A | B | C | D |
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Product | Manufacturer's storage period 1 to 5 deg. C (unless otherwise stated) | Manufacturer's storage period 0 deg. C or colder (unless otherwise stated) | Dating period after leaving manufacturer's storage when stored at 2 to 8 deg. C (unless otherwise stated) |
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Adenovirus Vaccine Live Oral | 6 months | Not applicable | 6 months. |
Albumin (Human) | 3 years | ......do | (a) 5 years. |
| ......do | ......do | (b) 3 years, provided labeling recommends storage at room temperature, no warmer than 37 deg. C. |
| Not applicable | ......do | (c) 10 years, if in a hermetically sealed metal container and provided labeling recommends storage between 2 and 8 deg. C. |
Allergenic Extracts labeled "No U.S. Standard of Potency": | | | |
| 1. With 50 percent or more glycerin3 years | ......do | 3 years. |
| 2. With less than 50 percent glycerin18 months | ......do | 18 months. |
| 3. Products for which cold storage conditions are inappropriateNot applicable | ......do | 18 months (from date of manufacture), provided labeling recommends storage at 30 deg. C or colder. |
| 4. Powders and tablets......do | ......do | 5 years (from date of manufacture), provided labeling recommends storage at 30 deg. C or colder. |
| 5. Freeze-dried products: | | |
| a. Unreconstituted......do | ......do | 4 years (from date of manufacture). |
| b. Reconstituted......do | ......do | 18 months (cannot exceed 4-year unreconstituted dating period plus an additional 12 months). |
Allergenic Extracts, Alum Precipitated labeled "No U.S. Standard of Potency" | 18 months | ......do | 18 months. |
Anthrax Vaccine Adsorbed | 2 years | ......do | 1 year. |
Antibody to Hepatitis B Surface Antigen: | | | |
| 1. Antibody to Hepatitis B Surface Antigen6 months | ......do | 6 months. |
| 2. Lyophilized coated red blood cells......do | ......do | Do. |
| 3. Enzyme conjugated products......do | ......do | Do. |
Iodinated (125l) products | Not applicable | ......do | 45 days (from date of manufacture). |
Antihemophilic Factor (Human) | ......do | ......do | 1 year (from date of manufacture). |
Anti-Human Globulin Liquid | ......do | ......do | 2 years. |
Anti-Inhibitor Coagulant Complex | ......do | ......do | Do. |
Antirabies Serum | 1 year | ......do | Do. |
Antivenin (Crotalidae) Polyvalent | ......do | ......do | 5 years with an initial 10 percent excess of potency, provided labeling recommends storage at 37 deg. C or colder. |
Antivenin (Latrodectus Mactans) | ......do | ......do | 5 years with an initial 10 percent excess of potency. |
Antivenin (Micurus fulvius) | ......do | ......do | Do. |
Asparaginase | Not applicable | ......do | 18 months from the date of the last valid potency test. |
BCG Vaccine | 1 year | Not applicable | 6 months. |
Blood Grouping Reagents | | | |
| 1. LiquidNot applicable | Not applicable | 2 years. |
| 2. Dried1 year | 2 years | 5 years. |
Blood Group Substance AB | ......do | ......do | 2 years. |
Blood Group Substance A | ......do | ......do | Do. |
Blood Group Substance B | ......do | ......do | Do. |
Botulism Antitoxin | ......do | Not applicable | 5 years with an initial 20 percent excess of potency. |
Cholera Vaccine | ......do | ......do | 18 months. |
Coccidioidin | ......do | ......do | 3 years. |
Collagenase | Not applicable | ......do | 4 years (from date of manufacture), provided labeling recommends storage at 37 deg. C or colder. |
Cryoprecipitated AFH | ......do | ......do | 12 months from the date of collection of source blood, provided labeling recommends storage at -18 deg. C or colder. |
Diphtheria Antitoxin: | | | |
| 1. Liquid1 year | ......do | 5 years with an initial 20 percent excess of potency. |
| 2. Dried......do | 2 years | 5 years with an initial 10 percent excess of potency. |
Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed | ......do | Not applicable | 18 months. |
Diphtheria and Tetanus Toxoids, Adsorbed | ......do | ......do | 2 years. |
Diphtheria Toxin for Schick Test | ......do | ......do | 1 year. |
Diphtheria Toxoid | ......do | ......do | 2 years. |
Diphtheria Toxoid Adsorbed | ......do | 2 years | Do. |
Diphtheria Toxoid-Schick Test Control | Not applicable | Not applicable | 1 year. |
Factor IX Complex | ......do | ......do | 1 year (from date of manufacture). |
Fibrinolysin (Human) | 1 year | 2 years | 2 years. |
Fibrinolysin and Desoxyribonuclease Combined (Bovine) | ......do | ......do | 3 years, provided labeling recommends storage at 30 deg. C or colder. |
Fibrinolysin and Desoxyribonuclease Combined (Bovine) with Chloramphenicol | ......do | ......do | Do. |
Hepatitis B Surface Antigen: | | | |
| 1. Unlyophilized coated red blood cellsNot applicable | ......do | 14 days (from date of manufacture). |
| 2. Iodinated (125l) product......do | ......do | 45 days (from date of manufacture). |
| 3. Enzyme conjugated product6 months | ......do | 6 months. |
Histoplasmin | 1 year | Not applicable | 2 years. |
Immunoglobulins: | | | |
| 1. Hepatitis B Immune Globulin (Human)Not applicable | ......do | 1 year. |
| 2. Immune Globulin (Human)3 years | ......do | 3 years. |
| 3. Immune Globulin Intravenous (Human)Not applicable | ......do | 1 year. |
| 4. Lymphocyte Immune Globulin, Anti-Thymocyte Globulin (Equine)......do | Not applicable | 2 years. |
| 5. Pertussis Immune Globulin (Human)3 years | ......do | 3 years from date the dried or frozen bulk product is placed in final solution. |
| 6. Rabies Immune Globulin (Human)1 year | ......do | 1 year. |
| 7. Rho(D) Immune Globulin (Human)6 months | ......do | 6 months. |
| 8. Tetanus Immune Globulin (Human)1 year | ......do | 3 years with an initial 10 percent excess of potency. |
| 9. Vaccinia Immune Globulin (Human)3 years | ......do | 3 years. |
| 10. Varicella-Zoster Immune Globulin (Human)Not applicable | ......do | 1 year. |
Hepatitis B Vaccine | 2 years at 2 to 8 deg. C | Not applicable | 3 years. |
Influenza Virus Vaccine | 1 year | ......do | 18 months. |
Limulus Amebocyte Lysate | Not applicable | Not applicable | 18 months (from date of manufacture). |
Measles, Mumps, and Rubella Virus Vaccine Live | ......do | 1 year (-20 deg. C or colder) | 1 year. |
Measles and Mumps Virus Vaccine Live | ......do | ......do | 1 year. |
Measles and Rubella Virus Vaccine Live | ......do | ......do | Do. |
Measles Live and Smallpox Vaccine | Not applicable | ......do | 1 year (from date of manufacture). |
Measles Virus Vaccine Live | ......do | ......do | 1 year. |
Meningococcal Polysaccharide Vaccine Group A: | | | |
| 1. Final bulk powder......do | 2 years (-20 deg. C or colder) | Not applicable. |
| 2. Final containerNot applicable | 3 years (-20 deg. C or colder) | 2 years. |
Meningococcal Polysaccharide Vaccine Group C: | | | |
| 1. Final bulk powder......do | 2 years (-20 deg. C or colder) | Not applicable. |
| 2. Final container......do | 3 years (-20 deg. C or colder) | 2 years. |
Meningococcal Polysaccharide Vaccine Groups A and C combined: | | | |
| 1. Final bulk powder......do | 2 years (-20 deg. C or colder) | Not applicable. |
| 2. Final container......do | 3 years (-20 deg. C or colder) | 2 years. |
Meningococcal Polysaccharide Vaccine Groups A, C, Y, and W135 combined: | | | |
| 1. Final bulk power......do | 2 years (-20 deg. C or colder) | Not applicable. |
| 2. Final container......do | 3 years (-20 deg. C or colder) | 2 years. |
Mumps Skin Test Antigen | 6 months | Not applicable | 18 months. |
Mumps Virus Vaccine Live | Not applicable | 1 year (-20 deg. C or colder) | 1 year. |
Normal Horse Serum | 1 year | 2 years | 5 years. |
Pertussis Vaccine | ......do | Not applicable | 18 months. |
Pertussis Vaccine Adsorbed | ......do | ......do | Do. |
Plague Vaccine | ......do | ......do | Do. |
Plasma products: | | | |
| 1. Fresh Frozen PlasmaNot applicable | ......do | 1 year from date of collection of source blood (-18 deg. C or colder). |
| 2. Liquid Plasma......do | ......do | (a) 26 days from date of collection of source blood (between 1 and 6 deg. C). |
| | | (b) 40 days from date of collection of source blood only when CPDA-1 solution is used as the anticoagulant (between 1 and 6 deg. C). |
| 3. Plasma......do | ......do | 5 years from date of collection of source blood (-18 deg. C or colder). |
| 4. Platelet Rich Plasma......do | ......do | 72 hours from time of collection of source blood, provided labeling recommends storage (20 to 24 deg. C or between 1 and 6 deg. C). 5 days if certain approved containers are used (20 to 24 deg. C). |
| 5. Source Leukocytes......do | ......do | In lieu of expiration date, the collection date shall appear on the label. |
| 6. Source Plasma......do | ......do | 10 years (at the recommended storage temperature stated on the label). |
| 7. Therapeutic Exchange Plasma......do | ......do | 10 years. |
Plasma Protein Fraction (Human) | 1 year | ......do | (a) 5 years.(b) 3 years provided labeling recommends storage at room temperature, no warmer than 30 deg. C). |
Platelets | Not applicable | ......do | 72 hours from time of collection of source blood, provided labeling recommends storage at 20 to 24 deg. C or between 1 and 6 deg. C, or as specified in the directions for use for the blood collecting, processing, and storage system approved for such use by the Director, Center for Biologics Evaluation and Research (CBER). |
Pneumococcal Vaccine Polyvalent: | | | |
| 1. Final bulk powder......do | 24 months after potency assay (-20 deg. C or colder) | Not applicable. |
| 2. Final container......do | Not applicable | 2 years (from date of manufacture). |
Poliovirus Vaccine Inactivated | 1 year | ......do | 1 year. |
Poliovirus Vaccine Live Oral Trivalent: | | | |
| 1. FrozenNot applicable | 1 year (-10 deg. C or colder) | 1 year, provided labeling recommends storage at a temperature which will maintain ice continuously in a solid state. |
| 2. Liquid......do | Not applicable | 30 days, provided labeling recommends storage between 2 and 8 deg. C and container has been unopened. |
Poliovirus Vaccine Live Oral Type I: | | | |
| 1. Frozen......do | 1 year (-10 deg. C or colder) | 1 year, provided labeling recommends storage at a temperature which will maintain ice continuously in a solid state. |
| 2. Liquid......do | Not applicable | 30 days, provided labeling recommends storage between 2 and 8 deg. C and container has been unopened. |
Poliovirus Vaccine Live Oral Type II: | | | |
| 1. Frozen......do | 1 year (-10 deg. C or colder) | 1 year, provided labeling recommends storage at a temperature which will maintain ice continuously in a solid state. |
| 2. Liquid......do | Not applicable | 30 days, provided labeling recommends storage between 2 and 8 deg. C and container has been unopened. |
Poliovirus Vaccine Live Oral Type III: | | | |
| 1. Frozen......do | 1 year (-10 deg. C or colder) | 1 year, provided labeling recommends storage at a temperature which will maintain ice continuously in a solid state. |
| 2. Liquid......do | Not applicable | 30 days, provided labeling recommends storage between 2 and 8 deg. C and container has been unopened. |
Polyvalent bacterial antigens with "No U.S. Standard of Potency" liquid | 1 year | ......do | 18 months. |
Polyvalent bacterial vaccines with "No U.S. Standard of Potency" liquid | ......do | ......do | Do. |
Rabies Vaccine: | | | |
| 1. Dried......do | 2 years | Do. |
| 2. Liquid3 months | Not applicable | 6 months. |
Reagent red blood cells | Not applicable | Not applicable | Thirty-five days from earliest date of collection if kept in liquid form (indefinite storage of reagent red blood cell source material at -65 deg. C or colder). |
ACD Red Blood Cells | ......do | ......do | (a) 21 days from date of collection of source blood, provided labeling recommends storage between 1 and 6 deg. C and the hermetic seal is not broken during processing.(b) 24 hours after plasma removal, provided labeling recommends storage between 1 and 6 deg. C and the hermetic seal is broken during processing. |
CPD Red Blood Cells | ......do | ......do | (a) 21 days from date of collection of source blood, provided labeling recommends storage between 1 and 6 deg. C and the hermetic seal is not broken during processing.(b) 24 hours after plasma removal, provided labeling recommends storage between 1 and 6 deg. C and the hermetic seal is broken during processing. |
CPDA-1 Red Blood Cells | ......do | ......do | (a) 35 days from date of collection of source blood, provided labeling recommends storage between 1 and 6 deg. C and the hermetic seal is not broken during processing.(b) 24 hours after plasma removal, provided labeling recommends storage between 1 and 6 deg. C and the hermetic seal is broken during processing. |
Red Blood Cells Deglycerolized | ......do | ......do | 24 hours after removal from storage at -65 deg. C or colder, provided labeling recommends storage between 1 and 6 deg. C, or as specified in the directions for use for the blood collecting, processing, and storage system approved for such use by the Director, CBER. |
Red Blood Cells Frozen | ......do | ......do | 10 years from date of collection of source blood, provided labeling recommends storage at -65 deg. C or colder, or as specified in the directions for use for the blood collecting, processing, and storage system approved for such use by the Director, CBER. |
Rubella and Mumps Virus Vaccine Live | ......do | 1 year (-20 deg. C or colder) | 1 year. |
Rubella Virus Vaccine Live | ......do | ......do | Do. |
Skin Test Antigens for Cellular Hypersensitivity | 6 months | Not applicable | Do. |
Smallpox Vaccine: | | | |
| 1. LiquidNot applicable | 9 months (-10 deg. C or colder, if product is maintained as glycerinated or equivalent vaccine in bulk or final containers) | 3 months, provided labeling recommends storage at 0 deg. C or colder. |
| 2. Dried6 months | Not applicable | 18 months. |
Streptokinase | Not applicable | ......do | Do. |
Tetanus and Diphtheria Toxoids Adsorbed for Adult Use | 1 year | ......do | 2 years. |
Tetanus Antitoxin: | | | |
| 1. Liquid......do | ......do | 5 years with an initial 20 percent excess or potency. |
| 2. Dried......do | 2 years | 5 years with an initial 10 percent excess or potency. |
Tetanus Toxoid | ......do | Not applicable | 2 years. |
Tetanus Toxoid Adsorbed | ......do | ......do | Do. |
Thrombin | ......do | 2 year | 3 years. |
Thrombin Impregnated Pad | Not applicable | Not applicable | 1 year, or 6 months at 20 to 24 deg. C. |
Tuberculin: | | | |
| 1. Purified Protein Derivative, diluted6 months | ......do | 1 year. |
| 2. Old or Purified Protein Derivative dried on multiple puncture device1 year (not to exceed 30 deg. C; do not refrigerate) | ......do | 2 years, provided labeling recommends storage at a temperature not to exceed 30 deg. C. Do not refrigerate. |
| 3. Old on multiple puncture device......do | ......do | Do. |
Typhoid Vaccine | 1 year | ......do | 18 months. |
ACD Whole Blood | Not applicable | ......do | 21 days from date of collection, provided labeling recommends storage between 1 and 6 deg. C. |
CPD Whole Blood | ......do | ......do | Do. |
CPDA-1 Whole Blood | ......do | ......do | 35 days from date of collection, provided labeling recommends storage between 1 and 6 deg. C. |
Heparin Whole Blood | ......do | ......do | 48 hours from date of collection, provided labeling recommends storage between 1 and 6 deg. C. |
Yellow Fever Vaccine | ......do | 1 year (-20 deg. C or colder) | 1 year, provided labeling recommends storage at 5 deg. C or colder. |