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Where no temperature or humidity is specified in the monograph or in the labeling of the product, controlled room temperature and a relative humidity corresponding to 60% are not to be exceeded during repackaging or storage.
A refrigerator or freezer shall not be considered to be a humidity-controlled environment.
However, this article is not a substitute for reading the chapter and implementing it in your pharmacy practice as applicable.
Notable Changes reintroduces the definition of what it means to have variability in strength.
Drugs that are to be stored at a cold temperature in a refrigerator or freezer must be protected during storage in the refrigerator or freezer.
Acceptable variability in strength in the new It is important to consider how each step of the compounding process affects the final potency and to have standard operating procedures addressing the use of certificates of analysis, base/salt conversions, minimum accurately weighable quantity for your balance, specificity in mixing instructions and many other factors.
Reprocessing of repackaged unit-dose containers (i.e., removing dosage unit from one unit-dose container and placing dosage unit into another unit-dose container) shall not be done.
However, reprocessing of the secondary package (e.g., removing the blister card from the cardboard carrier and placing the blister card into another cardboard carrier) is allowed provided that the original expiration date is maintained.
Alternatively, such required information may be incorporated into a single, overall educational insert provided by the pharmacist for the total patient med pak.
In the absence of more stringent packaging requirements for any of the drug products contained therein, each container of the patient med pak shall comply with the moisture permeation requirements for a Class B single-unit or unit-dose container (see It is the responsibility of the dispenser, when preparing a patient med pak, to take into account any applicable compendial requirements or guidelines and the physical and chemical compatibility of the dosage forms placed within each container, as well as any therapeutic incompatibilities that may attend the simultaneous administration of the medications.It is the responsibility of the dispenser, taking into account the nature of the drug repackaged, any packaging and expiration dating information in the manufacturer's product labeling, the characteristics of the containers, and the storage conditions to which the article may be subjected, to place a suitable expiration date on the label.