[Code of Federal Regulations]
[Title 9, Volume 1]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR112.5]
[Page 588-590]
TITLE 9--ANIMALS AND ANIMAL PRODUCTS
CHAPTER I--ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF
AGRICULTURE
PART 112--PACKAGING AND LABELING--Table of Contents
Sec. 112.5 Review and approval of labeling.
Labels used with biological products prepared at licensed
establishments or imported for general distribution and sale must be
submitted to the Animal and Plant Health Inspection Service for review
for compliance with the regulations and approval in writing prior to
use, except as provided in paragraph (c) of this section and under the
master label system provided in paragraph (d) of this section.
(a) Transmittal forms, furnished by Animal and Plant Health
Inspection Service upon request, shall be used with each submission of
sketches (including proofs) and labels. Separate forms shall be used for
each biological product but only one copy of the form shall be used for
all sketches and labels submitted at the same time for the same
biological product.
(b) Sketches may be submitted for comment to Animal and Plant Health
Inspection Service by the licensee or permittee before preparing the
finished label. Such sketches shall be returned to the licensee or
permittee with comments, if any. Failure of the reviewer to take
exception to a sketch shall not constitute approval of a finished label
subsequently prepared.
[[Page 589]]
(c)(1) Labels must be submitted to the Animal and Plant Health
Inspection Service for review and written approval. Only labels which
are approved as provided in Sec. 112.5(d) may be used. When changes are
made in approved labels, the new labels shall be subject to review and
approval before use: Provided, That certain minor changes may be made in
labels for products with approved labels or master labels, and the
revised labels may be used prior to review by APHIS, with the provision
that a new label or master label bearing these changes is submitted to
APHIS for review and written approval within 60 days of label use, and
that such minor changes do not render the product mislabeled or the
label false and misleading in any particular.
(2) Minor label changes that may be made under the provision for
products with approved labels or master labels are:
(i) Changes in the physical dimensions of the label provided that
such change does not affect the legibility of the label;
(ii) Change in the color of label print, provided that such change
does not affect the legibility of the label;
(iii) The addition or deletion of a Trade Mark (TM) or Registered
(R) symbol;
(iv) The correction of typographical errors;
(v) Adding or changing label control numbers of bar codes; and
(vi) Revising or updating logos.
(d) Labels and sketches submitted shall be prepared in the number
and manner prescribed in this paragraph.
(1) Copies required:
(i) For label sketches, submit two copies of each sketch of a final
container label, carton label, and enclosure. Sketches must be legible,
and must include all information specified in Sec. 112.2. One copy of
each sketch will be returned with applicable comments, and one copy will
be held on file by APHIS for no more than one year after processing,
until replaced by a finished label: Provided, That sketches submitted in
support of an application for a license or permit shall be held as long
as the application is considered active.
(ii) For master label sketches, submit for each product two copies
of each sketch of an enclosure, label for the smallest size final
container, and carton label; Provided, That labels for larger size
containers and/or cartons that are identical, except for physical
dimensions, need not be submitted. One copy of each master label sketch
will be returned with applicable comments, and one copy will be held on
file by APHIS for one year after processing, until replaced by a
finished master label that is submitted according to
Sec. 112.5(d)(1)(iii): Provided, That master label sketches submitted in
support of an application for license or permit shall be held as long as
the application is considered active.
(iii) For finished labels, submit three copies of each finished
final container label, carton label, and enclosure: Provided, That when
an enclosure is to be used with more than one product, one extra copy
shall be submitted for each additional product. Two copies of each
finished label will be retained by APHIS. One copy will be stamped and
returned to the licensee. Labels to which exceptions are taken shall be
marked as sketches and handled under Sec. 112.5(d)(1)(i).
(iv) For finished master labels, submit for each product three
copies each of the enclosure and the labels for the smallest size final
container and carton. Labels for larger sizes of containers or cartons
of the same product that are identical, except for physical dimensions,
need not be submitted. Such labels become eligible for use, concurrent
with the approval of the appropriate finished master label: Provided,
That the marketing of larger sizes of final containers is approved in
the filed Outline of Production, and the appropriate larger sizes of
containers or cartons are identified on the label mounting sheet. When a
master label enclosure is to be used with more than one product, one
extra copy for each additional product shall be submitted. Two copies of
each finished master label will be retained by APHIS. One copy will be
stamped and returned to the licensee. Master labels to which exceptions
are taken will be marked as sketches and handled under
Sec. 112.5(d)(1)(ii).
(2) Mounting:
[[Page 590]]
(i) Each label or sketch shall be securely fastened to a separate
sheet of heavy bond paper (8\1/2\ x 11) in such a
manner that all information is available for review.
(ii) Two-or three-part cartons, including ``sleeves,'' shall be
considered as one label. All parts shall be submitted together.
(iii)(A) When two final containers are packaged together in a
combination package, the labels for each shall be mounted on the same
sheet of paper and shall be treated as one label. For diagnostic test
kits, the labels for use on the individual reagent containers to be
included in the kit shall be mounted together on a single sheet of
paper, if possible; if necessary, a second sheet of paper may be used.
The carton label and enclosure shall be mounted on separate individual
sheets.
(B) If either final container label is also used alone or in another
combination package, sets of separate labels for each biological product
with which it is used shall be submitted for review.
(iv) When the same final container label is applied by different
methods such as paper or screen printing, one of each shall be mounted
on the same sheet of paper as one submission.
(3) To appear on the top of each page:
(i)(A) Name and product code number of the biological product as it
appears on the product license or permit.
(B) Extra copies of enclosures to be used with another product shall
bear the name and code number of the product affected.
(ii)(A) Designation of the specimen as a label or master label:
sketch, final container label, carton label, or enclosure.
(B) If two final container labels or multiple parts are on one
sheet, each shall be named, and the label or part being revised shall be
designated.
(iii) Size of package (dose, ml., cc., or units) for which the
labels or enclosures are to be used.
(4) To appear on the bottom of each page: The reason for and
information relevant to the submission shall be stated in the lower left
hand corner as:
(i) Master label dose sizes approved for code ------------.
(ii) Replacement for label, master label, and/or sketch No. --------
----.
(iii) Reference to label or master label No. ------------.
(iv) Addition to label No. ------------.
(v) License Application Pending ------------.
(vi) Foreign Language copy of Label No. ------------.
(e) Special requirements for foreign language labels:
(1) If true, a statement that the label is a direct translation from
a corresponding approved domestic label.
(2) If the foreign language label is not a direct translation of an
approved domestic label, an English version shall be submitted with an
explanation for the difference in texts.
(3) Foreign language portion of a bilingual label shall be a true
translation of the English portion. Reference to additional information
on the enclosure shall not be made unless that enclosure is also
bilingual.
(f) When a request is received from Animal and Plant Health
Inspection Service, the licensee or permittee shall submit a list of all
approved labels currently being used. Each label listed shall be
identified as to:
(1) Name and product code number as it appears on the product
license or permit for the product; and
(2) Where applicable, the size of the package (doses, ml., cc., or
units) on which the label shall be used; and
(3) Label number and date assigned; and
(4) Name of licensee or subsidiary appearing on the label as the
producer.
(g) At the time of an inspection, or when requested by APHIS,
licensees or permittees shall make all labels and master labels,
including labels approved for use but exempted from filing under the
master label system, available for review by authorized inspectors. Such
labels shall be identical to the approved label or master label except
for physical dimensions, reference to recoverable volume or doses and/or
certain minor differences permitted in accordance with Sec. 112.5(c).
(Approved by the Office of Management and Budget under control number
0579-0013)
[38 FR 12094, May 9, 1973, as amended at 48 FR 57473, Dec. 30, 1983; 49
FR 21044, May 18, 1984; 56 FR 66783, Dec. 26, 1991; 59 FR 43445, Aug.
24, 1994; 61 FR 29464, June 11, 1996; 61 FR 33175, June 26, 1996; 64 FR
43044, Aug. 9, 1999]
[[Page 591]]