Beyond use dating error validating saml response
I recently received a question from another pharmacist: “I wanted to get your thoughts on the current proposed revised USP standard.
Specifically, the lack of reference to extended BUD’s when stability/sterility literature references or method suitability studies have been performed.
One recent story, the compounding pharmacy Imprimis that made curcumin in PEG 40 castor oil; they weren’t using USP grade and degraded (no stability study done on this obviously).
Polyethelyne Glycol degrades to Diethylene glycol which is a great solvent but basically starts shutting down biological systems (liver kidney) in humans.
Because of compelling patient-care needs, a pharmacist may be unable to stay within the approved labeling and product guidelines stated in the package insert.
For example, a higher concentration of drug may be prescribed; different diluent, container, etc., may be necessary; or the patient may require the HSD for longer periods of time.
In this case, the USP34-NF29 Chapter gives the following recommended beyond use dates for nonsterile compounded preparations that are packaged in tight, light-resistant containers and stored at controlled room temperature, unless otherwise indicated: The beyond use date is not later than 14 days when stored at controlled cold temperature. The beyond use date is not later than the time remaining until the earliest expiration date of any API, or 6 months, whichever is earlier.However, reliable, published stability information is sometimes lacking for many types of drugs.In these instances, pharmacists should consult with the drug's manufacturer to establish a beyond use date.Beyond use dates are different from expiration dates.Expiration dates are required on commercially manufactured products and are determined after extensive study of the product's stability.