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I am not sure if anyone has run into this situation but I am going to
be running some clinical trials on an animal drug (tick repellent)
but it has been classified as a pesticide and not a drug. The FDA
said to go to the EPA for registration and regulation. Has anyone
run into this situation? does anyone know where I could find out
more information about this? This drug is manufactured in India and
has been classified as a drug in europe but not here in the USA. any
help would be great.
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The following message was posted to: PharmPK
"... I am going to be running some clinical trials on an animal drug
(tick repellent) but it has been classified as a pesticide and not a
drug. The FDA said to go to the EPA for registration and regulation. .."
Good luck with that ;-)
U.S. EPA is responsible under the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) for determining that pesticides will not pose
unreasonable risks to human health or the environment when used
according to label directions. FIFRA also requires EPA to balance the
risks of pesticide use against the benefits to society and the
economy when allowing a particular use.
The registration decisions are based on EPA's review and evaluation
of test data generated by the registrant in a variety of scientific
Registration Questions about Conventional Chemicals:
EPA Contact, Registration Division - (703) 305-5447
Quoted from http://www.ars.usda.gov/is/np/mba/jan97/epa.htm :
Three sets of documents describing the tests are available: 40 CFR
Part 158 describes which tests are required, the Pesticide Assessment
Guidelines give detailed guidance for how the tests may be performed,
and the Standard Evaluation Procedures (SEP's) describe how the
scientific reviewers at EPA evaluate test results for use in risk
"If someone wants to get a pesticide registered at EPA, the first
step should be a preregistration conference where the potential
registrant visits EPA to get the information and forms necessary to
process the application," [...]
See the links below:
About U.S. EPA Pesticide Program:
Pesticide Registration (PR) Notices:
NPIC's Guide to the US EPA's Pesticide Regulations:
Janusz Z. Byczkowski, Ph.D.,D.Sc.,D.A.B.T.
212 N. Central Ave.
Fairborn, OH 45324-5006
JZB Consulting web site: http://members.aol.com/JanuszB/consult.htm
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