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Printed by: Dang Van Vu Official Date: Official as of 01-Dec-2020 Document Type: GENERAL CHAPTER @2023 USPC
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á1178ñ GOOD REPACKAGING PRACTICES

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
1. the principal information provided in the USP general information chapters Plastic Packaging Systems and Their Materials
of Construction á661ñ, Plastic Materials of Construction á661.1ñ, and Plastic Packaging Systems for Pharmaceutical Use á661.2ñ
and
2. other beyond-use date references in Labeling á7ñ, Expiration Date and Beyond Use Date.

ESTABLISHING EXPIRATION DATE

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

Unit-Dose Packaging

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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 á671ñ
for either Class A or Class B containers.
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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 Packaging and Storage Requirements á659ñ.
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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.
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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 Packaging and Storage Requirements á659ñ. 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

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Printed on: Wed Feb 08 2023, 11:04:58 PM(EST) Status: Currently Official on 09-Feb-2023 DocId: GUID-0381AAEC-2353-46FC-8A5C-DE056B930ECC_5_en-US
Printed by: Dang Van Vu Official Date: Official as of 01-Dec-2020 Document Type: GENERAL CHAPTER @2023 USPC
Do Not Distribute DOI Ref: lzf63 DOI: https://doi.org/10.31003/USPNF_M523_05_01
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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.

Change to read:
REFERENCES FOR REPACKAGING REGULATIONS AND GUIDANCES

The references listed below are not meant to be all inclusive: specific repackaging operations may have additional
requirements.
• Food, Drug, and Cosmetic Act
• Food and Drug Administration Regulations and Guidances
Enforcement Policy: 21 CFR, Part 7
General Labeling Provisions: 21 CFR, Part 201, Subpart A
Drug Establishment Registration and Listing: 21 CFR, Part 207.20
Current Good Manufacturing Regulations: 21 CFR, Parts 210–211
Special Requirements for Specific Human Drugs: 21 CFR, Part 250
Controlled Substances: 21 CFR, Part 1300

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Potable Water: 40 CFR, Part 141
FDA Compliance Policy Guides, including the following:
Sub Chapter 430 Labeling and Repackaging
Sub Chapter 460 Pharmacy Issues
Sub Chapter 480 Stability/Expiration Dating
• Applicable USP Chapters
á660ñ Containers—Glass
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á661ñ Plastic Packaging Systems and Their Materials of Construction
á661.1ñ Plastic Materials of Construction
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á661.2ñ Plastic Packaging Systems for Pharmaceutical Use
á671ñ Containers—Performance Testing
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á1079ñ Risks and Mitigation Strategies for the Storage and Transportation of Finished Drug Products▲ (CN 1-Dec-2020)

GLOSSARY
á659ñ Packaging and Storage Requirements provides definitions related to repackaging. For the purposes of this chapter, a
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repackager, a contract packager, and an equivalent container–closure system are defined as follows:
Repackager: A repackager is an establishment that repackages drugs and sends them to a second location in anticipation
of a need. Repackaging firms repackage preparations for distribution (e.g., for resale to distributors, hospitals, or other
pharmacies), a function that is beyond the regular practice of a pharmacy. Distribution is not patient-specific in that there are
no prescriptions. Unlike dispensers, repackaging firms are required to register with the FDA and to comply with the Current
Good Manufacturing Practice Regulations in 21 CFR 210 and 211.
Contract packager: A contract packager is an establishment that is contracted to package or repackage a drug product
into a single- or multi-unit container. These containers should meet all of the applicable requirements in this chapter. A contract
packager does not take ownership from the manufacturer and generally receives the assigned expiration date from the
contractor.
Equivalent container–closure system: This term refers to a container–closure system that is 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. These values may be determined by the repackager, or they may be obtained from the container–
closure vendor for the specific container–closure system under consideration.

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