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. N

Dear Colleagues! We inform you that Order of the Ministry of Health of Russia dated July 11, 2017 N 403n “On approval of vacation rules” was issued medicines For medical use, including immunobiological drugs, pharmacy organizations, individual entrepreneurs, licensed to pharmaceutical activities"Registered with the Ministry of Justice of Russia on 09/08/2017 N 48125. Comes into force on 09/22/2017 The Russian Ministry of Health has updated the procedure for dispensing medicines from pharmacies. New rules have been approved for the dispensing of medicines for medical use, including immunobiological ones, by pharmacies and individual entrepreneurs licensed for pharmaceutical activities. Medicines are dispensed without a prescription, by prescription and according to the requirements of medical organizations and individual entrepreneurs with a license. 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, there are separate forms prescription forms for psychotropic drugs; medicines provided free of charge; 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 recipe or recipe spine, which remains with the purchaser, it is indicated exact time(in hours and minutes) vacation. 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.

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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"

In the current first edition dated 07/11/2017
Registered with the Ministry of Justice of the Russian Federation 09/08/2017 N 48125
Start of validity of the document: 09/22/2017
11 A4 pages
With Appendix (Rules)

According with article 55 Federal Law of April 12, 2010 N 61-FZ“On the circulation of medicines”, paragraph 3 of Article 12 Federal Law of September 17, 1998 N 157-FZ“On immunoprophylaxis of infectious diseases” and subparagraphs 5.2.169, 5.2.183 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, approve the rules for the dispensing of drugs for medical use, including immunobiological drugs, by pharmacy organizations, individual entrepreneurs with a license for pharmaceutical activities, according to the appendix.

Admits no longer in force “On the Procedure for Dispensing Medicines” (registered by the Ministry of Justice of the Russian Federation on January 16, 2006 N 7353).

Sections document (Rules):

I. General requirements for the dispensing of medicinal products for medical use
II. Requirements for the dispensing of narcotic and psychotropic drugs, drugs with anabolic activity, and other drugs subject to subject-quantitative accounting
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

Vacation medications without prescriptions are provided by: pharmacies; pharmacy points; pharmacy kiosks; individual entrepreneurs with a license for pharmaceutical activities. Prescription drugs are dispensed by: pharmacies; pharmacy points; individual entrepreneurs (with the exception of the supply 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. The supply of narcotic and psychotropic drugs according to prescriptions is carried out by pharmacies and pharmacies licensed to operate in the circulation of narcotic drugs, psychotropic substances and their precursors, and the cultivation of narcotic plants. The dispensing of immunobiological drugs according to prescriptions is carried out by pharmacies and pharmacies.

According to recipes, issued to prescription forms 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 for which control measures are established in accordance with the legislation of the Russian Federation and international treaties of the Russian Federation (List II), are dispensed (narcotic and psychotropic drugs of list II), with the exception of narcotic and psychotropic drugs in the form of transdermal therapeutic systems.

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

Vacation drugs are carried out during the validity period specified in the prescription when the person contacts the subject retail. 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 (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 required 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;
a prescription for a drug dispensed free of charge or at a discount and not included in the minimum range of drugs for medical use necessary for the provision of medical care is serviced within ten working days from the date of the person’s application to the retail trade entity;
prescriptions for drugs prescribed by decision of the medical commission are serviced within fifteen working days from the date the person contacts the retail trade entity.

Prohibited dispense medications according to prescriptions expired unless the prescription expired while it was in deferred care. If a prescription expires while it is under deferred servicing, the medicinal product for such a prescription is dispensed without reissuing it.

Medicinal drugs are dispensed in the quantity specified in the prescription, except in cases where the maximum permissible or recommended quantity for prescribing per prescription is established for the drug. When a prescription is presented that exceeds the maximum permissible or recommended amount of the drug for prescribing per prescription, the pharmacist informs the person who submitted the prescription, the head of the relevant medical organization, and releases to the specified person the correspondingly established maximum permissible or recommended amount of the drug for prescribing per prescription with an appropriate mark. in the recipe.

In the presence of for a retail trade entity of a drug with a dosage different from the dosage of the medicinal product specified in the prescription, the dispensing of the existing drug is allowed if the dosage of such medicinal product less dosage specified in the recipe. 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 drug specified in the prescription, the decision to dispense the medicinal product with such dosage is taken by medical worker who wrote the prescription.

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

On vacation prescription drugs, 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;
details of the identity document of the person who received the medicinal product;
surname, name, patronymic (if any) of the pharmaceutical worker who dispensed the medicinal product, and his signature;
date of release of the drug.

On vacation of a narcotic and psychotropic drug of List II, the prescription for dispensing the drug is affixed with a seal of the pharmacy or pharmacy point, which indicates their full name (if there is a seal). When dispensing an immunobiological drug, the exact time (in hours and minutes) of dispensing the drug is indicated on the prescription or prescription counterfoil, which remains with the person purchasing (receiving) the drug. The release of an immunobiological drug is carried out to the person purchasing (receiving) the drug, if he has a special thermal container in which the drug is placed, with an explanation of the need for delivery this drug to a medical institution, subject to storage in a special thermal container for a period not exceeding 48 hours after its purchase.

Remain and the retail trade entity stores prescriptions (with the mark “The medicinal product is dispensed”) for:

narcotic and psychotropic drugs of list II, psychotropic drugs of list III - for five years;
medicines dispensed free of charge or at a discount - in within three years;
combination medicinal products containing narcotic drugs or psychotropic substances a, 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;
medicines in liquid dosage form, containing more than 15% ethyl alcohol from volume finished products, other drugs related to ATC antipsychotics(code N05A), anxiolytics (code N05B), hypnotics and sedatives(code N05C), antidepressants (code N06A) and not subject to subject-quantitative accounting - within three months.

On vacation drug, the pharmacist informs the person purchasing (receiving) the drug about the regimen and doses of its administration, storage rules at home, and interactions with other drugs. When dispensing a drug, a pharmaceutical worker does not have the right to provide false and (or) incomplete information about the availability of drugs, including drugs that have the same international generic name, including hiding information about the availability of medicines that have more low price. The sale of falsified, substandard and counterfeit medicines is prohibited.

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 specified 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 for the right to receive such narcotic and psychotropic medications.

After dispensing narcotic and psychotropic drugs of list II, including in the form of transdermal therapeutic systems, psychotropic drugs of list III, the person who received the drug is issued a signature with a yellow stripe at the top and the inscription in black font on it “Signature”, 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 card 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 health 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.

Order No. 403n issued by the Russian Ministry of Health establishes new standards for the dispensing of drugs and changes the usual operating procedure of pharmacy organizations. New order raises many questions among pharmacists. Pharmacy organizations simply do not understand how to implement the norms included in the order in practice. And despite the fact that the first official explanation from the Russian Ministry of Health regarding of this document appeared 5 days after it came into force, pharmacy workers still have a lot of questions.

Order of the Ministry of Health No. 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” dated July 11, 2017, came into force on September 22, 2017 and at the same time With this, the order of the Ministry of Health and Social Development of the Russian Federation No. 785 dated December 14, 2005, “On the procedure for dispensing medicines,” well-known to pharmacists, became invalid.

There are many short stories in the document. Thus, individual entrepreneurs engaged in the sale of pharmaceutical products are separately mentioned. Their rights are somewhat curtailed compared to pharmacies and pharmacy points - they are prohibited from dispensing immunobiological prescription drugs.

Unlike the previously valid document, Order 403n devotes a separate paragraph 13 to the sale of immunobiological products. In particular, it talks about the need to indicate the exact time of release of immunobiological products in hours and minutes. The receipt or recipe with this information remains with the buyer. Two conditions are also mentioned, compliance with which is mandatory when selling immunobiological products. Firstly, the buyer must have a special thermal container or other equipment to maintain a special temperature regime when transporting medicines. Secondly, the pharmacy worker is obliged to inform the buyer about the need to deliver the drug to medical organization and about the limited storage time of the drug, since it can remain in a thermal container for no more than 48 hours.

However greatest number Questions from pharmacy workers are raised by Clause 14 of the new order, which introduces a new rule according to which drug retail entities, in addition to other prescriptions, are required to store for 3 months prescriptions for drugs that contain ethyl alcohol in an amount of more than 15%.

Commenting on the departmental order 403n, which came into force, regulating the rules for the dispensing of medicines, the executive director of the Russian Association pharmacy chains(RAAS) Nelly Ignatieva called this provision “wonderful,” but, according to her, pharmacy organizations do not understand how to implement it in practice.

Paragraph 14 of the Order of the Ministry of Health No. 403n states that prescriptions for narcotic and psychotropic drugs from List II must be stored with the mark “The drug is dispensed” for 5 years. According to the terminated order of the Ministry of Health and Social Development No. 785, they had to remain in the pharmacy for 10 years. Prescriptions for drugs dispensed free of charge or at a discount according to form No. 148-1/u-04 (l) and 06 (l), and combined drugs containing narcotic or psychotropic substances included in list II and III, prepared in a pharmacy; drugs with anabolic effects, as well as drugs subject to subject-quantitative accounting. A novelty of the document is an instruction to store for 3 months prescriptions for drugs in liquid dosage form with an ethyl alcohol content exceeding 15%, as well as a number of other drugs.

Some expressed fears that as a result, such popular drugs as Corvalol and Valocordin would become unavailable to the population. Since these heart medications are alcohol-containing, it means that they can be purchased in pharmacies only by prescription. However, as experts later clarified, patients will not have to stand in line at therapists for a prescription for Corvalol and Valocordin, since they were and are over-the-counter, and this rule does not apply to them.

It is the manufacturer who decides whether the drug should be sold with a prescription or is over-the-counter. And the lack of a unified list of prescription and over-the-counter INN drugs leads to confusion.

“A new norm is emerging - when dispensing medications containing 15% alcohol by volume, we must leave prescriptions in the pharmacy and store them for three months,” says Nelly Ignatieva. – It seems that everything is clear. But now we don't have a list of prescription and over-the-counter drugs. And if you take such an INN as “eucalyptus leaves” (available in the form alcohol solution volume of 100 ml), then four trade names are in circulation at once different manufacturers. Moreover, two of them are prescription, and two are over-the-counter. Although it was assumed that they clearly refer to either prescription or over-the-counter drugs. A paradoxical situation is emerging. How does a solution from one manufacturer differ from the exact same solution from another manufacturer? Nothing. We only have to keep prescriptions for some drugs, but not for others. I ask our department a question: why do drugs from one manufacturer need to be stored, but not from another? It turns out that the department simply doesn’t know about it.”

Another point is related to the fact that when dispensing a drug, the pharmacist needs to look for information about the ethyl alcohol content in it in order to understand which drug prescription should be left at the pharmacy. Since alcohol is not active substance, information about it is not indicated in large letters on the packaging. This means that the pharmacist will have to look for it in the instructions or calculate it himself, which is also problematic.

Pharmacy organizations also have many questions regarding cases where a prescription is written for three medications at once, two of which the buyer does not purchase. The legislator does not explain what the pharmacist should do with this prescription in this case. The prescriptions for the pills are also not entirely clear.

“The document included a norm that was not submitted for discussion. It appeared in order to implement the tasks outlined in the road map to combat alcoholism in relation to the circulation of alcohol-containing products. And as a result, drugs from four groups according to the anatomical-therapeutic-chemical (ATC) system of classification of drugs were included,” emphasizes Nelly Ignatieva.

“Women of a tender age who need medications today will be forced to run every time to get a prescription for drugs, because after purchasing one bottle, they will need to take a prescription for the next one,” she continues.

“How can we separate prescription drugs from over-the-counter drugs and identify those drugs for which prescriptions need to be kept? No one has created a list of prescription drugs. To do this, you need to go to the register of medicines, open registration certificate V PDF format, find the rules for dispensing medications to understand whether they are prescription or over-the-counter. And this will have to be done for each trade name,” notes the executive director of RAAS.

“How can you fulfill a norm that is defined in this way! – Nelly Ignatieva is perplexed. – The legislator today is trying to regulate literally everything related to pharmacies. For what purpose is not entirely clear. And this is the main problem: without understanding why something needs to be done, it is in principle impossible to do it.”