In the past, compounding pharmacies were inspected by the FDA based on a complaint or a medication error. With the enactment of the Drug Quality & Security Act after the NECC tragedy, the FDA is taking a different approach -- a risk-based plan to thoroughly inspect compounders. Are you prepared for an FDA inspection? Do you know what your responsibilities and rights are? Does your staff understand what is expected of them? This educational seminar will give you the tools to assess and prepare for an inspection as well as to understand the areas in which the FDA is most interested.
This lesson is a knowledge-based CE activity and is targeted to pharmacists and technicians.
The American College of Apothecaries (ACA) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. ACA has accredited this program for 1.0 contact hours (0.1 CEUs) of continuing education credit for pharmacists and technicians. 0201-9999-15-139-L03-P; 0201-9999-15-139-L03-T.
If you are interested in earning credit for this program, please note that you will be asked to enter your NABP e-Profile ID during the credit selection step of the registration process. If you have not yet registered your NABP e-Profile ID, please visit www.nabp.net.
CE credit and certificates of attendance will be provided only to those individuals who registered and logged into the webinar online. If you want CE credit and your certificate of attendance, you must have purchased the program and logged into the web portion under that registration so that we can verify attendance.
At the conclusion of this program, the pharmacist and technician attendee will be able to:
• Explain the legal basis for inspections of pharmacies by the Food & Drug Administration (FDA).
• Discuss the rights and responsibilities of pharmacy staff during an FDA inspection of a compounding pharmacy.
• Identify key inspection findings from Form 483 reports.
• List three action items to prepare a compounding pharmacy for an FDA inspection.