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14‑DAY TRIAL    FORMULATIONS    MY ACCOUNT 
Compounding This Week Newsletter from www.CompoundingToday.com
Brought to you by IJPC
Our Compounding Knowledge, Your Peace of Mind
February 23, 2024  |  Volume 21  |  Issue 2
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United States Pharmacopoeia 101, Part 13

In previous editions of this Newsletter on the topic of the United States Pharmacopoeia 101 we presented the Table of Contents, General Notices, and Reference Tables contained in the USP. In this issue, we will summarize the content and organization of the USP Compounding Compendium. In the next edition of this Newsletter, we will list other products and services provided by the USP organization for preparing drug products.

The USP Compounding Compendium is divided into 4 Sections, as follows.

SECTION 1Mission and Preface/General Notices/Admissions and Annotated List
SECTION 2Compounding Related General Chapters
SECTION 3Supporting General Chapters
SECTION 4Compounded Preparation Monographs
USP Guide to General Chapters
<1>Injections and Implanted Drug Products (Parenteral)-Product Quality Tests
<2>Oral Drug Products-Product Quality Tests
<3>Topical and Transdermal Drug Products-Product Quality Tests
<4>Mucosal Drug Products-Product Quality Tests
<7>Labeling
<17>Prescription Container Labeling
<31>Volumetric Apparatus
<41>Balances
<51>Antimicrobial Effectiveness Testing
<55>Biological Indicators-Resistance Performance Tests
<61>Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests
<62>Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
<63>Mycoplasma Tests
<71>Sterility Tests
<151>Pyrogen Tests
<381>Elastomeric Closures for Injections
<601>Inhalation and Nasal Drug Products: Aerosols, Sprays and Powders-Performance Quality Tests
<616>Bulk Density and Tapped Density of Powders.
<651>Congealing Temperature
<659>Packaging and Storage Requirements
<697>Container Content for Injections
<698>Deliverable Volume
<731>Loss on Drying
<741>Melting Range or Temperature
<755>Minimum Fill
<785>Osmolality and Osmolarity
<788>Particulate Matter in Injections
<789>Particulate Matter in Ophthalmic Solutions
<790>Visible Particulates in Injections
<795>Pharmaceutical Compounding-Nonsterile Preparations
<797>Pharmaceutical Compounding-Sterile Preparations
<800>Hazardous Drugs-Handling in Healthcare Settings
<821>Radioactivity
<823>Positron Emission Tomography Drugs for Compounding, Investigational, and Research uses
  1. Introduction
  2. Personnel Training
  3. Quality Assurance
  4. Facilities and equipment
  5. 4.1 Environmental Controls for Parenteral PET Drug Products
  6. 4.2 Equipment
  7. 4.3 Cleaning Equipment and Components
  8. 4.4 Day-of-Use Checks
  9. 4.5 System Suitability for QC Equipment
  10. 5. Control of Components, Material and Supplies
  11. 6. Process and Operational Controls
  12. 6.1 Process Controls
  13. 6.2 Operational Controls
  14. 6.3 Aseptic Operations for Parenteral PET Drug Products
    1. Components
      1. PET Drug Product Vial Assembly
      2. Aseptic techniques
      3. Sterility test Inoculations
  15. 7. Stability
  16. 8. Controls and Acceptance Criteria for Finished PET Drug Products
<841>Specific Gravity
<905>Uniformity of Dosage Units



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

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Did You Know ...

Lawmakers are concerned about US reliance on foreign drug firms.

During a recent House hearing on chronic drug shortages in the US, lawmakers raised concerns over a recent report that found the US imports over 80% of its active pharmaceutical ingredients from foreign companies, primarily in China and India. To become less reliant on foreign companies, experts recommended that Congress offer drugmakers financial incentives to return to the US, enter longer-term manufacturing deals, keep larger stores of medicine, and contribute to a government stockpile.

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