Page 121 - Microsoft Word -Cow Book 10-06-09 final update.doc

Storage areas designated for drugs for LACTATING animals include:

a. OTC drugs bearing the manufacturer's label indicating use in lactating cattle.

b. Rx drugs bearing the prescription label and the veterinarian's name and
address indicating use in lactating cattle.

c. Drugs used in an extra-label manner bearing the authorizing veterinarian's
label indicating an extra-label use in lactating cattle.

Storage areas designated for drugs for NON-LACTATING animals include:

a. OTC drugs bearing the manufacturer's label indicating use in non-lactating
cattle.

b. Rx drugs bearing the prescription label and the veterinarian's name and
address indicating use in non-lactating cattle.

c. Drugs used in an extra-label manner bearing the authorizing veterinarian's
label indicating an extra-label use in non-lactating cattle.

A. Satisfactory Labeling of the Drug Product

The labeling of a shelf, wall or carton (intended for holding multiple labeled
containers) is not discouraged, but will not satisfy the PMO requirements. If a
shelf, wall or carton is labeled instead of the immediate container then
adequate directions for use would not be in hand at the time the drug is
administered. This is especially important when multiple people or crews treat
cows on a farm. They need adequate directions for use, to avoid residues in
the milk.

B. Posting of Drug Use Protocols

FDA encourages any mechanism a veterinarian or layperson may deem
appropriate to educate the producer and his employees to strictly follow the
labeled directions and veterinarian's instructions. The posting of a treatment
protocol may have a positive effect in achieving adherence to label directions.
However, the use of this or a similar mechanism would not obviate the need
for individual container labeling. Not only is it required by the PMO and the F,
D,&C Act, but, in addition, appropriate labeling ensures that adequate
directions for use are present and in hand at the time of use.

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