FDAs Inspection Process For Compounding Pharmacies

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To learn more about FDAs Inspection Process For Compounding Pharmacies, check out: https://pharmasalon.com/ • The video is all about FDAs Inspection Process For Compounding Pharmacies and covers the following topics: • FDA inspection process for compounding pharmacies • Requirements upon FDA inspection • 503a vs 503b pharmacy • If you are interested in FDAs Inspection Process For Compounding Pharmacies, watch the entirety of this video and look for similar videos on our channel. • FDAs Inspection Process For Compounding Pharmacies however is a subject that I know nothing about. • ~~~~~~~~~~~~~~~~~~~~~ • If you want to find out even more about FDAs inspection process for compounding pharmacies I recommend you to have a look at our various other video clips: / pharmasalon • --------------------------------------- • Have I addressed all of your concerns about FDAs Inspection Process For Compounding Pharmacies? • Individuals who searched for FDAs inspection process for compounding pharmacies also searched for requirements upon FDA inspection. • --------------------------------------- • CE accredited for Pharmacists and Technicians. To get credits for this talk go https://compoundingce.com/courses/pha... • • What to Expect DURING the Inspection • Learning Objectives: • Describe FDA’s process and procedures for inspecting compounding facilities • Name what FDA inspectors are permitted to inspect and, by law, what they are not permitted to inspect • Outline how staff should interact with FDA during the course of an inspection and the problems that pharmacy staff can experience when dealing with FDA inspectors in a high-stress situation • Self-Assessment Questions • 1. What records are FDA inspectors not permitted to review during an inspection? • A. Financial Records • B. Prescription Records • C. Supplier Invoices • D. Pharmacist Training Records • 2. What are some of the key criteria FDA inspects against during an inspection of a compounding facility? • A. FDA Insanitary Conditions Guidance • B. FDA Essentially A Copy Guidance • C. A and B • D. None of the above • 3. What conduct is considered by FDA to be “impeding” or preventing an FDA inspection? • A. Preventing FDA from entering the facility • B. Preventing FDA from accessing areas where compounds are prepared • C. Preventing FDA from taking pictures • D. All of the above • (aligned with learning objective 3) • About the instructors: • Rachael G. Pontikes, Partner, Reed Smith • Rachael’s broad experience covers the full range of issues that arise for health • care companies in life sciences, most prominently with entities involved in the • compounding of drugs across both the human and animal health spheres. A • wide variety of health care entities, including telehealth platforms, drug • distributors, physician and veterinary practices, on line pharmacy and • prescription management services, as well as pharmacies (commercial/retail, • nuclear, compounding and institutional), hospital systems, and outsourcing • facilities, consistently seek her out to provide industry-tailored regulatory advice • for innovative business models and technological platforms. • Rachael has notable strength in representing health care facilities in high- • stakes Federal Food and Drug Administration, (FDA), Drug Enforcement • Administration (DEA), and state agency investigations and related litigation, as • well as acting as regulatory counsel for large-scale, high-profile transactions • involving major healthcare players in the compounding space. Widely regarded • as a thought leader on current issues facing the compounding sector, Rachael • is called upon to represent coalitions of compounding pharmacies and • outsourcing facilities to challenge FDA, state regulators, or other regulatory • bodies on critical issues defining the industry. A recognized national authority, • Rachael is the leading health care partner in our Chambers-ranked Illinois • Health Care group, and is personally ranked by Chambers USA in Band 1 for • the Illinois Healthcare: Pharmaceutical/Medical Products Regulatory category. • Clients describe her as “quick to understand and support the perspective of the • business, allowing her to help formulate business solutions that fit into the • regulatory framework of our industry” and saying “[h]er intellect, measured • responses, written expertise and work ethic are unsurpassed. • Rachael participated in discussions with the Senate HELP Committee about • the drafting of the federal law governing compounding, the Drug Quality and • Security Act (DQSA)-Compounding Quality Act (CQA). Her deep experience • with the laws governing compounding stems from her role as trial counsel in • Medical Center v. Mukasey and trial and appellate counsel in Wedgewood • Village Pharmacy v. United States, two seminal cases that shaped the legal • landscape. • Emily L. Hussey, Counsel, Reed Smith

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