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The document ceased to be valid since January 26, 2016 according to the Order of the Ministry of Health of the Russian Federation of July 24, 2015 No. 484n

It is registered

in Ministry of Justice

Russian Federation

On June 2, 2011 No. 20923

ORDER OF THE MINISTRY OF HEALTH AND SOCIAL DEVELOPMENT OF THE RUSSIAN FEDERATION

of May 16, 2011 No. 397n

About approval of Special requirements to storage conditions of the drugs and psychotropic substances registered in accordance with the established procedure in the Russian Federation as the medicines intended for medical application in pharmaceutical, treatment and prevention facilities, the research, educational organizations and the organizations of wholesale trade by medicines

According to Item 15 of Storage precautions of the drugs and psychotropic substances approved by the order of the Government of the Russian Federation of December 31, 2009 N 1148 "About procedure for storage of drugs and psychotropic substances" (The Russian Federation Code, 2010, N 4, Art. 394; To N 25, of the Art. 3178), I order:

1. Approve special requirements to storage conditions of the drugs and psychotropic substances registered in accordance with the established procedure in the Russian Federation as the medicines intended for medical application in pharmaceutical, lechebnoprofilaktichesky institutions, the research, educational organizations and the organizations of wholesale trade by medicines according to appendix.

 

Minister T. A. Golikova

Appendix

to the order of the Ministry of Health and Social Development of the Russian Federation of May 16, 2011 No. 397n

Special requirements to storage conditions of the drugs and psychotropic substances registered in accordance with the established procedure in the Russian Federation as the medicines intended for medical application in pharmaceutical, treatment and prevention facilities, the research, educational organizations and the organizations of wholesale trade by medicines

1. These special requirements determine features of storage of the drugs and psychotropic substances included in the list of the drugs, psychotropic substances and their precursors which are subject to control in the Russian Federation, approved by the order of the Government of the Russian Federation of June 30, 1998 N 681 (The Russian Federation Code, 1998, N 27, Art. 3198; 2004, N 8, Art. 663; N 47, of Art. 4666; 2006, N 29, Art. 3253; 2007, N 28, Art. 3439; 2009, N 26, Art. 3184; N 52, of Art. 6572; 2010, N 3, Art. 314; N 17, of Art. 2100; N 24, of the Art. 3035), and registered in accordance with the established procedure in the Russian Federation as the medicines intended for medical application (further - narcotic and psychotropic medicines), in pharmaceutical, treatment and prevention facilities, the research, educational organizations and the organizations of wholesale trade by medicines.

2. In pharmaceutical, treatment and prevention facility or the organization of wholesale trade narcotic and psychotropic medicines for parenteral, internal and external application shall be stored by medicines separately.

3. In pharmaceutical and treatment and prevention facilities on inside of doors of safes or metal cases in which storage of narcotic and psychotropic medicines is performed lists of the stored narcotic and psychotropic medicines with indication of their highest one-time and highest daily doses shall be hung out.

In addition in treatment and prevention facilities in storage locations of narcotic and psychotropic medicines tables of antidotes in case of poisonings with the specified means are placed.

4. Storage of pharmaceutical substances of narcotic and psychotropic medicines in pharmaceutical institutions shall be performed in shtanglaza with indication of the highest one-time and highest daily doses.

5. Storage of the narcotic and psychotropic medicines used during the working day in assistant rooms and prescription departments of pharmaceutical institutions, in audiences of the educational organizations, and also in laboratories of the research organizations is performed in safes (containers) of these rooms or departments.

After the working day narcotic and psychotropic medicines shall be returned to the place of the main storage of narcotic and psychotropic medicines.

6. In treatment and prevention facilities narcotic and psychotropic medicines shall be stored only in type of the ready dosage forms made by organizatsiyamiproizvoditel of medicines or pharmaceutical institution.

7. Storage in treatment and prevention facilities of the narcotic and psychotropic medicines made by pharmaceutical institution in case of lack of the label having text black Poison paint and containing is forbidden: designations "Internal", "External", "Eye Drops", etc.; the name or number of the pharmaceutical institution which made medicine; name of department (office) of treatment and prevention facility; composition of medicine according to the copy-book specified in the requirement of treatment and prevention facility; date of production, number of the analysis, expiration date; signatures of persons: made, checked and released medicine from pharmaceutical institution.

8. Storage of the narcotic and psychotropic medicines requiring protection against the increased temperature in pharmaceutical, treatment and prevention facilities, the nauchnoissledovatelsky, educational organizations and the organizations of wholesale trade is allowed by medicines:

in rooms of the 1st and 2nd categories which are specially equipped with engineering and technical means of protection - in the locked refrigerators (refrigerating chambers) or in the special zone for placement of refrigerators (refrigerating chambers) separated the main storage location by metal lattice with the locked trellised door;

in the rooms of 3rd category which are specially equipped with engineering and technical means of protection - in the special zone for placement of refrigerators (refrigerating chambers) separated the main storage location by metal lattice with the locked trellised door;

in rooms of the 4th category - in the thermal containers placed in safes;

in places of temporary storage - in the thermal containers placed in safes, or in the metal or made of other high-strength materials containers, placed in thermal containers.

9. Storage locations of the narcotic and psychotropic medicines requiring protection against the increased temperature (the refrigerating chamber, the refrigerator, thermal container) need to be equipped with temperature metering devices.

10. The substandard narcotic and psychotropic medicines revealed in pharmaceutical, treatment and prevention facility or the organization of wholesale trade by medicines and also the narcotic or psychotropic medicines which are handed over by relatives of the died patients in treatment and prevention facility before their write-off and destruction are subject to storage on the certain shelf or in separate department of the safe or metal case.

 

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