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An official dosage form is required to bear on its label an expiration date assigned for the particular formulation and package of the article. This date limits the time during which the product may be dispensed or used. Because the expiration date stated on the manufacturer's or distributor's package has been determined for the drug in that particular package and is not intended to be applicable to the product where it has been repackaged in a different container, repackaged drugs dispensed pursuant to a prescription are exempt from this expiration date labeling requirement. It is necessary, therefore, that other precautions be taken by the dispenser to preserve the strength, quality, and purity of drugs that are repackaged for ultimate distribution or sale to patients.
The following guidelines and requirements are applicable where official dosage forms are repackaged into single-unit or unit-dose containers or mnemonic packs for dispensing pursuant to prescription.
Labeling— It is the responsibility of the dispenser, taking into account the nature of the drug repackaged, any packaging and beyond-use 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 beyond-use date on the label. Repackaged dosage forms must bear on their labels beyond-use dates as determined from information in the product labeling. Each single-unit or unit-dose container bears a separate label, unless the device holding the unit-dose form does not allow for the removal or separation of the intact single-unit or unit-dose container therefrom.
Storage— Store the repackaged article in a humidity-controlled environment and at the temperature specified in the individual monograph or in the product labeling. 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 75% at 23 are not to be exceeded during repackaging or storage.
A refrigerator or freezer shall not be considered to be a humidity-controlled environment, and drugs that are to be stored at a cold temperature in a refrigerator or freezer shall be placed within an outer container that meets the monograph requirements for the drug contained therein.
Reprocessing— 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 beyond-use date is maintained.