Bot Detector
IJPC Seal
Download FREE Sample Issue or Article
LEARN MORE
Subscribe Today
A subscription to IJPC includes a print copy delivered by postal mail and on-line access to electronic PDF copies of your subscribed issues.

Compounding Pharmacies: Before and After an Inspection

Author(s):  Kulkarni Darshan, Ricketts Samantha

Issue:  Sep/Oct 2013 - Volume 17, Number 5
View All Articles in Issue

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

Download in electronic PDF format for $65

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

Printer-Friendly Version



Related Articles from IJPC
Title/Author
(Click for Abstract / Details / Purchase)
Issue/​Page
View/Buy
Compounding Pharmacies: Before and After an Inspection
Kulkarni Darshan
, Ricketts Samantha
Sep/Oct 2013
Pg. 358-362

Discrepancies in the Law and the U.S. Food and Drug Administration Pharmacy Compounding Compliance Policy Guidelines
Allen Loyd V Jr
Jul/Aug 2016
Pg. 351

View Sample
Quality Assurance and Quality Control: Being Prepared for U.S. Food and Drug Administration Inspections and Staying in Compliance with United States Pharmacopeia Chapter <797>: Part 1
Martin Matt
Sep/Oct 2018
Pg. 401-404

U.S. Food and Drug Administration Inspections: Guide to a Successful Outcome for 503A Sterile Compounding Pharmacies
Yoch Doug
Mar/Apr 2017
Pg. 95-102

U.S. Food and Drug Administration Inspection Authority: How to Know Whether U.S. Food and Drug Administration Inspectors Are Crossing the Line
Snow Stephen T
, Stannard Robert W, Bellis Jennifer, Moss Carrie A
Jan/Feb 2019
Pg. 32-33

PreScription: 2017 Pharmacy Compounding Issues: The U.S. Food and Drug Administration, Harzardous Drugs, and Wasted Drugs
Allen Loyd V Jr
Sep/Oct 2017
Pg. 356

PreScription: Formal Appeals to United States Pharmacopeia Regarding USP Chapters <795>,<797>, and <825>: Part 1
Allen Loyd V Jr
Mar/Apr 2020
Pg. 92

PreScription: GMPs vs. GCPs: Manufacturing and Compounding Definitions
Allen Loyd V Jr
Sep/Oct 2013
Pg. 356

U.S. Food and Drug Administration Proposed Guidance Document: Compounding Animal Drugs from Bulk Substances
Miller David G
Jul/Aug 2015
Pg. 303-305

The U.S. Food and Drug Administration Takes Aim at Compounded Thyroid Hormone
Brunner Scott
Jan/Feb 2023
Pg. 22-23

Safety Standards in Pharmaceutical Compounding, Part 2: A Closer Look at Agency Information, Oversight, and Assistance
Greeson Nicole MH
, Mixon William, Allan W Chris
Sep/Oct 2020
Pg. 371-379

PreScription: Formal Appeals to United States Pharmacopeia Regarding USP Chapters <795>, <797>, and <825>: Part 2
Allen Loyd V Jr
May/Jun 2020
Pg. 180

Documentation: Records and Reports
Akers Michael J
Sep/Oct 2017
Pg. 373-380

Quality Control Analytical Methods: A Summarized Discussion of Current Good Manufacturing Practice Regulations
Allen Loyd V Jr
May/Jun 2013
Pg. 210-219

Compounding in the Pharmacy Curriculum: Beyond the Basics
Hinkle Amanda R
, Newton Gail D
May/Jun 2004
Pg. 181-185

Applying Quality of Design Concepts to Pharmacy Compounding
Timko Robert J
Nov/Dec 2015
Pg. 453-463

Incorporating Quality Assurance in Pharmaceutical Compounding-related Courses in the PharmD Curricula
Hossain Mohammad Faisal
, Levesque Dan, Frye John, Rashid Mamoon
Jul/Aug 2020
Pg. 322-326

Quality Control: Minor Chapters, Major Impacts: What United States Pharmacopeia Chapters <51>, <61>, <62>, and <1207> Mean for Your Compounding Practice
Kelley Brian
Mar/Apr 2021
Pg. 115-124

U.S. Food and Drug Administration "Evaluation Criteria" for Difficult to Compound Drugs
Allen Loyd V Jr
Nov/Dec 2015
Pg. 487-488

Pharmaceutical Compounding or Pharmaceutical Manufacturing? A Regulatory Perspective
Timko Robert J
, Crooker Philip EM
Mar/Apr 2014
Pg. 101-111