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Professional judgment by the compounding pharmacist(s) and adherence to specific standards and guidelines set by the Joint Commission on Accreditation of Healthcare Organizations; United States Pharmacopeial Convention, Inc.; and American Society of Health-System Pharmacists help to ensure that such medications retain their expected potency and are properly labeled, stored, and administered. Clifford Gevirtz, MD, is employed by RAA of New York and practices anesthesiology throughout New York and Long Island, N. Since most ASCs do not have an isolator or glove box for this procedure, I advocate following USP 797, and consider those pre-drawn syringes an immediate-use compounded sterile preparation, and suggest a one-hour beyond use dating. Does USP 797 apply in these situations if they are not IV admixtures but are, for example, injectable local anesthetics which are not given intravenously? Clifford Gevirtz: Yes, I think you (the consulting pharmacist) are going a bit far in your interpretation.
Beyond-use dates for CSPs that lack justification from either appropriate literature sources or by direct testing evidence must be assigned as described in the section In addition, the pharmacist may refer to applicable publications to obtain relevant stability, compatibility, and degradation information regarding the drug or its congeners.
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.
When assigning a beyond-use date, pharmacists should consult and apply drug-specific and general stability documentation and literature where available, and they should consider the nature of drug and its degradation mechanism, the container in which it is packaged, the expected storage conditions, and the intended duration of therapy (see ).
Stability information must be carefully interpreted in relation to the actual compounded formulation and conditions for storage and use.