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4.
FORMS USED BY THE FDA
FD-2656. Registration of Drug Establishment.
This form is required for initial registration with the FDA
and must be submitted within five working days after
commencement of operation of the facility.
FD-2656e. Annual Registration of Drug Establishment.
This form is used for annual registration of facilities.
The FDA will send this form to your facility on an annual
basis.
FDA-1900. Medicated Feed Application.
This form is used to obtain FDA approval to manufacture or
use any Type A Category 2 feed article at your facility.
Purchase of a medicated premix or complete feed does not
require a FDA-1900 as the facility that blends and
manufactures the feed will have one on file. However, each
user is responsible for the correct level of drug contained
in the total feed. If your facility does not have a
FDA-1900 on file for the proper drugs, your facility must
first pass a CGMP inspection conducted by the FDA; then FDA
will approve your Medicated Feed Application ‘1900’.
These
forms can be obtained by writing to:
Department of Health, Education and Welfares
Food &
Drug Administration, Bureau of Drugs
Drug
Listing Staff (HFD-315)
5600
Fishers Lane
Rockville, MD 20857
call
or write to:
Toll Free
in SD - 800-228-5254 or (605) 773-5436
South
Dakota Department of Agriculture
523 East
Capital Avenue
Pierre, SD 57501
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