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.

The Evolution of 21 CFR Parts 210 & 211 for Drug Compounders: An Unspoken Opportunity for Pharmacists

Author(s):  Parks Kenneth Chase, Bernard Brian, Cogdill Christopher Blake

Issue:  Sep/Oct 2015 - Volume 19, Number 5
View All Articles in Issue

Page(s):  377-380

The Evolution of 21 CFR Parts 210 & 211 for Drug Compounders: An Unspoken Opportunity for Pharmacists Page 1
The Evolution of 21 CFR Parts 210 & 211 for Drug Compounders: An Unspoken Opportunity for Pharmacists Page 2
The Evolution of 21 CFR Parts 210 & 211 for Drug Compounders: An Unspoken Opportunity for Pharmacists Page 3
The Evolution of 21 CFR Parts 210 & 211 for Drug Compounders: An Unspoken Opportunity for Pharmacists Page 4

Download in electronic PDF format for $75

Abstract:  A high-level assessment of recent U.S. Food and Drug Administration audits of 503A facilities indicates that a regulatory paradigm shift is occurring. Data and rationale further indicates that the agency seems to be taking a proactive approach for how it monitors these facilities. The auditing practices and observations are eerily similar to those which are seen for 503B Outsourcing Facilities, as well as Current Good Manufacturing Practices Drug and Device Manufacture plants. Perhaps the U.S. Food and Drug Administration is attempting to avoid any major medical outbreaks that may stem from under-supervised drug preparation centers. This report presents the rationale that may be behind the U.S. Food and Drug Administration’s motive for increased 503A scrutiny. In addition, new market incentives are also highlighted, as it seems that firms, which are able to maintain good graces with the agency, will be uniquely positioned to obtain greater market share. All signs indicate that for 503A facilities, regulatory compliance may be the key to greater market share.

Related Keywords: Kenneth Chase Parks, PharmD, Brian Bernard, MS, Christopher Blake Cogdill, PharmD, 21 CFR Parts 210 & 211, U.S. Code of Federal Regulations, Drug Quality and Security Act, U.S. Food and Drug Administration, FDA, Current Good Manufacturing Practices, 503A pharmacy, 503B outsourcing facility, standards, drug shortages, new market opportunities, drug safety, interstate commerce, standard operating procedures, material flow, regulations

Related Categories: BUSINESS, LEGAL, PROFESSIONAL ISSUES

Printer-Friendly Version



Related Articles from IJPC
Title/Author
(Click for Abstract / Details / Purchase)
Issue/​Page
View/Buy
The Evolution of 21 CFR Parts 210 & 211 for Drug Compounders: An Unspoken Opportunity for Pharmacists
Parks Kenneth Chase
, Bernard Brian, Cogdill Christopher Blake
Sep/Oct 2015
Pg. 377-380

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

Determining Whether a Substance is Legal to Compound with Under Section 503A of the FDCA
Cabaleiro Joe
Sep/Oct 2021
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
PostScription: Thousands of Unapproved New Drugs are on the U.S. Market, Part 1
Allen Loyd V Jr
Jul/Aug 2007
Pg. 350-351

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

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

Standing Together Fixing the Drug Quality and Security Act
Miller David G
Mar/Apr 2015
Pg. 104-106

PostScription: Drug Disposal: Compounding Pharmacists' Involvement in the Prevention of Prescription Drug Misuse and Abuse
Williams LaVonn A
Nov/Dec 2011
Pg. 526-527

Nominations of Difficult to Compound Drugs to the U.S. Food and Drug Administration--Pharmacy Compounding Advisory Committee: Part 1
Allen Loyd V Jr
Sep/Oct 2015
Pg. 389-390

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

Basics of Compounding for Hazardous Drugs, Part 2: Regulation and Sources of Contamination
Allen Loyd V Jr
Nov/Dec 2006
Pg. 446-448

Quality Control: Bar Codes and Bar Code Scanners for Unit-Dose Medications in a Healthcare Setting
Medi-Dose Inc./EPS Inc.
Sep/Oct 2017
Pg. 384-387

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

Quality Control: Personal Protective Equipment for Use When Handling Hazardous Drugs
Dillon L R
Jan/Feb 2020
Pg. 30-36

The Role of Compounding Pharmacists During Drug Shortages
Ofei Kelvin
Jul/Aug 2022
Pg. 298-301

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 Responds to the International Academy of Compounding Pharmacists' Outsourcing Letter
Miller David G
May/Jun 2014
Pg. 208

PostScription: Thousands of Unapproved New Drugs are on the U.S. Market, Part 2
Allen Loyd V Jr
Sep/Oct 2007
Pg. 438-439

U.S. Food and Drug Administration Requests for Input on HR 3204 Enactment: The Drug Quality and Security Act of 2013
Miller David G
Jan/Feb 2014
Pg. 35-36

Return to Top