Can an organization utilize published scientific information to determine medication stability when considering alternative storage practices and expiration (beyond use) dates?

Any examples are for illustrative purposes only.

Medication storage practices and conditions are required to be in accordance with the original product manufacturer's instructions (MM.03.01.01 EP 2). When storage conditions for medication are not addressed in the original package insert, a pharmacist should be consulted to determine the appropriateness of alternate storage conditions, changes to the expiration date, and the stability of the medication. The Joint Commission is aware of published resources that may provide alternative stability data which may not reflect what is stated by the manufacturer.  However, these publications and tests are not required to be validated by the U.S. Food and Drug Administration (FDA) and therefore may not be consistent with the strenuous testing required.

Expiration dating is based on stability testing under specified conditions as part of the FDA's approval process. This is determined from results of rigorous analytical and performance testing, and are specific for a particular formulation in its container and at stated exposure conditions of illumination and temperature. It is possible that a medication could become unusable prior to its expiration date if it has been subjected to conditions that are inconsistent with the manufacturer's package insert stated requirements.

The Joint Commission is also aware that the FDA has allowed extensions of certain medication expiration dates beyond what is listed on product labeling.  The applicability of this must be approved by the FDA and established by the manufacturer with an assurance that the lot number utilized for patient care is within the approved lot numbers of the medication. 

NOTE: This FAQ only addresses the stability of the product and NOT the sterility.  An organization should ensure that alternate packaging and storage is consistent with National Standards to ensure appropriate sterility, such as USP 797.