Title 21, Part 201 — Labeling

Drugs; name and place of business of manufacturer, packer, or distributor.

Drugs and devices; National Drug Code numbers.

Drugs; adequate directions for use.

Drugs; misleading statements.

Drugs; statement of ingredients.

Drugs; prominence of required label statements.

Drugs; Spanish-language version of certain required statements.

Drugs; location of expiration date.

Drugs; significance of control numbers.

Drugs; use of term “infant”.

Declaration of presence of FD&C Yellow No. 5 and/or FD&C Yellow No. 6 in certain drugs for human use.

Declaration of presence of phenylalanine as a component of aspartame in over-the-counter and prescription drugs for human use.

Prescription drugs containing sulfites; required warning statements.

Required pediatric studies.

Labeling for systemic antibacterial drug products.

Bar code label requirements.

Exceptions or alternatives to labeling requirements for human drug products held by the Strategic National Stockpile.

Statement of identity.

Declaration of net quantity of contents.

Statement of dosage.

Requirements on content and format of labeling for human prescription drug and biological products.

Specific requirements on content and format of labeling for human prescription drug and biological products described in § 201.56(b)(1).

Waiver of labeling requirements.

Principal display panel.

Statement of identity.

Declaration of net quantity of contents.

Pregnancy/breast-feeding warning.

Sodium labeling.

Format and content requirements for over-the-counter (OTC) drug product labeling.

Labeling requirements for a nonprescription drug product with an additional condition for nonprescription use (ACNU).

Calcium labeling.

Magnesium labeling.

Potassium labeling.

Specific requirements on content and format of labeling for human prescription drug and biological products; older drugs not described in § 201.56(b)(1).

Prescription drugs for human use.

Veterinary drugs.

New drugs or new animal drugs.

Drugs having commonly known directions.

Inactive ingredients.

In vitro diagnostic products.

Prescription chemicals and other prescription components.

Drugs for processing, repacking, or manufacturing.

Drugs for use in teaching, law enforcement, research, and analysis.

Drugs; expiration of exemptions.

Meaning of “intended uses”.

Drugs; exemption for radioactive drugs for research use.

Exemption from adequate directions for use for a nonprescription drug product with an additional condition for nonprescription use (ACNU).

Drugs; processing, labeling, or repacking.

Medical gases.

Disclosure of drug efficacy study evaluations in labeling and advertising.

Notice to manufacturers, packers, and distributors of glandular preparations.

Notice to manufacturers, packers, and distributors of estrogenic hormone preparations.

Notice to manufacturers, packers, and distributors of drugs for internal use which contain mineral oil.

Labeling of drug preparations containing significant proportions of wintergreen oil.

Tannic acid and barium enema preparations.

Isoproterenol inhalation preparations (pressurized aerosols, nebulizers, powders) for human use; warnings.

Potassium salt preparations intended for oral ingestion by man.

Sodium phosphates; package size limitation, warnings, and directions for over-the-counter sale.

Ipecac syrup; warnings and directions for use for over-the-counter sale.

Acetophenetidin (phenacetin)-containing preparations; necessary warning statement.

Phenindione; labeling of drug preparations intended for use by man.

[Reserved]

Magnesium sulfate heptahydrate; label declaration on drug products.

Estradiol labeling.

Labeling of drug preparations containing salicylates.

Over-the-counter drugs for minor sore throats; suggested warning.

Drugs with thyroid hormone activity for human use; required warning.

Digitalis and related cardiotonic drugs for human use in oral dosage forms; required warning.

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.

Warning statements for drug products containing or manufactured with chlorofluorocarbons or other ozone-depleting substances.

Aluminum in large and small volume parenterals used in total parenteral nutrition.

Over-the-counter drugs for vaginal contraceptive and spermicide use containing nonoxynol 9 as the active ingredient; required warnings and labeling information.

Over-the-counter drug products containing internal analgesic/antipyretic active ingredients; required warnings and other labeling.

Over-the-counter sunscreen drug products; required labeling based on effectiveness testing.

Labeling of medical gas containers.