Food and Drugs Administration, (FDA) Haryana, India. |
Email ID: dahiya19@yahoo.com
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Last Updated on April 18, 2024 by The Health Master
Storage conditions of drugs
Storage conditions and limit
| Storage Condition | Limit |
| Room Temperature | 20° to 25° |
| Cool Storage Condition | 8° to 15° |
| Cold Storage condition | 2° to 8° |
| Fridge Storage condition | -4° to 2° |
List of Refrigerated Drugs and Medicines
Drugs/medicines that are required to be kept in the refrigerator are called refrigerated drugs/medicines.
The temperature of the refrigerator should be in the range of 2C to 8C.
This temperature is required for maintaining stability and potency throughout the drug’s life.
These drugs/medicines are very sensitive in nature and require some extra care while manufacturing, transportation, stocking, prescribing, etc.
There are some other drugs that are required to be stored at temperatures of -15C to -20C.
These drugs/medicines are covered under Schedule C of the Drug and Cosmetic Act & Rules, 1940.
The storage conditions are to be mentioned on the labels of the drugs/medicines.
The list of refrigerated drugs is as follows:
- Sera
- Serum proteins
- Vaccines.
- Toxins
- Antigen
- Antitoxins
- Neo-arsphenamine and analogous substances are used for the specific treatment of infectious diseases.
- Insulin
- Pituitary (Posterior Lobe) Extract
- Adrenaline and Solutions of Salts of Adrenaline
- Specific Antibiotics and preparations (Parenterals and Non-Parenterals)
- Bacteriophages
- Ophthalmic preparations
- Sterile Disposable Devices for single use only
- Some plant extracts like digitalis, ergotamine etc
Definitions of Storage Conditions As Per IP 96
1. COLD: Any temperature not exceeding 8°C and usually between 2°C to 8°C. A refrigerator is a cold place in which the temperature is maintained thermostatically between 2°C to 8°C.
2. COOL: Any temperature between 8°C and 25°C. An article, for which storage in a cool place is directed may alternately, be stored in a refrigerator unless otherwise specified in the individual monograph.
3. ROOM TEMPERATURE: The temperature prevailing in a working area.
4. WARM: Any temperature between 30°C and 40°C.
5. EXCESSIVE HEAT: Any temperature above 40°C.
6. LIGHT RESISTANT CONTAINERS: A light-resistant container protects the content from the effect of actinic light by virtue of the specific properties of the material of which it is made.
7. WELL-CLOSED CONTAINER: A well-closed container protects the contents from contamination by extraneous liquid and from loss under normal conditions of handling, shipment, storage, and distribution.
Storage conditions of different drugs as per IP
| 1. In a Frozen State: | Ceftazidime Inj |
| 2° to 8° C: | Antisera |
| Biphasic Isophane Insulin Inj | |
| BCG Vaccine | |
| Carbenicillin Sodium Inj. [Biopence™ Carbelin™ Pyopen™] | |
| Carboprost Tromethamine Inj. USP [Endoprost™, Prostodin™] | |
| Desferrioxamine Mesylate Inj. [Desferal 0.5 g™] | |
| Dilzem™ Inj. | |
| Dinoprostone Gel [Cerviprime 0.5mg.™Primiprost™] | |
| Ergometrine Maleate Inj. | |
| Gas-Gangrene Antitoxin (Oedematiens) | |
| Gas-Gangrene Antitoxin (Perfringes) | |
| Gas-Gangrene Antitoxin (Septicum) | |
| Hepatitis B Virus Vaccine (H B Vac™ Enivac HB™ Engerrix B™ | |
| Heppacine-B™ Shanvac-B™) | |
| Human Normal Immunoglobulin [Histaglobulin ™ (lyophillised) | |
| Insulin Inj. (e.g. Insuman ™ 50/50) | |
| Measles Vaccine, Live (M-Vac™) | |
| Methylergometrine Maleate Inj. | |
| Mixed Gas Gangrene Antitoxin | |
| Plague Vaccine | |
| Poliomyelitis Vaccine, Live (oral)[Polio Sabin™ Oral Polio™] | |
| Protamine Sulphate Inj. | |
| Rabies Anti-serum-Equine | |
| Rabies Immuno Globulin (Human) EP [Kamrab™] | |
| Rabies Vaccine Human (Neural Tissue) | |
| Rabies Vaccine, Human (Cell Culture)[Abhayrab™] | |
| Recombinant Streptokinase (r-Streptokinase) Inj. 1,500,000 IU | |
| Rho (D) Immune Globulin (Human) 50µg, 150µg, 300µg | |
| Rubell Vaccine Live BP [R-Vac™ (lyophillised)] | |
| Sandoglobulin™ | |
| Schick Control | |
| Schick Test Toxin | |
| Scorpion Venom Antiserum | |
| Snake Venom Antiserum | |
| Soluble Insulin Inj. | |
| Streptokinase Inj. [Embokinase™ Kabikinase™ Streptase™] | |
| Succinylcholine Chloride Inj. [Midarine™ Scoline™] | |
| Tetanus Immunoglobulin BP (Human) [Tetglob™] | |
| Tetanus Vaccine (Adsorbed) | |
| Typhoid Paratyphoid A Vaccine | |
| Typhoid Vaccine Oral [Typhoral™] | |
| Typhoid Vaccine [Typhim VI™] | |
| Typhus Vaccine | |
| Vaccines | |
| Vasopressin Inj. [Petresin™] | |
| Vinblastine Sulphate Inj. [Cytoblastin™] | |
| Vincristine Sulphate Inj. [Cytocristn™ Vincristine™ Oncristine AQ™] | |
| Yellow Fever Vaccine, Live | |
| 3. Below 10° C: | Japanese Encephalitis Vaccine, Human (Mouse Brain) |
| Methylprednisolone Acetate Inj. | |
| 4. At a temp. Not exceeding 20° C: | Chorionic Gonadotrophin Inj. |
| (Pubergen 2000 IU ™) | |
| Urokinase™ | |
| 5. Between 2° & 25° C: | Human Plasma Protein Fraction |
| 6. Between 20° & 30° C: | Mannitol Inj. |
| 7. In a Refrigerator: | Velocite ™ & Pregcolor ™ Test Kits |
| 8. 23° or below: | Desferrioxamine Inj. |
| 9. Store below 30°: | Dobutamine Inj. USP 50 mg/ml |
| Propofol Inj.™ | |
| 10. Store in Cool Place: | Heparin Inj. |
| Morphine Inj. | |
| 11. To Be Stored Below 25° C: | Cefotaxime Sodium Inj. |
| Cefuroxime Sodium Inj. | |
| Dopamine Hydrochloride Inj. USP [Dopasys™] | |
| Enoxaparin Sodium Inj. | |
| Human Chorionic Gonadotrophin [Profasi™] | |
| Human Normal Albumin Soln [Alburel™] | |
| Menotrophin (hMG)[Pergonal 75™] | |
| Meropenam Inj. | |
| Naloxone Inj. 400mcg/ml | |
| Nifedipine Sustained Release Tab (Calcigard-10 Retard Tab™) | |
| Urofolliotrophin (FSH) 75 IU [Metrodin 75] |
| PRECAUTIONS | |
| 1. Should not be allowed to freeze | Antisera Inj. Cortisone Acetate Inj. |
| Fluorouracil Inj. | |
| Gas Gangrene Antitoxin (Oedematiens) | |
| Gas-Gangrene Antitoxin (Perfringens) | |
| Gas-Gangrene Antitoxin (Septicum) | |
| Hepatitis B Virus Vaccine [H B Vac™ Inj., Shanvac-B™] | |
| Histaglobulin™ [lyophillised] | |
| Insulins | |
| Methylprednisolone Acetate Inj. | |
| Mixed Gas-Gangrene Antitoxin | |
| Oxytocin Inj. | |
| Plague Vaccine | |
| Rabies Vaccine, Human (Neural Tissue) | |
| Scorpion Venom Antiserum | |
| Snake Venom Antiserum | |
| Succinylcholine Chloride Inj. | |
| Typhoid Paratyphoid A Vaccine | |
| Typhoid Vaccine | |
| Vaccines | |
| 2. Avoid Long Exposure above 30° C | Cyclophosphamide Inj. |
Compiled by:
Rakesh Dahiya, SDCO cum Licensing Authority, FDA Haryana
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