USP 797/USP 795: Reviewing the Proposed Changes & How to Create and Manage a State of Control in Pharmacies

Duration: 60 Minutes
USP standards serve as a professional guide for compounding practices and medication administration. USP standard 797 will be finalized in February 2018 and will be used for survey purposes. USP standard 800, which was finalized in February 2016, is focused entirely on employee safety when handling hazardous medications.
Proposed Changes to USP 797 and 795
Product ID: 502001
With the recently published USP Chapter 800 standards for hazardous drug compounding and the proposed USP Chapter 797 revisions under review by the USP Compounding Expert Committee, those involved in hazardous drug and other sterile compounding should expect more focus on quality assurance and control. Pharmacies will need to ensure staff is knowledgeable to perform more frequent personnel and environmental testing, along with improved dedication to training and meaningful competencies.

Objectives of the Presentation
  • To discuss the different regulations for states as to 'for office use' compounding
  • Importance of pyrogen- free water; avoiding water as a source of contamination
  • Emphasis on particulate count and the role it plays in cleaning sterile products rooms
  • Safety associated with sterile compounding and closed syringe systems
  • How USP 800 Hazardous Drug Handling coordinates with USP 795 and 797 compounding
  • Review of FDA violations in compounding pharmacies and pitfalls to avoid
Why Should you Attend
It has been a challenge for the industry to establish and enforce standards related to sterile compounding to improve patient safety. Following a series of high-profile events, the oversight on sterile compounding has increased steadily, including needs for accreditation and routine inspections by regulatory bodies.

In this webinar, our speaker Sue Hudson Duran will cover the USP 797 and 795 rules for compounding for individual patients as well as for 'office use' compounding. The speaker will also discuss how changes to USP 800 for Hazardous drugs relate to USP 797 and USP 795. This webinar will cover information for both human and veterinary medicine, for pharmacists, veterinarians, pharmacy technicians, veterinary technicians and anyone ordering 'for office use' compounded drugs.

Areas Covered
  • USP 797 guidelines
  • USP 795 guidelines
  • USP 800 guidelines as related to USP 797
  • Importance of water sources in compounding products
  • Quality assurance programs
  • Microbiology sampling
Who will Benefit
  • Sterile products pharmacists
  • Compounding pharmacists
  • Veterinary compounding pharmacists
  • Pharmacists in charge
  • Chief operating officers
  • Chief compliance officers
  • Facilities managers and building engineers
  • CNOs
  • Quality and infection control managers
$375
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  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
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  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Dr Sue Hudson Duran is a professor at Auburn University College of Veterinary Medicine and Adjunct Clinical Professor, Harrison School of Pharmacy, Auburn, Alabama. She has experience as a GMP pharmacist in pharmaceuticals, biologicals, nutraceuticals and food. She is an active member of the Auburn Food Systems Institute. She has been the safety officer at the College of Veterinary Medicine since 2000, serving to educate medical professionals in safe handling of drugs. In addition she has worked on development of several infectious disease safety protocols.

She worked with several other professionals at Auburn to develop an occupational safety program for animal handlers. She was the supervisor of the intravenous admixture department at Johns Hopkins Hospital early in her career and has continued to attend seminars and training certifications in sterile product compounding and hazardous drug safety. Dr. Duran has been on the FDA advisory committee for veterinary medicine and work on development of several standard operating procedures for pedigree of drugs and safety protocols.
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