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Related post: storage generally occur shortly after beginning distribution. Various time
periods were recommended as alternatives. Several comments suggested a
retention period of 2 years after the batch was approved for marketing.
The Commissioner finds that these records must be available for review for
a reasonable time period beyond the expiration date of the products covered in
the records to provide an opportunity for appropriate followup of any complaints
or other adverse reports received during the entire marketing period. In
reconsidering the extent of such retention period in light of the comments,
however, the Commissioner has determined that a 1-year period following the
expiration date will generally be adequate to assure that the records will be
available for review if necessary. In the case of certain OTC drug products not
being required to bear an expiration date because they meet the criteria for
exemption under 211.137, the record retention period is 3 years after
distribution of the batch. This 3-year period is considered appropriate because
the exemption is based on an assumption that such products will be used within 3
years after manufacture. Therefore, record retention for 3 years after
distribution should be adequate to cover the time period during which records
are most likely to be needed. The Commissioner recognizes that these final
regulations will require retention of records beyond that currently required in
the CGMP regulations. The CGMP regulations require the retention of certain
records, e.g., batch production and control records, for time periods that are
based on the distribution of the lot or, where applicable, the expiration date
of the batch. The current regulations do not clearly specify the record
retention period for other records. For some firms, the retention period for
records will not change as a result of this regulation, as their practice is
being incorporated in these regulations. In other cases, however, these
regulations will require retention of records for a period of time longer than
the minimum retention period specified in previous CGMP regulations. With
specific regard to physical space for the storage of records, the Commissioner
advises that the regulations do not generally require retention of original
records, and that retention of suitable true copies in other forms such as
microfilm is permitted. The Commissioner believes that, in keeping with modern
business practices, there are many record retention systems that would fulfill
the intent of the record retention provisions. Section 211.180(d) of the final
regulations specifically provides for this flexibility.
424. One comment said 211.180 should be deleted because section 703 of the
act prescribes the maintenance of certain records that show the movement of
articles in interstate commerce and does not mention the retention of records as
described in 211.180.
The Commissioner disagrees with this comment. Section 703 of the act
permits FDA access to records of interstate shipment in the possession of
carriers (i.e., transportation companies) or other persons receiving or holding
food, drugs, devices, or cosmetics in interstate commerce. The provisions of
section 703 do not apply to the manufacturers of drug products insofar as
records of production are concerned.
425. One comment suggested that retention of records for components that
have an indefinite stability or components that are used only occasionally to
produce batches of drug products be excluded from 211.180(b).
The Commissioner rejects this suggestion. The retention period is related
to the expiration dates of the batches of drug products containing that batch of
the component in order to assure that the records would be available for review
during the marketing of the drug products and for a reasonable period
thereafter. The Commissioner seriously questions whether any drug product can
be considered indefinitely stable or would in fact carry an expiration date that
would require record retention for an extraordinarily long time. Finally, the
Commissioner notes that because the manufacturer has discretion to establish an
expiration date that is less than the actual stability of the drug product, the
manufacturer also has reasonable control over the periods during which he must
426. One comment said 211.180(b) is overly inclusive and should be reworded
to include only those components that come in actual contact with the drug
The Commissioner is unclear on the use of the word "component" in this
comment. The definition of "component" appearing in the CGMP regulations would
only include ingredients intended for use in the manufacture of a drug product,
including those that may not appear in the final product. Section 211.180(b)
limits records to components actually incorporated in the drug product. Thus,
it seems obvious that the regulations only apply to components "that come into
actual contact with the drug product" as requested in this comment. Therefore,
the Commissioner cannot agree that the requirement as proposed is too extensive,
and he sees no justification for revisions in the language in this paragraph.
427. Some comments suggested that reference to drug product containers and
closures be deleted because these items are not subject to deterioration. One
comment suggested that the requirement be retained for parenterals only.
The Commissioner does not agree that reference to container/closure record
retention should be deleted because they are not subject to deterioration. The
Commissioner is aware that some container/closure systems are subject to
deterioration and there are other possible problems with containers and closures
that may adversely affect the drug product. The purpose and intent of
recordkeeping requirements is to be able to trace the complete history of a
batch and thereby enable a firm and FDA to investigate fully any problems that
may arise with either the product, the container/closure system, or both.
Complete records would also make possible a determination of whether or not
other batches or other drug products are or could be involved with the same
problem. The failure to have these records available for any investigation could
prevent the resolution of an undesirable condition. Therefore, the Commissioner
is retaining this requirement to include all drug product containers and
428. A comment on 211.180(b) was submitted regarding the retention of
records for compressed medical gases. The comment, which assumed that
expiration dating would not be required for compressed medical gases, requested
a retention period to be some logical and meaningful period.
The Commissioner finds that there is no justification for Buy Keftab excluding
retention of records required for compressed medical gases under this paragraph.
The Commissioner has also decided to require expiration dating for medical
428a. Several comments objected to reference to recordkeeping and record
inspection requirements in proposed 211.180 (c) and (d) insofar as they apply to
over-the-counter (OTC) drugs and to "not new" drugs. These comments pointed out
that section 704(a) of the act authorizes inspection of records regarding
prescription drugs only and inspection of records regarding research data only
on "new drugs" subject to section 505 of the act. One comment cited extensively
from the legislative history of section 704 of the act indicating a
congressional intent to limit the scope of inspection granted to FDA.
The Commissioner has reviewed the legislative history of the 1953
amendments (Pub. L. 83-217), which originally enacted section 704(a) of the act,
as well as the amendments contained in the Drug Amendments of 1962 (Pub. L. 87-
781 (1961)), which extended FDA's authority to review records for prescription
drugs under the mandatory inspection authority of section 704 of the act. He
finds that Congress did not include in the scope of the inspection authority
under section 704 of the act (and its concomitant enforcement section under
section 301(f) of the act) authority to inspect records regarding the
manufacture of OTC drug products or research data on prescription drugs that are
not "new drugs" as defined in section 201(p) of the act. The Commissioner also
finds, however, that section 704 of the act does not exhaust the varieties of
inspections that FDA may be authorized to make regarding such drug products.
Manufacture of any drug product without compliance with current good
manufacturing practices renders the product adulterated, a prohibited act under
section 301(b) of the act and a Federal crime under section 303 of the act.
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