• 1. Schaffer AP, Larson RL, Cernicchiaro N, et al. The association between calfhood bovine respiratory disease complex and subsequent departure from the herd, milk production, and reproduction in dairy cattle. J Am Vet Med Assoc 2016; 248: 11571164.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 2. Virtala AM, Mechor GD, Gröhn YT, et al. The effect of calfhood diseases on growth of female dairy calves during the first 3 months of life in New York State. J Dairy Sci 1996; 79: 10401049.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 3. Donovan GA, Dohoo IR, Montgomery DM, et al. Calf and disease factors affecting growth in female Holstein calves in Florida, USA. Prev Vet Med 1998; 33: 110.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 4. Extralabel drug use in animals. 21 CFR 530.

  • 5. FDA. Guidance for Industry #207. Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: marker residue depletion studies to establish product withdrawal periods. March 2015. Available at: www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM207941.pdf. Accessed Jul 23, 2016.

    • Search Google Scholar
    • Export Citation
  • 6. FDA. Guidance for Industry #191. Changes to approved NADAs—new NADAs vs category II supplemental NADAs. May 2015. Available at: www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/ucm052460.pdf. Accessed Jan 20, 2016.

    • Search Google Scholar
    • Export Citation
  • 7. Stobo IJ, Roy JH, Gaston HJ. Rumen development in the calf. 2. The effect of diets containing different proportions of concentrates to hay on digestive efficiency. Br J Nutr 1966; 20: 189215.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 8. Drackley JK. Calf nutrition from birth to breeding. Vet Clin North Am Food Anim Pract 2008; 24: 5586.

  • 9. Toutain PL, Ferran A, Bousquet-Mélou A. Species differences in pharmacokinetics and pharmacodynamics. In: Cunningham F, Elliott J, Lees P eds. Comparative and veterinary pharmacology. Berlin, Germany: Springer-Verlag, 2010; 1948.

    • Search Google Scholar
    • Export Citation
  • 10. Brown SA, Chester ST, Robb EJ. Effects of age on the pharmacokinetics of single dose ceftiofur sodium administered intramuscularly or intravenously to cattle. J Vet Pharmacol Ther 1996; 19: 3238.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 11. Kissell LW, Brinson PD, Gehring R, et al. Pharmacokinetics and tissue elimination of flunixin in veal calves. Am J Vet Res 2016; 77: 634640.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 12. Gips M, Soback S. Norfloxacin nicotinate pharmacokinetics in unweaned and weaned calves. J Vet Pharmacol Ther 1996; 19: 130134.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 13. Kaartinen L, Pyörülü S, Moialen M, et al. Pharmacokinetics of enrofloxacin in newborn and one-week old calves. J Vet Pharmacol Ther 1997; 20: 479482.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 14. Nouws JF, Vree TB, Degen M, et al. Pharmacokinetics of sulphamethoxazole in calves and cows. Vet Q 1991; 13: 1015.

  • 15. Lichtenwalner DM, Cameron BD, Young C. The metabolism and pharmacokinetics of flunixin in cows and steers, in Proceedings. 14th World Cong Dis Cattle 1986; 11791183.

    • Search Google Scholar
    • Export Citation
  • 16. Waxman Dova S, Albarellos G, Kreil V, et al. Comparative pharmacokinetics of an injectable cephalexin suspension in beef cattle. Res Vet Sci 2008; 85: 570574.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 17. Riviere JE. Principles of drug movement in the body. In: Riviere JE, ed. Comparative pharmacokinetics: principles, techniques and applications. 2nd ed. Ames, Iowa: Wiley-Blackwell, 2011; 1325.

    • Search Google Scholar
    • Export Citation
  • 18. Ionescu C, Caira MR. Pathways of biotransformation—phase I reactions. In: Drug metabolism: current concepts. Dordrecht, The Netherlands: Springer Netherlands, 2005; 41128.

    • Search Google Scholar
    • Export Citation
  • 19. Gibson GG, Skett P. Pathways of drug metabolism. In: Introduction to drug metabolism. 3rd ed. Cheltenham, England: Nelson Thornes Ltd, 2001:137.

    • Search Google Scholar
    • Export Citation
  • 20. Shoaf SE, Schwark WS, Guard CL, et al. The development of hepatic drug-metabolizing enzyme activity in the neonatal calf and its effect on drug disposition. Drug Metab Dispos 1987; 15: 676681.

    • Search Google Scholar
    • Export Citation
  • 21. Schwark WS. Factors that affect drug disposition in food-producing animals during maturation. J Anim Sci 1992; 70: 36353645.

  • 22. Alcorn J, McNamara PJ. Ontogeny of hepatic and renal systemic clearance pathways in infants: part I. Clin Pharmacokinet 2002; 41: 959998.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 23. Alcorn J, McNamara PJ. Ontogeny of hepatic and renal systemic clearance pathways in infants: part II. Clin Pharmacokinet 2002; 41: 10771094.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 24. Fernandez E, Perez R, Hernandez A, et al. Factors and mechanisms for pharmacokinetic differences between pediatric population and adults. Pharmaceutics 2011; 3: 5372.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 25. Wrenn TR, Cecil HC, Connolly MR, et al. Extracellular body water of growing calves as measured by thiocyanate space. J Dairy Sci 1962; 45: 205209.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 26. Sekine J, Fujita K, Asahida Y. A prediction of body water compartments of growing cattle in vivo. Asian Aust J Anim 1992; 5: 711.

  • 27. Toutain PL, Bousquet-Mélou A. Volumes of distribution. J Vet Pharmacol Ther 2004; 27: 441453.

  • 28. Monti DJ. AMDUCA regulates small and large animal practice. J Am Vet Med Assoc 2000; 216: 1889.

  • 29. FDA. Guidance for industry #3. General principles for evaluating the human food safety of new animal drugs used in food-producing animals. Draft revised guidance. July 2016. Available at: www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/ucm052180.pdf. Accessed Dec 13, 2016.

    • Search Google Scholar
    • Export Citation
  • 30. USDA Food Safety and Inspection Service. Screening and confirmation of animal drug residues by UHPLC-MS-MS Available at: www.fsis.usda.gov/wps/wcm/connect/b9d45c8b-74d4-4e99-8eda-5453812eb237/CLG-MRM1.pdf?MOD=AJPERES. Accessed Sep 26, 2016.

    • Search Google Scholar
    • Export Citation
  • 31. FARAD. Extralabel drug use (ELDU) resource page. Available at: www.farad.org/eldu/eldumain.asp. Accessed Dec 14, 2016.

  • 32. North American Compendiums Inc. Compendium of veterinary products (CVP) electronic database. Available at: bayer-all.naccvp.com/?u=bayer&p=dvm. Accessed Dec 14, 2016.

    • Search Google Scholar
    • Export Citation
  • 33. FDA. Animal drugs @ FDA. Available at: www.accessdata.fda.gov/scripts/animaldrugsatfda/details.cfm?dn=140-338. Accessed Dec 14, 2016.

    • Search Google Scholar
    • Export Citation
  • 34. Vetgram FARAD. Available at: www.farad.org/vetgram/search.asp. Accessed Dec 14, 2016.

  • 35. USDA National Animal Health Monitoring System. Dairy 2014. Dairy Cattle Management Practices in the United States, 2014. Available at: www.aphis.usda.gov/animal_health/nahms/dairy/downloads/dairy14/Dairy14_dr_PartI.pdf. Accessed Dec 14, 2016.

    • Search Google Scholar
    • Export Citation
  • 36. Smith G. Antimicrobial decision making for enteric diseases of cattle. Vet Clin North Am Food Anim Pract 2015; 31: 4760.

  • 37. New animal drugs for use in animal feeds; oxytetracycline; neomycin. 21 CFR 558.

  • 38. USDA Food Safety and Inspection Service. United States national residue program for meat, poultry, and egg products. 2014 residue sample results. Available at: www.fsis.usda.gov/wps/wcm/connect/2428086b-f8ec-46ed-8531-a45d10bfef6f/2014-Red-Book.pdf?MOD=AJPERES. Accessed Dec 13, 2016.

    • Search Google Scholar
    • Export Citation
  • 39. Paige JC, Pell F. Drug residues in food producing animals. FDA Veterinarian 1997; 12.

  • 40. Rangel-Lugo M, Payne M, Webb AI, et al. Prevention of antibiotic residues in veal calves fed colostrum. J Am Vet Med Assoc 1998; 213: 4042.

    • Search Google Scholar
    • Export Citation
  • 41. Musser JM, Anderson KL, Rushing JE, et al. Potential for milk containing penicillin G or amoxicillin to cause residues in calves. J Dairy Sci 2001; 84: 126133.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 42. Musser JM, Anderson KL, Boison JO. Tissue disposition and depletion of penicillin G after oral administration with milk in unweaned dairy calves. J Am Vet Med Assoc 2001; 219: 346350.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 43. Guest GB, Paige JC. The magnitude of the tissue residue problem with regard to consumer needs. J Am Vet Med Assoc 1991; 198: 805808.

    • Search Google Scholar
    • Export Citation
  • 44. Hausler K, Godden SM, Schneider MJ, et al. Hot topic: investigating the risk of violative meat residues in bob veal calves fed colostrum from cows treated at dry-off with cephapirin benzathine. J Dairy Sci 2013; 96: 23492355.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 45. Adulterated drugs and devices. 21 CFR 501(a)(6) § 351(a)(6).

  • 46. FDA. Department of Health and Human Services: Warning letter #15-PHI-09. Available at: www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm432140.htm. Accessed Jan 12, 2017.

    • Search Google Scholar
    • Export Citation
  • 47. FDA. Veterinary feed directive. Fed Regist 2015; 80: 3170831735.

  • 48. California State Legislature. SB-27, Hill. Livestock: use of antimicrobial drugs. Available at: leginfo.legislature.ca.gov/faces/billTextClient.xhtml?bill_id=201520160SB27. Accessed Jul 25, 2016.

    • Search Google Scholar
    • Export Citation
  • 49. Romvary A, Sandor G. Distribution and elimination of sulfamethoxazole and N4-sulfamethoxazole in calf and piglet tissues. Acta Vet Scand Suppl 1991; 87: 432433.

    • Search Google Scholar
    • Export Citation
  • 50. Meijer LA, Ceyssens KG, de Jong WT, et al. Correlation between tissue and plasma concentrations of oxytetracycline in veal calves. J Toxicol Environ Health 1993; 40: 3545.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 51. Luthman J, Jacobsson SO. The availability of tetracyclines in calves. Nord Vet Med 1983; 35: 292299.

  • 52. Nouws JF, van Ginneken CA, Ziv G. Age-dependent pharmacokinetics of oxytetracycline in ruminants. J Vet Pharmacol Ther 1983; 6: 5966.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 53. Webster HB, Morin D, Jarrell V, et al. Effects of local anesthesia and flunixin meglumine on the acute cortisol response, behavior, and performance of young dairy calves undergoing surgical castration. J Dairy Sci 2013; 96: 62856300.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 54. Mintline EM, Varga A, Banuelos J, et al. Healing of surgical castration wounds: a description and an evaluation of flunixin. J Anim Sci 2014; 92: 56595665.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 55. Paull DR, Small AH, Lee C, et al. Effect of local infusion of NSAID analgesics administered alone or in combination on the pain associated with band castration in calves. Aust Vet J 2015; 93: 271277.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 56. Sidhu PK, Gehring R, Mzyk DA, et al. Avoiding violative flunixin meglumine residues in cattle and swine. J Am Vet Med Assoc 2017; 250: 182189.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 57. Glynn HD, Coetzee JF, Edwards-Callaway LN, et al. The pharmacokinetics and effects of meloxicam, gabapentin, and flunixin in postweaning dairy calves following dehorning with local anesthesia. J Vet Pharmacol Ther 2013; 36: 550561.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 58. Battaller N. FDA communication regarding the use of meloxicam in cattle. Available at: www.aabp.org/members/resources/FDA_Communication_meloxicam_AMDUCA_7.2014.pdf. Accessed Dec 14, 2016.

    • Search Google Scholar
    • Export Citation
  • 59. AVMA. AMDUCA extralabel drug use algorithm. Available at: www.avma.org/KB/Resources/Reference/Pages/AMDUCA2.aspx. Accessed Dec 14, 2016.

    • Search Google Scholar
    • Export Citation
  • 60. Coetzee JF, Mosher RA, Griffith GR, et al. Pharmacokinetics and tissue disposition of meloxicam in beef calves after repeated oral administration. J Vet Pharmacol Ther 2015; 38: 556562.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 61. European Medicines Agency. Annex 1. Summary of product characteristics. Metacam. Available at: www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/veterinary/000033/WC500065777.pdf. Accessed Jul 25, 2016.

    • Search Google Scholar
    • Export Citation
  • 62. FDA. Cephalosporin order of prohibition goes into effect. Available at: www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm299054.htm. Accessed Dec 14, 2016.

    • Search Google Scholar
    • Export Citation
  • 63. Drugs prohibited for extralabel use in animals. 21 CFR 530.41.

  • 64. Woodrow JS, Caldwel M, Cox S, et al. Comparative plasma pharmacokinetics of ceftiofur sodium and ceftiofur crystalline-free acid in neonatal calves. J Vet Pharmacol Ther 2016; 39: 271276.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 65. Foster DM, Jacob ME, Warren CD, et al. Pharmacokinetics of enrofloxacin and ceftiofur in plasma, interstitial fluid, and gastrointestinal tract of calves after subcutaneous injection, and bactericidal impacts on representative enteric bacteria. J Vet Pharmacol Ther 2016; 39: 6271.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 66. Merck Animal Health. Nuflor (florfenicol) product label. Madison, NJ: Merck Animal Health Intervet Inc, 2011.

  • 67. FDA. Extralabel animal drug use; fluoroquinolones and glycopeptides; order of prohibition. Fed Regist 1997; 62: 2794427947.

  • 68. Zoetis. Advocin (danofloxacin injection) product label. Kalamazoo, Mich: Zoetis Inc, 2014.

  • 69. Bayer. Baytril (enrofloxacin) product label. Shawnee Mission, Kan: Bayer Healthcare LLC, 2015.

  • 70. Tolerances for residues of new animal drugs in food. 21 CFR 556.

Advertisement

Considerations for extralabel drug use in calves

Danielle A. MzykFood Animal Residue Avoidance and Depletion Program (FARAD), Department of Population Health and Pathobiology, College of Veterinary Medicine, North Carolina State University, Raleigh, NC 27606.

Search for other papers by Danielle A. Mzyk in
Current site
Google Scholar
PubMed
Close
 BS
,
Ronette GehringFARAD, Institute of Computational Comparative Medicine, Department of Anatomy and Physiology, College of Veterinary Medicine, Kansas State University, Manhattan, KS 66506.

Search for other papers by Ronette Gehring in
Current site
Google Scholar
PubMed
Close
 BVSc, MMedVet
,
Lisa A. TellFARAD, Department of Medicine and Epidemiology, School of Veterinary Medicine, University of California-Davis, Davis, CA 95616.

Search for other papers by Lisa A. Tell in
Current site
Google Scholar
PubMed
Close
 DVM
,
Thomas W. VickroyFARAD, Department of Physiological Sciences, College of Veterinary Medicine, University of Florida, Gainesville, FL 32610.

Search for other papers by Thomas W. Vickroy in
Current site
Google Scholar
PubMed
Close
 PhD
,
Jim E. RiviereFARAD, Institute of Computational Comparative Medicine, Department of Anatomy and Physiology, College of Veterinary Medicine, Kansas State University, Manhattan, KS 66506.

Search for other papers by Jim E. Riviere in
Current site
Google Scholar
PubMed
Close
 DVM, PhD
,
Gail RaganFARAD, Institute of Computational Comparative Medicine, Department of Anatomy and Physiology, College of Veterinary Medicine, Kansas State University, Manhattan, KS 66506.

Search for other papers by Gail Ragan in
Current site
Google Scholar
PubMed
Close
 BA
,
Ronald E. BaynesFood Animal Residue Avoidance and Depletion Program (FARAD), Department of Population Health and Pathobiology, College of Veterinary Medicine, North Carolina State University, Raleigh, NC 27606.

Search for other papers by Ronald E. Baynes in
Current site
Google Scholar
PubMed
Close
 DVM, PhD
, and
Geof W. SmithFood Animal Residue Avoidance and Depletion Program (FARAD), Department of Population Health and Pathobiology, College of Veterinary Medicine, North Carolina State University, Raleigh, NC 27606.

Search for other papers by Geof W. Smith in
Current site
Google Scholar
PubMed
Close
 DVM, PhD

Contributor Notes

Address correspondence to Ms. Mzyk (dalindqu@ncsu.edu).