21cfr1271

Food and Drug Administration, HHS

§ 1271.155

(iii) Before entering into a contract,
agreement, or other arrangement with
another establishment to perform any
step in manufacture for you, you must
ensure that the establishment complies
with applicable CGTP requirements. If,
during the course of this contract,
agreement, or other arrangement, you
become aware of information suggesting that the establishment may no
longer be in compliance with such requirements, you must take reasonable
steps to ensure the establishment complies with those requirements. If you
determine that the establishment is
not in compliance with those requirements, you must terminate your contract, agreement, or other arrangement with the establishment.
(2) If you are the establishment that
determines that an HCT/P meets all release criteria and makes the HCT/P
available for distribution, whether or
not you are the actual distributor, you
are responsible for reviewing manufacturing and tracking records to determine that the HCT/P has been manufactured and tracked in compliance
with the requirements of this subpart
and subpart C of this part and any
other applicable requirements.
(3) With the exception of §§ 1271.150(c)
and 1271.155 of this subpart, the regulations in this subpart are not being implemented for reproductive HCT/Ps described in § 1271.10 and regulated solely
under section 361 of the Public Health
Service Act and the regulations in this
part, or for the establishments that
manufacture them.
(d) Compliance with parts 210, 211, and
820 of this chapter. With respect to HCT/
Ps that are drugs (subject to review
under an application submitted under
section 505 of the Federal Food, Drug,
and Cosmetic Act or under a biological
product license application under section 351 of the Public Health Service
Act) or that are devices (subject to premarket review or notification under
the device provisions of the act or
under a biological product license application under section 351 of the Public Health Service Act), the procedures
contained in this subpart and in subpart C of this part and the current good
manufacturing practice regulations in
parts 210 and 211 of this chapter and the
quality system regulations in part 820

of this chapter supplement, and do not
supersede, each other unless the regulations explicitly provide otherwise. In
the event that a regulation in part 1271
of this chapter is in conflict with a requirement in parts 210, 211, or 820 of
this chapter, the regulations more specifically applicable to the product in
question will supersede the more general.
(e) Where appropriate. When a requirement is qualified by ‘‘where appropriate,’’ it is deemed to be ‘‘appropriate’’ unless you can document justification otherwise. A requirement is
‘‘appropriate’’ if nonimplementation of
the requirement could reasonably be
expected to result in the HCT/P not
meeting its specified requirements related to prevention of introduction,
transmission, or spread of communicable diseases, or in your inability to
carry out any necessary corrective action.
§ 1271.155 Exemptions
and
alternatives.
(a) General. You may request an exemption from or alternative to any requirement in subpart C or D of this
part.
(b) Request for exemption or alternative.
Submit your request under this section
to the Director of the appropriate Center (the Director), e.g., the Center for
Biologics Evaluation and Research or
the Center for Devices and Radiological Health. The request must be accompanied by supporting documentation, including all relevant valid scientific data, and must contain either:
(1) Information justifying the requested exemption from the requirement, or
(2) A description of a proposed alternative method of meeting the requirement.
(c) Criteria for granting an exemption
or alternative. The Director may grant
an exemption or alternative if he or
she finds that such action is consistent
with the goals of protecting the public
health and/or preventing the introduction, transmission, or spread of communicable diseases and that:
(1) The information submitted justifies an exemption; or
(2) The proposed alternative satisfies
the purpose of the requirement.

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§ 1271.160

21 CFR Ch. I (4–1–06 Edition)

(d) Form of request. You must ordinarily make your request for an exemption or alternative in writing (hard
copy or electronically). However, if circumstances make it difficult (e.g.,
there is inadequate time) to submit
your request in writing, you may make
the request orally, and the Director
may orally grant an exemption or alternative. You must follow your oral
request with an immediate written request, to which the Director will respond in writing.
(e) Operation under exemption or alternative. You must not begin operating
under the terms of a requested exemption or alternative until the exemption
or alternative has been granted. You
may apply for an extension of an exemption or alternative beyond its expiration date, if any.
(f) Documentation. If you operate
under the terms of an exemption or alternative, you must maintain documentation of:
(1) FDA’s grant of the exemption or
alternative, and
(2) The date on which you began operating under the terms of the exemption or alternative.
(g) Issuance of an exemption or alternative by the Director. In a public health
emergency, the Director may issue an
exemption from, or alternative to, any
requirement in part 1271. The Director
may issue an exemption or alternative
under this section if the exemption or
alternative is necessary to assure that
certain HCT/Ps will be available in a
specified location to respond to an unanticipated immediate need for those
HCT/Ps.
§ 1271.160 Establishment and maintenance of a quality program.
(a) General. If you are an establishment that performs any step in the
manufacture of HCT/Ps, you must establish and maintain a quality program intended to prevent the introduction, transmission, or spread of communicable diseases through the manufacture and use of HCT/Ps. The quality
program must be appropriate for the
specific HCT/Ps manufactured and the
manufacturing steps performed. The
quality program must address all core
CGTP
requirements
listed
in
§ 1271.150(b).

(b) Functions. Functions of the quality program must include:
(1) Establishing and maintaining appropriate procedures relating to core
CGTP requirements, and ensuring compliance with the requirements of
§ 1271.180 with respect to such procedures, including review, approval, and
revision;
(2) Ensuring that procedures exist for
receiving, investigating, evaluating,
and documenting information relating
to core CGTP requirements, including
complaints, and for sharing any information pertaining to the possible contamination of the HCT/P or the potential for transmission of a communicable disease by the HCT/P with the
following:
(i) Other establishments that are
known to have recovered HCT/Ps from
the same donor;
(ii) Other establishments that are
known to have performed manufacturing steps with respect to the same
HCT/P; and
(iii) Relating to consignees, in the
case of such information received after
the HCT/P is made available for distribution, shipped to the consignee, or
administered to the recipient, procedures must include provisions for assessing risk and appropriate followup,
and evaluating the effect this information has on the HCT/P and for the notification of all entities to whom the affected HCT/P was distributed, the quarantine and recall of the HCT/P, and/or
reporting to FDA, as necessary.
(3) Ensuring that appropriate corrective actions relating to core CGTP requirements, including reaudits of deficiencies, are taken and documented, as
necessary. You must verify corrective
actions to ensure that such actions are
effective and are in compliance with
CGTP. Where appropriate, corrective
actions must include both short-term
action to address the immediate problem and long-term action to prevent
the problem’s recurrence. Documentation of corrective actions must include,
where appropriate:
(i) Identification of the HCT/P affected and a description of its disposition;
(ii) The nature of the problem requiring corrective action;

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