International Journal of Pharmaceutical Compounding

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Compounding Pharmacies: Before and After an Inspection

Author(s): Kulkarni Darshan, Ricketts Samantha

Issue: Sep/Oct 2013 - Volume 17, Number 5
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Page(s): 358-362

Compounding Pharmacies: Before and After an Inspection Page 1

Compounding Pharmacies: Before and After an Inspection Page 2

Compounding Pharmacies: Before and After an Inspection Page 3

Compounding Pharmacies: Before and After an Inspection Page 4

Compounding Pharmacies: Before and After an Inspection Page 5

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Abstract: Recent events have directed the U.S. Food and Drug Administration’s attention to compounding pharmacies and have increased the frequency and vigorousness of pharmacy inspections. It is critical for compounding pharmacists to be prepared for such inspections and to understand their responsibilities after an inspection is over.

Related Keywords: Darshan Kulkarni, PharmD, MS, Esq, Samantha Ricketts, BA, regulatory agency, regulation, U.S. Food and Drug Administration, FDA, United States Pharmacopeia, USP, good manufacturing practices, GMP, compounded sterile preparations, drug safety, audit, pharmacy inspection, response team, privileged information

Related Categories: BUSINESS, ENVIRONMENTAL , LEGAL, STERILE PREPARATIONS, QUALITY CONTROL, UNITED STATES PHARMACOPEIA CONVENTIONS

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