otc drug products which have no dosage limitation and which are stable for at least three years as demonstrated by appropriate data are exempt from the requirement to bear an expiration date.(g) new drug products for investigational use are exempt from the requirements of this section, provided that they meet appropriate standards or specifications as demonstrated by stability studies during their use in clinical investigations. you have not performed stability testing of your product and therefore are unable to appropriately determine storage conditions designed to assure the stability of your drug product (211.
Expiration Dating and Stability Testing for Human Drug Products
Stability Testing – Doing Everything or Doing the Right Thing
.(b) expiration dates shall be related to any storage conditions stated on the labeling, as determined by stability studies described in 211. of assurance that a product labeled as sterile has been tested to ascertain that the container and closure can maintain a sterile state throughout the labeled shelf life. requires a firm to have a written stability program, the results of which are to be used in determining appropriate storage conditions and a product's expiration date and specifies what must be included in the stability program.