Hospitals may unnecessarily discard these drugs, all subject to recent shortages, when following the manufacturer’s directions in order to comply with CMS rules. at Cedars-Sinai Medical Center in Los Angeles (personal communication), among 50 randomly selected drugs on the current national drug shortage list, the package insert for only 68 % of them included information on compatibility with diluents, and only half provided information on stability, storage, and BUD after dilution of the drug to a final form.When the manufacturers were contacted, half referred practitioners to published compendia for needed storage and information on BUD.
Currently, these draft documents are out for a 90 day public comment period.
to ensure that you continue to have reasonable access to repackaged Avastin® to treat your patients.
Pine Pharmaceuticals is committed to navigating this obstacle as efficiently as possible to ensure your continued access to repackaged Avastin®.
However, as you are aware, these expiration dating limitations will impose a challenging burden on your practice and its use of Avastin® when considering shipping times, logistics of inventory, etc.
Chiefly, the documents seek to limit expiration dating on repackaged Avastin® syringes to 24 hours when produced at a traditional 503A compounding pharmacy (patient specific) and to 5 days when produced at an FDA registered 503B outsourcing facility (non-patient specific).
This limitation comes in spite of published literature supporting more extended dating, and our facility having conducted a stability study validating the prefilled syringes to be stable at 90 days.
-----For information on storage, compatibility, stability, and BUD, manufacturers often refer practitioners to official compendia such as the American Hospital Formulary Service (AHFS) Drug Information, Trissel’s Handbook on Injectable Drugs, and/or studies published in peer reviewed journals.-----Conflicts may exist between the manufacturer’s directions in official labeling and more recent evidence-based compatibility/stability data and BUD published in official compendia endorsed by pharmacy organizations.
Examples of injectable drugs with evidence-based extended dating not mentioned in the manufacturer’s labeling include: succinylcholine (vial), LORazepam (vial), ni CARdipine (IV admixture), famotidine (IV admixture), and norepinephrine (IV admixture).
With award-winning software, a global talent network, and smart content strategy, Contently is the Fortune 500’s most trusted content marketing solution.