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.

Determining Whether a Substance is Legal to Compound with Under Section 503A of the FDCA

Author(s):  Cabaleiro Joe

Issue:  Sep/Oct 2021 - Volume 25, Number 5
View All Articles in Issue

Page(s):  358-362

Determining Whether a Substance is Legal to Compound with Under Section 503A of the FDCA Page 1
Determining Whether a Substance is Legal to Compound with Under Section 503A of the FDCA Page 2
Determining Whether a Substance is Legal to Compound with Under Section 503A of the FDCA Page 3
Determining Whether a Substance is Legal to Compound with Under Section 503A of the FDCA Page 4
Determining Whether a Substance is Legal to Compound with Under Section 503A of the FDCA Page 5

Download in electronic PDF format for $65

Abstract:  In the U.S., determining whether it is legal to compound with a particular substance for human patients is governed by a patchwork of laws, regulations, and U.S. Food and Drug Administration guidance. Furthermore, there is no single, unified source where a compounder can determine whether a particular substance is legal to compound with. This article provides 503a compounders a step by- step tool to evaluate the legality of compounding with a particular substance for human patients. It does so in a systematic way that considers the patchwork of law, regulations, and U.S. Food and Drug Administration guidance documents that must be considered.

Related Keywords: Joe Cabaleiro, RPh, FACA, BCSCP, Difficult to Compound list, U.S. Food, Drug and Cosmetic Act, FDCA, drug safety, Drug Products Withdrawn or Removed from the Market for Reasons of Safety or Effectiveness list, negative list, Code of Federal Regulations, CFR, biologics, biological agents, protein, Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food Drug and Cosmetic Act, Drug Quality and Security Act, DQSA, Bulk Drug Substances That Can be Used to Compound Drug Products in Accordance with Section 503A of the Federal Food Drug and Cosmetic Act, Bulks list, tetrahydrobioptermin deficiency, BH4, oxitriptan, domperidone, diethylstilbestrol, USP-NF Monograph, flowchart, investigational drugs

Related Categories: LEGAL, SUPPORT, UNITED STATES PHARMACOPEIA CONVENTIONS

Printer-Friendly Version



Related Articles from IJPC
Title/Author
(Click for Abstract / Details / Purchase)
Issue/​Page
View/Buy
Determining Whether a Substance is Legal to Compound with Under Section 503A of the FDCA
Cabaleiro Joe
Sep/Oct 2021
Pg. 358-362

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
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

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

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

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

Compounding OTC Drugs: A Legal Perspective
Gibbs Jeffrey N
, Mazan Kate Duffy
May/Jun 2000
Pg. 180-181

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

Allowing Compounding Pharmacies to Address Drug Shortages
Broughel James
Mar/Apr 2022
Pg. 100-109

The "Lists": What Do They Mean?
Voliva John
Nov/Dec 2016
Pg. 477-479

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

The US FDA List of Drugs Not to Be Used in Compounded Medications for Humans (the "Negative List")
Allen Loyd V Jr
, Ashworth Lisa D
Jan/Feb 2005
Pg. 44-46

PreScription: Drug Quality and Security Act Implementation Subcommittee Hearing
Allen Loyd V Jr
Mar/Apr 2018
Pg. 92

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

Finally: A Final U.S. Food and Drug Administration Memorandum of Understanding, but It's Flawed
Brunner Scott
Jul/Aug 2020
Pg. 296-297