About GPO   |   Newsroom/Media   |   Congressional Relations   |   Inspector General   |   Careers   |   Contact   |   askGPO   |   Help  
 
Home   |   Customers   |   Vendors   |   Libraries  

The Electronic Code of Federal Regulations (e-CFR) is a regularly updated, unofficial editorial compilation of CFR material and Federal Register amendments produced by the National Archives and Records Administration's Office of the Federal Register (OFR) and the Government Printing Office.

Parallel Table of Authorities and Rules for the Code of Federal Regulations and the United States Code
Text | PDF

Find, review, and submit comments on Federal rules that are open for comment and published in the Federal Register using Regulations.gov.

Purchase individual CFR titles from the U.S. Government Online Bookstore.

Find issues of the CFR (including issues prior to 1996) at a local Federal depository library.

[1]
 
 

Electronic Code of Federal Regulations

blue pill

e-CFR Data is current as of August 27, 2014

Title 21Chapter ISubchapter CPart 201


TITLE 21—Food and Drugs

CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

SUBCHAPTER C—DRUGS: GENERAL

PART 201—LABELING

rule

Subpart A—GENERAL LABELING PROVISIONS

§201.1
Drugs; name and place of business of manufacturer, packer, or distributor.
§201.2
Drugs and devices; National Drug Code numbers.
§201.5
Drugs; adequate directions for use.
§201.6
Drugs; misleading statements.
§201.10
Drugs; statement of ingredients.
§201.15
Drugs; prominence of required label statements.
§201.16
Drugs; Spanish-language version of certain required statements.
§201.17
Drugs; location of expiration date.
§201.18
Drugs; significance of control numbers.
§201.19
Drugs; use of term “infant”.
§201.20
Declaration of presence of FD&C Yellow No. 5 and/or FD&C Yellow No. 6 in certain drugs for human use.
§201.21
Declaration of presence of phenylalanine as a component of aspartame in over-the-counter and prescription drugs for human use.
§201.22
Prescription drugs containing sulfites; required warning statements.
§201.23
Required pediatric studies.
§201.24
Labeling for systemic antibacterial drug products.
§201.25
Bar code label requirements.
§201.26
Exceptions or alternatives to labeling requirements for human drug products held by the Strategic National Stockpile.
rule

Subpart B—LABELING REQUIREMENTS FOR PRESCRIPTION DRUGS AND/OR INSULIN

§201.50
Statement of identity.
§201.51
Declaration of net quantity of contents.
§201.55
Statement of dosage.
§201.56
Requirements on content and format of labeling for human prescription drug and biological products.
§201.57
Specific requirements on content and format of labeling for human prescription drug and biological products described in §201.56(b)(1).
§201.58
Waiver of labeling requirements.
rule

Subpart C—LABELING REQUIREMENTS FOR OVER-THE-COUNTER DRUGS

§201.60
Principal display panel.
§201.61
Statement of identity.
§201.62
Declaration of net quantity of contents.
§201.63
Pregnancy/breast-feeding warning.
§201.64
Sodium labeling.
§201.66
Format and content requirements for over-the-counter (OTC) drug product labeling.
§201.70
Calcium labeling.
§201.71
Magnesium labeling.
§201.72
Potassium labeling.
§201.80
Specific requirements on content and format of labeling for human prescription drug and biological products; older drugs not described in §201.56(b)(1).
rule

Subpart D—EXEMPTIONS FROM ADEQUATE DIRECTIONS FOR USE

§201.100
Prescription drugs for human use.
§201.105
Veterinary drugs.
§201.115
New drugs or new animal drugs.
§201.116
Drugs having commonly known directions.
§201.117
Inactive ingredients.
§201.119
In vitro diagnostic products.
§201.120
Prescription chemicals and other prescription components.
§201.122
Drugs for processing, repacking, or manufacturing.
§201.125
Drugs for use in teaching, law enforcement, research, and analysis.
§201.127
Drugs; expiration of exemptions.
§201.128
Meaning of “intended uses”.
§201.129
Drugs; exemption for radioactive drugs for research use.
rule

Subpart E—OTHER EXEMPTIONS

§201.150
Drugs; processing, labeling, or repacking.
§201.161
Carbon dioxide and certain other gases.
rule

Subpart F—LABELING CLAIMS FOR DRUGS IN DRUG EFFICACY STUDY

§201.200
Disclosure of drug efficacy study evaluations in labeling and advertising.
rule

Subpart G—SPECIFIC LABELING REQUIREMENTS FOR SPECIFIC DRUG PRODUCTS

§201.300
Notice to manufacturers, packers, and distributors of glandular preparations.
§201.301
Notice to manufacturers, packers, and distributors of estrogenic hormone preparations.
§201.302
Notice to manufacturers, packers, and distributors of drugs for internal use which contain mineral oil.
§201.303
Labeling of drug preparations containing significant proportions of wintergreen oil.
§201.304
Tannic acid and barium enema preparations.
§201.305
Isoproterenol inhalation preparations (pressurized aerosols, nebulizers, powders) for human use; warnings.
§201.306
Potassium salt preparations intended for oral ingestion by man.
§201.307
Sodium phosphates; package size limitation, warnings, and directions for over-the-counter sale.
§201.308
Ipecac syrup; warnings and directions for use for over-the-counter sale.
§201.309
Acetophenetidin (phenacetin)-containing preparations; necessary warning statement.
§201.310
Phenindione; labeling of drug preparations intended for use by man.
§201.311
[Reserved]
§201.312
Magnesium sulfate heptahydrate; label declaration on drug products.
§201.313
Estradiol labeling.
§201.314
Labeling of drug preparations containing salicylates.
§201.315
Over-the-counter drugs for minor sore throats; suggested warning.
§201.316
Drugs with thyroid hormone activity for human use; required warning.
§201.317
Digitalis and related cardiotonic drugs for human use in oral dosage forms; required warning.
§201.319
Water-soluble gums, hydrophilic gums, and hydrophilic mucilloids (including, but not limited to agar, alginic acid, calcium polycarbophil, carboxymethylcellulose sodium, carrageenan, chondrus, glucomannan ((B-1,4 linked) polymannose acetate), guar gum, karaya gum, kelp, methylcellulose, plantago seed (psyllium), polycarbophil tragacanth, and xanthan gum) as active ingredients; required warnings and directions.
§201.320
Warning statements for drug products containing or manufactured with chlorofluorocarbons or other ozone-depleting substances.
§201.323
Aluminum in large and small volume parenterals used in total parenteral nutrition.
§201.325
Over-the-counter drugs for vaginal contraceptive and spermicide use containing nonoxynol 9 as the active ingredient; required warnings and labeling information.
§201.326
Over-the-counter drug products containing internal analgesic/antipyretic active ingredients; required warnings and other labeling.
§201.327
Over-the-counter sunscreen drug products; required labeling based on effectiveness testing.
Appendix
Appendix A to Part 201—Examples of Graphic Enhancements Used by FDA


For questions or comments regarding e-CFR editorial content, features, or design, email ecfr@nara.gov.
For questions concerning e-CFR programming and delivery issues, email webteam@gpo.gov.