2014 - New Rules for Compounding Pharmacies: Best Practices for Compliance

Instructor: Mukesh Kumar
Description:
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".
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
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