Drug-use
Guidance...
Low Regulatory Priority Drugs
The following list of drugs has been determined
by CVM to be of low regulatory priority (LRP). In essence,
CVM is unlikely to object to the use of LRP substances
if all of the following five conditions are met:
1. the substances are used for the listed indications;
2. the substances are used at the prescribed levels;
3. the substances are used according to good management practices;
4. the product is of an appropriate grade for use in food
animals, and
5. there is not likely to be an adverse effect on the environment.
The list of LRP drugs includes:
- Acetic acid as a parasiticide for fish
- Calcium chloride to ensure proper egg hardening
- Calcium oxide as an external protozoacide
- Carbon dioxide gas as an anesthetic
- Fuller’s earth to reduce the adhesiveness
of fish eggs
- Garlic for control of parasitic infestations
of marine salmonids
- Ice to reduce metabolic rate of fish during
transport
- Magnesium sulfate to treat external parasitic
infestations in fish at all life stages
- Onions to treat external parasitic infections
of salmonids at all life stages
- Papain to remove gelatinous matrix of fish egg
masses
- Potassium chloride as an aid in osmoregulation
- Povidone iodine as an egg surface disinfectant
during and after water hardening
- Sodium bicarbonate to anesthetize fish
- Sodium chloride as an osmoregulatory aid and
as a parasiticide
- Sodium sulfite to treat eggs in order to improve
their hatchability
- Thiamine hydrochloride to prevent or treat thiamine
deficiency in salmonids
- Urea and tannic acid to denature the adhesive
component of fish eggs.
A complete and detailed listing of the LRP
drugs can be found on CVM’s website: http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/
PoliciesProceduresManual/UCM046931.pdf
|
