14A) (hereinafter - drugs with anabolic activity );
________________
Subparagraph 3 of paragraph 9 of the procedure for prescribing and prescribing medications, approved by order N 1175n.

medicinal products specified in paragraph 5 of the Procedure for dispensing medicinal products to individuals for medical use, containing, in addition to small quantities of narcotic drugs, psychotropic substances and their precursors, other pharmacological active substances, approved by order of the Ministry of Health and Social Development of the Russian Federation dated May 17, 2012 N 562n;
________________
Registered by the Ministry of Justice of the Russian Federation on June 1, 2012, registration N 24438, as amended by orders of the Ministry of Health of the Russian Federation dated June 10, 2013 N 369n (registered by the Ministry of Justice of the Russian Federation on July 15, 2013, registration N 29064), dated August 21, 2014 N 465n (registered by the Ministry of Justice of the Russian Federation on September 10, 2014, registration N 34024), dated September 10, 2015 N 634n (registered by the Ministry of Justice of the Russian Federation on September 30, 2015, registration N 39063).

medicinal products manufactured according to a prescription for a medicinal product and containing a narcotic drug or psychotropic substance included in List II of the List, and other pharmacological active substances in a dose not exceeding the highest single dose, and provided that this combined medicinal product is not a narcotic or Schedule II psychotropic drug.

According to prescriptions written on prescription forms, form N 148-1/u-04 (l) or form N 148-1/u-06 (l), medications are dispensed and prescribed to citizens entitled to receive free medications or receive medications with a discount (hereinafter referred to as medications sold free of charge or at a discount).

According to prescriptions written out on prescription forms of form N 107-1/u, other medications not specified in paragraphs one, three through nine of this paragraph are dispensed, with the exception of medications sold without a prescription.

5. The dispensing of medications not specified in paragraph 4 of these Rules, in accordance with the instructions for their medical use, is carried out without prescriptions.

6. Medicines are dispensed during the validity period specified in the prescription when a person contacts a retail trade entity.

If a retail trade entity does not have the medicinal product specified in the prescription, when the person contacts the retail trade entity, the prescription is accepted for servicing within the following terms (hereinafter referred to as deferred servicing):

a prescription marked “statim” (immediately) is served within one business day from the date the person contacts the retail trade entity;

a prescription marked “cito” (urgent) is served within two working days from the date the person contacts the retail trade entity;

a prescription for a medicinal product included in the minimum range of medicinal products for medical use necessary for the provision of medical care is serviced within five working days from the date of the person’s application to the retail trade entity;
________________
Order of the Government of the Russian Federation of December 26, 2015 N 2724-r (Collected Legislation of the Russian Federation, 2016, N 2, Art. 413).

a prescription for a medicinal product that is dispensed free of charge or at a discount and is not included in the minimum range of medicinal products for medical use required for the provision of medical care is serviced within ten working days from the date the person contacts the retail trade entity;

prescriptions for medications prescribed by decision of the medical commission are serviced within fifteen working days from the date the person contacts the retail trade entity.

Do not fill expired prescriptions unless the prescription expired while it was on deferred maintenance.

If a prescription expires while it is under deferred servicing, the medicinal product for such a prescription is dispensed without reissuing it.

7. Medicines are dispensed in the quantity specified in the prescription, except for cases where the maximum permissible or recommended quantity for prescribing per prescription is established for the medicine.
________________
Appendices No. 1 and No. 2 to the procedure for prescribing and prescribing medications, approved by Order No. 1175n.

When a prescription is presented that exceeds the maximum permissible or recommended amount of a medicinal product for prescribing per prescription, the pharmacist informs the person who submitted the prescription about this to the head of the relevant medical organization and releases to the specified person the correspondingly established maximum permissible or recommended amount of the medicinal product for prescribing per prescription. by putting the appropriate mark in the recipe.

If a retail trade entity has a medicinal product with a dosage different from the dosage of the medicinal product specified in the prescription, dispensing of the existing medicinal product is allowed if the dosage of such medicinal product is less than the dosage specified in the prescription. In this case, the amount of the drug is recalculated taking into account the course of treatment specified in the prescription.

If the dosage of a medicinal product available to a retail trade entity exceeds the dosage of the medicinal product specified in the prescription, the decision to dispense the medicinal product with such dosage is made by the medical professional who wrote the prescription.

8. Dispensing of a medicinal product is carried out in primary and secondary (consumer) packaging, the labeling of which must meet the requirements of Article 46 of the Federal Law of April 12, 2010 N 61-FZ “On the Circulation of Medicines”, and packaging for narcotic and psychotropic medicinal products of the list II - the requirements of paragraph 3 of Article 27 of the Federal Law of January 8, 1998 N 3-FZ "On Narcotic Drugs and Psychotropic Substances".
________________
Collection of Legislation of the Russian Federation, 2010, No. 16, Art. 1815; N 42, art. 5293; 2014, N 52, art. 7540.

Collection of Legislation of the Russian Federation, 1998, No. 2, Art. 219; 2012, N 53, art. 7630; 2013, N 48, art. 6165; 2015, N 1, art. 54.

Tampering with the primary packaging of the medicinal product when dispensing it is prohibited.

Violation of the secondary (consumer) packaging of the medicinal product and dispensing of the medicinal product in the primary packaging is permitted if the amount of the medicinal product specified in the prescription or required by the person purchasing the medicinal product (for over-the-counter dispensing) is less than the amount of the medicinal product contained in the secondary (consumer) packaging. ) packaging. In this case, when dispensing a medicinal product, the person purchasing the medicinal product is provided with instructions (a copy of the instructions) for the use of the dispensed medicinal product.

9. When dispensing drugs according to a prescription, the pharmacist puts a mark on the prescription about the dispensing of the drug indicating:

name of the pharmacy organization (last name, first name, patronymic (if any) of the individual entrepreneur);

trade name, dosage and quantity of the drug dispensed;

last name, first name, patronymic (if any) of the medical worker in the cases specified in paragraph four of clause 7 and paragraph three of clause 10 of these Rules;

details of the identity document of the person who received the medicinal product, in the case specified in paragraph 20 of these Rules;

surname, name, patronymic (if any) of the pharmaceutical worker who dispensed the medicinal product, and his signature;

date of release of the drug.

10. When dispensing medicinal products according to a prescription written out on prescription form Form N 107-1/u, which is valid for one year, and which indicates the periods and quantity of dispensing of the medicinal product (in each period), the prescription is returned to the person purchasing the medicinal product. drug, with a mark containing the information specified in paragraph 9 of these Rules.
________________
Appendix No. 2 to the procedure for prescribing and prescribing medications, approved by Order No. 1175n.

The next time a person contacts a retail trade entity with this prescription, the notes on the previous dispensing of the medicinal product according to such a prescription are taken into account and in the event that the person purchased a quantity of the medicinal product corresponding to the maximum quantity specified by the medical professional in the prescription, as well as after the expiration of the prescription, on the prescription a stamp “The drug has been dispensed” is affixed and the prescription is returned to the person.

A one-time dispensing of a medicinal product according to a prescription written out on prescription form Form N 107-1/u, which is valid for one year (13), and which indicates the periods and quantity of dispensing of the medicinal product (in each period), is allowed only in agreement with by the health care professional who wrote the prescription.

11. When dispensing medications according to a prescription written on a prescription form, Form N 148-1/u-04 (l) or Form N 148-1/u-06 (l), the completed counterfoil of such a prescription is handed over by the pharmacist to the person purchasing ( receiving) medications.

12. When dispensing a narcotic and psychotropic drug of List II, a seal of the pharmacy or pharmacy point is affixed to the prescription for the dispensing of the drug, which indicates their full name (if there is a seal).

13. When dispensing an immunobiological medicinal product, the exact time (in hours and minutes) of dispensing the medicinal product is indicated on the prescription or prescription counterfoil, which remains with the person purchasing (receiving) the medicinal product.

The release of an immunobiological medicinal product is carried out to the person purchasing (receiving) the medicinal product, if he has a special thermal container in which the medicinal product is placed, with an explanation of the need to deliver this medicinal product to a medical organization, subject to storage in a special thermal container for a period not exceeding 48 hours after its acquisition.

14. Recipes (with the mark “The medicinal product is dispensed”) remain and are stored by the retail trade entity for:

narcotic and psychotropic drugs of list II, list III - for five years;

medicines dispensed free of charge or at a discount - for three years;

combined medicinal products containing narcotic drugs or psychotropic substances included in lists II and III of the List, manufactured in a pharmacy organization, medicinal products with anabolic activity, medicinal products subject to subject-quantitative accounting - for three years;

medicinal products in liquid dosage form containing more than 15% ethyl alcohol by volume of the finished product, other medicinal products classified by ATC as antipsychotics (code N05A), anxiolytics (code N05B), hypnotics and sedatives (code N05C), antidepressants ( code N06A) and not subject to subject-quantitative accounting - within three months.

15. Prescriptions not specified in paragraph 14 of these Rules are marked with the stamp “The medicinal product is dispensed” and are returned to the person who received the medicinal product.

Prescriptions written in violation of the established rules are registered in a journal in which the identified violations in the execution of the prescription are indicated, the last name, first name, patronymic (if any) of the medical worker who wrote the prescription, the name of the medical organization, the measures taken, are marked with the stamp “The prescription is invalid” and returned to the person who submitted the prescription. The retail trade entity informs the head of the relevant medical organization about facts of violation of the rules for filling prescriptions.
________________
Order N 1175n and order N 54n.

16. When dispensing a medicinal product, the pharmacist informs the person purchasing (receiving) the medicinal product about the regimen and doses of its administration, storage rules at home, and interactions with other medications.

17. When dispensing a medicinal product, a pharmacist does not have the right to provide false and (or) incomplete information about the availability of medicinal products, including medicinal products that have the same international nonproprietary name, including hiding information about the availability of medicinal products that have a lower price.
________________
(Collected Legislation of the Russian Federation, 2011, No. 48, Art. 6724; 2013, No. 48, Art. 6165).

18. Dispensing counterfeit, substandard and counterfeit medicines is prohibited.
________________
.

II. Requirements for the dispensing of narcotic and psychotropic drugs, drugs with anabolic activity, and other drugs subject to subject-quantitative accounting

19. The dispensing of narcotic and psychotropic drugs, drugs with anabolic activity, drugs subject to subject-quantitative accounting is carried out by pharmaceutical workers holding positions included in the list of positions of pharmaceutical and medical workers in organizations that are granted the right to dispense narcotic drugs and psychotropic medications to individuals, approved by order of the Ministry of Health of the Russian Federation dated September 7, 2016 N 681n (registered by the Ministry of Justice of the Russian Federation on September 21, 2016, registration N 43748).

20. Narcotic and psychotropic drugs of List II, with the exception of drugs in the form of transdermal therapeutic systems, are dispensed upon presentation of an identification document to the person indicated in the prescription, his legal representative or a person who has a power of attorney issued in accordance with the legislation of the Russian Federation the right to receive such narcotic and psychotropic medications.
________________
In relation to the person specified in part 2 of Article 20 of the Federal Law of November 21, 2011 N 323-FZ “On the fundamentals of protecting the health of citizens in the Russian Federation” (Collected Legislation of the Russian Federation, 2011, N 48, Art. 6724; 2012, N 26, Art. 3442, 3446; 2013, N 27, Art. 3459, 3477; N 30, Art. 4038; N 39, Art. 4883; N 48, Art. 6165; N 52, Art. 6951; 2014, N 23, art. 2930; N 30, art. 4106, 4206, 4244, 4247, 4257; N 43, art. 5798; N 49, art. 6927, 6928; 2015, N 1, art. 72, 85; N 10 , art. 1403, 1425; N 14, art. 2018; N 27, art. 3951; N 29, art. 4339, 4356, 4359, 4397; N 51, art. 7245; 2016, N 1, art. 9, 28; N 15, art. 2055; N 18, art. 2488; N 27, art. 4219).

21. Narcotic and psychotropic drugs of List II (with the exception of drugs in the form of transdermal therapeutic systems), intended for citizens entitled to receive free drugs or receive drugs at a discount, are dispensed upon presentation of a prescription written out on the prescription form Form N 107/u-NP, and a prescription written out on a prescription form, form N 148-1/u-04 (l) or form N 148-1/u-06 (l).

Medicines specified in paragraphs three to eight of clause 4 of these Rules, intended for citizens entitled to receive medicines dispensed free of charge or at a discount, are dispensed upon presentation of a prescription written out on a prescription form, form N 148-1/у-88, and a prescription written out on a prescription form, form N 148-1/u-04 (l) or form N 148-1/u-06 (l).

22. After the dispensing of narcotic and psychotropic drugs of List II of List III, the person who received the drug is given a signature with a yellow stripe at the top and the inscription “Signature” in black font on it, which indicates:

name and address of the pharmacy or pharmacy;

number and date of the prescription;

last name, first name, patronymic (if any) of the person for whom the drug is intended, his age;

medical record number of the patient receiving medical care on an outpatient basis for whom the drug is intended;

last name, first name, patronymic (if any) of the medical worker who wrote the prescription, his contact phone number or the phone number of the medical organization;

recipe contents in Latin;

last name, first name, patronymic (if available) and signature of the pharmaceutical worker who dispensed the drug;

date of release of the drug.

23. Ethyl alcohol is dispensed according to a prescription, taking into account the established requirements for the volume of containers, packaging and completeness of medicines.
________________

Medicines containing ethyl alcohol, including those manufactured according to a prescription by a retail trade entity that has a license for pharmaceutical activities with the right to manufacture medicines, are dispensed taking into account the established requirements for the volume of containers, packaging and completeness of medicines.
________________
Part 4.1 of Article 45 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; 2014, N 52, Art. 7540; 2015, N 51 , Art. 7245), Decree of the Government of the Russian Federation dated July 23, 2016 N 716 “On the procedure for creating a list of medicinal products for medical use, in respect of which requirements are established for the volume of containers, packaging and completeness, a list of medicinal products for veterinary use, in in relation to which requirements for the volume of containers are established, and the definition of such requirements" (Collected Legislation of the Russian Federation, 2016, No. 31, Art. 5030).

24. Separate dispensing of medicinal products included in a medicinal product manufactured by a retail trade entity is prohibited.

25. It is prohibited for a retail trade entity to dispense medicinal products specified in paragraph 4 of these Rules according to prescriptions from veterinary organizations.

III. Requirements for the dispensing of medicinal products according to the invoice requirements of medical organizations and individual entrepreneurs with a license for medical activities

26. The demand-invoice for the dispensing of medicines is drawn up in accordance with the Instructions on the procedure for prescribing medicines and issuing prescriptions and demands-invoices, approved by order of the Ministry of Health and Social Development of the Russian Federation dated February 12, 2007 N 110 “On the procedure for prescribing and prescribing medicines, medical products and specialized medical nutrition products" (registered by the Ministry of Justice of the Russian Federation on April 27, 2007, registration No. 9364).
_________________
As amended by orders of the Ministry of Health and Social Development of the Russian Federation dated August 27, 2007 N 560 (registered by the Ministry of Justice of the Russian Federation on September 14, 2007, registration N 10133), dated September 25, 2009 N 794n (registered by the Ministry of Justice of the Russian Federation on November 25, 2009, registration N 15317), dated January 20, 2011 N 13n (registered by the Ministry of Justice of the Russian Federation on March 15, 2011, registration N 20103), by orders of the Ministry of Health of the Russian Federation dated August 1, 2012 N 54n (registered by the Ministry of Justice of the Russian Federation on August 15, 2012, registration N 25190), dated February 26, 2013 N 94n (registered by the Ministry of Justice of the Russian Federation on June 25, 2013, registration N 28881).

It is allowed to dispense medicines according to the requirements of invoices of medical organizations and individual entrepreneurs with a license for medical activities, issued in electronic form, if the medical organization, an individual entrepreneur with a license for medical activities, and a retail trade entity are respectively participants in the information exchange exchange system information.

27. Dispensing of narcotic and psychotropic drugs of list II, psychotropic drugs of list III, and other drugs subject to subject-quantitative accounting, including those sold without a prescription, is carried out according to separate invoice requirements.

28. It is prohibited to dispense narcotic and psychotropic drugs of List II, including in the form of transdermal therapeutic systems, psychotropic drugs of List III according to the invoice requirements of an individual entrepreneur who has a license for medical activities.
________________
Clause 4 of Article 31 of the Federal Law of January 8, 1998 N 3-FZ “On Narcotic Drugs and Psychotropic Substances” (Collected Legislation of the Russian Federation, 1998, N 2, Art. 219; 2003, N 27, Art. 2700; 2013, N 48, art. 6165; 2015, N 1, art. 54).

29. When dispensing medicines, the pharmacist checks the proper execution of the demand invoice and puts a note on it about the quantity and cost of the medicines dispensed.

30. All invoice requirements for which medications are dispensed must be left and stored with the retail trade entity:

for narcotic and psychotropic drugs of list II, psychotropic drugs of list III (in relation to pharmacies and pharmacy points) - for five years;

for medicinal products subject to subject-quantitative accounting - for three years;

for other drugs - for one year.

31. Violation of the primary packaging of a medicinal product when dispensing it upon request-invoice is permitted by a retail trade entity that has a license for pharmaceutical activities with the right to manufacture medicinal products. In this case, the medicinal product is dispensed in a package prepared in accordance with the established procedure, with instructions (copies of instructions) for the use of the dispensed medicinal product provided.
________________
Order of the Ministry of Health of Russia dated October 26, 2015 N 751n “On approval of the rules for the manufacture and dispensing of drugs for medical use by pharmacy organizations and individual entrepreneurs licensed for pharmaceutical activities” (registered by the Ministry of Justice of the Russian Federation on April 21, 2016, registration N 41897 ).

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www.pravo.gov.ru, 09.11.2017,
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