International Journal of Pharmaceutical Compounding

A subscription to IJPC provides on-line access to full-text, full-color, printable PDF copies of your subscribed issues, individual articles, and purchased archives.

LEARN MORE

Final Guidance for Pharmacy Compounding of Human Drug Products Under Section 503A

Author(s): Blankenship Cynthia E

Issue: Sep/Oct 2014 - Volume 18, Number 5
View All Articles in Issue

Page(s): 379-380

Final Guidance for Pharmacy Compounding of Human Drug Products Under Section 503A Page 1

Final Guidance for Pharmacy Compounding of Human Drug Products Under Section 503A Page 2

Download in electronic PDF format for $75

Abstract:

Related Keywords: Cynthia E. Blankenship, Esq., US Food and Drug Administration, FDA, Section 503A of the Food, Drug, and Cosmetic Act, International Academy of Compounding Pharmacists, IACP, drug safety, do not compound list, bulk drug substances list, office use, repackaging, Partnership for Personalized Prescriptions

Related Categories: LEGAL, PACKAGING

Printer-Friendly Version

Title/Author (Click for Abstract / Details / Purchase)	Issue/Page View/Buy
Related Articles from IJPC
Final Guidance for Pharmacy Compounding of Human Drug Products Under Section 503A Blankenship Cynthia E	Sep/Oct 2014 Pg. 379-380
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
Determining Whether a Substance is Legal to Compound with Under Section 503A of the FDCA Cabaleiro Joe	Sep/Oct 2021 Pg. 358-362
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
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
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
U.S. Food and Drug Administration Proposed Guidance Document: Compounding Animal Drugs from Bulk Substances Miller David G	Jul/Aug 2015 Pg. 303-305
Allowing Compounding Pharmacies to Address Drug Shortages Broughel James	Mar/Apr 2022 Pg. 100-109
U.S. Food and Drug Administration "Evaluation Criteria" for Difficult to Compound Drugs Allen Loyd V Jr	Nov/Dec 2015 Pg. 487-488
U.S. Food and Drug Administration List of Drugs NOT to be Used in Compounded Medications for Humans (The Negative List)	Nov/Dec 2016 Pg. 457-458
Finally: A Final U.S. Food and Drug Administration Memorandum of Understanding, but It's Flawed Brunner Scott	Jul/Aug 2020 Pg. 296-297
Standing Together Fixing the Drug Quality and Security Act Miller David G	Mar/Apr 2015 Pg. 104-106
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: Comments on the FDA Guidance "Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry" Allen Loyd V Jr	Mar/Apr 2022 Pg. 92
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
International Academy of Compounding Pharmacists' Legislative Regulatory Update: Take Action! Stop the U.S. Good and Drug Administration's Misguided Veterminary Guidance Miller David G	Nov/Dec 2015 Pg. 449-450
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
Compounding OTC Drugs: A Legal Perspective Gibbs Jeffrey N, Mazan Kate Duffy	May/Jun 2000 Pg. 180-181
The U.S. Food and Drug Administration Takes Aim at Compounded Thyroid Hormone Brunner Scott	Jan/Feb 2023 Pg. 22-23
Nonsterile Basics of Compounding: Using U.S. Food and Drug Administration-approved Commercial Products as Ingredients Allen Loyd V Jr	Nov/Dec 2023 Pg. 474-481
Return to Top