Office-Use + FDA = cGMP
That’s a heck of an equation! The Food and Drug Administration is directing its inspectors to find one… just one… instance of an office-use compound to justify allegations that a compounding pharmacists isn’t eligible for the exemptions provided for within section 503A of the Food, Drug and Cosmetic Act. And without those exemptions any compounder can then be held to Current Good Manufacturing Standards.
If you are a sterile compounder, understanding the approach and the areas which FDA inspectors are told to check is absolutely critical. For example, did you know that you are expected to validate and document the efficacy of your disinfectant? that you are supposed to audit your testing laboratory? that you must have SOPs to demonstrate assessments of the sterility of your containers and your container closures?
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. 0201-9999-15-141-L03-P; 0201-9999-15-141-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.
David G. Miller, R.Ph. is Executive Vice President and Chief Executive Officer of the International Academy of Compounding Pharmacists. IACP represents more than 4,000 practitioners and 163,000 consumers who recognize the value of customized medication solutions provided by the art and science of pharmacy compounding.
After receiving his bachelor of science in pharmacy degree from the University of Maryland School of Pharmacy in 1985, he joined the staff of the National Community...More
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