Outline of Production required.

CFR · 2024-01-01 · US · Title 9

An Outline of Production shall be on file with Animal and Plant Health Inspection Service for each licensed biological product or for each biological (a) The Outline of Production shall be prepared as prescribed in § 114.9 and submitted to Animal and Plant Health Inspection Service for filing. When objectionable features, if any, are corrected and no further exceptions are taken by Animal and Plant Health Inspection Service to an Outline of Production for a biological product, such Outline of Production shall be approved for filing. (b) Each page shall be stamped as filed on the date such action was taken in the bottom right hand corner. Although the filed outline may be referred to as an approved outline, approval for filing constitutes no endorsement by Animal and Plant Health Inspection Service of such biological product or the methods and procedures used to prepare such biological product. (c) One copy of the Outline of Production shall be retained by the Animal and Plant Health Inspection Service and one copy returned to the licensee or permittee. (d) Each licensee shall review each Outline of Production for accuracy and sufficiency not less frequently than once a year. Revisions necessary to bring an Outline of Production into compliance with the regulations shall be submitted to Animal and Plant Health Inspection Service. (e) When a list of licensed products to be continued in production at a licensed establishment is requested by the Administrator in accordance with §

official document · source cfr-2024 · id 9:§ 114.8