21cfr1271

Food and Drug Administration, HHS

§ 1271.350

(c) Review and evaluation of complaints. You must review and evaluate
each complaint relating to core CGTP
requirements to determine if the complaint is related to an HCT/P deviation
or to an adverse reaction, and to determine if a report under § 1271.350 or another applicable regulation is required.
As soon as practical, you must review,
evaluate, and investigate each complaint that represents an event required to be reported to FDA, as described in § 1271.350. You must review
and evaluate a complaint relating to
core CGTP requirements that does not
represent an event required to be reported to determine whether an investigation is necessary; an investigation
may include referring a copy of the
complaint to another establishment
that performed manufacturing steps
pertinent to the complaint. When no
investigation is made, you must maintain a record that includes the reason
no investigation was made, and the
name of the individual(s) responsible
for the decision not to investigate.

Subpart E—Additional Requirements for Establishments Described in § 1271.10
SOURCE: 69 FR 68686, Nov. 24, 2004, unless
otherwise noted.

§ 1271.330

Applicability.

The provisions set forth in this subpart are being implemented for nonreproductive HCT/Ps described in
§ 1271.10 and regulated solely under section 361 of the Public Health Service
Act and the regulations in this part,
and for the establishments that manufacture those HCT/Ps. HCT/Ps that are
drugs or devices regulated under the
act, or are biological products regulated under section 351 of the Public
Health Service Act, are not subject to
the regulations set forth in this subpart.
§ 1271.350

Reporting.

(a) Adverse reaction reports. (1) You
must investigate any adverse reaction
involving a communicable disease related to an HCT/P that you made available for distribution. You must report

to FDA an adverse reaction involving a
communicable disease if it:
(i) Is fatal;
(ii) Is life-threatening;
(iii) Results in permanent impairment of a body function or permanent
damage to body structure; or
(iv) Necessitates medical or surgical
intervention, including hospitalization.
(2) You must submit each report on a
Form FDA–3500A to the address in
paragraph (a)(5) of this section within
15 calendar days of initial receipt of
the information.
(3) You must, as soon as practical, investigate all adverse reactions that are
the subject of these 15-day reports and
must submit followup reports within 15
calendar days of the receipt of new information or as requested by FDA. If
additional information is not obtainable, a followup report may be required
that describes briefly the steps taken
to seek additional information and the
reasons why it could not be obtained.
(4) You may obtain copies of the reporting form (FDA–3500A) from the
Center for Biologics Evaluation and
Research (see address in paragraph
(a)(5) of this section). Electronic Form
FDA–3500A may be obtained at http://
www.fda.gov/medwatch or at http://
www.hhs.gov/forms.
(5) You must submit two copies of
each report described in this paragraph
to the Center for Biologics Evaluation
and Research (HFM–210), Food and
Drug Administration, 1401 Rockville
Pike, suite 200N, Rockville, MD 20852–
1448. FDA may waive the requirement
for the second copy in appropriate circumstances.
(b) Reports of HCT/P deviations. (1)
You must investigate all HCT/P deviations related to a distributed HCT/P
for which you performed a manufacturing step.
(2) You must report any such HCT/P
deviation relating to the core CGTP requirements, if the HCT/P deviation occurred in your facility or in a facility
that performed a manufacturing step
for you under contract, agreement, or
other arrangement. Each report must
contain a description of the HCT/P deviation, information relevant to the
event and the manufacture of the HCT/
P involved, and information on all follow-up actions that have been or will

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§ 1271.370

21 CFR Ch. I (4–1–06 Edition)

be taken in response to the HCT/P deviation (e.g., recalls).
(3) You must report each such HCT/P
deviation that relates to a core CGTP
requirement on Form FDA–3486 available at http://www.fda.gov/cber/biodev/
bpdrform.pdf, within 45 days of the discovery of the event either electronically at http://www.fda.gov/cber/biodev/
biodevsub.htm or by mail to the Director, Office of Compliance and Biologics
Quality, Center for Biologics Evaluation and Research (HFM–600), 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448.
§ 1271.370

Labeling.

The following requirements apply in
addition to §§ 1271.55, 1271.60, 1271.65,
and 1271.90:
(a) You must label each HCT/P made
available for distribution clearly and
accurately.
(b) The following information must
appear on the HCT/P label:
(1) Distinct identification code affixed to the HCT/P container, and assigned in accordance with § 1271.290(c);
(2) Description of the type of HCT/P;
(3) Expiration date, if any; and
(4)
Warnings
required
under
§ 1271.60(d)(2),
§ 1271.65(b)(2),
or
§ 1271.90(b), if applicable and physically
possible. If it is not physically possible
to include these warnings on the label,
the warnings must, instead, accompany
the HCT/P.
(c) The following information must
either appear on the HCT/P label or accompany the HCT/P:
(1) Name and address of the establishment that determines that the HCT/P
meets release criteria and makes the
HCT/P available for distribution;
(2) Storage temperature;
(3) Other warnings, where appropriate; and
(4) Instructions for use when related
to the prevention of the introduction,
transmission, or spread of communicable diseases.
[69 FR 68686, Nov. 24, 2004, as amended at 70
FR 29952, May 25, 2005]

Subpart F—Inspection and Enforcement of Establishments
Described in § 1271.10
SOURCE: 69 FR 68687, Nov. 24, 2004, unless
otherwise noted.

§ 1271.390

Applicability.

The provisions set forth in this subpart are applicable only to HCT/Ps described in § 1271.10 and regulated solely
under section 361 of the Public Health
Service Act and the regulations in this
part, and to the establishments that
manufacture those HCT/Ps. HCT/Ps
that are drugs or devices regulated
under the act, or are biological products regulated under section 351 of the
Public Health Service Act, are not subject to the regulations set forth in this
subpart.
§ 1271.400

Inspections.

(a) If you are an establishment that
manufactures HCT/Ps described in
§ 1271.10, whether or not under contract,
you must permit the Food and Drug
Administration (FDA) to inspect any
manufacturing location at any reasonable time and in a reasonable manner
to determine compliance with applicable provisions of this part. The inspection will be conducted as necessary in
the judgment of the FDA and may include your establishment, facilities,
equipment, finished and unfinished materials, containers, processes, HCT/Ps,
procedures, labeling, records, files, papers, and controls required to be maintained under the part. The inspection
may be made with or without prior notification and will ordinarily be made
during regular business hours.
(b) The frequency of inspection will
be at the agency’s discretion.
(c) FDA will call upon the most responsible person available at the time
of the inspection of the establishment
and may question the personnel of the
establishment as necessary to determine compliance with the provisions of
this part.
(d) FDA’s representatives may take
samples, may review and copy any
records required to be kept under this
part, and may use other appropriate

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