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
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• 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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