Veterinary Feed Directive (21 CFR Part 558) goes into effect 12/31/16. Are you ready?

“Over the past several years, the FDA has taken important steps toward fundamental change in how medically important antibiotics can be legally used in feed or water for food-producing animals. Now, the agency is moving to eliminate the use of such drugs for production purposes (i.e., growth promotion and feed efficiency) and bring their remaining therapeutic uses in feed and water under the supervision of licensed veterinarians – changes that are critical to ensure these drugs are used judiciously and only when appropriate for specific animal health purposes. The Veterinary Feed Directive (VFD) final rule is an important part of the agency’s overall strategy to ensure the judicious use of medically important antimicrobials in food-producing animals”.

As a feed manufacturer or a store that sells medications fed to animals that fall under this law what do you need to do?

Step 1: Identify the medications, combinations, premixes and products that require a VFD. At the 2016 CFD annual meeting Dr. Eric Reid presented a list of the most common drugs used by members that will now require a VFD:

– Apramycin

– Chlortetracycline

– Erythromycin

– Gentimycin

– Hyrgomycin B

– Lincomycin

– Neomycin

– Oleandomycin

– Oxytetracycline

– Penicillin

– Spectinomycin

– Streptomycin

– Sulfachloropyrazine

– Sulfadimethoxine

– Sulfamethazine

– Sulfaquinoxaline

– Tetracycline

– Tylosin

– Virginiamycin

This list is not all inclusive, some have trade names, some are part of a product where the other ingredient doesn’t need a VFD, but those products will still need a VFD. Be diligent in finding out which products will need a VFD. See below for more information from CFD to define these requirements…

 Step 2: Register with the FDA: There is a one-time registration requirement. To comply, send a letter to the FDA stating that your company is a distributor or animal feed products under 21 CFR part 558 Veterinary Feed Directive. Include: your company name and business address; signature and date of at least one owner. Mail the notification to:

Food and Drug Administration

Center for Veterinary Medicine

Division of Animal Feeds (HFV-220)
7519 Standish Place
Rockville, MD 20855          or faxed to: 240-453-6882

 Step 3: Define a process for obtaining and retaining VFD documents. Key components of this process should include:

  • Obtaining the VFD prior to manufacturing the feed.
  • VFD must be written and signed by a Veterinarian.
  • It can be a paper document or sent electronically.
  • It can be delivered by the Veterinarian, Customer or a Nutritionist.
  • Must contain specific information: Refer to this website for details: http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ucm455415.htm
  • Can only be used for the specified time period.
  • Must be retained for 2 years.

Step 4: Train employees: All employees who receive and process orders must be trained in this requirement.

 

More Information:

CFD Commonly Ordered Items:

Item # Description Item # Description
1100010 Aureomycin 4 g  5 lb. 1800654 Tylan 40
1100034 Aureomycin 4G  50 lb 1800411 Neo/Terra 10/10
1104042 AS 700 2g 1800006 Aureomix S 10/10
1104046 AS 700 3.5g 1800005 Aureo SP 250
1800651 Aureomycin 100 1104038 Terramycin 4 g
5575320150 Scours & Pneumonia Treatment Concentrate 50# 1104044 CTC 10 g
0232123 Scours & Pneumonia Treatment Concentrate 20# 1800648 Aureo 50
5575320239 Scours & Pneumonia Treatment Concentrate 4.34# 1800649 Aureo 90
1117530 Scours & Pneumonia Treatment 6.4 oz 1100020 Aureo 20 g
1127530 Scours & Pneumonia Treatment 6# 1800688 Sulmet 12.5% liquid
2500101  CFD 20-20 AM with OTC  (to be discontinued by MFG) 1800576 Terramycin Scour tabs
1800656 Tylan 10    

 

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