21 C.F.R. PART 201--LABELING
TITLE 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER C--DRUGS: GENERAL
PART 201--LABELING
Subpart A--GENERAL LABELING PROVISIONS
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| Drugs; name and place of business of manufacturer, packer, or distributor.
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| Drugs and devices; National Drug Code numbers.
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| Drugs; adequate directions for use.
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| Drugs; misleading statements.
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| Drugs; statement of ingredients.
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| Drugs; prominence of required label statements.
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| Drugs; Spanish-language version of certain required statements.
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| Drugs; location of expiration date.
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| Drugs; significance of control numbers.
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| Drugs; use of term ''infant''.
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| Declaration of presence of FD&C Yellow No. 5 and/or FD&C Yellow No. 6 in certain drugs for human use.
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| Declaration of presence of phenylalanine as a component of aspartame in over-the-counter and prescription drugs for human use.
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| Prescription drugs containing sulfites; required warning statements.
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| Required pediatric studies.
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| Labeling for systemic antibacterial drug products.
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| Bar code label requirements.
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Subpart B--LABELING REQUIREMENTS FOR PRESCRIPTION DRUGS AND/OR INSULIN
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| Declaration of net quantity of contents.
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| Requirements on content and format of labeling for human prescription drug and biological products.
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| Specific requirements on content and format of labeling for human prescription drug and biological products described in 201.56(b)(1).
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| Waiver of labeling requirements.
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Subpart C--LABELING REQUIREMENTS FOR OVER-THE-COUNTER DRUGS
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| Declaration of net quantity of contents.
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| Pregnancy/breast-feeding warning.
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| Format and content requirements for over-the-counter (OTC) drug product labeling.
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| Specific requirements on content and format of labeling for human prescription drug and biological products; older drugs not described in 201.56(b)(1).
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Subpart D--EXEMPTIONS FROM ADEQUATE DIRECTIONS FOR USE
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| Prescription drugs for human use.
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| New drugs or new animal drugs.
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| Drugs having commonly known directions.
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| In vitro diagnostic products.
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| Prescription chemicals and other prescription components.
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| Drugs for processing, repacking, or manufacturing.
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| Drugs for use in teaching, law enforcement, research, and analysis.
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| Drugs; expiration of exemptions.
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| Meaning of ''intended uses''.
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| Drugs; exemption for radioactive drugs for research use.
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Subpart E--OTHER EXEMPTIONS
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| Drugs; processing, labeling, or repacking.
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| Carbon dioxide and certain other gases.
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Subpart F--LABELING CLAIMS FOR DRUGS IN DRUG EFFICACY STUDY
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| Disclosure of drug efficacy study evaluations in labeling and advertising.
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Subpart G--SPECIFIC LABELING REQUIREMENTS FOR SPECIFIC DRUG PRODUCTS
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| Notice to manufacturers, packers, and distributors of glandular preparations.
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| Notice to manufacturers, packers, and distributors of estrogenic hormone preparations.
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| Notice to manufacturers, packers, and distributors of drugs for internal use which contain mineral oil.
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| Labeling of drug preparations containing significant proportions of wintergreen oil.
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| Tannic acid and barium enema preparations.
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| Isoproterenol inhalation preparations (pressurized aerosols, nebulizers, powders) for human use; warnings.
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| Potassium salt preparations intended for oral ingestion by man.
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| Sodium phosphates; package size limitation, warnings, and directions for over-the-counter sale.
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| Ipecac syrup; warnings and directions for use for over-the-counter sale.
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| Acetophenetidin (phenacetin)-containing preparations; necessary warning statement.
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| Phenindione; labeling of drug preparations intended for use by man.
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| Magnesium sulfate heptahydrate; label declaration on drug products.
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| Labeling of drug preparations containing salicylates.
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| Over-the-counter drugs for minor sore throats; suggested warning.
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| Drugs with thyroid hormone activity for human use; required warning.
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| Digitalis and related cardiotonic drugs for human use in oral dosage forms; required warning.
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| 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.
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| Warning statements for drug products containing or manufactured with chlorofluorocarbons or other ozone-depleting substances.
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| Over-the-counter drug products containing internal analgesic/antipyretic active ingredients; required alcohol warning.
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| Aluminum in large and small volume parenterals used in total parenteral nutrition.
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