Assad Kazeminy, Ph'D'

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Where We Are TodayUSP Council of Experts

• Assad Kazeminy, Ph.D.
• Member, Monograph DevelopmentOphthalmology,
  Oncology, Dermatology Expert Committee

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Structure of the Council of Experts
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40 Standards Expert Committees

• Dietary Supplements
• Bioavailability
• Botanicals
• General Chapters
• Information
• Non-botanicals, Nutrition, and Electrolytes
• Excipients
• General Chapters
• Monographs 1
• Monographs 2
• General Chapters
• General Toxicology and Medical Device
  Biocompatibility

• Aerosols
• Biologics and Biotechnology
• Blood and Blood Products
• Cell, Gene, and Tissue Therapies
• Proteins and Polysaccharides
• Vaccines and Virology
• Biopharmaceutics
• Compounding Pharmacy

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40 Standards Expert Committees, cont.

• Packaging and Storage
• Parenteral Products Industrial
• Pharmaceutical Dosage Forms
• Pharmaceutical Waters
• Radiopharmaceuticals and Medical Imaging Agents
• Radiopharmaceutical Information
• Reference Standards
• Statistics
• Sterile Products Compounding
• Veterinary Drugs
• Veterinary Medicine Information

• Microbiology and Sterility Assurance
• Monograph Development
• Antibiotics
• Antivirals and Antimicrobials
• Cardiovascular
• Cough, Cold, and Analgesics
• Gastrointestinal, Renal, and Endocrine
• Ophthalmology, Oncology, and Dermatology
• Psychiatrics and Psychoactives
• Pulmonary and Steroids
• Nomenclature

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Advisory Panels

• 32 on the books
• 20 Approved
• 3 Pending Approval
• 9 Not Yet Formed
• Includes
• Performance Panels (4)
• Resolution 3 (Executive Committee)
• BB General Chapters
• Translations
• Others

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USP is Focusing On

• MonographsNew/Updates
• General ChaptersNew/Updates

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Potential New/Updated Monographs

• USP 29NF 24 contains over 4000 monographs and
  over 180 general chapters
• Approximately 2000 drug substance, excipient, and
  drug products monographs are needed
• Approximately 8001200 current monographs need to
  be updated

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Monographs

• SALMOUS
• Approved for Implementation
• Monograph Acquisition
• Ongoing efforts
• Outreach program
• Personal contacts
• Letters
• Phone contacts
• High Priority List
• PF
• Website
• Alternative Source Monographs
• Is this working? Results to date gt80 new
  monographs recd

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General Chapters
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Major Transformations in CycleStandards

• Redesign of USP-NF and PF
• Enhance Monograph Acquisition
• Standards for Articles Legally Marketed in Other
  Countries (SALMOUS)
• Incorporation of New Technology (e.g., Raman
  other PAT General Chapters, PCR)
• Enhance USP Performance Testing
• Rewrite General Notices
• Major General Chapters lt467gt lt231gt, lt621gt
• Procedural and Ancillary Materials Standards
• Translations

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