incorporates General Chapter <1>, the provision regarding inclusion of a slight volume exceeding the labeled volume is a mandatory requirement; for injectable products without a USP monograph that incorporates General Chapter <1>, compliance with the slight excess volume provision is strongly recommended...
Periodic assessment of fill weights should also be conducted during aseptic filling to ensure that the required volume per container meets specifications, according to Adams. This information provides continuous feedback that the line is functioning as intended. During media fills (APS), microbiological...
By compounding in an individualized per-patient manner, limiting the amount of compounding performed in advance of prescription receipt, and limiting the volume of prescriptions dispensed across state lines, these pharmacies are exempt from certain provisions of the Food, Drug, and Cosmetic Act. ...