Fish and Aquatic Conservation


Oxytetracycline hydrochloride INAD #9033

A two year old juvenile Pallid sturgeon in Neosho National Fish Hatchery. Credit: Katie Steiger-Meister/USFWS

Summary

Oxytetracycline hydrochloride (OTIMM) is an aquaculture premix containing oxytetracycline hydrochloride and is available through Pharmagate. OTIMM is available for purchase through many local farm & ranch stores or veterinarian supply outlets. The primary goal of field studies conducted under INAD #9033 is to evaluate the efficacy of OTIMM for controlling mortality in a variety of freshwater and marine finfish species for bacterial diseases. Immersion therapy is often the only option when treating young fish not yet accustomed to feeding on man-made fish diets. Reluctance or refusal of young fish to consume such feed excludes medicated feed treatment as a therapy option. The treatment regimen is a 1-h static-bath or flow-through treatment at a dose of 20 mg OTC/L, and fish may be treated up to 4 consecutive days. The Investigational withdrawal period is 21 days for fish treated a single treatment and 60 days for multiple treatments. To participate in the INAD Program for OTIMM 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 supportive and pivotal data needed to establish the effectiveness of oxytetracycline (OTC) immersion therapy to control mortality caused by certain bacterial diseases.

Drug Name
Pennox 343® (oxytetracycline hydrochloride)

Drug Source
Drug Source: Pharmagate (often available from your local farm & ranch store, veterinary supply outlet, etc.)
14040 Industrial Road
Omaha, Nebraska 68144

Mr. Doug Rupp
Phone: 402-330-6000
email:doug.rupp@pharmgate.com

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

Method of administration: Immersion treatment

Treatment dosage:

  • Options A & B: single treatment up to 20 milligrams (mg) OTC per liter.
  • Options C & D: multiple treatments up to 20 milligrams (mg) OTC per liter.

Treatment regimen:

  • Option A: 1-hour single treatment for salmonids.
  • Option B: 1-hour single treatment for various cool and warmwater fish.
  • Option C: 1-hour treatment on 1 to 4 consecutive days for salmonids.
  • Option D: 1-hour treatment on 1 to 4 consecutive days for various cool and warmwater fish.

Investigational Withdrawal period:

  • Options A & B: 21 days. No Investigational withdrawal period is required for fish that will not be catchable for 21 or more days after release, or are illegal for harvest.
  • Options C & D: 60 days. No Investigational withdrawal period is required for fish that will not be catchable for 60 or more days after release, or are illegal for harvest.

Required test parameters:

  • Investigator must collect mortality data throughout the 5 day pre-treatment, treatment, and 10 day post-treatment periods. Investigator should also report general fish behavior and any adverse effects relating to treatment.

Limitations or restrictions on use of drug:

  • Investigator must follow all instructions in the Study Protocol for INAD 9033 regarding drug acquisition and handling, fish 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