International Journal of Pharmaceutical Compounding

A subscription to IJPC includes a print copy delivered by postal mail and on-line access to electronic PDF copies of your subscribed issues.

LEARN MORE

The U.S. Food and Drug Administration Takes Aim at Compounded Thyroid Hormone

Author(s): Brunner Scott

Issue: Jan/Feb 2023 - Volume 27, Number 1
View All Articles in Issue

Page(s): 22-23

The U.S. Food and Drug Administration Takes Aim at Compounded Thyroid Hormone Page 1

The U.S. Food and Drug Administration Takes Aim at Compounded Thyroid Hormone Page 2

Download in electronic PDF format for $75

Abstract:

Related Keywords: Scott Brunner, CAE, United States Food and Drug Administration, FDA, thyroid hormone, desiccated thyroid extract, biologic drug, regulation, regulatory policy, professional associations, United States Pharmacopeia Chapter <797>, USP, beyond-use dates, batch size restrictions, compounded sterile preparations

Related Categories: LEGAL, UNITED STATES PHARMACOPEIA CONVENTIONS, ALLERGY/IMMUNOLOGY/INFLAMMATION

Printer-Friendly Version

Title/Author (Click for Abstract / Details / Purchase)	Issue/Page View/Buy
Related Articles from IJPC
The U.S. Food and Drug Administration Takes Aim at Compounded Thyroid Hormone Brunner Scott	Jan/Feb 2023 Pg. 22-23
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
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
U.S. Food and Drug Administration "Evaluation Criteria" for Difficult to Compound Drugs Allen Loyd V Jr	Nov/Dec 2015 Pg. 487-488
Finally: A Final U.S. Food and Drug Administration Memorandum of Understanding, but It's Flawed Brunner Scott	Jul/Aug 2020 Pg. 296-297
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
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
U.S. Food and Drug Administration Takes Aim (Again) at Animal Compounding: Draft Guidance for Industry #256 Lacks Authority, Will Increase Costs, and Put Pets at Risk Brunner Scott	May/Jun 2020 Pg. 198-199
Standard Operating Procedure: U.S. Food and Drug Administration Inspection--Releasing a Sample to the U.S. Food and Drug Administration Kupiec Tom, Kemp Jesse	Jul/Aug 2007 Pg. 326-327
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
The Role of Drug Promotion in the Prescription of Hormone Replacement Therapy in the United States Stephenson Kenna, Jones William, Stephenson Douglas M M	May/Jun 2006 Pg. 175-183
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
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
FDA-funded Report on Compounded Hormones is Tainted, Analysis Shows Brunner Scott	May/Jun 2021 Pg. 206-209
PostScription: Thousands of Unapproved New Drugs are on the U.S. Market, Part 1 Allen Loyd V Jr	Jul/Aug 2007 Pg. 350-351
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
Hypothyroidism: Optimizing Therapy with Slow-Release Compounded Thyroid Replacement Milner Martin	Jul/Aug 2005 Pg. 268-273
Allowing Compounding Pharmacies to Address Drug Shortages Broughel James	Mar/Apr 2022 Pg. 100-109
Return to Top