BayerDVM.com

WHAT IS ILLEGAL?

1. "Copies" of products already approved by FDA (without FDA NADA number).
2. Product from unapproved USP active ingredient (United States Pharmacopeia).
3. Counterfeiting from bulk drugs for use in food animal production is never legal.
4. Sold without veterinary prescription & Veterinarian-Client-Patient-Relationship.

WHAT IS LEGAL?

1. Legal compounding of pharmaceuticals for food animal production is very limited.
2. Conditions related to extra label drug use in general have been complied with.
3. There is no approved new animal or approved new human drug that will treat the condition diagnosed.
4. On the order of a licensed practitioner, for a specific patient.

1. Global consumers of U.S. meat and milk products assume that only FDA approved products are correctly administered to food animals and that appropriate use label directions have been followed. This includes adherence to meat and milk withdrawal times.
   • Consumer confidence and ultimately consumer demand for meat and milk can be damaged with public awareness of counterfeit drug use in food producing animals.
   • Human safety can be impacted by unknown and untested contaminants (viruses, bacteria, endotoxins) present in illegally smuggled shipments of active ingredient or excipients.
2. Foreign pathogens such as Foot and Mouth Disease, can be intentionally or unintentionally brought into the U.S. that affect our homeland security.
3. Illegal drugs are not manufactured under FDA GMP guidelines.
   • There is no analytical testing to assure potency, stability, consistency, sterility, safety, and efficacy.
   • Batch to batch variability of the active ingredient, carriers, and potential contaminants can be substantial.
4. Business insurance protection is voided when a business owner knowingly commits an illegal act. This also applies to your business suppliers. If they use an illegal product, you could be legally and financially liable for the consequences.
5. Violative meat and milk residues can lead to significant financial and legal liability.

1. Remember that you are first and foremost in the food business. Your food animal production practices, including use of pharmaceutical medicines, should support a wholesome, safe, high quality, consumer food product.
2. Reject the use of counterfeit pharmaceuticals in your food animal production business.
3. Verify that your food animal suppliers use only FDA approved pharmaceuticals, under the direction of a veterinarian.
4. Make reports of suspected counterfeit products to the branded product manufacturer.
5. Report counterfeit drug activities to the Food and Drug Administration:
   
   Ms. Gloria Dunnavan, Director
   Division of Compliance (HFV-230)
   Office of Surveillance and Compliance
   Center for Veterinary Medicine
   U.S. Food and Drug Administration
   MPN IV Bldg., Room 146
   7519 Standish Place
   Rockville, MD 20855-2773
   Phone: (240) 276-9200
   FAX: (240) 276-9241
6. Educate your local cattle industry and organizations. Sophisticated counterfeit operations can provide counterfeit products that appear nearly identical to authentic product. Contact Bayer Animal Health Veterinary Services department at 1-800-422-9874 for assistance and to report any suspicious product.