Norms for dispensing medicines subject to prescription. Dispensing of medications from a pharmacy organization

18.10.2019 -

ORDER
DISPENDING OF MEDICINES

(as amended by Orders of the Ministry of Health and Social Development of the Russian Federation dated April 24, 2006 N 302, dated October 13, 2006 N 703, dated February 12, 2007 N 109, dated August 6, 2007 N 521, Order of the Ministry of Health of the Russian Federation dated April 22, 2014 N 183n)

I. General provisions

1.1. This Procedure defines the requirements for leave medicines<*>pharmacy institutions (organizations)

regardless of the organizational and legal form, form of ownership and departmental affiliation. 1.2. Medicines are subject to dispensing by pharmacies (organizations), including narcotic drugs, psychotropic, potent and toxic substances registered in

Russian Federation according to established order..

1.3.

Dispensing of medicines with a doctor’s prescription and without a doctor’s prescription is carried out by pharmacies (organizations) licensed to pharmaceutical activities 1.4.<*>.

<*>Medicines prescribed by doctor must be dispensed by pharmacies and pharmacy points.

Medicines in accordance with the List of medicines dispensed without a doctor's prescription, approved by the Order of the Ministry of Health and social development of the Russian Federation dated September 13, 2005 N 578 (registered with the Ministry of Justice of the Russian Federation on September 29, 2005 N 7053) (hereinafter referred to as the List of medicines dispensed without a doctor’s prescription) are subject to sale by all pharmacies (organizations)

Pharmacies, pharmacy points, pharmacy kiosks, pharmacy stores.

1.5.

2.1.

All medicines, with the exception of those included in the List of medicines dispensed without a doctor's prescription, must be dispensed by pharmacies (organizations) only according to prescriptions filled out in the prescribed manner on prescription forms of the relevant accounting forms. 2.2.

According to prescriptions written on prescription forms, the forms of which are approved by Order of the Ministry of Health and Social Development of the Russian Federation dated February 12, 2007 N 110, pharmacies (organizations) dispense: dated 06.08.2007 N 521) Narcotic drugs and psychotropic substances included in List II of the List

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 (Collected Legislation of the Russian Federation, 1998, N 27, Art. 3198; 2004, N 8, Art. 663; N 47, Art. 4666) (hereinafter referred to as the List), written out on special prescription forms for narcotic drugs;

Psychotropic substances included in List III of the List, prescribed on prescription forms, form N 148-1/у-88; In connection with the loss of force of the Order of the Ministry of Health of the Russian Federation dated 08.23.99 N 328, one should be guided by the Order of the Ministry of Health and Social Development of the Russian Federation dated 02.12.2007 N 110 adopted in its place

Other medicinal products subject to subject-quantitative accounting in pharmacies (organizations), drug wholesale trade organizations, medical institutions and private practitioners, the List of which is provided in Appendix No. 1 to this Procedure (hereinafter referred to as other medicinal products subject to subject-quantitative registration) registration), written out on prescription forms, form N 148-1/u-88; (as amended by Order of the Ministry of Health and Social Development of the Russian Federation dated April 24, 2006 N 302) Medicines included in the List of medicines dispensed on prescription from a doctor (paramedic) when providing additional free medical care individual categories, approved by Order of the Ministry of Health and Social Development of the Russian Federation on September 18, 2006 N 665 (registered with the Ministry of Justice of the Russian Federation on September 27, 2006 N 8322) (hereinafter referred to as medicines included in the List of medicines dispensed on prescription from a doctor (paramedic ), as well as other medicines dispensed free of charge or at a discount, prescribed on prescription forms of form N 148-1/u-04 (l)) and form N 148-1/u-06 (l); (as amended by Order of the Ministry of Health and Social Development of the Russian Federation dated February 12, 2007 N 109, dated August 6, 2007 N 521)

In connection with the loss of force of the Order of the Ministry of Health and Social Development of the Russian Federation dated September 28, 2005 N 601, one should be guided by the Order of the Ministry of Health and Social Development of the Russian Federation dated September 18, 2006 N 665 adopted in its place

Anabolic steroids prescribed on prescription forms N 148-1/у-88;

Other medicines not included in the List of medicines dispensed without a doctor's prescription, prescribed on prescription forms, form N 107/u.

2.3.

Prescriptions for narcotic drugs and psychotropic substances included in List II of the List are valid for five days. In connection with the loss of force of the Order of the Ministry of Health of the Russian Federation dated 08.23.99 N 328, one should be guided by the Order of the Ministry of Health and Social Development of the Russian Federation dated 02.12.2007 N 110 adopted in its place

Prescriptions for psychotropic substances included in List III of the List; other medicines subject to subject-quantitative accounting; anabolic steroids are valid for ten days. In connection with the loss of force of the Order of the Ministry of Health of the Russian Federation dated 08.23.99 N 328, one should be guided by the Order of the Ministry of Health and Social Development of the Russian Federation dated 02.12.2007 N 110 adopted in its place

Prescriptions for medicines included in the List of medicines dispensed by prescription from a doctor (paramedic), as well as other medicines dispensed free of charge or at a discount, with the exception of prescriptions for narcotic drugs and psychotropic substances included in List II of the List, for psychotropic substances included in List III of the List, for other medicines subject to subject-quantitative registration, for anabolic steroids are valid for one month. Prescriptions for other medicines are valid for two months from the date of their issuance and up to one year in accordance with paragraph 1.17 of the Instructions on the procedure for prescribing medicines and issuing prescriptions and invoice requirements, approved by the Order of the Ministry of Health and Social Development of the Russian Federation dated February 12, 2007 N 110 (hereinafter referred to as the Instructions).

(as amended by Order of the Ministry of Health and Social Development of the Russian Federation dated August 6, 2007 N 521) 2.4. actions, with the exception of prescription drugs that expired while the prescriptions were on deferred maintenance.

2.5. Medicines are dispensed by pharmacies (organizations) in the quantities specified in the prescription, with the exception of medicines, the dispensing rates of which are specified in paragraph 1.11 of the Instructions and Appendix No. 1 to the Instructions.

(as amended by Order of the Ministry of Health and Social Development of the Russian Federation dated April 24, 2006 N 302, dated August 6, 2007 N 521) Medicines containing narcotic drugs, psychotropic substances and their precursors and included in the List of Medicines Dispensed Without a Prescription are subject to dispensing by pharmacies in quantities of no more than 2 packages to the consumer.

(as amended by Order of the Ministry of Health and Social Development of the Russian Federation dated February 12, 2007 N 109)

2.6. When dispensing medicines according to a doctor's prescription, an employee of a pharmacy institution (organization) makes a note on the prescription about the dispensing of the drug (name or number of the pharmacy institution (organization), name and dosage of the drug, quantity dispensed, signature of the dispenser and date of dispensing). 2.7.

If there are medicines in a pharmacy institution (organization) with a dosage different from the dosage prescribed in the doctor’s prescription, the employee of the pharmacy institution (organization) may decide to dispense the available medicines to the patient if the dosage of the drug

less dosage

specified in the doctor’s prescription, taking into account the recalculation for the course dose.

If the dosage of a medicinal product available in a pharmacy institution (organization) exceeds the dosage specified in the doctor’s prescription, the decision to dispense the medicinal product to the patient is made by the doctor who wrote the prescription.

The patient is provided with information about changing the single dose of the drug.

2.9.

When dispensing medicines according to a doctor’s prescription valid for one year, the prescription is returned to the patient indicating on the back the name or number of the pharmacy institution (organization), the signature of the employee of the pharmacy institution (organization), the quantity of the drug dispensed and the date of dispensing.

When the patient next contacts a pharmacy institution (organization), notes on the previous receipt of the medicine are taken into account. Upon expiration of the validity period, the prescription is canceled with the stamp “Prescription is invalid” and left at the pharmacy institution (organization). In connection with the loss of force of the Order of the Ministry of Health of the Russian Federation dated 08.23.99 N 328, one should be guided by the Order of the Ministry of Health and Social Development of the Russian Federation dated 02.12.2007 N 110 adopted in its place

2.10.

In exceptional cases (a patient leaving the city, the inability to regularly visit a pharmacy institution (organization), etc.), pharmaceutical workers of a pharmacy institution (organization) are allowed to make a one-time dispensing of a medicine prescribed by a doctor according to prescriptions valid for one year, in an amount necessary for treatment for two months, with the exception of medicines subject to subject-quantitative accounting, the List of which is provided in Appendix No. 1 to this Procedure. Medicines containing narcotic drugs, psychotropic substances and their precursors and included in the List of Medicines Dispensed Without a Prescription are subject to dispensing by pharmacies in quantities of no more than 2 packages to the consumer.

2.11.

If a pharmacy institution (organization) does not have a medicinal product prescribed by a doctor, with the exception of a medicinal product included in the List of Medicines Dispensed on the Prescription of a Doctor (Paramedic), as well as other medicinal products dispensed free of charge or at a discount, the employee of the pharmacy institution (organization) ) can carry out its synonymous replacement with the consent of the patient.

When dispensing a medicinal product included in the List of Medicinal Products dispensed on prescription from a doctor (paramedic), as well as another medicinal product dispensed free of charge or at a discount, an employee of a pharmacy institution (organization) can make a synonymous replacement of the medicinal product. 2.12. Prescriptions for medicines marked “statim” (immediately) are processed within a period not exceeding one working day from the moment the patient contacts the pharmacy institution (organization).

2.13.

Prescriptions for medicines included in the List of medicines dispensed by prescription from a doctor (paramedic) and not included in the minimum range of medicines are serviced within a period not exceeding ten working days from the moment the patient contacts the pharmacy institution (organization).

Prescriptions for medicines prescribed by decision of a medical commission approved by the chief physician of a medical institution are processed within a period not exceeding fifteen working days from the moment the patient contacts the pharmacy institution (organization). In connection with the loss of force of the Order of the Ministry of Health of the Russian Federation dated 08.23.99 N 328, one should be guided by the Order of the Ministry of Health and Social Development of the Russian Federation dated 02.12.2007 N 110 adopted in its place

2.14. In connection with the loss of force of the Order of the Ministry of Health of the Russian Federation dated 08.23.99 N 328, one should be guided by the Order of the Ministry of Health and Social Development of the Russian Federation dated 02.12.2007 N 110 adopted in its place

Prescriptions for medicines subject to subject-quantitative recording, the list of which is provided in Appendix No. 1 to this Procedure; medicines included in the List of medicines dispensed on prescription from a doctor (paramedic), as well as other medicines sold free of charge or at a discount; anabolic steroids remain in the pharmacy institution (organization) for subsequent separate storage and destruction after the expiration of the storage period.

2.15.

The pharmacy institution (organization) must ensure conditions for the safety of prescriptions left for storage that are subject to subject-quantitative recording, the List of which is provided in Appendix No. 1 to this Procedure; medicines included in the List of medicines dispensed on prescription from a doctor (paramedic), as well as other medicines sold free of charge or at a discount; anabolic steroid.

2.16. In connection with the loss of force of the Order of the Ministry of Health of the Russian Federation dated 08.23.99 N 328, one should be guided by the Order of the Ministry of Health and Social Development of the Russian Federation dated 02.12.2007 N 110 adopted in its place

The shelf life of prescriptions in a pharmacy institution (organization) is:

The procedure for the destruction of prescriptions left in a pharmacy institution (organization) after the established storage periods have expired, and the composition of the commission for their destruction may be determined by the health care or pharmaceutical authorities of the constituent entity of the Russian Federation.

2.17.

Medicines of good quality purchased by citizens are not subject to return or exchange in accordance with the List of non-food products of good quality that cannot be returned or exchanged for a similar product of a different size, shape, size, style, color or configuration, approved by the Decree of the Government of the Russian Federation of January 19, 1998 No. 55 (Collected Legislation of the Russian Federation, 1998, No. 4, Art. 482; No. 43, Art. 5357; 1999, No. 41, Art. 4923; 2002, No. 6, Art. 584; 2003, No. 29, Art. . 2998; 2005, N 7, art.

It is not permitted to re-dispense (sell) medicines recognized as goods of inadequate quality and returned by citizens for this reason.

2.18.

Prescriptions for tranquilizers that are not subject to subject-quantitative accounting; antidepressants, neuroleptics; industrially produced alcohol-containing medicines are redeemed with the stamp of the pharmacy institution (organization) “Medicine dispensed” and returned to the patient. In connection with the loss of force of the Order of the Ministry of Health of the Russian Federation dated 08.23.99 N 328, one should be guided by the Order of the Ministry of Health and Social Development of the Russian Federation dated 02.12.2007 N 110 adopted in its place

To re-dispense the drug, the patient must consult a doctor for a new prescription.

2.19.

Incorrectly written prescriptions are canceled with the stamp “Prescription invalid” and registered in a journal, the form of which is provided in Appendix No. 4 to this Procedure, and returned to the patient.

Information about all incorrectly prescribed prescriptions is brought to the attention of the head of the relevant medical institution.

3.2. The right to work with narcotic drugs and psychotropic substances included in List II of the List, and psychotropic substances included in List III of the List, has only pharmacy institutions (organizations) that have received the appropriate licenses in established by law

Russian Federation is ok.

3.3.

The dispensing to patients of narcotic drugs and psychotropic substances included in List II of the List, and psychotropic substances included in List III of the List, is carried out by pharmaceutical workers of pharmacy institutions (organizations) who have the right to do so in accordance with the Order of the Ministry of Health and Social Development of the Russian Federation dated 13 May 2005 N 330 (registered with the Ministry of Justice of the Russian Federation on June 10, 2005 N 6711).

3.4.

In a pharmacy institution (organization), the dispensing of narcotic drugs and psychotropic substances included in List II of the List is carried out by patients assigned to a specific outpatient clinic, which is assigned to the pharmacy institution (organization).

The assignment of an outpatient clinic to a pharmacy institution (organization) can be carried out by the health care or pharmaceutical management body of a constituent entity of the Russian Federation in agreement with the territorial body for control over the circulation of narcotic drugs and psychotropic substances. In connection with the loss of force of the Order of the Ministry of Health of the Russian Federation dated 08.23.99 N 328, one should be guided by the Order of the Ministry of Health and Social Development of the Russian Federation dated 02.12.2007 N 110 adopted in its place

3.7. Pharmacy institutions (organizations) are prohibited from dispensing narcotic drugs and psychotropic substances included in List II of List III of the List; other medicines subject to subject-quantitative accounting; anabolic steroids according to veterinary prescriptions medical organizations In connection with the loss of force of the Order of the Ministry of Health of the Russian Federation dated 08.23.99 N 328, one should be guided by the Order of the Ministry of Health and Social Development of the Russian Federation dated 02.12.2007 N 110 adopted in its place

for treating animals.

3.8. In connection with the loss of force of the Order of the Ministry of Health of the Russian Federation dated 08.23.99 N 328, one should be guided by the Order of the Ministry of Health and Social Development of the Russian Federation dated 02.12.2007 N 110 adopted in its place

Separate dispensing of medicinal products subject to subject-quantitative accounting and other medicinal products included in the composition of a combined medicinal product manufactured according to an individual prescription (hereinafter referred to as an extemporaneous medicinal product) is not allowed. 3.9. A pharmacist at a pharmacy institution (organization), upon receipt of a prescription for an individually manufactured medicinal prescription, is obliged to dispense a medicinal product subject to subject-quantitative recording in half the highest single dose if a doctor prescribes medicinal products in a dose exceeding the highest single dose.

3.10. When making extemporaneous medicines

containing medicinal products subject to subject-quantitative recording, in accordance with prescriptions written by a doctor, the pharmacist of the pharmacy institution (organization) signs on the prescription for issuance, and the pharmacist of the pharmacy institution (organization) signs for the receipt of the required quantity of medicinal products.

3.11.

Vacation In connection with the loss of force of the Order of the Ministry of Health of the Russian Federation dated 08.23.99 N 328, one should be guided by the Order of the Ministry of Health and Social Development of the Russian Federation dated 02.12.2007 N 110 adopted in its place

ethyl alcohol

IV. Control over the dispensing of medicines by pharmacies (organizations)

4.1.

Internal control over compliance by employees of a pharmacy institution (organization) with the procedure for dispensing medicines (including those subject to subject-quantitative accounting; medicines included in the List of medicines dispensed according to prescriptions of a doctor (paramedic), as well as other medicines dispensed free of charge or at a discount) is carried out by the head (deputy head) of a pharmacy institution (organization) or a pharmaceutical employee of a pharmacy institution (organization) authorized by him. 4.2. External control of compliance by pharmacies (organizations) with the procedure for dispensing medicines is carried out

Federal service<*>for supervision in the field of health care and social development and authorities for control of the circulation of narcotic drugs and psychotropic substances within their competence.

ACT on the destruction of prescriptions for narcotic drugs and psychotropic substances after their shelf life has expired

dated "__" ___________ 200_ N ________ Commission composed of.

MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION ORDER Additionally, see letter of the Ministry of Health of Russia dated September 27, 2017 N 2853/25-4 “Explanation of the norms of the order dated July 11, 2017 N 403n “On approval of the rules for the dispensing of drugs for
_____________________________________________________________________________________________

In accordance with Article 55 of the Federal Law of April 12, 2010 N 61-FZ “On the Circulation of Medicines” (Collection of Legislation of the Russian Federation, 2010, N 16, Art. 1815; N 31, Art. 4161; 2013; N 48, Art. 6165; 2014, No. 52, Art. 7540; 2015, No. 29, Art. 4388; 2016, No. 27, Art. 4238), paragraph 3 of Article 12 of the Federal Law of September 17, 1998 No. 157-FZ “On immunoprophylaxis of infectious diseases" (Collected Legislation of the Russian Federation, 1998, N 38, Art. 4736; 2009, N 1, Art. 21; 2013, N 48, Art. 6165) and subparagraphs 5.2.169, 5.2.183 of the Regulations on the Ministry of Health Russian Federation, approved by Decree of the Government of the Russian Federation of June 19, 2012 N 608 (Collection of Legislation of the Russian Federation, 2012, N 26, Art. 3526; 2013, N 16, Art. 1970; N 20, Art. 2477; N 22, Art. 2812; No. 4386; Art. 5822; 2014; Art. 1296; Art. 3577; Art. 4307; N 2, art. 491; N 23, art. 3333; N 2, art. 325; N 27, art. 4497; N 28, art. 4741; N 34, art. 5255; N 49, art. 6922; 2017, N 7, art. 1066),

I order:

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

2. To recognize as invalid:

Order of the Ministry of Health and Social Development of the Russian Federation dated December 14, 2005 N 785 “On the Procedure for Dispensing Medicines” (registered by the Ministry of Justice of the Russian Federation on January 16, 2006, registration N 7353);

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

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

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

Minister
V.I.Skvortsova

Registered
at the Ministry of Justice
1.2.
September 8, 2017,
registration N 48125

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

Application
to the order
Ministry of Health
1.2.
dated July 11, 2017 N 403n

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

1. These rules determine the procedure for the dispensing of medicinal products for medical use, including immunobiological medicinal products (hereinafter - medicinal products), by pharmacy organizations and individual entrepreneurs with a license for pharmaceutical activities (hereinafter - retail trade entities), without a prescription and (or ) according to a prescription for a medicinal product, written out in the prescribed manner by medical workers, as well as according to the invoice requirements of the organization carrying out medical activities(hereinafter referred to as a medical organization), or an individual entrepreneur with a license for medical activities (hereinafter referred to as a prescription, demand invoice).
________________
Subparagraph "h" of paragraph 5 of part 4 of Article 18, subparagraph "k" of paragraph 1 of part 1 of Article 33 of the Federal Law of April 12, 2010 N 61-FZ "On the Circulation of Medicines" (Collected Legislation of the Russian Federation, 2010, N 16, Art. 1815; N 42, Art. 5293; N 49, Art. 6409; 2014, N 52, Art. 7540).

Orders of the Ministry of Health of the Russian Federation:

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

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

2. Dispensing of medications without prescriptions is carried out:

pharmacies;

pharmacy points;

pharmacy kiosks;

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

3. Dispensing of prescription drugs is carried out:

pharmacies;

pharmacy points;

individual entrepreneurs (with the exception of the sale of narcotic drugs and psychotropic substances included in the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation, approved by Decree of the Government of the Russian Federation of June 30, 1998 N 681 (hereinafter referred to as the List, respectively) .
________________
Collection of Legislation of the Russian Federation, 1998, No. 27, Art. 3198; 2004, N 8, art. 663; N 47, art. 4666; 2006, N 29, art. 3253; 2007, N 28, art. 3439; 2009, N 26, art. 3183; N 52, art. 6572; 2010, N 3, art. 314; N 17, Art. 2100; N 24, art. 3035; N 28, art. 3703; N 31, art. 4271; N 45, art. 5864; N 50, art. 6696, 6720; 2011, N 10, art. 1390; N 12, art. 1635; N 29, art. 4466, 4473; N 42, art. 5921; N 51, art. 7534; 2012, N 10, art. 1232; N 11, art. 1295; N 19, art. 2400; N 22, art. 2864; N 37, art. 5002; N 48, art. 6686; N 49, art. 6861; 2013, N 9, art. 953; N 25, art. 3159; N 29, art. 3962; N 37, art. 4706; N 46, art. 5943; N 51, art. 6869; 2014, N 14, art. 1626; N 23, art. 2987; N 27, art. 3763; N 44, art. 6068; N 51, art. 7430; 2015, N 11, art. 1593; N 16, art. 2368; N 20, art. 2914; N 28, art. 4232; N 42, art. 5805; 2016, N 15, art. 2088; 2017, N 4, art. 671; N 10, art. 1481.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

If a prescription is presented that exceeds the maximum permissible or recommended quantity of a medicinal product for prescribing for one prescription, the pharmacist informs the person who submitted the prescription, the head of the relevant medical organization about this and releases it. to the specified person the correspondingly established maximum permissible or recommended amount of a medicinal product for prescribing per prescription with the corresponding mark being placed in the prescription.

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

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

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

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

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

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

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

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

trade name, dosage and quantity of the drug dispensed;

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

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

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

date of release of the drug.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

20. Narcotic and psychotropic drugs of list II, with the exception of drugs in the form of transdermal therapeutic systems, are dispensed upon presentation of an identification document to the person 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 the right to receive such narcotic and psychotropic medications.
________________
In relation to the person specified in part 2 of Article 20 of the Federal Law of November 21, 2011 N 323-FZ “On the fundamentals of protecting the health of citizens in the Russian Federation” (Collected Legislation of the Russian Federation, 2011, N 48, Art. 6724; 2012, N 26, Art. 3442, 3446; 27, Art. 3459, 3477; No. 39, Art. 4883; Art. 6165; 23, Art. 2930; No. 4106, 4206, 4247, 4257; No. 43, Art. 5798; No. 6927, 6928, No. 1, Art. 72, 85; , art. 1403, 1425; N 27, art. 3951; 28; N 15, art. 2055; N 18, art. 2488; N 27, art. 4219).

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

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

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

name and address of the pharmacy or pharmacy;

number and date of the prescription;

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

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

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

contents of the recipe for Latin;

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

date of release of the drug.

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

Medicines containing ethyl alcohol, including those manufactured according to a prescription by a retail trade entity that has a license for pharmaceutical activities with the right to manufacture medicines, are dispensed taking into account the established requirements for the volume of containers, packaging and completeness of medicines.
________________
Part 4.1 of Article 45 of the Federal Law of April 12, 2010 N 61-FZ “On the Circulation of Medicines” (Collected Legislation of the Russian Federation, 2010, N 16, Art. 1815; 2014, N 52, Art. 7540; 2015, N 51 , Art. 7245), Decree of the Government of the Russian Federation dated July 23, 2016 N 716 “On the procedure for creating a list of medicinal products for medical use, in respect of which requirements for container volume, packaging and completeness are established, a list of medicinal products for veterinary use, in in relation to which requirements for the volume of containers are established, and the definition of such requirements" (Collected Legislation of the Russian Federation, 2016, No. 31, Art. 5030).

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

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

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

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

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

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

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

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

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

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

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

for other drugs - for one year.

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

Electronic document text
prepared by Kodeks JSC and verified against:
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legal information
www.pravo.gov.ru, 09.11.2017,
N 0001201709110035

"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"

Revision dated 07/11/2017 - Valid from 09/22/2017

MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

ORDER
dated July 11, 2017 N 403n

ON APPROVAL OF THE RULES FOR THE DISCLAIMER OF MEDICINES FOR MEDICAL USE, INCLUDING IMMUNOBIOLOGICAL MEDICINES, BY PHARMACY ORGANIZATIONS, INDIVIDUAL ENTREPRENEURS HAVING A PHARMACEUTICAL LICENSED ACTIVITY

2. To recognize as invalid:

dated December 14, 2005 N 785 “On the Procedure for Dispensing Medicines” (registered by the Ministry of Justice of the Russian Federation on January 16, 2006, registration N 7353);

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

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

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

Minister
IN AND. SKVORTSOVA

The rules for the release of drugs for medical use, including immunobiological drugs, pharmacy organizations, individual entrepreneurs licensed for pharmaceutical activities

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

1. These rules determine the procedure for the dispensing of medicinal products for medical use, including immunobiological medicinal products (hereinafter referred to as medicinal products), by pharmacies and individual entrepreneurs with a license for pharmaceutical activities (hereinafter referred to as retail entities), without a prescription<1>and (or) according to a prescription for a medicinal product issued in accordance with the established procedure<2>medical workers, as well as according to the invoice requirements of an organization engaged in medical activities (hereinafter referred to as the medical organization), or an individual entrepreneur who has a license for medical activities (hereinafter referred to as the prescription, the invoice requirement, respectively).

2. Dispensing of medications without prescriptions is carried out:

pharmacies;

pharmacy points;

pharmacy kiosks;

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

3. Dispensing of prescription drugs is carried out:

pharmacies;

individual entrepreneurs (except for the sale of narcotic drugs and psychotropic substances included in the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation, approved by Decree of the Government of the Russian Federation of June 30, 1998 N 681<3>(hereinafter referred to as the List).

<3>Collection of Legislation of the Russian Federation, 1998, No. 27, Art. 3198; 2004, N 8, art. 663; N 47, art. 4666; 2006, N 29, art. 3253; 2007, N 28, art. 3439; 2009, N 26, art. 3183; N 52, art. 6572; 2010, N 3, art. 314; N 17, art. 2100; N 24, Art. 3035; N 28, art. 3703; N 31, art. 4271; N 45, art. 5864; N 50, art. 6696, 6720; 2011, N 10, art. 1390; N 12, art. 1635; N 29, art. 4466, 4473; N 42, art. 5921; N 51, art. 7534; 2012, N 10, art. 1232; N 11, art. 1295; N 19, art. 2400; N 22, art. 2864; N 37, art. 5002; N 48, art. 6686; N 49, art. 6861; 2013, N 9, art. 953; N 25, art. 3159; N 29, art. 3962; N 37, art. 4706; N 46, art. 5943; N 51, art. 6869; 2014, N 14, art. 1626; N 23, art. 2987; N 27, art. 3763; N 44, Art. 6068; N 51, art. 7430; 2015, N 11, art. 1593; N 16, art. 2368; N 20, art. 2914; N 28, art. 4232; N 42, art. 5805; 2016, N 15, art. 2088; 2017, N4, Art. 671; N 10, art. 1481.

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

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

4. N 107/u-NP<4>, narcotic and psychotropic drugs included in the List of Narcotic Drugs and Psychotropic Substances, the circulation of which is limited in the Russian Federation and in respect of which control measures are established in accordance with the legislation of the Russian Federation and international treaties of the Russian Federation (List II), the List (hereinafter - narcotic and psychotropic drugs of list II), with the exception of narcotic and psychotropic drugs in the form of transdermal therapeutic systems.

<4>Appendix No. and to Order No. 54n.

According to prescriptions written out on prescription forms of form N 148-1/у-88, they are dispensed<5>:

<5>Clause 9 of the procedure for prescribing and prescribing medications, approved by Order N 1175n.

psychotropic drugs included in the List of psychotropic substances, the circulation of which is limited in the Russian Federation and in respect of which certain control measures are allowed to be excluded in accordance with the legislation of the Russian Federation and international treaties of the Russian Federation (list III), the List (hereinafter referred to as psychotropic drugs 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<6>, with the exception of the medicines specified in paragraphs one and three of this paragraph, and medicines sold without a prescription (hereinafter referred to as medicines subject to subject-quantitative accounting);

<6>Order of the Ministry of Health of the Russian Federation dated April 22, 2014 N 183n “On approval of the list of medicines for medical use subject to subject-quantitative registration” (registered by the Ministry of Justice of the Russian Federation on July 22, 2014, registration N 33210) as amended by the order Ministry of Health of the Russian Federation dated September 10, 2015 N 634n (registered by the Ministry of Justice of the Russian Federation on September 30, 2015, registration N 39063).

drugs with anabolic activity (in accordance with the main pharmacological action)<7>and related, according to the anatomical-therapeutic-chemical classification recommended by the World Health Organization (hereinafter - ATC), to anabolic steroids (code A14A) (hereinafter - drugs with anabolic activity);

<8>Registered by the Ministry of Justice of the Russian Federation on June 1, 2012, registration N 24438, as amended by orders of the Ministry of Health of the Russian Federation dated June 10, 2013 N 369n (registered by the Ministry of Justice of the Russian Federation on July 15, 2013, registration N 29064), dated August 21, 2014 N 465n (registered by the Ministry of Justice of the Russian Federation on September 10, 2014, registration N 34024), dated September 10, 2015 N 634n (registered by the Ministry of Justice of the Russian Federation on September 30, 2015, registration N 39063).

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

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

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

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

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

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

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

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

a prescription for a medicinal product included in the minimum range of medicinal products for medical use required to provide medical care<9>, serviced within five working days from the date the person contacts the retail trade entity;

<9>Order of the Government of the Russian Federation of December 26, 2015 N 2724-r (Collected Legislation of the Russian Federation, 2016, N 2, Art. 413).

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

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

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

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

7. Medicines are dispensed in the quantity specified in the prescription, except in cases where the maximum permissible or recommended quantity for prescribing per prescription is established for the medicine<10>.

<10>Appendices No. 1 and No. 2 to the procedure for prescribing and prescribing medications, approved by Order No. 1175n.

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

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

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

8. The medicinal product is sold in primary and secondary (consumer) packaging, the labeling of which must meet the requirements of Article 46 Federal Law dated April 12, 2010 N 61-FZ "On the circulation of medicines"<11>, and packaging for narcotic and psychotropic drugs of List II - the requirements of paragraph 3 of Article 27 of the Federal Law of January 8, 1998 N 3-FZ "On Narcotic Drugs and Psychotropic Substances"<12>.

<11>Collection of Legislation of the Russian Federation, 2010, No. 16, Art. 1815; N 42, art. 5293; 2014, N 52, art. 7540.

<12>Collection of Legislation of the Russian Federation, 1998, No. 2, Art. 219; 2012, N 53, art. 7630; 2013, N 48, art. 6165; 2015, N 1, art. 54.

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

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

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

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

trade name, dosage and quantity of the drug dispensed;

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

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

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

date of release of the drug.

10. When dispensing medications according to a prescription written out on prescription form Form N 107-1/u<13>, and which indicates the periods and quantity of dispensing of the medicinal product (in each period), the prescription is returned to the person purchasing the medicinal product with a note containing the information specified in paragraph 9 of these Rules.

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

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

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

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

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

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

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

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

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

Prescriptions written in violation of established rules<14>, are registered in a journal in which the identified violations in the execution of the prescription are indicated, the last name, first name, patronymic (if any) of the medical worker who wrote the prescription, the name of the medical organization, the measures taken, are marked with the stamp “The prescription is invalid” and are returned to the person who submitted the prescription. The retail trade entity informs the head of the relevant medical organization about facts of violation of the rules for filling prescriptions.

<14>Order N 1175n and order N 54n.

17. When dispensing a medicinal product, a pharmacist does not have the right to provide false and (or) incomplete information about the availability of medicinal products, including medicinal products that have the same international nonproprietary name, including hiding information about the availability of medicinal products that have a lower price<15>.

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

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

<17>In relation to the person specified in part 2 of Article 20 of the Federal Law of November 21, 2011 N 323-FZ “On the fundamentals of protecting the health of citizens in the Russian Federation” (Collected Legislation of the Russian Federation, 2011, N 48, Art. 6724; 2012, N 26, Art. 3446, N. 27, Art. 3477; Art. 4883; Art. 23, Art. 2930, Art. 4206, 4247, 4257; Art. 5798, Art. 6928; , art. 1403, 1425, art. 2951, art. 4356, 4397; 28; N 15, Art. 2055; N 18, Art. 2488;

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

22. After dispensing narcotic and psychotropic drugs of list II, including in the form of transdermal therapeutic systems, psychotropic drugs of list III person who has received the medicinal product is issued a signature with a yellow stripe at the top and the inscription “Signature” in black font on it, which indicates:

name and address of the pharmacy or pharmacy;

number and date of the prescription;

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

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

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

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

date of release of the drug.

23. Ethyl alcohol is dispensed according to a prescription, taking into account the established requirements for the volume of containers, packaging and completeness of medicines<18>.

Medicines containing ethyl alcohol, including those manufactured according to a prescription by a retail trade entity that has a license for pharmaceutical activities with the right to manufacture medicines, are dispensed taking into account the established requirements for the volume of containers, packaging and completeness of medicines<18>.

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

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

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

<19>As amended by orders of the Ministry of Health and Social Development of the Russian Federation dated August 27, 2007 N 560 (registered by the Ministry of Justice of the Russian Federation on September 14, 2007, registration N 10133), dated September 25, 2009 N 794n (registered by the Ministry of Justice of the Russian Federation on November 25, 2009, registration N 15317), dated January 20, 2011 N 13n (registered by the Ministry of Justice of the Russian Federation on March 15, 2011, registration N 20103), by orders of the Ministry of Health of the Russian Federation dated August 1, 2012 N 54n (registered by the Ministry of Justice of the Russian Federation on August 15, 2012, registration N 25190), dated February 26, 2013 N 94n (registered by the Ministry of Justice of the Russian Federation on June 25, 2013, registration N 28881).

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

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

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

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

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

for other drugs - for one year.

<21>Order of the Ministry of Health of Russia dated October 26, 2015 N 751n “On approval of the rules for the manufacture and dispensing of drugs for medical use by pharmacy organizations and individual entrepreneurs licensed for pharmaceutical activities” (registered by the Ministry of Justice of the Russian Federation on April 21, 2016, registration N 41897 ).

State budget educational institution higher vocational education St. Petersburg State Chemical and Pharmaceutical Academy

Pharmaceutical College

Professional PM module. 01 “Sales of medicines and pharmaceutical products”

MDK 01.02 “Dispensing of medicines and pharmaceutical products”

Section 2. Procedure for dispensing medicines and other pharmaceutical products

Topic 2.8. Procedure for dispensing medicines

Lecture notes

Procedure for dispensing medicines

Prepared by: Deputy Director of the Pharmaceutical College for Development and innovative technologies Petrova E.N.

for specialty 060301 “Pharmacy”

(a basic level of)

Saint Petersburg

Lecture outline:

1. Regulatory documents regulating the procedure for dispensing medicines. Preparing prescriptions for chronically ill patients. Long-acting prescriptions. Synonymous replacement of a prescribed drug.

2. Standards for one-time leave. Terms of servicing of issued prescriptions. Shelf life of recipes.

Regulatory documents regulating the procedure for dispensing medicines:

1. dated 04.03.2003 No. 80 Order of the Ministry of Health of the Russian Federation “On approval of the industry standard”, “Rules for the dispensing (sale) of drugs in pharmacies. Basic provisions"

2. dated December 14, 2005 No. 785 Order of the Ministry of Health and Social Development of the Russian Federation “On the procedure for dispensing medications”

3. dated 05/17/2012 No. 562n Order of the Ministry of Health of the Russian Federation “Procedure for the dispensing of medicinal products containing, in addition to small quantities of narcotic, psychotropic substances and their precursors, other pharmacological active substances”

4. dated 09/15/2010 No. 805 Order of the Ministry of Health and Social Development of the Russian Federation “On the minimum range of medicines”

5. dated June 30, 1998 No. 681 P shutdown of the Russian Government“List of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation

6. dated December 29, 2007 No. 964 Decree of the Government of the Russian Federation“List of potent and toxic substances for the purposes of Art. 234 and other articles of the Criminal Code of the Russian Federation"

7. Order of the Russian Ministry of Health dated August 1, 2012. N 54н"On approval of the form of prescription forms containing the prescription of narcotic drugs or psychotropic substances, the procedure for their production, distribution, registration, accounting and storage, as well as registration rules"

8. Order of the Russian Ministry of Health dated December 20, 2012.N1181н"On approval of the procedure for prescribing and prescribing medical products, as well as prescription forms for medical products and the order of execution of these forms, their recording and storage"

Procedure for dispensing (sales) of medicines (drugs)

The procedure for dispensing drugs is defined in the Industry Standard “Rules for the dispensing (sale) of drugs in pharmacies,” approved by Order of the Ministry of Health and Social Development of the Russian Federation dated March 4, 2003 No. 80.

The industry standard is mandatory for all pharmacy organizations, regardless of the organizational and legal form and form of ownership, carrying out retail trade medications.

General provisions

1. A pharmacy organization operates on the basis of a license for pharmaceutical activities, issued in the prescribed manner.

Purchase, storage and sale of narcotic drugs and psychotropic substances included in the List NS, PV and their precursors subject to control in the Russian Federation should be carried out only if there is licenses for activities related to the turnover of NS and PV.

2. Pharmacy organizations in their work must be guided by certain requirements established state standards, sanitary, fire regulations and other regulatory documents, labor protection and safety regulations.

3. Pharmacy organizations can be represented pharmacies, pharmacy points, pharmacy kiosks.

4. A pharmacy organization (pharmacy, pharmacy point) sells medicines registered in the manner prescribed by the legislation of the Russian Federation or manufactured in a pharmacy organization according to doctors’ prescriptions or the requirements of medical organizations.

5. The sale of drugs and other goods that have become unusable, expired, or illegal copies of drugs is not allowed.

6. A pharmacy organization must have the necessary premises, equipment and inventory to ensure, in accordance with the requirements of standards for maintaining the quality and safety of medicinal products, drugs and other goods authorized for dispensing from pharmacies.

7. In the pharmacy organizations in convenient places on the sales floor should be located:

Copies of licenses for pharmaceutical activities and other types of activities in accordance with the current legislation of the Russian Federation;

Information about telephone numbers and addresses of health and pharmaceutical authorities;

Book of reviews and suggestions;

Information about population groups entitled to free and preferential provision and extraordinary service, in accordance with the current legislation of the Russian Federation;

Information about the person responsible for drug provision disabled people of the Great Patriotic War and equivalent categories of the population on benefits (for pharmacy organizations providing preferential leave medications);

Information about telephone numbers and operating hours of the pharmaceutical reference service;

Information on the names of departments or distribution zones of the corresponding groups of goods;

Information on the shelf life of medicines in a pharmacy (pharmacy point);

Price lists for the proposed over-the-counter drugs and other goods approved for sale from pharmacies;

Information about the employees of the pharmacy organization directly serving the population (plates, badges, etc. indicating full name and position);

Information about the administrator on duty (full name, position) and the location of the alarm call button for the administrator on duty (with the exception of the pharmacy kiosk);

If there is a rental point, information about the list of items available for rental;

A copy or extract from Federal Law No. FZ-2300-1 dated 02/07. 1992 “On the protection of consumer rights”;

A copy or extract from the “Rules for the sale of certain types of goods, a list of durable goods that are not subject to the buyer’s requirement to provide him free of charge for the period of repair or replacement of a similar product and a list of non-food products of appropriate quality that cannot be returned or exchanged for a similar product of a different size , shape, size, style, color or configuration" (Resolution of the Government of the Russian Federation of January 19, 1998 No. 55);

8. In the course of their activities, specialists of a pharmacy organization are obliged to comply with the norms of pharmaceutical deontology and ethics.

Requirements for the dispensing (sale) of drugs in pharmacies

1. The dispensing (sale) of medicinal products is carried out according to a prescription and without a doctor’s prescription, as well as according to requirements healthcare institutions on the basis of an agreement.

2. When a pharmacy organization receives prescriptions and requirements, a pharmacy organization specialist assesses their compliance with certain requirements and, in accordance with the tariffs, determines the cost of the dispensed drug.

3. If a prescribed drug is replaced by its synonym (generic), with the consent of the buyer or in agreement with the doctor, the trade name of the dispensed drug should be indicated on the back of the prescription, signed and the date of dispensing.

4. Medicines sold from pharmacies must have information in accordance with the state information standard for medicines.

The buyer, at his request, may be provided Additional Information about the purchased drug, about the synonyms (generics) of the purchased drug available in the pharmacy organization and their prices.

5. When dispensing a medicine, an authorized employee of a pharmacy organization informs the buyer about the rules for taking the medicine:

Reception mode;

One-time and daily dose;

Method of administration (including food intake, etc.);

Storage rules, etc.;

Draws the buyer's attention to the need to carefully read the information about the drug.

6. When dispensing medicines, in exceptional cases, it is allowed to violate the secondary packaging with the obligatory indication of the series and expiration date of the medicine on the pharmaceutical packaging and providing the necessary information.

IT IS NOT ALLOWED TO VIOLATE THE PRIMARY PACKAGING OF THE MEDICINE

7. At the buyer’s request, an authorized employee of a pharmacy organization provides information on documents on the prices and expiration dates of drugs and other goods authorized for sale from pharmacies and on documents confirming their quality:

certificate or declaration about compliance;

copy of the certificate, certified by the holder of the original certificate, a notary or the goods certification body that issued the certificate;

Commodity accompanying documents prepared by the manufacturer or supplier (seller) and containing for each product name information on confirmation of its compliance with the established requirements (number of the certificate of conformity, its validity period, the body that issued the certificate, or the registration number of the declaration of conformity, its validity period, name of the manufacturer or supplier (seller) who accepted the declaration and the body that registered it).

These documents must be certified by the signature and seal of the manufacturer (supplier, seller) indicating his address and telephone number.

8. Display cases can be used for information about medicines and other products approved for dispensing from pharmacies. various types, where medications sold without a doctor’s prescription and samples of available products are displayed.

Medicines are placed separately on display cases: medicines for internal use and medicines for external use. Within the groups, drugs are arranged according to pharmacotherapeutic criteria.

9. Cash registers of a pharmacy organization must be registered in tax authorities at the location of the pharmacy
organizations.

10. The buyer has the right to return or replace goods of inadequate quality purchased from a pharmacy.

RULES FOR DRUG SUPPLY

Approved by order of the Ministry of Health and Social Development of the Russian Federation dated December 14, 2005 No. 785.

I. General provisions

1.1. This Procedure defines the requirements for the dispensing of medicines by pharmacies (organizations) regardless of their organizational and legal form, form of ownership and departmental affiliation.

1.2. Dispensing by pharmacies (organizations) is subject to
medicines, including narcotic drugs, psychotropic drugs,
potent and toxic substances registered in the Russian Federation
Federation in the prescribed manner.

1.3. Medicines are dispensed with a doctor's prescription and without a doctor's prescription by pharmacies (organizations) licensed for pharmaceutical activities.

1.4. Medicines prescribed by doctor must be dispensed by pharmacies and pharmacy points.

Over-the-counter medicines are subject to sale all pharmacies(organizations).

1.5. For the uninterrupted supply of medicines to the population, pharmacies (organizations) are required to have minimal assortment available medicines necessary for the provision of medical care, approved by Order of the Ministry of Health and Social Development of the Russian Federation dated September 15, 2010 No. 805.

II. General requirements for dispensing medicines

2.1. All medicines, with the exception of medicines dispensed without a doctor's prescription, must be dispensed by pharmacies (organizations) only according to prescriptions filled out in the prescribed manner on prescription forms of the relevant accounting forms.

2.2. According to prescriptions written on prescription forms, the forms of which are approved by Order of the Ministry of Health of the Russian Federation dated December 20, 2012 No. 1175n and Order of the Ministry of Health of Russia dated August 1, 2012. N 54n pharmaceutical institutions (organizations) dispense:

Narcotic drugs and psychotropic substances included in List II of 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, written out on special prescription forms for narcotic drugs;

Psychotropic substances included in List III of the List, prescribed on prescription forms, form N 148-1/u-88;

Other medicines subject to subject-quantitative accounting in pharmacies, drug wholesale trade organizations, medical institutions and private practitioners, the list of which is provided by order of the Ministry of Health and Social Development of the Russian Federation dated 02.12.07, No. 109 and dated 08.06.07 No. 521 written out on prescription forms N 148-1/у-88;

Medicines included in the List of medicines dispensed according to doctor's prescriptions when providing additional free medical care to certain categories of citizens entitled to receive state social assistance, prescribed on prescription forms, form N 148-1/u-04 (l), 148- 1/у-06 (l);

Anabolic steroids prescribed on prescription forms N 148-1/у-88;

Other medications prescribed on prescription forms, form N 107/u.

2.3. Prescriptions for narcotic drugs and psychotropic substances included in List II List, valid within five days.

Prescriptions for psychotropic substances included in List III List; other medicines subject to subject-quantitative accounting; Are anabolic steroids valid? within ten days.

Prescriptions for medicines included in the List of medicines dispensed by prescription from a doctor (paramedic), as well as other medicines, sold free or at a discount, with the exception of prescriptions for narcotic drugs and psychotropic substances included in List II of the List, for psychotropic substances included in List III of the List, for other medicines subject to subject-quantitative recording, for anabolic steroids valid for one month or three months(addition to order No. 110 as amended by order No. 13).

Recipes for other medicines valid for two months from the date of prescription and up to one year.

2.4. Pharmacy institutions (organizations) are prohibited from dispensing
drugs with expired prescriptions, with the exception of drugs with prescriptions that expired while the prescriptions were on deferred service.

2.5. Medicines are dispensed by pharmacies (organizations) in the quantities specified in the prescription, with the exception of medicines whose dispensing rates are specified in Order No. 1175n dated December 20, 2012.

Medicines containing narcotic drugs, psychotropic substances and their precursors and included in the List of Medicines Dispensed Without a Prescription are subject to dispensing by pharmacies in quantities of no more than 2 packages to the consumer (Corvalol, Valocordin, Andipal).

2.7. If a pharmacy institution (organization) has medications with a dosage different from the dosage prescribed in the doctor’s prescription, the employee of the pharmacy institution (organization) may decide to dispense the available medications to the patient if the dosage of the drug is less than the dosage specified in the prescription doctor, taking into account the recalculation for the course dose.

less dosage

2.8. In exceptional cases, if it is impossible for a pharmacy institution (organization) to fulfill the doctor’s (paramedic’s) prescription, violation of the secondary factory packaging is allowed.

In this case, the medicinal product must be dispensed in pharmaceutical packaging with the obligatory indication of:

■ name of the medicinal product,

■ factory series,

■ shelf life of the medicinal product,

■ series and dates according to the laboratory packaging register

■ and providing the patient with other necessary information (instructions, leaflet, etc.).

The patient is provided with information about changing the single dose of the drug.

2.9. When dispensing medicines according to doctor’s prescriptions valid in within one year, the prescription is returned to the patient with indication on the back:

■ name or number of the pharmacy institution (organization),

■ signature of an employee of a pharmacy institution (organization),

■ amount of drug dispensed

■ vacation dates.

When the patient next contacts a pharmacy institution (organization), notes on the previous receipt of the medicine are taken into account.

Upon expiration of the validity period, the prescription is canceled with the stamp “Prescription is invalid” and left at the pharmacy institution (organization).

2.10. In exceptional cases (a patient leaving the city, the inability to regularly visit a pharmacy institution (organization), etc.), pharmaceutical workers of a pharmacy institution (organization) are allowed to make a one-time dispensing of a medicine prescribed by a doctor according to prescriptions valid for one year, in an amount necessary for treatment for two months, with the exception of medicines subject to subject-quantitative accounting.

2.11. If a pharmacy institution (organization) does not have a medicinal product prescribed by a doctor, with the exception of a medicinal product included in the List of Medicines Dispensed on the Prescription of a Doctor (Paramedic), as well as other medicinal products dispensed free of charge or at a discount, the employee of the pharmacy institution (organization) ) can implement it synonymous substitution with the patient's consent.

When dispensing a medicinal product included in the List of Medicinal Products dispensed on prescription from a doctor (paramedic), as well as other medicinal products dispensed free of charge or at a discount, pharmacy worker(organization) can carry out synonymous replacement of the drug in agreement with the doctor who wrote the prescription.

2.12. Prescriptions for drugs marked "statim" (immediately)
are serviced within a period not exceeding one business day from the date of

Prescriptions for medicines included in the minimum range of medicines are processed within a period not exceeding five working days from the moment the patient contacts the pharmacy institution (organization).

2.13. Prescriptions for medicines included in the List
medicines prescribed by a doctor (paramedic), and not
included in the minimum range of medicines,
are serviced within a period not exceeding ten working days from the date of
a patient's visit to a pharmacy institution (organization).

2.14. Prescriptions for medicines subject to subject-specific
quantitative accounting, medicines included in the List
medicines prescribed by a doctor (paramedic), as well as other medicines sold free of charge or at a discount;
anabolic steroids remain in the pharmacy for subsequent separate storage and destruction after the expiration of the shelf life.

2.15. The pharmacy organization must ensure conditions for the safety of prescriptions left for storage for medicines that are subject to subject-quantitative accounting, medicines included in the List of medicines dispensed according to prescriptions of a doctor (paramedic), as well as other medicines dispensed free of charge or at a discount. ; anabolic steroid.

2.16. The shelf life of prescriptions in a pharmacy organization is:

For medicines included in the List of Medicines dispensed on prescription from a doctor (paramedic), as well as other medicines dispensed free of charge or at a discount - 5 years;

For narcotic drugs and psychotropic substances included in List II of the List, and psychotropic substances included in List III of the List - 10 years;

For other medicines subject to subject-quantitative registration (with the exception of narcotic drugs and psychotropic substances included in List II of the List, and psychotropic substances included in List III of the List); anabolic steroids - 3 years.

After the expiration of the storage period, recipes are subject to destruction in the presence of a commission, about which acts of the established form are drawn up.

The procedure for destroying prescriptions left in a pharmacy after the established storage period has expired, and the composition of the commission for their destruction may be determined by the health care or pharmaceutical authorities of the constituent entity of the Russian Federation.

2.17. Medicines of good quality purchased by citizens are not subject to return or exchange in accordance with the List of non-food products of good quality that cannot be returned or exchanged for a similar product of a different size, shape, size, style, color or configuration, approved by the Decree of the Government of the Russian Federation of January 19, 1998 . N 55.

It is not permitted to re-dispense (sell) medicines recognized as goods of inadequate quality and returned by citizens for this reason.

2.18. Recipes for:

Tranquilizers that are not subject to subject-quantitative accounting;

Antidepressants;

Neuroleptic drugs;

2.18.

2.19. Incorrectly written prescriptions are canceled with the stamp “Prescription invalid” and recorded in a journal of the established form, and returned to the patient.

To re-dispense the drug, the patient must consult a doctor for a new prescription.

2.20. Pharmacy organizations carry out separate accounting of medicines included in the List of medicines dispensed according to prescriptions of a doctor (paramedic), dispensed to citizens living in the territory of the corresponding subject of the Russian Federation, and to citizens temporarily staying in the territory of this subject of the Russian Federation.

III. Requirements for the dispensing of narcotic drugs and psychotropic substances, medicines subject to subject-quantitative accounting, anabolic steroids

3.1. Drugs and psychotropic substances included in List II of the List, and psychotropic substances included in List III of the List are subject to dispensing by pharmacies.

3.2. The right to work with narcotic drugs and psychotropic substances included in List II of the List, and psychotropic substances included in List III of the List, are only available to pharmacy institutions (organizations) that have received the appropriate licenses in the manner prescribed by the legislation of the Russian Federation.

3.3. The dispensing to patients of narcotic drugs and psychotropic substances included in List II of the List, and psychotropic substances included in List III of the List, is carried out by pharmaceutical workers of pharmacy institutions (organizations) who have the right to do so.

3.4. In a pharmacy institution (organization), the dispensing of narcotic drugs and psychotropic substances included in List II of the List is carried out by patients assigned to a specific outpatient clinic, which is assigned to the pharmacy institution (organization).

The assignment of an outpatient clinic to a pharmacy organization can be carried out by the health care or pharmaceutical management body of a constituent entity of the Russian Federation in agreement with the territorial body for control over the circulation of narcotic drugs and psychotropic substances.

3.5. Narcotic drugs and psychotropic substances included in List II of the List prescribed by a doctor are dispensed to the patient or the person representing him upon presentation of an identity document issued in the prescribed manner.

3.6. Narcotic drugs and psychotropic substances included in List II of the List and included in the List of medicines dispensed by prescription from a doctor (paramedic), as well as those dispensed free of charge or at a discount, are dispensed upon presentation of a prescription written on a special prescription form for a narcotic medicine, and prescription written out on prescription form N 148-1/у-04 (l) or 148-1/у-06 (l).

Psychotropic substances included in List III of the List, other drugs subject to subject-quantitative recording, anabolic steroids included in the List of drugs dispensed by prescription from a doctor (paramedic), as well as those dispensed free of charge or at a discount, are dispensed upon presentation of a prescription issued on prescription form N 148-1/u-88, and a prescription written out on prescription form N 148-1/u-04 (l) or 148-1/u-06 (l).

3.7. Pharmacy institutions (organizations) are prohibited from dispensing narcotic drugs and psychotropic substances included in List II of the List; psychotropic substances included in List III of the List; other medicines subject to subject-quantitative accounting; anabolic steroids according to prescriptions from veterinary medical organizations for the treatment of animals.

3.8. Separate dispensing of medicinal products subject to subject-quantitative accounting and other medicinal products included in the composition of a combined medicinal product manufactured according to an individual prescription (hereinafter referred to as an extemporaneous medicinal product) is not allowed.

3.9. A pharmacist at a pharmacy institution (organization), upon receipt of a prescription for an individually manufactured medicinal prescription, is obliged to dispense a medicinal product subject to subject-quantitative accounting in half the highest single dose if a doctor prescribes medicinal products in a dose exceeding the highest single dose.

3.10. In the manufacture of extemporaneous medicinal products containing medicinal products subject to subject-quantitative recording, in accordance with prescriptions prescribed by a doctor, the pharmacist of the pharmacy institution (organization) signs on the prescription for issuance, and the pharmacist of the pharmacy institution (organization) signs for the receipt of the required quantity of medicinal products .

3.11. Ethyl alcohol is released:

According to prescriptions written by doctors with the inscription “For applying compresses” (indicating the required dilution with water) or “For treating the skin” - up to 50 grams in pure form;

According to prescriptions written by doctors for individually prepared medicinal prescriptions - up to 50 grams in the mixture;

According to prescriptions written by doctors for individually prepared medicinal prescriptions, with the inscription “For special purposes”, separately certified by the doctor’s signature and the seal of the medical institution “For prescriptions”, for patients with a chronic course of the disease - up to 100 grams in a mixture and in pure form.

3.12. When dispensing narcotic drugs and psychotropic substances included in List II; psychotropic substances included in Schedule III; extemporaneous medicinal products containing medicinal products subject to subject-quantitative accounting, instead of a prescription, patients are given a signature with a yellow stripe at the top and the inscription in black on it “Signature” in the established form.

Features of registration of prescriptions for medicines for the treatment of patients with chronic diseases

1. Prescriptions for drugs written out on prescription forms forms N 148-1/у-04 (l) and forms N 148-1/у-06 (l), citizens who have reached retirement age, disabled people of the first group and disabled children are valid for three months from the date of issue.

For the treatment of chronic diseases prescriptions for medications may be issued to these categories of citizens for a course of treatment of up to 3 months.

2. When a medical professional writes prescriptions for finished medicinal products and individually manufactured medicinal products for patients with chronic diseases on prescription forms N 107-1/у it is allowed to set the validity period of the prescription within up to one year and exceed the recommended amount of the drug to be prescribed per prescription.

When writing such prescriptions, the medical professional makes a note "Patient with a chronic disease", indicates the validity period of the prescription and the frequency of dispensing of medications from a pharmacy organization or an individual entrepreneur with a license for pharmaceutical activities (weekly, monthly and other periods), certifies this indication with his signature and personal seal, as well as the seal of a medical organization "For recipes".

3. Prescriptions for barbituric acid derivatives, ephedrine, pseudoephedrine in pure form and in mixtures with other drugs, drugs with anabolic activity, combination drugs containing codeine (its salts) for the treatment of patients with chronic diseases can be prescribed for a course treatment up to two months.

In these cases, the prescriptions are marked "For special purposes", separately signed by a medical worker and the seal of a medical organization "For recipes."

Leave proceduremedicines for individuals, containing, in addition to small quantities of narcotic drugs, psychotropic substances and their precursors, other pharmacological

active substances

(Order of the Ministry of Health and Social Development of Russia dated May 17, 2012 N 562n)

(as amended by Order of the Ministry of Health of Russia dated June 10, 2013 N 369n)

1. Combined medicinal preparations containing narcotic drugs, psychotropic substances and their precursors in quantities not exceeding the maximum permissible amount of narcotic drugs, psychotropic substances and their precursors contained in preparations containing small amounts of narcotic drugs, psychotropic substances and their precursors are subject to dispensing. included in lists II, III and IV of 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.

2. Dispensing according to prescriptions written out on prescription forms form N 107-1/у , combination medicinal products containing:

A) ergotamine hydrotartrate in amounts up to 5 mg inclusive (caffeamine, nomigren, syncapton, etc.)

b) ephedrine hydrochloride in an amount up to 100 mg inclusive(per 100 ml or 100 g liquid dosage form For internal use) (broncholitin, bronchitusen, etc.)

V) pseudoephedrine hydrochloride in an amount not exceeding 30 mg(per 1 dose of solid dosage form) (Maxicold, Nurofen Stop Cold, Clarinase 12, etc.)

G) pseudoephedrine hydrochloride in an amount not exceeding 30 mg, in combination with dextromethorphan hydrobromide in an amount exceeding 10 mg and up to 30 mg inclusive (per 1 dose of solid dosage form) (Mulsinex, Caffetin Cold, Grippex, Tylenol tablets, etc.)

d) dextromethorphan hydrobromide in an amount exceeding 10 mg and up to and including 30 mg(per 1 dose of solid dosage form) (Fervex for dry cough, Toff plus caps., Alex plus paste, etc.)

e) phenobarbital in amounts exceeding 20 mg and up to 50 mg inclusive(per 1 dose of solid dosage form);

and) phenobarbital in amounts up to 20 mg inclusive in combination with ergotamine hydrotartrate regardless of quantity (per 1 dose of solid dosage form) (bellataminal, bellaspon)

h) chlordiazepoxide in amounts up to 10 mg inclusive(per 1 dose of solid dosage form).

3. Dispensing according to prescriptions written out on prescription forms N 148-1/у-88, are subject to combination medicinal products containing:

A) codeine or its salts(in terms of pure substance) in amounts up to 20 mg inclusive(per 1 dose of solid dosage form) or in quantities up to 200 mg inclusive (per 100 ml or 100 g of liquid dosage form for internal use) (panadeine, noshpalgin, solpadeine, unispaz, cough tab, prodol forte tab., codelac tab. , terpincode tab., nurofen plus, caffetin, codeterpine, neo-codion, etc.);

b) pseudoephedrine hydrochloride in an amount exceeding 30 mg and up to and including 60 mg(per 1 dose of solid dosage form) (sudafed tab., antiflu, teraflu, fervex rhinitis, nurofen stop cold., etc.)

No. 55 “On appeal medical supplies", the rules of sale have been approved prescription drugs in pharmacies for their use in hospitals and clinics that are licensed to engage in pharmaceutical activities.

Basic provisions

Regulations on licensing activities in the field of pharmaceuticals No. 1081 dated December 22, 2011 is a key document that defines the list of requirements, as well as conditions imposed by the state on licensees. The licensees are legal entities that carry out retail trade in drugs intended for medical use, for example, pharmacy chains and individual entrepreneurs who have the right to this activity. There is a specific list of prescription drugs.

What are the consequences of a violation?

All persons listed in mandatory must comply with the rules for dispensing these products, which are intended for medical use. The same provision defines the concept of gross violation of licensing conditions and requirements, which include issues related to the dispensing of medicines. In the event that the established rules for the dispensing of drugs are violated, regulatory authorities have the right to regard the detected crime as gross with all the ensuing consequences, ranging from serious penalties to suspension of the licensee’s activities.

So, how do you properly dispense a prescription drug?

Legal regulation of the rules for dispensing drugs

Federal Law No. 55 “On the Circulation of Medicines” provides rules for the dispensing of drugs for the purpose of medical use pharmacies, as well as individual entrepreneurs.

In addition to this law, the following regulatory documents have been approved that regulate the procedure for dispensing medications:

Law No. 323 “On the Fundamentals of Health Care”.
Law No. 2300 “On the Protection of Consumer Rights”.
Order of the Ministry of Health No. 647 "On approval of rules pharmacy practice medical drugs."
A number of departmental regulations.

Who is responsible?

The prescription drug dispensing process involves close collaboration between medical and pharmaceutical professionals. Doctors are responsible for prescribing medications within the framework of compliance necessary requirements. Pharmacy workers must conduct a pharmaceutical examination before dispensing a prescription. Therefore, an important requirement is the presence of feedback between medical and pharmaceutical structures. That is, regulatory requirements imply the regular sending of information about all incorrectly written prescriptions to a medical institution. This regular feedback process ensures that questions regarding prescription drug violations do not arise.

Who, according to the rules, has the right to write prescriptions?

Currently, five forms of prescription forms are valid. At the beginning of 2016, some changes were made to prescription forms. In order to use stocks of prescription forms purchased long ago for their intended purpose, it was allowed to use the old sample until Order No. 385 of the Russian Ministry of Health came into force. Now pharmacy workers are required to demand those versions of forms, the structure of which has been changed in accordance with the current regulatory documents.

Government Order No. 1175 introduced a lot of new things into the procedure for prescribing and prescribing medications. An important place in the significance of changes should be given directly to the paradigm of prescribing medications. Previously, a health worker had the right to use any name of the product, that is, group or trade. But in connection with the entry into force of Order No. 1175, priority is now given to prescribing drugs by international nonproprietary name. In the case where it is absent, the group option should be used. If both names are missing, then by trade type.

Who has been added to the list?

The list of those who have the right to prescribe and issue prescriptions now includes workers with average medical education, these in particular include midwives and paramedics, but only if such powers are assigned to them by the relevant decree of the head medical institution. Individual entrepreneurs also traditionally have the right to prescribe medications and write prescriptions, albeit under certain restrictions. For example, the nuances are related to the fact that these entrepreneurs who carry out private medical practice, cannot prescribe psychotropic and narcotic drugs from pharmaceutical lists “2” and “3”. There are also cases where prescription drugs are dispensed without a prescription.

What about a prescription that comes under a trade name? Is it possible to reject it or is it considered to have been issued correctly? An explanation of this issue is found in the order of the Ministry of Health No. 1175. The bottom line is that a medical employee has the right to use a trade name when prescribing, subject to individual intolerance or according to health conditions. True, such a decision must be approved medical commission, which confirms the presence of a stamp on the back of the recipe.

Rules for dispensing prescription drugs and differences in forms

What is the difference between the forms and how should they be formatted correctly? medical workers to avoid incorrect pharmaceutical examination? And what are the basic rules when dispensing drugs? Prescription forms can be distinguished by the purpose of use, their structure and composition of details, as well as by the period of validity and storage. Let us give an example of several options for prescription forms.

Special prescription form

It is the most complex in terms of the composition of the details, as well as the structure. However, from the point of view of use, there is only one case in which a health care worker should use it. This strict registration form is protected and is intended for prescribing psychotropic and narcotic drugs. Any such prescription must be certified by the doctor’s personal signature and seal. The form must necessarily indicate the last name, first name and patronymic of the authorized specialist, who can be the head or deputy of the medical institution. This person can also be the one who certifies the forms. In addition, certification with the seal of a medical organization is required. Next on the prescription form there is a note from the pharmacy structure about the dispensing of the medicine. If the pharmacy employee is satisfied with everything in terms of filling out the prescription, then he indicates information about what is dispensed, what is the dosage and packaging of the medicine. The prescription is certified by indicating the full name, date of issue, as well as the seal of the pharmacy.

Prescription form No. 107

It is a simplified form compared to the special form described above. According to regulatory documents, this option can be used when prescribing, as well as prescribing a list of prescription drugs that contain small doses of psychotropic and narcotic substances. This form must have the stamp of the medical organization, its full name along with the address, telephone number and date. In addition, a mark is placed on the patient’s age category: children or adults. The name of the patient, the name of the drug in Latin according to the international nonproprietary name along with packaging and dosage are also indicated. In that prescription form You can enter up to three names of medications, which cannot be done in other options. On the form, among other things, a personal signature is placed with the seal of the attending physician. Such a prescription is considered valid for up to sixty days, and for patients with chronic diseases an extension of up to one year is allowed. What other rules does it involve? prescription medications?

Additional rules

The legislation provides the following rules:

What drugs are prescription?

This list is fixed by order of the Ministry of Health No. 403 dated July 11, 2017.

Combination medications containing:

ergotamine hydrotartrate in an amount of up to five mg;
ephedrine hydrochloride up to 100 mg;
pseudoephedrine hydrochloride 30 mg, 10 mg;
dextromethorphan hydrobromide 10 mg;
codeine or its salts 20 mg;
pseudoephedrine hydrochloride 30 mg;
pseudoephedrine hydrochloride from 30 mg to 60 mg, dextromethorphan hydrobromide in the amount of 10 mg;
dextromethorphan hydrobromide 200 mg;
ephedrine hydrochloride 100 mg;
phenylpropanolamine 75 mg.

Norms for dispensing medicines subject to prescription. Dispensing of medications from a pharmacy organization

I. General provisions

1.5.

Incorrectly written prescriptions are canceled with the stamp “Prescription invalid” and registered in a journal, the form of which is provided in Appendix No. 4 to this Procedure, and returned to the patient.

IV. Control over the dispensing of medicines by pharmacies (organizations)

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

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

MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

ORDER dated July 11, 2017 N 403n

ON APPROVAL OF THE RULES FOR THE DISCLAIMER OF MEDICINES FOR MEDICAL USE, INCLUDING IMMUNOBIOLOGICAL MEDICINES, BY PHARMACY ORGANIZATIONS, INDIVIDUAL ENTREPRENEURS HAVING A PHARMACEUTICAL LICENSED ACTIVITY

The rules for the release of drugs for medical use, including immunobiological drugs, pharmacy organizations, individual entrepreneurs licensed for pharmaceutical activities

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

Basic provisions

What are the consequences of a violation?

Legal regulation of the rules for dispensing drugs

Who is responsible?

Who, according to the rules, has the right to write prescriptions?

Who has been added to the list?

Rules for dispensing prescription drugs and differences in forms

Special prescription form

Prescription form No. 107

Additional rules

What drugs are prescription?

Recent Entries

ORDER
dated July 11, 2017 N 403n