Review and approval of labeling.

CFR · 2024-01-01 · US · Title 9

Labels used with biological products prepared at licensed establishments or imported for general distribution and sale must be submitted to the Animal and Plant Health Inspection Service for review for compliance with the regulations and approval in writing prior to use, except as provided in paragraph (d) of this section and under the master label system provided in paragraph (e) of this section. (a) Transmittal forms, available on the APHIS Web page at (b) A data summary, available on the Internet at (c) Sketches may be submitted for comment to Animal and Plant Health Inspection Service by the licensee or permittee before preparing the finished label. Such sketches shall be returned to the licensee or permittee with comments, if any. Failure of the reviewer to take exception to a sketch shall not constitute approval of a finished label subsequently prepared. (d)(1) Labels must be submitted to the Animal and Plant Health Inspection Service for review and written approval. Only labels which are approved as provided in paragraph (e) of this section may be used. When changes are made in approved labels, the new labels shall be subject to review and approval before use: (2) Minor label changes that may be made under the provision for products with approved labels or master labels are: (i) Changes in the physical dimensions of the label provided that such change does not affect the legibility of the label; (ii) Changes in the color of label print or background, provided that such

official document · source cfr-2024 · id 9:§ 112.5