FDA understands there are limited approved, conditionally approved, or indexed drugs available for use in aquatic animals, including those used in aquaculture, and that the stakeholders in this area differ from traditional animal drug sponsors. In response, FDA has made this reference tool publicly available to assist investigators developing new animal drugs for aquatic species. The database can also be used to support FDA Center for Veterinary Medicine's mission of protecting human and animal health by serving as a resource for the aquatic drug approval process and by consolidating information for drug residue surveillance.
The Phish-Pharm database was built because information about pharmacokinetic parameters and drug residues in aquatic species (fish, shellfish, crustaceans, etc.) is relatively sparse. Phish-Pharm currently consists of over 700 articles that include data from 191 aquatic species (fish, shellfish, and more).
Phish-Pharm is not intended for aquaculture farmers to evaluate safety or effectiveness of unapproved drugs. Aquaculture farmers should only use approved, conditionally approved, or indexed drugs in their operations. For information on approved or indexed products for use in aquaculture, see Approved Aquaculture Drugs.
How to Use Phish-Pharm
Phish-Pharm enables users to quickly evaluate what information is available on drugs and chemicals studied in fish and to identify research gaps to guide future research. However, Phish-Pharm is not an appropriate tool for recommending withdrawal intervals of drug and chemical residues due to variability in experimental designs, analytical methods, statistical methods, low sample sizes, few studies, lack of repeatability, environmental variability, and use of different animal life stages. A link to the abstract for each article is also included in the database.
Phish-Pharm supports CVM’s mission of “protecting human and animal health” by consolidating articles to provide information for the aquatic drug approval process and drug residue surveillance. Many of the listed compounds are not approved for use in fish in the U.S. Please note this database is intended to aid in aquatic animal drug development and is not to be used to inform unauthorized use of drugs and chemicals. Half-life estimates reported in the database should not be used to determine withdrawal times.
Inclusion of articles in Phish-Pharm is not an endorsement of reported results, since FDA has not reviewed critical aspects of the studies such as data, methods, and conclusions. Users are encouraged to personally review literature of interest. During the data entry process, entries are subject to quality review. However, there is no guarantee all data entry is without entry error. Errors in data entry, or suggestions for articles to include in the database, may be reported by emailing the current Phish-Pharm team.