0338 21cfr600 15 2007

§ 600.15

21 CFR Ch. I (4–1–05 Edition)

transfusion services, do not report biological product deviations for those
products under this section but must
report under § 606.171 of this chapter;
(iii) Persons who manufacture Source
Plasma or any other blood component
and use that Source Plasma or any
other blood component in the further
manufacture of another licensed biological product must report:
(A) Under § 606.171 of this chapter, if a
biological product deviation occurs
during the manufacture of that Source
Plasma or any other blood component;
or
(B) Under this section, if a biological
product deviation occurs after the
manufacture of that Source Plasma or
any other blood component, and during
manufacture of the licensed biological
product.
(b) What do I report under this section?
You must report any event, and information relevant to the event, associated with the manufacturing, to include testing, processing, packing, labeling, or storage, or with the holding
or distribution, of a licensed biological
product, if that event meets all the following criteria:
(1) Either:
(i) Represents a deviation from current good manufacturing practice, applicable regulations, applicable standards, or established specifications that
may affect the safety, purity, or potency of that product; or
(ii) Represents an unexpected or unforeseeable event that may affect the
safety, purity, or potency of that product; and
(2) Occurs in your facility or another
facility under contract with you; and
(3) Involves a distributed biological
product.
(c) When do I report under this section?
You should report a biological product
deviation as soon as possible but you
must report at a date not to exceed 45calendar days from the date you, your
agent, or another person who performs
a manufacturing, holding, or distribution step under your control, acquire
information
reasonably
suggesting
that a reportable event has occurred.
(d) How do I report under this section?
You must report on Form FDA–3486.
(e) Where do I report under this section?
(1) For biological products regulated by

the Center for Biologics Evaluation
and Research (CBER), send the completed Form FDA–3486 to the Director,
Office of Compliance and Biologics
Quality (HFM–600) (see mailing addresses in § 600.2), or an electronic filing through CBER’s Web site at http://
www.fda.gov/cber/biodev/biodev.htm.
(2) For biological products regulated
by the Center for Drug Evaluation and
Research (CDER), send the completed
Form FDA–3486 to the Division of Compliance Risk Management and Surveillance (HFD–330) (see mailing addresses
in § 600.2). CDER does not currently accept electronic filings.
(3) If you make a paper filing, you
should identify on the envelope that a
biological product deviation report
(BPDR) is enclosed.
(f) How does this regulation affect other
FDA regulations? This part supplements
and does not supersede other provisions
of the regulations in this chapter. All
biological product deviations, whether
or not they are required to be reported
under this section, should be investigated in accordance with the applicable provisions of parts 211 and 820 of
this chapter.
[65 FR 66634, Nov. 7, 2000, as amended at 70
FR 14982, Mar. 24, 2005]

§ 600.15 Temperatures
ment.

during

The following products shall be maintained during shipment at the specified
temperatures:
(a) Products.
Product
Cryoprecipitated AHF ............
Measles and Rubella Virus
Vaccine Live.
Measles Live and Smallpox
Vaccine.
Measles, Mumps, and Rubella Virus Vaccine Live.
Measles and Mumps Virus
Vaccine Live.
Measles Virus Vaccine Live ..
Mumps Virus Vaccine Live ....
Fresh Frozen Plasma ............
Liquid Plasma ........................
Plasma ...................................

Temperature
¥18 °C or colder.
10 °C or colder.
Do.
Do.
Do.
Do.
Do.
¥18 °C or colder.
1 to 10 °C.
¥18 °C or colder.

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Food and Drug Administration, HHS
Product

Temperature

Platelet Rich Plasma .............

Between 1 and 10 °C if the
label indicates storage between 1 and 6 °C, or all
reasonable methods to
maintain the temperature
as close as possible to a
range between 20 and 24
°C, if the label indicates
storage between 20 and 24
°C.
Between 1 and 10 °C if the
label indicates storage between 1 and 6 °C, or all
reasonable methods to
maintain the temperature
as close as possible to a
range between 20 to 24
°C, if the label indicates
storage between 20 and 24
°C.
0 °C or colder.

Platelets .................................

Poliovirus Vaccine Live Oral
Trivalent.
Poliovirus Vaccine Live Oral
Type I.
Poliovirus Vaccine Live Oral
Type II.
Poliovirus Vaccine Live Oral
Type III.
Red Blood Cells (liquid product).
Red Blood Cells Frozen ........
Rubella and Mumps Virus
Vaccine Live.
Rubella Virus Vaccine Live ...
Smallpox Vaccine (Liquid
Product).
Source Plasma ......................
Source Plasma Liquid ...........
Whole Blood ..........................

Yellow Fever Vaccine ............

§ 600.22

Subpart C—Establishment
Inspection
§ 600.20

Inspectors.

Inspections shall be made by an officer of the Food and Drug Administration having special knowledge of the
methods used in the manufacture and
control of products and designated for
such purposes by the Commissioner of
Food and Drugs, or by any officer,
agent, or employee of the Department
of Health and Human Services specifically designated for such purpose by
the Secretary.
[38 FR 32048, Nov. 20, 1973]

§ 600.21

Do.

Time of inspection.

The inspection of an establishment
for which a biologics license application is pending need not be made until
the establishment is in operation and
is manufacturing the complete product
for which a biologics license is desired.
In case the license is denied following
inspection for the original license, no
reinspection need be made until assurance has been received that the faulty
conditions which were the basis of the
denial have been corrected. An inspection of each licensed establishment and
its additional location(s) shall be made
at least once every 2 years. Inspections
may be made with or without notice,
and shall be made during regular business hours unless otherwise directed.

Do.
Do.
Between 1 and 10 °C.
¥65 °C or colder.
10 °C or colder.
Do.
0 °C or colder.
¥5 °C or colder.
10 °C or colder.
Blood that is transported from
the collecting facility to the
processing facility shall be
transported in an environment capable of continuously cooling the blood toward a temperature range
of 1 to 10 °C, or at a temperature as close as possible to 20 to 24 °C for a
period not to exceed 6
hours. Blood transported
from the storage facility
shall be placed in an appropriate environment to
maintain a temperature
range between 1 to 10 °C
during shipment.
0 °C or colder.

[38 FR 32048, Nov. 20, 1973, as amended at 48
FR 26314, June 7, 1983; 64 FR 56449, Oct. 20,
1999]

§ 600.22

Duties of inspector.

The inspector shall:
(a) Call upon the active head of the
establishment, stating the object of his
visit,
(b) Interrogate the proprietor or
other personnel of the establishment as
he may deem necessary,
(c) Examine the details of location,
construction, equipment and maintenance, including stables, barns, warehouses, manufacturing laboratories,
bleeding clinics maintained for the collection of human blood, shipping
rooms, record rooms, and any other
structure or appliance used in any part
of the manufacture of a product,

(b) Exemptions. Exemptions or modifications shall be made only upon written approval, in the form of a supplement to the biologics license application, approved by the Director, Center
for Biologics Evaluation and Research.
[39 FR 39872, Nov. 12, 1974, as amended at 49
FR 23833, June 8, 1984; 50 FR 4133, Jan. 29,
1985; 50 FR 9000, Mar. 6, 1985; 55 FR 11013,
Mar. 26, 1990; 59 FR 49351, Sept. 28, 1994; 64 FR
56449, Oct. 20, 1999]

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