USDA’s Animal and Plant Health Inspection Service (APHIS) this week issued updates to its regulations to clarify points about how expiration dates on veterinary biologics should be calculated and confirmed.
The new rule, which becomes effective on April 13, 2018, specifies that the expiration date of a serial or subserial of a veterinary biologic should be computed from the date of the initiation of the first potency test. APHIS also will require the expiration dating period (stability) of a product to be confirmed by conducting a real-time stability study with a stability-indicating assay, stability monitoring of products after licensing, and specifying a single standard for determining the expiration date for veterinary biologics.
APHIS initially published a proposed rule in September 2010, followed by a 60-day comment period. Based on public comments, the agency clarified and changed some points in the final rule.
A key point affecting manufacturers of veterinary biologics is that APHIS does not consider stability estimates based on potency tests conducted at just two points – at the beginning and end of dating – to be either accurate or precise. “A two point profile will determine a fixed line, but if a stability profile is non-linear, two points are inadequate to estimate the profile,” APHIS notes. The revised rule specifies testing of serials or subserials using a stability-indicating assay on multiple occasions throughout the predicted dating period, and adds a definition of the term stability-indicating assay to clarify what types of assays would be considered acceptable.
Read more in the Federal Register.