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Now shipping orders for our April 1, 2020 Books

Also accepting PRE-ORDERS for our REVISED APRIL 1, 2021 BOOKS shipping in May.

PRE-ORDER 21 CFR Parts 1-99, as of April 1, 2021

$ 45.00

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Spiral-bound, 5.5" x 8.5" version of the Code of Federal Regulations, Title 21: Food and Drugs, Parts 1-99, April 1, 2020, previously available only from the Government Printing Office.  548 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 1-99. 

What's the Price?
• 1-249 copies:  $45.00             • 250-499 copies:  $42.00
• 500-749 copies: $38.00          • 750+ copies:  $35.00

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)

1 General Enforcement Regulations
2 General Administrative Rulings and Decisions
3 Product Jurisdiction
4 Regulation of Combination Products
5 Organization
7 Enforcement Policy
10 Administrative Practices and Procedures
11 Electronic Records; Electronic Signatures
12 Formal Evidentiary Public Hearing
13 Public Hearing Before a Public Board of Inquiry
14 Public Hearing Before a Public Advisory Committee
15 Public Hearing Before the Commissioner
16 Regulatory Hearing Before the Food and Drug Administration
17 Civil Money Penalties Hearings
19 Standards of Conduct and Conflicts of Interest
20 Public Information
21 Protection of Privacy
25 Environmental Impact Considerations
26 Mutual Recognition of Pharmaceutical Good Manufacturing
Practice Reports, Medical Device Quality System Audit Reports,
and Certain Medical Device Product Evaluation Reports: United
States and the European Community
50 Protection of Human Subjects
54 Financial Disclosure by Clinical Investigators
56 Institutional Review Boards
58 Good Laboratory Practice For Nonclinical Laboratory Studies
60 Patent Term Restoration
70 Color Additives
71 Color Additive Petitions
73 Listing of Color Additives Exempt From Certification
74 Listing of Color Additives Subject To Certification
80 Color Additive Certification
81 General Specifications and General Restrictions For Provisional
Color Additives for Use in Foods, Drugs, and Cosmetics
82 Listing of Certified Provisionally Listed Colors and
99 Dissemination of Information on Unapproved/New Uses For
Marketed Drugs, Biologics, and Devices

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