(a) A PET drug product must be suitably labeled and packaged to protect the product from alteration, contamination, and damage during the established conditions of shipping, distribution, handling, and use.

(b) Labels must be legible and applied so as to remain legible and affixed during the established conditions of processing, storage, handling, distribution, and use.

(c) All information stated on each label must also be contained in each batch production record.

(d) Labeling and packaging operations must be controlled to prevent labeling and product mix-ups.