June 2012 Dr Dragan Momcilovic Medicated Feeds Specialist Dr Gabriel Davila Staff Fellow Food and Drug Administration Center for Veterinary Medicine Division of Animal Feeds Medicated Feeds Team ID: 138504
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Rockville, MD June 2012
Dr. Dragan Momcilovic, Medicated Feeds SpecialistDr. Gabriel Davila, Staff FellowFood and Drug AdministrationCenter for Veterinary MedicineDivision of Animal FeedsMedicated Feeds Team
Medicated Feeds OverviewSlide2
Definitions and usagesDrug CategoriesTypes of DistributionMedicated ProductsPre-approval activitiesFDA’s new animal drug approval process (basics)Label reviewLabeling of medicated productsPost-approval activities Current Good Manufacturing Practices (
cGMP)Program MonitoringLicensing and RegistrationWhere to look for more information
AgendaSlide3
Drug Categories Slide4
Drug Categories
Category II
Category ISlide5
Drug Categories
Category II
Category I
Drugs with no withdrawal period required at the lowest use level for each species for which they are approvedSlide6
Drug Categories
Category II
Category I
Drugs with no withdrawal period required at the lowest use level for each species for which they are approved
Drugs with a withdrawal period required at the lowest use level for at least one of the species for which they are approvedSlide7
Drug Categories
Category II
Category I
Drugs with no withdrawal period required at the lowest use level for each species for which they are approved
Drugs with a withdrawal period required at the lowest use level for at least one of the species for which they are approved
Drugs regulated on a “no-residue” basis or with a “zero” tolerance level because of a carcinogenic concernSlide8
Drug Categories
Category II
Category I
Drugs with no withdrawal period required at the lowest use level for each species for which they are approved
Drugs with a withdrawal period required at the lowest use level for at least one of the species for which they are approved
Drugs regulated on a “no-residue” basis or with a “zero” tolerance level because of a carcinogenic concern
Drugs that are veterinary feed directiveSlide9
Drug Categories
Category II
Category I
Drugs with no withdrawal period required at the lowest use level for each species for which they are approved
Drugs with a withdrawal period required at the lowest use level for at least one of the species for which they are approved
Drugs regulated on a “no-residue” basis or with a “zero” tolerance level because of a carcinogenic concern
Drugs that are veterinary feed directive
Level of riskSlide10
Drug Categories
Category II
Category I
Drugs with no withdrawal period required at the lowest use level for each species for which they are approved
Drugs with a withdrawal period required at the lowest use level for at least one of the species for which they are approved
Drugs regulated on a “no-residue” basis or with a “zero” tolerance level because of a carcinogenic concern
Drugs that are veterinary feed directive
Level of riskSlide11
Less risky
Drug Categories
Category II
Category I
Drugs with no withdrawal period required at the lowest use level for each species for which they are approved
Drugs with a withdrawal period required at the lowest use level for at least one of the species for which they are approved
Drugs regulated on a “no-residue” basis or with a “zero” tolerance level because of a carcinogenic concern
Drugs that are veterinary feed directive
Level of riskSlide12
Drug Categories
Category II
Category I
Drugs with no withdrawal period required at the lowest use level for each species for which they are approved
Drugs with a withdrawal period required at the lowest use level for at least one of the species for which they are approved
Drugs regulated on a “no-residue” basis or with a “zero” tolerance level because of a carcinogenic concern
Drugs that are veterinary feed directive
Level of risk
Less risky
More riskySlide13
Medicated Feeds are distributed: - Over-The-Counter - Veterinary Feed DirectiveTypes of DistributionSlide14
Medicated Products Type A medicated article Type B medicated feed Type C medicated feed
Slide15
Medicated Products Type A medicated article is a new animal drug
Slide16
*Federal Food, Drug, and Cosmetic Act
Section 201(v)*: - any drug intended for use for animals other than man, including any drug intended for use in animal feed - does not include animal feed
A new animal drug is….Slide17
Medicated Products Type A medicated article is a new animal drug with or without inactive ingredients intended for use in animal feed intended solely for further manufactureSlide18
Medicated Products Type A medicated article is used to make another Type A medicated article a Type B medicated feed a Type C medicated feedSlide19
*Federal Food, Drug, and Cosmetic Act
Section 201(w)*: an article intended for use for food for animals other than man intended for use as a substantial source of nutrients in the diet of the animalis not limited to a mixture intended to be the sole ration of the animal.
Animal feed is...Slide20
Type A medicated article - DRUG Type B medicated feed - FEED containing DRUG Type C medicated feed - FEED containing DRUG
Medicated ProductsSlide21
contains a substantial quantity of nutrients originates from: a) a Type A medicated article b) another Type B medicated feed c) an unstandardized drug component (bulk or “drum run”)Type B Medicated FeedSlide22
intended solely for the manufacture of: - other Type B medicated feed - Type C medicated feedType B Medicated FeedSlide23
the maximum concentration of drug(s) is: a) if a Category I drug - 200 X the highest continuous use level b) if a Category II drug - 100 X the highest continuous use level
c) if a drug is not approved for continuous use - the highest level used for disease prevention/control Type B Medicated FeedSlide24
product name purpose or indications for use active ingredients guaranteed analysis
ingredients mixing directions
warning and caution sections (if any)
name and address of manufacturer
net weight statement
Components of a Type B Blue Bird Label Slide25
Originates from: a) a Type A medicated article b) a Type B medicated feed c) another Type C medicated feed d) an unstandardized drug component
(bulk or drum run)Type C Medicated FeedSlide26
is intended for feeding as: a) the complete feed b) ‘top dressed’ c) ‘free choice’Type C Medicated Feed Slide27
product name purpose or indications for use active ingredients guaranteed analysis
ingredients feeding directions
warning and caution sections (if any)
name and address of manufacturer
net weight statement
Components of a Type C Blue Bird Label Slide28
Type C for feedingto be fedLabelingFeeding directionsType B for further mixing
cannot be fedLabelingMixing directionsMajor differences between Type B and Type C medicated feed labelsSlide29
FDA’s animal drug approval process (basics)Slide30
Required for: - the manufacture of all Type A medicated articlesNew Animal Drug Application (NADA)Slide31
mandates that a new animal drug may not be sold in interstate commerce unless it is the subject of a New Animal Drug Application (NADA) The Federal Food, Drug, and Cosmetic ActSlide32
What does an approved NADA mean? The Federal Food, Drug, and Cosmetic ActSlide33
What does an approved NADA mean?The product is safe and effective for its intended use The Federal Food, Drug, and Cosmetic ActSlide34
What does an approved NADA mean?The product is safe and effective for its intended useThe methods, facilities and controls used for the manufacturing, processing and packaging of the drug are adequate to preserve its identity, strength, quality and purity The Federal Food, Drug, and Cosmetic ActSlide35
EffectivenessBased on substantial evidence consisting of one or more adequate and well controlled investigations, such as - a study in a target species - a study in laboratory animals - a bioequivalence study - an in vitro study
The Federal Food, Drug, and Cosmetic ActSlide36
Safety - Adequate tests by all methods reasonably applicable show that the drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labelingThe Federal Food, Drug, and Cosmetic ActSlide37
NADA - is a systematic approach to document evidence that drug products are safe and effective - consists of the drug, the packaging, and the labeling
The Federal Food, Drug, and Cosmetic ActSlide38
Division of Animal FeedsOffice of Surveillance and Compliance (OSC), Center for Veterinary Medicine
Label review Slide39
Division of Animal Feeds
Office of Surveillance and Compliance (OSC), Center for Veterinary Medicine
Pre-approval
Post-approval
Label review
Slide40
Division of Animal Feeds
Office of Surveillance and Compliance (OSC), Center for Veterinary Medicine
Office of New Animal Drug Evaluation
(ONADE)
Center for Veterinary Medicine
Pre-approval
Post-approval
Label review
Slide41
Division of Animal Feeds
Office of Surveillance and Compliance (OSC), Center for Veterinary Medicine
Office of New Animal Drug Evaluation
(ONADE)
Center for Veterinary Medicine
Other units within the OSC
Field personnel- FDA
State Officials
Drug Manufacturers
Pre-approval
Post-approval
Label review
Slide42
Labeling of Medicated ProductsSlide43
21 CFR 514.1(b)(3)(v)Labeling for new animal drugs intended for use in the manufacture of medicated feeds shall include:( a ) Specimens of labeling to be used for such new animal drug with 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. Ingredient labeling may utilize collective names as provided in §501.110 of this chapter.( b ) Representative labeling proposed to be used for Type B and Type C medicated feeds containing the new animal drug.NADA RegulationSlide44
Type A medicated article
Type B medicated feed Type C medicated feed
Medicated ProductsSlide45
Types of labels Type A medicated article Brand BrandType B medicated feed Blue Bird BrandType C medicated feed Blue Bird Brand
Medicated Product Pre-approval Post-approval
Label ReviewSlide46
Drug X/Drug Y
Growing Turkey RationType B MEDICATED FEEDFor the prevention of coccidiosis caused by Eimeria
meleagrimitis
, E
gallopavonis
,
and
E.
adenoeides
and for increased rate of weight gain and improved feed efficiency in growing turkeys.ACTIVE DRUG INGREDIENTS Drug X ...........................................................................…….…………….……….....80,000 g/ton Drug Y…………………………………………….……………………….........……………6,000 g/tonGUARANTEED ANALYSIS Crude Protein (min)……………………………………………….........................................…..……….…..______%Lysine (min)………………………………………………………...........................................….….….……..______%
Methionine (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
….……..…………………………………..........................................………………....……..______%
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 turkey feed containing 400 grams of Drug X and 30 grams of Drug Y.
CAUTION: Do not feed to breeding turkeys.WARNING: Do not feed five days before slaughter.
MANUFACTURED BY:
BLUE BIRD FEED MILL
Robin, IN 00000
Net Weight____
lbs
(______kg)
Bag or Bulk
Blue Bird LabelSlide47
YOUR NAME FEEDS
Breeding Swine RationMedicated
For control and treatment of leptospirosis (reducing the incidence of abortion and shedding of leptospirae) caused by
Leptospira pomona
susceptible to Drug Y
Active drug ingredient
Drug X…………………….................................400 grams/ton
Drug Y……………………….............................400 grams/ton
Guaranteed Analysis
Crude Protein, minimum ............................18.0%
Lysine…………………………………………..1.27%
Crude Fat, minimum .....................................7.0%
Crude Fiber, maximum .................................3.5%
Calcium, minimum ........................................0.7%
Calcium, maximum .......................................1.2%
Phosphorus, minimum ..................................0.65%
Selenium, minimum ......................................0.29
ppm
Zinc, minimum…………………… ……….2000 ppm
Ingredient Statement
Grain Products, Plant Protein Products, Whey, Animal Fat (preserved with
Ethoxyquin
), Vitamin A Supplement, D-Activated Animal Sterol (source of Vitamin D
3
), Vitamin E Supplement, Folic Acid, Biotin, Ascorbic Acid, Copper Sulfate,
Manganous
Oxide, Zinc Oxide, Ferrous Sulfate, Cobalt Carbonate, Calcium
Iodate
, Sodium
Selenite
, Sodium
Silico
Aluminate
, Natural and Artificial Flavors.
FEEDING DIRECTIONS
Feed continuously for not more than 14 days as the sole ration to provide 10 mg/lb body weight per day of each of the two drugs.
CAUTION: Consult your veterinarian if abortions continue to occur at an unacceptable level.
WARNING: Withdraw 5 days before slaughter.
YOUR NAME FEEDS
City, State Zip
NET WT 50 LB (22.67 kg)
Brand LabelSlide48
YOUR NAME FEEDS
Breeding Swine RationMedicated
For control and treatment of leptospirosis (reducing the incidence of abortion and shedding of leptospirae) caused by
Leptospira pomona
susceptible to Drug Y
Active drug ingredient
Drug X…………………….................................400 grams/ton
Drug Y……………………….............................400 grams/ton
Guaranteed Analysis
Crude Protein, minimum ............................18.0%
Lysine…………………………………………..1.27%
Crude Fat, minimum .....................................7.0%
Crude Fiber, maximum .................................3.5%
Calcium, minimum ........................................0.7%
Calcium, maximum .......................................1.2%
Phosphorus, minimum ..................................0.65%
Selenium, minimum ......................................0.29 ppm
Zinc, minimum…………………… ……….2000 ppm
Ingredient Statement
Grain Products, Plant Protein Products, Whey, Animal Fat (preserved with
Ethoxyquin
), Vitamin A Supplement, D-Activated Animal Sterol (source of Vitamin D
3
), Vitamin E Supplement, Folic Acid, Biotin, Ascorbic Acid, Copper Sulfate,
Manganous
Oxide, Zinc Oxide, Ferrous Sulfate, Cobalt Carbonate, Calcium Iodate, Sodium Selenite, Sodium
Silico
Aluminate, Natural and Artificial Flavors.
FEEDING DIRECTIONS
Feed continuously for not more than 14 days as the sole ration to provide 10 mg/lb body weight per day of each of the two drugs.
CAUTION: Consult your veterinarian if abortions occur at an unacceptable level.
WARNING: Withdraw 5 days before slaughter.
YOUR NAME FEEDS
City, State Zip
NET WT 50 LB (22.67 kg)
Drug X/Drug Y
Growing Turkey Ration
Type B MEDICATED FEED
For the prevention of coccidiosis caused by
Eimeria meleagrimitis, E gallopavonis,
and
E. adenoeides
and for increased rate of weight gain and improved feed efficiency in growing turkeys.
ACTIVE DRUG INGREDIENTS
Drug X ....................................................................…….…………….……….....80,000 g/ton
Drug Y……………………………………….……………………….........……………6,000 g/ton
GUARANTEED ANALYSIS
Crude Protein (min)……………………………………………….........................................…..……….…..______%
Lysine (min)………………………………………………………...........................................….….….……..______%
Methionine (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
….……..…………………………………..........................................………………....……..______%
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 turkey feed containing 400 grams of Drug X and 30 grams of Drug Y.
CAUTION: Do not feed to breeding turkeys.
WARNING: Do not feed five days before slaughter.
MANUFACTURED BY:
BLUE BIRD FEED MILL
Robin, IN 00000
Net Weight____lbs (______kg)
Bag or Bulk
Blue Bird v Brand labelSlide49
Section Blue Bird Brand
Product name Generic BrandIndications for use As regulation says SameActive ingredients As regulation says SameGuaranteed analysis Blank levels Specific levels
Ingredients AAFCO statement List ingredients
Directions for use As regulation says Mostly same
Warning section As regulation says Same
Caution section As regulation says Same
Manufacturer information Generic Exact information
Net weight statement Generic Exact
Comparison between Blue Bird and Brand labelsSlide50