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Until things are sorted out, you’re better off going with six hours.
While I do not agree with treating a stock bag as a single-dose container, it is wise to follow current best practice when it comes to the board of pharmacy.
The BUD after initially entering or opening (e.g., needle-punctured) multiple-dose containers is 28 days unless otherwise specified by the manufacturer.” Is a stock bag a single dose container or something else? However, some state boards have taken to treating stock bags as single dose containers, forcing pharmacies to discard unused portions within 6 hours of compounding.
Should a stock bag really be considered a single dose container? Without being specifically addressed in writing, state boards can pretty much do as they please.
BUDs are best assigned on the basis of direct testing or extrapolation from reliable literature sources and other documentation (see Stability Criteria and Beyond-Use Dating under Pharmaceutical Compounding-Nonsterile Preparations ) or, if not available using the default dates provided in the chapters.
Please use the submission template when sending your comments to Compounding [email protected]
It’s beyond me how the state board can interpret a stock bag differently from any other low-risk or medium-risk level CSP, but they are.
At least that’s how things are in California at the moment. Does that still count if one uses a CSTD or other port that prevents re-entry via the stopper?
Opened or needle-punctured single-dose containers, such as bags, bottles, syringes, and vials of sterile products and CSPs shall be used within 1 hour if opened in worse than ISO Class 5 air quality, and any remaining contents must be discarded.
Single-dose vials exposed to ISO Class 5 or cleaner air may be used up to 6 hours after initial needle puncture.
Type of Posting: Notice of Intent to Revise Posting Date: 25–Sept–2015 Expert Committee: Compounding In accordance with section 7.05(c) of the Rules and Procedures of the Council of Experts, this is to provide notice that the Compounding Expert Committee intends to propose several revisions to General Chapter Pharmaceutical Compounding—Sterile Preparations.