Fish and Aquatic Conservation


Oxytetracycline for Shrimp INAD #8069

A healthy Whiteleg shrimp as harvested.
Credit: Wikipedia

Summary

Terramycin 200® for shrimp is an aquaculture premix containing oxytetracycline dehydrate (OTC) and is available through Syndel USA. OTC medicated feed can be purchased from aquaculture feed mills. OTC medicated feed can be used for the control of mortality caused by bacterial diseases in marine penaeid shrimp (primarily species of the genera Litopeneaus, Farfantepenaeus, and Penaeus). The primary goal of field studies conducted under INAD #8069 is to generate additional OTC-medicated feed efficacy data which can be used to expand existing OTC label claims. The allowed treatment dose is 4.5 gram (g) oxytetracycline per kilogram (kg) of feed for 14 consecutive days. The Investigational withdrawal period for treated shrimp is 2 days. To participate in the INAD Program for OTC medicated feed visit the data collecting site.

Please read the Study Protocol prior to any treatments. It contains the protocol, MSDS, and a copy of the forms to be used as a guide for collecting data that will be entered into the online INAD database. The FDA authorization letter(s) for this INAD is currently only available by emailing Bonnie Johnson.


INAD objective/purpose: Collect scientific data necessary to support pivotal efficacy trials to further establish the effectiveness of oxytetracycline (OTC) to control bacterial diseases of marine penaeid shrimp species that occur under a variety of environmental conditions and over a range of temperatures.

Drug Name
Oxytetracycline dihydrate (Terramycin 200® for Fish; TM200)

Drug Source
Syndel USA
1441 W Smith Rd,
Ferndale, WA 98248 USA

Jason Montgomery
Phone: 800-283-5292
Fax: 360-384-0270
email: jasonm@syndel.com
Website: www.syndel.com

Target pathogen(s): Bacterial shrimp pathogens susceptible to oxytetracycline.

Method of administration: Medicated feed treatment

Treatment dosage:

  • 4.5 gram (g) oxytetracycline per kilogram (kg) of feed

Treatment regimen:

  • Medicated feed will be administered as a single treatment regimen, to be fed to satiation daily for 14 days.
  • A new treatment regimen may be initiated no sooner than five (5) days after the last treatment regimen has ended.

Investigational Withdrawal period:

  • 2 days
  • No Investigational withdrawal period is required for treated shrimp what will be rendered.

Required test parameters:

  • Source data must be collected for at least 5 days before treatment, during treatment, and for at least 10 days post-treatment period.
  • Collection of this data is critically important. Samples of hepatopancreas or other typically affected tissue will be removed from groups of representative shrimp and tested by bacteriological, serological, or other methods to determine the presence of target pathogens.
  • Investigator should also report general shrimp behavior and any possible adverse effects relating to treatment.

Limitations or restrictions on use of drug:

  • Investigator must follow all instructions in the Study Protocol for INAD 8069 regarding drug acquisition and handling, shrimp treatment and disposition, and data reporting requirements.
  • Drug discharge must be in compliance with local NPDES permitting requirements.

Required INAD fee: $700/facility/year

AADAP Contact Information:
Ms. Bonnie Johnson, FWS-AADAP
Phone: 406-994-9905
Fax: 406-582-0242
email: bonnie_johnson@fws.gov