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Home Page > Executive Branch > Code of Federal Regulations > Electronic Code of Federal Regulations
e-CFR Data is current as of February 4, 2010
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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| Exceptions or alternatives to labeling requirements for human drug products held by the Strategic National Stockpile. |
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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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| Over-the-counter drugs for vaginal contraceptive and spermicide use containing nonoxynol 9 as the active ingredient; required warnings and labeling information. |
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