Rules for the storage of medicines in a pharmacy. Accounting and storage of medicines and products in medical institutions

27.06.2020 -

Answers on questions:

1. Does paragraph 35 of Order 647n (information regarding price tags) apply to dietary supplements?
- In this case, paragraph 35 of Order 647n refers specifically to over-the-counter drugs. As for price tags for dietary supplements, the requirements for them are regulated by Decree of the Government of the Russian Federation of January 19, 1998 No. 55 “On approval of 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 a similar product, and a list of non-food products of good quality that are not subject to return or exchange for a similar product of a different size, shape, size, style, color or configuration.

2. Recent changes in legislation regarding the storage and accounting of narcotic drugs and psychotropic substances?
- There are currently no significant changes regarding the issue of storage of narcotic drugs and psychotropic substances.
There will definitely be amendments regarding accounting. They will be spelled out in Decree of the Government of the Russian Federation of November 4, 2006 No. 644 "On the procedure for submitting information on activities related to the circulation of narcotic drugs and psychotropic substances, and registration of operations related to the circulation of narcotic drugs and psychotropic substances." This document is currently under development and as soon as it is released, we will hold a new webinar on this Resolution.

3. The Rules of Good Pharmacy Practice include the position of the head of a retail entity. Is this the director of the entire pharmacy chain or the head of one pharmacy in this chain?
- The head of a retail trade entity means the head of a legal entity, i.e. in this case, the director of the pharmacy chain.

4. Should prescription drugs be kept separate from OTC drugs?
- According to clause 36 of Order 647n, “prescription drugs are placed separately from OTC drugs in closed cabinets with a mark “by prescription for a drug applied to the shelf or cabinet in which such drugs are placed.”

5. How many work instructions / SOPs should a pharmacy have, guided by the requirements of Order 647n?
- The basic information regarding SOPs is spelled out in paragraphs 37, 47, 66 and 68 of Order 647n. Order 647n does not give an exact figure of how many SOPs should be in a pharmacy organization, but special attention should be paid to paragraph 68:
“Standard operating procedures should describe the procedures for:
a) analysis of complaints and suggestions of buyers and making decisions on them;
b) establishing the reasons for the violation of the requirements of these Rules and other requirements of regulatory legal acts regulating the circulation of pharmacy goods;
c) assessing the need and feasibility of adopting appropriate ones in order to avoid the recurrence of a similar violation;
d) determination and implementation of the necessary actions in order to prevent the ingress of counterfeit, low-quality, counterfeit goods of the pharmacy assortment to the buyer;
e) analyzing the effectiveness of the preventive and corrective actions taken.”
Referring to this paragraph, you will be able to form SOPs on the Rules of Good Pharmacy Practice yourself.

6. A medical organization has a structural unit - a pharmacy. Do the requirements of Order 646n regarding the storage of medicines apply to nursing posts, treatment rooms and other premises?
- Clause 2 of Order 646n states that its requirements apply to both pharmacy and medical organizations. But as already discussed above, attributing violations of Order 646n to a specific article of the Code of Administrative Offenses of the Russian Federation is a rather complicated issue. In this case, it is necessary to wait for the first court decisions on these violations, because there is a possibility that violations of Order 646n will not be related to medical and pharmacy organizations.
Nevertheless, based on clause 2 of this Order, it is still worthwhile for medical organizations to comply with its requirements.

The creation of a material flow management system in health care facilities is the basis for a stable and harmonious provision of the medical process with pharmacy products. The cost of drug provision is 25-30% of the budget of the hospital, so today there is an acute issue of strengthening control over the accounting of medicines. It is necessary to have an inextricable relationship between the pharmacy service and many departments of health care facilities at different levels: the administration of the institution, the head nurse, the guard and procedural nurses who fulfill the appointments of the attending physician. Under the current working conditions, it is required to maintain strict accountability, professional control over the rational use, storage, expiration dates of drugs in the departments of healthcare facilities, and over activities related to the circulation of narcotic and psychotropic drugs.

The daily work of the nursing staff of the hospital, along with the pharmacy unit, is related to medicines and medical products in terms of systematizing their storage, accounting and control over spending, expiration dates, as well as compliance with storage rules. In this regard, medical personnel should also know the legislative and legal documents in the field of drug circulation and have an idea about the activities of the HCI pharmacy.

The existing regulatory framework for the circulation of medicines and medical devices, as a rule, is aimed at retail pharmacies and wholesale, and information for pharmacies of a healthcare institution (hospital pharmacies) is fragmentary, there are no modern specialized documents, recommendations that would regulate the procedure for the circulation of medicines and medical devices in health facilities. The proposed Instruction on the procedure for the circulation of medicines and medical devices in the units of medical facilities (hereinafter referred to as the Instruction) can serve these purposes and be a means of monitoring and evaluating the activities of paramedical personnel in terms of accounting, storage, movement of medicines and medical devices. Considering the Instruction as a given standard, the head of the health facility can rely on the objective indicators of control chosen for this institution and corresponding to its capabilities. The instruction not only systematizes the requirements for the processes of circulation of medicines and medical devices, but also corresponds to the general plan of the medical institution to ensure the quality of service.

The coordination of monitoring and evaluation of drug circulation within the health facility should be considered at the level of the medical institution and the unit of the health facility.

The instruction was developed with the participation of specialists from health facilities: the head of the pharmacy, pharmacists, chief, senior and ordinary nurses, as well as on the basis of legal documents regulating the circulation of medicines:

order of the Ministry of Health of Russia dated 02.06.1987 No. 747 “On approval of the Instruction for accounting for medicines, dressings and medical products in medical and preventive health care institutions financed by the state budget of the USSR”;
appendices “Memo to a medical worker on the storage of medicines in the departments of medical institutions” to the order of the Ministry of Health of the RSFSR dated September 17, 1976 No. 471 “On poor storage of medicines and a case of poisoning of children in the children's hospital No. 3 in Yaroslavl”;
order of the Ministry of Health of the USSR of July 3, 1968 No. 523 “On the procedure for storing, accounting, prescribing, dispensing and using poisonous, narcotic and highly effective drugs” (as amended and supplemented);
Order of the Ministry of Health of the USSR dated December 30, 1987 No. 1337 “On Approval of Specialized (Intradepartmental) Forms of Primary Accounting for Healthcare Institutions on the State Budget of the USSR”;
Order of the Ministry of Health of Russia dated November 13, 1996 No. 377 “On approval of requirements for the organization of storage in pharmacies of various groups of medicines and medical products”;
Order of the Ministry of Health of Russia dated 05.11.1997 No. 318 "On Approval of the Instruction on the Procedure for Storage and Handling in Pharmaceutical (Pharmacy) Organizations with Medicines and Medical Devices Possessing Flammable and Explosive Properties";
order of the Ministry of Health of Russia dated November 12, 1997 No. 330 “On measures to improve the accounting, storage, prescribing and use of narcotic drugs and psychotropic drugs” (as amended and supplemented);
Decree of the Government of the Russian Federation of June 30, 1998 No. 681 “On Approval of the List of Narcotic Drugs, Psychotropic Substances and Their Precursors Subject to Control in the Russian Federation” (as amended and supplemented);
Decree of the Government of the Russian Federation of 04.11.2006 No. 644 “On the procedure for submitting information on activities related to the circulation of narcotic drugs and psychotropic substances, and registration of operations related to the circulation of narcotic drugs, psychotropic substances and their precursors”;
Order of the Ministry of Health of Russia dated March 15, 2002 No. 80 “On approval of the industry standard “Rules for the wholesale trade of medicines. Basic Provisions” (as amended and supplemented);
order of the Ministry of Health and Social Development of Russia dated December 14, 2005 No. 785 “On the procedure for dispensing medicines” (as amended and supplemented);
Order of the Ministry of Health and Social Development of Russia dated February 12, 2007 No. 110 “On the procedure for prescribing and prescribing medicines, medical devices and specialized health food products” (as amended and supplemented).

Instructions on the procedure for the circulation of medicines and medical devices in the units of a medical institution

The procedure for obtaining medicines and medical products from pharmacies

To ensure the diagnostic and treatment process, medical facilities receive medicines from a pharmacy institution (organization) according to the requirements-waybills approved in the prescribed manner.

The requirement-invoice for receipt of medicines from pharmacies (organizations) must have a stamp, a round seal of the health facility, the signature of its head or his deputy for the medical unit.

The invoice request shall indicate the number, date of preparation of the document, the sender and recipient of the medicinal products, the name of the medicinal products (indicating the dosage, the form of release (tablets, ampoules, ointments, suppositories, etc.), type of packaging (boxes, vials, tubes etc.), method of administration (for injections, external use, oral administration, eye drops, etc.), the number of requested drugs, the quantity and cost of dispensed drugs.

The names of medicines are written in Latin, and the names of medical products are written in Russian.

Invoice requirements for medicinal products subject to subject-quantitative accounting are issued on separate forms of invoice requirements for each group of drugs.

When drawing up applications for narcotic drugs and psychotropic substances of lists II and III, health care facilities must be guided by the calculation standards approved in the prescribed manner.

Requirements-waybills of a structural unit of a healthcare facility (office, department, etc.) for medicines sent to the pharmacy of this institution are drawn up in the prescribed manner, signed by the head of the relevant unit and issued with a stamp of the healthcare facility.

When prescribing medicines for an individual patient, his surname and initials, the number of the medical history are additionally indicated.

Dentists, dentists can write out with their signature requirements-waybills only for medicines used in the dental office, without the right to hand them over to patients.

Requirements for poisonous medicines, in addition to the signature of a dentist or dentist, must have the signature of the head of the institution (department) or his deputy and the round seal of the health facility.

In pharmacies (organizations) and divisions of health care facilities, requirements-waybills of health facilities for the release of narcotic drugs and psychotropic substances of lists II and III are stored for 10 years, for the release of other medicines subject to subject-quantitative accounting - for 3 years, other groups medicines and medical products - within one calendar year.

Medicines from the pharmacy are received by financially responsible persons: head nurses of departments (offices), chief (senior) nurses of outpatient clinics by proxy, the validity of which is set for no more than a quarter. The financially responsible persons of the subdivisions sign on the invoice in receipt of medicines from the pharmacy, and the financially responsible persons of pharmacies - in their issuance.

Health care facilities that do not have their own pharmacies should receive narcotic drugs and psychotropic substances only in the form of finished dosage forms of industrial or pharmacy production. When issuing a power of attorney to receive narcotic drugs and psychotropic substances from a pharmacy, their name and quantity should be indicated. The power of attorney is valid for 1 month.

Medicines containing narcotic drugs and psychotropic substances obtained from pharmacies must have on the label the designations: “Internal”, “External”, “For injection”, “Eye drops”, etc., the name or number of the pharmacy that manufactured the drug , the name of the department (office), the composition of the medicinal product in accordance with the prescription specified in the requirement of the health facility, the date of manufacture, the number of the analysis, the expiration date and the signature of the persons who manufactured, checked and dispensed the medicinal product from the pharmacy.

In the absence of the listed designations on the packages of medicines containing narcotic drugs and psychotropic substances, their storage and use in medical facilities is not allowed. Packaging, scattering, pouring and transferring to the container of the department (office), as well as replacing labels are strictly prohibited.

Rules for the storage of medicines and medical products

The head of the department (office) is responsible for the storage and consumption of medicines and medical devices, as well as for the order in the places of storage, compliance with the rules for dispensing and prescribing medicines. The head nurse is the direct executor of the organization of storage and consumption of medicines and medical devices.

In the premises where medicines are stored, a certain temperature and humidity of the air must be maintained. Checking the compliance of their condition with the established requirements is carried out at least once a day based on the indicators of hygrometers and thermometers, its results are reflected in special log books.

Storage of medicines in departments (offices) should be organized in lockable cabinets, while the storage conditions of medicines are given on the packaging of each dosage form. Provision is made for placement in storage areas, taking into account the division into groups: toxicological - narcotic drugs, psychotropic substances, potent and poisonous drugs; according to the method of application: “External”, “Internal”; according to the form of release: “Injectable”, “Eye drops”, etc .; pharmacotherapeutic: “Hypotensive”, “Hypertensive”, “Diuretic”, as well as according to the physicochemical properties of drugs and the influence of various environmental factors. In addition, in each compartment of the cabinet (for example, “Internal”) there should be a division into powders, mixtures, ampoules, tablets, which are placed separately, with powders and tablets stored, as a rule, on the top shelf, and solutions - on the bottom. .

Odorous and coloring substances should be placed in a separate cabinet, and medicines that require storage in a cool place - in refrigerators equipped with thermometers.

Storage of medicines in the operating room, dressing room, procedural room is organized in glassed instrument cabinets or on surgical tables. Each vial, jar, package containing a medicinal product must have an appropriate label.

Narcotic drugs and psychotropic substances, potent and poisonous substances must be stored in sealed or sealed safes. It is allowed to store narcotic drugs and psychotropic substances in metal cabinets in technically fortified premises. Safes (metal cabinets) must be kept closed. After the end of the working day, they must be sealed or sealed. Keys to safes, seals and ice-cream should be kept by financially responsible persons authorized to do so by orders from health authorities or institutions.

Narcotic drugs and psychotropic substances, potent and poisonous substances received by shift medical personnel must be stored in a closed and sealed safe attached to the floor or wall in a specially designated room.

On the inside of the safe door there should be a list of narcotic drugs and psychotropic substances indicating the highest single and daily doses.

Narcotic drugs and psychotropic substances for parenteral, internal and external use should be stored separately.

Health care facilities should have tables of higher single and daily doses of narcotic drugs and psychotropic substances, as well as tables of antidotes for poisoning by them, in places of storage and at the posts of doctors and nurses on duty.

In the departments and offices of health care facilities, all narcotic drugs and psychotropic substances are subject to quantitative accounting at the head nurse, at the head nurse, at posts and in treatment rooms.

Medicines belonging to lists “A” and “B” (regardless of the dosage form) are stored in isolation, in locked metal cabinets under lock and key (list “A”) and in wooden cabinets under lock and key (list “B”).

On the inside of the doors of the cabinet, which stores medicines of list “A”, there should be an inscription “A”, and on the inside of the doors of the cabinet, in which medicines of list “B” are stored, the inscription “B” and lists of drugs of lists “A” ” and “B” indicating the highest single and daily doses.

Medical products should be stored separately in groups: rubber products, plastic products, dressings and auxiliary materials, medical equipment products.

Accounting procedure for medicines and medical devices

Health care facilities, as well as their subdivisions, carrying out activities related to the circulation of narcotic drugs, psychotropic substances and their precursors, are required to keep registration logs in accordance with established forms.

Registration of transactions related to the circulation of narcotic drugs, psychotropic substances and their precursors is carried out for each item of narcotic drugs, psychotropic substances and their precursors on a separate expanded sheet of the registration log or in a separate registration log.

Registration logs must be bound, numbered and sealed with the signature of the head of the health facility and the seal of the health facility.

The head of the health facility appoints persons responsible for maintaining and storing registration logs, including in departments.

Entries in the registration logs are made by the person responsible for their maintenance and storage, with a ballpoint pen (ink) in chronological order immediately after each operation for each name of narcotic drugs, psychotropic substances and their precursors on the basis of documents confirming the completion of this operation.

Documents or their copies confirming the transaction with narcotic drugs, psychotropic substances and their precursors, duly certified, are filed in a separate folder, which is stored together with the relevant registration log.

The registration logs indicate both the names of narcotic drugs and psychotropic substances and their precursors in accordance with the approved list, as well as other names of narcotic drugs and psychotropic substances and synonyms of precursors under which they were received by the legal entity.

The numbering of entries in the registration logs for each item of narcotic drugs, psychotropic substances and their precursors is carried out within the calendar year in ascending order of numbers. The numbering of entries in new logbooks starts from the number following the last number in the completed logbooks.

Pages of registration logs not used in the current calendar year are crossed out and are not used in the next calendar year.

An entry in the registers of each operation performed is certified by the signature of the person responsible for their maintenance and storage, indicating the surname and initials.

Corrections in the registration logs are certified by the signature of the person responsible for their maintenance and storage. Erasures and uncertified corrections in the logs are not allowed.

Subdivisions of healthcare facilities monthly, in accordance with the established procedure, carry out an inventory of narcotic drugs and psychotropic substances, as well as reconciliation of precursors by comparing their actual availability with accounting data (book balances).

The registration logs must reflect the results of the inventory of narcotic drugs and psychotropic substances and reconciliations of their precursors.

Discrepancies or inconsistencies in the reconciliation results are brought to the attention of the relevant territorial body of the Federal Drug Control Service of the Russian Federation within 10 days from the moment they are discovered.

The journal of registration of narcotic drugs and psychotropic substances is stored in a metal cabinet (safe) in a technically reinforced room. The keys to the metal cabinet (safe) and the technically fortified room are held by the person responsible for maintaining and storing the registration log.

The log of registration of precursors of narcotic drugs and psychotropic substances is kept in a metal cabinet (safe), the keys to which are kept by the person responsible for maintaining and storing the log of registration.

Completed registration logs, together with documents confirming the implementation of transactions related to the circulation of narcotic drugs, psychotropic substances and their precursors, are handed over to the archives of medical institutions, where they are stored for 10 years after the last entry is made in them. After the specified period, the registration logs are subject to destruction according to an act approved by the head of the medical facility.

The rest of the medicines and medical devices subject to subject-quantitative accounting in the health facility are registered in a special journal, numbered, laced and sealed and signed by the head physician of the health facility. On the first page of the journal, medicinal products subject to subject-quantitative accounting are indicated, while a separate page opens for each name, packaging, dosage form, dosage of the medicinal product. Corrections are crossed out and certified by the signature of the financially responsible person.

At the end of each month, the head (senior) nurse submits to the accounting department of the medical facility a report on the movement of medicines and medical devices subject to subject-quantitative accounting, which is approved by the head of the health facility.

The list of medicines subject to subject-quantitative accounting in departments and offices of healthcare facilities:

narcotic drugs, psychotropic substances and their precursors (Lists II, III, IV of the List of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation);
substances of apomorphine hydrochloride, atropine sulfate, dicaine, homatropine hydrochloride, silver nitrate, pachycarpine hydroiodide;
medicinal products containing substances (their salts) in combination with pharmacologically inactive components, regardless of the dosage form;
combination medicines:

a) prescription formulations with pseudoephedrine hydrochloride;

b) prescription prescriptions with phenylpropanolamine;

c) prescription prescriptions for ephedrine hydrochloride;

d) diazepam + cyclobarbital (reladorm);

e) chlordiazepoxide + amitriptyline (tablets);

ethanol (ethyl alcohol, medical antiseptic solution);
clozapine (leponex, azaleptin);
butorphanol tartrate (butorphanol, stadol, moradol);
tianeptine (coaxyl);
tramadol hydrochloride 37.5 mg and paracetamol 325 mg (zaldiar);
expensive medicines and dressings, the list of which is approved by the head of the medical facility.

The procedure for the use of medicines and medical products

Stocks of narcotic drugs and psychotropic substances in departments (offices) are determined by the head of the medical facility and should not exceed the 3-day need for them (in the pharmacies of the health facility - a monthly requirement), potent and toxic substances - no more than 5-day need, and other medicines - 10-day requirement.

For the provision of emergency medical care in the evening and at night, according to vital indications, it is allowed to create a 5-day reserve of narcotic drugs and psychotropic substances in the emergency departments and departments of specialized cardiological care in hospitals. The specified reserve can be used with the permission of the responsible doctor on duty in all departments of the hospital.

Registration of used drugs can be carried out after providing assistance to the patient in the prescribed manner.

Responsible for the storage and issuance of narcotic drugs and psychotropic substances to patients are the head of the health facility or his deputies, as well as persons authorized to do so by order of the health facility.

Prescribing medicines must be signed by a doctor, indicating the date of prescription and the date of withdrawal. After the end of treatment, the prescription sheet is pasted into the patient's medical history (inpatient or outpatient medical record). The distribution of medicines is carried out by a nurse in accordance with the prescription sheet. When prescribing medicines, the following are indicated: the name of the medicine, its dosage, frequency of administration, time and mode of administration.

The opening of ampoules, the introduction of ampouled narcotic drugs and psychotropic substances to the patient is carried out by a procedural (ward) nurse in the presence of a doctor with a note on the injection in the medical history and a list of prescriptions, certified by the signatures of the nurse and the doctor.

The patient takes oral narcotic drugs and psychotropic substances in the presence of a procedural (ward) nurse and a doctor, while the fact of admission should be reflected in the medical history and prescription list, and the corresponding record is certified by the signatures of the nurse and doctor.

Preventive measures to prevent professional errors

It is forbidden:

joint storage of medicines and medical devices with food; drugs for external use with solutions for cleansing enemas; opened bottles with the remnants of medicines for newborns;
store disinfectants, solutions for technical purposes (treatment of hands, tools, furniture, linen, etc.) together with medicines used to treat patients;
in departments and at posts, pack, hang, pour, transfer medicines from one package to another, replace labels;
issue medicines without a doctor's prescription, replace one medicine with another;
prescribe, draw up and store medicines under conditional, abbreviated names (for example, cough syrup, hand disinfection solution, "triple solution", etc.);
dispensing of medicines into the containers of health facilities intended for transportation of used pharmacy utensils;
installation of containers for the delivery of medicines on the floor or on the ground.

The issuance of medicines containing narcotic drugs, psychotropic substances, potent and poisonous substances to patients should be carried out only separately from other medicines.

To avoid mistakes, before opening the ampoule, the package should read the name of the drug, the dosage aloud, check with the prescription and then release it to the patient.

The duration of storage of medicinal products of pharmaceutical and industrial production is limited by certain expiration dates indicated on the label or packaging. In accordance with Art. 31 of the Federal Law of June 22, 1998 No. 86-FZ “On Medicines” (as amended and supplemented), the use of expired medicines is prohibited, they are subject to destruction.

The instruction is offered as a standard and, if necessary, can be supplemented or modified in accordance with new regulations or features of healthcare facilities.

In our opinion, before use in the work, this Instruction must be approved by order of the head of the medical institution or his deputy for medical work. In the same order, it is necessary to provide a list of departments that have the right to receive medicines and medical products, as well as other pharmacy products from the HCI pharmacy, and a list of financially responsible persons of HCI departments responsible for the storage, accounting and consumption of medicines, medical devices and other pharmaceutical products.

Prescription, receipt of medicines from the pharmacy is carried out by the head nurse of the department in accordance with the needs of the department at the request of the ward nurses.

Requirements for obtaining medicines from a pharmacy are issued in three copies.

For poisonous, narcotic, potent, ethyl alcohol, one more copy is issued. The requirements are signed by the chief physician and certified by the seal of the medical institution. The requirements for obtaining poisonous, narcotic, acutely scarce medicines from a pharmacy indicate the numbers of case histories, surnames, first names, patronymics of patients.

Narcotic drugs and psychotropic substances of List III must be issued to citizens on a special pink form on paper with watermarks, stamped by a medical institution and a serial number. Accounting for special prescription forms for narcotic drugs is kept in a special journal: numbered, laced, sealed and signed by the head.

When receiving medicines from a pharmacy, the head nurse checks their compliance with the prescription in the requirements (name of the drug, dosage), as well as the expiration date, date of manufacture, batch of the drug, compliance with the original factory or pharmacy packaging.

When storing medicines, the rules for placing them in groups are observed: list A (poisonous and narcotic), list B (potent)- located in a safe, under lock and key. On the inside of the safe door there should be a list of narcotic drugs indicating the values of daily and single doses.

The keys to the safe are kept only by the persons appointed by the order of the medical facility, responsible for the storage and dispensing of medicines of group "A".

Other drugs are stored in the department at the nurse's station in lockable cabinets marked "External", "Internal", "Parenteral". When handing over duty, the nurse makes an entry in the appropriate journals in the form.

Stocks of narcotic medicines should not exceed the three-day requirement separation, poisonous - five days, potent - ten days.

Temperature conditions are observed in storage areas. Photosensitive products are stored in dark, closed cabinets. Odorous are stored separately, in tightly closed boxes. Decoctions, infusions, emulsions, antibiotics, suppositories, serums, vaccines, hormonal preparations, heparin, oxytocin, adrenaline are stored only in a refrigerator specially marked “for medicines”. at a temperature of +2 °C to +10 °C, intended for the storage of medicines.

Medicines must be used within the established expiration dates.

Narcotic, poisonous, ethyl alcohol, acutely scarce drugs are subject to quantitative accounting, control, which is carried out in a special book, numbered, laced and sealed and signed by the head physician of the medical institution. The labels of all drugs containing narcotic drugs must be stamped in black ink "Poison".

As powders, tablets and ampouled narcotic drugs accumulate, they are produced no later than the 30th day of each month. destruction: powders and tablets - by burning, ampouled preparations - by crushing. In the "Journal of accounting for unused narcotic drugs and prescriptions for their prescribing" a note is made on the number of destroyed drugs.

Order 330"On measures to improve the accounting, storage, prescribing and use of narcotic drugs."

PRESCRIBING MEDICINAL SUBSTANCES FOR THE MEDICAL DEPARTMENT

The doctor, daily examining patients in the department, writes down in the case history or prescription list the medicines necessary for this patient, their doses, frequency of administration and routes of administration.

The ward nurse makes a daily selection of appointments, copying the prescribed drugs in the "Book of appointments". Information about the injections is transmitted to the procedural nurse who performs them.

The list of prescribed drugs that are not available at the post or in the treatment room is submitted to the head nurse of the department.

The head nurse (if necessary) writes out in a certain form an invoice (requirement) for receiving medicines from a pharmacy in 2 copies in Latin, which is signed by the head. department. The department must have a 3-day supply of necessary medicines.

When receiving medicines from a pharmacy, the head nurse checks their compliance with the order.

On dosage forms made in a pharmacy, there must be a certain color of the label:

for external use - yellow

for indoor use - white

for parenteral administration - blue

(on vials with sterile solutions).

The labels should have clear names of drugs, designations of concentration, dose, dates of manufacture and the signature of the pharmacist who manufactured these dosage forms.

Some medicinal substances

included in list A(poisonous drugs) Atropine Cocaine DikainMorphine Omnopon Promedol Prozerin Strychnine Strophanthin Reserpine Sovkain Platifillin

Some drugs on list B(potent medicinal substances) Nicotinic acid Adonizide Amyl nitrite Analgin Adrenaline Barbamyl Barbital Aminazine Chloral hydrate Codeine Caffeine Cordiamine Cititone Ephedrine Lobelin Luminal Nitroglycerin in solution Norsulfazol Novocain Ftivazide Papaverine Pituitrin Sulfodimesin Insuli Levomycetin Mezaton Phthalazol Prednisolone

GENERAL STORAGE REQUIREMENTS

MEDICINES IN THE DEPARTMENT

To store medicines at the nurse's station, there are cabinets that must be locked with a key.

In the cabinet, medicinal substances are placed in groups (sterile, internal, external) on separate shelves or in separate cabinets. Each shelf should have a corresponding indication (“For external use”, “For internal use”, etc.).

Medicinal substances for parenteral and enteral administration should be placed on the shelves according to their intended purpose (antibiotics, vitamins, antihypertensives, etc.).

Larger dishes and packages are placed at the back, and smaller ones at the front. This makes it possible to read any label and quickly take the right medicine.

Medicinal substances included in List A, as well as expensive and acutely scarce drugs are stored in a safe.

Preparations that decompose in the light (therefore they are produced in dark bottles) are stored in a place protected from light.

Strong-smelling drugs (iodoform, Vishnevsky ointment, etc.) are stored separately so that the smell does not spread to other drugs.

Perishable drugs (infusions, decoctions, potions), as well as ointments, vaccines, serums, rectal suppositories and other drugs are stored in the refrigerator.

Alcoholic extracts, tinctures are stored in vials with tightly ground stoppers, as due to the evaporation of alcohol, they can become more concentrated over time and cause an overdose.

The shelf life of sterile solutions made in a pharmacy is indicated on the bottle. If during this time they are not sold, they must be poured out, even if there are no signs of unsuitability.

Signs of unsuitability are:

in sterile solutions - a change in color, transparency, the presence of flakes;

infusions, decoctions - turbidity, discoloration, the appearance of an unpleasant odor;

in ointments - discoloration, delamination, rancid smell;

in powders, tablets - discoloration.

13. A nurse has no right:

change the form of medicines and their packaging;

combine the same drugs from different packages into one;

replace and correct labels on medicines;

store medicinal substances without labels.

RULES OF STORAGE AND ACCOUNTING OF NARCOTIC DRUGS.

Narcotic drugs are discharged from the pharmacy to the medical department on a separate request (in several copies), which is signed by the head physician of the health facility and stamped.

Narcotic drugs are stored in a safe, on the inner surface of the door of which there should be a list of drugs indicating the highest single and daily doses.

The keys to the safe are kept by the doctor on duty and are handed over by shift.

Narcotic drugs are subject to subject-quantitative accounting.

Narcotic drugs are administered to the patient only on the written prescription of the doctor and in his presence.

6. An entry about the introduction of the drug must be made in the book of registration of narcotic drugs, stored in a safe.

In the drug accounting book, all sheets must be numbered, laced, and the free ends of the cord are sealed on the last sheet of the book with a paper sheet, on which the number of pages is indicated, the head of the medical institution or his deputies is signed and sealed.

Separate sheets are allocated for accounting for each drug. The following entries are made in the drug register:

Name of the medical institution

BOOK of registration of narcotic drugs in departments and offices

Empty drug ampoules are not thrown away, but are collected and transferred along with the unused ampoules to the shift, and ultimately the empty ampoules are given to the head nurse.

When handing over the keys to the safe, they check the correspondence of the entries in the log book (the number of used ampoules and the balance) with the actual number of filled and used ampoules, and put their signatures in the log that transferred and accepted the keys. Empty ampoules from narcotic drugs are handed over by the head nurse according to the act of a special commission approved by the head of the health facility, in the presence of which the ampoules are destroyed.

FOR THE DESTRUCTION OF USED NARCOTIC DRUG AMPOULES IN HEALTH CARE INSTITUTIONS

made the destruction of used ampoules from under narcotic drugs, for the period from the number (in words) of the number of patients who were used narcotic substances (full name of the patient and no. of the case history).

The ampoules are destroyed by crushing.

The act is kept for 3 years.

Each department of health care facilities should have tables of higher single and daily doses of poisonous and potent substances and antidotes for poisoning.

In accordance with Article 58 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 31, Art. 4161) I order:

1. Approve the Rules for the storage of medicinal products in accordance with the appendix.

2. Recognize as invalid:

sections 1 and 2, paragraphs 3.1 - 3.4, 3.6 and 3.7 of section 3, sections 4 - 7, 12 and 13 Instructions for organizing storage in pharmacies of various groups of medicines and medical devices, approved by Order of the Ministry of Health of the Russian Federation of November 13, 1996 g. N 377 "On approval of requirements for the organization of storage in pharmacies of various groups of medicines and medical products" (registered by the Ministry of Justice of Russia on November 22, 1996 N 1202).
Appendix to the Order of the Ministry of Health and Social Development of the Russian Federation of 23.08.2010 N 706n Rules for the storage of medicines (as amended by the Order of the Ministry of Health and Social Development of the Russian Federation of 28.12.2010 N 1221n)

I. General provisions

1. These Rules establish requirements for storage facilities for medicinal products for medical use (hereinafter referred to as medicinal products), regulate the storage conditions for these medicinal products and apply to drug manufacturers, drug wholesalers, pharmacies, medical and other organizations that carry out activities in the circulation of medicines, individual entrepreneurs holding a license for pharmaceutical activity or a license for medical activity (hereinafter, respectively - organizations, individual entrepreneurs).

II. General requirements for the arrangement and operation of medicinal storage facilities
funds

2. The device, composition, size of areas (for manufacturers of medicines, drug wholesalers), operation and equipment of premises for storing medicines must ensure their safety. (clause 2 as amended by the Order of the Ministry of Health and Social Development of the Russian Federation of December 28, 2010 N 1221n)

3. Premises for the storage of medicinal products must be maintained at a certain temperature and humidity to ensure the storage of medicinal products in accordance with the requirements of the medicinal product manufacturers indicated on the primary and secondary (consumer) packaging.

4. Premises for the storage of medicines must be equipped with air conditioners and other equipment to ensure the storage of medicines in accordance with the requirements of medicine manufacturers indicated on the primary and secondary (consumer) packaging, or it is recommended that the premises be equipped with vents, transoms, second lattice doors.

5. Premises for the storage of medicines should be provided with racks, cabinets, pallets, and storage boxes.

6. Finishing of premises for storing medicines (internal surfaces of walls, ceilings) should be smooth and allow for wet cleaning.

III. General requirements for premises for the storage of medicines and their organization
storage

7. Premises for the storage of medicines must be equipped with devices for recording air parameters (thermometers, hygrometers (electronic hygrometers) or psychrometers). The measuring parts of these devices must be placed at a distance of at least 3 m from doors, windows and heating devices. Devices and (or) parts of devices from which visual readings are taken should be located in a place accessible to personnel at a height of 1.5 - 1.7 m from the floor.
The readings of these devices must be recorded daily in a special log (card) of registration on paper or in electronic form with archiving (for electronic hygrometers), which is maintained by a responsible person. The log (card) of registration is stored for one year, not counting the current one. Control devices must be certified, calibrated and verified in the prescribed manner.

8. Medicinal products are placed in the storage rooms in accordance with the requirements of the regulatory documentation indicated on the packaging of the medicinal product, taking into account:
physico-chemical properties of medicines;
pharmacological groups (for pharmacy and medical organizations);
method of application (internal, external);
aggregate state of pharmaceutical substances (liquid, bulk, gaseous).
When placing medicines, it is allowed to use computer technologies (alphabetically, by codes).

9. Separately, in technically fortified premises that meet the requirements 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; 2002, N 30 , item 3033; 2003, N 2, item 167, N 27 (part I), item 2700; 2005, N 19, item 1752; 2006, N 43, item 4412; 2007, N 30, item 3748, N 31, item 4011; 2008, N 52 (part I), item 6233; 2009, N 29, item 3614; 2010, N 21, item 2525, N 31, item 4192), stored:
narcotic and psychotropic drugs;
potent and poisonous medicines, which are controlled in accordance with international legal norms.

10. Shelves (cabinets) for storing medicines in the premises for storing medicines should be installed in such a way as to ensure access to medicines, free passage of personnel and, if necessary, loading devices, as well as accessibility of shelves, walls, floors for cleaning .
Racks, cabinets, shelves intended for storage of medicines must be identified. (As amended by the Order of the Ministry of Health and Social Development of the Russian Federation of December 28, 2010 N 1221n)
Stored medicinal products must also be identified using a shelf card containing information about the stored medicinal product (name, form of release and dosage, batch number, expiration date, manufacturer of the medicinal product).
When using computer technology, identification using codes and electronic devices is allowed.

11. In organizations and individual entrepreneurs, it is necessary to keep records of medicines with a limited shelf life on paper or in electronic form with archiving. Control over the timely sale of medicinal products with a limited shelf life should be carried out using computer technology, rack cards indicating the name of the medicinal product, series, expiration date or expiration date registers. The procedure for keeping records of these medicines is established by the head of the organization or individual entrepreneur.

12. If expired medicinal products are identified, they must be stored separately from other groups of medicinal products in a specially designated and designated (quarantine) area.

IV. Requirements for premises for storage of flammable and explosive drugs
funds and organization of their storage

13. Premises for the storage of flammable and explosive medicines must fully comply with current regulations.

14. Premises for the storage of medicines in drug wholesalers and manufacturers of medicines (hereinafter referred to as warehouses) are divided into separate rooms (compartments) with a fire resistance limit of building structures of at least 1 hour in order to ensure the storage of flammable and explosive medicines according to the principle of uniformity in accordance with their physicochemical, fire hazardous properties and the nature of the packaging. (clause 14 as amended by the Order of the Ministry of Health and Social Development of the Russian Federation of December 28, 2010 N 1221n)

15. The quantity of flammable medicinal products required for packaging and manufacturing of medicinal products for medical use per one work shift may be kept in production and other premises. The remaining amount of flammable drugs at the end of the shift is transferred to the next shift or returned to the main storage place.

16. The floors of storage rooms and unloading areas should have a hard, even surface. It is forbidden to use boards and iron sheets to level the floors. Floors must provide convenient and safe movement of people, goods and vehicles, be of sufficient strength and withstand loads from stored materials, and ensure simplicity and ease of cleaning the warehouse.

17. Warehouses for the storage of flammable and explosive medicines must be equipped with fireproof and stable racks and pallets designed for the appropriate load. Racks are installed at a distance of 0.25 m from the floor and walls, the width of the racks should not exceed 1 m and, in the case of storing pharmaceutical substances, have flanges of at least 0.25 m. Longitudinal aisles between the racks should be at least 1.35 m.

18. In pharmacies and individual entrepreneurs, isolated premises are allocated, equipped with automatic fire protection and alarm systems, for the storage of flammable pharmaceutical substances and explosive medicines.
(clause 18 as amended by the Order of the Ministry of Health and Social Development of the Russian Federation of December 28, 2010 N 1221n)

19. In pharmacies and individual entrepreneurs, it is allowed to store pharmaceutical substances with flammable and combustible properties in a volume of up to 10 kg outside the premises for storing flammable pharmaceutical substances and
explosive drugs in built-in fireproof cabinets. Cabinets must be removed from heat-removing surfaces and passages, with doors not less than 0.7 m wide and not less than 1.2 m high. Free access must be organized to them.
(As amended by the Order of the Ministry of Health and Social Development of the Russian Federation of December 28, 2010 N 1221n)
It is allowed to store explosive medicinal products for medical use (in secondary (consumer) packaging) for use for one work shift in metal cabinets outside the premises for storing flammable pharmaceutical substances and explosive medicinal products. (As amended by the Order of the Ministry of Health and Social Development of the Russian Federation of December 28, 2010 N 1221n)

20. The amount of flammable pharmaceutical substances allowed for storage in storage rooms for flammable pharmaceutical substances and explosive medicines located in buildings for other purposes should not exceed 100 kg in bulk.
Premises for the storage of flammable pharmaceutical substances and explosive medicinal products used for the storage of flammable pharmaceutical substances in excess of 100 kg must be located in a separate building, and
storage should be carried out in glass or metal containers isolated from storage rooms for other groups of flammable pharmaceutical substances. (clause 20 as amended by the Order of the Ministry of Health and Social Development of the Russian Federation of December 28, 2010 N 1221n)

21. In rooms for storage of flammable pharmaceutical substances and explosive
medicines are prohibited from entering with open sources of fire.

V. Features of the organization of storage of medicines in warehouses

22. Medicinal products stored in warehouses should be placed on racks or on undercarriages (pallets). It is not allowed to place medicines on the floor without a pallet.
Pallets can be placed on the floor in one row or on racks in several tiers, depending on the height of the rack. It is not allowed to place pallets with medicines in several rows in height without the use of racks.

23. With the manual method of unloading and loading operations, the height of the stacking of medicines should not exceed 1.5 m.
When using mechanized devices for unloading and loading
works medicines should be stored in several tiers. However, the total height
placement of medicines on the shelves should not exceed the capacity
mechanized handling equipment (lifts, trucks, hoists).

23.1. The area of storage facilities should correspond to the volume of stored medicines, but be at least 150 square meters. m, including:
drug acceptance area;
area for the main storage of medicines;
expedition zone;
premises for medicines requiring special storage conditions.
(clause 23.1 was introduced by Order of the Ministry of Health and Social Development of the Russian Federation of December 28, 2010 N 1221n)

VI. Features of storage of certain groups of medicines depending on
physical and physico-chemical properties, exposure to various factors of external
environments

Storage of medicines requiring protection from light

24. Medicines that require protection from the action of light are stored in rooms or specially equipped places that provide protection from natural and artificial lighting.
25. Pharmaceutical substances that require protection from light should be stored in containers made of light-protective materials (orange glass glass containers, metal containers, packaging made of aluminum foil or polymeric materials painted black, brown or orange), in a dark room or cabinets. .
For the storage of pharmaceutical substances that are especially sensitive to light (silver nitrate, prozerin), glass containers are pasted over with black opaque paper.

26. Medicinal products for medical use that require protection from the action of light, packed in primary and secondary (consumer) packaging, should be stored in cabinets or on racks, provided that measures are taken to prevent direct sunlight or other bright directional light from reaching these medicinal products (use of reflective film, blinds, visors, etc.).

Storage of medicinal products requiring protection from moisture

27. Pharmaceutical substances that require protection from moisture should be stored in a cool place at temperatures up to +15 degrees. C (hereinafter referred to as a cool place), in a tightly closed container made of materials impervious to water vapor (glass, metal, aluminum foil, thick-walled plastic containers) or in the manufacturer's primary and secondary (consumer) packaging.

28. Pharmaceutical substances with pronounced hygroscopic properties should be stored in a glass container with a hermetic seal, filled with paraffin on top.

29. In order to avoid damage and loss of quality, storage of medicinal products should be organized in accordance with the requirements indicated in the form of warning labels on the secondary (consumer) packaging of the medicinal product.

Storage of medicinal products requiring protection from volatilization and drying out

30. Pharmaceutical substances that require protection from volatilization and drying (actually volatile drugs; drugs containing a volatile solvent (alcohol tinctures, liquid alcohol concentrates, thick extracts); solutions and mixtures of volatile substances (essential oils, solutions of ammonia, formaldehyde, chloride hydrogen over 13%, carbolic acid, ethyl alcohol of various concentrations, etc.); medicinal plant materials containing essential oils; drugs containing crystallization water - crystalline hydrates; drugs that decompose with the formation of volatile products (iodoform, hydrogen peroxide, bicarbonate sodium); medicines with a certain lower limit of moisture content (magnesium sulfate, sodium paraaminosalicylate, sodium sulfate)), should be stored in a cool place, in a hermetically sealed container made of materials impermeable to volatile substances (glass, metal, aluminum foil) or in primary and secondary (consumer) packaging of the manufacturer.
The use of polymer containers, packaging and capping is allowed in accordance with the requirements of the State Pharmacopoeia and regulatory documentation.

31. Pharmaceutical substances - crystalline hydrates should be stored in hermetically sealed glass, metal and thick-walled plastic containers or in the manufacturer's primary and secondary (consumer) packaging under conditions that meet the requirements
regulatory documentation for these medicinal products.

Storage of medicines requiring protection from exposure to elevated temperatures

32. Organizations and individual entrepreneurs should store medicinal products that require protection from exposure to elevated temperatures (thermolabile medicinal products) in accordance with the temperature regime indicated on the primary and secondary (consumer) packaging of the medicinal product in accordance with the requirements of regulatory documentation.

Storage of medicines requiring protection from exposure to low temperatures

33. Storage of medicines that require protection from exposure to low temperatures (medicines whose physical and chemical state changes after freezing and is not restored upon subsequent warming to room temperature (40% formaldehyde solution, insulin solutions)), organizations and individual entrepreneurs must carry out in accordance with the temperature regime indicated on the primary and secondary (consumer) packaging of the medicinal product in accordance with the requirements of regulatory documentation.

34. Freezing of insulin preparations is not allowed.

Storage of medicinal products requiring protection from environmental gases

35. Pharmaceutical substances that require protection from exposure to gases (substances that react with atmospheric oxygen: various aliphatic compounds with unsaturated intercarbon bonds, cyclic compounds with side aliphatic groups with unsaturated intercarbon bonds, phenolic and polyphenolic, morphine and its derivatives with unsubstituted hydroxyl groups; sulfur-containing heterogeneous and heterocyclic compounds, enzymes and organic preparations; substances that react with atmospheric carbon dioxide: alkali metal salts and weak organic acids (sodium barbital, hexenal), drugs containing polyhydric amines (eufillin), magnesium oxide and peroxide, sodium hydroxide, caustic potash) should be stored in a hermetically sealed container made of materials impervious to gases, if possible filled to the top.

Storage of odorous and coloring medicines

36. Odorous medicinal products (pharmaceutical substances, both volatile and practically non-volatile, but with a strong odor) should be stored in a hermetically sealed container, impervious to odor.

37. Coloring medicinal products (pharmaceutical substances that leave a colored mark that is not washed off by ordinary sanitary and hygienic treatment on containers, closures, equipment and inventory (brilliant green, methylene blue, indigo carmine)) should be stored in a special cabinet in a tightly closed container .

38. To work with coloring medicines, it is necessary to allocate special scales, a mortar, a spatula and other necessary equipment for each item.

Storage of disinfectants

39. Disinfectants should be stored in hermetically sealed containers in an isolated room away from plastic, rubber and metal storage facilities and distilled water production facilities.

Storage of medicinal products for medical use

40. Storage of medicinal products for medical use is carried out in accordance with the requirements of the state pharmacopoeia and regulatory documentation, as well as taking into account the properties of the substances that make up them.

41. When stored in cabinets, on racks or shelves, medicinal products for medical use in secondary (consumer) packaging must be placed with the label (marking) outward.

42. Organizations and individual entrepreneurs must store medicinal products for medical use in accordance with the requirements for their storage indicated on the secondary (consumer) packaging of the specified medicinal product.
drug.

Storage of medicinal plant materials

43. Bulk medicinal plant materials should be stored in a dry (no more than 50% humidity), well-ventilated area in a tightly closed container.

44. Bulk medicinal plant materials containing essential oils are stored in isolation in a well-closed container.

45. Bulk medicinal plant materials must be subject to periodic control in accordance with the requirements of the state pharmacopoeia. Grass, roots, rhizomes, seeds, fruits that have lost their normal color, smell and the required amount of active substances, as well as those affected by mold, barn pests, are rejected.

46. Storage of medicinal plant materials containing cardiac glycosides is carried out in compliance with the requirements of the state pharmacopoeia, in particular, the requirement for repeated control for biological activity.

47. Bulk medicinal plant materials included in the lists of potent and toxic substances approved by Decree of the Government of the Russian Federation of December 29, 2007 N 964 “On approval of the lists of potent and toxic substances for the purposes of Article 234 and other articles of the Criminal Code of the Russian Federation, as well as large size of potent substances for the purposes of Article 234 of the Criminal Code of the Russian Federation” (Sobraniye Zakonodatelstva Rossiyskoy Federatsii, 2008, No. 2, Art. 89; 2010, No. 28, Art. 3703), is stored in a separate room or in a separate cabinet under lock and key.
48. Packaged medicinal herbal raw materials are stored on racks or in cabinets.

Storage of medicinal leeches

49. Storage of medical leeches is carried out in a bright room without the smell of medicines, for which a constant temperature regime is established.

Storage of flammable medicines

51. Storage of flammable medicines (medicines with flammable properties (alcohol and alcohol solutions, alcohol and ether tinctures, alcohol and ether extracts, ether, turpentine, lactic acid, chloroethyl, collodion, cleol,
Novikov liquid, organic oils); drugs with flammable properties (sulfur, glycerin, vegetable oils, bulk medicinal plant materials)) should be carried separately from other drugs. (As amended by the Order of the Ministry of Health and Social Development of the Russian Federation of December 28, 2010 N 1221n)

52. Flammable medicines are stored in tightly sealed strong, glass or metal containers to prevent the evaporation of liquids from the vessels.

53. Bottles, cylinders and other large containers with flammable and easily combustible medicines should be stored on the shelves of racks in one row in height.
It is forbidden to store them in several rows in height using different cushioning materials.
It is not allowed to store these medicines near heating devices.
The distance from the rack or stack to the heating element must be at least 1 m.

54. Storage of bottles with flammable and highly combustible pharmaceutical substances should be carried out in containers that protect against impacts, or in cylinder-tippers in one row.

55. At the workplaces of industrial premises allocated in pharmacy organizations and individual entrepreneurs, flammable and easily combustible medicines can be stored in quantities not exceeding the shift requirement. At the same time, the containers in which they are stored must be tightly closed.

56. It is not allowed to store flammable and easily combustible medicines in fully filled containers. The degree of filling should be no more than 90% of the volume. Alcohols in large quantities are stored in metal containers, filled no more than 75% of the volume.

57. Joint storage of flammable medicines with mineral acids (especially sulfuric and nitric acids), compressed and liquefied gases, flammable substances (vegetable oils, sulfur, dressings), alkalis, as well as with inorganic salts that give explosive explosives with organic substances is not allowed. mixtures (potassium chlorate, potassium permanganate, potassium chromate, etc.).

58. Medical ether and ether for anesthesia are stored in industrial packaging, in a cool, dark place, away from fire and heating devices.

Storage of explosive medicines

59. When storing explosive drugs (drugs with explosive properties (nitroglycerin); drugs with explosive properties (potassium permanganate, silver nitrate)) measures should be taken to prevent dust contamination.

60. Containers with explosive drugs (barrels, tin drums, bottles, etc.) must be tightly closed to prevent vapors of these drugs from getting into the air.

61. Storage of bulk potassium permanganate is allowed in a special compartment of storage facilities (where it is stored in tin drums), in barbells with ground stoppers separately from other organic substances - in pharmacies and individual entrepreneurs.

62. Bulk nitroglycerin solution is stored in small well-sealed
bottles or metal containers in a cool, dark place, taking precautions against fire. Move dishes with nitroglycerin and weigh this drug should be in conditions that exclude spillage and evaporation of nitroglycerin, as well as its contact with the skin.

63. When working with diethyl ether, shaking, shock, friction is not allowed.

Storage of narcotic and psychotropic medicines

Note.

Order of the Ministry of Health and Social Development of the Russian Federation of May 16, 2011 N 397n approved Special requirements for the storage conditions of narcotic drugs and psychotropic substances duly registered in the Russian Federation as medicines intended for medical use in pharmacies, medical institutions, research and educational institutions organizations and wholesalers of medicines.

65. Narcotic and psychotropic medicines are stored in organizations in isolated rooms specially equipped with engineering and technical security equipment, and in places of temporary storage, subject to the requirements in accordance with the Rules for the Storage of Narcotic Drugs and Psychotropic Substances established by Decree of the Government of the Russian Federation of December 31, 2009 No. N 1148 (Sobraniye zakonodatelstva Rossiyskoy Federatsii, 2010, N 4, art. 394; N 25, art. 3178).
Storage of potent and poisonous medicines, medicines subject to subject-quantitative accounting

66. Pursuant to Decree of the Government of the Russian Federation No. 964 of 29 December 2007 “On Approval of the Lists of Potent and Poisonous Substances for the Purposes of Article 234 and Other Articles of the Criminal Code of the Russian Federation, Federation” potent and toxic drugs include drugs containing potent and toxic substances included in the lists of potent and toxic substances.

67. Storage of potent and poisonous drugs under control in accordance with international legal norms (hereinafter - potent and toxic drugs under international control) is carried out in rooms equipped with engineering and technical security equipment similar to those provided for the storage of narcotic and psychotropic drugs.

68. Potent and poisonous medicines under international control and narcotic and psychotropic medicines may be stored in one technically fortified room.
At the same time, the storage of potent and poisonous medicines should be carried out (depending on the volume of stocks) on different shelves of the safe (metal cabinet) or in different safes (metal cabinets).

69. Storage of potent and poisonous medicines not under international control is carried out in metal cabinets sealed or sealed at the end of the working day.

70. Medicines subject to quantitative accounting in accordance with the Order of the Ministry of Health and Social Development of the Russian Federation of December 14, 2005 N 785 "On the procedure for dispensing medicines" (registered with the Ministry of Justice of the Russian Federation on January 16, 2006 N 7353 ), with the exception of narcotic, psychotropic, potent and poisonous medicines, are stored in metal or wooden cabinets, sealed or sealed at the end of the working day.

MINISTRY OF HEALTH AND SOCIAL DEVELOPMENT

RUSSIAN FEDERATION

ORDER

ON THE APPROVAL OF THE RULES FOR THE STORAGE OF MEDICINAL PRODUCTS

List of changing documents

1. Approve the Rules for the storage of medicinal products in accordance with the appendix.

2. Recognize as invalid:

T.A.GOLIKOVA

Appendix

to the Order

Ministry of Health

and social development

Russian Federation

RULES FOR THE STORAGE OF MEDICINES

List of changing documents

(As amended by the Order of the Ministry of Health and Social Development of the Russian Federation of December 28, 2010 N 1221n)

I. General provisions

II. General requirements for the arrangement and operation of premises

storage of medicines

2. The device, composition, size of areas (for manufacturers of medicines, drug wholesalers), operation and equipment of premises for storing medicines must ensure their safety.

(clause 2 as amended by the Order of the Ministry of Health and Social Development of the Russian Federation of December 28, 2010 N 1221n)

5. Premises for the storage of medicines should be provided with racks, cabinets, pallets, and storage boxes.

6. Finishing of premises for storing medicines (internal surfaces of walls, ceilings) should be smooth and allow for wet cleaning.

III. General requirements for storage rooms

medicines and organization of their storage

The readings of these devices must be recorded daily in a special log (card) of registration on paper or in electronic form with archiving (for electronic hygrometers), which is maintained by a responsible person. The log (card) of registration is stored for one year, not counting the current one. Control devices must be certified, calibrated and verified in the prescribed manner.

8. Medicinal products are placed in the storage rooms in accordance with the requirements of the regulatory documentation indicated on the packaging of the medicinal product, taking into account:

physico-chemical properties of medicines;

pharmacological groups (for pharmacy and medical organizations);

method of application (internal, external);

aggregate state of pharmaceutical substances (liquid, bulk, gaseous).

When placing medicines, it is allowed to use computer technologies (alphabetically, by codes).

narcotic and psychotropic drugs;

potent and poisonous medicines, which are controlled in accordance with international legal norms.

Racks, cabinets, shelves intended for storage of medicines must be identified.

(As amended by the Order of the Ministry of Health and Social Development of the Russian Federation of December 28, 2010 N 1221n)

Stored medicinal products must also be identified using a shelf card containing information about the stored medicinal product (name, form of release and dosage, batch number, expiration date, manufacturer of the medicinal product). When using computer technology, identification using codes and electronic devices is allowed.

12. If expired medicinal products are identified, they must be stored separately from other groups of medicinal products in a specially designated and designated (quarantine) area.

IV. Requirements for premises for the storage of flammable

and explosive drugs

and organization of their storage

13. Premises for the storage of flammable and explosive medicines must fully comply with current regulations.

(clause 14 as amended by the Order of the Ministry of Health and Social Development of the Russian Federation of December 28, 2010 N 1221n)

(clause 18 as amended by the Order of the Ministry of Health and Social Development of the Russian Federation of December 28, 2010 N 1221n)

(As amended by the Order of the Ministry of Health and Social Development of the Russian Federation of December 28, 2010 N 1221n)

It is allowed to store explosive medicinal products for medical use (in secondary (consumer) packaging) for use for one work shift in metal cabinets outside the premises for storing flammable pharmaceutical substances and explosive medicinal products.

(As amended by the Order of the Ministry of Health and Social Development of the Russian Federation of December 28, 2010 N 1221n)

Premises for the storage of flammable pharmaceutical substances and explosive medicinal products used for the storage of flammable pharmaceutical substances in excess of 100 kg must be located in a separate building, and the storage itself must be carried out in glass or metal containers isolated from the storage rooms for other groups of flammable pharmaceutical substances .

(clause 20 as amended by the Order of the Ministry of Health and Social Development of the Russian Federation of December 28, 2010 N 1221n)

21. It is forbidden to enter the premises for the storage of flammable pharmaceutical substances and explosive medicines with open sources of fire.

(As amended by the Order of the Ministry of Health and Social Development of the Russian Federation of December 28, 2010 N 1221n)

V. Features of the organization of storage of medicines

in warehouses

22. Medicinal products stored in warehouses should be placed on racks or on undercarriages (pallets). It is not allowed to place medicines on the floor without a pallet.

Pallets can be placed on the floor in one row or on racks in several tiers, depending on the height of the rack. It is not allowed to place pallets with medicines in several rows in height without the use of racks.

23. With the manual method of unloading and loading operations, the height of the stacking of medicines should not exceed 1.5 m.

When using mechanized devices for unloading and loading operations, medicinal products should be stored in several tiers. At the same time, the total height of placement of medicines on the racks should not exceed the capabilities of mechanized handling equipment (lifts, trucks, hoists).

23.1. The area of storage facilities should correspond to the volume of stored medicines, but be at least 150 square meters. m, including:

drug acceptance area;

area for the main storage of medicines;

expedition zone;

premises for medicines requiring special storage conditions.

(clause 23.1 was introduced by Order of the Ministry of Health and Social Development of the Russian Federation of December 28, 2010 N 1221n)

VI. Features of storage of individual groups of medicinal

means depending on the physical and physico-chemical

properties, the impact on them of various

environmental factors

from the action of light

24. Medicines that require protection from the action of light are stored in rooms or specially equipped places that provide protection from natural and artificial lighting.

25. Pharmaceutical substances that require protection from light should be stored in containers made of light-protective materials (orange glass glass containers, metal containers, packaging made of aluminum foil or polymeric materials painted black, brown or orange), in a dark room or cabinets. .

For the storage of pharmaceutical substances that are especially sensitive to light (silver nitrate, prozerin), glass containers are pasted over with black opaque paper.

Storage of medicines requiring protection

from moisture

27. Pharmaceutical substances that require protection from moisture should be stored in a cool place at temperatures up to +15 degrees. C (hereinafter - a cool place), in a tightly closed container made of materials impervious to water vapor (glass, metal, aluminum foil, thick-walled plastic containers) or in the manufacturer's primary and secondary (consumer) packaging.

28. Pharmaceutical substances with pronounced hygroscopic properties should be stored in a glass container with a hermetic seal, filled with paraffin on top.

Storage of medicines requiring protection

from volatilization and drying

30. Pharmaceutical substances that require protection from volatilization and drying (actually volatile drugs; drugs containing a volatile solvent (alcohol tinctures, liquid alcohol concentrates, thick extracts); solutions and mixtures of volatile substances (essential oils, solutions of ammonia, formaldehyde, chloride hydrogen over 13%, carbolic acid, ethyl alcohol of various concentrations, etc.); medicinal plant materials containing essential oils; drugs containing crystallization water - crystalline hydrates; drugs that decompose with the formation of volatile products (iodoform, hydrogen peroxide, bicarbonate sodium); medicines with a certain lower limit of moisture content (magnesium sulfate, sodium paraaminosalicylate, sodium sulfate)), should be stored in a cool place, in a hermetically sealed container made of materials impermeable to volatile substances (glass, metal, aluminum foil) or in primary and secondary (consumer) packaging of the manufacturer. The use of polymer containers, packaging and capping is allowed in accordance with the requirements of the State Pharmacopoeia and regulatory documentation.

31. Pharmaceutical substances - crystalline hydrates should be stored in hermetically sealed glass, metal and thick-walled plastic containers or in the manufacturer's primary and secondary (consumer) packaging under conditions that comply with the requirements of regulatory documentation for these medicinal products.

Storage of medicines requiring protection

from exposure to elevated temperature

Storage of medicines requiring protection

from exposure to low temperatures

34. Freezing of insulin preparations is not allowed.

Storage of medicines requiring protection

from exposure to gases contained in the environment

Storage of odorous and coloring medicines

36. Odorous medicinal products (pharmaceutical substances, both volatile and practically non-volatile, but with a strong odor) should be stored in a hermetically sealed container, impervious to odor.

38. To work with coloring medicines, it is necessary to allocate special scales, a mortar, a spatula and other necessary equipment for each item.

Storage of disinfectants

39. Disinfectants should be stored in hermetically sealed containers in an isolated room away from plastic, rubber and metal storage facilities and distilled water production facilities.

Storage of medicines

for medical use

41. When stored in cabinets, on racks or shelves, medicinal products for medical use in secondary (consumer) packaging must be placed with the label (marking) outward.

Storage of medicinal plant materials

43. Bulk medicinal plant materials should be stored in a dry (no more than 50% humidity), well-ventilated area in a tightly closed container.

44. Bulk medicinal plant materials containing essential oils are stored in isolation in a well-closed container.

47. Bulk medicinal plant materials included in the lists of potent and toxic substances approved by Decree of the Government of the Russian Federation of December 29, 2007 N 964 "On approval of the lists of potent and toxic substances for the purposes of Article 234 and other articles of the Criminal Code of the Russian Federation, as well as large size of potent substances for the purposes of Article 234 of the Criminal Code of the Russian Federation" (Sobranie Zakonodatelstva Rossiyskoy Federatsii, 2008, No. 2, Art. 89; 2010, No. 28, Art. 3703), is stored in a separate room or in a separate cabinet under lock and key.

48. Packaged medicinal herbal raw materials are stored on racks or in cabinets.

Storage of medicinal leeches

49. Storage of medical leeches is carried out in a bright room without the smell of medicines, for which a constant temperature regime is established.

Storage of flammable medicines

51. Storage of flammable medicines (medicines with flammable properties (alcohol and alcohol solutions, alcohol and ether tinctures, alcohol and ether extracts, ether, turpentine, lactic acid, chloroethyl, collodion, cleol, Novikov liquid, organic oils); drugs with flammable properties (sulfur, glycerin, vegetable oils, bulk medicinal plant materials)) should be administered separately from other drugs.

(As amended by the Order of the Ministry of Health and Social Development of the Russian Federation of December 28, 2010 N 1221n)

52. Flammable medicines are stored in tightly sealed strong, glass or metal containers to prevent the evaporation of liquids from the vessels.

It is not allowed to store these medicines near heating devices. The distance from the rack or stack to the heating element must be at least 1 m.

54. Storage of bottles with flammable and flammable pharmaceutical substances should be carried out in containers that protect against impacts, or in cylinder-tilters in one row.

58. Medical ether and ether for anesthesia are stored in industrial packaging, in a cool, dark place, away from fire and heating devices.

Storage of explosive medicines

60. Containers with explosive drugs (barrels, tin drums, bottles, etc.) must be tightly closed to prevent vapors of these drugs from getting into the air.

62. Bulk nitroglycerin solution is stored in small, well-closed bottles or metal containers in a cool, dark place, taking fire precautions. Move dishes with nitroglycerin and weigh this drug should be in conditions that exclude spillage and evaporation of nitroglycerin, as well as its contact with the skin.

Rules for the storage of medicines in a pharmacy. Accounting and storage of medicines and products in medical institutions

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