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The Most-Trusted Regulations & Guidelines Books on the Market.
Celebrating 18 Years of Excellence.


Now Accepting Orders for our REVISED APRIL 1, 2020 Books

21 CFR Parts 300-499, as of April 1, 2020

21 CFR Parts 300-499, as of April 1, 2020

$ 35.00

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Spiral-bound, 5.5" x 8.5" version of the Code of Federal Regulations, Title 21: Food and Drugs, Parts 300-499, April 1, 2020, previously available only from the Government Printing Office. 357 pages.

This book is for pharmaceutical industry and health care professionals who want hard-copy access to all of the food and drug regulations in parts 300-499. 

What's the Price?
• 1-249 copies:  $35.00             • 250-499 copies:  32.00
• 500-749 copies: $28.00          • 750+ copies:  $25.00

Custom Cover Prices*?
• 1-24 copies:  unavailable             • 25-100 copies:  $2.00/book
• 100-249 copies: $1.00/book        • 250+ copies:  No charge

* Based on quantities of a single book title

  CFR Title 21:  Food and Drugs (Revised as of April 1, 2020)

300 General
310 New Drugs
312 Investigational New Drug Application
314 Applications for FDA Approval to Market a New Drug
315 Diagnostic Radiopharmaceuticals
316 Orphan Drugs
317 Qualifying Pathogens
320 Bioavailability and Bioequivalence Requirements
328 Over-the-Counter Drug Products Intended for Oral Ingestion that
Contain Alcohol
329 Nonprescription Human Drug Products Subject to Section 760 of the
Federal Food, Drug, and Cosmetic Act
330 Over-the-Counter (OTC) Human Drugs Which Are Generally
Recognized as Safe and Effective and Not Misbranded
331 Antacid Products for Over-the-Counter (OTC) Human Use
332 Antiflatulent Products for Over-the-Counter Human Use
333 topical Antimicrobial Drug Products for Over-the-Counter Human Use
335 Antidiarrheal Drug Products for Over-the-Counter Human Use
336 Antiemetic Drug Products for Over-the-Counter Human Use
338 Nighttime Sleep-Aid Drug Products for Over-the-Counter Human Use
340 Stimulant Drug Products for Over-the-Counter Human Use
341 Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products
for Over-the-Counter Human Use
343 Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for
Over-the-Counter Human Use
344 Topical Otic Drug Products for Over-the-Counter Human Use
346 Anorectal Drug Products for Over-the-Counter Human Use
347 Skin Protectant Drug Products for Over-the-Counter Human Use
348 External Analgesic Drug Products for Over-the-Counter Human Use
349 Ophthalmic Drug Products for Over-the-Counter Human Use
350 Antiperspirant Drug Products for Over-the-Counter Human Use
352 Sunscreen Drug Products for Over-the-Counter Human Use [Stayed
Indefinitely]
355 Anticaries Drug Products for Over-the-Counter Human Use
357 Miscellaneous Internal Drug Products for Over-the-Counter Human Use
358 Miscellaneous External Drug Products for Over-the-Counter Human
Use
361 Prescription Drugs for Human Use Generally Recognized as Safe and
Effective and Not Misbranded: Drugs Used in Research
369 Interpretative Statements Re Warnings on Drugs and Devices for Overthe-
Counter Sale
370-499 [Reserved]

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