21 CFR
Part 201 Labeling
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
- § 201.67 Labeling requirements for a nonprescription drug product with an additional condition for nonprescription use (ACNU)
- § 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
- § 201.130 Exemption from adequate directions for use for a nonprescription drug product with an additional condition for nonprescription use (ACNU)
Subpart E - Other Exemptions
Subpart F - Labeling Claims for Drugs in Drug Efficacy Study
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
- § 201.312 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
- § 201.328 Labeling of medical gas containers