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PF 44(5) Table of Contents Publish date: September 7, 2018

PROPOSED IRA

Proposed Interim Revision Announcements

NF MONOGRAPHS

Medium-Chain Triglycerides (1-Mar-2019)

IN-PROCESS REVISION

In-Process Revision

GENERAL CHAPTERS

<3> Topical and Transdermal Drug Products - Product Quality Tests (USP42-NF37 2S)
<60> Microbiological Examination of Nonsterile Products - Tests for Burkholderia Cepacia Complex [NEW] (USP42-NF37 2S)
<81> Antibiotics - Microbial Assays (USP42-NF37 2S)
<601> Inhalation and Nasal Drug Products - Aerosols, Sprays, and Powders - Performance Quality Tests (USP42-NF37 2S)
<771> Opthalmic Products - Quality Tests (USP42-NF37 2S)
<785> Osmolality and Osmolarity (USP42-NF37 2S)
<797> Pharmaceutical Compounding - Sterile Preparations (USP42-NF37 2S)
TABLE OF CONTENTS
INTRODUCTION
ORGANIZATION OF THIS CHAPTER
RESPONSIBILITY OF COMPOUNDING PERSONNEL
CSP MICROBIAL CONTAMINATION RISK LEVELS
PERSONNEL TRAINING AND EVALUATION IN ASEPTIC MANIPULATION SKILLS
IMMEDIATE-USE CSPs
SINGLE-DOSE AND MULTIPLE-DOSE CONTAINERS
HAZARDOUS DRUGS AS CSPs
RADIOPHARMACEUTICALS AS CSPs
ALLERGEN EXTRACTS AS CSPs
VERIFICATION OF COMPOUNDING ACCURACY AND STERILITY
ENVIRONMENTAL QUALITY AND CONTROL
SUGGESTED STANDARD OPERATING PROCEDURES (SOPs)
ELEMENTS OF QUALITY CONTROL
VERIFICATION OF AUTOMATED COMPOUNDING DEVICES (ACDs) FOR PARENTERAL NUTRITION COMPOUNDING
FINISHED PREPARATION RELEASE CHECKS AND TESTS
STORAGE AND BEYOND-USE DATING
MAINTAINING STERILITY, PURITY, AND STABILITY OF DISPENSED AND DISTRIBUTED CSPs
PATIENT OR CAREGIVER TRAINING
PATIENT MONITORING AND ADVERSE EVENTS REPORTING
QUALITY ASSURANCE (QA) PROGRAM
ABBREVIATIONS AND ACRONYMS
GLOSSARY
APPENDICES
1. INTRODUCTION AND SCOPE
2.PERSONNEL QUALIFICATIONS--TRAINING, EVALUATION, AND REQUALIFICATION
3.PERSONAL HYGIENE AND GARBING
4.FACILITIES AND ENGINEERING CONTROLS
5. MICROBIOLOGICAL AIR AND SURFACE MONITORING
6. CLEANING AND DISINFECTING COMPOUNDING AREAS
7. EQUIPMENT, SUPPLIES, AND COMPONENTS
8. STERILIZATION AND DEPYROGENATION
9. SOPs AND MASTER FORMULATION AND COMPOUNDING RECORDS
10. RELEASE TESTING
11. LABELING
12. ESTABLISHING BEYOND-USE DATES
13. USE OF CONVENTIONALLY MANUFACTURED PRODUCTS
14. USE OF CSPs AS COMPONENTS
15. QUALITY ASSURANCE AND QUALITY CONTROL
16. CSP STORAGE, HANDLING, PACKAGING, SHIPPING, AND TRANSPORT
17. DOCUMENTATION
18. COMPOUNDING ALLERGENIC EXTRACTS
GLOSSARY
APPENDICES
<825> Radiopharmaceuticals - Preparation, Compounding, Dispensing, and Repackaging [NEW] (USP42-NF37 2S)
<856> Near-Infrared Spectroscopy [NEW] (USP42-NF37 2S)
<857> Ultraviolet-Visible Spectroscopy (USP42-NF37 2S)
<1010> Analytical Data - Interpretation and Treatment (USP42-NF37 2S)
<1071> Rapid Sterility Testing of Short-Life Products - A Risk Based Approach [NEW] (USP42-NF37 2S)
<1103> Immunological Test Methods - Enzyme-Linked Immunosorbent Assay (ELISA) (USP42-NF37 2S)
<1119> Near-Infrared Spectroscopy (USP42-NF37 2S)
<1136> Packaging and Repackaging - Single-Unit Containers (USP42-NF37 2S)
<1177> Good Packaging Practices (USP42-NF37 2S)
<1227> Validation of Microbial Recovery From Pharmacopeial Articles (USP42-NF37 2S)
<1229.16> Prion Sterilization [NEW] (USP42-NF37 2S)
<1236> Solubility Measurements [NEW] (USP42-NF37 2S)
<1711> Oral Solid Dosage Forms - Dissolution Testing [NEW] (USP42-NF37 2S)

REAGENTS, INDICATORS, AND SOLUTIONS
Reagent Specifications
Aluminum Chloride Hexahydrate [NEW] (USP42-NF37 2S)

Indicators
Eriochrome Black T (USP42-NF37 2S)

REFERENCE TABLES
Container Specifications
Container Specifications [NEW] (USP42-NF37 2S)

Description and Solubility
Description and Relative Solubility of USP and NF Articles (USP42-NF37 2S)
Description and Solubility - G

USP MONOGRAPHS

Abacavir, Lamivudine and Zidovudine Tablets [NEW] (USP42-NF37 2S)
Arginine (USP42-NF37 2S)
Arginine Hydrochloride (USP42-NF37 2S)
Arginine Hydrochloride Compounded Oral Solution [NEW] (USP42-NF37 2S)
Astemizole (USP42-NF37 2S)
Astemizole Tablets (USP42-NF37 2S)
Atovaquone and Proguanil Hydrochloride Tablets [NEW] (USP42-NF37 2S)
Atropine Sulfate Tablets (USP42-NF37 2S)
Azatadine Maleate (USP42-NF37 2S)
Azithromycin for Oral Suspension (USP42-NF37 2S)
Baclofen Injection [NEW] (USP42-NF37 2S)
Bisoprolol Fumarate (USP42-NF37 2S)
Bisoprolol Fumarate Tablets (USP42-NF37 2S)
Cetylpyridinium Chloride (USP42-NF37 2S)
Chlorambucil Compounded Oral Suspension [NEW] (USP42-NF37 2S)
Chloramphenicol Compounded Oral Suspension, Veterinary [NEW] (USP42-NF37 2S)
Chlordiazepoxide (USP42-NF37 2S)
Chlordiazepoxide Hydrochloride (USP42-NF37 2S)
Clonidine Hydrochloride Compounded Oral Suspension [NEW] (USP42-NF37 2S)
Clozapine (USP42-NF37 2S)
Clozapine Tablets (USP42-NF37 2S)
Dehydrocholic Acid Tablets (USP42-NF37 2S)
Demeclocycline (USP42-NF37 2S)
Demeclocycline Oral Suspension (USP42-NF37 2S)
Demeclocycline Hydrochloride Capsules (USP42-NF37 2S)
Deslanoside (USP42-NF37 2S)
Desmopressin Acetate (USP42-NF37 2S)
Dexamethasone Acetate Injectable Suspension (USP42-NF37 2S)
Dexamethasone Sodium Phosphate Cream (USP42-NF37 2S)
Dexamethasone Sodium Phosphate Ophthalmic Ointment (USP42-NF37 2S)
Dextroamphetamine Sulfate Capsules (USP42-NF37 2S)
Diatrizoate Sodium (USP42-NF37 2S)
Diazepam Capsules (USP42-NF37 2S)
Diazepam Extended-Release Capsules (USP42-NF37 2S)
Dichloralphenazone (USP42-NF37 2S)
Dicloxacillin Sodium for Oral Suspension (USP42-NF37 2S)
Diethylstilbestrol Injection (USP42-NF37 2S)
Diethylstilbestrol Tablets (USP42-NF37 2S)
Diphenhydramine Hydrochloride Oral Powder [NEW] (USP42-NF37 2S)
Doxazosin Tablets (USP42-NF37 2S)
Enalapril Maleate (USP42-NF37 2S)
Epinephrine Bitartrate (USP42-NF37 2S)
Ezetimibe (USP42-NF37 2S)
Felodipine (USP42-NF37 2S)
Fenoldopam Mesylate Injection (USP42-NF37 2S)
Hard Gelatin Capsule Shell (USP42-NF37 2S)
Hydrochlorothiazide Compounded Oral Suspension [NEW] (USP42-NF37 2S)
Hydrocortisone (USP42-NF37 2S)
Hard Hypromellose Capsule Shell (USP42-NF37 2S)
Levodopa Capsules (USP42-NF37 2S)
Levodopa Tablets (USP42-NF37 2S)
Levofloxacin Tablets (USP42-NF37 2S)
Lidocaine, Racepinephrine and Tetracaine Hydrochlorides Compounded Topical Gel [NEW] (USP42-NF37 2S)
Loracarbef (USP42-NF37 2S)
Magnesium Citrate (USP42-NF37 2S)
Memantine Hydrochloride Oral Solution [NEW] (USP42-NF37 2S)
Methacholine Chloride (USP42-NF37 2S)
Oxtriphylline Oral Solution (USP42-NF37 2S)
Oxtriphylline Tablets (USP42-NF37 2S)
Oxycodone Hydrochloride Extended-Release Tablets (USP42-NF37 2S)
Oxytetracycline and Nystatin Capsules (USP42-NF37 2S)
Oxytetracycline and Nystatin for Oral Suspension (USP42-NF37 2S)
Oxytetracycline Calcium (USP42-NF37 2S)
Oxytetracycline Calcium Oral Suspension (USP42-NF37 2S)
Phensuximide (USP42-NF37 2S)
Phensuximide Capsules (USP42-NF37 2S)
Phenytoin Compounded Topical Gel [NEW] (USP42-NF37 2S)
Physostigmine Salicylate Ophthalmic Solution (USP42-NF37 2S)
Piroxicam (USP42-NF37 2S)
Potassium Perchlorate Capsules (USP42-NF37 2S)
Pregabalin Capsules [NEW] (USP44-NF39 1S)
Propoxycaine Hydrochloride (USP42-NF37 2S)
Propyliodone Injectable Oil Suspension (USP42-NF37 2S)
Quinine Sulfate Capsules (USP42-NF37 2S)
Repaglinide and Metformin Hydrochloride Tablets [NEW] (USP42-NF37 2S)
Rifampin (USP42-NF37 2S)
Rifampin Capsules (USP42-NF37 2S)
Rifampin for Injection (USP42-NF37 2S)
Sodium Fluoride Tablets (USP42-NF37 2S)
Thioridazine Oral Suspension (USP42-NF37 2S)
Timolol Maleate (USP42-NF37 2S)
Torsemide Compounded Oral Suspension [NEW] (USP42-NF37 2S)
Tranexamic Acid (USP42-NF37 2S)
Triamcinolone Acetonide Cream (USP42-NF37 2S)
Triamcinolone Acetonide Dental Paste (USP42-NF37 2S)
Vancomycin (USP42-NF37 2S)

DIETARY SUPPLEMENT MONOGRAPHS

Bael Tree Fruit [NEW] (USP42-NF37 2S)
Bael Tree Fruit Dry Extract [NEW] (USP42-NF37 2S)
Bael Tree Fruit Powder [NEW] (USP42-NF37 2S)
Cobamamide (USP42-NF37 2S)
Coptis Species Rhizome [NEW] (USP42-NF37 2S)
Coptis Species Rhizome Dry Extract [NEW] (USP42-NF37 2S)
Coptis Species Rhizome Powder [NEW] (USP42-NF37 2S)
Cystine (USP42-NF37 2S)
Indian Barberry Stem [NEW] (USP42-NF37 2S)
Indian Barberry Stem Dry Extract [NEW] (USP42-NF37 2S)
Indian Barberry Stem Powder [NEW] (USP42-NF37 2S)
Terminalia Chebula Fruit [NEW] (USP42-NF37 2S)
Terminalia Chebula Fruit Dry Extract [NEW] (USP42-NF37 2S)
Terminalia Chebula Fruit Powder [NEW] (USP42-NF37 2S)

EXCIPIENTS

Excipients (USP and NF), Listed By Category (USP42-NF37 2S)
Briefing
Introduction
Emulsifying Agent
Lubricant

NF MONOGRAPHS

Purified Bentonite (USP42-NF37 2S)
Galactose (USP42-NF37 2S)
Glyceryl Mono and Dicaprylate [NEW] (USP42-NF37 2S)
Glyceryl Mono and Dicaprylocaprate [NEW] (USP42-NF37 2S)
Glyceryl Monocaprylate (USP42-NF37 2S)
Glyceryl Monocaprylocaprate (USP42-NF37 2S)

STAGE 4 HARMONIZATION

Stage 2 Harmonization

STIMULI TO THE REVISION PROCESS

STIMULI TO THE REVISION PROCESS
Acceptance Sampling Strategies Applied to USP <790> Visible Particulates In Injections