Compliance Requirements for Compounding Pharmacies Based on USP Chapters 795, 797, and 800 - Recorded Webinar

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Webinar Duration: 60 minutes

RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)

SPEAKER: Venkata Kashyap Yellepeddi B.Pharm

The course will be delivered in two modules. The first module will cover federal and state regulatory agencies governing compounding pharmacies and handling of hazardous drugs for sterile and nonsterile compounding according to USP 800. The second module will cover FDA guidance on applying good compounding practices for the preparation of nonsterile (USP 795), and sterile (USP 797) compounded formulations.

Following are the learning objectives that are covered in this course:

Identify federal and state regulatory agencies governing the compounding pharmacies
Compare regulations of traditional (503 A) and outsourcing (503B) compounding pharmacies under sections 503A and 503B of the FD & C Act
Identify the requirements according to USP 795 for compounding sterile preparations
Summarize compliance aspects of sterile compounding according to USP 797 guidelines
Recognize the scope of USP 800 for handling hazardous drugs in healthcare settings

Why should you Attend: After the debacle of New England Compounding Center meningitis outbreak, the field of compounding pharmacy came into extensive scrutiny by federal and state regulatory agencies. To avoid such incidents in the future and to safe-guard public health The Drug Quality and Security Act (DQSA) was passed by United States congress and is currently enforced by FDA. According to the DQSA, the compliance requirements for compounding pharmacies were significantly updated, and it is expected that all compounding pharmacies must follow the DQSA if they intend to compound medications for patients.

If you don't understand the nuances of this act, you may end up being cited by FDA inspector or may even risk of losing your compounding pharmacy licensure. Furthermore, the new United States Pharmacopeia (USP) chapter USP 800 which deals with the handling of hazardous drugs in healthcare settings will be official from July 1, 2018, and it is expected that all compounding pharmacies must implement USP 800. Failure to comply with USP 800 may result in citations from both state board of pharmacies and FDA inspectors. This course is specifically designed to educate compounding pharmacies and all personnel involved to understand the intricacies of DQSA and USP 800.

Areas Covered in the Session:
- Introduction to the field of compounding pharmacy
- Overview of state regulatory agencies governing compounding pharmacy
- Sections related to compounding pharmacy under the Federal Food, Drug and Cosmetics Act
- Introduction to United States Pharmacopeia (USP) general chapters related to a compounding pharmacy
- Scope of USP 800
- Potential types of exposures to hazardous drugs
- Requirements for protection and training of personnel who handle HDs
- Personnel, facilities, and quality requirements under USP 797 for compounding sterile preparations

Who Will Benefit:
- Compounding Pharmacists
- Hospital Pharmacists
- Nurse Practitioners
- Compounding Pharmacy Technicians
- Hospital Pharmacy Administrators
- Long-term care Providers
- Veterinarian
- Veterinary Pharmacists
- Veterinary technicians
- Pharmacy Benefit Management Executives
- Health Insurance Executives
- Chemists
- Formulators
- Scientists
- Operators
- Auditors
- Regulatory Personnel
- Sales and Marketing Executives
- Patent and Intellectual Property Attorneys
- Documentation Specialists
- Inspectors
- Project Managers

Venkata Kashyap Yellepeddi B.Pharm., Ph.D., is Assistant Professor of Pharmaceutical Sciences, College of Pharmacy, Roseman University of Health Sciences, Utah and Adjunct Assistant Professor, Department of Pharmaceutics and Pharmaceutical Chemistry, College of Pharmacy, University of Utah, Utah. Kash has 12 years of experience in teaching pharmaceutical compounding and pharmaceutics to students at bachelors, masters, and doctoral levels. Kash also works as a consultant for Isomeric Pharmacy Solutions, Salt Lake City, Utah, USA (a 503 B outsourcing compounding pharmacy) and Smith-Rexall Drug Company, Pleasant Grove, Utah, USA ( a 503 A compounding pharmacy). Kash’s research interest in compounding involves stability analysis and beyond-use-dating of extemporaneously compounded preparations.

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