U.S. Code of Federal Regulations

Regulations most recently checked for updates: Aug 08, 2022

§ 114.17 - Rebottling of biological products.

The Administrator may authorize the rebottling of a completed product in liquid form subject to the conditions prescribed in this section.

(a) All or part of a serial which has not left the licensed establishment may be aseptically returned to the mixing tank, thoroughly mixed, and rebottled in new final containers.

(b) The rebottled product shall be adequately identified by serial number or subserial number, as the case may be.

(c) Required purity tests for final container samples of the product shall be conducted on new samples selected from the rebottled product (serial or subserials). Rebottled product found to be unsatisfactory by such tests shall not be released.

(d) New test samples from each serial or subserial and copies of test reports of all tests conducted on the rebottled product shall be submitted to Animal and Plant Health Inspection Service.

(e) The licensee shall not release the rebottled product unless notified by Animal and Plant Health Inspection Service that such product is eligible for release. Production records shall show the results of all tests conducted and shall accurately reflect the actions taken.

[39 FR 16869, May 10, 1974, as amended at 56 FR 66784, Dec. 26, 1991]