EXPIRATION DATING OF PHARMACEUTICAL PRODUCTS

To support and actively promote the maximal extension of expiration dates of commercially available pharmaceutical products as a means of increasing access to drugs, such as medications in shortage or used for medical countermeasures, and reducing healthcare costs; further,

To advocate that the Food and Drug Administration implement procedures for pharmaceutical manufacturers to readily update expiration dates to reflect current evidence regarding the maximum length of drug potency and safety, using technology solutions when available; further,

To advocate that regulators and accreditation agencies recognize authoritative data on extended expiration dates for commercially available pharmaceutical products.

Rationale

Extending the expiration date of commercially available pharmaceutical products for as long as possible, while maintaining drug potency and safety, reduces healthcare costs and increases access. This is especially important with medications in short supply or those used as medical countermeasures (i.e., FDA-regulated products [biologics, drugs, devices] that may be used in the event of a potential public health emergency stemming from a terrorist attack with a biological, chemical, or radiological/nuclear material, or a naturally occurring emerging disease). ASHP encourages pre- and post-marketing research on expiration dates and the use of the most current authoritative data on expiration dates in drug product management. However, the current process for updating expiration dates in drug product labeling presents barriers to timely revision and should be streamlined to allow for timely updates. Technology solutions should be leveraged when possible to determine and communicate about expiration date extensions. Until such a process is implemented, regulators and accreditation agencies should permit healthcare organizations to rely on authoritative data when determining appropriate extended expiration dates for commercially available pharmaceutical products.