Compounding Today Newsletter

Our Compounding Knowledge, Your Peace of Mind

August 4, 2023 | Volume 20 | Issue 31

United States Pharmacopeia <101>, Part 4

Composition of the USP Pharmacists Pharmacopeia

We continue our journey at the 30,000 foot level by looking at the Table of Contents of the USP Pharmacists Pharmacopeia.

Following this introduction, we will look at more detail in the specific highlighted areas shown below in future issues of this Newsletter and how the information can be useful in practice, as well as listing all the official USP compounding formulas with validated beyond-use dates.

Section 1

Mission and Preface

General Notices and Requirements

Admissions and Annotated List of Changes

Section 2

<795>	Pharmaceutical Compounding-Nonsterile Preparations
<797>	Pharmaceutical Compounding-Sterile Preparations
<800>	Hazardous Drugs-Handling in Healthcare Settings
<825>	Radiopharmaceuticals- Preparation, Compounding, Dispensing, and Repackaging
<1160>	Pharmaceutical Calculations in Pharmacy Practice
<1163>	Quality Assurance in Pharmaceutical Compounding
<1168>	Compounding for Phase I Investigational Studies
<1176>	Prescription Balances and Volumetric Apparatus Used in Compounding

Section 3

<7>	Labeling
<31>	Volumetric Apparatus
<41>	Balances
<51>	Antimicrobial Effectiveness Testing
<61>	Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests
<62>	Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
<71>	Sterility Tests
<85>	Bacterial Endotoxins Test
<151>	Pyrogen Test
<381>	Elastomeric Components in Injectable Pharmaceutical Product Packaging/Delivery Systems
<659>	Packaging and Storage Requirements
<660>	Containers-Glass
<661>	Plastic Packaging Systems and Their Materials of Construction
<661.1>	Plastic Materials of Construction
<661.2>	Plastic Packaging Systems for Pharmaceutical Use
<671>	Containers-Performance Testing
<731>	Loss on Drying
<785>	Osmolality and Osmolarity
<821>	Radioactivity
<823>	Positron Emission Tomography Drugs for Compounding, Investigational, and Research Uses
<1066>	Physical Environments That Promote Safe Medication Use
<1072>	Disinfectants and Antiseptics
<1079>	Risks and Mitigation Strategies for the Storage and Transportation of Finished Drug Products
<1079.1>	Storage and Transportation of Investigational Drug Products
<1079.2>	Mean Kinetic Temperature in the Evaluation of Temperature Excursions During Storage and Transportation of Drug Products
<1111>	Microbiological Examination of Nonsterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use
<1112>	Application of Water Activity Determination to Nonsterile Pharmaceutical Products
<1113>	Microbial Characterization, Identification, and Strain Typing
<1116>	Microbiological Control and Monitoring of Aseptic Processing Environments
<1149>	Guidelines for Assessing and Controlling the Physical Stability of Chemical and Biological Pharmaceutical Raw Materials, Intermediates, and Dosage Forms
<1151>	Pharmaceutical Dosage Form
<1178>	Good Repackaging Practices
<1191>	Stability Considerations in Dispensing Practice
<1211>	Sterility Assurance
<1228>	Depyrogenation
<1228.1>	Dry Heat Depyrogenation
<1228.5>	Endotoxin Indicators for Depyrogenation
<1229>	Steam Sterilization by Direct Contact
<1229.2>	Moist Heat Sterilization of Aqueous Liquids
<1229.4>	Sterilizing Filtration of Liquids
<1229.5>	Biological Indicators for Sterilization
<1229.8>	Dry Heat Sterilization
<1231>	Water for Pharmaceutical Purposes
<1251>	Weighing on an Analytical Balance
<1265>	Written Prescription Drug Information-Guideline
<1821>	Radioactivity-Theory and Practice

Next week, we will list Section 4 "Table of Contents" of the USP Pharmacists Pharmacopeia, to include the Official Monographs.

Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition

Did You Know (On Advertising) ...

...the following?

"Advertising may be described as the science of arresting the human mind long enough to get money from it." (Stephen Leacock)

Looking Back (On Committees)

"If you want to kill any idea, get a committee working on it." (C.F. Kettering)

Latest Issue of IJPC Available

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From Out of the Past

O, no!
She said
To her bristly beau
I'd rather
Eat the mistletoe!"
Burma-Shave

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