(a) General. The minimum dating periods in paragraph (c) of this section are based on data relating to usage, clinical experience, or laboratory tests that establish the reasonable period beyond which the product cannot be expected to yield its specific results and retain its safety, purity, and potency, provided the product is maintained at the recommended temperatures. The standards prescribed by the regulations in this subchapter are designed to ensure the continued safety, purity, and potency of the products and are based on the dating periods set forth in paragraph (c) of this section. Package labels for each product shall recommend storage at the stated temperatures.
(b) When the dating period begins. The dating period for a product shall begin on the date of manufacture, as prescribed in Sec. 610.50. The dating period for a combination of two or more products shall be no longer than the dating period of the component with the shortest dating period.
(c) Table of dating periods. In using the table in this paragraph, a product in column A may be stored by the manufacturer at the prescribed temperature and length of time in either column B or C, plus the length of time in column D. The dating period in column D shall be applied from the day the product leaves the manufacturer's storage, provided the product has not exceeded its maximum storage period, as prescribed in column B or C. If a product is held in the manufacturer's storage beyond the period prescribed, the dating period for the product being distributed shall be reduced by a corresponding period. ----------------------------------------------------------------------------------------------------------------
A B C D----------------------------------------------------------------------------------------------------------------
Dating period after
Manufacturer's storage Manufacturer's storage leaving manufacturer's
Product period 1 to 5 [deg]C period 0 [deg]C or storage when stored at 2
(unless otherwise colder (unless to 8 [deg]C (unless
(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 3 years................ ......do.............. 3 years.
glycerin.
2. With less than 50 percent 18 months.............. ......do.............. 18 months.
glycerin.
3. Products for which cold Not applicable......... ......do.............. 18 months (from date of
storage conditions are manufacture), provided
inappropriate. 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 18 months.............. ......do.............. 18 months.
Precipitated labeled ``No U.S.
Standard of Potency''.Anthrax Vaccine Adsorbed........... 2 years................ ......do.............. 1 year.Antibody to Hepatitis B Surface
Antigen:
1. Antibody to Hepatitis B 6 months............... ......do.............. 6 months.
Surface Antigen.
2. Lyophilized coated red blood ......do............... ......do.............. Do.
cells.
3. Enzyme conjugated products.. ......do............... ......do.............. Do.Iodinated (\125\l) 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. Liquid...................... Not applicable......... Not applicable........ 2 years.
2. Dried....................... 1 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 AHF............... ......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. Liquid...................... 1 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 ......do............... Not applicable........ 18 months.
Pertussis Vaccine Adsorbed.Diphtheria and Tetanus Toxoids, ......do............... ......do.............. 2 years.
Adsorbed.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 Not applicable......... Not applicable........ 1 year.
Control.Factor IX Complex.................. ......do............... ......do.............. 1 year (from date of
manufacture).Fibrinolysin (Human)............... 1 year................. 2 years............... 2 years.Fibrinolysin and Desoxyribonuclease ......do............... ......do.............. 3 years, provided labeling
Combined (Bovine). recommends storage at 30
[deg]C or colder.Fibrinolysin and Desoxyribonuclease ......do............... ......do.............. Do.
Combined (Bovine) with
Chloramphenicol.Hepatitis B Surface Antigen:
1. Unlyophilized coated red Not applicable......... ......do.............. 14 days (from date of
blood cells. manufacture).
2. Iodinated (\125\ l) product. ......do............... ......do.............. 45 days (from date of
manufacture).
3. Enzyme conjugated product... 6 months............... ......do.............. 6 months.Histoplasmin....................... 1 year................. Not applicable........ 2 years.Immunoglobulins:
1. Hepatitis B Immune Globulin Not applicable......... ......do.............. 1 year.
(Human).
2. Immune Globulin (Human)..... 3 years................ ......do.............. 3 years.
3. Immune Globulin Intravenous Not applicable......... ......do.............. 1 year.
(Human).
4. Lymphocyte Immune Globulin, ......do............... Not applicable........ 2 years.
Anti-Thymocyte Globulin
(Equine).
5. Pertussis Immune Globulin 3 years................ ......do.............. 3 years from date the
(Human). dried or frozen bulk
product is placed in
final solution.
6. Rabies Immune Globulin 1 year................. ......do.............. 1 year.
(Human).
7. Rho(D) Immune Globulin 6 months............... ......do.............. 6 months.
(Human).
8. Tetanus Immune Globulin 1 year................. ......do.............. 3 years with an initial 10
(Human). percent excess of
potency.
9. Vaccinia Immune Globulin 3 years................ ......do.............. 3 years.
(Human).
10. Varicella-Zoster Immune Not applicable......... ......do.............. 1 year.
Globulin (Human).Hepatitis B Vaccine................ 2 years at 2 to 8 Not applicable........ 3 years.
[deg]C.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 ......do............... 1 year (-20 [deg]C or 1 year.
Vaccine Live. colder).Measles and Mumps Virus Vaccine ......do............... ......do.............. 1 year.
Live.Measles and Rubella Virus Vaccine ......do............... ......do.............. Do.
Live.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 Not applicable.
colder).
2. Final container............. Not applicable......... 3 years (-20 [deg]C or 2 years.
colder).Meningococcal Polysaccharide
Vaccine Group C:
1. Final bulk powder........... ......do............... 2 years (-20 [deg]C or Not applicable.
colder).
2. Final container............. ......do............... 3 years (-20 [deg]C or 2 years.
colder).Meningococcal Polysaccharide
Vaccine Groups A and C combined:
1. Final bulk powder........... ......do............... 2 years (-20 [deg]C or Not applicable.
colder).
2. Final container............. ......do............... 3 years (-20 [deg]C or 2 years.
colder).Meningococcal Polysaccharide
Vaccine Groups A, C, Y, and W135
combined:
1. Final bulk power............ ......do............... 2 years (-20 [deg]C or Not applicable.
colder).
2. Final container............. ......do............... 3 years (-20 [deg]C or 2 years.
colder).Mumps Skin Test Antigen............ 6 months............... Not applicable........ 18 months.Mumps Virus Vaccine Live........... Not applicable......... 1 year (-20 [deg]C or 1 year.
colder).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 Plasma......... Not applicable......... ......do.............. 1 year from date of
collection of source
blood (-18 [deg]C or
colder).
(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).
(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 Not applicable.
potency assay (-20
[deg]C or colder).
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. Frozen...................... Not applicable......... 1 year (-10 [deg]C or 1 year, provided labeling
colder). 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 1 year, provided labeling
colder). 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 1 year, provided labeling
colder). 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 1 year, provided labeling
colder). 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 1 year................. ......do.............. 18 months.
``No U.S. Standard of Potency''
liquid.Polyvalent bacterial vaccines with ......do............... ......do.............. Do.
``No U.S. Standard of Potency''
liquid.Rabies Vaccine:
1. Dried....................... ......do............... 2 years............... Do.
2. Liquid...................... 3 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
(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
(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
(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 ......do............... 1 year (-20 [deg]C or 1 year.
Live. colder).Rubella Virus Vaccine Live......... ......do............... ......do.............. Do.Skin Test Antigens for Cellular 6 months............... Not applicable........ Do.
Hypersensitivity.
Smallpox Vaccine:
1. Liquid...................... Not applicable......... 9 months (-10 [deg]C 3 months, provided
or colder, if product labeling recommends
is maintained as storage at 0 [deg]C or
glycerinated or colder.
equivalent vaccine in
bulk or final
containers).
2. Dried....................... 6 months............... Not applicable........ 18 months.Streptokinase...................... Not applicable......... ......do.............. Do.Tetanus and Diphtheria Toxoids 1 year................. ......do.............. 2 years.
Adsorbed for Adult Use.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, 6 months............... ......do.............. 1 year.
diluted.
2. Old or Purified Protein 1 year (not to exceed ......do.............. 2 years, provided labeling
Derivative dried on multiple 30 [deg]C; do not recommends storage at a
puncture device. refrigerate). temperature not to exceed
30 [deg]C. Do not
refrigerate.
3. Old on multiple puncture ......do............... ......do.............. Do.
device.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 1 year, provided labeling
colder). recommends storage at 5
[deg]C or colder.----------------------------------------------------------------------------------------------------------------
(d) Exemptions. Exemptions or modifications shall be made only upon written approval, in the form of a supplement to the biologics license application, issued by the Director, Center for Biologics Evaluation and Research or the Director of the Center for Drug Evaluation and Research. [50 FR 4134, Jan. 29, 1985, as amended at 51 FR 15607, Apr. 25, 1986; 51 FR 19750, June 2, 1986; 52 FR 37450, Oct. 7, 1987; 53 FR 12764, Apr. 19, 1988; 62 FR 15110, Mar. 31, 1997; 64 FR 56453, Oct. 20, 1999; 70 FR 14985, Mar. 24, 2005; 72 FR 45887, Aug. 16, 2007; 72 FR 54208, Sept. 24, 2007; 73 FR 49942, Aug. 25, 2008]