Prescription drugs from 1 July. Rules for the dispensing of medicinal products for medical use, including immunobiological medicinal products, by pharmacy organizations, individual entrepreneurs licensed for pharmaceutical

You can buy antibiotics in a pharmacy only if they have been prescribed to a citizen. They banned uncontrolled sale through the introduction of new legislation that began to regulate both how often antibiotics are sold and what dosages people take.

Antibiotic prescription law

Antibiotics are a special group of medicines, the sale of which should be regulated at the legislative level. It is necessary to study in more detail the regulations governing the sale of prescription drugs in Russia.

The sale of medicines is regulated by the following regulatory legal acts:

  1. Order of the Ministry of Health under the number 785 "On the procedure for dispensing medicines".
  2. Order of the Ministry of Health No. 647n “On Approval of the Rules for Good Pharmacy Practice of Medicinal Products for Medical Use”.
  3. Federal Law No. 61 “On the Circulation of Medicines”, etc.

A new law in 2017 mandated that most antibiotics can only be dispensed by prescription.

This is due to a number of factors. For example, the global health community is largely concerned about the fact that the citizens of many countries have begun to use antibiotics uncontrollably. This contributes to the habituation and development of the citizen's immune system in the sense that antibiotics simply cease to act and perform their direct function. Among other things, antibiotics disrupt the functioning of various organs in the human body and adversely affect the liver, kidneys and stomach.

Changes in the law and why antibiotics are sold only by prescription

The news in the legislation was the introduction of amendments to certain regulatory legal acts in March 2017. It stipulates that a separate list of drugs belonging to the group of antibiotics is accepted, which are dispensed in pharmacies only on the recommendation of a doctor. A pharmacist is not authorized to dispense such drugs without a prescription.

As noted above, these innovations came into effect for a reason. The state revealed the fact of uncontrolled use of these drugs, which largely damages the health of the population.

Pharmacies are also subject to control in this area. Bodies of the Ministry of Health and Rospotrebnadzor check the availability of prescriptions for certain dispensed drugs in pharmacies.


Rules for dispensing antibiotics from pharmacies

In pharmacies, all received drugs are subject to accounting and control. Prescription drugs are in a separate category and are accounted for more strictly. If it is necessary to sell a particular prescription drug, the pharmacist must warn the buyer that this medicine belongs to a special category, and a prescription must be presented for it.

Once the prescription has been presented in the proper form, the pharmacist has the right to sell the medicine. Relevant information is entered into a special reporting journal of the pharmacy, and the prescription itself is saved and attached to the reporting.

In a situation where a prescription drug was sold to a citizen without presenting the relevant document, he has the right to write a complaint to the relevant department and hold the pharmacy accountable.

What pills are antibiotics

The Decree of the Ministry of Health defines a list of medicines that belong to antibiotics:

  1. Amoxicillin.
  2. Ampicillin.
  3. Oxacillin.
  4. Penicillin.
  5. Augmentin.
  6. Carbenicillin.
  7. Azlocillin etc.

The list of antibiotics is very long. Speaking about the general wording, it is worth noting that these are drugs that are aimed at preventing the reproduction of bacterial microorganisms or their complete death. All antibiotics are divided into groups depending on the spectrum of their action.

All antibiotics: list

To date, the following types of antibiotics are recognized and allowed for sale in the Russian Federation:

  • Penicillins.
  • Tetracyclines.
  • Erythromycin.
  • Quinolones.
  • Metronidazole.
  • Vancomycin.
  • Imipenem.
  • Aminoglycoside.
  • Levomycetin (chloramphenicol).
  • Neomycin.
  • Monomycin.
  • Rifamcin.
  • Cephalosporins.
  • Kanamycin.
  • Streptomycin.
  • Ampicillin.
  • Azithromycin.
  • Cefaclor.
  • Cefamandol.
  • Unidox Solutab.
  • Cefuroxime.
  • Rulid.
  • Amoxiclav.
  • Cephroxitin.
  • Lincomycin.
  • Cefoperazone.
  • Ceftazidime.
  • Cefotaxime.
  • Latamoxef.
  • Cefixime.
  • Cefpodoxime.
  • Spiramycin.
  • Rovamycin.
  • Clarithromycin.
  • Roxithromycin.
  • Klacid.
  • Sumamed.
  • Fusidin.
  • Avelox.
  • Moxifloxacin.
  • Ciprofloxacin.

It is almost impossible to list the entire list of antibiotics, since today there are a huge number of them with a different spectrum of action, different duration of action and side effects. They can be divided into both drugs for adults and drugs for children.

Over-the-counter antibiotics: a list

  1. Gramicidin C.
  2. Ketoconazole.
  3. Clindamycin.
  4. Clotrimazole.
  5. Metronidazole.
  6. Natamycin.
  7. Nitrofural.
  8. Nifuroxazide.
  9. Sulfadiazine.
  10. Sulfanilamide.
  11. Sulfacetamide.
  12. Terbinafine.
  13. Tetracycline (for local use - ointment).
  14. Fluconazole.
  15. Furazolidone.
  16. Chloramphenicol.
  17. Cyclopirox.
  18. Econazole.
  19. Erythromycin + zinc acetate.

You can download all antibacterial drugs for which a prescription is not needed. ⇐

Prescription-only antibiotics: a list

  1. Doxycycline.
  2. Tetracycline.
  3. Amoxicillin +.
  4. clavulanic acid.
  5. Cephalexin.
  6. Benzathine benzylpenicillin.
  7. Cefuroxime.
  8. Sulfasalazine.
  9. Clarithromycin.
  10. Azithromycin.
  11. Ciprofloxacin.
  12. Fluconazole.
  13. Clotrimazole.
  14. Tiloron.
  15. Acyclovir.
  16. Metronidazole.
  17. Benzyl benzoate.
  18. Hydroxyurea.
  19. Busulfan.
  20. Mercaptopurine.
  21. Melphalan.
  22. Methotrexate.
  23. Chlorambucil.
  24. Mitomycin.
  25. Cyclophosphamide.
  26. Azathioprine
  27. Tamoxifen.
  28. medroxyprogesterone.
  29. Anastrozole.
  30. Flutamide.
  31. Interferon alfa-2a.
  32. Interferon alfa-2b.

How and where to buy antibiotics without a doctor's prescription

You can buy antibiotics without a doctor's prescription at absolutely any pharmacy in Moscow or any other region of the Russian Federation. There are no restrictions on the sale of a medical product in this case. Recently, so-called online pharmacies have become widespread. It is there that you can choose the necessary drug without leaving your home and order it. It will be delivered to the nearest pharmacy to the person's home.

Home delivery of medicines is not allowed!

How to write a prescription for an antibiotic

It is impossible to obtain such a recipe by mere expression of the will of a citizen. This happens solely at the discretion of the doctor and in a situation where a citizen really needs antibiotics.

To get a prescription, you need to visit your GP. It is he who has the right to issue this kind of document.

The prescription is certified by the seal of the medical organization and the nominal seal of the doctor himself. Prescriptions have the right to issue not only doctors of state institutions, but also specialists from private medical accredited clinics.

What should the recipe look like?

A recipe is, in essence, a reference that has such structural elements as:

  1. The name of the medical institution.
  2. The name of the document itself.
  3. A list of prescription drugs that a citizen needs.
  4. Physician's signature and date of issue of the certificate.
  5. The seal of the medical organization and the nominal seal of the doctor himself.

Prescription forms are approved by the Ministry of Health and are the same for all state budget polyclinics.

Prescription for antibiotics: blank

You can download the prescription form . ⇐

Full text of the law on the sale of antibiotics by prescription, as amended

You can download the full text of the law with changes and additions,. ⇐

Finally.

As we can see, since January and March 2017, changes have been made to certain legislative acts regulating the sale of medicines. You can no longer buy antibiotics without a prescription. When drugs are sold by pharmacies contrary to the rules, administrative liability in the form of a fine is provided. Thus, the normal dosage of antibiotics is regulated and the fact of self-medication is excluded.


“A new order has come out, now it will always be like this”

24-hour pharmacy near the metro in a residential area. I need a medicine that the doctor prescribed me in the summer: yesterday the pack ran out, the next morning I need to take a new pill. I have a prescription for a year.

“Oh, we have to take the prescription from you,” the pharmacist at the pharmacy tells me.

- And on what basis? Why? - I'm outraged.

“A new order has been issued, the 403rd, now it will always be like this,” they answer me.

I see that near the cash register on the shelf there are already recipes taken from someone - three or four. I take more air into my lungs and tell the pharmacist:

- You know, no. It won't. I have read the order. And the explanations of the Ministry of Health on this matter, too.

The pharmacist calls the director of the pharmacy for help ...

Why a new order?

“If a doctor gives a patient a prescription for 60 days or a year, then such a prescription cannot be taken away in a pharmacy,” says Elena Nevolina. The physician is responsible for prescribing to his patient. But the prescription will remain in the pharmacy only when the patient has received the entire course of treatment.

On the back of the prescription, the pharmacy must put a stamp that such and such a product has been dispensed. It should also include the date and signature of the person dispensing the medicine.

“In principle, this should not have been news for pharmacies - it should have been so before, according to the instructions of previous orders on the procedure for dispensing medicines,” says the head of the Pharmacy Guild.

But maybe the recipe needs to be formatted differently now? This idea was expressed by drug buyers in social networks.

“The rules for issuing prescriptions were approved by order of the Ministry of Health No. 1175 n of December 20, 2012, and since then little has changed in this matter,” says Elena Nevolina.

“Yes, make a note on the back and give the recipe to the customer”

... When the director of the pharmacy comes to me, I have to tell her that I need to put a mark on the drug sold to me on my prescription and release me along with the prescription until next summer. Just then, my prescription will become invalid and with peace of mind I will leave it at the pharmacy, as required by the order of the Ministry of Health.

The director studies my prescription for a long time, but in the end he says to the pharmacist:

- Yes, make a note on the back that the medicine was sold today. And give the prescription to the customer.

In general, read order 403n and the explanations of the Ministry of Health before going to the pharmacy. And do not be afraid to retell it to the pharmacist, who decides to take your prescription.

If this does not help, your prescription was unmotivated, then, as Elena Nevolina advises, contact the Ministry of Health or the Roszdravnadzor hotline with a request.

In accordance with Article 55 of the Federal Law of April 12, 2010 No. 61-FZ “On the Circulation of Medicines” (Collected Legislation of the Russian Federation, 2010, No. 16, Art. 1815; No. 31, Art. 4161; 2013; No. 48, 6165; 2014, No. 52, article 7540; 2015, No. 29, article 4388; 2016, No. 27, article 4238), paragraph 3 of Article 12 of the Federal Law of September 17, 1998 No. immunoprophylaxis of infectious diseases” (Sobraniye zakonodatelstva Rossiyskoy Federatsii, 1998, No. 38, Art. 4736; 2009, No. 1, Art. 21; 2013, No. 48, Art. 6165) 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 No. 608 (Collected Legislation of the Russian Federation, 2012, No. 26, Art. 3526; 2013, No. 16, Art. 1970; No. 20, Art. 2477; No. 22, 2812; No. 33, 4386; No. 45, 5822; 2014, No. 12, 1296; No. 26, 3577; No. 30, 4307; No. 37, 4969; 2015, No. 2, item 491; No. 12, item 1763; No. 23, item 3333; 2016, No. 2, item 32 five; No. 9, art. 1268; No. 27, art. 4497; No. 28, Art. 4741; No. 34, art. 5255; No. 49, Art. 6922; 2017, no. 7, art. 1066), I order:

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

2. Recognize as invalid:

order of the Ministry of Health and Social Development of the Russian Federation dated December 14, 2005 No. 785 “On the Procedure for Dispensing Medicines” (registered by the Ministry of Justice of the Russian Federation on January 16, 2006, registration No. 7353);

order of the Ministry of Health and Social Development of the Russian Federation of April 24, 2006 No. 302 “On Amendments to the Order of the Ministry of Health and Social Development of the Russian Federation of December 14, 2005 No. 785” (registered by the Ministry of Justice of the Russian Federation on May 16, 2006, registration number 7842);

Order of the Ministry of Health and Social Development of the Russian Federation dated February 12, 2007 No. 109 "On Amendments to the Procedure for Dispensing Medicines, approved by Order of the Ministry of Health and Social Development of the Russian Federation dated December 14, 2005 No. 785" (registered by the Ministry of Justice of the Russian Federation March 30, 2007, registration number 9198);

Order of the Ministry of Health and Social Development of the Russian Federation of August 6, 2007 No. 521 “On Amendments to the Procedure for Dispensing Medicines, approved by Order of the Ministry of Health and Social Development of the Russian Federation of December 14, 2005 No. 785” (registered by the Ministry of Justice of the Russian Federation August 29, 2007, registration number 10063).

Minister IN AND. Skvortsova

psychotropic medicinal products included in the List of Psychotropic Substances, the circulation of which in the Russian Federation is limited and for which the exclusion of certain control measures is allowed 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;

medicinal products included in the list of medicinal products for medical use subject to subject-quantitative accounting, with the exception of the medicinal products specified in and of this paragraph, and medicines dispensed without a prescription (hereinafter referred to as medicinal products subject to subject-quantitative accounting);

medicinal products with anabolic activity (in accordance with the main pharmacological action) and related to the anatomical-therapeutic-chemical classification recommended by the World Health Organization (hereinafter - ATC) to anabolic steroids (code A14A) (hereinafter - medicinal products with anabolic activity );

Medicinal products specified in paragraph 5 of the Procedure for dispensing to individuals medicinal products for medical use containing, in addition to small amounts of narcotic drugs, psychotropic substances and their precursors, other pharmacologically active substances, approved by order of the Ministry of Health and Social Development of the Russian Federation dated May 17, 2012 No. 562n;

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 pharmacologically active substances in a dose not exceeding the highest single dose, and provided that this combination medicinal product is not a narcotic or psychotropic medicinal product of list II.

According to prescriptions issued on prescription forms of form No. 148-1 / y-04 (l) or form No. drugs at a discount (hereinafter referred to as drugs dispensed free of charge or at a discount).

According to prescriptions issued on prescription forms of form No. 107-1 / y, other medicinal products are dispensed that are not specified in this paragraph, with the exception of over-the-counter medicinal products.

5. The release of medicinal products not specified in these Rules, in accordance with the instructions for their medical use, is carried out without prescriptions.

6. Dispensing of medicinal products is carried out during the term of its validity specified in the prescription when a person applies to a retail trade entity.

If the retailer does not have the medicinal product specified in the prescription, when a person applies to the retailer, the prescription is accepted for service within the following terms (hereinafter referred to as deferred service):

a prescription marked “statim” (immediately) is serviced within one working day from the day the person applied to the retailer;

a prescription marked “cito” (urgently) is serviced within two working days from the day the person applied to the retailer;

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 retailer;

a prescription for a medicinal product dispensed free of charge or at a discount and not included in the minimum range of medicinal products 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 retailer;

prescriptions for medicinal products prescribed by decision of the medical commission are serviced within fifteen working days from the date of the person's application to the retailer.

Expired prescription drugs may not be dispensed unless the prescription expired while on deferred maintenance.

Upon expiration of a prescription while it is on deferred maintenance, the medicinal product is dispensed under such a prescription without reissuing it.

7. Medicinal products are dispensed in the amount specified in the prescription, except for cases when the maximum allowable or recommended amount for prescribing per prescription is established for the medicinal product.

When a prescription is presented that exceeds the maximum allowable or recommended amount of the medicinal product for prescribing per prescription, the pharmacist informs the person who submitted the prescription, the head of the relevant medical organization about this and dispenses to the indicated person the maximum permissible or recommended amount of the medicinal product established accordingly for prescribing per one prescription with putting down the appropriate mark in the recipe.

If a retail entity has a medicinal product with a dosage different from the dosage of the medicinal product indicated in the prescription, the available medicinal product may be dispensed if the dosage of such medicinal product is less than the dosage indicated in the prescription. In this case, the amount of the medicinal product is recalculated, taking into account the course of treatment indicated in the prescription.

If the dosage of the medicinal product available at the retailer 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 worker who issued the prescription.

8. The medicinal product is dispensed in primary and secondary (consumer) packages, the labeling of which must meet the requirements of Article 46 of the Federal Law of April 12, 2010 No. II - the requirements of paragraph 3 of Article 27 of the Federal Law of January 8, 1998 No. 3-FZ "On Narcotic Drugs and Psychotropic Substances".

Violation of the primary packaging of the medicinal product during its dispensing is prohibited.

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

9. When dispensing medicinal products by prescription, a pharmacist shall make a mark on the prescription for the dispensing of a medicinal product indicating:

name of the pharmacy organization (surname, name, patronymic (if any) of an individual entrepreneur);

trade name, dosage and quantity of the dispensed medicinal product;

last name, first name, patronymic (if any) of a medical worker in the cases specified in and these Rules;

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

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

date of release of the medicinal product.

10. When dispensing medicinal products according to a prescription issued on a prescription form No. drug, with a mark containing the information specified in these Rules.

When a person next applies to a retailer with this prescription, the notes on the previous release of the medicinal product according to such a prescription are taken into account and if the person purchases the amount of the medicinal product corresponding to the maximum amount indicated by the medical worker in the prescription, and also after the expiration of the prescription, on the prescription the stamp “Drug is dispensed” is affixed and the prescription is returned to the person.

A one-time dispensing of a medicinal product under a prescription issued on a prescription form No. 107-1 / y, the validity of which is one year, and in which the periods and the number of dispensing of the medicinal product (in each period) are indicated, is allowed only upon agreement with a medical professional, who wrote the prescription.

11. When dispensing medicinal products under a prescription issued on a prescription form No. 148-1 / y-04 (l) or form No. 148-1 / y-06 (l), the completed spine of such a prescription is transferred by a pharmaceutical worker to the person purchasing ( recipient) medicines.

12. When dispensing a narcotic and psychotropic medicinal product of List II, the pharmacy or pharmacy center stamp is affixed to the prescription for the dispensing of the medicinal product, 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 shall be indicated on the prescription or prescription stub, which remains with the person purchasing (receiving) the medicinal product.

An immunobiological medicinal product is dispensed to the person who purchases (receives) 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, provided that it is stored in a special thermal container for a period not exceeding 48 hours after purchasing it.

14. Prescriptions remain and are stored at the retailer (with the mark "Medicinal product dispensed") for:

narcotic and psychotropic drugs of list II, psychotropic drugs of list III - within 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 quantitative accounting - within 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 quantitative accounting - within three months.

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

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

19. Dispensing of narcotic and psychotropic medicinal products, medicinal products with anabolic activity, medicinal products 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 have been granted the right to dispense narcotic medicinal products and psychotropic drugs to individuals, approved by Order of the Ministry of Health of the Russian Federation No. 681n dated September 7, 2016 (registered by the Ministry of Justice of the Russian Federation on September 21, 2016, registration No. 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 identity 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 medicinal products.

21. Narcotic and psychotropic drugs of list II (with the exception of drugs in the form of transdermal therapeutic systems), intended for citizens who have the right to receive drugs free of charge or receive drugs at a discount, are dispensed upon presentation of a prescription written out on a prescription form No. 107 / y-NP, and a prescription issued on the prescription form of form No. 148-1 / y-04 (l) or form No. 148-1 / y-06 (l).

Medicinal products specified in these Rules, intended for citizens who have the right to receive drugs dispensed free of charge or at a discount, are dispensed upon presentation of a prescription written out on a prescription form No. form No. 148-1 / y-04 (l) or form No. 148-1 / y-06 (l).

22. After the dispensing of 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 in the upper part and the inscription in black on it "Signature", which states:

the name and address of the location of the pharmacy or pharmacy;

number and date of the issued prescription;

surname, name, patronymic (if any) of the person for whom the medicinal product is intended, his age;

number of the medical card of the patient receiving medical care on an outpatient basis for whom the medicinal product is intended;

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

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

date of release of the medicinal product.

23. The release of ethyl alcohol is made according to the prescription, taking into account the established requirements for the volume of containers, packaging and completeness of medicinal products.

Medicinal products containing ethyl alcohol, including those manufactured by prescription by a retail trade entity that has a license for pharmaceutical activities with the right to manufacture medicinal products, are dispensed subject to the established requirements for the volume of containers, packaging and completeness of medicinal products.

24. Separate dispensing of medicinal products that are part of a medicinal product manufactured by a retail trade entity is prohibited.

25. It is prohibited to dispense medicines specified in these Rules by a retail trade entity according to prescriptions of veterinary organizations.

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

26. The requirement-invoice for the dispensing of medicinal products is drawn up in accordance with the Instructions on the procedure for prescribing medicinal products and issuing prescriptions and invoices, approved by order of the Ministry of Health and Social Development of the Russian Federation dated February 12, 2007 No. 110 "On the procedure for prescribing and prescribing medicines, medical devices and specialized health food products” (registered by the Ministry of Justice of the Russian Federation on April 27, 2007, registration number 9364) .

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

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

28. It is prohibited to sell narcotic and psychotropic drugs of list II, including in the form of transdermal therapeutic systems, psychotropic drugs of list III according to the requirements-invoices of an individual entrepreneur who has a license for medical activities.

29. When dispensing medicinal products, the pharmaceutical worker checks the proper execution of the invoice request and puts a mark on it on the quantity and cost of the dispensed medicinal products.

30. All requirements-invoices, according to which medicinal products are dispensed, shall be left and stored at the retailer:

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

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

for other medicinal products - within one year.

31. Violation of the primary packaging of a medicinal product when it is dispensed on demand-invoice is allowed 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 drawn up in accordance with the established procedure, with the provision of instructions (copies of instructions) for the use of the dispensed medicinal product.

______________________________

*(1) 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 No. 61-FZ “On the Circulation of Medicines” (Collected Legislation of the Russian Federation, 2010 , No. 16, item 1815; No. 42, item 5293; No. 49, item 6409; 2014, No. 52, item 7540).

*(2) Orders of the Ministry of Health of the Russian Federation:

dated December 20, 2012 No. 1175n "On approval of the procedure for prescribing and prescribing medicines, as well as forms of prescription forms for medicines, the procedure for issuing these forms, their accounting and storage" (registered by the Ministry of Justice of the Russian Federation on June 25, 2013, registration No. 28883), as amended by orders of the Ministry of Health of the Russian Federation dated December 2, 2013 No. 886n (registered by the Ministry of Justice of the Russian Federation on December 23, 2013, registration No. 30714), dated June 30, 2015 No. 386n (registered by the Ministry of Justice August 6, 2015, registration No. 38379) and April 21, 2016 No. 254n (registered by the Ministry of Justice of the Russian Federation on July 18, 2016, registration No. 42887) (hereinafter - Order No. 1175n);

dated August 1, 2012 No. 54n “On approval of the form of prescription forms containing the prescription of narcotic drugs and psychotropic substances, the procedure for their manufacture, distribution, registration, accounting and storage, as well as registration rules” (registered by the Ministry of Justice of the Russian Federation on August 15, 2012 ., registration No. 25190), as amended by orders of the Ministry of Health of the Russian Federation dated June 30, 2015 No. 385n (registered by the Ministry of Justice of the Russian Federation on November 27, 2015, registration No. 39868) and dated April 21, 2016 No. 254n ( registered by the Ministry of Justice of the Russian Federation on July 18, 2016, registration No. 42887) (hereinafter - Order No. 54n).

*(3) Collection of Legislation of the Russian Federation, 1998, No. 27, art. 3198; 2004, no. 8, art. 663; No. 47, Art. 4666; 2006, no. 29, art. 3253; 2007, no. 28, art. 3439; 2009, no. 26, art. 3183; No. 52, Art. 6572; 2010, no. 3, art. 314; No. 17, Art. 2100; No. 24, Art. 3035; No. 28, Art. 3703; No. 31, Art. 4271; No. 45, Art. 5864; No. 50, art. 6696, 6720; 2011, no. 10, art. 1390; No. 12, art. 1635; No. 29, art. 4466, 4473; No. 42, Art. 5921; No. 51, Art. 7534; 2012, no. 10, art. 1232; No. 11, Art. 1295; No. 19, Art. 2400; No. 22, Art. 2864; No. 37, Art. 5002; No. 48, Art. 6686; No. 49, Art. 6861; 2013, no. 9, art. 953; No. 25, Art. 3159; No. 29, art. 3962; No. 37, Art. 4706; No. 46, Art. 5943; No. 51, Art. 6869; 2014, no. 14, art. 1626; No. 23, Art. 2987; No. 27, art. 3763; No. 44, Art. 6068; No. 51, Art. 7430; 2015, no. 11, art. 1593; No. 16, Art. 2368; No. 20, Art. 2914; No. 28, Art. 4232; No. 42, Art. 5805; 2016, no. 15, art. 2088; 2017, No. 4, art. 671; No. 10, Art. 1481.

*(4) Appendices No. 1 and 2 to Order No. 54n.

*(5) Clause 9 of the procedure for prescribing and prescribing drugs, approved by order No. 1175n.

*(6) Order of the Ministry of Health of the Russian Federation dated April 22, 2014 No. 183n “On approval of the list of medicines for medical use subject to subject-quantitative accounting” (registered by the Ministry of Justice of the Russian Federation on July 22, 2014, registration No. 33210) with as amended by Order of the Ministry of Health of the Russian Federation dated September 10, 2015 No. 634n (registered by the Ministry of Justice of the Russian Federation on September 30, 2015, registration No. 39063).

*(7) Subparagraph 3 of paragraph 9 of the procedure for prescribing and prescribing medicines, approved by order No. 1175n.

*(8) Registered by the Ministry of Justice of the Russian Federation on June 1, 2012, registration No. 24438, as amended by orders of the Ministry of Health of the Russian Federation dated June 10, 2013 No. 369n 29064), dated August 21, 2014 No. 465n (registered by the Ministry of Justice of the Russian Federation on September 10, 2014, registration No. 34024), dated September 10, 2015 No. 634n (registered by the Ministry of Justice of the Russian Federation on September 30, 2015, registration No. 39063).

*(9) Decree of the Government of the Russian Federation of December 26, 2015 No. 2724-r (Sobraniye Zakonodatelstva Rossiyskoy Federatsii, 2016, No. 2, Art. 413).

*(10) Annexes No. 1 and No. 2 to the procedure for prescribing and prescribing medicines, approved by order No. 1175n.

*(11) Collection of Legislation of the Russian Federation, 2010, No. 16, art. 1815; No. 42, Art. 5293; 2014, no. 52, art. 7540.

* (12) Collection of Legislation of the Russian Federation, 1998, No. 2, art. 219; 2012, no. 53, art. 7630; 2013, no. 48, art. 6165; 2015, no. 1, art. 54.

*(13) Appendix No. 2 to the procedure for prescribing and prescribing medicines, approved by order No. 1175n.

*(14) Order No. 1175n and Order No. 54n.

*(15) Article 74 of the Federal Law of November 21, 2011 No. 323-FZ “On the Basics of Protecting the Health of Citizens in the Russian Federation” (Sobraniye Zakonodatelstva Rossiyskoy Federatsii, 2011, No. 48, Art. 6724; 2013, No. 48, Art. 6165).

*(16) Article 57 of the Federal Law of April 12, 2010 No. 61-FZ "On the Circulation of Medicines".

*(17) In relation to the person specified in Part 2 of Article 20 of the Federal Law of November 21, 2011 No. 323-FZ “On the Basics of Protecting the Health of Citizens in the Russian Federation” (Collected Legislation of the Russian Federation, 2011, No. 48, Art. 6724 ; 2012, No. 26, items 3442, 3446; 2013, No. 27, items 3459, 3477; No. 30, item 4038; No. 39, item 4883; No. 48, item 6165; No. 52, item 6951 2014, No. 23, item 2930; No. 30, item 4106, 4206, 4244, 4247, 4257; No. 43, item 5798; No. 49, item 6927, 6928; 2015, No. 1, item 72, 85; No. 10, items 1403, 1425; No. 14, item 2018; No. 27, item 3951; No. 29, items 4339, 4356, 4359, 4397; No. 51, item 7245; 2016, No. 1, 9, 28; No. 15, 2055; No. 18, 2488; No. 27, 4219).

*(18) Part 4.1 of Article 45 of the Federal Law of April 12, 2010 No. 61-FZ “On the Circulation of Medicines” (Sobraniye Zakonodatelstva Rossiyskoy Federatsii, 2010, No. 16, Art. 1815; 2014, No. 52, Art. 7540; 2015, No. 51, art. 7245), Decree of the Government of the Russian Federation dated July 23, 2016 No. 716 “On the procedure for compiling a list of medicinal products for medical use, in respect of which requirements are established for the volume of packaging, packaging and completeness, a list of medicinal products for veterinary use, in respect of which the requirements for the volume of containers are established, and the definition of such requirements ”(Collected Legislation of the Russian Federation, 2016, No. 31, article 5030).

*(19) As amended by orders of the Ministry of Health and Social Development of the Russian Federation dated August 27, 2007 No. 560 (registered by the Ministry of Justice of the Russian Federation on September 14, 2007, registration No. 10133), dated September 25, 2009 No. 794n ( registered by the Ministry of Justice of the Russian Federation on November 25, 2009, registration No. 15317), dated January 20, 2011 No. 13n (registered by the Ministry of Justice of the Russian Federation on March 15, 2011, registration No. 20103), by orders of the Ministry of Health of the Russian Federation dated August 1, 2012 No. 54n (registered by the Ministry of Justice of the Russian Federation on August 15, 2012, registration No. 25190), dated February 26, 2013 No. 94n (registered by the Ministry of Justice of the Russian Federation on June 25, 2013, registration No. 28881).

*(20) Clause 4 of Article 31 of the Federal Law of January 8, 1998 No. 3-FZ “On Narcotic Drugs and Psychotropic Substances” (Sobraniye Zakonodatelstva Rossiyskoy Federatsii, 1998, No. 2, Art. 219; 2003, No. 27, Art. 2700; 2013, No. 48, article 6165; 2015, No. 1, article 54).

*(21) Order of the Ministry of Health of Russia dated October 26, 2015 No. 751n “On Approval of the Rules for the Manufacture and Dispensing of Medicinal Products for Medical Use by Pharmacy Organizations, Individual Entrepreneurs Licensed for Pharmaceutical Activities” (registered by the Ministry of Justice of the Russian Federation on April 21, 2016 , registration number 41897).

Document overview

New rules have been approved for dispensing medicinal products 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 who have a license for medical activities. The rules apply to pharmacies, pharmacy points, pharmacy kiosks and individual entrepreneurs licensed for pharmaceutical activities. Of these, only pharmacies and drugstores can dispense prescription drugs, as well as narcotic and psychotropic drugs. For the release of the latter, there must be an appropriate license.

As before, there are separate prescription forms for psychotropic drugs; drugs dispensed free of charge; for others. It is clarified which drugs are dispensed for them. Recipe service times have been kept the same.

The features of the release of the immunobiological preparation are fixed. So, on the prescription or prescription spine, which remains with the purchaser, the exact time (in hours and minutes) of the holiday is indicated. In this case, the purchaser must have a special thermal container. The first one receives clarifications on the delivery time of the drug to the medical facility.

The shelf life of recipes has been clarified.

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

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

Samvel Grigoryan talks about a 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 IBLP leave is spelled out separately, which is not in order No. 785. It will be regulated by paragraph 13 of the first of the mentioned acts. This paragraph, in particular, determines that when the IBLP is dispensed, the exact time of this very issue, in hours and minutes, is indicated on the prescription or prescription spine that remains with the buyer.

Violation of the secondary

With the entry into force of Order No. 403n, new accents will appear on the topic of the possibility of violating the secondary (consumer) packaging of medicines. The norm of the "retiring" order No. 785 allows this to be done in exceptional cases, if the pharmacy organization cannot fulfill the doctor's prescription.

Order No. 403n, which replaces it, is more specific in this regard and more in line with modern requirements, medical practice and consumer needs. Clause 8 of the order determines that violation of the secondary packaging and dispensing of the medicinal product in the primary packaging is allowed in cases where the amount of the drug indicated in the prescription or required by the consumer (in case of 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 of it, and violation of the primary packaging is prohibited. By the way, the new order does not contain a rule that, in case of violation of the secondary drug, the drug should be dispensed in a pharmacy package with the obligatory indication of the name, factory batch, expiration date of the drug, series and date according to the laboratory packing journal, which is determined by order No. 785.

"Medication 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, Form No. 107/y-NP dispenses narcotic and psychotropic drugs of Schedule II, with the exception of narcotic and psychotropic drugs in the form of transdermal therapeutic systems.

The remaining prescription drugs, as you know, are dispensed according to the forms of the form No. 107-1 / y. 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 medicines, as well as forms of prescription forms ...”, prescriptions written out on the forms of this form are valid for two months from the date of issuance. However, for patients with chronic diseases, it is allowed to set the validity of the prescription form No. 107-1 / y 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 the amount of dispensing of the medicinal product (in each period), is returned to the buyer, of course, with the appropriate notes on the date of dispensing, dosage and quantity of the dispensed drug. This is prescribed by paragraph 10 of order No. 403n. He also determines that the next time the patient contacts the pharmacy with the same prescription, the first-timer must take into account the notes on the previous release of the drug.

The prescription remains in 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 retailer retains (with the mark "Drug product dispensed") and stores:

within 5 years prescriptions for:

within 3 years prescriptions for:

within 3 months recipes for:

The order of the Ministry of Health of Russia No. 403n did not do without a cherry on the cake, however, a dubious one. In paragraph 15 of the order, it is written that prescriptions that are not specified in the previous paragraph 14 (we listed them a little higher) are marked with the stamp “The drug is dispensed” and returned to the indicator. This seems to imply that Form 107-1/2-month-validity prescriptions become "single use." We advise readers to pay special attention to this new norm.

The topic of combating the abuse of alcohol-containing drugs in the pharmacy range, which was recently trumpeted by the media, was 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 stamp "released"); under the new order, they must remain in the pharmacy organization.

To not get caught

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

Clause 17 of Order No. 403n contains a rule that a pharmaceutical worker is not entitled to provide false or incomplete information about the presence of drugs in the assortment of a pharmacy facility - including drugs that have the same INN - and also 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 basics 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 of August 21, 2016 No. 647n). Here, the only new thing is that this norm first appears in the order on the rules of leave.

It was a review of the order, so to speak, "on a fresh trail." Probably, readers will 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 “one-time” 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 drugs are dispensed. As soon as the pharmacists had time to return from summer vacation and look around, a new order of the Ministry of Health of the Russian Federation dated July 11, 2017 No. 403n was published with annexes “On approval of the rules for dispensing drugs for medical use, including immunobiological drugs, by pharmacy organizations, individual entrepreneurs with pharmaceutical license. Order No. 403n on the vacation procedure was registered with the Ministry of Justice of the Russian Federation on September 8; the beginning of its action is September 22 of the current year.

The first thing I would like to say in this regard is to forget now the number "785". The new order 403n with amendments and additions recognizes as invalid 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 made changes to it. new normative 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 to a greater extent, setting out the first observations and notes in the margins of the freshly baked 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 dispensing medicinal products, including immunobiological medicinal products (IBLP); the second - the requirements for the release of narcotic and psychotropic drugs, drugs with anabolic activity, and other drugs subject to subject-quantitative accounting (PKU). The third annex establishes the rules for dispensing medicines according to the requirements of invoices of medical organizations, as well as individual entrepreneurs (IEs) who have a license for medical activities.

The release of over-the-counter drugs and under the new procedure will be allowed both for pharmacies and pharmacy points, and for individual entrepreneurs and pharmacy kiosks. Otherwise, if we sum up points 2 and 3 of order No. 403n and the list of drugs, the following picture emerges.

  • The release of narcotic and psychotropic drugs can only be carried out by pharmacies and pharmacy points that have the appropriate license.
  • The rest of the prescription drugs are dispensed by pharmacies, drugstores and individual entrepreneurs (of course, those who have a license for pharmaceutical activity - this clarification will be further considered accepted by default and omitted).
  • The release 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 IBLP drugs is prescribed separately, which is not in order No. 785. It will be regulated by paragraph 13 of the first of the mentioned acts. This paragraph, in particular, determines that when the IBLP is dispensed, the exact time of this very issue, in hours and minutes, is indicated on the prescription or prescription spine that remains with the buyer.

It is possible to release IBLP under two conditions. Firstly, if the buyer has a special thermal container, in which it is possible to comply with the required mode of transportation and storage of these thermolabile drugs. The second condition is an explanation (pharmacy worker 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.

Recall in this regard that this topic is also regulated by subparagraph 8.11.5 of the Sanitary and Epidemiological Rules "Conditions for the transportation and storage of immunobiological preparations" (SP 3.3.2.3332-16), which are approved by the Decree of the Chief State Sanitary Doctor of the Russian Federation of February 17, 2016 No. 19 It obliges the pharmacy worker to instruct the buyer on the need to comply with the "cold chain" when transporting IBLP.

The fact of this briefing is recorded by a mark - on the drug package, prescription or other accompanying document. The mark is certified by the signature of the buyer and the first owner (or other representative of the pharmacy organization) and also includes the date and time of the vacation. However, SanPiN does not specify that the time in this case should be entered in hours and minutes.

Violation of the secondary

With the amendments and additions to Order No. 403n, new accents will appear on the topic of the possibility of violating the secondary (consumer) packaging of medicines. The norm of the "retiring" order No. 785 allows this to be done in exceptional cases, if the pharmacy organization cannot fulfill the doctor's prescription.

Order No. 403n, which replaces it, with a list of drugs in this regard, is more specific and more in line with modern requirements, medical practice and consumer needs. Clause 8 of the order determines that violation of the secondary packaging and dispensing of the medicinal product in the primary packaging is allowed in cases where the amount of the drug indicated in the prescription or required by the consumer (in case of 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 of it, and violation of the primary packaging is prohibited. By the way, in the new order of the Ministry of Health of the Russian Federation No. 403n there is no rule that, in case of violation of the secondary drug, the drug should be dispensed in a pharmacy package with the obligatory indication of the name, factory batch, expiration date of the drug, series and date according to the laboratory packing journal, which is determined by order No. 785.

What does this mean in practice? Let's assume two situations: the first - preparation X tablets (or pills) No. 56, primary packaging - blister; the second - the preparation of N tablets No. 56, in a vial. And in both cases, there is a question about his release to the patient who presented the prescription to the head of state, on which, say, 28 tablets or 42 tablets (pellets) are written.

It is clear that in the first case this is permissible, since it is possible to release 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 vial, and it is strictly forbidden to violate it. So, our pioneers do not have the right to count pills or dragees from a bottle, as they do in pharmacies in some foreign countries.

"Medication 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, Form No. 107/y-NP dispenses narcotic and psychotropic drugs of Schedule II, with the exception of narcotic and psychotropic drugs in the form of transdermal therapeutic systems.

According to the form No. 148–1 / y-88, the following are released:

  • psychotropic drugs of Schedule III;
  • narcotic and psychotropic medicinal products of Schedule II in the form of transdermal therapeutic systems;
  • drugs included in the list of medicines subject to PKU, with the exception of those drugs that are dispensed in accordance with the form No. 107 / y-NP;
  • drugs with anabolic activity and related to the anatomical-therapeutic-chemical classification (ATC) recommended by the World Health Organization as anabolic steroids (code A14A);
  • preparations specified in clause 5 of the “Procedure for the sale of medicinal products to individuals containing, in addition to small amounts of narcotic drugs, psychotropic substances and their precursors, other pharmacologically 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 or psychotropic substance included in Schedule II and other pharmacologically active substances in a dose not exceeding the highest single dose, and provided that this combination medicinal product is not a narcotic or psychotropic medicinal product Schedule II drug.

The list of other prescription drugs, as you know, are released according to the forms of the form No. 107-1 / y. 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 medicines, as well as forms of prescription forms ...”, prescriptions written out on the forms of this form are valid for two months from the date of issuance. However, for patients with chronic diseases, it is allowed to set the validity of the prescription form No. 107-1 / y 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 the amount of dispensing of the medicinal product (in each period), is returned to the buyer, of course, with the appropriate notes on the date of dispensing, dosage and quantity of the dispensed drug. This is prescribed by paragraph 10 of order No. 403n. He also determines that the next time the patient contacts the same prescription for the list of drugs at the pharmacy, the first-timer must take into account the notes on the previous release of the drug.

At the time when the maximum amount indicated in the prescription is purchased, it must be stamped “Medicinal product dispensed”. And a one-time vacation of the entire amount, according to the same paragraph, is allowed only in agreement with the doctor who wrote out this prescription.

The prescription remains in 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 retailer retains (with the mark “Drug product dispensed”) and stores:

within 5 years prescriptions for:

  • narcotic and psychotropic drugs of Schedule II, psychotropic drugs of Schedule III (according to the outgoing Order 785, 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 / y-04 (l) or No. 148-1 / y-06 (l));
  • combined medicinal products containing narcotic drugs or psychotropic substances included in Schedules II and III, manufactured in a pharmacy organization, drugs with anabolic activity, drugs subject to PKU;

within 3 months recipes for:

  • preparations in liquid dosage form containing more than 15% ethyl alcohol by volume of finished products, other preparations related by ATC to antipsychotics (code N05A), anxiolytics (code N05B), hypnotics and sedatives (code N05C), antidepressants (code N06A ) and not subject to CSP.

Note that in the 785th order there is no this group of recipes for three-month storage.

Order No. 403n of the Ministry of Health did not do without a cherry on the cake, however, a dubious one. In paragraph 15 of the order, it is written that prescriptions that are not indicated in the previous paragraph 14 (we listed them a little higher) are marked with the stamp “The drug is dispensed” and returned to the indicator. This seems to imply that Form 107-1/2-month-validity prescriptions become "single use." We advise readers to pay special attention to this new norm.

The topic of combating the abuse of alcohol-containing drugs in the pharmacy assortment, which was recently trumpeted by the media, was 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 stamp "released"); under the new order, they must remain in the pharmacy organization.

To not get caught

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

According to this paragraph, during drug dispensing, the pharmacist informs the buyer not only about the regimen of its administration and doses, but also about the rules for storage at home and interaction with other drugs.

Theoretically, 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 first-timer, dispensing the medicine, does not inform him, for example, that this medicine must be stored at a temperature not exceeding 25 ° C, or does not ask if he is currently taking other medicines, then the inspector can “throw off the mask” and draw up an act on an administrative offense. So the norm of paragraph 16 is serious and fraught. And, of course, it requires that the pervostolnik be thoroughly savvy on the complex and voluminous topic of drug interaction.

Clause 17 of Order No. 403n, as amended, contains a rule that a pharmacist is not entitled to provide false or incomplete information about the availability of drugs in the assortment of a pharmacy facility - including drugs that have the same INN - and also 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 of August 21, 2016 No. 647n). Here, the only new thing is that this norm first appears in the order on the order of vacation.

These were explanations of order No. 403n, so to speak, "on a fresh trail." Probably, readers will 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 “one-time use” of prescriptions with a two-month validity period, which was discussed 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, our website will host a webinar by Larisa Garbuzova, Ph.D. n., Associate Professor of the Department of Management and Economics of Pharmacy, North-Western 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.

" № 10/2017

From September 22, 2017, the rules for dispensing medicinal products for medical use, including immunobiological medicinal products, apply.

Order of the Ministry of Health of Russia No. 403n dated July 11, 2017 approved the new Rules for dispensing medicinal products for medical use, including immunobiological medicinal products, by pharmacy organizations, individual entrepreneurs licensed for pharmaceutical activities (hereinafter referred to as the Rules). The document entered into force on September 22, 2017. From this date, the previously valid Order of the Ministry of Health and Social Development of Russia dated December 14, 2005 No. 785 “On the procedure for dispensing medicines” became invalid.

What changes in work will pharmacy organizations face in connection with this?

From September 22, 2017, a new procedure for dispensing medicines, including immunobiological ones, is in effect for retailers (pharmacy organizations and individual entrepreneurs) engaged in pharmaceutical activities. The document includes three sections:

    general requirements for dispensing medicinal products for medical use;

    requirements for the dispensing of narcotic and psychotropic medicinal products, medicinal products with anabolic activity, other medicinal products subject to quantitative accounting;

    requirements for the release of medicinal products according to the requirements-waybills of medical organizations, individual entrepreneurs who have a license for medical activities. The Rules revised the requirements for the dispensing of narcotic and psychotropic drugs, as well as medicinal products subject to subject-quantitative accounting, defined the requirements for primary and secondary packaging of a medicinal product dispensed from a pharmacy, established the specifics of the dispensing of drugs according to the requirements-invoices of medical organizations, individual entrepreneurs with a license for medical activities. The document also specifies:

    the terms during which medicinal products are dispensed, including those marked in the prescription as “statim” (immediately) and “cito” (urgently);

    terms of storage of prescriptions for dispensed drugs in a pharmacy organization.

Let us dwell on the most important provisions of the Rules, noting that they apply to the following subjects of the pharmaceutical business:

  • pharmacy points;

    pharmacy kiosks;

    individual entrepreneurs who have a license to carry out pharmaceutical activities.

Dispensing prescription drugs.

The procedure for prescribing and prescribing medicines, as well as forms of prescription forms for medicines, the procedure for issuing these forms, their accounting and storage are approved by Order of the Ministry of Health of Russia dated December 20, 2012 No. 1175n. The forms of prescription forms containing the prescription of narcotic drugs or psychotropic substances, the procedure for their manufacture, distribution, registration, accounting and storage, as well as the rules for registration, were approved by Order of the Ministry of Health of Russia dated 08/01/2012 No. 54n.

Prescription drugs are dispensed by pharmacies and drugstores. They also have the right to dispense immunobiological, narcotic and psychotropic drugs. At the same time, for the release of the latter, these subjects of pharmaceutical activity should be able to conduct activities for the circulation of narcotic drugs, psychotropic substances and their precursors, and the cultivation of narcotic plants.

Note:

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 No. 681 of 30.06.1998, is not carried out by individual entrepreneurs.

The rules establish the procedure for the release of narcotic and psychotropic forms according to prescriptions issued on prescription forms of various forms.

The form
prescription blank

Dispensed drugs

Narcotic and psychotropic medicinal products included in the List of narcotic drugs and psychotropic substances, the circulation of which in the Russian Federation is limited 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)*, with the exception of narcotic and psychotropic medicinal products as transdermal therapeutic systems

Psychotropic medicinal products included in the List of psychotropic substances whose circulation in the Russian Federation is restricted and for which the exclusion of certain control measures is allowed in accordance with the legislation of the Russian Federation and international treaties of the Russian Federation (List III)**

Narcotic and psychotropic medicinal products of Schedule II in the form of transdermal therapeutic systems

Medicinal products included in the list of medicinal products for medical use subject to subject-quantitative accounting***

Drugs with anabolic activity (in accordance with the main pharmacological action) and related to the anatomical-therapeutic-chemical classification recommended by the World Health Organization as anabolic steroids

Medicinal products specified in clause 5 of the Procedure for dispensing to individuals medicinal products for medical use, containing, in addition to small amounts of narcotic drugs, psychotropic substances and their precursors, other pharmacologically active substances ****

Prescription medicinal products containing a narcotic drug or psychotropic substance included in Schedule II, in a dose not exceeding the highest single dose, and provided that this combination product is not a Schedule II narcotic or psychotropic drug

Medicines prescribed to citizens entitled to free (at a discount) receipt of medicines

Other medicines

* Approved by Decree of the Government of the Russian Federation No. 681.

** Approved by Decree of the Government of the Russian Federation No. 681.

*** Approved by the Order of the Ministry of Health of Russia dated April 22, 2014 No. 183n.

**** Approved by the Order of the Ministry of Social Health Development of Russia dated May 17, 2012 No. 562n.

The terms during which the dispensing of medicinal products is carried out, including those marked in the prescription as “statim” (immediately) and “cito” (urgently), remain the same and are prescribed in clause 6 of the Rules.

Dispensing medicines without prescriptions

Dispensing of drugs not listed in the table is carried out without prescriptions in accordance with the instructions for their medical use.

Requirements for primary and secondary packaging of a medicinal product dispensed from a pharmacy

Clause 8 of the Rules now establishes that the medicinal product is dispensed in primary and secondary (consumer) packages, the labeling of which must meet the requirements of Art. 46 of the Federal Law No.  61-FZ.

Packaging for narcotic and psychotropic medicinal products of Schedule II must comply with the requirements of paragraph 3 of Art. 27 of the Federal Law of January 8, 1998 No. 3-FZ "On Narcotic Drugs and Psychotropic Substances" (hereinafter - Federal Law No. 3-FZ).

Note:

Primary packages and secondary (consumer) packages of narcotic drugs, psychotropic substances included in List II and used for medical purposes and (or) in veterinary medicine must be marked with a double red stripe.

Violation of the primary packaging of the medicinal product during its dispensing is prohibited by the Rules.

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

Release of immunobiological preparations.

The rules establish (clause 13) that the release of an immunobiological medicinal product is carried out by the person acquiring (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 it to a medical organization, provided that it is stored in a special thermal container within a period not exceeding 48 hours after its acquisition.

When dispensing an immunobiological medicinal product, the exact time (in hours and minutes) of its dispensing is indicated on the prescription or prescription spine, which remains with the purchaser of this drug.

Dispensing of medicinal products according to invoice requirements.

The requirement-invoice for the release of medicinal products is drawn up in accordance with the Instructions on the procedure for prescribing medicinal products and issuing prescriptions and invoice requirements.

Recall: to ensure the diagnostic and treatment process, medical organizations receive medicines from the pharmacy organization according to the requirements-waybills (clause 3.1 of the document). The requirement-consignment note must have a stamp, a round seal of a medical organization, the signature of its head or his deputy for the medical unit. The document also indicates the number, the date of its compilation, the sender and recipient of the medicinal product, its name (indicating the dosage, form of release (tablets, ampoules, ointments, suppositories, etc.)), type of packaging (boxes, vials, tubes and etc.), method of administration (for injections, for external use, oral administration, eye drops, etc.), the number of requested drugs, the number and cost of dispensed drugs.

Note:

Dispensing of medicinal products according to the requirements-invoices of medical organizations and individual entrepreneurs with a license for medical activities, issued in electronic form, is permissible if they, as well as retailers (pharmacies and individual entrepreneurs), respectively, are participants in the information exchange system for exchange of information.

When dispensing medicinal products, the pharmaceutical worker checks the proper execution of the invoice request and puts a mark on it on the quantity and cost of the dispensed medicinal products.

Paragraph 31 of the Rules establishes that violation of the primary packaging of a medicinal product when it is dispensed on demand-invoice is allowed 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 drawn up in accordance with the established procedure, with the provision of instructions (copies of instructions) for the use of the dispensed medicinal product.

The above instruction establishes that invoice requirements for medicinal products subject to subject-quantitative accounting are written out on separate forms of invoice requirements for each group of drugs. So, for individual requirements-waybills, the following are carried out (clause 27 of the Rules):

    dispensing of Schedule II narcotic and psychotropic medicinal products;

    psychotropic medicinal products of Schedule III;

    other medicinal products subject to subject-quantitative accounting, including those sold without a prescription.

At the same time, it is prohibited to sell narcotic and psychotropic drugs of Schedule II, including in the form of transdermal therapeutic systems, psychotropic drugs of Schedule III according to the requirements-invoices of an individual entrepreneur who has a license for medical activities (clause 4, article 31 of Federal Law No.  3- FZ).

All requirements-invoices, according to which medicinal products are dispensed, are subject to storage at the retailer:

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

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

    within one year - for other drugs.

Ministry of Health clarification.

To date, the competent authorities have begun to receive applications for the application of the new Rules, as a result of which the Ministry of Health issued clarifications dated September 27, 2017 in order to bring this information to the attention of pharmacy organizations and entrepreneurs who have a license for pharmaceutical activities and dispense medicines. In particular, the officials spoke out on the issue of dispensing a prescription drug that expired while it was on deferred maintenance (clause 9 of the Rules). They pointed out that the said norm applies to all groups of drugs, including those subject to subject-quantitative accounting, with the exception of narcotic and psychotropic drugs included in Schedule II. For them, the norm provided for by Part 6 of Art. 25 of Federal Law No. 3-FZ, regarding the prohibition of their dispensing on prescriptions issued more than 15 days ago.

Paragraph 20 of the Rules clarifies the rule on persons entitled to receive narcotic and psychotropic drugs included in Schedule II. So, these drugs can receive:

    patients who are prescribed these drugs;

    legal representatives of patients (if the patients are minors or incapacitated);

    other persons in the presence of a power of attorney from the patient, drawn up in the prescribed manner.

With regard to the power of attorney from the patient, the Ministry of Health explained the following: it is issued in a simple written form (Article 185 of the Civil Code of the Russian Federation) and can be notarized at the request of the patient or if it is impossible for them to write (Articles 163 and 185.1 of the Civil Code of the Russian Federation).

Note:

If the power of attorney does not specify the period of its validity, it remains valid for a year from the date of its signing.

The clarifications of the Ministry of Health also touched upon the release of immunobiological drugs. When they leave, the requirements provided for in clause 13 of the Rules must be observed. At the same time, according to officials, in addition to thermal containers, other devices can be used to maintain the temperature regime required for storing an immunobiological drug for the period of its delivery to a medical organization.

You should also pay attention to the fact that the Rules do not introduce a provision on the need for patients to obtain prescriptions for drugs that are duly registered as non-prescription drugs and have a corresponding entry in the instructions for medical use “dispensed without a prescription”.

For your information:

Attribution of medicinal products to prescription or over-the-counter dispensing is carried out at the stage of their state registration; dispensing conditions are indicated in the registration documents for medicinal products, including instructions for medical use.

The rules, as explained by the Ministry of Health, regulate only the shelf life of prescriptions and do not create additional restrictions on the circulation of the above medicines. Paragraph 14 introduced a new rule on storage for three months of prescriptions for medicinal products in liquid dosage form containing more than 15% ethyl alcohol of the volume of finished products. At the same time, according to the clarifications of the department, prescriptions for the above medicines, written out on prescription forms of form 107-1 / y, with a validity period of up to 60 days and up to 1 year, are subject to storage. In the latter case, the prescription remains and is stored for a specified period after the last batch of the medicinal product has been dispensed to the patient.

Approved by the Order of the Ministry of Health and Social Development of Russia dated February 12, 2007 No. 110 “On the procedure for prescribing and prescribing medicines, medical devices and specialized medical food products”.

The corresponding procedure is established by Order of the Ministry of Health of Russia dated October 26, 2015 No. 751n "On approval of the rules for the manufacture and dispensing of drugs for medical use by pharmacy organizations, individual entrepreneurs licensed for pharmaceutical activities."

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