New Rules for Compounding Pharmacies: Best Practices for Compliance

Duration: 90 Minutes
The Drug Quality and Security Act (DQSA), signed into law on the 27 Nov 2013, created new rules for the good manufacturing requirements for compounding pharmacies along with registration requirements and safety reporting obligations. These rules bring compounding pharmacies under more vigorous supervision by giving FDA clearer authority to audit such pharmacies while creating a pathway for compounding pharmacies to voluntarily register with the Agency and sign up to be inspected by the FDA under a new category of FDA-regulated facilities called the "Outsourcing Facility".
Compounding Pharmacies
Instructor: Mukesh Kumar
Product ID: 500297

Within days of the signing of DQSA, FDA released three guidance documents to assist the affected pharmacies with interpreting the law. These rules and guidance documents are expected to also assist prescribers and patients in assuring the quality of the compounded drugs manufactured at a given facility by creating a transparent quality system. This seminar will highlight the key elements of the new rules along with practical suggestions for complying using examples and case studies from past Warning Letters that lead to these rules in the first place.

Why Should you Attend:
The new rules for compounding pharmacies creates clearer definitions of the drugs that can be compounded, the ingredients that can be used or must be avoided, the facilities and personnel that be involved in compounding of drugs, labeling and shipping requirements, and documentation that must be created and maintained to demonstrate compliance. This seminar will provide a summary of the all the rules along with suggestions to assure high level of compliance. Compliance techniques can be simple and implemented with relative ease leading to better products both in terms of quality and potential benefit to consumers leading to better acceptance. If you are a pharmacy involved in compounding activities for individually identifiable patients or for more broadly used compounded drugs, a physician using compounding pharmacies, or a consumer of such products, this seminar will describe the current federal requirements and strategies to comply.

Learning Objectives:
Learn how to be compliant with current GMP, registration and reporting requirements for compounding pharmacies operating in the US.

Objectives of the Presentation:
  • The conditions under which a compounded product must be produced
  • Raw material sourcing, validation, accountability, and documentation techniques
  • Facility design and planning issues
  • Drugs that can or cannot be compounded
  • Facility registration requirements
  • Type and format of reports required to be submitted periodically to FDA
  • How do these changes impact products currently in the market
Who can Benefit:
This webinar will provide valuable assistance to all personnel in:
  • Compounding Pharmacies
  • Pharmacists and other drug handling professionals
  • Regulatory and Quality Professionals working in compounding pharmacies
  • Hospital and clinics using internal or contract compounding pharmacies
  • Regulatory, Compliance and Quality Professionals consulting with companies using compounding pharmacies
  • Medical Insurance and Reimbursement Professionals
  • Physicians and Consumers using compounded drugs
$375
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Instructor Profile:
Mukesh Kumar, leads the Regulatory Affairs and Quality Assurance departments at Amarex Clinical Research, a full service CRO based in Germantown, MD. His key expertise is in developing Global Regulatory Business Strategies for biomedical product development and his passion is to bring traditional therapies for India, China and the Latin-America to the Western markets. In addition to regulatory expertise, Mukesh is an experienced auditor and a trainer in regulatory and business processes.

Mukesh started his professional career as a research scientist at the NIH, Baylor College of Medicine, Houston, and several premier institutions in India. With more than 11 years of experience in virology, gene therapy, and molecular biology, Mukesh has expertise in biological and combination products. He has been a global Regulatory Affairs Specialist (US, EU, and India) for the last 5 years. He has filed several new-INDs for drugs, biologics and combinations products, NDAs, 510K, PMAs, etc. He has made several hundred FDA submissions, and arranged a number of meetings and responses to FDA comments. In addition, he has had made regulatory submission in the EU and India. Mukesh has reviewed/compiled more than 100 clinical trial protocols and has supervised more than 60 multi-national clinical trials (both under IND and non-IND trials), in the US, Canada, Latin America, Africa, and Asia. In addition to drugs and Biologics, he has extensive experience in medical device and diagnostic product regulatory filings and safety monitoring.

Specialties: Technology transfer, global regulatory strategy, global clinical trials, safety reporting, training, and GLP/GCP audits.

Honors and Awards: US patent awarded "Gene Therapy vectors derived from Sendai virus".

Education: Education: Delhi University - Ph.D., Biochemistry - 1993 – 1997
National Dairy Research Institute - MS, Biochemistry - 1990 – 1993
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