mhtml:file://k:\guidemgr\files\2010_fda_compliance Program Manual.mht
|
|
- Amos Webster
- 6 years ago
- Views:
Transcription
1 Page 1 of 5 Home > Inspections, Compliance, Enforcement, and Criminal Investigations > Compliance Manuals > Compliance Program Guidance Manual Inspections, Compliance, Enforcement, and Criminal Investigations Compliance Program Manual FDA compliance programs provide guidance and instructions to FDA staff for obtaining information to help fulfill agency plans in the specified program area. These compliance programs neither create or confer any rights for, or on, any person and do not operate to bind FDA or the public. Alternative approaches may be used as long as said approaches satisfy the requirements of applicable statutes and regulations. These programs are intended for FDA personnel but are made available electronically to the public as they become available. Numerical listing of all FDA Compliance Programs with hyperlinks to those available electronically on FDA websites, organized by these program areas: Biologics 1 Bioresearch Monitoring (BIMO) 2 Devices/Radiological Health 3 Drugs 4 Food and Cosmetics 5 Veterinary Medicine 6 Reference: FDA Freedom of Information Act Handbook for Requesting Information and Records from FDA 7 Foods and Cosmetics Import Acidified and Low Acid Canned Foods Program Link to CFSAN list Domestic and Imported Cheese and Cheese Products Link to CFSAN list National Drug Residue Milk Monitoring Program Link to CFSAN list Domestic Food Safety Link to CFSAN list A Domestic Acidified and Low-Acid Canned Foods Link to CFSAN list Imported Foods - General Program Link to CFSAN list Domestic Fish and Fishery Products Inspection Program Link to CFSAN list Import Seafood Products Link to CFSAN list Juice HACCP Inspection Program Pesticides and Industrial Chemicals in Domestic Foods Link to CFSAN list Pesticides and Industrial Chemicals in Imported Foods Link to CFSAN list Chemotherapeutics in Seafood Compliance Link to CFSAN list Toxic Elements in Food and Foodware Import and Domestic Link to CFSAN list Total Diet Studies Link to CFSAN list Mycotoxins in Domestic Foods Link to CFSAN list Mycotoxins in Imported Foods Link to CFSAN list Imported Foods - Food and Color Additives Link to CFSAN list Retail Food Protection - State Link to CFSAN list Milk Safety Program Link to CFSAN list Molluscan Shellfish Evaluation Link to CFSAN list Interstate Travel Program Link to CFSAN list Medical Foods - Import and Domestic Link to CFSAN list Domestic and Import NLEA, Nutrient Sample Analysis General Food Labeling Program Link to CFSAN list Infant Formula Program - Import and Domestic Link to CFSAN list Food Composition, Standards, Labeling And Economics Dietary Supplements - Import Link to CFSAN list 31 and Domestic Cosmetics Program - Domestic & Imports Link to CFSAN list 32 Page Top 33 Biologics Inspection of Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps) Link to CBER list A Inspection of Tissue Establishments Link to CBER list Inspection of Licensed and Unlicensed Blood Banks, Brokers, Reference Laboratories, and Link to CBER list 36 Contractors Inspection of Source Plasma Establishments Link to CBER list Imported CBER-Regulated Products Link to CBER list A Imported Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps) Link to CBER list Inspections of Licensed Viral Marker Test Kits Link to CBER list 40 or PDF (3129 kb) Inspection of Biological Drug Products Link to CBER list 41
2 Page 2 of 5 Page Top 42 BIMO In Vivo Bioequivalence HTML 43 PDF 44 (78 kb) Good Laboratory Practice (Nonclinical Laboratories) HTML 45 PDF 46 (117 kb) A Good Laboratory Practice Program (Nonclinical Laboratories) EPA Data Audit HTML 47 PDF 48 (38 kb) Inspections Institutional Review Board PDF 49 (293 kb) A Radioactive Drug Research Committee Sponsors, Contract Research Organization and Monitors HTML 50 PDF 51 (80 kb) Clinical Investigators HTML 52 PDF 53 (2437 kb) Drugs Pre-Approval Inspections/Investigations PDF 55 (156kb) Post-Approval Audit Inspections PDF 56 (159kb) Unapproved New Drugs (Marketed, Human, Prescription Drugs only) PDF 57 HTML In Vitro Methods Development and Validation for Generic Drugs Enforcement of the Postmarketing Adverse Drug Experience Reporting Regulations HTML Drug Manufacturing Inspections HTML 60 PDF 61 (80 kb) A Sterile Drug Process Inspections PDF 62 (79 kb) B Drug Repackers and Relabelers PDF 63 (189 kb) C Radioactive Drugs PDF 64 (187 kb) E Compressed Medical Gases PDF 65 (249 kb) F Active Pharmaceutical Ingredients PDF 66 (252 kb) M Inspections of Licensed Biological Therapeutic Drug Products HTML 67 PDF 68 (89 kb) Postmarket Drug Product Surveys Drug Listing A Drug Listing - Labeling Review Compendial Monographs Evaluation and Development (CMED) A Compendial Methods Assessment Drug Quality Reporting System NDA Field Alert Reporting Enforcement of the Prescription Drug Marketing Act (PDMA) Government-Wide Quality Assurance OTC Drug Monograph Implementation PDF 69 (76 kb) Fraudulent Drugs PDF 70 (69 kb) Veterinary Medicine Pre-Approval Inspection New Animal Drug Applications (NADA) Abbreviated New Animal Link to CVM list 72 Drug Applications (ANADA) Animal Drug Manufacturing Inspections Link to CVM list Illegal Sales of Veterinary Prescription Drugs Link to CVM list Feed Contaminants Program Link to CVM list Feed Manufacturing Compliance Program Link to CVM list Type A Medicated Articles Link to CVM list Illegal Drug Residues in Meat & Poultry Program Link to CVM list Imported Bulk New Animal Drugs Link to CVM list National Drug Residue Milk Monitoring Link to CVM list BSE/Ruminant Feed Ban Inspections Link to CVM list 81 Page Top 54 Page Top 71 Page Top 82 Devices Monitoring Devices of Foreign Origin Import Conformance Assessment of Devices to Product Specifications in Pre-Market Notifications (510(k)s) Inspection of Medical Device Manufacturers HTML Medical Device Premarket Approval and Postmarket Inspections (k) Premarket Approval Inspections Mammography Facility Inspections DOC 84 (730 kb) Inspection and Field Testing of Radiation- Emitting Electronic Products PDF 85 (1190 kb) Field Compliance Testing of Diagnostic Medical X-Ray Equipment PDF 86 (75 kb) DOC 87 (143 kb) Attachments A-C PDF 88 (9 kb) DOC 89 (28 kb) Attachment D PDF 90 (25 kb)
3 Page 3 of 5 Attachment E Attachment F Attachment G Attachments H-K Attachment L DOC 91 (53 kb) PDF 92 (672 kb) DOC 93 (126 kb) PDF 94 (30 kb) DOC 95 (122 kb) PDF 96 (27 kb) DOC 97 (61 kb) PDF 98 (22 kb) DOC 99 (46 kb) PDF 100 (7 kb) DOC 101 (24 kb) PDF 102 (37 kb) Attachment M DOC 103 (74 kb) Inspection of Domestic and Foreign a Link to CDRH List 104 Manufacturers of Diagnostic X Ray Equipment or PDF 105 (3.51 kb) Compliance Testing of Electronic Products at WEAC Imported Electronic Product Imported Non-certified Radiation-Emitting Electronic Products (Special Exemption for A Television Receivers, Microwave Ovens, and Certain Class I Laser Products Medical Device and Radiological Health Use Control and Policy Implementation Emergency Planning and Response Activities Part VI Links on this page:
4 Page 4 of cescgmpfordrugs/ucm pdf
5 Page 5 of
They're not all the same: Why FDA approval of animal drugs matters
They're not all the same: Why FDA approval of animal drugs matters Elizabeth Luddy, DVM Deputy Director, Office of New Animal Drug Evaluation Center for Veterinary Medicine US Food and Drug Administration
More informationGuidance for FDA Staff
Guidance for FDA Staff Compliance Policy Guide Sec. 690.800 Salmonella in Animal Feed Draft Guidance This guidance document is being distributed for comment purposes only. Additional copies are available
More informationUnapproved Animal Drugs Initiative
Animal Drugs Initiative Elizabeth Luddy, DVM Deputy Director Office of New Animal Drug Evaluation Center for Veterinary Medicine Animal Drugs Initiative Publically launched December 20, 2010 drugs webpage
More informationCOMPOUNDING REGULATORY PERSPECTIVE
COMPOUNDING REGULATORY PERSPECTIVE Janice Steinschneider Supervisory Regulatory Counsel Office of Surveillance & Compliance FDA/Center for Veterinary Medicine USP Veterinary Drugs Stakeholder Forum November
More informationCenter for Veterinary
Center for Veterinary Medicine: Overview Sanja Modric, DVM, PhD Office of New Animal Drug Evaluation Center for Veterinary Medicine i Food and Drug Administration USP Veterinary Stakeholder Forum, 11-09-2012
More informationRegulatory Framework for the Availability and Use of Animal Drugs in the United States
Regulatory Framework for the Availability and Use of Animal Drugs in the United States Sanja Modric, DVM, PhD KEYWORDS Drug approval process Approved versus unapproved drugs Regulatory Safety KEY POINTS
More informationAnimal Feed GRAS Notifications
Animal Feed GRAS Notifications Geoffrey K. Wong, M.S. Division of Animal Feeds Center for Veterinary Medicine 2010 AAFCO Midyear Meeting January 19, 2010 GRAS Notification What is GRAS?!? AAFCO January
More informationRecognition of Export Controls and Certification Systems for Animals and Animal Products. Guidance for Competent Authorities of Exporting Countries
Recognition of Export Controls and Certification Systems for Animals and Animal Products Guidance for Competent Authorities of Exporting Countries Disclaimer This guidance does not constitute, and should
More informationWebinar: Update and Briefing on Feed Rule November 13, 2008 FDA, Center for Veterinary Medicine Office of Surveillance & Compliance
2008 BSE Feed Rule Webinar: Update and Briefing on Feed Rule November 13, 2008 FDA, Center for Veterinary Medicine Office of Surveillance & Compliance 1 The New 2008 Rule Published in the Federal Register
More informationCHAPTER 1 DISPENSING VETERINARY PRESCRIPTION DRUGS (2 CE Hours)
CHAPTER 1 DISPENSING VETERINARY PRESCRIPTION DRUGS (2 CE Hours) Adapted from: The Center for Veterinary Medicine within the Food and Drug Administration. Additional material and editing by: Christopher
More information[amended May 5, 2005]
The FARAD Newsletter is an electronic publication from the Food Animal Residue Avoidance Databank (FARAD) for veterinarians, animal scientists, extension specialists and the regulatory community. Issue
More informationRESIDUE MONITORING AND CONTROL PROGRAM. Dr. T. Bergh Acting Director: Veterinary Public Health Department Agriculture, Forestry and Fisheries
RESIDUE MONITORING AND CONTROL PROGRAM Dr. T. Bergh Acting Director: Veterinary Public Health Department Agriculture, Forestry and Fisheries Scope of Presentation Introduction Roles Residue control programmes
More informationMitigating Pain in Livestock: What Options are Available
Mitigating Pain in Livestock: What Options are Available NIAA 2014 Annual Conference Omaha, Nebraska April 2, 2014 Craig A. Lewis, DVM, MPH, DACVPM Center for Veterinary Medicine U.S. Food and Drug Administration,
More informationUNAPPROVED VETERINARY DRUGS
UNAPPROVED VETERINARY DRUGS Janice Steinschneider Supervisory Regulatory Counsel Office of Surveillance & Compliance FDA/Center for Veterinary Medicine USP Veterinary Drugs Stakeholder Forum February 20,
More informationAmerican Veterinary Medical Association
AVMA American Veterinary Medical Association Governmental Relations Division 1910 Sunderland Place, NW Washington, DC 20036-1642 phone 202.789.0007 800.321.1473 fax 202.842.4360 AVMA Headquarters 1931
More informationHuman Food Safety of Veterinary Drugs. Bettye K. Walters, DVM
Human Food Safety of Veterinary Drugs Bettye K. Walters, DVM Bettye.walters@fda.hhs.gov Pertinent International Resources Organization for Economic Co-Operation and Development (OECD) Understanding the
More informationCHAPTER Committee Substitute for Senate Bill No. 1540
CHAPTER 2006-92 Committee Substitute for Senate Bill No. 1540 An act relating to veterinary drug distribution; amending s. 499.006, F.S.; providing that a drug is adulterated if it is a certain prescription
More informationHerbal Medicine for Animal Use in JAPAN
Herbal Medicine for Animal Use in JAPAN Quality Assay Section, Assay Division Ⅱ, National Veterinary Assay Laboratory 21 Dec. 2016 6 Oct. 2016 1 Veterinary Drugs Veterinary Drugs Veterinary Pharmaceuticals
More informationThe Changing Veterinary Pharmaceutical Landscape
The Changing Veterinary Pharmaceutical Landscape Dan Grooms DVM, PhD Michigan State University College of Veterinary Medicine The use of pharmaceutical products in food animals is under close scrutiny
More informationRegulatory Information
Home Regulatory Information Search for FDA Guidance Documents Regulatory Information The Sourcing and Processing of Gelatin to Reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy (BSE)
More informationPanel Discussion: Industry Perspective on PET Drug Manufacturing
Panel Discussion: Industry Perspective on PET Drug Manufacturing Standards for Imaging Endpoints & Manufacturing of PET Radiopharmaceutical Products in Clinical Trials RSNA/SNM/FDA Natcher Center April
More informationVeterinary Drugs Stakeholder Forum Meeting 1 - Summary
Veterinary Drugs Stakeholder Forum Meeting 1 - Summary Sanja Modric, D.V.M., Ph.D., Chair j,,, FDA Center for Veterinary Medicine Wrap Up Session Friday, November 9, 2012 Organization Overviews FDA Center
More informationQuality of Veterinary Medicinal Products. How to ensure the quality of Veterinary Medicinal Products
Quality of Veterinary Medicinal Products How to ensure the quality of Veterinary Medicinal Products Jean-Pierre Orand Anses/ANMV OIE Collaborating Centre on Veterinary medicinal products Jean-pierre.orand@anses.fr
More informationSession 1: An introduction to the new requirements under the Food and Drug Regulations affecting industry and health care practitioners who compound
Session 1: An introduction to the new requirements under the Food and Drug Regulations affecting industry and health care practitioners who compound veterinary drugs February 13, 2018 Webinar Presentation
More informationCVM: Protecting human and animal health 2011 Update. Renate Reimschuessel CVM/Office of Research
CVM: Protecting human and animal health 2011 Update Renate Reimschuessel CVM/Office of Research CVM s Vision / Mission Mission "Protecting Human and Animal Health" CVM Organizational Chart Associate Director
More informationFREEDOM OF INFORMATION (FOI) SUMMARY
Date of Approval: March 25, 2003 FREEDOM OF INFORMATION (FOI) SUMMARY Acepromazine Maleate Injection 10 mg/ml Tranquilizer for use in dogs, cats, and horses ANADA 200-319 Phoenix Scientific, Inc. 3915
More information3. records of distribution for proteins and feeds are being kept to facilitate tracing throughout the animal feed and animal production chain.
CANADA S FEED BAN The purpose of this paper is to explain the history and operation of Canada s feed ban and to put it into a broader North American context. Canada and the United States share the same
More informationANNEXES. to the Proposal. for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
EUROPEAN COMMISSION Brussels, XXX SANCO/12328/2013 Rev. 4 ANNEX (POOL/G1/2013/12328/12328R4-EN ANNEX.doc) [ ](2014) XXX draft ANNEXES 1 to 6 ANNEXES to the Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT
More informationShow Animals Challenges at the Packer. Paula Alexander Project Manager, Sustainable Food Production & Food Safety Quality Assurance
Show Animals Challenges at the Packer Paula Alexander Project Manager, Sustainable Food Production & Food Safety Quality Assurance 1 Show Animals Packer Challenges Residue Sampling Product on hold, tracking,
More informationFDA Antibiotic Resistance Strategy
FDA Antibiotic Resistance Strategy NIAA Antimicrobial Use and Resistance Symposium November 14, 2014 William T. Flynn, DVM, MS Center for Veterinary Medicine (CVM) U.S. Food and Drug Administration (FDA)
More informationThe Veterinary Feed Directive. Dr. Dave Pyburn National Pork Board
The Veterinary Feed Directive Dr. Dave Pyburn National Pork Board Antibiotic Regulation US Food and Drug Administration regulates animal and human antibiotics State pharmacy boards have authority over
More informationSUMMARY: The Food and Drug Administration (FDA) is amending its animal drug
This document is scheduled to be published in the Federal Register on 06/03/2015 and available online at http://federalregister.gov/a/2015-13393, and on FDsys.gov 4164-01-P DEPARTMENT OF HEALTH AND HUMAN
More informationApplied-for scope of designation and notification of a Conformity Assessment Body Regulation (EU) 2017/746 (IVDR)
Ref. Ares(2018)2576484-17/05/2018 NBOG s Best Practice Guide applicable for MDR IVDR NBOG F 2017-4 This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article
More informationGuidance for Industry
Guidance for Industry #213 New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food- Producing Animals: Recommendations for Drug Sponsors
More informationVETERINARY PRODUCT REGISTRATION
VETERINARY PRODUCT REGISTRATION Biologics & Veterinary Drug Control Unit Department of Veterinary Services, Malaysia PURPOSE OF REGISTRATION To regulate the sale and use of biologics for animal use in
More informationGuidance for Industry
Guidance for Industry #213 New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food- Producing Animals: Recommendations for Drug Sponsors
More informationTHE ADVANTAGES OF cgmp Manufactured Veterinary Drugs
THE ADVANTAGES OF cgmp Manufactured Veterinary Drugs VS Compounded Drugs - WHY IT MATTERS Educational content provided by: 8809 Ely Rd, Pensacola, FL 32514 (850) 476-9462 www.prnpharmacal.com Veterinary
More informationImpact on Feed Mills Serving the Aquaculture Industry
Veterinary Feed Directive (VFD) Drugs: Impact on Feed Mills Serving the Aquaculture Industry Schering-Plough Animal Health 2004 Schering-Plough Animal Health Corporation. All rights reserved. SPAH-AQF-03
More informationProceedings of the 56th Annual Convention of the American Association of Equine Practitioners - AAEP -
http://www.ivis.org Proceedings of the 56th Annual Convention of the American Association of Equine Practitioners - AAEP - December 4-8, 2010 Baltimore, Maryland, USA Next Meeting : Nov. 18-22, 2011 -
More informationOIE Standards for Animal feed and food safety: terrestrial and aquatic animals
OIE Standards for Animal feed and food safety: terrestrial and aquatic animals OIE regional seminar on food safety Singapore, 12-14 October 2010 Yamato Atagi 1 Deputy Head, International Trade Department,
More informationResponsible Use of Veterinary Products. Bettye K. Walters, DVM
Responsible Use of Veterinary Products Bettye K. Walters, DVM Bettye.walters@fda.hhs.gov Pertinent International Resources Organization for Economic Co-Operation and Development (OECD) Understanding the
More informationdrugs, which examine by central competent authorities.
Veterinary Drugs Control Act Promulgated on August 16, 1971 Article 2. 15, 19, 22, 25,26, 29, 30 and 46 were amended and promulgated on June 19, 2002 Article 3-1, 3-2, 7, 12, 12-1 to 12-4, 16, 16-1, 18,
More informationTHE IMPORTANCE OF QUALITY IN COMPOUNDED VETERINARY MEDICINES
THE IMPORTANCE OF QUALITY IN COMPOUNDED VETERINARY MEDICINES GOOD MANUFACTURING PRACTICES On the 12th of June 2015 Bova was the first pharmacy in Australia to be granted a licence to manufacture veterinary
More informationWorking for organic farming in Europe
Working for organic farming in Europe International Federation of Organic Agriculture Movements EU Regional Group 9 st November 2012 President: Christopher Stopes Director: Marco Schlüter European Office
More informationNestlé S.A. Independent Assurance of Compliance with the Nestlé Policy and Instructions for Implementation of the WHO International Code Marketing
Nestlé S.A. Independent Assurance of Compliance with the Nestlé Policy and Instructions for Implementation of the WHO International Code of Marketing of Breast milk Substitutes in Egypt (November 2015)
More informationREGULATION (EC) No 854/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 29 April 2004
30.4.2004 EN Official Journal of the European Union L 155/206 REGULATION (EC) No 854/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 29 April 2004 laying down specific rules for the organisation
More informationVirginia Aquaculture Conference 2017: Becoming a Certified Dealer
Virginia Aquaculture Conference 2017: Becoming a Certified Dealer Danielle Schools Virginia Department of Health Division of Shellfish Sanitation Plant Program Manager Shellfish Dealer Certification- Becoming
More informationScientific Discussion post-authorisation update for Rheumocam extension X/007
5 May 2011 EMA/170257/2011 Veterinary Medicines and Product Data Management Scientific Discussion post-authorisation update for Rheumocam extension X/007 Scope of extension: addition of 20 mg/ml solution
More informationFDA/CVM Div. of Compliance
Deborah A. Cera Division of Compliance Center for Veterinary Medicine, FDA This Compliance program contains Center instructions to Field investigators on how to conduct inspections to follow up violative
More informationMedically Important Antimicrobials in Animal Agriculture. Sheep
Medically Important Antimicrobials in Animal Agriculture Sheep Mike Murphy DVM, JD, Ph.D., DABVT, DABT Veterinary Medical Officer Office of the Director Center for Veterinary Medicine FDA Outline Take
More informationPrudent use of antimicrobial agents Dairy Sector Initiatives. Robin Condron Dairy Australia
Prudent use of antimicrobial agents Dairy Sector Initiatives Robin Condron Dairy Australia INTERNATIONAL DAIRY FEDERATION Our mission To represent the dairy sector as a whole at international level, by
More informationPET FOOD REGULATIONS & INGREDIENT DEFINITIONS FOR CONSUMERS
This document is based on the Model Bills and legal definitions published in the AAFCO Official Publication. All content is accurate and written in consumer language (not legal language). This document
More informationL 210/36 Official Journal of the European Union DECISIONS COMMISSION
L 210/36 Official Journal of the European Union 10.8.2007 II (Acts adopted under the EC Treaty/Euratom Treaty whose publication is not obligatory) DECISIONS COMMISSION COMMISSION DECISION of 9 August 2007
More informationAquaculture Drugs: Industry Concerns
Washington DC New York Denver Seattle Aquaculture Drugs: Industry Concerns Lisa Weddig Vice President, Regulatory and Technical Affairs National Fisheries Institute Who is NFI? Leading advocacy organization
More informationFact Sheet: Veterinary Natural Health Products and CQM
January 2008 Fact Sheet: Veterinary Natural Health Products and CQM Introduction: The demand for organic production is increasing across Canada and the number of organic dairy farms is increasing to meet
More informationBeef Producers. The Judicious Use of Antimicrobials for
The Judicious Use of Antimicrobials for Beef Producers Introduction The production of safe and wholesome animal products for human consumption is a primary goal of beef producers. To achieve that goal,
More informationANTIBIOTICS IN AQUACULTURE: A (FISH) VETERINARIAN S PERSPECTIVE
ANTIBIOTICS IN AQUACULTURE: A (FISH) VETERINARIAN S PERSPECTIVE HUGH MITCHELL, MS, D.V.M. AQUATACTICS FISH HEALTH KIRKLAND, WA HUGHM@AQUATACTICS.COM MISSION STATEMENT OF A FOODFISH VET PRACTICE: To assist
More informationCFA Veterinary Residues Management Guidance
CFA Veterinary Residues Management Guidance Kaarin Goodburn Food Safety & Technology Management Consultant Chilled Food Association www.chilledfood.org Programme Support and endorsement Need for Guidance?
More informationQuality of Veterinary Medicinal Products. How to ensure the quality of Veterinary Medicinal Products
Quality of Veterinary Medicinal Products How to ensure the quality of Veterinary Medicinal Products Gérard Moulin Anses/ANMV OIE Collaborating Centre on Veterinary medicinal products gerard.moulin@anses.fr
More informationThe Integration of WTO Agreements into National Legislation: Case of the SPS Agreement
The Integration of WTO Agreements into National Legislation: Case of the SPS Agreement Lalaina Ravelomanantsoa Legal Officer Development Law Branch FAO Legal Office QUICK REMINDER ON THE SPS AGREEMENT
More informationThe Future of Antibiotic Alternatives
The Future of Antibiotic Alternatives @Elanco #feedthe9 Grady Bishop Sr. Director Market Access Elanco 1 The Global Landscape our WHY 2 Today s 3 Food Security Realities 3 The Protein Gap 4 The impact
More informationTips for Choosing Cat Food
Cats Tips for Choosing Cat Food Part 1: The Basics About Cat Food Standards You are what you eat, and this is equally true for the cats that depend on us for "room and board." Indeed, cat food is one of
More informationApproved by the Food Safety Commission on September 30, 2004
Approved by the Food Safety Commission on September 30, 2004 Assessment guideline for the Effect of Food on Human Health Regarding Antimicrobial- Resistant Bacteria Selected by Antimicrobial Use in Food
More informationAbout Food Health Impact Assessment
Food Safety No. 1015001 from the Ministry of Health, Labour and Welfare Consumer Safety No. 5410, 2004 October 15, 2004 To: Mr. Masaaki Terada, Chairman Food Safety Commission Hidehisa Otsuji Minister
More informationColorado State Laws Affected by H.R. 4879
Colorado State Laws Affected by H.R. 4879 I. Food a. Food Safety i. Date Label Laws 1. These laws require and regulate sell-by date labels on food items. They are intended to promote both food quality
More informationFDA S ANTIPARASITIC RESISTANCE MANAGEMENT STRATEGY (ARMS)
FDA S ANTIPARASITIC RESISTANCE MANAGEMENT STRATEGY (ARMS) Michelle Kornele, DVM Anna O Brien, DVM Aimee Phillippi-Taylor, DVM, DABVP (Equine) Overview Antiparasitic resistance is an issue for grazing livestock
More informationThe legislation and handling poisons
The legislation and handling poisons The legislation and handling poisons 2 The Poisons list (Division 2) 2 Prescriptions 3 Re-packaging and labelling 4 Pesticides 5 Stock control 7 Other relevant legislation
More informationVeterinary Feed Directive Information
Veterinary Feed Directive Information Focus and Scope Veterinary- Patient-Client Relationship Veterinarian issuing a VFD is required to be licensed to practice veterinary medicine and operate in compliance
More informationPHARMACIST CLINICIAN:
16.19.4.17 PHARMACIST CLINICIAN: D. Prescriptive authority, guidelines or protocol: (1) Only a registered pharmacist clinician with current protocols, registered with the New Mexico medical board or the
More informationFOOD SAFETY SYSTEM Legislation, Responsibilities and Challenges
www.minpolj.gov.rs REPUBLIC OF SERBIA MINISTRY OF AGRICULTURE, FORESTRY AND WATER MANAGEMENT FOOD SAFETY SYSTEM Legislation, Responsibilities and Challenges Zoran MICOVIC, CVO Slobodan ŠIBALIĆ, Head of
More informationSnapshot Current Vet Drugs AMR Initiatives
Snapshot Current Vet Drugs AMR Initiatives These regulatory and policy initiatives are interconnected and mutually supportive: 1) Increasing oversight on importation of veterinary drugs (Personal Use Importation)
More informationThe OIE Relevant Standards and Guidelines for Veterinary Medicinal Products
The OIE Relevant Standards and Guidelines for Veterinary Medicinal Products REGIONAL SEMINAR OIE NATIONAL FOCAL POINTS FOR VETERINARY PRODUCTS EZULWINI, SWAZILAND, 6-8 DECEMBER 2017 Dr Mária Szabó OIE
More informationDEPARTMENT OF LICENSING AND REGULATORY AFFAIRS DIRECTOR'S OFFICE VETERINARY MEDICINE - GENERAL RULES
DEPARTMENT OF LICENSING AND REGULATORY AFFAIRS DIRECTOR'S OFFICE VETERINARY MEDICINE - GENERAL RULES (By authority conferred on the department of licensing and regulatory affairs by sections 16145 and
More informationAntibiotics use and Considerations: Calves and Heifers CLASSIFICATION OF CALVES. Danielle A. Mzyk TITLE 24 PT. ARIAL BOLD ALL CAPS
CALF AND HEIFER CONGRESS - 2016 Antibiotics use and Considerations: Calves and Heifers Danielle A. Mzyk TITLE 24 PT. ARIAL BOLD ALL CAPS Today s Presentation Classification of Calves Define Preruminant
More informationThe College of Veterinarians of Ontario. Guidelines. for the Compounding of Veterinary Drugs
The College of Veterinarians of Ontario Guidelines for the Compounding of Veterinary Drugs GUIDELINES Compounding of Veterinary Drugs Approved by Council: September 26, 2007 Publication Date: Website September
More informationChanges to Antibiotic Labeling & Veterinary Feed Directive. Craig A. Payne, DVM, MS Director, Veterinary Extension & CE University of Missouri
Changes to Antibiotic Labeling & Veterinary Feed Directive Craig A. Payne, DVM, MS Director, Veterinary Extension & CE University of Missouri Outline How did we get here? What changes will occur? Getting
More informationOutline Changes to Antibiotic Labeling & Veterinary Feed Directive
Outline Changes to Antibiotic Labeling & Veterinary Feed Directive Craig A. Payne, DVM, MS Director, Veterinary Extension & CE University of Missouri How did we get here? What changes will occur? Getting
More informationJanuary 23, 2014 Anna O Brien, DVM Veterinary Medical Officer Office of New Animal Drug Evaluation Center for Veterinary Medicine-FDA
CVM s Antiparasitic Resistance Management Strategy January 23, 2014 Anna O Brien, DVM Veterinary Medical Officer Office of New Animal Drug Evaluation Center for Veterinary Medicine-FDA Goals for this presentation
More informationOpening Remarks. Presenters. What Did FDA Say About Antibiotics in Food Animals? Jim Larry Hans Pettigrew Firkins Stein. How to Respond?
What Did FDA Say About How to Respond? Presenters Jim Larry Hans Pettigrew Firkins Stein Opening Remarks First Comments The debate is done Antibiotics are not eliminated 3 years Dr. James E. Pettigrew
More informationLaw on Special Measures Against Bovine Spongiform Encephalopathy (Law No. 70 of June 14, 2002)
Law on Special Measures Against Bovine Spongiform Encephalopathy (Law No. 70 of June 14, 2002) Last amendment: Law No. 119 of July 16, 2003 (Laws and regulations yet to be enforced at the time of last
More informationIndiana State Laws Affected by H.R. 4879
Indiana State Laws Affected by H.R. 4879 I. Food a. Food Safety i. Date Label Laws 1. These laws require and regulate sell-by date labels on food items. They are intended to promote both food quality and
More informationThe Sheep Safety and Quality Assurance Program
Producing Consumer Products From Sheep: The Sheep Safety and Quality Assurance Program SHEEP SAFETY & QUALITY ASSURANCE Written For: The American Sheep Industry Association By: Travis W. Deborah L. Roeber2,
More informationThe OIE Relevant Standards and Guidelines for Vaccines
The OIE Relevant Standards and Guidelines for Vaccines GALVMED/OIE STAKEHOLDER WORKSHOP ON THE HARMONISATION OF THE REGISTRATION OF VETERINARY MEDICINAL PRODUCTS, JOHANNESBURG, SOUTH AFRICA 9-11 MAY 2017
More informationOverview of Pet Food Safety Act
Overview of Pet Food Safety Act August 2017 Ministry of Agriculture, Forestry and Fisheries Food Safety and Consumer Affairs Bureau Animal Products Safety Division 1. Background of Legislation of Pet Food
More informationCOMMISSION OF THE EUROPEAN COMMUNITIES. Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
COMMISSION OF THE EUROPEAN COMMUNITIES Brussels, 16.6.2009 COM(2009) 268 final 2009/0077 (COD) C7-0035/09 Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EC)
More informationComplying with California Senate Bill 27 Livestock: Use of Antimicrobial Drugs
Complying with California Senate Bill 27 Livestock: Use of Antimicrobial Drugs Annette Jones, DVM State Veterinarian and Director Animal Health and Food Safety Services California Department of Food And
More informationFirst Coast No More Homeless Pets, Inc. Audit of the SpayJax Program December 8, 2003 REPORT #586
First Coast No More Homeless Pets, Inc. Audit of the SpayJax Program December 8, 2003 REPORT #586 First Coast No More Homeless Pets, Inc. Audit of SpayJax Program Report #586 TABLE OF CONTENTS Executive
More informationSpecific Rules for Animal Product
Bilateral Screening Specific Rules for Animal Product Ministry of Agriculture and Environmental Protection Veterinary Directorate Brussels 20 24 October 2014 CONTENT Serbian legal framework Specific hygiene
More informationFood Safety Act: foods of animal origin other than meat
Food Safety Act: foods of animal origin other than meat Dr Stuart A. Slorach Chairman, OIE Animal Production Food Safety Working Group Training seminar on veterinary legislation, Gaborone, 2011 1 Commodities
More informationIllegal veterinary drugs. How to ensure the quality and traceability of Veterinary Medicinal Products
Illegal veterinary drugs How to ensure the quality and traceability of Veterinary Medicinal Products Catherine LAMBERT Anses/ANMV OIE Collaborating Centre on Veterinary medicinal products catherine.lambert@anses.fr
More informationGlobal Food Supply Chain Risks. Antibiotics and the emergence of antibiotic-resistant bacteria in the food chain
Global Food Supply Chain Risks Antibiotics and the emergence of antibiotic-resistant bacteria in the food chain Antibiotics and the emergence of antibiotic-resistant bacteria in the food chain Antibiotic-resistant
More informationMeat: is the common term used to describe the edible portion of animal tissues.
What is Meat Hygiene? Meat: is the common term used to describe the edible portion of animal tissues. Hygiene: (which comes from the name of the Greek goddess of health, Hygieia), is a set of practices
More informationREZIDUE CONTROL IN SERBIA & MRLs
REZIDUE CONTROL IN SERBIA & MRLs Presented by: Slobodan ŠIBALIC,DVM and Tamara BOŠKOVIĆ,DVM, MAFWM-Veterinary Directorate Legislation In-Force Law on Veterinary Matters (OG RS, No. 91/2005 + amend. OG
More informationIllegal veterinary medicines
Illegal veterinary medicines Regional Seminar for OIE National Focal Points for Veterinary Products Beirut, Lebanon, 7-9 November 2017 Philippe Sabot on behalf of HealthforAnimals. www.animalhealthmatters.org
More informationImport Health Standard
Import Health Standard Pig Semen PIGSEMEN.GEN Issued under the Biosecurity Act 1993 TITLE Import Health Standard: Import Health Standard: Pig Semen COMMENCEMENT This Import Health Standard comes into force
More informationChanges in Antibiotic Labeling Veterinary Feed Directive. Changes in Antibiotic Regulations. Concerns with Antibiotic Use 2/29/2016
Changes in Antibiotic Labeling Veterinary Feed Directive Craig A. Payne, DVM, MS Extension Veterinarian Commercial Agriculture Program University of Missouri Changes in Antibiotic Regulations How did we
More informationSENATE BILL No AN ACT enacting the Kansas retail pet shop act; establishing the Kansas retail pet shop act fee fund.
Session of 0 SENATE BILL No. By Committee on Assessment and Taxation - 0 0 0 AN ACT enacting the Kansas retail pet shop act; establishing the Kansas retail pet shop act fee fund. Be it enacted by the Legislature
More informationSUMMARY: The Food and Drug Administration (FDA) is proposing to amend its animal drug
This document is scheduled to be published in the Federal Register on 12/12/2013 and available online at http://federalregister.gov/a/2013-29696, and on FDsys.gov 4160-01-P DEPARTMENT OF HEALTH AND HUMAN
More informationGeneral Directorate of Animal Health and EpizooticDiseases Control. Dr.Sabah Hassan Abdelgadir Sudan Focal Point for Veterinary products
REPUBLIC OF SUDAN Ministry of Animal Resources General Directorate of Animal Health and EpizooticDiseases Control Dr.Sabah Hassan Abdelgadir Sudan Focal Point for Veterinary products Sudan experiences
More informationManagement Issues That You Need To Know About. Dr. Matt Hersom Extension Beef Cattle Specialist Dept. of Animal Sciences
Management Issues That You Need To Know About Dr. Matt Hersom Extension Beef Cattle Specialist Dept. of Animal Sciences Topics of Concern Veterinary Feed Directive Food Safety and Modernization Act Veterinary
More information