FDA Releases Exceptions to Labeling Requirements for Strategic National Stockpile

Posted 07 February 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) released a new final rule on 6 February 2012 that allows FDA center directors leeway in the labeling requirements for products held at the Strategic National Stockpile (SNS).

SNS is a stockpile of drug products to be used in the case of a national emergency, such as an outbreak of disease. Products at the stockpile are frequently overseen by FDA due to the need for continued stability testing and labeling updates. Instead of replacing products in the SNS at the manufacturer's labeled date of expiry, FDA conducts regular stability testing to prolong the shelf life of the products and save SNS money.

The final rule issued by FDA, Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile, is intended to make sure that FDA center directors have the authority to grant exceptions to labeling requirements, which might otherwise "render such products misbranded under section 502 of the Federal Food, Drug and Cosmetic Act.

"Under this rule, the appropriate FDA center director may grant exceptions or alternatives to certain regulatory labeling requirements applicable to medical products that are or will be included in the SNS if he or she determines that compliance with the labeling requirements could adversely affect the safety, effectiveness, or availability of specified lots, batches, or other units of medical products that are or will be included in the SNS," says the notice in the Federal Register. "An exception or alternative granted under this rule may include conditions or safeguards deemed appropriate by the FDA Center Director to ensure that the labeling for such products includes information necessary for the safe and effective use of the product given the product's anticipated circumstances of use."

Regulatory Focus newsletters

All the biggest regulatory news and happenings.


Most Viewed Articles