Dating of multi use containers
Because drugs packaged in unit-of-use packaging are intended to be dispensed to the consumer without repackaging by the pharmacist, the manufacturer or repackager is responsible for the special packaging of PPPA-regulated substances in unit-of-use containers (l.1).Unit-of-use containers are required to be child-resistant if they are intended to be dispensed directly to the patient pursuant to a prescription.However, unit-of-use repackagers should conform to all requirements as presented in .There are a number of reasons why repackagers produce unit-of-use packaging: for example, (1) requests from institutions, (2) better inventory control, (3) reduced dispensing times, and (4) variations in some drug therapies.According to the guidance, “applicants should determine the proper package type term (‘single-dose,’ ‘multiple-dose,’ or ‘single-patient-use’) for injectable medical products for human use.” In order to allow users to easily identify the package type, the Agency also states that applicants should provide the appropriate package type term on all components of the product’s label, which includes the container label, carton label, and prescribing information (where applicable).The guidance states that the term “single-dose” should be included on the labels of all single-dose products that have a United States Pharmacopeia (USP) monograph.
Unit-of-use packaging, when provided by repackagers, offers the same attractive advantages as those offered by the manufacturer.
(2) The counting and repackaging of dosage units in the pharmacy is eliminated, thereby reducing the possibility of human error.
(3) The pharmacist is able to affix the label for the patient onto the unit-of-use package and is free to use the manufacturer's expiration date as the beyond-use date.
Each single-unit container shall be labeled to indicate the identity, quantity, and/or strength, name of the manufacturer, lot number, and expiration date of the article.
Packaging fabrication materials include substances used to manufacture packaging containers such as glass, plastics (including high-density polyethylene (HDPE), low-density polyethylene (LDPE), polyethylene terephthalate, polyethylene terephthalate G and polypropylene (PP), other resins, and other materials as listed in the general test chapter Nonreclosables are containers with closures that are nonreclosable, such as blisters, sachets, strips, and other single-unit containers.