medicated feeds overview

Download Medicated Feeds Overview

Post on 25-Feb-2016

106 views

Category:

Documents

2 download

Embed Size (px)

DESCRIPTION

Medicated Feeds Overview. 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. Rockville, MD June 2012. Agenda. Definitions and usages - PowerPoint PPT Presentation

TRANSCRIPT

General discussion on the regulation of medicated feed

Rockville, MD June 2012Dr. Dragan Momcilovic, Medicated Feeds SpecialistDr. Gabriel Davila, Staff Fellow

Food and Drug AdministrationCenter for Veterinary MedicineDivision of Animal FeedsMedicated Feeds Team

Medicated Feeds OverviewDefinitions and usagesDrug CategoriesTypes of DistributionMedicated Products

Pre-approval activitiesFDAs new animal drug approval process (basics)Label reviewLabeling of medicated products

Post-approval activities Current Good Manufacturing Practices (cGMP)Program MonitoringLicensing and Registration

Where to look for more information

Agenda2004 AAFCO Midyear MeetingIngredient Definitions Workshop2Definitions are specified in 21 CFR 558.3Drug Categories Drug Categories Category IICategory IDrug Categories Category IICategory IDrugs with no withdrawal period required at the lowest use level for each species for which they are approvedDrug Categories Category IICategory IDrugs with no withdrawal period required at the lowest use level for each species for which they are approvedDrugs with a withdrawal period required at the lowest use level for at least one of the species for which they are approvedDrug Categories Category IICategory IDrugs with no withdrawal period required at the lowest use level for each species for which they are approvedDrugs with a withdrawal period required at the lowest use level for at least one of the species for which they are approvedDrugs regulated on a no-residue basis or with a zero tolerance level because of a carcinogenic concernDrug Categories Category IICategory IDrugs with no withdrawal period required at the lowest use level for each species for which they are approvedDrugs with a withdrawal period required at the lowest use level for at least one of the species for which they are approvedDrugs regulated on a no-residue basis or with a zero tolerance level because of a carcinogenic concernDrugs that are veterinary feed directiveDrug Categories Category IICategory IDrugs with no withdrawal period required at the lowest use level for each species for which they are approvedDrugs with a withdrawal period required at the lowest use level for at least one of the species for which they are approvedDrugs regulated on a no-residue basis or with a zero tolerance level because of a carcinogenic concernDrugs that are veterinary feed directiveLevel of riskDrug Categories Category IICategory IDrugs with no withdrawal period required at the lowest use level for each species for which they are approvedDrugs with a withdrawal period required at the lowest use level for at least one of the species for which they are approvedDrugs regulated on a no-residue basis or with a zero tolerance level because of a carcinogenic concernDrugs that are veterinary feed directiveLevel of riskLess riskyDrug Categories Category IICategory IDrugs with no withdrawal period required at the lowest use level for each species for which they are approvedDrugs with a withdrawal period required at the lowest use level for at least one of the species for which they are approvedDrugs regulated on a no-residue basis or with a zero tolerance level because of a carcinogenic concernDrugs that are veterinary feed directiveLevel of riskDrug Categories Category IICategory IDrugs with no withdrawal period required at the lowest use level for each species for which they are approvedDrugs with a withdrawal period required at the lowest use level for at least one of the species for which they are approvedDrugs regulated on a no-residue basis or with a zero tolerance level because of a carcinogenic concernDrugs that are veterinary feed directiveLevel of riskLess riskyMore riskyMedicated Feeds are distributed:

- Over-The-Counter

- Veterinary Feed Directive

Types of DistributionMedicated Products

Type A medicated article

Type B medicated feed

Type C medicated feed

2004 AAFCO Midyear MeetingIngredient Definitions Workshop14Medicated Products

Type A medicated article is a new animal drug

2004 AAFCO Midyear MeetingIngredient Definitions Workshop15Type A article cannot be fed without being mixed in feed first; a Type C medicated feed is to be fed.*Federal Food, Drug, and Cosmetic ActSection 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.2004 AAFCO Midyear MeetingIngredient Definitions Workshop16Sec. 201 of the FFDCA statesMedicated 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 manufacture

2004 AAFCO Midyear MeetingIngredient Definitions Workshop17Medicated Products

Type A medicated article is used to make another Type A medicated article a Type B medicated feed a Type C medicated feed

2004 AAFCO Midyear MeetingIngredient Definitions Workshop18*Federal Food, Drug, and Cosmetic ActSection 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 animal

is not limited to a mixture intended to be the sole ration of the animal.

Animal feed is...2004 AAFCO Midyear MeetingIngredient Definitions Workshop19 Type A medicated article- DRUG

Type B medicated feed- FEED containing DRUG

Type C medicated feed- FEED containing DRUG

Medicated Products2004 AAFCO Midyear MeetingIngredient Definitions Workshop20 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 Feed2004 AAFCO Midyear MeetingIngredient Definitions Workshop21 intended solely for the manufacture of:- other Type B medicated feed- Type C medicated feed

Type B Medicated Feed2004 AAFCO Midyear MeetingIngredient Definitions Workshop22 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 Feed2004 AAFCO Midyear MeetingIngredient Definitions Workshop23The highest continuous use level means the highest dosage at which the drug is approved for continuous use (14 days or more). The highest approved level in any species is the one used to determine the maximum drug level in a Type B feed. Give an example for each. 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 2004 AAFCO Midyear MeetingIngredient Definitions Workshop24 Originates from:a) a Type A medicated articleb) a Type B medicated feedc) another Type C medicated feed d) an unstandardized drug component (bulk or drum run)

Type C Medicated Feed2004 AAFCO Midyear MeetingIngredient Definitions Workshop25is intended for feeding as:a) the complete feed b) top dressed c) free choice

Type C Medicated Feed 2004 AAFCO Midyear MeetingIngredient Definitions Workshop26Define each use. 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 2004 AAFCO Midyear MeetingIngredient Definitions Workshop27Type C for feedingto be fed

LabelingFeeding directionsType B for further mixing cannot be fed

LabelingMixing directionsMajor differences between Type B and Type C medicated feed labelsFDAs animal drug approval process (basics)Required for:

- the manufacture of all Type A medicated articles

New Animal Drug Application (NADA)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 ActWhat does an approved NADA mean?

The Federal Food, Drug, and Cosmetic ActSome history on safety and effectiveness.What does an approved NADA mean?The product is safe and effective for its intended use

The Federal Food, Drug, and Cosmetic ActSome history on safety and effectiveness.What does an approved NADA mean?The product is safe and effective for its intended use

The 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 ActSome history on safety and effectiveness.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 studyThe Federal Food, Drug, and Cosmetic ActSafety- 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 Act NADA- is a systematic approach to document evidence that drug products are safe and effective

- consists of the drug, the packaging, and the labelingThe Federal Food, Drug, and Cosmetic ActDivision

Recommended

View more >