Storing medications from exposure to light. Guidelines for completing tests in the specialty “pharmaceutical technology”

"Economic Bulletin of Pharmacy. Appendix: Legislation, accounting, taxes, management", 2005, N 3

Question: Please clarify the requirements for the storage of photosensitive drugs when placing them on pharmacy windows and pharmacy points. Center for Certification and Quality Control medicines The Ryazan region believes that drugs whose packaging states “store in a place protected from light” cannot be placed on display cases even if they are placed in secondary packaging. According to the Certification Center, only empty secondary packaging can be displayed on display, and drugs must be removed from the secondary packaging and stored in a closed cabinet. However, in the official response to Novartis Consumer Health Switzerland from the Institute for Drug Standardization in Moscow dated December 15, 2003 (ref. N 1650), the following is said: “packaging of the drug in such primary packaging as dark glass bottles, aluminum tubes, disposable bags made of a combined material polyethylene/aluminum foil/polyethylene/paper, an opaque plastic bottle made of low-density polyethylene, an opaque plastic tube with their subsequent insertion into secondary consumer packaging (a box or a cardboard pack) allows you to ensure that the drug is stored in a place protected from light "under natural and artificial lighting in a pharmacy."

Answer: In accordance with clause 5.4. "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 the Russian Federation dated 03/04/2003 N 80 (as amended on 08/23/2004), medications should be stored separately, taking into account their physical and physical and chemical properties, impact on them various factors external environment in accordance with established requirements.

The procedure for storing medicines in pharmacies is determined by the "Instructions for organizing storage in pharmacies" various groups medicines and products medical purposes", approved by Order of the Ministry of Health of the Russian Federation dated November 13, 1996 N 377.

The requirements for the storage of various groups of medicines and medical products are set out in section 4 of this Instruction.

In accordance with clause 4.1.2. of this section, medicinal products that require protection from light should be stored in containers made of light-protective materials (orange glass containers, metal containers, packaging made of aluminum foil or polymer materials painted black, brown or orange colors), in a dark room or cabinets painted inside with black paint with tightly fitting doors or in tightly packed drawers with a tightly fitting lid.

At the same time, from the structural features of this section of the Instructions, we can conclude that the requirements for the storage of medicines in paragraphs 4.1.-4.8. The instructions do not apply to finished dosage forms, since such requirements are highlighted in a separate paragraph of Instructions 4.9. "Peculiarities of storage of finished medicinal products."

According to the requirements of this paragraph, the storage of finished medicinal products must meet the requirements of the State Pharmacopoeia and all general requirements Instructions for storing medicines taking into account the properties of the ingredients included in their composition (clause 4.9.1.), while the storage of tablets and dragees should be carried out in a dry place and, if necessary, protected from light (clause 4.9 .3.).

Thus, formally, this kind of medicine should be stored in a “place protected from light.” It should be noted that there is no clear definition of the concept of “light-protected place”. In our opinion, the expert opinion of the Institute for Standardization to which you refer actually determines this concept for GDF as “storage under natural and artificial conditions in a pharmacy.” Taking into account this conclusion, it can be assumed that the storage conditions “in a place protected from light” for FDF packaged in primary and secondary packaging, when displayed on display cases located inside the pharmacy and not exposed to direct contact sun rays(in this case it is difficult to talk about natural lighting in the pharmacy) are observed.

Nevertheless, regional center certification and quality control of medicinal products is entitled in case of detection of a change pharmacological properties drugs under the influence of light, file a claim against the pharmacy in connection with the storage of drugs in improper conditions.

Director of a law firm

"Yunico-94"

M.I.MILUSHIN

Signed for seal

20.01.2005

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Dear readers, you can always contact us with questions about the intricacies of pharmaceutical legislation, and our authors will give competent answers to them in the “Legal Blog”. Write to us at [email protected]

Detecting violations of storage conditions for medicinal products is one of the special interests of inspectors. At the same time, this topic is the Achilles heel of pharmacy organizations. Because the legislation governing it is ambiguous, sometimes contradictory and somewhat incomplete.

Take, for example, the problem of storing medications in a place protected from light, as most instructions for their use prescribe. Pharmacists and pharmacists periodically have questions regarding certain aspects of this problem.

For example, they are interested in whether such drugs can be placed on a pharmacy display or stored in a refrigerator with a glass door. We will try to answer these and other questions.

Our expert

Elena Nevolina

Executive Director of the non-profit partnership "Pharmacy Guild"

Three storage points

First, let's outline the general part. Here, first of all, you should be guided Order of the Ministry of Health and Social Development of the Russian Federation dated August 23, 2010 No. 706n “On approval of the rules for storing medicines.” Section VI of the order contains a subsection entitled “Storage of medicinal products requiring protection from light” and includes paragraphs 24–26. Here are its provisions:

- medicines that require protection from light must be stored in rooms or specially equipped places that provide protection from natural and artificial light (paragraph 24);

- pharmaceutical substances that require protection from light must be stored in containers made of light-protective materials, in a dark room or cabinet(paragraph 25). This point is relevant primarily for pharmacies with a prescription and production department. By “light-protective materials” we mean glass containers of orange glass, metal containers, packaging made of aluminum foil or polymer materials painted black, brown or orange;

- medicines for medical use, requiring protection from light, packaged in primary and secondary packaging, should be stored in cabinets or on racks, provided that measures are taken to prevent exposure to direct sunlight or other brightly directed light(paragraph 26). This paragraph also contains instructions on how this can be prevented - through the use of reflective films, blinds, visors and other appropriate devices.

Indoor illumination

Next we turn to general pharmacopoeial monograph with the same name “Storage of medicines” (OFS 1.1.0010.15), first introduced in XIII edition of the State Pharmacopoeia of the Russian Federation. Let us highlight from it what is directly related to the topic under consideration.

Firstly, natural and artificial lighting in storage areas must ensure that all work operations can be carried out accurately and safely. In other words, each workplace must have appropriate lighting so that an employee of a pharmacy organization has enough of it to carry out his professional functions and responsibilities.

You can find out what it should be like in Order of the Ministry of Health of the Russian Federation dated October 21, 1997 No. 309 “On approval of instructions on the sanitary regime of pharmacy organizations (pharmacies)”. Appendix 3 of this order, in particular, provides illumination standards (in lux) for various pharmacy premises - from the hall for serving visitors to premises for storing medicines, containers, various pharmacy departments, assistant, packaging, etc. The appendix also indicates how there must be a light source in each of these cases (fluorescent lamp or incandescent lamp), type of lamps, acceptable indicator discomfort, etc.

The head of a pharmacy organization must ensure compliance with these requirements of Order No. 309 in order to successfully pass the certification of the facility’s workplaces for working conditions (in terms of lighting), the results of which he must send to the State Labor Inspectorate for the subject of the Federation. Let us add to the above that paragraph 3.6 of the Instructions for the sanitary regime of pharmacies determines that pharmacies must have both natural and artificial lighting, and general artificial lighting must be provided in all pharmacy premises; In addition, local lighting is also installed for individual workplaces.

Photosensitive theme

Let's return to the Pharmacopoeia. According to the above-mentioned General Pharmacopoeia Monograph 1.1.0010.15, if necessary, protection of medicinal products from solar radiation must be ensured. For this purpose, in particular, the storage rooms must be equipped with a sufficient number of cabinets, racks, and safes.

In the section of the General Pharmacopoeia Monograph on the peculiarities of storing certain groups of medicines, several paragraphs are devoted to the topic we are considering. The first instruction is general character– pharmacists are obliged to ensure the storage regime specified in the pharmacopoeial monograph or instructions for use. A disclaimer immediately follows: Deviations from regulated conditions are allowed once only for short term(no more than 24 hours), if at the same time special conditions not specified separately.

Continuing to shed light on this topic, OFS 1.1.0010.15 reminds that some drugs under the influence of light energy can change their properties: oxidize or, conversely, be reduced, decompose, change color, etc. Such drugs are called photo- or photosensitive . Their labeling, as noted in the pharmacopoeial monograph, usually contains the instruction “Store in a place protected from light.”

Further provisions of the pharmacopoeia textually almost coincide with the norms of paragraphs 24–25 of Order No. 706n “On approval of rules for storing medicines,” being, apparently, borrowed from it. The General Pharmacopoeia clarifies that if glass containers are used as packaging for pharmaceutical substances that are particularly sensitive to light (here the text of the Pharmacopoeia does not indicate the color of the glass), then it is necessary to cover it with black opaque paper.

OFS 1.1.0010.15 also establishes that photosensitive medicinal products must be packaged in light-protective secondary (consumer) packaging and/or should be stored in a place protected from light. Let's reverse Special attention to the presence of two conjunctions here – not only “and”, but also “or”. This nuance will come up below when we try to answer common questions on the topic.

Secondary packaging as protection from light

Some pharmacists and pharmacists say that during control activities, claims against their pharmacy organization arose from inspectors for the reason that the latter believed: medications, which, according to the instructions, should be stored in a place protected from light, cannot be placed on the pharmacy counter. display or store in a refrigerator with a glass door. The logic of the inspectors similar cases is as follows: on the display case these medicines are under direct influence of artificial lighting; it penetrates through any transparent glass.

Accordingly, such cases were often regarded as an administrative offense, that is, a gross violation of licensing requirements, and could result in the imposition of an appropriate administrative penalty. For officials– this is a fine from 5,000 to 10,000 rubles; For individual entrepreneurs(IP) – fine from 4000 to 8000 rubles. or administrative suspension of activities (ASA) for up to 90 days; For legal entities– fine from 100,000 to 200,000 rubles. or APD up to 90 days. From January 2017, these fines may increase significantly: for officials - from 25,000 to 35,000 rubles, for legal entities and individual entrepreneurs - from 200,000 to 300,000 rubles. or APD for up to 90 days.

In short, the punishment for errors in the storage of photosensitive drugs is significant, almost ruinous. But is there any error in the above cases? Let us quote once again an excerpt from the Pharmacopoeia: Vetosensitive medications must be packaged in light-protective secondary (consumer) packaging and/or must be stored in a place protected from light.

What does the presence of the conjunction “or” mean here? It means that Even if we consider a pharmacy display case or a pharmaceutical refrigerator with a glass door to be a place not protected from light, then placing a medicinal product in secondary packaging in these places is not a violation of storage rules.

“If the medicine is stored in the manufacturer’s secondary packaging,” comments Elena Nevolina, executive director of the Non-Profit Partnership “Pharmacy Guild” and the Union “National Chamber of Pharmacy,” this already indicates that the storage conditions (in terms of protection from light) have been met.” Based on this provision of the Pharmacopoeia, Elena Nevolina considers the claims of the inspectors described above to be insufficiently substantiated and recommends pharmacy organizations in such cases, defend your position.

Even to the point of submitting a written request to the manufacturer asking whether the cardboard of their secondary packaging provides light protection. The text of such a request, together with the cited provisions of the General Regulations, may be presented when considering a case of an administrative offense.

Models on display

Some pharmacy workers offer the following way out of the situation - to place empty boxes of medications on the display case. Such a decision seems doubtful. If these are dummies, then you won’t have enough of them for all the drugs with light-protective storage conditions. And it’s troublesome and expensive to do this - a huge waste of time that could be spent more usefully, in particular, on serving visitors. And if you put empty secondary packaging on display cases, then this is even more wrong. Indeed, in this case, the problem of storing the primary packaging of this drug arises. And they just need to be stored in a place protected from light, because primary packaging, as follows from the legislation, unlike secondary packaging, does not provide light protection.

Elena Nevolina gives a corresponding example. It is impossible to remove light glass ampoules, placed in transparent plastic, from secondary packaging (which is “for display”) and place them for storage in a refrigerator with a glass door. In this case, it will be necessary to take additional measures to protect these ampoules from light, emphasizes Elena Nevolina, summarizing: "Any such removal from the manufacturer's secondary packaging violates the guarantee of protection from light that it provides."

Manufacturer's warranty

Of course, inspectors - in an effort to prove their case - can refer to paragraph 26 of Order No. 706n, the provisions of which partially contradict the cited pharmacopoeial norm. This the main problem regulation of this topic.

To solve this, we can suggest next measure: express the pharmacopoeial norm in the form of a brief inscription “Consumer packaging guarantees protection from light” on each secondary (consumer) medicinal packaging. This inscription would be important not only for resolving contradictions between pharmacy workers and inspectors, but also for consumers.

Elena Nevolina reminds that in due time Non-profit partnership "Pharmacy Guild" made inquiries on this topic to many pharmaceutical manufacturers. In the responses to it, in particular, it was emphasized that the instruction “Store in a place protected from light” is written not only for pharmacists, but also for consumers - so that they do not throw away secondary packaging or transfer the dosage form to other storage containers.

And the final aspect of the topic. Some drugs with the instruction “Store away from light” are formally produced in primary packaging (for example, in blisters), without secondary packaging. According to the above standards, they cannot be placed on display, but should be stored in dark cabinets. Elena Nevolina in this regard, he notes that the manufacturer is primarily interested in ensuring that its packaging provides proper storage conditions. Otherwise, any violation - for example, during transportation - will inevitably lead to damage to the drug. “And here the reputational damage can be very high, much higher than the costs that go into providing secondary packaging,” concludes Elena Nevolina.

Dear readers, you can always contact us with questions about the intricacies of pharmaceutical legislation, and our authors will give competent answers to them in the “Legal Blog”. Write to us at [email protected]

Detecting violations of storage conditions for medicinal products is one of the special interests of inspectors. At the same time, this topic is the Achilles heel of pharmacy organizations. Because the legislation governing it is ambiguous, sometimes contradictory and somewhat incomplete.

Take, for example, the problem of storing medications in a place protected from light, as most instructions for their use prescribe. Pharmacists and pharmacists periodically have questions regarding certain aspects of this problem.

For example, they are interested in whether such drugs can be placed on a pharmacy display or stored in a refrigerator with a glass door. We will try to answer these and other questions.

Our expert

Elena Nevolina

Executive Director of the non-profit partnership "Pharmacy Guild"

Three storage points

First, let's outline the general part. Here, first of all, you should be guided Order of the Ministry of Health and Social Development of the Russian Federation dated August 23, 2010 No. 706n “On approval of the rules for storing medicines.” Section VI of the order contains a subsection entitled “Storage of medicinal products requiring protection from light” and includes paragraphs 24–26. Here are its provisions:

- medicines that require protection from light must be stored in rooms or specially equipped places that provide protection from natural and artificial light (paragraph 24);

- pharmaceutical substances that require protection from light must be stored in containers made of light-protective materials, in a dark room or cabinet(paragraph 25). This point is relevant primarily for pharmacies with a prescription and production department. By “light-protective materials” we mean glass containers of orange glass, metal containers, packaging made of aluminum foil or polymer materials painted black, brown or orange;

- medicinal products for medical use that require protection from light, packaged in primary and secondary packaging, should be stored in cabinets or on racks, provided that measures are taken to prevent exposure to direct sunlight or other brightly directed light(paragraph 26). This paragraph also contains instructions on how this can be prevented - through the use of reflective films, blinds, visors and other appropriate devices.

Indoor illumination

Next we turn to general pharmacopoeial monograph with the same title “Storage of medicinal products” (OFS 1.1.0010.15), first introduced in XIII edition of the State Pharmacopoeia of the Russian Federation. Let us highlight from it what is directly related to the topic under consideration.

Firstly, natural and artificial lighting in storage areas must ensure that all work operations can be carried out accurately and safely. In other words, each workplace must have appropriate lighting so that an employee of a pharmacy organization has enough of it to carry out his professional functions and responsibilities.

You can find out what it should be like in Order of the Ministry of Health of the Russian Federation dated October 21, 1997 No. 309 “On approval of instructions on the sanitary regime of pharmacy organizations (pharmacies)”. Appendix 3 of this order, in particular, provides illumination standards (in lux) for various pharmacy premises - from the hall for serving visitors to premises for storing medicines, containers, various pharmacy departments, assistant, packaging, etc. The appendix also indicates how there must be a light source in each of these cases (fluorescent lamp or incandescent lamp), type of lamps, acceptable level of discomfort, etc.

The head of a pharmacy organization must ensure compliance with these requirements of Order No. 309 in order to successfully pass the certification of the facility’s workplaces for working conditions (in terms of lighting), the results of which he must send to the State Labor Inspectorate for the subject of the Federation. Let us add to the above that paragraph 3.6 of the Instructions for the sanitary regime of pharmacies determines that pharmacies must have both natural and artificial lighting, and general artificial lighting must be provided in all pharmacy premises; In addition, local lighting is also installed for individual workplaces.

Photosensitive theme

Let's return to the Pharmacopoeia. According to the above-mentioned General Pharmacopoeia Monograph 1.1.0010.15, if necessary, protection of medicinal products from solar radiation must be ensured. For this purpose, in particular, the storage rooms must be equipped with a sufficient number of cabinets, racks, and safes.

In the section of the General Pharmacopoeia Monograph on the peculiarities of storing certain groups of medicines, several paragraphs are devoted to the topic we are considering. The first instruction is of a general nature - pharmacists are required to ensure the storage regime specified in the pharmacopoeial monograph or instructions for use. A disclaimer immediately follows: Deviations from regulated conditions are allowed once only for a short period (no more than 24 hours), unless special conditions are specified separately.

Continuing to shed light on this topic, OFS 1.1.0010.15 reminds that some drugs under the influence of light energy can change their properties: oxidize or, conversely, be reduced, decompose, change color, etc. Such drugs are called photo- or photosensitive . Their labeling, as noted in the pharmacopoeial monograph, usually contains the instruction “Store in a place protected from light.”

Further provisions of the pharmacopoeia textually almost coincide with the norms of paragraphs 24–25 of Order No. 706n “On approval of rules for storing medicines,” being, apparently, borrowed from it. The General Pharmacopoeia clarifies that if glass containers are used as packaging for pharmaceutical substances that are particularly sensitive to light (here the text of the Pharmacopoeia does not indicate the color of the glass), then it is necessary to cover it with black opaque paper.

OFS 1.1.0010.15 also establishes that photosensitive medicinal products must be packaged in light-protective secondary (consumer) packaging and/or should be stored in a place protected from light. Let us pay special attention to the presence of two conjunctions here – not only “and”, but also “or”. This nuance will come up below when we try to answer common questions on the topic.

Secondary packaging as protection from light

Some pharmacists and pharmacists say that during control activities, claims against their pharmacy organization arose from inspectors for the reason that the latter believed: medications, which, according to the instructions, should be stored in a place protected from light, cannot be placed on the pharmacy counter. display or store in a refrigerator with a glass door. The logic of inspectors in such cases is as follows: on the display case, these drugs are under the direct influence of artificial lighting; it penetrates through any transparent glass.

Accordingly, such cases were often regarded as an administrative offense, that is, a gross violation of licensing requirements, and could result in the imposition of an appropriate administrative penalty. For officials, this is a fine from 5,000 to 10,000 rubles; for individual entrepreneurs (IP) – a fine from 4,000 to 8,000 rubles. or administrative suspension of activities (ASA) for up to 90 days; for legal entities – a fine from 100,000 to 200,000 rubles. or APD up to 90 days. From January 2017, these fines may increase significantly: for officials - from 25,000 to 35,000 rubles, for legal entities and individual entrepreneurs - from 200,000 to 300,000 rubles. or APD for up to 90 days.

In short, the punishment for errors in the storage of photosensitive drugs is significant, almost ruinous. But is there any error in the above cases? Let us quote once again an excerpt from the Pharmacopoeia: Vetosensitive medications must be packaged in light-protective secondary (consumer) packaging and/or must be stored in a place protected from light.

What does the presence of the conjunction “or” mean here? It means that Even if we consider a pharmacy display case or a pharmaceutical refrigerator with a glass door to be a place not protected from light, then placing a medicinal product in secondary packaging in these places is not a violation of storage rules.

“If the medicine is stored in the manufacturer’s secondary packaging,” comments Elena Nevolina, executive director of the Non-Profit Partnership “Pharmacy Guild” and the Union “National Chamber of Pharmacy,” this already indicates that the storage conditions (in terms of protection from light) have been met.” Based on this provision of the Pharmacopoeia, Elena Nevolina considers the claims of the inspectors described above to be insufficiently substantiated and recommends that pharmacy organizations defend their position in such cases.

Even to the point of submitting a written request to the manufacturer asking whether the cardboard of their secondary packaging provides light protection. The text of such a request, together with the cited provisions of the General Regulations, may be presented when considering a case of an administrative offense.

Models on display

Some pharmacy workers offer the following way out of the situation - to place empty boxes of medications on the display case. Such a decision seems doubtful. If these are dummies, then you won’t have enough of them for all the drugs with light-protective storage conditions. And it’s troublesome and expensive to do this - a huge waste of time that could be spent more usefully, in particular, on serving visitors. And if you put empty secondary packaging on display cases, then this is even more wrong. Indeed, in this case, the problem of storing the primary packaging of this drug arises. And they just need to be stored in a place protected from light, because primary packaging, as follows from the legislation, unlike secondary packaging, does not provide light protection.

Elena Nevolina gives a corresponding example. It is impossible to remove light glass ampoules, placed in transparent plastic, from secondary packaging (which is “for display”) and place them for storage in a refrigerator with a glass door. In this case, it will be necessary to take additional measures to protect these ampoules from light, emphasizes Elena Nevolina, summarizing: "Any such removal from the manufacturer's secondary packaging violates the guarantee of protection from light that it provides."

Manufacturer's warranty

Of course, inspectors - in an effort to prove their case - can refer to paragraph 26 of Order No. 706n, the provisions of which partially contradict the cited pharmacopoeial norm. This is the main problem of regulating this topic.

To solve it, the following measure can be proposed: express the pharmacopoeial norm in the form of a short inscription “Consumer packaging guarantees protection from light” on each secondary (consumer) medicinal packaging. This inscription would be important not only for resolving contradictions between pharmacy workers and inspectors, but also for consumers.

Elena Nevolina reminds that in due time Non-profit partnership "Pharmacy Guild" made inquiries on this topic to many pharmaceutical manufacturers. In the responses to it, in particular, it was emphasized that the instruction “Store in a place protected from light” is written not only for pharmacists, but also for consumers - so that they do not throw away secondary packaging or transfer the dosage form to other storage containers.

And the final aspect of the topic. Some drugs with the instruction “Store away from light” are formally produced in primary packaging (for example, in blisters), without secondary packaging. According to the above standards, they cannot be placed on display, but should be stored in dark cabinets. Elena Nevolina in this regard, he notes that the manufacturer is primarily interested in ensuring that its packaging provides proper storage conditions. Otherwise, any violation - for example, during transportation - will inevitably lead to damage to the drug. “And here the reputational damage can be very high, much higher than the costs that go into providing secondary packaging,” concludes Elena Nevolina.

QUESTION: Please clarify the requirements for the storage of photosensitive drugs when placing them on the windows of pharmacies and pharmacy points. The Center for Certification and Quality Control of Medicines of the Ryazan Region believes that drugs whose packages indicate “store in a place protected from light” cannot be placed on display cases even if they are placed in secondary packaging.

Question: Please clarify the requirements for the storage of photosensitive drugs when placing them on the windows of pharmacies and pharmacy points. The Center for Certification and Quality Control of Medicines of the Ryazan Region believes that drugs whose packages indicate “store in a place protected from light” cannot be placed on display cases even if they are placed in secondary packaging. According to the Certification Center, only empty secondary packaging can be displayed on display, and drugs must be removed from the secondary packaging and stored in a closed cabinet. However, in the official response to Novartis Consumer Health Switzerland from the Institute for Drug Standardization in Moscow dated December 15, 2003 (ref. N 1650), the following is said: “packaging of the drug in such primary packaging as dark glass bottles, aluminum tubes, disposable bags made of a combined material polyethylene/aluminum foil/polyethylene/paper, an opaque plastic bottle made of low-density polyethylene, an opaque plastic tube with their subsequent insertion into secondary consumer packaging (a box or a cardboard pack) allows you to ensure that the drug is stored in a place protected from light "under natural and artificial lighting in a pharmacy."
Answer: In accordance with clause 5.4. "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 the Russian Federation dated 03/04/2003 N 80 (as amended on 08/23/2004), medicinal products should be stored separately, taking into account their physical and physicochemical properties, the impact of various environmental factors on them in accordance with established requirements.
The procedure for storing medicines in pharmacies is determined by the “Instructions for organizing the storage of various groups of medicines and medical products in pharmacies”, approved by Order of the Ministry of Health of the Russian Federation dated November 13, 1996 N 377.
The requirements for the storage of various groups of medicines and medical products are set out in section 4 of this Instruction.
In accordance with clause 4.1.2. of this section, medicines that require protection from light should be stored in containers made of light-protective materials (orange glass containers, metal containers, packaging made of aluminum foil or polymer materials painted black, brown or orange), in a dark room or cabinets , painted inside with black paint with tightly fitting doors or in tightly packed boxes with a tightly fitting lid.
At the same time, from the structural features of this section of the Instructions, we can conclude that the requirements for the storage of medicines in paragraphs 4.1.-4.8. The instructions do not apply to finished dosage forms, since such requirements are highlighted in a separate paragraph of Instructions 4.9. "Peculiarities of storage of finished medicinal products."
According to the requirements of this paragraph, the storage of finished medicinal products must meet the requirements of the State Pharmacopoeia and all general requirements of the Instructions for the storage of medicinal products, taking into account the properties of the ingredients included in their composition (clause 4.9.1.), while the storage of tablets and dragees must be carried out in a dry place and, if necessary, protected from light (clause 4.9.3.).
Thus, formally, this kind of medicine should be stored in a “place protected from light.” It should be noted that there is no clear definition of the concept of “light-protected place”. In our opinion, the expert opinion of the Institute of Standardization, to which you refer, actually defines this concept for GDF as “storage under natural and artificial conditions in a pharmacy.” Taking into account this conclusion, we can assume that the storage conditions are “in a place protected from light” for FDF packaged in primary and secondary packaging, when they are displayed on display cases located inside the pharmacy and not exposed to direct sunlight (in this case it is difficult to say on natural lighting in a pharmacy) are observed.
However, the regional Center for Certification and Quality Control of Medicines has the right, if it detects a change in the pharmacological properties of drugs under the influence of light, to file claims against the pharmacy in connection with the storage of medicines in improper conditions.
Director of a law firm
"Yunico-94"
M.I.MILUSHIN
20.01.2005

To prevent spoilage of medicines in pharmacies, it is necessary to strictly observe the conditions of their storage, taking into account the influence of various external factors. According to storage conditions, all medications are divided into the following groups.

Medicines that react negatively to light (photosensitive drugs). This group includes a very large number of drugs, some of which cannot withstand direct sunlight, while others change even in diffused light. Such preparations should be stored in orange or dark glass bottles in cabinets protected from light. IN in some cases To store drugs that are particularly sensitive to light, stand stands completely covered with black opaque paper are used. On direct sunlight Only preparations containing ferric oxide should be stored.

Moisture-sensitive drugs. A fairly significant group of drugs lose activity or deteriorate when exposed to moist air. These drugs should be stored in well-sealed containers in a dry place.

Medicines that require protection from exposure to low temperatures. These drugs include those whose physicochemical state changes after freezing and is not restored upon subsequent warming to room temperature (solution of formaldehyde, insulin, glacial acetic acid).

Medicines that change when exposed to oxygen and other gases. Some medications may react chemically with oxygen, carbon dioxide and other gaseous substances in the air, and as a result of this interaction, lose activity or deteriorate. For example, under the influence of moisture and carbon dioxide in the air, magnesium oxide can turn into magnesium carbonate. At open contact Urethane and some other medications deteriorate with air.

Drugs exposed to gases are stored in well-sealed bottles and in cabinets protected from light.

Medicines stored in low temperature. Many drugs require lower temperatures for better preservation. For example, sera and vaccines should be stored in dark place at temperatures from 2°C to 10°C. Organic preparations and hormonal drugs usually stored at a temperature of 10-15°C. Antibiotics, medicinal fats and oils, fat-based ointments, dosage forms with insulin, etc. However, the temperature should not be below 0°C, as this entails freezing and spoilage or inactivation of the drugs.

Medicines requiring protection from volatilization. These agents include: volatile substances themselves (camphor, chloral hydrate, etc.); medications containing a volatile solvent (alcohol concentrates, etc.); solutions in a mixture of volatile substances; plant materials containing essential oils; medicinal preparations - crystalline hydrates; medicinal substances, decomposing to form volatile products.

The listed substances should be stored in hermetically sealed containers in a cool place.

Flammable and explosive drugs. Flammable substances in the pharmacy include alcohol, ether, turpentine, collodion, etc. They are stored in well-closed vessels, cans, flasks in a cool place, protected from light. Often, specially equipped rooms or niches in basements are used for this, and in rural pharmacies - independent cellars. Where such substances are stored, fire protection measures must be provided and good ventilation must be provided.

Explosive substances include nitroglycerin solution, potassium permanganate powder and some other strong oxidizing agents.

In order to correctly comply with all storage requirements for the listed groups of medications, pharmacists must be well aware Chemical properties drugs and their ability to react with other substances, water vapor and gases in the air.