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Posted by / 06-Aug-2017 22:15

Dating of multi use containers

Unit-of-use packaging intended for institutional or hospital use may or may not be required to be child-resistant.

Unit-of-use containers that are child-resistant single-unit containers include supported blisters, such as separate, peel, push, and tear notch, and enclosed or in-card blisters, such as pull tabs and slide packs.

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.

However, if the beyond-use-date is different than the assumed 28 days, a discard statement should be included on the container and carton labeling and in the prescribing information.

Examples of discard statements for multiple-dose containers include: According to the draft guidance, FDA is recommending that necessary labeling changes are made within two years of the publication of the final guidance.

Unit-of-use packaging, when provided by the manufacturer, offers some of the following attractive advantages.

(1) A dosage form can be dispensed to a patient in the manufacturer's original container, a practice that recognizes that the suitability of the container has been established on the basis of the manufacturer's stability studies.

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Nonreclosables may include packs such as cold-formed foil blisters, foil strip packs, and PVC/Aclar combining multilayer materials that are thermo-formed or cold-formed foil blisters (see).

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