Understanding the Veterinary Feed Directive

Transcription

1 Understanding the Veterinary Feed Directive JENNIFER R. KAUF, VMD D A I R Y S I D E V E T E R I N A R Y S E R V I C E M A R T I N S B U R G, P A J U N E ,

2 One Health Integrative effort of multiple disciplines Optimal health for people, animals, and environment Veterinarian s oath: Being admitted to the profession of veterinary medicine, I solemnly swear to use my scientific knowledge and skills for the benefit of society through the protection of animal health and welfare, the prevention and relief of animal suffering, the conservation of animal resources, the promotion of public health, and the advancement of medical knowledge. Healthy animals = safe food supply

3 Alphabet Soup

4 What is the Veterinary Feed Directive? Written or electronic document Provided by a licensed veterinarian with an established VCPR with the producer, to allow legal purchase and use VFD drugs in feed Is NOT the same as a prescription Law Enforced by FDA to increase veterinary oversight of certain food animal medications ( VFD drugs ) and eliminate the use of these drugs for purposes other than treatment or prevention of disease (no growth promotion). Drug ( VFD drug ) Administered in or on feed in accordance to conditions for use approved, conditionally approved, or indexed by the FDA. Targeting medically important drug for humans

5 History of VFD Animal Drug Availability Act (ADAA amendment): 1996 Established a new category of animal drugs for use in feed as VFD drugs to be used under the supervision of a veterinarian First Rule: December 2000 Required written orders for a small number of animal drugs Second Rule (The New Rule): June 2015 October 2015 Requires VFD from vet for drugs previously on the list January 2017 VFD will be required for all drugs on expanded list

6 Why does FDA care about these drugs? Drug residue avoidance Problems still primarily with OTC injectable Penicillin Sulfas are zero-tolerance residues Antimicrobial resistance to drugs used in human medicine 2014 U. S. usage (sales) data: 62% of livestock antibiotic usage (sales) was medically important antimicrobials 70% of this 62% was tetracyclines Usage increases (3 to 4%) from 2013 to 2014 aligned well with increases in national livestock inventories (3 to 4%). Source: FDA s 2014 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals.

7 What is Medically Important? Antimicrobials that are important for therapeutic use in humans

8 Is this Necessary? Reducing unnecessary use of such drugs in animals and to slowing or preventing the potential for the development of bacterial resistance to antimicrobial drugs administered through medicated feed. The use of antibiotics is the single most important factor leading to antibiotic resistance around the world. Natural and inevitable evolution.

9 Why Increased Regulation? Evidence of microbial resistance Guidance for Industry #209 CDC 2013 drug threat report Evidence of antibiotic misuse In food animals In pets In humans

10 Antibiotic resistance: A public health concern Increased cost to healthcare ($3 billion/yr, range $100 million to $30 billion) More expensive antibiotics required Longer hospital stays ~23, 000/ year die as result of resistance/complications Development of new antibiotics is slow and costly Greater risk of antibiotic resistant food borne illness (Salmonella DT-104, fluoroquinilone resistant Campylobacter)

11 Public Perception Time Magazine, March 19, 2014 p. 20

12 Human Medical Opinions Yes No Antibiotic Residues Use of Medically Impt Drugs Hormones

13 Monitoring Progress National Antimicrobial Resistance Monitoring System (NARMS) State and local, CDC, FDA, USDA collaboration Strategic assessment outlined in GFI #152 Goal is to promote judicious use of antibiotics, protect public health & help curb the development of antimicrobial resistance

14 VFD Drug Summary Unaffected Non-Medically Important Products used exclusively in animals or deemed non-medically important if used by both animals & humans: - Ionophores (Rumensin ) - Polypeptides - Carbadox - Bambermycin - Pleuromutilin Medically Important Products deemed important for human medicine & used by both animals & humans, such as: - Penicillins - Cephalosporins - Quinolones - Fluoroquinolones - Tetracyclines Affected - Macrolides - Sulfas - Glycopeptides - Others Production uses Still allowed Enhance growth or improve feed efficiency Production uses No longer allowed Enhance growth or improve feed efficiency Therapeutic uses still allowed under veterinary supervision Treat animals diagnosed with an illness Control the spread of illness in a herd Prevent illness in healthy animals when exposure is likely

15 Current VFD Drug List 1) Florfenicol (Aquaflor, Nuflor ) 2) Avilamycin (Kavault ) 3) Tilmicosin (Pulmotil ) This is the only feed grade antibiotic of the three labeled for use in cattle

16 VFD drugs as of January 1, 2017 Chlortetracycline (C) Neomycin (N) Tylosin (T) Oxytetracycline (O) Sulfamethazine (S) Virginiamycin (V) medically important antibiotics used in feed for the prevention, control, and/or treatment of disease

17 Brand Names Affected (Cattle) Aureomycin, Chloratet, ChlorMax, Pennchlor (C) Terramycin, Pennox (O) Neo-Oxy, Neo- Terramycin (N) Pennchlor S, Aureo S 700 (S) Tylan, Tylovet (T) V-Max (V) V-Max (V)

18 Products not requiring a VFD**? Ionophores: Rumensin, Bovatec, Cattlyst Other antimicrobials: Gainpro, BMD 60 Dewormers: Safe-Guard Coccidiostats: Deccox, Corid Others: HeifermaX, MGA, Optaflexx ** UNLESS used in a label-approved combination with one of the VFD antibiotics.

19 Getting Started Resources for you: Elanco Feed Mill Preparedness Check List FDA Distributor tri-folds /DevelopmentApprovalProcess/ucm htm 2015 Feed Compendium /author/427/2015/3/compendium_ Part6.pdf A copy of this presentation (upon request)

20 Defining New Animal Drugs Category I Category II No withdrawal Rumensin Bovitec Deccox Withdrawal or No-Residue CTC Neomycin Sulfa

21 Defining Animal Drugs Type A medicated Article Drug source +/- carrier, very concentrated Requires Medicated Feed Mill License (MFML)* Rumensin 90, Pulmotil 90 Type B medicated FEED Substantial quantity of nutrients Further mixing required CTC 50 Type C medicated FEED A complete feed, top dress or FC ready for consumption CTC 4G, AS700 *Source: 21 CFR 558.3

22 Distributor Responsibilities File one time notice - intent to handle/distribute complete name and business address distributor s or authorized agent s signature date the notification was signed. Food and Drug Administration Center for Veterinary Medicine Division of Animal Feeds (HFV-220) 7519 Standish Place Rockville, MD faxed to: A distributor must also notify FDA within 30 days of a change in ownership, business name, or business address

23 Distributor Responsibilities Acknowledgement Letter (AL) If you are distributing to another distributor Provided to you from the distributor to which you are consigning to Must be written (non-verbal) or electronic They verify to you that they will abide by VFD regulations No shipment to animal production facility without VFD No shipment to another distributor without AL Have already filed distributor notification 2015 Feed Additive Compendium Feedstuffs:

24 Feed Distributor Requirements May only provide a VFD feed if: The VFD Contains all required information The VFD feed Complies with terms of the VFD The VFD and VFD feed Conforms to product approval

25 VFD Required Information Contact info Vet and Client Premise Issue and Expiration dates VFD name Species and production class Approximate number fed Indication Concentration and duration Withdrawals and cautions Number of reorders allowed VFD statement Combo affirmation statement Signature

26 Terms of the VFD Terms of VFD Expiration - period of time it is lawful to provide the animal the feed containing the VFD drug. Specifies the last day the VFD feed can be fed to the group of animals. Duration the length of time the VFD feed is allowed to be fed to the animals as specified on the label. Concentration the resulting feed or product must match the VFD order. Substitution approved generics for approved pioneer VFD may be at your discretion unless generic is not part of approved combination VFD drug.

27 Product Approval NO extralabel use is permitted Drug dose/concentration must be approved Must be used for a labeled indication Must be fed for the prescribed time period Must be approved for use in the species in question, and for the age/size animal(s) in question Use of feed containing this veterinary feed directive (VFD) drug in a manner other than as directed on the labeling (extralabel use), is not permitted

28 Label Example

29 Labeling of Product VFD drug labeling and advertising must prominently and conspicuously display the VFD caution statement. "Caution: Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian."

30 Record Keeping Must retain for 2ys: VFD orders Acknowledgement letters from consigning distributors Records of receipt and distribution of all medicated feeds containing a VFD drug Must retain for 1 yr: If manufacturing formulation ID, date of mixing, date of shipment according to 21 CFR 225 (cgmp) FDA can inspect or request VFD documentation from the veterinarian, distributor or producer at any time to verify compliance with VFD rules. You are legally obligated to produce records on demand.

31 A little help with that. GlobalVetLINK ( ) RxExpress (

32 VFD vs RX GFI #213 Water soluble medically important drugs intended for the treatment of disease are now moved into prescription status. Stores must authorized to dispense prescription drugs or stop selling them.

33 Falls on the one authorizing the use of the medication = VET. Must determine when appropriate (indications and timing) Producers must understand, VFDs are not automatic use must be justified. PREVENTION is key! Liability

34 Questions?