In the early 2010s, there were several scandals with adulterated drugs compounded in pharmacies. Hundreds of patients were infected and several of them died. Inspections in the facilities revealed serious deficiencies in Good Manufacturing Practices (GMPs). Consequently, section 503B was created as part of the drug quality and security act in 2013, putting these facilities under FDA supervision for the first time. This resulted in a big shift in the sector and this webinar will show how the field has developed.
The webinar will include the following:
FDA Compounding Laws and Policies
Food and Drug Cosmetic Act 503a and 503b
FDA policies on Compounding and other related activities