Regulatory Brief

 Biologic stability


Formal title: Docket Number [APHIS-2009-0028]Viruses, Serums, Toxins, and Analogous Products; Expiration Date Required for Serials and Subserials and Determination of Expiration Date of Product

The U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) proposed to amend the Virus-Serum-Toxin Act.

Brief Description:

The U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) proposed to amend the Virus-Serum-Toxin Act regulations concerning expiration dating to clarify 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.

USDA APHIS also proposed to require the expiration dating period (stability) of a product to be confirmed by conducting a real-time stability study with a stability-indicating assay; require stability monitoring of products after licensing; and specify a single standard for determining the expiration date for veterinary biologics in place of the current standard that specifies different procedures for products contingent upon whether they consist of viable or nonviable organisms. These amendments would update and clarify the regulations concerning expiration dating and establish a single uniform standard for determining the stability of veterinary biological products. This proposed rule replaces a previously published proposed rule, which is being withdrawn as part of this document.

AVMA Response:

The AVMA underscores our commitment to the continuing availability of products that are pure, safe, potent, and efficacious for animals. Consequently, the AVMA asserts that vaccine products must be potent throughout the dating period. We recognize the importance of USDA's current evaluation of applicable USDA regulations regarding product potency, and consequently safety and efficacy, as these standards are important to veterinarians and critical for product quality.

The AVMA encourages the USDA to work collaboratively with the veterinary biological product industry to ensure regulations are mutually acceptable, clearly understood, and achievable within a reasonable time frame. Moreover, USDA regulations should be effective – ensuring product safety, efficacy, and potency – while also supportive of continued product availability and flexible enough for application across the spectrum of licensed biologic products.