Fact Sheet: Oxytetracycline Medicated Feed INAD 9332

for detailed information, see INAD study protocol, use link on the left
last updated: 1 December 2011

The following links are specific to:
Oxytetracycline
Medicated Feed

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INAD study protocol

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(MSDS)

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Authorization & Categorical Exclusion Letters

Objective/purpose: Collect supportive and pivotal data needed to establish the effectiveness of oxytetracycline (OTC) when fed as a feed additive to 1) control mortality caused by bacterial diseases in a variety of freshwater and marine fish, and abalone; and 2) mark skeletal tissue of finfish.
Drug name: Oxytetracycline dihydrate (Terramycin 200® for Fish)
Source of drug: Phibro Animal Health
Address: 65 Challenger Road
Ridgefield, NJ 07660
Contact:

Paul Duquette
Phone: 973-575-5255
Fax: 973-575-4354
email: paul.duquette@pahc.com
webpage:
http://www.phibroah.com/

Target pathogen(s): Bacterial pathogens susceptible to oxytetracycline.
Method of administration: Medicated-feed treatment
Treatment dosage:

Standard therapeutic finfish dose: 2.5 - 3.75 g OTC per 100 pounds fish per day.
High therapeutic finfish dose: 10 g OTC per 100 pounds fish body weight per day.
Standard abalone dose: up to 6.0 g OTC per 100 pound abalone body weight per day.
Skeletal marking dose: same as standard or high therapeutic finfish dose.

Treatment regimen:

Option A: standard therapeutic finfish dose; 10-day treatment duration (all salmonids).
Option B: high therapeutic finfish dose; 14-day treatment duration; temp > 4°C (all finfish).
Option C: standard therapeutic finfish dose; 10-day treatment duration (non-salmonid freshwater and marine fish).
Option D: standard abalone dose; 14-day treatment duration.
Option E: skeletal marking at standard therapeutic dose, 10-day treatment duration; skeletal marking at high therapeutic dose, 14-day treatment duration.

Withdrawal period:

Option A: 21 days;
Option B: 70 days;
Option C: 40 days
Option D: 35 days
Option E (standard dose): 21 days (salmonids);
40 days (non-salmonids).
Option E (high dose): 70 days
(all finfish)

No withdrawal period is required for treated fish that will not be susceptible to legal harvest or slaughtered for market for the appropriate number of days as specified in the Options listed above.

Required test parameters: Investigator must collect mortality data throughout the 5-day pre-treatment, treatment, and 21-day post-treatment periods. Investigator should also report general fish behavior and any possible adverse effects relating to treatment.
Limitations or restrictions on use:

Investigator must follow all instructions in the Study Protocol for INAD 9332 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: $400.00 per facility per year
AADAP contact for other information: Ms. Bonnie Johnson, FWS - AADAP
Phone: 406-994-9905
Fax: 406-582-0242

bonnie_johnson@fws.gov
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