This chapter is intended to provide guidance to those engaged in repackaging of oral solid drug products; and the chapter provides information to any person who removes drugs from their original container–closure system (new primary package) and repackages them into a different container–closure system for sale and/or for distribution.

This chapter does not apply to pharmacists engaged in dispensing prescription drugs in accordance with state practice of pharmacy. The pharmacist needs to apply

The section Preservation, Packaging, Storage, and Labeling under General Notices and Requirements provides definitions related to repackaging. For the purposes of this chapter, a repackager, a contract packager, and an equivalent container–closure system are defined as follows:

In the absence of stability data, the following criteria should be considered by repackagers when assigning an expiration date.

Unit-Dose Packaging

1. The original container–closure system of the drug product to be used for repackaging must be received un-opened and show no outward signs of having been previously opened.
2. The unit-dose container–closure system must meet the testing requirements under Containers—Performance Testing 671 for either Class A or Class B containers.
3. The contents of the original bulk drug product to be repackaged are repackaged at one time unless the repackager has data and/or other scientific information from literature sources demonstrating that the drug product is not sensitive to exposure to moisture, oxygen, or light.
4. The unit-dose container–closure system must meet or exceed the original container's specification for light resistance.
5. The conditions of storage must meet the storage specifications provided in the USP General Notices and as described in the labeling of the original container–closure system received for repackaging. Where no specific storage conditions are specified, the product must be maintained at controlled room temperature and in a dry place during the repackaging process, including storage.
6. The expiration dating period used for the repackaged product does not exceed (1) 6 months from the date of repackaging; or (2) the manufacturer's expiration date; or (3) 25% of the time between the date of repackaging and the expiration date shown on the manufacturer's bulk article container of the drug being repackaged, whichever is earlier.
7. Nitroglycerin Sublingual Tablets or any other drug product known to have stability problems should not be repackaged. This would include any drug known to be oxygen-sensitive or one that exhibits extreme moisture or light sensitivity. In deciding whether a particular drug product is suitable for repackaging, the repackager should take into consideration any available information from the manufacturer, published literature, the USP, and the FDA.
8. Documentation must be maintained to demonstrate that the preceding criteria are met.
9. Documentation must be maintained that specifies the container–closure packaging material used in repackaging operations.

Multiple-Unit Packaging

1. A repackager may use the manufacturer's original expiration date without additional stability testing if the drug product is repackaged into an equivalent container–closure system that is at least as protective as, or more protective than, the original system and complies with criteria established for equivalency.
2. The original container–closure system of the drug product to be used for repackaging must be received un-opened and shows no outward signs of having been previously opened.
3. The contents of the original bulk drug product to be repackaged are repackaged at one time unless the repackager has data and/or other scientific information from literature sources demonstrating that the drug product is not sensitive to exposure to moisture, oxygen, or light.
4. The conditions of storage meet the storage specifications in the General Notices and as described in the labeling of the original container–closure system received for repackaging. When no specific storage conditions are specified, the product should be maintained at controlled room temperature and in a dry place during repackaging operations.
5. The type of container–closure system used for repackaging must be at least as protective or more protective than the original container–closure system in terms of moisture vapor transmission rate (MVTR), oxygen transmission, light transmission, and compatibility of the container–closure system with the drug product. System equivalency extends to any special protective materials, such as for light transmission, seals, or desiccants associated with the original container–closure system.
6. The container–closure system must meet or exceed the original container–closure system's results for light transmission.
7. Nitroglycerin Sublingual Tablets or any other drug product known to have stability problems should not be repackaged. This would include any drug known to be oxygen-sensitive or one that exhibits extreme moisture or light sensitivity. In deciding whether a particular drug product is suitable for repackaging, the repackager should take into consideration any available information from the manufacturer, published literature, the USP, and the FDA.
8. Documentation must be maintained to demonstrate that the preceding criteria are met.
9. Documentation must be maintained that specifies the container–closure packaging material used in repackaging operations.

The references listed below are not meant to be all inclusive: specific repackaging operations may have additional requirements.