XXI  SEQ CHAPTER \h \r 1 .  Comments on Records and Recordkeeping 

(Final Subpart P)

A.  Organization of Final Subpart P

     In the 2003 CGMP Proposal, the requirements for records and
recordkeeping were set forth in proposed § 111.125.   As shown in table
17, we are reorganizing the requirements for records and recordkeeping
into a distinct subpart (final Subpart P – Records and Recordkeeping).
 Table 17 lists the sections in final Subpart P and identifies the
proposed provisions that form the basis for the final rule. 

Table 17. - Derivation of Sections in Final Subpart P

Final Rule	2003 CGMP Proposal

§ 111.605  What Requirements Apply to the Records You Make and Keep?	§
111.125(a) and (b)

§ 111.610 What Records Must be Made Available to FDA?	§ 111.125(b) and
(c)



  B.  Highlights of Changes to the Proposed Requirements 

for Records and Recordkeeping 

1.  Revisions

    The final rule reflects that it applies to persons who manufacture,
package, label, or hold a dietary supplement unless subject to an
exclusion in § 111.1. 

2.  Changes After Considering Comments

	This final rule requires you to keep written records required by this
subpart for either one year past the shelf life date, if shelf life
dating is used, or 3 years beyond the date of distribution of the last
batch of dietary supplements associated with those records (final §
111.605(a)).

C.  General Comments on Proposed § 111.125

     (Comment 324) Some comments support the requirements in proposed §
111.125 because documentation helps to ensure CGMPs are consistently
followed and retention of records provides an effective trail when
subsequent problems need to be identified and corrected.

     Another comment asserts the recordkeeping requirements would
represent a large burden for companies that manufacture vitamin and
mineral supplements with a large number of active ingredients. 

     (Response)  We agree that records are useful in identifying
manufacturing problems and tracking the source of failures in CGMPs.  

	We understand the burden on manufacturers may be heavier for
manufacturers who use many dietary ingredients and discuss the burden of
the recordkeeping requirements in sections XXVIII and XXIV. However, we
do not believe that a manufacturer who elects to put several components
into one finished batch of dietary supplement would have any larger
burden than one who, instead, elects to manufacture multiple dietary
supplements each containing one component.  A manufacturer can decide
whether it wants to manufacture and market a dietary supplement
containing a single component or ingredient or one containing multiple
components or ingredients.  We believe that the requirements, for
example, for ensuring the identity, purity, strength, and composition of
each component in a dietary supplement, need to be the same for a
dietary supplement containing one ingredient or component and one
containing multiple ingredients or components.  To the extent the
comment is suggesting that the recordkeeping requirements for those who
manufacture multivitamin/mineral dietary supplements (containing
components) are too large and should be less, the comment provided no
basis for such a suggestion,     

 

D.  What Requirements Apply to the Records You Make and Keep?

 (Final § 111.605)

1.  Final § 111.605(a)

     Final § 111.605(a) requires you to keep written records for 1 year
past the shelf life date, if shelf life dating is used, or 3 years
beyond the date of distribution of the last batch of dietary supplements
associated with those records.  Final § 111.605(a) derives from
proposed § 111.125(a). 

     (Comment 325) Several comments suggest that the requirement in
proposed § 111.125(a) to keep records for 3 years beyond the date of
manufacture should be modified.  One comment favors record retention for
3 years beyond the date of manufacture or for the shelf life of the
product, whichever is longer.  Some comments state the rule should
require establishment of an expiration date and that the manufacturer
should have the option of retaining records for 1 year beyond the
expiration date, when an expiration date has been established by the
manufacturer.  Some comments point out that under section 306(a) of the
Bioterrorism Act, FDA is authorized to issue recordkeeping regulations
with a record retention period of “not longer than two years.”  One
comment, therefore, asserts CGMP records should not be kept for more
than 2 years. 

     (Response)  We believe a record retention period for records
related to CGMP requirements should correlate generally with the length
of time that the dietary supplement is likely to be in the marketplace,
including the time during which consumers may be using such product, and
generally, with the length of time between facility inspections.  Such
correlation will increase the likelihood that if a problem with a
dietary supplement is identified that may be associated with a violation
of CGMP, the dietary supplement manufacturer, packager, labeler, or
holder will have access to the CGMP records associated with that dietary
supplement.  In addition, we will have access to such records at
inspection.

For non-high risk establishments, we (in conjunction with State
agencies) generally inspect food establishments at an annual rate of
once every 3.4 years.  We believe that 3 years is a reasonable estimate
of the time most dietary supplements are in the marketplace after
distribution.  When a dietary supplement has a shelf life date (or
expiration date) we believe that the dietary supplement would be
expected to remain in the marketplace only for one year past the shelf
life date.  Therefore, we believe that a period of one year past the
shelf life date would provide a reasonable period during which consumers
may still be using the product and the CGMP records could be needed in
the event of a product complaint.  It is important to note that, as
discussed in this section, the term “shelf life dating,” includes
shelf life dating as well as expiration dating and “best if used by”
dating.  A 3 year period is similar to other foods (e.g., canned foods)
which we expect to remain in the marketplace for extended periods of
time (see §§ 108.25(g), 113.100(e), and 114.100(e)).  

Maintaining records for 3 years after the date of distribution of the
last batch of dietary supplements associated with those records may
create unnecessary recordkeeping requirements for manufacturers that
have determined and declared a shelf life for their product.  For
example, if the shelf-life of the product was only one year, it would be
unlikely that there would be a need to keep records for 3 years, rather
than for 2 years (1 year past the shelf life date), since consumers
would be unlikely to purchase such outdated product and retailers would
be unlikely to keep it on their shelves. 

We disagree with the comment that suggests we require an expiration date
on all products.  Many products will not have a determinable expiration
date due to the state of knowledge about these products.  We believe the
manufacturer is in the best position to determine if its product
requires an expiration date.

Finally, we disagree with the comments stating a record retention period
beyond 2 years is in conflict with the Bioterrorism Act regulations. 
Section 306 of the Bioterrorism Act amended the act by adding section
414; it did not amend section 402(g) which provides the authority for
this final rule.  Therefore, for purposes of this final rule, we are not
bound by the two year retention period established under the
Bioterrorism Act.  Although the products regulated by the Bioterrorism
Act encompass the dietary supplement products regulated by this final
rule and the ultimate goal of both is to protect the public health, the
purpose of the two provisions is different.  The Bioterrorism Act’s
recordkeeping provisions provide that the Secretary, may by regulation,
establish requirements regarding the establishment and maintenance, for
not longer than 2 years, of records by persons (excluding farms and
restaurants) who manufacture, process, pack, transport, distribute,
receive, hold, or import food.  The records required to be kept by the
Bioterrorism regulations are those needed by the Secretary for
inspection to allow the Secretary to identify the immediate previous
sources and immediate subsequent recipients of food, including its
packaging, to address credible threats of serious adverse health
consequences or death to humans or animals.  FDA envisions using these
records primarily in “traceback” investigations to trace backwards
to locate the source of any similarly adulterated food, then to trace
forward from that source point to all other locations where similarly
adulterated food has been shipped.  The records are needed not only to
help remove contaminated food from commerce, but also to help identify
the source of the contamination.  

Records required to be maintained under this final rule are focused on
the manufacture, packaging, labeling, and holding of dietary supplements
under CGMP.  The purpose of the recordkeeping requirements is not
limited to addressing credible threats of serious adverse health
consequences or death to humans and animals through the identification
of immediate previous sources and immediate subsequent recipients of
food.  The records must be retained for a sufficient period of time to
ensure that the records are available during the period that the dietary
supplements are likely to be in the marketplace (and consumed by
consumers).  

We recognize that some of the products covered by the Bioterrorism Act
may be in commerce longer than two years and consumed by consumers after
this time; however, the Bioterrorism Act expressly limited the period of
time that we could require records to be retained in any regulations
issued under that authority to two years; thus, we were not able to
require longer retention periods in that rule.  As noted above, this
CGMP rule is not being issued under the authority in section 414 of the
act and thus there is no similar limitation.  

Because many dietary supplements are expected to have a shelf life
longer than 2 years, we believe it is important for the manufacturer,
packager, labeler, holder, and us to have access to CGMP records while
the dietary supplement is in the marketplace and for the period between
our expected inspection cycle. 

     (Comment 326)  One comment requests clarification of the “date of
manufacture.”  The comment asserts if an expiration date is shown on
the label of a product, the date of manufacture should be considered to
be the date on which the expiration date is based.  The comment gives an
example of vitamin C tablets having a two year shelf life.  The comment
explains if the tablets are compressed, tested, and approved for
packaging in August 2003, they would generally be assigned an expiration
date of August 2005 regardless of the date of packaging.  The comment
argues if the tablets are held and later packaged in February 2004,
records for this batch should only have to be kept for 1 year beyond the
expiration date (i.e., August 2006), rather than 3 years beyond the
packaging date (i.e., February 2007).

     (Response)  In the scenario described above, where an expiration
date (shelf life) has been determined, records for this batch must only
be kept for 1 year beyond the expiration date (i.e., shelf life date). 
The packaging date in the above scenario has no effect on the amount of
time records must be kept.  However, in the final rule, we have decided
that it is more appropriate to determine the record retention period
from the date of distribution rather than the “date of manufacture.”
The date on which the manufacturer completes the manufacture of a batch
of a dietary supplement (the date of manufacture) does not necessarily
indicate the availability of the dietary supplement product in the
marketplace.  It is possible that such product could be held for a
period of time before entry into the marketplace and possible consumer
consumption.  A more accurate time period for entry is calculated by the
date of distribution.  Final § 111.605(a)(2) requires that
manufacturers, packagers, labelers, and holders keep their records for 3
years from the date of distribution of the last batch of dietary
supplement associated with those records.  For products with a shelf
life date, the records associated with those dietary supplements are
required to be kept for one year past the shelf life date of that
particular dietary supplement.  Packagers and labelers that return the
product to the manufacturer for distribution are not required to keep
separate records under this subpart.

2.  Final § 111.605(b)

     Final § 111.605(b) requires you to keep records as original
records, true copies (such as photocopies, microfilm, etc.), or as
electronic records.  Final § 111.605(b) derives from proposed §
111.125(b).  

     We did not receive comments specific to proposed § 111.125(b).

3.  Final § 111.605(c)

     Final § 111.605(c) requires that all electronic records comply
with part 11 of this chapter. Final § 111.605(c) derives from proposed
§ 111.125(b).

     (Comment 327) One comment believes part 11 should only apply to
records that do not have paper counterparts. 

     (Response) This comment is beyond the scope of this CGMP
rulemaking.

     (Comment 328) One comment suggests the proposed requirement that
CGMP electronic records must comply with part 11 should be deleted
because the FDA guidelines on part 11 have not yet been finalized.

     (Response) Part 11 applies to electronic CGMP records.  Therefore,
final § 111.605(c) requires that all electronic records, including
electronic signatures, must comply with part 11.  We have finalized
guidance for industry.  The guidance entitled “Part 11, Electronic
Records; Electronic Signatures Scope and Application,” sets out our
enforcement policies with respect to certain aspects of part 11. (Ref.
30) The guidance is available at http://  HYPERLINK
"http://www.fda.gov/cder/guidance/"  www.fda.gov/cder/guidance/
5667fnl.htm.  

The guidance applies to any CGMP electronic records and signatures. 

E.  What Records Must be Made Available to FDA?

 (Final § 111.610)

1.  Final § 111.610(a)

     Final § 111.610(a) requires you to keep records, or copies of such
records, required by this final rule, readily available during the
retention period for inspection and copying by FDA when requested. 
Final § 111.610(a) derives from proposed § 111.125(c).  We responded
to comments that we received on FDA's statutory authority to inspect and
copy records in section V.  We made one editorial, non-substantive
change from the language in proposed § 111.125(c).  We removed the word
“authorized” to prevent any confusion regarding whether some
authorization other than the statutory authority that provides the legal
basis for this final rule is necessary for our access to inspect and
copy records.

2.  Final § 111.610(b)

     Final § 111.610(b) requires that if you use reduction techniques,
such as microfilming, you must make suitable reader and photocopying
equipment readily available to us.  Final § 111.610(b) derives from
proposed § 111.125(b).

     We did not receive any comments specific to proposed § 111.125(b)
and final § 111.610(b). 

XXII.   Other Comments and Miscellaneous

A.  Comments on Guidance Documents to be Used

with the Final Rule 

In the 2003 CGMP Proposal, we invited comment on the usefulness of
guidance documents, education, training, or other approaches and
potential sources of education and training that would assist industry
efforts to implement the 2003 CGMP Proposal, if finalized as proposed
(68 FR 12157 at 12163).

     (Comment 329) A few comments state booklets, videos, seminars, and
other training would be useful on topics such as sanitation,
recordkeeping, quality assurance methods, microbiological testing, and
botany.  Another comment states a subset of CGMPs that focuses on plant
authenticity, purity, proper handling, and hygiene should be developed
for parties who exclusively deal with bulk raw agricultural commodities
(with the exception of individual wildcrafters).  If such CGMPs are not
developed, the comment requests we develop guidance documents on the
identification, cultivation, and handling of botanicals.  The same
comment also notes guidance specifically is needed on the use of
microscopy to identify plants. 

     (Response) We acknowledge these comments and, in the future, we may
issue guidance that relates to certain dietary supplement CGMP
requirements. 

B.  Comments on Consideration for Other CGMP Programs

     (Comment 330) One comment asserts several existing dietary
supplement CGMP programs (e.g., those developed by the NNFA, NSF
International, ANSI, and USP) are well designed and represent useful
examples for us to follow.  The comment notes section 12(d) of the
National Technology Transfer and Advancement Act directs Federal
agencies to use such voluntary consensus standards whenever possible, as
long as the standards are consistent with federal law and are practical.
 The comment recommends we include standards from these existing CGMP
programs where suitable in the final rule. 

      (Response) In the development of the 2003 CGMP Proposal and this
final rule, we carefully considered the comments that recommended
aspects of other CGMP programs.  For example, as discussed previously,
the ANPRM for this rule contained the entire text of an outline
presented to us by representatives of the dietary supplement industry. 
Furthermore, where comments recommended aspects of other CGMP programs,
we considered those recommendations and, in some cases, incorporated
certain recommendations into requirements in this final rule (e.g., the
use of a certificate of analysis).      

     (Comment 331) Another comment states CGMPs that reflect common
elements and areas of uniqueness should be placed in sub-categories of
CGMPs as is the case with the current food CGMP model.  The comment
recommends we follow a similar approach and establish sub-categories of
CGMPs for dietary supplements (e.g., for vitamin-mineral and probiotic
tablets). 

     (Response) In the 1997 ANPRM, we asked for comment about whether
broad CGMP regulations would be adequate, or whether it would be
necessary to address the operations of particular segments of the
dietary supplement industry (68 FR 12157 at 12174).  Based on the
comments received to the 1997 ANPRM, we were persuaded that a broad
final rule is preferable to multiple regulations focused on particular
segments of the dietary supplement industry, or to general CGMP
provisions plus subcategories applicable to segments of the dietary
supplement industry.  We stated in the 2003 CGMP Proposal that we would
consider whether we needed to reevaluate our decision to establish one
set of requirements for all dietary supplements (id.).  This comment did
not provide any basis to persuade us to reevaluate the decision we made
that a broad CGMP rule was appropriate.  Thus, in this final rule, we
are establishing one set of requirements for all persons who
manufacture, package, label, or hold dietary supplements and not subject
to an exclusion under final § 111.1.  

C.  Comments on Public Involvement

1.  Public Involvement

    (Comment 332) Several comments express general concerns with our
public involvement process.  Several comments state additional public
meetings and workshops are necessary to permit FDA, industry, and other
stakeholders to work together to seek a more workable solution to
dietary supplement CGMPs and to resolve differences of opinion.  One
comment states the differences of opinion identified by the comment
process will not be meaningfully resolved without active and forthright
communication with stakeholders.  According to the comment, we should
establish a forum prior to the publication of the final rule to
communicate our perception of these differences of opinion.  Another
comment - a trade association – expresses disappointment that our 2003
CGMP Proposal disregards industry efforts to draft CGMPs over the last
decade.  Another comment contends the proposal was rushed and the
comment period was established without publication of a core economic
analysis to support it.

     (Response) We disagree with these comments.  We believe there has
been sufficient public involvement given the public meetings that were
held and the opportunity for comment during the comment periods
provided.  We discuss the public involvement in section I.  Further, the
2003 CGMP Proposal did contain an economic analysis.  We received
extensive comments on the economic analysis in the 2003 CGMP Proposal. 
We have made several changes to the economic analysis of this final rule
in response to these comments as discussed in section XXIV. 
Furthermore, we have made various changes in response to comments to the
CGMP requirements in this final rule.

    

D.  Comments on Implementation and Enforcement

    (Comment 333) Several comments suggest postponing the effective date
of the rule for 24 months to allow a voluntary inspection and compliance
program to take effect in the interim.  One comment recommends adoption
of a voluntary program similar to that of OSHA regulations in Volume 29
of the CFR, where companies would invite FDA inspection without penalty
or cost unless a serious violation occurs.  In cases of serious
violation, companies would have the option to voluntarily correct the
problem and inform the public before the effective date of the rule. 

     (Response) We disagree with these comments regarding the
establishment of a voluntary compliance period.  The effective date of
this final rule is 60 days after its publication in the Federal
Register.  However, as discussed in section VI and XXIV, we have
staggered compliance dates to 12 months, 24 months, and 36 months,
respectively, after the final rule’s publication date for businesses
of over 500 employees, businesses with under 500 employees but 20 or
more employees, and businesses with less than 20 employees.

     (Comment 334) Several comments indicate they want differential
treatment under the final rule based on the seriousness of a violation,
others ask for strict enforcement, and others ask how FDA would enforce
against those who continually adulterate dietary supplements. 

     (Response) We consider these comments to be outside the scope of
this final rule.  In general, we would provide guidance on our
enforcement policy through the issuance of guidance documents if we
determine that any variance from full enforcement is warranted.

     (Comment 335) Another comment expresses concern the 2003 CGMP
Proposal works at “cross purposes” with recent regulations
associated with bioterrorism.  The comment recommends these rules be
harmonized to reduce costs and increase efficiencies for manufacturers. 
   

     (Response) It is not clear what the comment means when it states
the 2003 CGMP Proposal works at “cross purposes” with the
regulations issued under the Bioterrorism Act or that we should
“harmonize” the regulations issued under the Bioterrorism Act with
the final rule establishing dietary supplement CGMP requirements.  We
have made every effort to consider the regulations issued under the
Bioterrorism Act and their relationship to this final rule.  As
discussed in this section, there are different purposes to the
Bioterrorism Act and these CGMP requirements; however, we have
harmonized to the extent possible.  We are not making any changes in
response to this comment.

     (Comment 336) One comment states the 1-year compliance period for
large firms is reasonable as long as we modify the rule to better
reflect existing CGMPs already in practice among responsible companies. 
The comment also notes the 3-year compliance period for small firms may
be reasonable, but urges us to enforce compliance of basic food GMP
requirements, which some of these firms may not be observing.  

     (Response) The effective date for this final rule is 60 days from
its date of publication in the Federal Register, though we are
staggering the compliance dates as described in sections VI and XXIV. 
Dietary supplement products in the marketplace must already be in
compliance with all other statutory and regulatory provisions that
affect dietary supplements under this chapter.

E. Removal of References to Part 112

	The 2003 CGMP Proposal (68 FR 12157 at 12175) had proposed the heading
and table of contents for part 112.  Proposed part 112 had the heading
“Restrictions for Substances Used in Dietary Supplements.”  At the
time, we said that it was necessary to amend part 112 because at that
time the 2003 CGMP Proposal for dietary supplements containing ephedrine
alkaloids (62 FR 30678, June 4, 1997) had not been finalized and
included proposed revisions to part 111.  The 2003 CGMP Proposal for
dietary supplement CGMPs proposed using part 111 and proposed the
relocation of the  “Restrictions for Substances Used in Dietary
Supplements” to part 112.  Since the issuance of the 2003 CGMP
Proposal, the final rule for dietary supplements containing ephedrine
alkaloids has been finalized (69 FR 6788, February 11, 2004) and has
been included in part 119.  Thus, there is no need to reserve part 112
in this final rule.  The references to part 112 have been removed from
the final rule. 

HHS/FDA-Internal-Confidential-Deliberative	

Final Subpart P- Misc 9-28-05

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