Page 111 - Microsoft Word -Cow Book 10-06-09 final update.doc

product in hand every time the drug is administered. Great emphasis is placed
on proper drug labeling and storage in an attempt to heighten the producer's
awareness of proper drug use and prevent accidental drug residues in our milk and
meat products.

Accidents and mistakes cause the majority of the drug residues in milk.
Examples:
► Failure to follow drug use and withdrawal time directions
► Failure to identify treated cows and keep them out of the milking herd.
► Failure to keep adequate treatment and drug use records.
► Using common equipment to milk treated and not-treated cows.
► Pulling vacuum off the milk line to operate abnormal milking buckets.
► Multiple drugs and/or double dosing and following single dose
discard/withdrawal times.

PMO DAIRY OPERATION INSPECTIONAL AREAS:

The proper labeling and storage of drugs on the dairy operation is important to
ensuring that the producer has adequate directions for use in hand every time a drug
is administered to assist in preventing drug residues. It is important that drugs are
stored in areas where they may be reviewed during routine inspections, state ratings
and FDA check-ratings. Such review provides verification that proper labeling and
storage criteria, required under Item 15r of the PMO, are in compliance.

FDA has consistently defined that the inspection of a Grade “A” dairy operation
includes the milkhouse, milking barn, stable or parlor, adjacent storage areas, cow
yard and cattle housing areas, surroundings, waste disposal areas and the water
supply and its distribution system. These areas may include dairy animal maternity
areas, animal treatment areas or hospital barns, replacement heifer areas, offices,
utility rooms, tool sheds (drug cabinets, refrigerators, etc.) or other areas where
drugs, used to treat dairy animals, may be used or stored.

With regard to drug storage, labeling and use, the scope of a dairy
operation/inspection extends beyond the milkhouse, milking barn or parlor. FDA
believes the following areas are part of the milking operations: any area reasonably
expected to contain drugs used to treat lactating cattle, cattle that may soon be
placed in or returned to a milking herd, or other cattle intended for milk production
(replacement heifers). Private residences and vehicles are not included without the
permission of the owner or their authorized agent.

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