Excipient Quality Assurance Handling, Sampling, and Regulatory Issues

Excipient Quality Assurance Handling, Sampling, and Regulatory Issues 

Office of New Animal Drug Evaluation, Center for Veterinary Medicine, 

School of Pharmacy, University of Maryland, Baltimore, Maryland, U.S.A. 

For finished drug products, cGMP under 21 CFR, Parts 210 and 211, refers to the finished drug products. Section 501(a)(2)(B) of the FFDCA requires that all 

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