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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER C--DRUGS: GENERAL
 
PART 201LABELING
 

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.

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.

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).

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.

Subpart E--Other Exemptions
   § 201.150 - Drugs; processing, labeling, or repacking.
   § 201.161 - Carbon dioxide and certain other gases.

Subpart F--Labeling Claims for Drugs in Drug Efficacy Study
   § 201.200 - Disclosure of drug efficacy study evaluations in labeling and advertising.

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 A to Part 201--Examples of Graphic Enhancements Used by FDA

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 358, 360, 360b, 360gg-360ss, 371, 374, 379e; 42 U.S.C. 216, 241, 262, 264.
Source: 40 FR 13998, Mar. 27, 1975, unless otherwise noted.

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