Sign-In
Cart
Code of Federal Regulations, Title 21, Food and Drugs, PT. 300-499, Revised as of April 1, 2017
Paperback
Currently unavailable to order
Please enter your email and a message will be sent to you when this product becomes available on our website.
ISBN13: 9780160938139
Publisher: Government Printing Office
Published: Aug 14 2017
Pages: 401
Weight: 1.06
Height: 0.75 Width: 5.75 Depth: 9.13
Language: English
Title 21 CFR, Parts 300-499, includes rules, regulations, procedures and administrative procedures associated with the Food and Drug Administration and Health and Human Services (drugs for human use), investigational new drug applications, diagnostic radiopharmaceuticals, orphan drugs, bioavailability and bioequivalence requirements, over-the-counter (OTC) drug products indtended for oral ingestion that contain alcohol, OTC human drugs generally recognized as safe and effective and not misbranded, OTC digestion-related drugs, OTC antimicrobials, OTC sleep aid drugs, OTC stimulant drugs, OTC skin protectant drugs, OTC antipersperants, OTC miscellaneaous internal and external drug products, and more...
Audience: Physicians, pharmacists, medical practitioners, drug and pharmaceutical manufacturers, and the general public may be interested in this regulatory volume.
Other related products:
Drug Master File (Red Polyethylene Folder) can be found here: https: //bookstore.gpo.gov/products/sku/017-012-00404-1
Drug Master File (Blue Polyethylene Folder) can be found here: https: //bookstore.gpo.gov/products/sku/017-012-00405-9
Minor Species Index File FDA Drug Folder (Purple Polyethylene) can be found here: https: //bookstore.gpo.gov/products/sku/017-012-00406-7
Investigational New Drug Application (Green Paper Folder) can be found here: https: //bookstore.gpo.gov/products/investigational-new-drug-application-green-paper-folder
Investigational New Drug Application (Red Polyethylene Folder) can be found here: https: //bookstore.gpo.gov/products/investigational-new-drug-application-red-polyethylene-folder
Investigational New Drug Application (Orange Paper Folder) can be found here: https: //bookstore.gpo.gov/products/investigational-new-drug-application-orange-paper-folder
New Drug Application: Statistics Section (Green Paper Folder) can be found here: https: //bookstore.gpo.gov/products/new-drug-application-statistics-section-green-paper-folder
New Drug Application: Pharmacology Section (Yellow Paper Folder) can be found here: https: //bookstore.gpo.gov/products/new-drug-application-pharmacology-section-yellow-paper-folder
New Drug Application: Microbiology (White Paper Folder) can be found here: https: //bookstore.gpo.gov/products/new-drug-application-microbiology-white-paper-folder
New Drug Application: Field Submission Chemistry Section (Maroon Paper Folder) can be found here: https: //bookstore.gpo.gov/products/new-drug-application-field-submission-chemistry-section-maroon-paper-folder
New Drug Application: Chemistry Section (Red Paper Folder) can be found here: https: //bookstore.gpo.gov/products/new-drug-application-chemistry-section-red-paper-folder
New Drug Application: Clinical Data Section (Tan Paper Folder) can be found here: https: //bookstore.gpo.gov/products/new-drug-application-clinical-data-section-tan-paper-folder
New Drug Application: Pharmacokinetic Section (Orange Paper Folder) can be found here: https: //bookstore.gpo.gov/products/new-drug-application-pharmacokinetic-section-orange-paper-folder
New Drug Application: Biologic Licensing Application, Archival Copy (Blue Polyethylene Folder) can be found here: https: //bookstore.gpo.gov/products/new-drug-application-biologic-licensing-application-archival-copy-blue-polyethylene-folder
Minor Species Index File FDA Drug Folder (Purple Polyethylene) can be found here: https: //bookstore.gpo.gov/products/minor-species-index-file-fda-drug-folder-purple-polyethylene
Health United States 2013 With Special Feature on Prescription Drugs can be found here: https: //bookstore.gpo.gov/products/health-united-states-2013-special-feature-prescription-drugs
Also in
General Law
Before All Is Said and Done: Practical Advice on Living and Dying Well
Watson, Suzanne
Miles, Pat
Hardcover
Boy with a Knife: A Story of Murder, Remorse, and a Prisoner's Fight for Justice
Trounstine, Jean
Paperback
With Liberty and Justice for Some: How the Law Is Used to Destroy Equality and Protect the Powerful
Greenwald, Glenn
Hardcover
The U.S. Constitution: A Comprehensive and Annotated Guide for the Modern Reader
Murray, Melissa
Hardcover
Last Branch Standing: A Potentially Surprising, Occasionally Witty Journey Inside Today's Supreme Court
Isgur, Sarah
Hardcover
North Carolina Notary Public Manual, 2016
North Carolina Department of the
Secretary of State
Secretary of State, Nc Department
Hardcover
Unreasonable Women: Three Stories of Violence, Imprisonment, and Extraordinary Survival
Van Der Leun, Justine
Hardcover
Discovering the Club: Piecing Together the Puzzling Network of Parental Pimping, Ritualistic Abuse, and Sex Trafficking
Clack, Cynthia L.
Paperback
Department of Fate: The Promise, the Power, and the Collapse of America's Most Consequential Institution
Maddow, Rachel
Hardcover
Social Security, Medicare & Government Pensions: Get the Most Out of Your Retirement and Medical Benefits
Matthews, Joseph
Paperback
The Price of Mercy: Unfair Trials, a Violent System, and a Public Defender's Search for Justice in America
Galvin Almanza, Emily
Hardcover
Nolo's Guide to Social Security Disability: Getting & Keeping Your Benefits
Morton III, David A.
Paperback
Captain's Dinner: A Shipwreck, an Act of Cannibalism, and a Murder Trial That Changed Legal History
Cohen, Adam
Hardcover
Five Bullets: The Story of Bernie Goetz, New York's Explosive '80s, and the Subway Vigilante Trial That Divided the Nation
Williams, Elliot
Hardcover
Federal Rules of Civil Procedure; 2026 Edition: With Statutory Supplement
Michigan Legal Publishing Ltd
Paperback
The Water Remembers: My Indigenous Family's Fight to Save a River and a Way of Life
Cordalis, Amy Bowers
Hardcover
Our Minds Were Always Free: A History of How Black Brilliance Was Exploited--And the Fight to Retake Control
Davis, Lisa E.
Hardcover
The Criminal Law Handbook: Know Your Rights, Survive the System
Berman, Sara J.
Bergman, Paul
Paperback
So Ordered: An Originalist's View of the Constitution, the Court, and Our Country
Alito, Samuel A., Jr.
Hardcover
The Pain Brokers: How Con Men, Call Centers, and Rogue Doctors Fuel America's Lawsuit Factory
Chamblee Burch, Elizabeth
Hardcover
Your Data Will Be Used Against You: Policing in the Age of Self-Surveillance
Ferguson, Andrew Guthrie
Hardcover
Bone Valley: A True Story of Injustice and Redemption in the Heart of Florida
King, Gilbert
Hardcover
Revenge for the Sixties: Sam Alito and the Triumph of the Conservative Legal Movement
Canellos, Peter S.
Hardcover
Robert's Rules of Order Newly Revised in Brief, 3rd Edition
Honemann, Daniel H.
Balch, Thomas J.
Robert, Henry M., III
Paperback
Searching for Jane Crow: Black Women and Mass Incarceration in America from the Auction Block to the Cell Block
Leflouria, Talitha L.
Hardcover
The Public Domain: Find and Use Free Content for Your Website, Book, App, Music, Video, Art, and More
Secor, Glen
Paperback
Supremacy: How Rule by the Court Replaced Government by the People
Renan, Daphna
Bowie, Nikolas
Hardcover
The Trustee's Legal Companion: A Step-By-Step Guide to Administering a Living Trust
Zolla, Carol Elias
Buckley, Shaila
Hanks, Liza
Paperback
When Companies Run the Courts: How Forced Arbitration Became America's Secret Justice System
Ballou, Brendan
Hardcover
One in Five: Why Child Sexual Abuse Is Our Biggest Public Health Crisis--And What We Can Do to Stop It
Letourneau, Elizabeth J.
Malone, Luke
Hardcover
Oops...That's Illegal!: A Handbook for the Wildly Curious (and the Accidental Outlaw)
Mandell, Mike
Hardcover
Dig Me a Grave: The Inside Story of the Serial Killer Who Seduced the South
Harpootlian, Richard A.
Assael, Shaun
Hardcover
38 Londres Street: On Impunity, Pinochet in England, and a Nazi in Patagonia
Sands, Philippe
Hardcover
Represent Yourself in Court: Prepare & Try a Winning Civil Case
Berman, Sara J.
Bergman, Paul
Paperback
Is the Government Legally Killing Us?: Is the Evidence Obvious? How Fear of Death and the Illusion of Freedom Turn Us Into Accomplices to Evil
(Scott Schara), Grace's Dad
Paperback
Iras, 401(k)S & Other Retirement Plans: Strategies for Taking Your Money Out
Shea, Tracy
Slesnick, Twila
Paperback
Lawless: How the Supreme Court Runs on Conservative Grievance, Fringe Theories, and Bad Vibes
Litman, Leah
Paperback
Federal Rules of Evidence; 2026 Edition (Casebook Supplement): With Advisory Committee notes, Rule 502 explanatory note, internal cross-references, qu
Michigan Legal Publishing Ltd
Paperback
Understanding Living Trusts(R): How You Can Avoid Probate, Keep Control, Save Taxes, and Enjoy Peace of Mind
Schumacher, Vickie
Paperback
The Constitution Cannot Save Us: Why We Can No Longer Rely on Our Founding Document
Seidman, Louis Michael
Hardcover
Getting Permission: Using & Licensing Copyright-Protected Materials Online & Off
Stim, Richard
Paperback
Federal Rules of Evidence; 2026 Edition: With Internal Cross-References
Michigan Legal Publishing Ltd
Paperback
The Constitution of the United States of America: The Declaration of Independence, The Bill of Rights
Founding Fathers
Paperback
Pink Crime: Fighting Against the Criminalization of Motherhood, Pregnancy, and Queer Identity
Beety, Valena
Hardcover
The Presidential Pardon: The Short Clause with a Long, Troubled History
Prakash, Saikrishna Bangalore
Hardcover
Stitching Freedom: A True Story of Injustice, Defiance, and Hope in Angola Prison
Tyler, Gary
Hardcover
The U.S. Constitution and Other Writings (Deluxe Leatherbound Edition)
Editors of Canterbury Classics
Hardcover
Lawless: How the Supreme Court Runs on Conservative Grievance, Fringe Theories, and Bad Vibes
Litman, Leah
Hardcover
The Cases That Haunt Us: From Jack the Ripper to JonBenet Ramsey, the Fbi's Legendary Mindhunter Sheds Light on the Mysteries That Won't Go Away
Douglas, John E.
Olshaker, Mark
Paperback
No Loose Ends: The Smart & Slightly Morbid Guide to Estate Planning & End-Of-Life Tasks
Zuckerman, Adam
Hardcover
J.K. Lasser's Small Business Taxes 2026: Your Complete Guide to a Better Bottom Line
Weltman, Barbara
Paperback
The U.S. Constitution - Anti-Federalist Edition
Henry, Patrick
Convention, Constitutional
Adams, Samuel
Paperback
Special Needs Trusts: Protect Your Child's Financial Future
Urbatsch, Kevin
Farinas Jones, Jessica
Paperback
Beyond the Body Farm: A Legendary Bone Detective Explores Murders, Mysteries, and the Revolution in Forensic Science
Bass, Bill
Jefferson, Jon
Paperback
The Only Living Trusts Estate Planning Guide: Protect Your Assets, Avoid Probate, Slash Taxes and Secure Your Heirs' Future.
Sterling, Thayer
Paperback
Fireproof: A Five-Step Model to Take Your Law Firm from Unpredictable to Wildly Profitable
Morse, Mike
Nachazel, John
Hardcover
Every Californian's Guide to Estate Planning: Wills, Trust & Everything Else
Hanks, Liza W.
Paperback
The Fall of Affirmative Action: Race, the Supreme Court, and the Future of Higher Education
Driver, Justin
Paperback
55 Successful Harvard Law School Application Essays, 2nd Edition: With Analysis by the Staff of the Harvard Crimson
Staff of the Harvard Crimson
Paperback
Medical Terminology Made Simple: Easily Learn, Memorize, and Pronounce Medical Terms
Temple, John, MD
Paperback
Contempt of Court: The Turn-Of-The-Century Lynching That Launched a Hundred Years of Federalism
Phillips, Leroy
Curriden, Mark
Paperback
Campus Speech and Academic Freedom: A Guide for Difficult Times
Chemerinsky, Erwin
Gillman, Howard
Hardcover
Little Book of Restorative Justice & Community: Reclaiming Connection and Responsibility for Our Neighbors
Morneau, Caitlin
Wilson, Sheryl
Paperback
Solve Your Money Troubles: Strategies to Get Out of Debt and Stay That Way
Loftsgordon, Amy
O'Neill, Cara
Paperback
Dealing with Problem Employees: How to Manage Performance & Personal Issues in the Workplace
Nolo, The Editors of
Paperback
Hitler's American Model: The United States and the Making of Nazi Race Law
Whitman, James Q.
Paperback
The Trump Indictments: The 91 Criminal Counts Against the Former President of the United States
Velshi, Ali
Paperback
Beyond the Grave, Revised and Updated Edition: The Right Way and the Wrong Way of Leaving Money to Your Children (and Others)
Condon, Jeffery L.
Paperback
Georgia Real Estate License Exam Prep: All-in-One Review and Testing to Pass Georgia's PSI Real Estate Exam
Cusic, David
Mettling, Ryan
Mettling, Stephen
Paperback