Animal and Plant Health Inspection Service April 28, 2005 – Federal Register Recent Federal Regulation Documents

We are proposing to amend the Virus-Serum-Toxin Act regulations to require licensees and permittees to confirm the proposed expiration dating period of products by potency testing serials on multiple occasions throughout the proposed dating period, rather than only at release and at the approximate expiration date as is currently required. We would require that those stability test data be submitted to the Animal and Plant Health Inspection Service for review and filing, and that the approval date be specified in a filed Outline of Production. In addition, after a product is licensed and its dating period confirmed, the licensee or permittee would have to submit a plan to monitor the stability of the product and the suitability of its dating period; that plan would have to include regular testing of serials for potency during and at the end of dating. The proposed changes would help clarify the distinction between specifying an expiration date for an individual serial of a product and establishing the appropriate expiration dating period for the product. The effect of these proposed changes would be to establish a single uniform standard for determining expiration dates for veterinary biological products.