Beyond Use Dating Pharmacy

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Beyond Use Date (BUD) is very different from expiration date . USP Chapter 797 defines BUD as the date or time after which a compounded sterile preparation (CSP) may not be stored or transported and is calculated from the date or time of compounding . Expiration date is a manufacturer defined term based on very specific testing used for commercially available products .
What are Beyond-Use Dates? Beyond-use dates (BUDs) are the date or time after which a compounded sterile preparation (CSP) or compounded nonsterile preparation (CNSP) may not be stored or transported and are calculated from the date or time of compounding . Why are Beyond-Use Dates Necessary? BUDs help decrease the risks that may be posed to patients .
Most expiration dates are given in years for commercial products . Beyond use dates are used for compounded preparations and are generally in days or months . The major problem for pharmacists is that the stability of compounded formulations often is not known . Also,
The NABP Model Rules for the Practice of Pharmacy recommends that a beyond-use date be included on the prescription label . As a result, many states have adopted this standard . Check the regulations for the state in which you are practicing for information about requirements for labeling prescription containers with beyond-use dates . 2 .
A beyond-use date is assigned by the pharmacy for a preparation that they compound . Q: What factors are used to determine a CSP's beyond-use date? A: Of the three factors used - stability, sterility, and risk level - you should use the shortest of the beyond-use dates dictated by those factors . People sometimes think, "Well, I read in the literature that this is stable for 30 days," but that doesn't mean it's going to remain sterile for 30 days .
To support compounding of products that are sterile and chemically stable, beyond use dating of admixtures must include a thorough evaluation of appropriate resources . In most instances, resources provide documentation of a specific compounded admixture, at a specific concentration and storage parameters, that does not coincide with current operations or patient-specific requirements .
A beyond-use date is a date placed on a prescription by a pharmacy for compounded medications they prepare, noting when that prescription should no longer be used . It will often say "discard after . . ." or "do not use after . . ."
503A Compounding Pharmacies - Beyond-Use Date . Traditional compounding pharmacies, also referred to as 503A pharmacies, modify medications to fill individual, patient-specific prescriptions . Medication alterations can include combining two or more drugs together, dosage modifications, adding flavorings palpable to the patient, and other changes as needed for the patient . 503A pharmacies label their products with a BUD, not an expiration date .
file .cop .ufl .edu › ce › consultwb › 2015Workbook › CHAPTER 20 .pdf
1 . All drugs in the nursing home must have a " beyond use " date . 2 . Unit dosed medication (unless direct from the manufacturer) should not exceed 1 year from package date 3 . Bulk containers (ex Multivitamins) -the manufacturer's expiration date may be used unless the facility policy shortens this date 4 .
petition to extend the usp797 beyond use dating for sterile compounded parenteral nutrition from 9 to 17 days Home Parenteral Nutrition patients (HPN) as well as 503A Practicing Nutrition Support Clinicians (PNSC) are affected by USP797 guidelines which initially established a Beyond Use Dating (BUD) for sterile compounded parenteral nutrition (PN) HPN of 7 Days when stored at refrigerated temperature .
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Beyond Use Dating Pharmacy

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