Expiration dating of repackaged medications
We recently launched a new site to showcase the many benefits of Rx PACK™ and the Rx TOOLKIT Label Solutions Library.
These tools can help you increase safety and efficiency, and establish standardization and quality control within your labeling and repackaging processes.
In 2010, the United States spent .6 trillion, or 17.9% of its gross domestic product, on health care, of which nearly 6 billion was spent on retail prescription drugs.
The Federal Food, Drug, and Cosmetic Act and its subsequent amendments provide the authority and responsibility to the Food and Drug Administration (FDA) to ensure that all drug products approved for U. marketing meet standards of quality, safety, and efficacy.
A critical fact that should be acknowledged is that all drug products studied under SLEP are stored in their unopened original container under the exact same conditions as recommended on the product labeling.
As stated above, most drug products dispensed by retail pharmacies have been removed from their original container closure system and are stored according to the individual patient’s preferences.
We will also help you navigate the many choices for quality printers and label stock.
Standardization of Process and Rx PACK™ gets your staff on the same page by establishing a standardized process for verification and documentation.
In the last few decades, the cost of health care has outpaced U. Despite the volume of the drugs dispensed at the retail level, there are minimal supportive data available on the quality and stability of oral drug products dispensed by community pharmacies from an open bulk container stored on the pharmacy shelf.
With Rx PACK™, all relevant information is automatically cataloged and stored in a compliant digital logbook.
Users can easily find and reference any data element including information on source ingredients.
Given the fact that most drug products approved by FDA have a two-year expiration date, one may argue that the recommended one-year beyond-use date for a repackaged drug product may be too conservative.
Since 1986, in collaboration with the Department of Defense, FDA has tested 122 products (3005 lots) in the Shelf Life Extension Program (SLEP) and found that the labeled expiration date of a drug product might markedly underestimate its actual shelf life, as most drug products remain potent for many years after they have expired.