GMP for Compounding Pharmacies: New Rules of 2013

Event Information
Product Format
Prerecorded Event
90 Minutes
Product Description

Documentation That Must Be Created And Maintained To Demonstrate Compliance For Compounded Drug

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 session by Dr. Mukesh Kumar will provide a summary of 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 session will describe the current federal requirements and strategies to comply.

This program 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 led to these rules in the first place.

The Drug Quality and Security Act (DQSA), signed into law on 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 it and sign up to be inspected by the FDA under a new category of FDA-regulated facilities called the “Outsourcing Facility”. 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.

Session highlights:

  • 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 should attend:

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

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About Our Speaker

Dr. Mukesh Kumar - Pharma Regulation Expert

Dr. Mukesh Kumar is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD ( His key expertise is in regulatory affairs, clinical trials, and multi-national project management for medicinal and diagnostic products. He has been involved in about 100...   More Info
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