What factors should be considered when assigning a beyond use date?
What factors should be considered when assigning a beyond use date?
How the Beyond-Use Date Is Determined
- The type of drug and how fast it degrades.
- The dosage of the medication1
- The type of container being used.
- The storage conditions the medication is expected to be in1
- How long the medication will be taken.
What is the date when revised 797 is official?
June 1, 2019
Reason for Revision The currently official <797>, last revised in 2008, remains official. On June 1, 2019, USP published revisions to General Chapter <795> for nonsterile compounding and General Chapter <797> for sterile compounding, as well as a new General Chapter <825> for radiopharmaceuticals.
How do you calculate beyond use date?
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.
How do you identify BUDs?
The BUD is determined from the date the CNSP is compounded. When determining BUD, the pharmacist must take into account stability information regarding the specific drug(s) and specific CNSP. Stability information may come from documentation, literature or stability tests.
What is the main purpose of USP 797?
The purpose of USP Chapter <797> Pharmaceutical Compounding is to provide standards for the protection and safety of patients and healthcare workers involved in sterile compounding preparations such as pharmacists, nurses, physicians and pharmacy technicians by reducing the potential for microbial contamination caused …
What is the maximum beyond use date?
Keywords: beyond use dating, BUD, stability, sterile compounding, USP <797> Beyond use date (BUD) is the date after which a compounded preparation shall not be used, and it is set based on the date on which the preparation was compounded.
What is the immediate-use provision in USP <797>?
The immediate-use provision allows for the preparation and dispensing of compounded sterile products (CSPs) without the need to be in compliance with USP <797> requirements such as ISO Class 5 hood or isolator, facility design, environmental controls, personnel cleansing and garbing.
What are the USP 797 guidelines?
USP 797 Guidelines & Standards. The objective of the USP 797 Guidelines is to describe conditions and practices to prevent harm, including death, to patients resulting from a contaminated or improperly made compounded sterile preparations (CSPs). USP 797 provides minimum practice and quality standards for CSPs of drugs and nutrients,…
What is USP Chapter 797?
USP Chapter <797> is a set of enforceable sterile compounding standards issued by the United States Pharmacopeia (USP) that set the standards that apply to all settings in which sterile preparations are compounded. 7.
