681 REPACKAGING INTO SINGLE-UNIT CONTAINERS AND UNIT-DOSE CONTAINERS FOR NONSTERILE SOLID AND LIQUID DOSAGE FORMS
This chapter is intended to provide guidance to those engaged in pharmaceutical dispensing, not commercial repackaging. 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 original manufacturer's containerclosure system has been determined for the drug in that particular system 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 using the expiration date from the original manufacturer's package. However, under no circumstance should the repackaged pharmaceutical preparation's expiration date exceed the original manufacturer's expiration date. 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 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. Repackaged dosage forms must bear on their labels expiration dates as determined from information in the product labeling (see Preservation, Packaging, Storage, and Labeling section of the General Notices and Requirements). 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 60% are not to be exceeded during repackaging or storage.
A refrigerator or freezer shall not be considered to be a humidity-controlled environment. 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. An outer container may be necessary for such protection; it is recommended that the drug monograph be referenced for storage.
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 expiration date is maintained.
CUSTOMIZED PATIENT MEDICATION PACKAGES
In lieu of dispensing two or more prescribed drug products in separate containers, a pharmacist may, with the consent of the patient, the patient's caregiver, or a prescriber, provide a customized patient medication package (patient med pak).1
A patient med pak is a package prepared by a pharmacist for a specific patient comprising a series of containers and containing two or more prescribed solid oral dosage forms. The patient med pak is so designed or each container is so labeled as to indicate the day and time, or period of time, that the contents within each container are to be taken.
It is the responsibility of the dispenser to instruct the patient or caregiver on the use of the patient med pak.
Label The patient med pak shall bear a label stating:
If the patient med pak allows for the removal or separation of the intact containers therefrom, each individual container shall bear a label identifying each of the drug products contained therein.
Labeling The patient med pak shall be accompanied by a patient package insert, in the event that any medication therein is required to be dispensed with such insert as accompanying labeling. Alternatively, such required information may be incorporated into a single, overall educational insert provided by the pharmacist for the total patient med pak.
Packaging 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 ContainersPerformance Testing 671). Each container shall be either not reclosable or so designed as to show evidence of having been opened.
Guidelines 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. In this regard, pharmacists are encouraged to report to USP headquarters any observed or reported incompatibilities. Once a medication has been placed in a patient med pak with another solid dosage form, it may not be returned to stock, redistributed, or resold if unused.
Recordkeeping In addition to any individual prescription filing requirements, a record of each patient med pak shall be made and filed. Each record shall contain, as a minimum:
1 It should be noted that there is no special exemption for patient med paks from the requirements of the Poison Prevention Packaging Act. Thus the patient med pak, if it does not meet child-resistant standards, shall be placed in an outer package that does comply, or the necessary consent of the purchaser or physician, to dispense in a container not intended to be child-resistant, shall be obtained.
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USP35NF30 Page 285Pharmacopeial Forum: Volume No. 32(4) Page 1197