Title 21

PART 201

Part 201 - Labeling

PART 201 - LABELING 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. Editorial Note:Nomenclature changes to part 201 appear at 69 FR 13717, Mar. 24, 2004.

21:4.0.1.1.2.1SUBPART A
Subpart A - General Labeling Provisions
21:4.0.1.1.2.1.1.1SECTION 201.1
   201.1 Drugs; name and place of business of manufacturer, packer, or distributor.
21:4.0.1.1.2.1.1.2SECTION 201.2
   201.2 Drugs and devices; National Drug Code numbers.
21:4.0.1.1.2.1.1.3SECTION 201.5
   201.5 Drugs; adequate directions for use.
21:4.0.1.1.2.1.1.4SECTION 201.6
   201.6 Drugs; misleading statements.
21:4.0.1.1.2.1.1.5SECTION 201.10
   201.10 Drugs; statement of ingredients.
21:4.0.1.1.2.1.1.6SECTION 201.15
   201.15 Drugs; prominence of required label statements.
21:4.0.1.1.2.1.1.7SECTION 201.16
   201.16 Drugs; Spanish-language version of certain required statements.
21:4.0.1.1.2.1.1.8SECTION 201.17
   201.17 Drugs; location of expiration date.
21:4.0.1.1.2.1.1.9SECTION 201.18
   201.18 Drugs; significance of control numbers.
21:4.0.1.1.2.1.1.10SECTION 201.19
   201.19 Drugs; use of term “infant”.
21:4.0.1.1.2.1.1.11SECTION 201.20
   201.20 Declaration of presence of FD&C Yellow No. 5 and/or FD&C Yellow No. 6 in certain drugs for human use.
21:4.0.1.1.2.1.1.12SECTION 201.21
   201.21 Declaration of presence of phenylalanine as a component of aspartame in over-the-counter and prescription drugs for human use.
21:4.0.1.1.2.1.1.13SECTION 201.22
   201.22 Prescription drugs containing sulfites; required warning statements.
21:4.0.1.1.2.1.1.14SECTION 201.23
   201.23 Required pediatric studies.
21:4.0.1.1.2.1.1.15SECTION 201.24
   201.24 Labeling for systemic antibacterial drug products.
21:4.0.1.1.2.1.1.16SECTION 201.25
   201.25 Bar code label requirements.
21:4.0.1.1.2.1.1.17SECTION 201.26
   201.26 Exceptions or alternatives to labeling requirements for human drug products held by the Strategic National Stockpile.
21:4.0.1.1.2.2SUBPART B
Subpart B - Labeling Requirements for Prescription Drugs and/or Insulin
21:4.0.1.1.2.2.1.1SECTION 201.50
   201.50 Statement of identity.
21:4.0.1.1.2.2.1.2SECTION 201.51
   201.51 Declaration of net quantity of contents.
21:4.0.1.1.2.2.1.3SECTION 201.55
   201.55 Statement of dosage.
21:4.0.1.1.2.2.1.4SECTION 201.56
   201.56 Requirements on content and format of labeling for human prescription drug and biological products.
21:4.0.1.1.2.2.1.5SECTION 201.57
   201.57 Specific requirements on content and format of labeling for human prescription drug and biological products described in § 201.56(b)(1).
21:4.0.1.1.2.2.1.6SECTION 201.58
   201.58 Waiver of labeling requirements.
21:4.0.1.1.2.3SUBPART C
Subpart C - Labeling Requirements for Over-the-Counter Drugs
21:4.0.1.1.2.3.1.1SECTION 201.60
   201.60 Principal display panel.
21:4.0.1.1.2.3.1.2SECTION 201.61
   201.61 Statement of identity.
21:4.0.1.1.2.3.1.3SECTION 201.62
   201.62 Declaration of net quantity of contents.
21:4.0.1.1.2.3.1.4SECTION 201.63
   201.63 Pregnancy/breast-feeding warning.
21:4.0.1.1.2.3.1.5SECTION 201.64
   201.64 Sodium labeling.
21:4.0.1.1.2.3.1.6SECTION 201.66
   201.66 Format and content requirements for over-the-counter (OTC) drug product labeling.
21:4.0.1.1.2.3.1.7SECTION 201.70
   201.70 Calcium labeling.
21:4.0.1.1.2.3.1.8SECTION 201.71
   201.71 Magnesium labeling.
21:4.0.1.1.2.3.1.9SECTION 201.72
   201.72 Potassium labeling.
21:4.0.1.1.2.3.1.10SECTION 201.80
   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).
21:4.0.1.1.2.4SUBPART D
Subpart D - Exemptions From Adequate Directions for Use
21:4.0.1.1.2.4.1.1SECTION 201.100
   201.100 Prescription drugs for human use.
21:4.0.1.1.2.4.1.2SECTION 201.105
   201.105 Veterinary drugs.
21:4.0.1.1.2.4.1.3SECTION 201.115
   201.115 New drugs or new animal drugs.
21:4.0.1.1.2.4.1.4SECTION 201.116
   201.116 Drugs having commonly known directions.
21:4.0.1.1.2.4.1.5SECTION 201.117
   201.117 Inactive ingredients.
21:4.0.1.1.2.4.1.6SECTION 201.119
   201.119 In vitro diagnostic products.
21:4.0.1.1.2.4.1.7SECTION 201.120
   201.120 Prescription chemicals and other prescription components.
21:4.0.1.1.2.4.1.8SECTION 201.122
   201.122 Drugs for processing, repacking, or manufacturing.
21:4.0.1.1.2.4.1.9SECTION 201.125
   201.125 Drugs for use in teaching, law enforcement, research, and analysis.
21:4.0.1.1.2.4.1.10SECTION 201.127
   201.127 Drugs; expiration of exemptions.
21:4.0.1.1.2.4.1.11SECTION 201.128
   201.128 Meaning of “intended uses”.
21:4.0.1.1.2.4.1.13SECTION 201.129
   201.129 Drugs; exemption for radioactive drugs for research use.
21:4.0.1.1.2.5SUBPART E
Subpart E - Other Exemptions
21:4.0.1.1.2.5.1.1SECTION 201.150
   201.150 Drugs; processing, labeling, or repacking.
21:4.0.1.1.2.5.1.2SECTION 201.161
   201.161 Medical gases.
21:4.0.1.1.2.6SUBPART F
Subpart F - Labeling Claims for Drugs in Drug Efficacy Study
21:4.0.1.1.2.6.1.1SECTION 201.200
   201.200 Disclosure of drug efficacy study evaluations in labeling and advertising.
21:4.0.1.1.2.7SUBPART G
Subpart G - Specific Labeling Requirements for Specific Drug Products
21:4.0.1.1.2.7.1.1SECTION 201.300
   201.300 Notice to manufacturers, packers, and distributors of glandular preparations.
21:4.0.1.1.2.7.1.2SECTION 201.301
   201.301 Notice to manufacturers, packers, and distributors of estrogenic hormone preparations.
21:4.0.1.1.2.7.1.3SECTION 201.302
   201.302 Notice to manufacturers, packers, and distributors of drugs for internal use which contain mineral oil.
21:4.0.1.1.2.7.1.4SECTION 201.303
   201.303 Labeling of drug preparations containing significant proportions of wintergreen oil.
21:4.0.1.1.2.7.1.5SECTION 201.304
   201.304 Tannic acid and barium enema preparations.
21:4.0.1.1.2.7.1.6SECTION 201.305
   201.305 Isoproterenol inhalation preparations (pressurized aerosols, nebulizers, powders) for human use; warnings.
21:4.0.1.1.2.7.1.7SECTION 201.306
   201.306 Potassium salt preparations intended for oral ingestion by man.
21:4.0.1.1.2.7.1.8SECTION 201.307
   201.307 Sodium phosphates; package size limitation, warnings, and directions for over-the-counter sale.
21:4.0.1.1.2.7.1.9SECTION 201.308
   201.308 Ipecac syrup; warnings and directions for use for over-the-counter sale.
21:4.0.1.1.2.7.1.10SECTION 201.309
   201.309 Acetophenetidin (phenacetin)-containing preparations; necessary warning statement.
21:4.0.1.1.2.7.1.11SECTION 201.310
   201.310 Phenindione; labeling of drug preparations intended for use by man.
21:4.0.1.1.2.7.1.12SECTION 201.311
   201.311 [Reserved]
21:4.0.1.1.2.7.1.13SECTION 201.312
   201.312 Magnesium sulfate heptahydrate; label declaration on drug products.
21:4.0.1.1.2.7.1.14SECTION 201.313
   201.313 Estradiol labeling.
21:4.0.1.1.2.7.1.15SECTION 201.314
   201.314 Labeling of drug preparations containing salicylates.
21:4.0.1.1.2.7.1.16SECTION 201.315
   201.315 Over-the-counter drugs for minor sore throats; suggested warning.
21:4.0.1.1.2.7.1.17SECTION 201.316
   201.316 Drugs with thyroid hormone activity for human use; required warning.
21:4.0.1.1.2.7.1.18SECTION 201.317
   201.317 Digitalis and related cardiotonic drugs for human use in oral dosage forms; required warning.
21:4.0.1.1.2.7.1.19SECTION 201.319
   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.
21:4.0.1.1.2.7.1.20SECTION 201.320
   201.320 Warning statements for drug products containing or manufactured with chlorofluorocarbons or other ozone-depleting substances.
21:4.0.1.1.2.7.1.21SECTION 201.323
   201.323 Aluminum in large and small volume parenterals used in total parenteral nutrition.
21:4.0.1.1.2.7.1.22SECTION 201.325
   201.325 Over-the-counter drugs for vaginal contraceptive and spermicide use containing nonoxynol 9 as the active ingredient; required warnings and labeling information.
21:4.0.1.1.2.7.1.23SECTION 201.326
   201.326 Over-the-counter drug products containing internal analgesic/antipyretic active ingredients; required warnings and other labeling.
21:4.0.1.1.2.7.1.24SECTION 201.327
   201.327 Over-the-counter sunscreen drug products; required labeling based on effectiveness testing.
21:4.0.1.1.2.7.1.25SECTION 201.328
   201.328 Labeling of medical gas containers.
21:4.0.1.1.2.7.1.26.1APPENDIX Appendix A
   Appendix A to Part 201 - Examples of Graphic Enhancements Used by FDA