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C. Use of Package Inserts

Federal law allows drug sponsors to include the necessary use information on
drug package inserts. Often the immediate container label of a drug
(especially small vials) will state “see package insert”. If the PMO required
drug labeling information (Item 15r) is included on the insert and not on the
vial label the insert must be readily available at inspection time.

D. Veterinarian Prescriptions

Many veterinarians prefer to write prescriptions for drug distributors to fill and
deliver prescription or extra-label use drugs to dairy farms. The PMO does
not mandate who should dispense the drug or who should affix the necessary
label information. In many States, there are regulations as to who may
dispense veterinary drugs and who may label drug products. These
regulations vary. The appropriate State agency should be consulted. For
PMO purposes the drugs must be properly labeled at inspection time. The
PMO does not specify who is allowed to label a product.

THE PRODUCER is responsible for assuring that the veterinarian has provided the
specific label information required by the PMO. These minimum label requirements
provide inspectional evidence that adequate directions for use of the product are
available to the dairy farmer and, in the case of veterinary prescription drugs or
extra-label use drugs, that a veterinarian has prescribed the product. If these
requirements are not met, the producer may not have adequate directions for safe
and effective use of the drugs.

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