Document ID: FDA-1996-N-0028-0087
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-08-01T04:00Z

XVI. Comments on Requirements for 

Packaging and Labeling Operations

(Final Subpart L)

A.  Organization of Final Subpart L

     In the 2003 CGMP Proposal, the requirements for packaging and
labeling operations were set forth in § 111.70. As shown in table 13,
the final rule reorganizes the requirements related to quality control
operations into a distinct subpart (Final Subpart L - Production and
Process Control System: Requirements for Packaging and Labeling
Operations).  Table 13 lists the sections in final subpart L and
identifies the proposed sections that form the basis of the final rule.

Table 13. - Derivation of Sections in Final Subpart L

Final Rule	2003 CGMP Proposal

§ 111.403  What Are the Requirements Under this Subpart for Written
Procedures?	N/A

§111.410   What Requirements apply to Packaging and Labels?	§
111.70(a), (b)(6), and (f)

§ 111.415  What Requirements Apply to Filling, Assembling, Packaging,
Labeling and Related Operations?	§ 111.70(b)

§111.420  What Requirements Apply to Repackaging and Relabeling?	§
111.70(d) and (e)

§111.425  What Requirements Apply to a Packaged and Labeled Dietary
Supplement that is Rejected for Distribution?	§ 111.74 

§ 111.430  Under this Subpart, What Records Must You Make and Keep?	§
111.70(g) and (h)

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●	Reflects that the final rule applies to persons who manufacture,
package, label, or hold dietary supplements unless subject to an
exclusion in § 111.1.  

●	Reflects that the labeling requirements of the rule address the
operation of putting the label specified in the master manufacturing
record on the final product. 

●	Clarifies the applicability of the rule to labeling operations. 

2.  Changes Associated With the Reorganization

     We are moving to final § 111.260(k)) in subpart I the requirements
for the documentation, in the batch production record, of packaging and
labeling operations (proposed § 111.70(g)).

3.  Changes After Considering Comments

	The final rule:

•   Requires you to establish and follow written procedures for
packaging and labeling operations.

•   Provides for an exception to the requirements for label
reconciliation for cut or rolled labels if a 100 percent examination for
correct labels is performed by appropriate electronic or
electromechanical equipment during or after completion of finishing
operations.

•  Clarifies the requirement for “retesting or reexamining” any
repackaged or relabeled dietary supplements - i.e., consistent with
final § 111.75(g) you must examine a representative sample of each
batch of repackaged or relabeled dietary supplements to determine
whether repackaged or relabeled dietary supplements meet all
specifications established in accordance with § 111.70(g). 

     

C.  General Comments on Proposed Requirements 

for Packaging and Labeling Operations

     (Comment 296)  Some comments assert that the proposed packaging and
labeling requirements are unnecessarily stringent for dietary
ingredients, because the potential for abuse is primarily at the final
product stage.

     (Response) To the extent that the comment is saying that a dietary
ingredient manufacturer who manufactures, packages, labels, and holds a
dietary ingredient that is further processed and incorporated into a
dietary supplement by another person should not have to comply with the
packaging and labeling requirements in subpart L, we agree.  We are
modifying the scope of the rule as to who is subject to the CGMP
requirements, as discussed in Subpart A, section VI.  The final rule
applies to persons who manufacture, package, label, or hold dietary
supplements unless subject to an exclusion in § 111.1.  

	(Comment 267)  Several comments assert that it is imperative that a
dietary supplement contain what it purports on its label. Some comments
state that the amounts of ingredients listed on the label must
accurately reflect what is in the package.

     (Response) To the extent that the comments are suggesting that
there need to be requirements for labeling operations as part of CGMP to
ensure that the label applied to the dietary supplement is the label
specified in the master manufacturing record for the finished product,
we agree.  To the extent that the comments suggest that CGMP
requirements should ensure the quality of the dietary supplement
manufactured, we also agree.  If consumers believe that dietary
supplements contain the ingredients as labeled, as with any other
product they purchase, then CGMP requirements should help to ensure that
dietary supplements are manufactured consistently to ensure the quality
of the dietary supplement and to help ensure the proper identity and
amount of ingredients identified on the label. 

D.  General Comments on Requirements for What

Must Be on the Product Label Rather than for 

Labeling Operations

     (Comment 298)  Some comments express disappointment that the 2003
CGMP Proposal does not address product claims included on product
labels.  These comments state that, if FDA is not going to review label
claims, it should, at a minimum, require the following statement be
placed on dietary supplement products: “This product has not been
reviewed for safety and efficacy by the FDA.”  These comments assert
that such a statement should be included on all dietary supplement
products, regardless of whether the product makes structure/function
claims.  These comments also recommend that dietary supplement labeling
encourage consumers to share information about their use of the dietary
supplements with their pharmacists and physicians and encourage
consumers to seek the input of a health care provider if symptoms that
prompted use of the dietary supplement are not resolved.

     One comment requests we establish specific label content to include
on dietary supplement labels.  The comment asserts that the technology
and mechanical tools exist to produce expanded labeling for dietary
supplements efficiently and cost-effectively.  The comment asserts that
the content should include a complete listing of ingredients, relative
percentages, batch or lot number, intended use, safety information,
directions, and product information.  Specifically, the comment supports
the labeling recommendations of the U.S. Department of Health and Human
Services (HHS), Office of the Inspector General (OIG) (Ref. 341) March
2003, “Dietary Supplement Labels: Key Elements,” publication no.
OEI-01-01-00120; available at   HYPERLINK "http://"  http://
oig.hhs.gov/oei/reports/oei-01-01-00120.pdf).  The comment endorses the
HHS/OIG recommendations, with the addition of batch or lot number on the
label.  The comment also endorses the OIG’s proposed label
presentation which calls for: (1) A standardized format with similar
types of information in a similar order across supplements; (2) distinct
product features to assist consumers in distinguishing supplements from
other healthcare products; (3) readability, with language and visual
cues that are easily understood by consumers; (4) balance to present
information in a fair and balanced format that omits marketing and sales
pitches; and (5) constructive use of space whereby innovative packaging
is employed to expand label space.

     Several comments address whether we should permit manufacturers to
state on their products that the manufacturer of the product is in
compliance with FDA CGMP requirements.  Several comments assert that a
CGMP statement on labels should not be allowed.  These comments assert
that the proposed “made in a CGMP facility” language is fraught with
potential misuse, and that the potential for confusion is overwhelming. 
These comments state that the rule also should be modified to exclude
other similar statements such as “produced using good laboratory
practices,” “produced using good practices,” or “produced in
compliance with USP good manufacturing practices.”  According to these
comments, similar statements currently appear on dietary supplement
labels and also may be misleading.  These comments assert that CGMP
requirements are not voluntary and should not be marketed as such. 

     Some comments state that a voluntary label statement that a dietary
supplement complies with CGMP should be allowed.  According to these
comments, there are several third party organizations such as USP and
National Nutritional Foods Association (NNFA) that have proposed or
established CGMP requirements as rigorous as, or more rigorous than,
those proposed by FDA.  These comments assert that a voluntary statement
that characterizes the nature of the GMP compliance should be allowed.

     (Response)  The comments related to requests about specific label
content, such as ingredient listing, relative percentage of ingredients,
intended use, safety information, label format, use of label space, and
directions and product information are outside the scope of this final
rule.  Further, with respect to requiring specific statements about
dietary supplement product, such as, “This product has not been
reviewed for safety and efficacy by the FDA,” or “This product has
been produced using good manufacturing practice,” we have stated
previously that the manufacturer is responsible for ensuring that any
voluntary labeling statements on its dietary supplement products are
truthful and not misleading (49 FR 12164).  We would review the
lawfulness of such statements under sections 403(a)(1) and 201(n) of the
act (21 U.SC. 343(a)(1) and 321(n)).  

We did not propose to require any specific statements.  We stated that
an unqualified statement such as “produced in compliance with dietary
supplement current good manufacturing practice requirements,” without
more, could suggest a product may be safe and effective or somehow
superior to other dietary supplement products that are subject to the
same CGMP requirements (id.).  Further, we stated that such a statement
would likely be considered misleading by us under sections 403(a)(1) and
201(n) of the act, but that including language clarifying to consumers
that all dietary supplements must be manufactured in compliance with
CGMP requirements and that such compliance does not mean that the
dietary supplement is safe or effective may be a way to cure that
unqualified statement (id.).  Thus, we are not prohibiting voluntary
statements on the dietary supplement label, provided that such
statements are truthful and not misleading. 

      (Comment 299) Some comments assert that the labeling standards
found in the 2003 CGMP Proposal should be uniformly applied across
manufacturers, regardless of size, because consumers are unlikely to
differentiate between small companies and large ones when selecting
dietary supplements.  These comments assert that we should, therefore,
only allow one year for labeling compliance for all manufacturers
regardless of their size.

     Some comments assert that small manufacturers are more likely to
suffer competitively if their labels lack important ingredient and other
information relative to labeling employed by their larger competitors. 
These comments argue that enhanced labeling is a cost-effective
packaging feature and should not represent a significant cost burden
when outsourced to a qualified print-packaging vendor.  Moreover, labels
already represent a budgeted cost item for dietary supplement producers.
Labels with additional content would add little to manufacturer
overhead.

     (Response) These comments may have misinterpreted the 2003 CGMP
Proposal.  The CGMP requirements do not impose any requirements for the
specific content of the label.  We discuss the requirements necessary to
determine the complete manufacturing history and control of a packaged
and labeled dietary supplement through distribution in this subpart in
our discussion on final § 111.410(d).  To the extent that businesses
with fewer than 500 employees want to comply with the CGMP requirements
for labeling operations in a shorter timeframe than what we are allowing
in this final rule, such businesses may do so.  However, to assist
businesses with fewer than 500 employees in complying with dietary
supplement CGMPs, we are giving businesses with fewer than 500 but 20 or
more employees a compliance date of 24 months after the date of
publication of this final rule, and we are giving businesses with fewer
than 20 employees a compliance date of 36 months after the date of
publication of this final rule. 

E.  What Are the Requirements Under This Subpart 

for Written Procedures? 

(Final §  111.403)

	We received many comments that recommended written procedures for
various provisions.  We address the need for written procedures
generally in section IV.  We also respond to individual comments on
specific provisions in the same section.

Final § 111.403 requires you to establish and follow written procedures
for packaging and labeling operations.  Under final 111.430(b), relating
to records you must make and keep,  we require that you make and keep
records of such written procedures.  

F.  What Requirements Apply to

Packaging and Labels?

(Final § 111.410)

1.  Final § 111.410(a) 

     Final § 111.410(a) requires that you take necessary actions to
determine whether the packaging for dietary supplements meets
specifications so that the condition of the packaging will ensure the
quality of your dietary supplements.  Final § 111.410(a) is similar to
proposed § 111.70(a) which would require you to take necessary actions
to ensure that each packaging container for holding dietary ingredients
or dietary supplements meets specifications so that the condition of the
packaging container will not contaminate your dietary supplements or
cause them to deteriorate.  We have made changes to be consistent with
final § 111.70 and the definition of “quality” by substituting the
phrase “ensure the quality of your dietary supplement” instead of
using the words “contamination” and “deterioration” which would
be encompassed in the definition of “quality.”   We are deleting the
words “container” and “holding” from final § 111.410(a) to
emphasize that all packaging must meet specifications and ensure the
quality of the dietary supplement.

    (Comment 300)  One comment requests the removal of the word
“each” from proposed § 111.70(a) because the inclusion of the word
mandates that each and every container, rather than a representative
sample, be inspected.

     (Response)  Because the final rule only requires the use of
representative samples to ensure compliance, as provided in final
§ 111.80, to reduce the potential for confusion, we are deleting the
word “each” and making associated grammatical revisions.

     (Comment 301) Some comments request we clarify our expectations
under proposed § 111.70(a) with respect to substantiating that
packaging containers meet specifications and will not contaminate
dietary supplements.  The comments assert that it is not necessary for a
manufacturer to test these types of products proactively, and that a
continuing product guarantee combined with a statement of intended use
from the manufacturer of the packaging material should suffice to meet
the proposed requirements.  The comments assert this is consistent with
expected practice in other industries that the FDA regulates. 

     (Response)  Final § 111.410(a) reiterates the requirement of final
§ 111.70(d) to establish packaging specifications and the requirement
of final § 111.75(f)(1) to determine whether packaging specifications
are met.  Under final § 111.75(f)(1), to determine whether packaging
meets its specifications, you must conduct a visual identification of
the containers and closures and review the supplier’s invoice,
guarantee, or certification.  Thus, the final rule does not require that
you test packaging proactively, and does allow you to rely on
documentation such as a continuing product guarantee combined with a
statement of intended use from the manufacturer of the packaging.

     As we discussed in the preamble to 2003 CGMP Proposal (68 FR 12157
at 12212), proposed § 111.70(a) would require you to take into account
factors such as whether your product is sensitive to light when setting
specifications for packaging.  Other factors to consider include whether
your product is sensitive to moisture or could interact with certain
kinds of packaging. (For other requirements related to packaging, see
final §§ 111.70(d), (f), (g) and 111.160).   

2.  Final § 111.410(b) 

     Final § 111.410(b) requires you to control the issuance and use of
packaging and labels and reconciliation of any issuance and use
discrepancies, except that label reconciliation is not required for cut
or rolled labels if a 100 percent examination for correct labels is
performed by appropriate electronic or electromechanical equipment
during or after completion of finishing operations.  Final § 111.410(b)
derives from proposed § 111.70(f)(1) which would require you to control
the issuance and use of packaging and labels and reconciliation of any
issuance and use discrepancies.  

     (Comment 302) Some comments assert that comprehensive label
reconciliation should not be required if appropriate electronic controls
are instituted to ensure that correct labels are used during labeling
operations.  The comments state this alternative is permitted for
labeling operations for drug products, which are generally identical or
similar in nature to labeling operations for dietary supplements.  As
such, the comments assert that the same flexibility should be afforded
to dietary supplement manufacturers.

    (Response) We agree with these comments and the revisions are
reflected in final § 111.410 (b) (proposed § 111.70(f)(1)).  

3.  Final § 111.410(c)

     Final § 111.410(c) requires you to examine, before packaging and
labeling operations, packaging and labels for each batch of dietary
supplement to determine whether the packaging and labels conform to the
master manufacturing record.  Final § 111.410(c) derives from proposed
§ 111.70(f)(2).  We did not receive comments specific to proposed §
111.70(f)(2).

4.  Final § 111.410(d)

Final § 111.410(d) requires you to be able to determine the complete
manufacturing history and control of the packaged and labeled dietary
supplement through distribution.  We are revising the language of
proposed § 111.70(b)(6) and including in final § 111.410 the similar
requirement stated in proposed § 111.70(b)(6).  Section 111.410 is
where we chose to place this requirement because it is likely that you
will affix the batch, lot, or control number that you used for the
finished batch of dietary supplement on the immediate container or on
the product label as the means to trace the product through
distribution, although this is not required.  Other means are acceptable
besides the use of a batch, lot, or control number.

     (Comment 303) Some comments assert that we do not propose in the
2003 CGMP Proposal the affixing of a lot number to the container of
product marketed to the consumer.  These comments assert that all the
recordkeeping in the 2003 CGMP Proposal is of little value unless issues
can be traced back from the individual container, perhaps received from
a customer complaint, to a specific batch.  These comments state that
such labeling should be a requirement.

     (Response) We agree that it is necessary to be able to trace a
dietary supplement in distribution to a specific batch or lot of
product.  We disagree that we did not provide any requirements in the
2003 CGMP Proposal that would require you to be able to trace a
distributed dietary supplement to a specific batch or lot.  

In proposed § 111.70(b)(6) we stated that a batch, lot, or control
number is necessary for you to trace the manufacturing history for a
particular batch, which will help you investigate and correct any safety
problems for a batch or to recall a dietary supplement.  We discussed
the fact that, without such a batch, lot, or control number, consumers
would be unable to determine which product was the subject of a recall
and they would not know which product to stop using, or there would be a
need to recall more product than otherwise may be necessary (68 FR 12157
at 12212).  

We also proposed several other requirements related to the need to be
able to trace the components, packaging, and labeling used in the
manufacture of a dietary supplement with the distributed dietary
supplement.  Under proposed § 111.40(a) (with respect to components
and dietary supplements) and proposed § 111.40(b)(3) (with respect to
packaging and labeling) we would require you to identify each lot of
product received in a shipment in a manner to allow you to trace the
shipment lot to the dietary supplement manufactured and distributed.  In
the preamble to the ANPRM (49 FR at 12202), we stated that using a
unique identifier throughout the manufacturing process will make it
possible to track and account for components and dietary supplements
received to any necessary investigation of consumer complaints.  In
proposed § 111.50(c)((1) we provided that the batch production record
must include a batch, lot, or control number, and in proposed
§ 111.50(c)(5) we provided that the batch production record must
include the shipment lot unique identifier of each component, dietary
ingredient, dietary supplement, packaging, and label used.  Further, in
proposed § 111.85(d), we required that you conduct an investigation if
a returned dietary supplement implicates associated batches.  Thus, we
proposed to require that you be able to trace a dietary supplement
through distribution.  However, we did not require you to use a specific
mechanism, such as affixing a batch, lot, or control number to the
immediate container or product label.  Under the 2003 CGMP Proposal, the
manufacturer would have flexibility to determine the method to trace its
product in distribution to the batch, lot, or control number assigned to
the finished batch or lot of dietary supplement.

In final § 111.415(f), we require you to assign a batch, lot, or
control number to: (1) Each lot of packaged and labeled dietary
supplement from a finished batch of dietary supplement, and (2) each lot
of dietary supplement, from a finished batch of dietary supplement, that
you distribute to another person for packaging or labeling.  We do not
require you to affix this batch, lot, or control number to the immediate
container or the product label.  Instead, we provide flexibility for you
to determine how you track the (1) batch, lot, or control number, you
assign to each lot of packaged and labeled dietary supplement from a
finished batch of dietary supplement and (2) each lot of dietary
supplement from a finished batch of dietary supplement you distribute to
another person for packaging or labeling, to distributed dietary
supplements.  To clarify that we do not require you to affix a batch,
lot, or control number on the immediate container or product label,
final § 111.410(d) provides that you must be able to determine the
complete manufacturing history and control of the packaged and labeled
dietary supplement through distribution by a method of your choice.  For
example, a dietary supplement manufacturer may make one type of product
that it distributes to a select few customers and may be able to trace
its dietary supplement using dates on distribution records to such
customers, or may use different containers or labeling, other than a
batch, lot, or control number that is affixed to the label.  

We are retaining the use of a unique identifier in final
§§ 111.155(d), 111.160(d), and 111.260(a), (d), and (k).  These
requirements relate to the tracking of a component, packaging, labeling,
or dietary supplement throughout the manufacturing process.  The use of
a batch, lot, or control number or other unique identifier, as required,
for product in the manufacturing process is needed for tracking
components, packaging and labels used to manufacture, package, or label
a dietary supplement so that once a batch is identified, the components,
packaging, and labels used in a batch will also be known.  But by
contrast, when the distribution of a final product may be distributed to
a few select customers, or where every unique batch is placed in a
different type of container, there may not be a need to use batch, lot,
or control numbers affixed to the immediate container or product labels
to be able to trace the product.

	This final rule will enhance the benefits of the new statutory
requirement for mandatory reporting to FDA of serious adverse events as
the result of the enactment of the “Dietary Supplement and
Non-Prescription Drug Consumer Protection Act” (Pub. L. 109-462)
signed into law on December 22, 2006.  This final rule will facilitate
the additional traceback activities taking place as a result of the
additional serious adverse events discovered through mandatory
reporting.  We will evaluate such mandatory reports for patterns or
“signals” of problems with particular products so that further harm
to consumers may be prevented by removing the products and, in some
cases, related products from the marketplace.  This cannot be done
without first quickly and accurately identifying the products of
interest.  To efficiently determine which specific products or group of
products are associated with the serious (or non-serious) adverse event
report, traceback ability is crucial.  This final rule includes
requirements that will provide the information needed to quickly and
accurately conduct a sufficient traceback.  The provisions that require
maintenance of records for production processes include records such as
batch records, unique identifiers, and master manufacturing records. 
The recordkeeping provisions of this final rule give us access to those
records, so we will have an enhanced ability to investigate the serious
adverse events reported to us, using records such as information on
ingredients, processing, storage, composition, and distribution.  This
enhanced ability to track information related to serious adverse events
will increase both the accuracy and the speed of the response to such
events, which may in many cases reduce the number of illnesses or deaths
associated with unsafe dietary supplements. 

G.  What Requirements Apply to Filling, Assembling, 

Packaging, Labeling, and Related Operations? 

(Final § 111.415)

	Final § 111.415 requires that you fill, assemble, package, label, and
perform other related operations in a way that ensures the quality of
the dietary supplement and that the dietary supplement is packaged and
labeled as specified in the master manufacturing record.  Final §
111.415 also requires that you do these functions using any effective
means you choose, including: (1) Cleaning and sanitizing all filling and
packaging equipment, utensils, and dietary supplement packaging, as
appropriate; (2) protecting manufactured dietary supplements from
contamination, particularly airborne contamination; (3) using sanitary
handling procedures; (4) establishing physical or spatial separation of
packaging and label operations from operations on other components and
dietary supplements to prevent mix-ups; (5) identifying, by any
effective means, filled dietary supplement containers that are set aside
and held in unlabeled condition for future label operations, to prevent
mix-ups; (6) aAssigning a batch, lot, or control number to (i) each lot
of packaged and labeled dietary supplement from a finished batch of
dietary supplement and (ii) each lot of dietary supplement, from a
finished batch of dietary supplement that you distribute to another
person for packaging or labeling; (7) examining a representative sample
of each batch of the packaged and labeled dietary supplement to
determine whether the dietary supplement meets specifications
established in accordance with final § 111.70(g); and (8) suitably
disposing of labels and packaging for dietary supplements that are
obsolete or incorrect to ensure that they are not used in any future
packaging and labeling operations.  

	Final § 111.415 derives from proposed § 111.70(b).  We revised the
section to be consistent with other revisions.

	(Comment 304) Some comments request clarification as to what
specifications we are referring to in proposed § 111.70(b)(7).  The
comments state that if we are referring to specifications required by
proposed § 111.35(e), then we should indicate so in any final rule. 
The comment asserts that, if we intend this provision to mean that
persons who simply package, label, and store dietary supplements must
conduct full product testing, then proposed § 111.70(b)(7) is
unwarranted and unreasonable.  

     The comments assert that full product testing should not be
required for companies that merely package, label, and store finished
products.  The comments assert that in route contamination from the
facility of a supplier or manufacturer to the facility of a packager,
labeler, or distributor facility is unlikely to occur if the proper
environmental conditions are maintained as required by other provisions
of the 2003 CGMP Proposal.  The comments assert that the responsibility
for raw material and finished product testing should lie solely with the
companies that handle the raw materials and dietary ingredients and that
perform manufacturing duties.  According to the comments, assuming the
supplier/manufacturer complies with the final rule and adequately
performs the required testing, reasonable cost/benefit analysis would
dictate that redundant testing not be performed.  Therefore, the
comments assert that those who perform packaging and labeling operations
should only be required to test those areas of contamination that are
likely to occur during the shipment, or in the receipt, identification,
packaging and holding areas of production operations (e.g., surface
contamination).  

     The comments state it is our duty to ensure that the industry is
complying with any final rule, not the duty of certain segments of the
industry to ensure that other segments of the industry are complying. 
Since in route contamination is unlikely and rare, consumers would enjoy
little or no benefit from redundant testing at a tremendous cost to the
industry, particularly small businesses.

     (Response) The term “specifications” in proposed
§ 111.70(b)(7) included any specifications that you established for
packaged and labeled dietary supplements under proposed § 111.35(e). 
In final § 111.415(g), we identify the specifications as those you
establish in accordance with final § 111.70(g).  In final
§ 111.70(g), we require you to establish specifications for the
packaging and labeling for the finished packaged and labeled dietary
supplements.  We distinguish these specifications (final § 111.70(g))
from product specifications you must establish for a finished batch that
you manufacture (final § 111.70(e)).  The specifications that you
establish and follow ensure that your product is what you establish in
your master manufacturing record.  As discussed in section VI and
section XII, a master manufacturing record for a firm that only packages
and labels the dietary supplement would include specifications that are
applicable to its operations and would not include specifications
related to, for example, components.

H.  What Requirements Apply to 

Repackaging and Relabeling? 

(Final § 111.420)

1.  Final § 111.420(a) 

     Final § 111.420(a) provides that you may repackage or relabel
dietary supplements only after your quality control unit personnel haves
approved such repackaging or relabeling.  Final § 111.420(a) is similar
to proposed § 111.70(d) with a restructuring of the provision for
clarity.  We did not receive comments specific to proposed § 111.70(d).
  

2.  Final § 111.420 (b) and (c)

     Final § 111.420(b) requires you to examine a representative sample
of each batch of repackaged or relabeled dietary supplements to
determine whether the repackaged or relabeled dietary supplements meet
all specifications established in accordance with § 111.70(g).  Final
§ 111.420(c) requires that the quality control personnelunit approve or
reject each batch of repackaged or relabeled dietary supplement prior to
its release for distribution.  Final § 111.420(b) and (c) derive from
proposed § 111.70(e) which would require you to retest or reexamine any
repackaged or relabeled dietary supplements.  Proposed § 111.70(e) also
would require that any repackaged or relabeled dietary supplements meet
all specifications and that the quality control unit approve or reject
their release for distribution.

     (Comment 305) Some comments assert that the proposed requirement
that directs companies to retest or reexamine any repackaged or
relabeled dietary supplement unnecessarily restricts the ability of the
quality control unit to make an appropriate disposition decision.  These
comments assert that testing would not be necessary, for example, when a
packager repackages a multiple vitamin softgel from a 500-count bottle
to a 60-count bottle.  The comments also assert that it would be costly
to retest such product, and that such testing would not benefit consumer
health and safety.  The comments would revise proposed § 111.70(e) to
give the quality control unit the authority to make an appropriate
disposition decision - e.g., to assess the repackaged dietary supplement
for conformity to specifications.

     (Response) We agree that there are circumstances, such as those
described by these comments, when testing would not be necessary. 
However, we disagree that it would not be necessary to “examine” a
representative sample of the repackaged and relabeled dietary supplement
to determine whether the required specifications are met – i.e., that
you used the specified packaging and applied the specified label.  If no
examination of a representative sample took place, there would be no
basis for the determination.  We believe that final § 111.420(b) makes
this clear. 

I.  What Requirements Apply

to a Packaged and Labeled Dietary Supplement

That is Rejected for Distribution? 

(Final § 111.425)

	Final § 111.425 requires you to clearly identify, hold, and control
under a quarantine system for appropriate disposition any packaged and
labeled dietary supplement that is rejected for distribution.  Final §
111.425 derives from proposed § 111.74 which would require you to
clearly identify, hold, and control under a quarantine system any
component, dietary ingredient, dietary supplement, packaging, and label
that is rejected and unsuitable for use in manufacturing, packaging, or
label operations.  Under the final rule, the requirements of proposed §
111.74 for components, packaging, and labels are being set forth in
final § 111.170, and the requirements for a finished batch of dietary
supplement are set forth in final § 111.370.  Although the proposal did
not include any packaged and labeled dietary supplement rejected for
distribution, we are making this change to be consistent with the
principle that rejected components, dietary supplements, packaging, or
labels unsuitable for the distribution supply include finished product
already packaged and labeled.   

J.  Under This Subpart L, What Records Must 

You Make and Keep? 

(Final § 111.430)

1.  Final § 111.430(a)

 

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make and keep records required under this subpart in accordance with
subpart P.  Final § 111.430(a) derives from proposed § 111.70(h) with
revisions associated with the reorganization.  We did not receive
comments specific to proposed § 111.70(h).

2.  Final § 111.430(b)

     As discussed in this section, final § 111.403 requires you to
establish and follow written procedures for packaging and labeling
operations.  The written procedures are records.  Therefore, final §
111.430(b) requires you to make and keep records of the written
procedures for packaging and labeling operations. 

FDA-Internal-Confidential-Deliberative

Final Subpart L 9-28-05, 6-26-06, 3-30-07, 5-04-07

Page   PAGE  859