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pdf§ 610.50
21 CFR Ch. I (4–1–05 Edition)
Administration’s regulations on conditions of Medicare participation for hospitals (42 CFR part 482) are required to
take appropriate action in accordance
with paragraphs (b) and (c) of this section when a recipient has received
Whole Blood or blood components from
a donor determined to be unsuitable
when tested for human immunodeficiency virus (HIV) infection in accordance with § 610.45 and the results of
the additional tests as provided for in
§ 610.46(b) are positive.
(b) Notification of recipients of prior
transfusion. If the transfusion service
has administered Whole Blood or blood
components as described in paragraph
(a) of this section, the transfusion service shall notify the recipient’s attending physician (physician of record) and
ask him or her to inform the recipient
of the need for HIV testing and counseling. If the physician is unavailable
or declines to notify the recipient, the
transfusion service shall notify the recipient and inform the recipient of the
need for HIV testing and counseling.
The notification process shall include a
minimum of three attempts to notify
the recipient and be completed within
a maximum 8 weeks of receipt of the
result of the licensed, more specific
test for HIV. The transfusion service is
responsible for notification, including
basic explanations to the recipient and
referral for counseling, and shall document the notification or attempts to
notify the attending physician or the
recipient, pursuant to § 606.160 of this
chapter.
(c) Notification to legal representative
or relative. If the transfusion recipient
has been adjudged incompetent by a
State court, the transfusion service or
physician must notify a legal representative designated in accordance
with State law. If the transfusion recipient is competent, but State law
permits a legal representative or relative to receive the information on the
recipient’s behalf, the transfusion service or physician must notify the recipient or his or her legal representative or
relative. If the transfusion recipient is
deceased, the transfusion service or
physician must continue the notification process and inform the deceased
recipient’s legal representative or relative. Reasons for notifying the recipi-
ent’s relative or legal representative on
his or her behalf shall be documented
pursuant to § 606.160 of this chapter.
[61 FR 47423, Sept. 9, 1996]
Subpart F—Dating Period
Limitations
§ 610.50
Date of manufacture.
The date of manufacture shall be determined as follows:
(a) For products for which an official
standard of potency is prescribed in either § 610.20 or § 610.21, or which are subject to official potency tests, the date
of initiation by the manufacturer of
the last valid potency test.
(b) For products that are not subject
to official potency tests, (1) the date of
removal from animals, (2) the date of
extraction, (3) the date of solution, (4)
the date of cessation of growth, or (5)
the date of final sterile filtration of a
bulk solution, whichever is applicable.
[38 FR 32056, Nov. 20, 1973, as amended at 42
FR 27582, May 31, 1977]
§ 610.53 Dating periods for licensed biological products.
(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 § 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
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Food and Drug Administration, HHS
§ 610.53
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 exA
ceeded 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.
B
C
D
Manufacturer’s
storage period 1
to 5 °C (unless
otherwise stated)
Manufacturer’s
storage period 0
°C or colder (unless otherwise
stated)
Dating period after leaving manufacturer’s storage when stored at 2 to 8 °C
(unless otherwise stated)
6 months ..............
3 years .................
......do ...................
Not applicable ......
......do ...................
......do ...................
Not applicable ......
......do ...................
3 years .................
18 months ............
Not applicable ......
......do ...................
......do ...................
......do ...................
4. Powders and tablets .......................
......do ...................
......do ...................
5. Freeze-dried products:
a. Unreconstituted ...........................
b. Reconstituted ..............................
......do ...................
......do ...................
......do ...................
......do ...................
Allergenic Extracts, Alum Precipitated labeled ‘‘No U.S. Standard of Potency’’.
Anthrax Vaccine Adsorbed ........................
Antibody to Hepatitis B Surface Antigen:
1. Antibody to Hepatitis B Surface
Antigen.
2. Lyophilized coated red blood cells
3. Enzyme conjugated products .........
Iodinated (125l) products .............................
Antihemophilic Factor (Human) .................
Anti-Human Globulin Liquid .......................
Anti-Inhibitor Coagulant Complex ..............
Antirabies Serum ........................................
Antivenin (Crotalidae) Polyvalent ...............
18 months ............
......do ...................
Product
Adenovirus Vaccine Live Oral ....................
Albumin (Human) .......................................
Allergenic Extracts labeled ‘‘No U.S.
Standard of Potency’’:
1. With 50 percent or more glycerin ...
2. With less than 50 percent glycerin
3. Products for which cold storage
conditions are inappropriate.
6 months.
(a) 5 years.
(b) 3 years, provided labeling recommends storage at room temperature, no warmer than 37 °C.
(c) 10 years, if in a hermetically sealed
metal container and provided labeling
recommends storage between 2 and 8
°C.
3 years.
18 months.
18 months (from date of manufacture),
provided labeling recommends storage
at 30 °C or colder.
5 years (from date of manufacture), provided labeling recommends storage at
30 °C or colder.
4 years (from date of manufacture).
18 months (cannot exceed 4-year
unreconstituted dating period plus an
additional 12 months).
18 months.
2 years .................
......do ...................
1 year.
6 months ..............
......do ...................
6 months.
......do ...................
......do ...................
Not applicable ......
......do ...................
......do ...................
......do ...................
1 year ..................
......do ...................
......do
......do
......do
......do
......do
......do
......do
......do
Antivenin (Latrodectus Mactans) ...............
......do ...................
......do ...................
Antivenin (Micurus fulvius) .........................
Asparaginase .............................................
......do ...................
Not applicable ......
......do ...................
......do ...................
BCG Vaccine ..............................................
Blood Grouping Reagents
1. Liquid ..............................................
2. Dried ...............................................
Blood Group Substance AB .......................
Blood Group Substance A .........................
Blood Group Substance B .........................
Botulism Antitoxin .......................................
1 year ..................
Not applicable ......
Do.
Do.
45 days (from date of manufacture).
1 year (from date of manufacture).
2 years.
Do.
Do.
5 years with an initial 10 percent excess
of potency, provided labeling recommends storage at 37 ° C or colder.
5 years with an initial 10 percent excess
of potency.
Do.
18 months from the date of the last valid
potency test.
6 months.
Not applicable ......
1 year ..................
......do ...................
......do ...................
......do ...................
......do ...................
Not applicable ......
2 years .................
......do ...................
......do ...................
......do ...................
Not applicable ......
Cholera Vaccine .........................................
Coccidioidin ................................................
......do ...................
......do ...................
......do ...................
......do ...................
...................
...................
...................
...................
...................
...................
...................
...................
2 years.
5 years.
2 years.
Do.
Do.
5 years with an initial 20 percent excess
of potency.
18 months.
3 years.
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§ 610.53
21 CFR Ch. I (4–1–05 Edition)
A
B
C
D
Product
Manufacturer’s
storage period 1
to 5 °C (unless
otherwise stated)
Manufacturer’s
storage period 0
°C or colder (unless otherwise
stated)
Dating period after leaving manufacturer’s storage when stored at 2 to 8 °C
(unless otherwise stated)
Collagenase ...............................................
Not applicable ......
......do ...................
Cryoprecipitated AFH .................................
......do ...................
......do ...................
Diphtheria Antitoxin:
1. Liquid ..............................................
1 year ..................
......do ...................
4 years (from date of manufacture), provided labeling recommends storage at
37 °C or colder.
12 months from the date of collection of
source blood, provided labeling recommends storage at ¥18 °C or colder.
2. Dried ...............................................
......do ...................
2 years .................
Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed.
Diphtheria and Tetanus Toxoids, Adsorbed.
Diphtheria Toxin for Schick Test ................
Diphtheria Toxoid .......................................
Diphtheria Toxoid Adsorbed ......................
Diphtheria Toxoid-Schick Test Control ......
Factor IX Complex .....................................
Fibrinolysin (Human) ..................................
Fibrinolysin and Desoxyribonuclease Combined (Bovine).
Fibrinolysin and Desoxyribonuclease Combined (Bovine) with Chloramphenicol.
Hepatitis B Surface Antigen:
1. Unlyophilized coated red blood
cells.
2. Iodinated (125 l) product ..................
3. Enzyme conjugated product ...........
Histoplasmin ...............................................
Immunoglobulins:
1. Hepatitis B Immune Globulin
(Human).
2. Immune Globulin (Human) .............
3. Immune Globulin Intravenous
(Human).
4. Lymphocyte Immune Globulin, AntiThymocyte Globulin (Equine).
5.
Pertussis
Immune
Globulin
(Human).
6. Rabies Immune Globulin (Human)
7. Rho(D) Immune Globulin (Human)
8. Tetanus Immune Globulin (Human)
......do ...................
Not applicable ......
5 years with an initial 20 percent excess
of potency.
5 years with an initial 10 percent excess
of potency.
18 months.
......do ...................
......do ...................
2 years.
......do ...................
......do ...................
......do ...................
Not applicable ......
......do ...................
1 year ..................
......do ...................
......do ...................
......do ...................
2 years .................
Not applicable ......
......do ...................
2 years .................
......do ...................
......do ...................
......do ...................
1 year.
2 years.
Do.
1 year.
1 year (from date of manufacture).
2 years.
3 years, provided labeling recommends
storage at 30 °C or colder.
Do.
Not applicable ......
......do ...................
14 days (from date of manufacture).
......do ...................
6 months ..............
1 year ..................
......do ...................
......do ...................
Not applicable ......
45 days (from date of manufacture).
6 months.
2 years.
Not applicable ......
......do ...................
1 year.
3 years .................
Not applicable ......
......do ...................
......do ...................
3 years.
1 year.
......do ...................
Not applicable ......
2 years.
3 years .................
......do ...................
1 year ..................
6 months ..............
1 year ..................
......do ...................
......do ...................
......do ...................
9. Vaccinia Immune Globulin (Human)
10. Varicella-Zoster Immune Globulin
(Human).
Hepatitis B Vaccine ....................................
3 years .................
Not applicable ......
......do ...................
......do ...................
3 years from date the dried or frozen bulk
product is placed in final solution.
1 year.
6 months.
3 years with an initial 10 percent excess
of potency.
3 years.
1 year.
2 years at 2 to 8
°C.
1 year ..................
Not applicable ......
......do ...................
Not applicable ......
3 years.
......do ...................
Not applicable ......
1 year (¥20 °C or
colder).
......do ...................
......do ...................
......do ...................
......do ...................
18 months.
18 months (from date of manufacture).
1 year.
2 years (¥20 °C
or colder).
3 years (¥20 °C
or colder).
Not applicable.
2 years (¥20 °C
or colder).
Not applicable.
Influenza Virus Vaccine .............................
Limulus Amebocyte Lysate ........................
Measles, Mumps, and Rubella Virus Vaccine Live.
Measles and Mumps Virus Vaccine Live ...
Measles and Rubella Virus Vaccine Live ..
Measles Live and Smallpox Vaccine .........
Measles Virus Vaccine Live .......................
Meningococcal Polysaccharide Vaccine
Group A:
1. Final bulk powder ...........................
......do ...................
......do ...................
Not applicable ......
......do ...................
......do ...................
2. Final container ................................
Not applicable ......
Meningococcal Polysaccharide Vaccine
Group C:
1. Final bulk powder ...........................
......do ...................
1 year.
Do.
1 year (from date of manufacture).
1 year.
2 years.
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Food and Drug Administration, HHS
§ 610.53
A
B
C
D
Product
Manufacturer’s
storage period 1
to 5 °C (unless
otherwise stated)
Manufacturer’s
storage period 0
°C or colder (unless otherwise
stated)
Dating period after leaving manufacturer’s storage when stored at 2 to 8 °C
(unless otherwise stated)
2. Final container ................................
......do ...................
3 years (¥20 °C
or colder).
2 years.
Meningococcal Polysaccharide Vaccine
Groups A and C combined:
1. Final bulk powder ...........................
......do ...................
2 years (¥20 °C
or colder).
3 years (¥20 °C
or colder).
Not applicable.
Not applicable.
1 year from date of collection of source
blood (¥18 °C or colder).
(a) 26 days from date of collection of
source blood (between 1 and 6 °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 °C).
5 years from date of collection of source
blood (¥18 °C or colder).
72 hours from time of collection of source
blood, provided labeling recommends
storage (20 to 24 °C or between 1 and
6 °C). 5 days if certain approved containers are used (20 to 24 °C).
In lieu of expiration date, the collection
date shall appear on the label.
10 years (at the recommended storage
temperature stated on the label).
10 years.
(a) 5 years.
(b) 3 years provided labeling recommends storage at room temperature, no warmer than 30 °C).
72 hours from time of collection of source
blood, provided labeling recommends
storage at 20 to 24 °C or between 1
and 6 °C. 5 days if certain approved
containers are used (20 to 24 °C).
2. Final container ................................
......do ...................
Meningococcal Polysaccharide Vaccine
Groups A, C, Y, and W135 combined:
1. Final bulk power .............................
......do ...................
2 years.
2. Final container ................................
......do ...................
Mumps Skin Test Antigen ..........................
Mumps Virus Vaccine Live ........................
6 months ..............
Not applicable ......
Normal Horse Serum .................................
Pertussis Vaccine .......................................
Pertussis Vaccine Adsorbed ......................
Plague Vaccine ..........................................
Plasma products:
1. Fresh Frozen Plasma .....................
1 year ..................
......do ...................
......do ...................
......do ...................
2 years (¥20 °C
or colder).
3 years (¥20 °C
or colder).
Not applicable ......
1 year (¥20 °C or
colder).
2 years .................
Not applicable ......
......do ...................
......do ...................
Not applicable ......
......do ...................
2. Liquid Plasma .................................
......do ...................
......do ...................
3. Plasma ............................................
......do ...................
......do ...................
4. Platelet Rich Plasma ......................
......do ...................
......do ...................
5. Source Leukocytes .........................
......do ...................
......do ...................
6. Source Plasma ...............................
......do ...................
......do ...................
7. Therapeutic Exchange Plasma .......
Plasma Protein Fraction (Human) .............
......do ...................
1 year ..................
......do ...................
......do ...................
Platelets ......................................................
Not applicable ......
......do ...................
Pneumococcal Vaccine Polyvalent:
1. Final bulk powder ...........................
......do ...................
24 months after
potency assay
(¥20 °C or
colder).
Not applicable ......
......do ...................
Not applicable.
1 year, provided labeling recommends
storage at a temperature which will
maintain ice continuously in a solid
state.
30 days, provided labeling recommends
storage between 2 and 8 °C and container has been unopened.
2. Final container ................................
Poliovirus Vaccine Inactivated ...................
Poliovirus Vaccine Live Oral Trivalent:
1. Frozen .............................................
......do ...................
1 year ..................
Not applicable ......
1 year (¥10 °C or
colder).
2. Liquid ..............................................
......do ...................
Not applicable ......
2 years.
18 months.
1 year.
5 years.
18 months.
Do.
Do.
2 years (from date of manufacture).
1 year.
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§ 610.53
21 CFR Ch. I (4–1–05 Edition)
A
B
C
D
Product
Manufacturer’s
storage period 1
to 5 °C (unless
otherwise stated)
Manufacturer’s
storage period 0
°C or colder (unless otherwise
stated)
Dating period after leaving manufacturer’s storage when stored at 2 to 8 °C
(unless otherwise stated)
Poliovirus Vaccine Live Oral Type I:
1. Frozen .............................................
......do ...................
1 year (¥10 °C or
colder).
2. Liquid ..............................................
......do ...................
Not applicable ......
Poliovirus Vaccine Live Oral Type II:
1. Frozen .............................................
......do ...................
1 year (¥10 °C or
colder).
2. Liquid ..............................................
......do ...................
Not applicable ......
Poliovirus Vaccine Live Oral Type III:
1. Frozen .............................................
......do ...................
1 year (¥10 °C or
colder).
2. Liquid ..............................................
......do ...................
Not applicable ......
Polyvalent bacterial antigens with ‘‘No
U.S. Standard of Potency’’ liquid.
Polyvalent bacterial vaccines with ‘‘No
U.S. Standard of Potency’’ liquid.
Rabies Vaccine:
1. Dried ...............................................
2. Liquid ..............................................
Reagent red blood cells .............................
1 year ..................
......do ...................
......do ...................
......do ...................
......do ...................
3 months ..............
Not applicable ......
2 years .................
Not applicable ......
Not applicable ......
ACD Red Blood Cells ................................
......do ...................
......do ...................
CPD Red Blood Cells ................................
......do ...................
......do ...................
CPDA–1 Red Blood Cells ..........................
......do ...................
......do ...................
Red Blood Cells Deglycerolized ................
......do ...................
......do ...................
Red Blood Cells Frozen .............................
......do ...................
......do ...................
1 year, provided labeling recommends
storage at a temperature which will
maintain ice continuously in a solid
state.
30 days, provided labeling recommends
storage between 2 and 8 °C and container has been unopened.
1 year, provided labeling recommends
storage at a temperature which will
maintain ice continuously in a solid
state.
30 days, provided labeling recommends
storage between 2 and 8 °C and container has been unopened.
1 year, provided labeling recommends
storage at a temperature which will
maintain ice continuously in a solid
state.
30 days, provided labeling recommends
storage between 2 and 8 °C and container has been unopened.
18 months.
Do.
Do.
6 months.
Thirty-five days from earliest date of collection if kept in liquid form (indefinite
storage of reagent red blood cell
source material at ¥65 °C or colder).
(a) 21 days from date of collection of
source blood, provided labeling recommends storage between 1 and 6 °C
and the hermetic seal is not broken
during processing.
(b) 24 hours after plasma removal, provided labeling recommends storage between 1 and 6 °C and the hermetic
seal is broken during processing.
(a) 21 days from date of collection of
source blood, provided labeling recommends storage between 1 and 6 °C
and the hermetic seal is not broken
during processing.
(b) 24 hours after plasma removal, provided labeling recommends storage between 1 and 6 °C and the hermetic
seal is broken during processing.
(a) 35 days from date of collection of
source blood, provided labeling recommends storage between 1 and 6 °C
and the hermetic seal is not broken
during processing.
(b) 24 hours after plasma removal, provided labeling recommends storage between 1 and 6 °C and the hermetic
seal is broken during processing.
24 hours after removal from storage at
¥65 °C or colder, provided labeling
recommends storage between 1 and 6
°C.
3 years from date of collection of source
blood, provided labeling recommends
storage at ¥65 °C or colder.
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Food and Drug Administration, HHS
§ 610.60
A
B
C
D
Product
Manufacturer’s
storage period 1
to 5 °C (unless
otherwise stated)
Manufacturer’s
storage period 0
°C or colder (unless otherwise
stated)
Dating period after leaving manufacturer’s storage when stored at 2 to 8 °C
(unless otherwise stated)
Rubella and Mumps Virus Vaccine Live ....
......do ...................
......do ...................
6 months ..............
1 year (¥20 °C or
colder).
......do ...................
Not applicable ......
1 year.
Rubella Virus Vaccine Live ........................
Skin Test Antigens for Cellular Hypersensitivity.
Smallpox Vaccine:
1. Liquid ..............................................
3 months, provided labeling recommends
storage at 0 °C or colder.
2. Dried ...............................................
Streptokinase .............................................
Tetanus and Diphtheria Toxoids Adsorbed
for Adult Use.
Tetanus Antitoxin:
1. Liquid ..............................................
6 months ..............
Not applicable ......
1 year ..................
9 months (¥10 °C
or colder, if
product is maintained as
glycerinated or
equivalent vaccine in bulk or
final containers).
Not applicable ......
......do ...................
......do ...................
......do ...................
......do ...................
2. Dried ...............................................
......do ...................
2 years .................
Tetanus Toxoid ..........................................
Tetanus Toxoid Adsorbed ..........................
Thrombin ....................................................
Thrombin Impregnated Pad .......................
Tuberculin:
1. Purified Protein Derivative, diluted
2. Old or Purified Protein Derivative
dried on multiple puncture device.
......do ...................
......do ...................
......do ...................
Not applicable ......
Not applicable ......
......do ...................
2 year ..................
Not applicable ......
5 years with an initial 20 percent excess
or potency.
5 years with an initial 10 percent excess
or potency.
2 years.
Do.
3 years.
1 year, or 6 months at 20 to 24 °C.
......do ...................
......do ...................
3. Old on multiple puncture device .....
Typhoid Vaccine .........................................
ACD Whole Blood ......................................
6 months ..............
1 year (not to exceed 30 °C; do
not refrigerate).
......do ...................
1 year ..................
Not applicable ......
CPD Whole Blood ......................................
CPDA–1 Whole Blood ................................
......do ...................
......do ...................
......do ...................
......do ...................
Heparin Whole Blood .................................
......do ...................
......do ...................
Yellow Fever Vaccine ................................
......do ...................
1 year (¥20 °C or
colder).
Not applicable ......
......do ...................
......do ...................
......do ...................
(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.
Do.
Do.
18 months.
Do.
2 years.
1 year.
2 years, provided labeling recommends
storage at a temperature not to exceed
30 °C. Do not refrigerate.
Do.
18 months.
21 days from date of collection, provided
labeling recommends storage between
1 and 6 °C.
Do.
35 days from date of collection, provided
labeling recommends storage between
1 and 6 °C.
48 hours from date of collection, provided
labeling recommends storage between
1 and 6 °C.
1 year, provided labeling recommends
storage at 5 °C or colder.
Subpart G—Labeling Standards
§ 610.60 Container label.
(a) Full label. The following items
shall appear on the label affixed to
each container of a product capable of
bearing a full label:
(1) The proper name of the product;
(2) The name, address, and license
number of manufacturer;
(3) The lot number or other lot identification;
(4) The expiration date;
(5) The recommended individual dose,
for multiple dose containers.
[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]
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Jkt 205071
PO 00000
Frm 00097
Fmt 8010
Sfmt 8010
Y:\SGML\205071.XXX
205071
| File Type | application/pdf |
| File Title | Document |
| Subject | Extracted Pages |
| Author | U.S. Government Printing Office |
| File Modified | 2007-01-17 |
| File Created | 2005-05-04 |