U.S. flag An official website of the United States government
  1. Home
  2. Animal & Veterinary
  3. Safety & Health
  4. Product Safety Information
  5. Letter to Aquaculture Professionals
  1. Product Safety Information

Letter to Aquaculture Professionals

Issued: October 2012
Reissued: October 2015

Dear Aquaculture Professional:

The U.S. Food and Drug Administration (FDA) wants to remind you that not all drugs currently marketed for food fish (fish that will enter the human food supply) are approved. And even if a marketed product has the same established name (active ingredient) as an FDA-approved drug, that doesn’t mean it’s also FDA-approved.

Please see the table below for a list of all FDA-approved fish drugs. If a product currently marketed for food fish isn't listed, it's not FDA-approved, and therefore, hasn’t been shown to be safe and effective in food fish. For example, only the three listed formalin products are approved by FDA for fish. Any other formalin-containing products marketed are not FDA-approved.

Benefits of FDA Approval

FDA rigorously evaluates an animal drug before approving it. As part of the approval process, the drug company must prove to FDA that:

  • The drug is safe and effective for a specific use in a specific animal species. For food fish intended for human consumption, the drug company must also prove that food made from fish treated with the drug is safe for people to eat;
  • The manufacturing process is adequate to preserve the drug’s identity, strength, quality, and purity; and
  • The drug’s labeling is truthful and not misleading.

FDA’s role doesn’t stop after the agency approves an animal drug. As long as the drug company markets the animal drug, the agency continues to monitor:

  • The drug's safety and effectiveness. Sometimes, the agency’s post-approval monitoring uncovers safety and effectiveness issues that were unknown at the time of approval;
  • The manufacturing process to ensure quality and consistency are maintained;
  • The drug's labeling to make sure the information remains truthful and not misleading; and
  • The company’s marketing communications related to the drug to make sure the information is truthful and not misleading.

FDA-Approved Fish Drugs - Immersion Products

Trade Name (established name)1 Application Type & Number
Halamid® Aqua
(chloramine-T powder)
NADA2 141-423
ANADA3 200-414
NADA 137-687
NADA 140-989
35% Perox-aid
(hydrogen peroxide)
NADA 141-255
(oxytetracycline hydrochloride)
NADA 130-435
Oxytetracycline HCl Soluble Powder-343
(oxytetracycline hydrochloride)
ANADA 200-247
Pennox 343
(oxytetracycline hydrochloride)
ANADA 200-026
Terramycin-343 Soluble Powder
(oxytetracycline hydrochloride)
NADA 008-622
Tetroxy Aquatic
(oxytetracycline hydrochloride)
ANADA 200-460
(tricaine methanesulfonate)
ANADA 200-226

FDA-Approved Fish Drugs - Injectable Products

Trade Name (established name)1 Application Type & Number
(chorionic gonadotropin)
NADA 140-927

FDA-Approved Fish Drugs - Medicated Feed

Trade Name (established name)1 Application Type & Number
Aquaflor® Type A Medicated Article
NADA 141-246
Terramycin® 200 for Fish
(oxytetracycline dihydrate)
NADA 038-439
(sulfadimethoxine & ormetoprim)
NADA 125-933
Sulfamerazine In Fish Grade
NADA 033-950

1The drug’s established name is the active ingredient.
2NADA – New Animal Drug Application.
3ANADA – Abbreviated New Animal Drug Application for a generic animal drug.

More information about approved drugs for aquaculture

Besides the approved drugs listed in this table, two drugs for ornamental fish are on the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species.

FDA-approved animal drugs are scientifically shown to be safe and effective when used according to the directions on the label. If the approved drugs are for food fish, food made from treated fish is safe for people to eat. FDA-approved animal drugs also meet the agency’s strict standards for quality, purity, and potency.

FDA’s Center for Veterinary Medicine (CVM) is committed to promoting and protecting animal health by ensuring safe and effective drugs are available for animals. For more information, please contact the CVM Education & Outreach Staff at 240-402-7002 or AskCVM@fda.hhs.gov.


FDA’s Center for Veterinary Medicine