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.