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3.
REGISTRATION WITH THE FDA
a) Who
must register with the FDA?
Any
establishment that uses one or more Type A sources of a
Category 2 drug to manufacture or produce medicated feed
articles. Registration requires completion of either Form
FD-2656 (for first time registrants) or 2656e (for annual
re-registration), together with a separate Form FDA-1900 for
each of the Type A Category 2 drugs being used. The forms
are described in paragraph 4 below.
b)
What about feed mixed on the farm?
All
producers of medicated feeds are subject to the same rules.
If commercial mills, feedlots, producers, mobile mixers,
etc. use only Category 1 products and/or Category 2 Type B
drug products, registration with FDA is not required. These
products are subject to follow the relaxed set of CGMPs and
are not subject to routine inspections by FDA.
If a firm uses one or more Category 2 Type A medicated
articles as drug sources, it must register with FDA and
comply with the full CGMPs and is subject to FDA inspections
for compliance with these CGMPs at least once very two
years.
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