CVM GFI #181 Blue Bird Medicated Feed Labels

Administrative guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.

#181
Blue Bird Medicated Feed Labels
Guidance for Industry
This version of the guidance replaces the version that was made available on September 29,
2015. This version incorporates relevant policy previously located in the withdrawn CPG Sec.
665.200 Checklist Labeling for Custom Mixed Medicated Feeds.
Submit comments on this guidance at any time. Submit electronic comments to
https://www.regulations.gov. Submit written comments to the Dockets Management Staff (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All
comments should be identified with the docket number [Insert docket number].
For further information regarding this document, contact AskCVM@fda.hhs.gov.
Additional copies of this guidance document may be requested from the Policy and Regulations
Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish
Place, Rockville MD 20855, and may be viewed on the Internet at either
https://www.fda.gov/AnimalVeterinary/default.htm or https://www.regulations.gov.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Veterinary Medicine
July 2019

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Table of Contents
I. 	INTRODUCTION ............................................................................................................... 3
II. 	BACKGROUND ................................................................................................................. 3
III. BLUE BIRD LABEL FORMAT AND CONTENT RECOMMENDATIONS ................. 4
A. Type “B ” Blue Bird Medicated Feed Label:................................................................. 4
1. 	Name of the Medicated Feed .................................................................................. 4
2. 	Indication(s) for Use ............................................................................................... 5
3. 	Active Drug Ingredient(s)....................................................................................... 5
4. 	Guaranteed Analysis............................................................................................... 5
5. 	Ingredients .............................................................................................................. 5
6. 	Mixing Directions................................................................................................... 6
7. 	Caution ................................................................................................................... 7
8. 	Warning .................................................................................................................. 7
9. 	Manufacturer Information ...................................................................................... 7
10. Weight Statement ................................................................................................... 8
11. Other Label Information ......................................................................................... 8
B. Type “C” Blue Bird Medicate d Feed Label:................................................................. 8
1. 	Name of the Medicated Feed .................................................................................. 8
2. 	Indication(s) for Use ............................................................................................... 8
3. 	Active Drug Ingredient(s)....................................................................................... 8
4. 	Guaranteed Analysis............................................................................................... 9
5. 	Ingredients .............................................................................................................. 9
6. 	Feeding Directions.................................................................................................. 9
7. 	Caution ................................................................................................................... 9
8. 	Warning .................................................................................................................. 9
9. 	Manufacturer Information ...................................................................................... 9
10. Weight Statement ................................................................................................... 9
11. Other Label Information ......................................................................................... 9
C. Examples of Type B and Type C Blue Bird Labels : .................................................. 10

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Blue Bird Medicated Feed Labels
Guidance for Industry
This guidance represents the current thinking of the Food and Drug Administration (FDA or
Agency) on this topic. It does not establish any rights for any person and is not binding on FDA
or the public. You can use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff
responsible for this guidance as listed on the title page.
I. 	INTRODUCTION
A new animal drug application (NADA) for a Type A medicated article is required to include,
among other things, representative labeling proposed to be used for Type B and Type C
medicated feeds containing the new animal drug (21 CFR 514.1 (b)(3)(v)(b)). The Center for
Veterinary Medicine (the Center or CVM) uses the term Blue Bird labels to refer to such
representative labeling (November 19, 1999; 64 FR 63195 at 63197). Blue Bird labels are
created by Type A medicated article sponsors and function as a guide to manufacturers of
medicated feeds in the preparation of final printed feed labels.1 The purpose of this guidance is to
provide NADA sponsors of Type A medicated articles with the Center’s current thinking on the
recommended content and format of Blue Bird labels.
In general, FDA’s guidance documents do not establish legally enforceable responsibilities.
Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only
as recommendations, unless specific regulatory or statutory requirements are cited. The use of
the word should in Agency guidances means that something is suggested or recommended, but
not required.
II. 	BACKGROUND
Type A medicated articles are intended solely for use in the manufacture of another Type A
medicated article or in the manufacture of Type B or Type C medicated feed (21 CFR
558.3(b)(2)). Type B medicated feed is intended solely for the manufacture of other medicated
feeds (Type B or Type C) and therefore it cannot be fed as is without being further diluted to
Type C medicated feed. Type B medicated feed contains a substantial quantity of nutrients
including vitamins and/or other nutritional ingredients in an amount not less than 25% of the
weight. 	Type B medicated feed is manufactured by diluting a Type A medicated article or
another Type B medicated feed (21 CFR 558.3(b)(3)). Type C medicated feed is intended as the
complete feed for the animal or may be fed 'top dressed' (added on top of usual ration) or offered
'free choice' in conjunction with other animal feed. It is manufactured by diluting a Type A
medicated article, a Type B medicated feed, or another Type C medicated feed (21 CFR
558.3(b)(4)).
1 Final printed feed labels are also known as product or brand labels.

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The sponsor of a Type A medicated article must submit, as part of its NADA, two labeling
components. One is the specimens of labeling to be used for such new animal drug which must
include adequate directions for the manufacture and use of finished feeds for all conditions for
which the new animal drug is intended, recommended, or suggested in any of the labeling,
including advertising, sponsored by the applicant (21 CFR 514.1 (b)(3)(v)(a)). The other
labeling component required for such drugs is the representative labeling proposed to be used for
the Type B and Type C medicated feeds containing the new animal drug (21 CFR 514.1
(b)(3)(v)(b)). 	This guidance provides recommendations on the content and format of the
representative Blue Bird labeling proposed to be used for Type B and Type C medicated feeds
only. It does not address the labeling of Type A medicated articles.
III. 	BLUE BIRD LABEL FORMAT AND CONTENT RECOMMENDATIONS2
The Act and its implementing regulations require animal food containing new animal drugs to be
labeled in conformance with an approved application. As stated previously, during the new
animal drug approval process, the drug sponsor submits representative labeling for Type B and
Type C medicated feeds as part of the drug approval process. These labels are referred to as Blue
Bird labels. 	Blue Bird labels serve as a guide to manufacturers of medicated animal feeds when
preparing final printed medicated feed labeling. If the final Type B or C labeling does not
conform with the new animal drug approval, including the approved representative labeling, the
medicated feed is deemed unsafe under section 512(a)(2) of the Act, adulterated under section
501(a)(6), and/or misbranded under section 502(f)(1) of the Act.
Medicated feeds are required to be labeled with adequate directions for use enabling their use in a
safe and effective manner. Therefore, clear medicated feed labeling is essential to ensure the
medicated feed is properly used. As a result, Blue Bird labels generally include information on a
single drug or drug combination use in a single animal species or production class within a
species. 	The final printed labels for Type B or Type C medicated feeds are expected to follow
the format of the respective Blue Bird label. Therefore, the final medicated feed labeling
typically would include only a single drug or drug combination use in a single animal species of
production class within a species.
A label typically should not include more than one approved use in more than one animal species
or production category, or more than one withdrawal period, because such labeling could confuse
the user. However, a final printed label may contain multiple drug or drug combination uses in
multiple species or production classes when the Blue Bird label does so. Misleading labeling and
incorrect use of a medicated feed could result in the medicated feed being deemed unsafe,
adulterated, and/or misbranded.
A. TYPE “B ” BLUE BIRD MEDICATED FEED LABEL:
1. 	Name of the Medicated Feed
2 In an effort to modernize and consolidate policy related to medicated feed labeling, this section incorporates
relevant policy previously located in the withdrawn CPG Sec. 665.200 Checklist Labeling for Custom Mixed
Medicated Feeds.

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We recommend that the name of a medicated feed on the Blue Bird label include the
intended species and production class and the Type B medicated feed designation. Blue
Bird feed names for the same drug or combination should allow the Blue Bird label to be
distinguishable from other Blue Bird labels for the same drug or combination. Any
information that is not part of the Blue Bird feed’s name (e.g., weight statement) should
not appear in the name.
2. 	Indication(s) for Use
This section should include the specific approved intended use of the medicated feed. The
language in this section should match exactly the approved language found in the
approved application.
3. 	Active Drug Ingredient(s)
We recommend that only established drug name(s) (21 CFR 514.1(a)(4)(i)) appear in this
section. The drug name may be asterisked with trade or brand names included at the
bottom of the label.
Maximum drug concentrations in Type B medicated feed are specified in 21 CFR 558.4.
The drug concentration should be listed to the right of the drug name either as a single
drug concentration or a range (e.g., 1,000 to 20,000 g/ton). Where drug concentrations
are listed in a range, the drug level should reference a footnote indicating that the final
printed feed label should only include a single drug concentration.
For example: “The final printed feed label should list only a single drug concentration.”
Drug concentration is usually expressed in grams per ton (g/ton) of feed. Alternatively, if
the drug level exceeds 2,000 g/ton, it may be stated in grams per pound (g/lb) of feed. If a
drug combination is used in the feed, the same units of measurement should be used for
all drugs in the combination.
4. 	Guaranteed Analysis
We recommend that this section of a Blue Bird label include nutritional guarantees that
are tailored for a species/production class the feed is intended for, as listed in the current
year’s Association of American Feed Control Officials (AAFCO) Official Publication3.
Additional guarantees, such as pH and dry matter content, should be included when
necessitated by NADA approval, e.g., for liquid medicated feeds.
5. 	Ingredients
Instead of including the names of actual feed ingredients on the Blue Bird label, we
3 Copies may be obtained through http://www.aafco.org.

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recommend the inclusion of a statement indicating that the ingredient names on a final
label will be AAFCO-defined names.
Examples of two acceptable statements for this section are:
“Each ingredient as named in accordance with the names and definitions adopted by
the Association of American Feed Control Officials” or “Ingredients as defined by
AAFCO.”
6. 	Mixing Directions
The mixing directions should instruct the user on how to prepare either another Type B or
a Type C medicated feed using a Type B medicated feed.
Mixing directions may be for a single concentration or for a range of drug concentrations.
(i) 	An example statement for a single drug concentration:
“Mix ___ pounds of this Type B medicated feed with ___ pounds of non-
medicated feed to manufacture one ton of Type C medicated feed
containing ___ grams of ___ per one ton.”
For example, if the concentration of drug “X” in a Type B medicated feed is
1000 grams per ton and the desired drug concentration in a final Type C
medicated feed is 50 grams per ton, then the mixing directions statement could
read:
“Mix 100 pounds of this Type B medicated feed with 1,900 pounds of non-
medicated feed to manufacture one ton of Type C medicated feed
containing 50 grams of “X” per one ton.”
(ii) 	An example statement for a drug range in which w and x correspond to the
amount of the low (w) and high (x) range of the drug listed on the Type B
medicated feed label that would result in a concentration of 50 grams of the
drug per ton on feed when diluted with non-medicated feed in the amount
signified by y when the low drug concentration is used and z when the high
drug concentration is used.
“Mix _w to x_ pounds of this Type B medicated feed with _y to z_ pounds
of non- medicated feed to manufacture one ton of Type C medicated feed
containing ____ grams of ____ per one ton.”
For example, if the concentration of drug “X” in a Type B medicated feed is
0.05 to 2.5 grams per pound and the desired drug concentration in a final Type
C medicated feed is 50 grams per ton, then the mixing directions statement
could read:

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“Mix 1000 to 20 pounds of this Type B medicated feed with 1000 to 1980
pounds of non-medicated feed to manufacture one ton of Type C medicated
feed containing 50 grams of “X” per one ton.”
Since Type B medicated feeds are intended solely for the manufacture of other medicated
feeds (21 CFR 558.3(b)(3)), the inclusion of feeding instructions for the resulting Type C
medicated feed on the label of a Type B medicated feed may be misleading and cause the
Type B product to be misbranded. However, if the proposed labeling for the Type B feed
includes feeding instructions for the Type C feed and, upon reviewing such labels, CVM
finds that the information presented is presented in a manner that is not misleading
regarding the proper use of Type B medicated feed, then the labeling would not misbrand
the Type B product.
The agitation/recirculation directions, sometimes called “Mixing Directions,” which are
required under the regulations for liquid Type B medicated feeds (21 CFR 558.5), to be
included on the labels for certain liquid medicated feeds, should be clearly distinguished
from the mixing/feed preparation instructions of this section.
7. 	Caution
Any applicable caution statements including those related to animal safety, drug stability,
or misuse of the feed containing the drug, that were deemed necessary for approval of the
NADA should be listed in this section.
Example: “Not for use in pregnant swine.”
In addition, if the product is a Veterinary Feed Directive (VFD) drug, the following
caution statement is required by regulation and should appear in this section (21 CFR
558.6(a)(6)):
“CAUTION: Federal law restricts medicated feed containing this veterinary feed
directive (VFD) drug to use by or on the order of a licensed veterinarian.”
8. 	Warning
Any applicable warning statements including those related to human food safety or
human user safety that were deemed necessary for approval of the NADA should be listed
in this section.
Example: “Withdraw 5 days before slaughter.”
9. 	Manufacturer Information
A generic statement may appear in this section of the Blue Bird label to indicate where
the actual identifying information for the manufacturer is to be inserted in the final feed
labeling.

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Example: Blue Bird Feed Mill, Robin, Indiana 12345
10. Weight Statement
A template statement may appear in this section of the Blue Bird label with the actual
weight in U.S. standard (avoirdupois) and metric units to be inserted in the final labeling.
Example: Net Weight____lb (__ 	kg)
Bag or Bulk
11. Other Label Information
The label should include the following information as applicable:
(i) 	Lot, Batch or Control Number
(ii) 	Expiration Date - Medicated feeds that contain certain drugs or certain drugs at
certain levels are required (21 CFR 514.1(b)(5)(x)) to establish an expiration
date. When applicable, the expiration date should be included on the Blue Bird
label.
(iii) 	Any other information that may be specifically required for NADA approval.
B. TYPE “C” BLUE BIRD MEDICATE D FE E D LABE L:
1. 	Name of the Medicated Feed
The same principles that apply to the Type B Blue Bird medicated feed label apply here
except the name includes the Type C designation.
2. 	Indication(s) for Use
Same recommendation as for the Type B Blue Bird medicated feed label.
3. 	Active Drug Ingredient(s)
Only established drug name(s) should appear in this section. The drug name may be
asterisked with trade or brand names included at the bottom of the label.
The amount of the drug approved for use in the feed should be listed to the right of the
drug name. If a drug combination is used in the feed, the same units of measurement
should be used for all drugs in the combination. Drug levels are usually expressed in
grams per ton of feed. Alternatively, if the drug level exceeds 2,000 g/ton, it may be
stated in grams per pound (g/lb) of feed.

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Where drug concentrations are approved in a range (e.g., 10 to 30 grams per ton), the
drug level could be expressed as a range and should reference a footnote indicating that
the final printed feed label should only include a single drug concentration. For example:
“The final printed feed label should list only a single drug concentration.”
Where the amount of the drug that animals need to consume daily, and not the drug
concentration in feed, is specified in the approval, the label may bear the appropriate
concentration in which the drug should be present in Type C medicated feed to deliver the
approved amount of the drug.
4. 	Guaranteed Analysis
Same recommendation as for the Type B Blue Bird medicated feed label.
5. 	Ingredients
Same recommendation as for the Type B Blue Bird medicated feed label. When a
formula for a free-choice medicated feed is made public, the ingredients should be listed
exactly as approved.
6. 	Feeding Directions
The feeding directions should instruct the user on how to feed this Type C medicated
feed. Individual drug approvals may state specifically how the feed is to be fed. An
example of typical feeding directions is “Feed continuously as the sole ration.”
7. 	Caution
Same recommendation as for the Type B Blue Bird medicated feed label.
8. 	Warning
Same recommendation as for the Type B Blue Bird medicated feed label.
9. 	Manufacture r Information
Same recommendation as for the Type B Blue Bird medicated feed label.
10. Weight Statement
Same recommendation as for the Type B Blue Bird medicated feed label.
11. Other Label Information
Same recommendation as for the Type B Blue Bird medicated feed label.

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C. EXAMPLES OF TYPE B AND TYPE C BLUE BIRD LABELS :
Examples of Blue Bird Labels for Type B and Type C Medicated Feed can be found starting
on pages 11 and 12, respectively.

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Drug X/Drug Y Growing Swine Ration
(drug X and drug Y Type B Medicated Feed)
For the reduction in severity of swine mycoplasma pneumonia caused by Mycoplasma
hyopneumoniae; aid in the prevention of migration and establishment of large roundworm
(Ascaris suum) infections; aid in the prevention of establishment of nodular worm
(Oesophagostomum spp.) infections.
Active Drug Ingredients
Drug X................................................................…….…………….………......19,200 g/ton
Drug Y…………………….…………………………………….……….…….40,000 g/ton
Guaranteed Analysis
Crude Protein (min)………………………………………………………………______%
Lysine (min)…………………..…………………………….….….…………...…______%
Crude Fat (min)…………………………………………………………...………______%
Crude Fiber (max)………………………………………………………………...______%
Calcium (min)…………………………………………………………………….______%
Calcium (max)……………………………………………………………………______%
Phosphorus (min)…………………………………………………………………______%
Salt (min)1 ...……………………………………………………………………...______%
Salt (max)1 ....…………………………………………………………...………...______%
Sodium (min)2 ...………………………………………………………………….______%
Sodium (max)2 ……………………………………………………………………______%
Selenium (min)…………………………………………………………………______ppm
Zinc (min)……………………………………………………………………... ______ppm
1 If added.
2 Shall be guaranteed only when total Sodium exceeds that furnished by the maximum salt guarantee.
Ingredients
Ingredients as defined by AAFCO.
Mixing Directions
Mix 10 pounds of this Type B medicated feed with 1990 lb non-medicated feed ingredients
to manufacture one ton of complete Type C medicated swine feed containing 96 grams of
Drug X and 200 grams of Drug Y.
CAUTION: Not to be fed to swine that weigh more than 250 pounds.
WARNING: 	Withdraw 6 days before slaughter.
Manufactured by
Blue Bird Feed Mill
Robin, IN 00000
Net Weight___lb (_____kg)
Bag or Bulk
Lot number (if applicable)_______________

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Drug X/Drug Y Growing Swine Ration
(drug X and drug Y Type C Medicated Feed)
For the reduction in severity of swine mycoplasma pneumonia caused by Mycoplasma
hyopneumoniae; aid in the prevention of migration and establishment of large roundworm
(Ascaris suum) infections; aid in the prevention of establishment of nodular worm
(Oesophagostomum spp.) infections.
Active Drug Ingredients
Drug X……………………………………………………………………………...96 g/ton
Drug Y…………………………….…………….………………………………...200 g/ton
Guaranteed Analysis
Crude Protein (min)………………………………………………………………______%
Lysine (min)………………………………………………………………………______%
Crude Fat (min)…………………………………………………………………..______%
Crude Fiber (max)………………………………………………………………...______%
Calcium (min)………………………………………………………...…………. ______%
Calcium (max)…………………………………………………………………… ______%
Phosphorus (min)…………………………………………………………………______%
Salt (min)1 ………………………………………………………………………...______%
Salt (max)1 ………………………………...……………………………………...______%
Sodium (min)2 …………………………………………………………………….______%
Sodium (max)2 ……………………………………………………………………______%
Selenium (min)…………………………………………………………………...______%
Zinc (min)………………………………………………………………………...______%
1 If added.
2 Shall be guaranteed only when total Sodium exceeds that furnished by the maximum salt guarantee.
Ingredients
Ingredients as defined by AAFCO.
Feeding Directions
Feed as sole ration for 21 days.
CAUTION: Not to be fed to swine that weigh more than 250 pounds.
WARNING: Withdraw 6 days before slaughter.
Manufactured by
Blue Bird Feed Mill
Robin, IN 00000
Net Weight ____lb (_____kg)
Bag or Bulk
Lot number (if applicable)________________