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[PMC free article: PMC435850] [PubMed: 16694075] 389

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503B Outsourcing Facilities Enhanced Oversight of Large-Scale Outsourcing Facilities With respect to 503B outsourcing facilities, the SAFE Drugs Act would require (i) a pre-compounding inspection of any outsourcing facility before it initiates work on a new drug and (ii) biennial re-inspections of facilities that compound more than 100 products in a calendar year

Cheng X, Xie Q, Sun Y