Mini bag plus expiration dating
Single-dose vials continuously exposed to ISO Class 5 or cleaner air may be used up to six hours after initial needle puncture.
Opened single-dose ampuls shall not be stored for any time period., when possible.
It has since been adopted by some pharmacy regulatory and accrediting bodies, especially some U. state boards of pharmacy, and the Joint Commission on Accreditation of Health Care Organizations, JCAHO. The process to create or revise USP content, which includes opportunity for public involvement, is described in the front pages of each bimonthly issue of USP’s official journal, Pharmacopeial Forum, PF.
The SCC met October 13-14, 2004, during and within five weeks following which it approved the proposed revisions to that are summarized here.
The revisions to proposed by the SCC during and following the October 13-14, 2004 SCC meeting are condensed in Table 1 (content that is not in in USP 27 and USP 28) and Table 2.
Despite receipt of several external comments referring to a 30-day CDC limit, a careful search of CDC documents by SCC members did not locate any specific time limit].
The next official will appear either in an annual USP revision, e.g., USP 29 in 2006, or in one of the two semiannual supplements to each annual USP revision.
The earliest possibility, but an unlikely probability, would be Supplement 2 to USP 28 in late 2005.
[This exemption has been honored by the JCAHO in 2004].
The storage and beyond use times for attached and activated (closures punctured allowing contact of contents) of these proprietary packaging systems of drug products for intravascular administration (e.g., ADD-Vantage® and Mini-Bag Plus®) are those stated in the FDA-approved labeling of their manufacturers.), and any remaining contents must be discarded.