Printed on: Wed Feb 08 2023, 11:07:33 PM(EST) Status: Currently Official on 09-Feb-2023 DocId: GUID-791408CB-A1C6-467E-AF5A-3EC16B43A9A6_2_en-US

Printed by: Dang Van Vu Official Date: Official as of 01-May-2022 Document Type: GENERAL CHAPTER @2023 USPC
Do Not Distribute DOI Ref: 2vyb0 DOI: https://doi.org/10.31003/USPNF_M16307_02_01
1

Chapter Guide: Drug Product Distribution

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Manufacturer
• á7ñ Labeling
• á87ñ Biological Reactivity Tests, In Vitro
• á88ñ Biological Reactivity Tests, In Vivo
• á381ñ Elastomeric Components in Injectable Pharmaceutical Product Packaging/Delivery Systems
• á382ñ Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems
• á659ñ Packaging and Storage Requirements
• á660ñ Containers—Glass
• á661ñ Plastic Packaging Systems and Their Materials of Construction
• á661.1ñ Plastic Materials of Construction
• á661.2ñ Plastic Packaging Systems for Pharmaceutical Use
• á670ñ Auxiliary Packaging Components
• á671ñ Containers—Performance Testing
• á698ñ Deliverable Volume
• á735ñ X-Ray Fluorescence Spectrometry

al
• á755ñ Minimum Fill
• á1079ñ Risks and Mitigation Strategies for the Storage and Transportation of Finished Drug Products
• á1079.1ñ Storage and Transportation of Investigational Drug Products
• á1079.2ñ Mean Kinetic Temperature in the Evaluation of Temperature Excursions During Storage and Transportation of
Drug Products ci
• á1118ñ Monitoring Devices—Time, Temperature, and Humidity
• á1151ñ Pharmaceutical Dosage Forms
• á1152ñ Animal Drugs for Use in Animal Feeds
• á1191ñ Stability Considerations in Dispensing Practice
• á1660ñ Evaluation of the Inner Surface Durability of Glass Containers
ffi
• á1661ñ Evaluation of Plastic Packaging Systems for Pharmaceutical Use and Their Materials of Construction
• á1663ñ Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems
• á1664ñ Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems
Shipper
• á659ñ Packaging and Storage Requirements
O

• á1079ñ Risks and Mitigation Strategies for the Storage and Transportation of Finished Drug Products
• á1079.2ñ Mean Kinetic Temperature in the Evaluation of Temperature Excursions During Storage and Transportation of
Drug Products
• á1118ñ Monitoring Devices—Time, Temperature, and Humidity
Wholesaler
• á659ñ Packaging and Storage Requirements
• á1079ñ Risks and Mitigation Strategies for the Storage and Transportation of Finished Drug Products
• á1079.2ñ Mean Kinetic Temperature in the Evaluation of Temperature Excursions During Storage and Transportation of
Drug Products
• á1118ñ Monitoring Devices—Time, Temperature, and Humidity
Sample Distribution
• á659ñ Packaging and Storage Requirements
• á1079ñ Risks and Mitigation Strategies for the Storage and Transportation of Finished Drug Products
• á1079.2ñ Mean Kinetic Temperature in the Evaluation of Temperature Excursions During Storage and Transportation of
Drug Products
• á1118ñ Monitoring Devices—Time, Temperature, and Humidity
Repackager
• á87ñ Biological Reactivity Tests, In Vitro
• á88ñ Biological Reactivity Tests, In Vivo
• á659ñ Packaging and Storage Requirements
• á660ñ Containers—Glass
• á661ñ Plastic Packaging Systems and Their Materials of Construction
• á661.1ñ Plastic Materials of Construction
• á661.2ñ Plastic Packaging Systems for Pharmaceutical Use
• á671ñ Containers—Performance Testing
• á698ñ Deliverable Volume

https://online.uspnf.com/uspnf/document/1_GUID-791408CB-A1C6-467E-AF5A-3EC16B43A9A6_2_en-US 1/2
Printed on: Wed Feb 08 2023, 11:07:33 PM(EST) Status: Currently Official on 09-Feb-2023 DocId: GUID-791408CB-A1C6-467E-AF5A-3EC16B43A9A6_2_en-US
Printed by: Dang Van Vu Official Date: Official as of 01-May-2022 Document Type: GENERAL CHAPTER @2023 USPC
Do Not Distribute DOI Ref: 2vyb0 DOI: https://doi.org/10.31003/USPNF_M16307_02_01
2

•á735ñ X-Ray Fluorescence Spectrometry

•á755ñ Minimum Fill
•á1066ñ Physical Environments That Promote Safe Medication Use
•á1079ñ Risks and Mitigation Strategies for the Storage and Transportation of Finished Drug Products
•á1079.2ñ Mean Kinetic Temperature in the Evaluation of Temperature Excursions During Storage and Transportation of
Drug Products
• á1118ñ Monitoring Devices—Time, Temperature, and Humidity
• á1178ñ Good Repackaging Practices
• á1660ñ Evaluation of the Inner Surface Durability of Glass Containers
• á1661ñ Evaluation of Plastic Packaging Systems for Pharmaceutical Use and Their Materials of Construction
Pharmacy
• á17ñ Prescription Container Labeling
• á87ñ Biological Reactivity Tests, In Vitro
• á88ñ Biological Reactivity Tests, In Vivo
• á381ñ Elastomeric Components in Injectable Pharmaceutical Product Packaging/Delivery Systems
• á659ñ Packaging and Storage Requirements
• á660ñ Containers—Glass
• á661ñ Plastic Packaging Systems and Their Materials of Construction
• á661.1ñ Plastic Materials of Construction
• á661.2ñ Plastic Packaging Systems for Pharmaceutical Use

al
• á671ñ Containers—Performance Testing
• á1066ñ Physical Environments That Promote Safe Medication Use
• á1079ñ Risks and Mitigation Strategies for the Storage and Transportation of Finished Drug Products
• á1079.2ñ Mean Kinetic Temperature in the Evaluation of Temperature Excursions During Storage and Transportation of
ci
Drug Products
• á1118ñ Monitoring Devices—Time, Temperature, and Humidity
• á1191ñ Stability Considerations in Dispensing Practice
• á1265ñ Written Prescription Drug Information—Guidelines
• á1660ñ Evaluation of the Inner Surface Durability of Glass Containers
ffi
• á1661ñ Evaluation of Plastic Packaging Systems for Pharmaceutical Use and Their Materials of Construction
Practitioner
• á659ñ Packaging and Storage Requirements
• á1066ñ Physical Environments That Promote Safe Medication Use
• á1079.2ñ Mean Kinetic Temperature in the Evaluation of Temperature Excursions During Storage and Transportation of
O

Drug Products
• á1152ñ Animal Drugs for Use in Animal Feeds
• á1191ñ Stability Considerations in Dispensing Practice

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