I CONFIRM:

Deputy

Minister of Agriculture

economy and food

Russian Federation

A.V.KOLGANOV.

Head of department

veterinary medicine

Chief State

Veterinary inspector of the Federation

V.M.AVILOV

AGREED:

Deputy

Minister of Health

Russian Federation

A.E.VILKEN

1998

Chairman of the Permanent

drug control committee

under the Ministry of Health of the Russian Federation

E.A.BABAYAN

1998

RULES

STORAGE, ACCOUNTING AND DISPENSING OF MEDICINES

LIST A AND B, INTENDED FOR VETERINARY PURPOSES

These Rules apply to the activities of organizations, institutions and legal entities (regardless of business forms) engaged in the acquisition, storage and sale of medicines intended for veterinary purposes.

The following lists of medicines A and B are published from the perspective of veterinary treatment and preventive institutions, veterinary pharmacy chains and do not contradict lists A and B approved by the Ministry of Health of the Russian Federation.

As for poisonous and potent drugs, these concepts are defined by regulatory documents and lists of the Standing Committee for Drug Control under the Ministry of Health of the Russian Federation. These lists operate independently, regardless of lists A and B, for purposes arising from the dispositions of Article 226(2) of the Criminal Code of the Russian Federation.

1. General Provisions

Medicines belonging to list A (Appendix 1), medicines belonging to list B (Appendix 2), intended for use in veterinary medicine, are allowed to be possessed and stored under the conditions provided for by these rules: in republican, regional, regional associations, interdistrict associations and veterinary pharmacies of the Zoovetsnab system; at stations for the control of animal diseases (district, interdistrict and regional veterinary stations), in district, city veterinary hospitals, regional (regional, republican) veterinary clinics, veterinary laboratories; in veterinary research institutes and stations. In all other veterinary institutions (including veterinary sites and points), on collective farms, state farms and other enterprises, organizations and institutions, regardless of the form of ownership, it is allowed to store drugs of list A and B for veterinary purposes only in the form of ready-made forms and at the existence of the conditions provided for by these rules.

Note. Lists A and B are supplemented and amended by the Veterinary Department of the Russian Ministry of Agriculture and Food annually.

Medicines of list A and B for veterinary purposes are permitted to be purchased in the prescribed manner at enterprises, organizations and veterinary pharmacies of the Zoovetsnab system, as well as in medical pharmacies and other organizations that are granted the right to sell these products. Providing institutions with list A and B drugs for veterinary purposes is carried out as planned on the basis of agreements concluded by animal owners of all forms of ownership and individuals with suppliers of the Zoovetsnab system, drug manufacturers and foreign companies.

At the bases and warehouses of the Zoovetsnab system, veterinary organizations, collective farms, state farms, joint-stock companies, research and other institutions, the person responsible for storing list A and B drugs is the head of the institution or a person authorized to do so from among those working in this institution pharmacists, veterinarians or, as an exception, veterinary paramedics with completed secondary education.

It is prohibited to purchase drugs of list A and B for veterinary purposes at enterprises, organizations and institutions, as well as from private individuals who do not have a license to sell these drugs.

It is prohibited to store in bases, warehouses, veterinary pharmacies of the Zoovetsnab system, in institutions of the state veterinary network, collective farms, state farms and other enterprises and organizations of list A and B medicines, as well as disinfection, insecticidal and deratization drugs that are not approved by the Department of Veterinary Medicine of the Ministry of Agriculture of Russia instructions for use.

2. Personnel requirements

The head of the institution appoints a person from among the veterinarians working in this institution or, as an exception, veterinary paramedics with secondary specialized education, responsible for the storage, accounting and dispensing of drugs of list A and B. The appointment is formalized by an order for the institution (organization).

The head of the institution is obliged to acquaint, against receipt (in a special journal), persons engaged in the storage and dispensing of medicines of lists A and B, with the rules for handling them. The journal must be kept by the head of the institution.

3. Requirements for premises for storing medicines

list A drugs

In rooms intended for storing medicines, lists A and B, the windows are equipped with iron bars and the doors are lined with iron. At the same time, conditions must be created that exclude the possibility of their theft or use by persons who do not have the right to do so.

The storage room for list A drugs must be equipped with security alarms connected to the private security console of the local police department.

For the storage of List B medicinal products, conditions must be created that exclude the possibility of their theft.

In the premises where list A and B medicinal products are stored, it is necessary to have: safes, metal cabinets, scales, weighing scales, funnels, mortars, cylinders and other materials necessary for packaging, grinding, weighing, measuring these medicinal products.

It is prohibited to use the specified equipment for other purposes! This equipment and utensils must be washed and disinfected separately from other equipment and other utensils under the supervision of a pharmacist, warehouse manager or person responsible for storing medicines.

The room must be equipped with supply and exhaust ventilation, a washbasin, and first aid equipment.

List B medicinal products in large containers (containers, barrels, cans, bags) are stored in warehouses equipped with supply and exhaust ventilation, fire extinguishing and alarm systems.

All work on packaging of list A drugs is carried out in a fume hood under a draft in compliance with the rules of personal hygiene.

Cabinets and safes in which List A medicinal products are stored are locked and sealed after the end of the working day. Premises and warehouses are locked, sealed or sealed.

The keys and wax seal (seal) must be kept by the person responsible for storing medicines.

4. Storage, accounting and dispensing of medicines

list A and B

Medicines (in any dosage form) of lists A and B must be stored in rooms specially equipped for these purposes or in safes, metal cabinets or boxes under lock and key.

Medicines of list A (Appendix 1) are stored in internal, locked compartments of safes or cabinets.

On the outside of the door of the safe (cabinet, drawer) for storing drugs of list A there must be a corresponding inscription: list A. On the inside of the doors of the safe (cabinet, drawer) a list of medicines stored in it is attached.

Medicines on lists A and B are stored only in special factory or pharmacy packaging, on which the name must be indicated.

Access to the premises in which list A and B drugs are stored is permitted only to persons directly working with them, which is formalized by the relevant order of the institution (enterprise, organization).

Accounting procedure. List A medicinal products, regardless of the dosage form, are subject to subject-quantitative (except accounting) accounting in special journals at enterprises and organizations. The journal is started for 1 year. The first page contains a list of drugs from List A, and then to record each drug, a separate page (spread) is allocated, which reflects the days the drug was received, the supplier, the batch number and expiration date, the date of issue (sale) or write-off. When writing off a drug with an expired shelf life, a commission with the participation of the head of the institution and the person in charge draws up a report that is filed in the book.

When drugs of list A and B are received, the head of the institution or the person responsible for storing these drugs is obliged to personally check the compliance of the received funds with the entries in the accompanying documents. These funds are accepted on the day they are received (but no later than the next day) and are formalized in the prescribed manner.

List B medicinal products are kept in registration books, numbered, laced, sealed with wax and signed by the head of the institution. Accounting books and receipts and expenditure documents for these funds are stored in the same room, in appropriate cabinets or safes.

All documents for recording the receipt, storage and dispensing of list A medicines are kept separately from documents for other medicines and goods and are stored for 3 years under conditions that guarantee their complete safety. Responsibility for the safety of these documents rests with the persons responsible for storage.

The head of the institution or the commission appointed by him, or the person responsible for the storage of medicines, checks the actual availability of medicines of lists A and B on a monthly basis as of the first day of the month. The results of the check are compared with the book balance derived on the basis of receipt and expenditure documents.

If deviations from the volume are detected (shortages in quantities exceeding the approved norms of natural loss, or surpluses), the person responsible for storing these funds is obliged to notify the head of the institution about this in writing within 3 days. The latter informs the head of the higher organization and, if necessary, the internal affairs bodies about this.

Leave order. List A medicinal products are dispensed to veterinary institutions only upon request. At the request of the head (or deputy head) of the enterprise (organization or institution), there must be permission from the relevant higher veterinary authority to dispense the medicinal product with a seal attached.

Before dispensing List A medicinal products, the person responsible for their storage must personally check the basis for dispensing, the compliance of the dispensed medicinal product with the entries in the accompanying documents, the correctness of packaging and packing, and sign for a copy of the request and invoice left at the base or warehouse.

Republican, regional associations, interdistrict branches, veterinary pharmacies and bases of the Zoovetsnab system issue medicines to recipients only if they have a power of attorney, executed in the prescribed manner, indicating the name and quantity of the drug in words.

If institutions of the state veterinary network and other enterprises are attached to the organization of the Zoovetsnab system for permanent supply, then medicines can be dispensed under a power of attorney issued for a certain period, but not more than 3 months.

Medicines of lists A and B, depending on the dosage form, are sold in whole factory packaging, and by weight in well-closed glass, porcelain, plastic or polyethylene containers. Drugs according to list A are released sealed with a wax seal or sealed. Each package must have precise and clear designations (in the signature or on the label): “For veterinary purposes”, “Internal”, “External”, “For injection”, etc., as well as the name of the institution that manufactured the drug, composition it, the compliance of the substances specified in the prescription with those indicated in the requirement, the date of manufacture and the signature of the persons who manufactured, tested and dispensed the drug.

Write-off. Medicines of lists A and B that have reached a state in which they are unsuitable for use by animals, but can be processed, are, in agreement with a higher organization, sent to the institution from which they were received.

Medicines that have become unusable and cannot be processed, medicines suitable for processing, but for some reason not delivered to industrial enterprises, are destroyed on site by burning.

The act of writing off list A and B medicines is drawn up by a commission with the participation of the head of the institution (organization) and the person responsible for storing these funds.

5. Storage, accounting and dispensing of medicines

list A and B in pharmacies of disease control stations

animals, district, inter-district (city)

veterinary hospitals, regional, regional

and republican clinics

In pharmacies of stations for the control of animal diseases, district (city) veterinary hospitals, regional, regional and republican veterinary clinics, drugs belonging to list A, regardless of the dosage form (with the exception of lapis pencils), are stored in compliance with the requirements stipulated by these rules . List A drugs are stored in pharmacies, veterinary institutions listed above, in safes, metal or iron-lined wooden cabinets under lock and key. Pharmacy windows must be equipped with metal bars.

List B medicines are allowed to be stored in the same room with other (non-strong) medicines, but always in separate cabinets and under lock and key.

Medicines of list A and B in pharmacies are stored separately in groups on separate shelves of cabinets, depending on the method of their use.

The stock of drugs of list A and B in veterinary institutions should not exceed the standards established for the relevant veterinary institutions.

Stations for the control of animal diseases purchase drugs of list A and B, taking into account the need for them in veterinary institutions of districts (regions).

List A of medicines, attached to the inside of the doors of the cabinet (safe, drawer) in which these medicines are stored, indicates the highest single and daily doses of medicines for different types of animals.

6. Storage, accounting and dispensing of medicines

lists A and B in local veterinary hospitals,

at veterinary sites and points, as well as on collective farms,

state farms and other enterprises and organizations,

having animals, regardless of ownership

In veterinary hospitals (except for regional and city ones), at veterinary sites, points, on farms of collective farms, state farms, experimental, educational and other farms, as well as in other organizations and institutions, regardless of the form of ownership, it is prohibited to store List A medicinal products in pure form. form, as well as to make medicines from them for veterinary purposes.

List B medicinal products (in the form of finished forms) are stored in institutions, organizations and enterprises in accordance with these rules.

In the absence of a special premises (pharmacy), storage of list A drugs in an institution (on a farm) is not allowed.

When storing, dispensing and working with medicines, a veterinarian (paramedic) of an institution of the state veterinary network, collective farm, state farm, other enterprise (organization, institution), regardless of the form of ownership, must be guided by the requirements set out in these rules.

List A drugs stored in institutions, organizations and farms are subject to subject-quantitative (except accounting) accounting in a special form.

The accounting book and receipt and expenditure documents for list A medications are stored in a closet, safe or drawer.

Medicines on list A and B in pharmacies of veterinary institutions, collective farms and state farms are written off according to prescriptions or requirements prescribed by veterinarians or veterinary assistants holding the position of heads of veterinary areas, points, hospitals.

All documents for recording the receipt, storage, dispensing and consumption of list A drugs are kept separately from documents for other documents and goods and are stored under conditions that guarantee their safety within the established time frame.

In pharmacies of veterinary institutions, tables of daily and one-time medicines of List A for animals of different species and ages, as well as tables of antidotes for poisoning, are posted in a prominent place.

It is strictly prohibited to purchase, store and sell List A medicinal products to owners of private trade pavilions (tents) licensed to trade in veterinary drugs, feed and accessories for animals.

Control over compliance with trade rules in these pavilions rests with local state veterinary inspection authorities. If cases of trade in List A drugs are detected, the owner’s trade license is confiscated and local internal affairs authorities are notified.

7. Storage, accounting and dispensing of medicines

list A and B in veterinary research

institutes (stations, laboratories, veterinary

educational institutions)

Veterinary research institutes, stations, laboratories purchase list A and B medicinal products in quantities corresponding to the approved thematic plans for research work, and veterinary educational institutions - in quantities necessary for laboratory practical classes provided for by training programs and for the implementation of the approved topics of research work.

In research institutes, stations, laboratories and veterinary educational institutions, medicinal products of list A and B for veterinary purposes are stored in compliance with the requirements set out in these rules.

In research institutes, stations, laboratories with a small volume of work with drugs of list A and B, they are allowed to be stored in a room with other medications and reagents, but in separate safes, metal or iron-lined wooden cabinets or boxes under lock and key. Storage of these funds in the classrooms of educational institutions is prohibited.

Responsibility for the use of List A equipment issued for practical classes with students lies with the teacher leading the class.

List A drugs at an institute (department, department, laboratory, department) for current work are dispensed only with the written permission of the head of the institution or his deputy and only upon request from the pharmacy with a prescription signed by the head of the laboratory (department, department, office, department) , indicating in it the name of the person receiving this remedy.

List A medicinal products used in research institutions and educational institutions are subject to subject-quantitative recording using special forms.

Samples of List A medicinal products received for analysis at research institutions and institutions upon completion of analysis are stored for 3 months. The remains of the specified products suitable for use are left at the institution and handed over to the person responsible for storage. With the permission of a higher veterinary authority, they are used in this institution.

The Rules for the storage, accounting and dispensing of poisonous and potent drugs intended for veterinary purposes, approved by the Main Veterinary Directorate of the State Agricultural Industry of the USSR on June 7, 1988, shall be considered invalid.

Appendix No. 1

List A

Arecoline hydrobromide (arecoline hydrobromide)

Atropine sulfate (atropine sulfate)

Ditilin

Carbacholine

Miarsenol

Osarsol

Pilocarpine hydrochloride (pilocarpine hydrochloride)

Platyphylline hydrotartrate (platyphylline bitartrate)

Prozerin

Reserpine

Appendix No. 2

List B

Drug name

Aversect (pharmacin)

Avikocin<*>

Avotan<*>

Azidin

Azinox plus

Akrodex<*>

Acrosol<*>

Albadri plus<*>

Aldifal<*>

Aldozan

Albamilin

Albex"

Albendazole<*>

Albipen L.A. e.d.s.<*>

Amoxiclav<*>

Amoxinject<*>

Amoxicillin<*>

Amoxicillin trihydrate p.<*>

Amol

Ampivet v.r.p.<*>

Ampioks<*>

Ampisur<*>

Ampicillin sodium salt

Amprol plus<*>

Amprolium<*>

Amuril v.r.p.

Anesthezon

Aniprost

Aprolan<*>

AF-20<*>

Acetomepregenol

Aerolfam<*>

Aerosol-cyodrine<*>

Baycox<*>

Baymek<*>

Baytril<*>

Bantel<*>

Belkospira<*>

Benzylpenicillin sodium salt

Berenil<*>

Bilozin-200 r.d.i.<*>

Bimoksil L.A. s.d.i.<*>

Biovermin<*>

Biovit

Biosul 70% p<*>

Biotrop

Biopharm-120

Biofusol

Bifethrin<*>

Bovex<*>

Bumectin<*>

Valbasen<*>

Veriben<*>

Vermitan<*>

Verpanil<*>

Vetofloc<*>

Vetrim r.d.n.<*>

Vetrimoxin<*>

Vigal<*>

Virginiamycin 50 p.<*>

Intrauterine sticks with oxytetracycline hydrochloride<*>

Intrauterine sticks with gentamicin<*>

Intrauterine sticks with furazolidone

Gallimicin 200 and 50 r.d.i.<*>

Gamma-plant., solution for injections

Gump

Hexyhol

Gentaral r.d.i.<*>

Gentamast<*>

Gentamicin

Geovet

Geomycin<*>

Geomycin + vitamins<*>

Geotilin n.<*>

Hypodectin-N

Gonadestrin<*>

Deadtril r.d.o.p.<*>

Desistrep p.<*>

Dexaford<*>

Dectomax<*>

Depot-promon<*>

Depotocin<*>

Dermatosol<*>

Dihydrostreptomycin sulfate r.d.i.<*>

Dinolptik (Lutaliz)<*>

Dioxidine

Diregestran<*>

Ditrivet t.<*>

Difurol A

Difurol B

Dichlorphene<*>

DMSO-90

Drontal<*>

Drontsit<*>

Duotin"

Ivergen

Ivermectin"

Ivomek<*>

Izatizon

Intramycin s.d.i.<*>

Iodine monochloride

Iodinocol

Iodoxide

Iodotriethylene glycol

Ichthyofur

Kanamycin<*>

Kanikquantel<*>

Cardanone

Katalin r.d.<*>

Quinabique<*>

Kitasamicin c. R. powder<*>

Clamoxyl<*>

Clathroprostin

Klinakox

Kloksavet M

Cloxamast<*>

Cloxataryl<*>

Cloxafort<*>

Cowinan<*>

Coyden-25<*>

Coccidiovit<*>

Kokcisan<*>

Koktsistak<*>

Kolivet p.<*>

Coliprim r.d.o.p.<*>

Colistin<*>

Kolmik E - r.d.o.p.<*>

Combi-Kel s.d.i.<*>

Cospiravit r.d.o.p.<*>

Cosumix plus<*>

Lazin

Lambivet T.<*>

Lauthecin<*>

Levamisole<*>

Levacid<*>

Levomycetin

Levotetrasulfine

Levoerythrocycline

Lenefur

Lenomak

Lefuran

Lincomycin<*>

Linko-spectin<*>

Aversectin ointment"

Yam ointment

Mastitis Forte<*>

Mastilex<*>

Mastisept A

Masticide

Mastogal ZK<*>

Mepatar p.d.o.p.<*>

Mesalin<*>

Metavetrim<*>

Metrigent 200<*>

Metronidazole<*>

Mikotil r.d.i.

Monensin<*>

Multimast susp. in powder<*>

Nafpenzal<*>

Neodiar s.d.o.p.<*>

Neomycin sulfate

Neonidan<*>

Neofur

Nicarbazine<*>

Nilverm<*>

Nilzan<*>

Niratil pur-on<*>

Nitazol

Nifulin

Nonidan<*>

Norodin-24 r.d.i.<*>

Norsulfazole

Nutricin sulfate 140 p.<*>

Oxacillin sodium salt

Oxyvert r.d.i.<*>

Oxygel L.A.<*>

Oxican

Oxytetracycline

Oxytacin

Olaquindox 10% pr.<*>

Oldoxin<*>

Optitrim 48% s.d.i.<*>

Oradelt<*>

Oramek<*>

Orbenin<*>

Palekhin

Panacur<*>

Pandex<*>

Paraquistel<*>

PG-600<*>

Penicillin

Penstrepten<*>

Pentard s.d.i.<*>

Perol<*>

Piavermin<*>

Pillkan<*>

Piperazine

Pirantel<*>

Poliverkan<*>

Polymyxin sulfate<*>

Polytreme

Polzomicin n.<*>

Pometin

Proziquantel<*>

Primazine p.<*>

Prosolvin<*>

Will get stuck<*>

Pulmotil<*>

Rivicycline

Rilexin<*>

Rimoks L.A.<*>

Rodovet 25 p.d.o.p.<*>

Rolenol<*>

Rometar<*>

Romet 30<*>

Ronidazole 10% v.p.<*>

Ronidazole 10%<*>

Rustomectin

Sacox<*>

Salinopharm

Salozin<*>

Salocin 120 micro granules<*>

Santel<*>

Sergon<*>

Sizovet

Silka<*>

Sinulox<*>

Sytamex<*>

Spectam<*>

Spectolin r.d.i.<*>

Stapenor retard<*>

Stafak<*>

Streptovirus

Streptomycin sulfate

Streptofur

Suanovil-20<*>

Suivermine<*>

Sulfadimezin

Sulfadox

Sulfamine

Sulfanite

Sulfatyl<*>

Sulfetrim r.d.i.<*>

Surfagon

Takelan P.<*>

Taltrin<*>

Terravetin-500

Tetravet E-691<*>

Tetra-delta<*>

Tetramisole<*>

Tetracycline chloride for injection

Tetroxy<*>

Tiamulin Sandoz<*>

Thiamutin 10%<*>

Thixotropin

Tilanik - 5% and 20% injection solution

Tilasul<*>

Tylosin<*>

Tilosulfuran<*>

Totocilin<*>

Trivertine<*>

Trimethosul<*>

Tripanodad<*>

Triprim r.d.i.<*>

Trisulfone r.d.i.<*>

Tricillin

Troscan<*>

Ursovermit<*>

Ursolevamisole<*>

Ursometronide p.d.o.p.<*>

Ursofenicol<*>

Urcycline 5% r.d.i.<*>

Farmazin

Fascoverm<*>

Phenax<*>

Fenakur<*>

Fenapeg

Fenbendazole<*>

Fertagil<*>

Flavomycin<*>

Flubactin n.<*>

Flubactin r.d.o.p.<*>

Flumiquil<*>

Flumisol r.d.o.p.<*>

Folligon<*>

Fradisin

FSH-super

Furabimin

Furagalli 20/20 w.r.p.<*>

Furazol 50 MB<*>

Furazolidone

Furapen

Furbaplast

Chemical coccide

Chloramphene - 50 MB p.d.o.p.<*>

Chloramphenicol 20% p.d.o.p.

Chlorvet p.<*>

Khorulon<*>

Chronitsin r.d.i.

Tsevamek<*>

Celbar 4.5% s.d.o.l.<*>

Cigro<*>

Cydectin<*>

Cycloferon 12.5% ​​solution for injection

Cyprinocestin

Shanacycline r.d.i.<*>

Egotsin<*>

Equest<*>

Excelel p.d.i.<*>

Elankogran Ave.<*>

Emtril<*>

Enzaprost-25<*>

Enromycin n.<*>

Enrobioflox 10% r.d.o.p.<*>

Enroxil<*>

Enrotil 10% pp.<*>

Enroflox<*>

Eridin

Eridon

Estradiol benzoate<*>

Estrofan

Estrumat<*>

Estufalan

Eustin<*>

Yumamycin<*>

Note:

<*>- foreign drugs

R.d.i. - injection

P. - powder

V.r.p. - water-soluble powder

R.d.o.p. - solution for oral use

S.d.i. - suspension for injection

E.d.i. - emulsion for injection

P.d.o.p. - powder for oral use

The association assists in providing services in the sale of timber: at competitive prices on an ongoing basis. Forest products of excellent quality.

"Moscow pharmacies", 2010, N 10
MEDICINES OF LIST A AND LIST B:
WHAT SHOULD WE KEEP TODAY
Back in 1922, the Instruction of the People's Commissariat of Health "On the right to open and conduct trade in medicines" established the rules for the circulation of potent and toxic substances (trade in such substances and their storage). The instructions, for example, stated that “poisonous and potent substances should be stored in special compartments under lock and key...”. In addition, a number of provisions of this document revealed the existing approaches to the definition of potent and toxic substances and the establishment of their lists.
To determine which specific substances are considered potent and toxic, the instructions also referred to the Russian Pharmacopoeia. In particular, § 4 of the instructions stated that “to record the arrival and release of poisons according to List “A” of the 6th edition of the Russian Pharmacopoeia, a special corded book must be kept in wholesale warehouses, certified by the health department.”
The inspector is always right?! This statement-question refers to the “ever-memorable” lists A and B, the list of which has become invalid since May 24, 2010 in accordance with the order of the Ministry of Health and Social Development N 380. But as for the conditions of their storage established by the order of the Ministry of Health of the Russian Federation dated 04.03.03 N 80 "On approval of the industry standard "Rules for the dispensing (sale) of medicines in pharmacies. Basic provisions", then they remain in force. Moreover, they are especially carefully checked by regional Ministries of Health and Departments of Health and are classified as "gross violations of licensing requirements and conditions" and entail administrative punishment in the form of a fine of 40 thousand rubles or suspension of the license for a period up to 90 days. Their argument is that the concept of lists A and B are given in the State Pharmacopoeia (SP), which is of a legislative nature. However, in arguing that they are right, the specialists conducting the checks do not mention in which issue of this very GF they found them. We decided to figure out what we should store today in accordance with the requirements for lists A and B. The definition of lists A and B is given in the State Pharmacopoeia X - edition of 1968, in the “Introduction” section:
“List A includes medicines, the prescription, use, dosing and storage of which, due to their high toxicity, must be carried out with extreme caution. This list also includes medicines that cause drug addiction.
List B includes medicines, the prescription, use, dosing and storage of which must be carried out with caution due to possible complications when used without medical supervision.
Storage and dispensing in pharmacies and in all other institutions of medicines according to lists A and B is carried out in compliance with the rules given in the special instructions approved by the Ministry of Health of the USSR." Here is a list of medicinal substances included in list A, which includes 121 items, and list B - 340 items, by the way, in the Global Fund VIII edition (1948) list A consisted of 36 medicinal substances, and list B - of 192. List A also included narcotic drugs, since they were considered not as an independent group, but as a type of toxic substances.
A deeper retrospective look into history showed that historically all “strong” medications were allocated to group B (list B), and “highly toxic” ones to group (list) A.
Medicines of group A are stored separately from other medicines in permanently closed safes or cabinets, on the inside of the door of which there must be the inscription “A. Venena” indicating the list of stored substances, their single and daily doses. After work, safes or cabinets are sealed. Group B medications are stored separately in special cabinets, which are closed at the end of the working day. On the inside of the door there must be the inscription "B. Heroica".
The fact that all poisonous and narcotic drugs in the Soviet period were identified with the concept of “drugs of List A”, and the concept of “potent drugs” with the concept of “drugs of List B” is confirmed by previously valid regulatory documents, for example, paragraph 3.3. "Instructions for organizing storage in pharmacies of various groups of medicines and medical products", approved by Order of the USSR Ministry of Health dated May 15, 1981 N 520 (by the way, in the Order of the Ministry of Health dated November 13, 1996 N 377, which replaced Order N 520, the concept of "list “A” and “B” disappeared, and only “narcotic, psychotropic and potent drugs” remained), paragraphs 2 and 4 of the “Rules for the storage, recording and dispensing of poisonous, narcotic and potent drugs in self-supporting pharmacies”, approved by the Order of the USSR Ministry of Health dated 07/03/68 N 523, also give grounds to interpret list “A” as poisonous and narcotic drugs, and list “B” as potent.
A study of documents showed that until 1991, lists A and B, given in the Global Fund, were the only professional lists defining groups of potent, poisonous drugs, along with lists of narcotic drugs, published by the PCKN in relation to drugs. They were a mandatory legal document that determined the activities of doctors, pharmacists and other medical specialists in prescribing, organizing the receipt, storage, accounting and dispensing of these medicines, they were mandatory in nature, they were a legal document that determined the activities of pharmacies regarding these medicines.
However, the Plenum of the Supreme Court of the Russian Federation, by its resolution dated April 27, 1993 N 2, indicated that in order to determine which drugs are classified as narcotic, potent, poisonous, it is necessary to use the lists published by the Standing Committee for Drug Control (PKKN). It goes without saying that such a solution to the issue fundamentally changed the legal status of lists A and B given in the Global Fund X (1968). The Lists published by the PCKN covered many medicines that were previously listed in parallel in both Lists A and B.
In connection with the above, there was a need, from a fundamental standpoint, to review the lists of medicines A and B, to develop criteria for their formation, since the nomenclature of medicines had changed significantly and, moreover, there were actually no clear criteria for classifying medicines as lists A and B. Before the Ministry of Health the task arose, based on all legal norms in the field of narcotic, toxic, potent substances and legal acts regulating the import and export of these drugs and the procedure for writing prescriptions for narcotic, potent, toxic substances, for the first time to develop clear criteria for the formation and assignment of medicines to lists A and B, as well as to find the proper place for lists A and B in the entire system of legal regulation and determine the legal boundaries and boundaries of competence. The rule-makers successfully dealt with this, and on December 31, 1999, Order No. 472 “On the list of lists A and B” was issued. In the preamble to the list it is noted that “medicines of list “A” and “B” do not have an alternative name of “potent drugs and toxic substances”, are not included in the list of ADD and toxic substances of the PCKN, are not in the List of narcotic drugs and psychotropic substances and their precursors. In the list, list “A” includes more than a hundred drugs according to INN, list “B” has gone far beyond 1000 INN. The list that existed since 1999 ceased to exist on May 24, 2010.
So, taking into account the above, we summarize that all drugs can be divided into the following control groups:
- narcotic drugs and psychotropic substances, the list was approved by the RF Government of June 30, 1998 N 681;
- potent drugs and toxic substances, the list is approved by the RF Government No. 964;
- medicines of lists A and B, the list was approved by order of the Ministry of Health of the Russian Federation dated December 31, 1999 N 472, canceled by order of the Ministry of Health of Russia dated May 24, 10 N 380;
- over-the-counter medicines, the list is approved by order of the Ministry of Health of the Russian Federation No. 578.
Now about the industry standard “Rules for the dispensing (sale) of medicines in pharmacies. Basic provisions” and the State Pharmacopoeia. So, in the Industry Standard in clause 5.6, which defines the storage conditions for drugs of lists A and B, we read: “the list of drugs (medicines) classified as lists “A” and “B” is determined in accordance with current regulatory documents" . The key word is "acting".
The latest List of medicinal substances included in lists A and B is given in the Global Fund X (1968). Order of the Ministry of Health of the Russian Federation dated November 1, 2001 N 388 established that a pharmacopoeia is published once every 5 years and the validity of a pharmacopoeial article cannot exceed 5 years. In this case, can GF X be considered a valid regulatory document? In addition, the current Federal Law N 86-FZ defines that the State Fund is “a collection of state standards for a medicinal product, containing a list of indicators and methods for monitoring the quality of a medicinal product.” The basic law does not say anything regarding the fact that this collection, which is of a legislative nature, establishes that medicinal substances belong to lists A and B! Moreover, in the Global Fund XII (2007) we did not find the concept of lists A and B at all, however, as in the Global Fund XI (1987).
It can be assumed that the “inspectors” establish whether a drug belongs to List B on the basis of the instructions for use, but formally they are not regulations mandatory for implementation by organizations of wholesale and retail trade in medicines. By the way, it is easier in this sense for wholesalers, for whom in their industry standard “requirements for the storage of medications of lists A and B are determined in accordance with the established procedure.” Since no one has ever established such an order, there are no requirements.
One good thing is that the Decree of the All-Russian Central Executive Committee of 1919 “On the Cheka” was canceled in time, which granted the right to “direct reprisal (up to execution..., including for illegal actions with poisonous (list A) and potent (list B) substances ..." Otherwise...
It is a pity that advanced training, at least once every 5 years, is not provided for “inspectors” serving in regional health authorities. Otherwise, maybe they would be smart enough to understand the regulatory framework and finally put things in order.
Executive Director
Non-profit partnership
promoting the development of the pharmacy industry
"Pharmacy Guild", Ph.D.
E.V.NEVOLINA
Signed for seal
25.10.2010

Nevolina Elena Viktorovna
Executive Director of the NP "Pharmacy Guild", Ph.D.

SALES OF NS and PV FOR PHARMACIES IS NOT PROFITABLE

A license for the right to sell potent drugs costs from 200 to 650 thousand rubles. depending on the region. The safe will need to be replaced, the doors strengthened, and the alarm system updated. The problem of storing DM medications has not yet been resolved. By imposing increased safety requirements for the storage of potent drugs, pharmaceutical companies create additional difficulties that are incomparable with the actual conditions of their storage.

The owner of a pharmacy company needs to say “thank you” for the fact that he takes on the burdensome function of providing a certain category of patients with the necessary medications, but instead they are trying to crush him with the requirements of regulations to ensure the maintenance of logs, additional training of personnel and control over the discharge of diabetes by medical workers. drugs.

Example. Clause 3.4. Order of the Ministry of Health of Russia dated December 20, 2012 No. 1175 “On approval of the procedure for prescribing and prescribing medicines, as well as forms of prescription forms for medicines, the procedure for completing these forms, their recording and storage” (PR-1175) allows you to increase the dosage permissible for prescribing by twice. At the same time, no one canceled the order of the Russian Ministry of Health dated December 14, 2005. No. 785, paragraph 2.5 “On the procedure for dispensing drugs that are subject to subject-quantitative accounting...” says that “it is impossible to exceed the amount of dosage allowed for prescribing” (PR-785). According to PR-1175, patients with severe pain syndrome of any origin can be prescribed drugs of both Schedule II and Schedule III. The question arises, how is the supply of drugs from List II currently carried out? If the drug was prescribed urgently due to indications, how to attach it, what does the signature of the doctor who has the right to prescribe the drug look like, what does his personal seal look like? Despite the appearance of PR-1175, pharmacies continue to dispense drugs from Lists II and III by appointment.

MAJOR DISORDERS - DUE TO STORAGE CONDITIONS

The main violations that are revealed during inspections of pharmacy enterprises, both scheduled and extraordinary, are storage conditions. There are still incompetent employees of the inspection bodies who pay special attention to drugs from Lists A and B, without taking into account the fact that by the corresponding order of the Ministry of Health of Russia No. 380 dated May 24, 2010, these lists... were cancelled!

Example. Violations of storage of List B drugs and the pharmacy organization is required to provide a sufficient number of wooden cabinets with locks. How long will the pharmacy be responsible for the negligence of drug manufacturers who were obliged, in accordance with regulations, to make changes to the instructions for its use? At IP No. 851 there is a pharmacy at the address: st. Kastanaevskaya, 17, according to the inspection report dated 10/05/13, penalties in the amount of 40 thousand rubles were imposed. for improper storage of drugs from List B. I have one wish for pharmacies for the future: in order not to pay for someone else’s mistake, keep the following in mind. When a pharmacy accepts a drug for sale and sees a discrepancy with regulations in the text of the instructions for use, it thereby shares responsibility with the dishonest manufacturer of this drug.

Unfortunately, the Ministry of Health does not have any measures of influence on negligent manufacturers, most of whom do what is easier for them. In turn, the pharmacy will show excessive adherence to principles and refuse to accept drugs from “Lists A and B” for sale, and the consumer may lose the necessary drug.

In accordance with clause 5.6 of the Industry Standard “Rules for the dispensing (sale) of medicines in pharmacies. Basic provisions" OST 91500.05.0007-2003, approved by order of the Ministry of Health of Russia dated March 4, 2003 No. 80 (as amended on April 18, 2007), there are special requirements for the storage of drugs Lists A and B in pharmacies. In this case, it is necessary to demand the repeal of the clauses of the above normative act.

Based on materials from the section within the framework of the XV All-Russian Conference “PharmMedAppeal 2013”

Storage of over-the-counter medicines is possible on open shelves

Medicines on list “a”

The list of medicines in lists “A” and “B” was approved by Order of the Ministry of Health of the Russian Federation No. 472 of December 31, 1999. In May 2010, this order was canceled, but the storage of medicines in lists “A” and “B” is not.

The latest list of medicinal substances included in lists “A” and “B” and the definitions of these concepts are given in the Global Fund, X ed. (1968) Order of the Ministry of Health of the Russian Federation No. 388 dated November 1, 2001 established that a pharmacopoeia is published once every 5 years and the validity of a pharmacopoeial article cannot exceed 5 years. Whether in this case the Global Fund (1968) can be considered a valid regulatory document is a question.

In GF XII ed. (2007) there are no concepts of lists “A” and “B”.

Therefore, it can be assumed that the belonging of medicines to these lists for pharmacies and wholesale organizations can only be determined by the instructions for use, since in accordance with Federal Law No. 61 of April 12, 2010 “On the Circulation of Medicines”, manufacturers

when labeling medicinal products, they are required to indicate the storage conditions and conditions for dispensing the medicinal product (“dispensed without a doctor’s prescription”, List “B”, List “A”)

 Medicines of list “A” are stored in isolation, in locked metal cabinets under lock and key

 There should be an inscription “A” on the inside of the cabinet doors.

(“Venena”) and a list of drugs on the list indicating the highest

single and daily doses

 The inscriptions on the shelves in which list “A” drugs are stored must be white on a black background and their highest single and daily doses must be indicated

 During working hours, the keys to the metal cabinet with medicines ( drugs) List "A" located in the assistant's room must be kept by an authorized employee of the pharmacy organization. After the end of the working day, the cabinets are sealed or sealed, and the keys to them, the seal and the seal must be kept by the head of the pharmacy organization or by persons authorized by order of the pharmacy organization

 In pharmacies on duty, drugs of list “A” are left overnight, which are kept by the pharmacist on duty in a separate locked cabinet, in quantities and assortment necessary to provide emergency medical care. After the end of duty, this cabinet is sealed or sealed.

 Reagents containing drugs of list “A” and located on the table of the pharmacist-analyst or pharmacist-technologist during work must be stored in a locked cabinet after completion of work.

Medicines from list “b”

List B drugs are stored isolated in wooden cabinets under lock and key.

On the inside of the cabinet doors in which they are stored medications(medicines) of list "B" there must be the inscription "B" ("Heroica") and a list of drugs indicating the highest single and daily doses

The inscriptions on the shelves in which drugs of list “B” are stored must be red on a white background and their highest single and daily doses must be indicated.

Wooden cabinets for storing medicines ( drugs) list "B" after the end of the working day must be locked

In the on-duty pharmacies, drugs of list “B” are left overnight, which are kept by the pharmacy employee on duty in a separate locked cabinet, in quantities and assortment necessary to provide emergency medical care. After the end of duty, this cabinet is sealed or sealed;

Among pharmaceutical drugs, there is a group of drugs, small doses of which already have a significant effect on the body. A slight overdose of such drugs leads to irreversible processes in the body and death. These drugs are included in the List of Poisonous and Potent Medicines and are subject to special accounting and storage rules. The instructions for use of medications always indicate that the drug belongs to a specific group. Poisonous and potent drugs belong to Lists A and B, which are approved by the Ministry of Health of the Russian Federation. They require careful handling and careful adherence to doctor's instructions in order to avoid accidents due to negligence or intentional harm to health.

Basic provisions of the List of toxic and potent substances

The list of poisonous and potent substances is approved by the Standing Committee on Narcotics Control (PCDN) and is periodically reviewed and updated.

It is compiled taking into account:

• physiological effects of natural or chemical substances on humans;
• recommendations of the World Health Organization;
• current international legislative acts and protocols preventing the illegal distribution of narcotic drugs;
• information from criminal practice about the effects of substances on the body.

The lists of potent and toxic substances differ from Lists A and B, approved by the Ministry of Health of the Russian Federation, since they include not only drugs used in medical institutions to treat various diseases, but also substances not included in the State Register of Medicines (prohibited for use in healthcare organs).

All substances listed in the IPC Lists are listed according to their international nonproprietary names, and all known synonyms are also indicated.

Lists of toxic substances and medications

The List of Toxic Substances (Sheet 2 of the PKKN List) includes 65 names of substances of plant, animal or synthesized origin, which, when exposed to a living organism, cause acute or chronic poisoning, often leading to death. These are mainly poisons of natural or chemical origin, for example:

• serpentine;
• bee;
• arsenic;
• potassium cyanide (calcium, cadmium, sodium, copper);
• mercury;
• hydrocyanic acid;
• aconite;
• sum of belladonna alkaloids and other substances.

List A of medicines (Venena) includes 116 medicines produced on the basis of toxic and narcotic substances included in the List of Narcotic and Psychotropic Substances or the List of Poisonous Substances of the PKKN. These include the following groups of funds:

• antitumor (Bleomycin, Vincristine, Imifos);
• cardiac glycosides (Digotoxin, Cordigit, Methyldigoxin);
• anesthetics (Ketamine, Butorphanol, Tetracoin);
• psychostimulants (Methylphenidate)
• immunosuppressive (Azathioprine);
• muscle relaxants (Alcuronium chloride, Mivacurium chloride, Pipecuromium bromide);
• m-anticholinergic agents (Atropine, Metocinium iodide, Platiphylline) and others.

Such medications are dispensed from pharmacies strictly according to a prescription with a stamp from the medical institution that prescribed it. It is impossible to find drugs in the public domain.

The label of all toxic pharmaceutical drugs must indicate:

• mode of application;
• composition of the drug;
• date of manufacture;
• best before date;
• place of manufacture;
• signatures of persons who took part in the process of its preparation.

Medicines containing poisons, psychotropic substances or narcotics must be stamped on the label with the warning “Poison”.

Lists of potent substances and medicines

Substances of natural or synthetic origin, small doses of which have a noticeable effect on the body, are called potent substances. They are included in Sheet 1 of the List of Poisonous and Potent Medicines and number 126 items.

Based on this list, List B (Heroica) was compiled of 326 finished medicinal products in various forms (tinctures, tablets, dietary supplements, ampoules, suppositories, etc.) These include, for example:

• NSAIDs (Diclofenac, Ibuprofen, Indomethacin);
• antibiotics (Azithromycin, Gentamicin, Oxacillin);
• sleeping pills (Zolpidem tartrate, Zopiclone);
• glucocorticosteroids (Hydrocortisone, Dexamethasone, Prednisolone);
• antidepressants (Clomipramine, Maprotiline, Metralindole);
• hormone-containing drugs (Clomiphene, Mestranol, Testosterone);
• vitamins (Hydroxocobalamin, Calcium pantothenate, Nicotinic acid) and other groups of drugs.

All potent ready-made medicines, like poisonous ones, must be sold with a doctor’s prescription, but in practice, most often pharmacists do not require a prescription when selling most of them; they can be freely purchased at any pharmacy chain. This is their danger to the population during self-medication.

How to store poisonous and potent drugs

To prevent poisoning or abuse for personal or criminal purposes, the Ministry of Health has established Rules for the storage of poisons, drugs and potent drugs from Lists A and B. For these groups of drugs, special storage conditions must be observed to ensure their quality and safety when used as prescribed by a doctor.

When storing poisonous and potent drugs in a pharmacy, the organization must have the necessary premises, equipment and inventory that meet all legal requirements.

1. The pharmacy storage of medicines is equipped with a multi-level alarm system connected to the 24-hour monitoring console of a licensed security organization. A fire alarm is required.
2. The storage facility must be equipped with an iron entrance door or a wooden one, but upholstered with metal (the thickness of which is at least 40 mm) with a doorway made of a steel profile.
3. All pharmacy windows are equipped with finely patterned steel bars.

The storage of potent and toxic drugs is carried out on the basis of the order of the Ministry of Health of the Russian Federation in 1997. The pharmacy has special cabinets and safes for this purpose. Particularly toxic substances are stored separately from other poisons and drugs in the inner, locked compartment of the safe.

Narcotic and poisonous drugs are stored in a safe marked: “A.Venena” indicating the names of all drugs stored in it and their quantity. Also in this cabinet they store the necessary equipment and tools used for preparing prescription medications. The safe must be closed during the day (it is opened only if necessary by a pharmacy employee authorized by order or by the manager who holds the key). At night the safe is sealed and sealed.

Entrance to the room in which this safe is located is restricted. Access to it is granted with the permission of the Internal Affairs Directorate only for people whose work is directly related to the preparation of medicines from toxic, psychotropic and narcotic substances.

The doors of the safe in which potent drugs are stored are marked: “B. Heroica." The quantity and name of the drugs contained in it must be indicated. There are no such strict requirements as for storing toxic substances - authorized pharmacists have access to the cabinet, and the safe is locked with a key only at night.

Precautions when handling toxic and potent substances

Handling toxic substances requires increased caution. It is important to adhere to and comply with the following rules.

1. Only specially trained personnel over 18 years of age who are well aware of the effects of toxic substances on the body and the risks associated with such work can work with potent, narcotic and toxic drugs.
2. Pregnant and lactating women are prohibited from working with poisons and narcotic substances.
3. Poisonous drugs are issued to the public or medical institutions only on a specially established form - a prescription. It is written out in legible handwriting without errors or corrections by a qualified specialist indicating his surname and initial. Inaccuracies or errors made in the recipe may cause an accident.
4. Devices used to prepare prescription medications must be constantly checked and adjusted, instruments and devices must be thoroughly washed and disinfected.
5. Poisonous and narcotic substances are prescribed only in extreme cases, and the dose, which is accurately calculated by the doctor taking into account the age and weight of the patient, is strictly prohibited from being exceeded during treatment.
6. In case of accidental or intentional use of a high dose of drugs from List A, the victim should be taken to a medical facility for emergency assistance as soon as possible (minutes are counting). Without resuscitation measures (connection to a ventilator, hemodialysis, intravenous administration of solutions and diuretics), the life of a person poisoned by poisons cannot be saved.

Potent drugs that exceed the recommended single or daily dose cause symptoms of severe poisoning. With long-term use of such drugs, changes in the functioning of internal organs and body systems, addiction and withdrawal syndrome, sometimes leading to death, can be observed.

Poisonous and potent drugs in small doses have a therapeutic effect, but even their slight excess and abuse cause extremely negative health consequences, leading to disability and death. When handling any medications (a large number of potent drugs are used by a person in everyday life to relieve the symptoms of various diseases and are prescribed independently), one must be careful and exercise caution.

Abuse of poisonous, narcotic or psychotropic drugs always ends tragically.