NATIONAL COORDINATOR

FOR AQUACULTURE NEW ANIMAL DRUG APPLICATIONS

Recent Approvals (Oxytetracycline)

OXYTETRACYCLINE HCI SOLUBLE POWDER—343® APPROVED FOR ALL FINFISH

 SUMMARY:  The Food and Drug Administration (FDA) amended the animal drug regulations (i.e., Code of Federal Regulations) on September 15, 2004 to reflect the approval of a supplemental new animal drug application (NADA # 200-247) filed by Phoenix Scientific, Inc. (3915 South 48^th Street Terrance, St. Joseph, Missouri 64503).  The supplemental NADA was published in the Federal Register October 22, 2004.  The supplement provides for use of OXYTETRACYCLINE HCI SOLUBLE POWDER—343® (oxytetracycline hydrochloride soluble powder) for skeletal marking of finfish fry and fingerlings by immersion.

 Specifications

Each gram of powder contains 753 mg oxytetracycline hydrochloride.

Conditions for use in finfish (21 CFR Part 529.1660)  

• Amount.  Immerse fish in a solution containing 200 to 700 mg oxytetracycline hydrochloride (buffered) per liter of water for 2 to 6 hours.

• Indications for use.  For skeletal marking of finfish fry and fingerlings.

 Tolerances for residues of new animal drugs in food (21 CFR Part 556.500)  

• Acceptable daily intake (ADI).  The ADI for total tetracycline residues (chlortetracycline, oxytetracycline, and tetracycline) is 25 micrograms per kilogram of body weight per day.
• Tolerances.  A tolerance for the sum of residues of the tetracyclines including chlortetracycline, oxytetracycline, and tetracycline, in tissues for finfish and lobster is 2 parts per million (ppm) in muscle.

  U.S. Food and Drug Administration. 2004.  Certain other dosage form new animal drugs; oxytetracycline.  Code of Federal Regulations, 21 CFR Part 529.1660 and Part 556.500, October 14, 2004.