Title 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
PART 201--LABELING
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| 201.1 |
Drugs; name and place of business of manufacturer, packer, or distributor. |
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| 201.2 |
Drugs and devices; National Drug Code numbers. |
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| 201.5 |
Drugs; adequate directions for use. |
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| 201.6 |
Drugs; misleading statements. |
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| 201.10 |
Drugs; statement of ingredients.
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| 201.15 |
Drugs; prominence of required label statements. |
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| 201.16 |
Drugs; Spanish-language version of certain required statements. |
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| 201.17 |
Drugs; location of expiration date. |
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| 201.18 |
Drugs; significance of control numbers. |
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| 201.19 |
Drugs; use of term ``infant''. |
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| 201.20 |
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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| 201.21 |
Declaration of presence of phenylalanine as a component of aspartame in over-the-counter and prescription drugs for human use. |
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| 201.22 |
Prescription drugs containing sulfites; required warning statements. |
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| 201.23 |
Required pediatric studies. |
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| 201.24 |
Labeling for systemic antibacterial drug products. |
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| 201.25 |
Bar code label requirements. |
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| 201.50 |
Statement of identity. |
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| 201.51 |
Declaration of net quantity of contents. |
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| 201.55 |
Statement of dosage. |
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| 201.56 |
General requirements on content and format of labeling for human prescription drugs. |
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| 201.56 |
Requirements on content and format of labeling for human prescription drug and biological products. |
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| 201.57 |
Specific requirements on content and format of labeling for human prescription drugs. |
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| 201.57 |
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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| 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). |
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| 201.58 |
Requests for waiver of requirement for adequate and well-controlled studies to substantiate certain labeling statements. |
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| 201.58 |
Waiver of labeling requirements. |
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| 201.59 |
Effective date of 201.56, 201.57, 201.100(d)(3), and 201.100(e). |
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| 201.60 |
Principal display panel. |
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| 201.61 |
Statement of identity. |
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| 201.62 |
Declaration of net quantity of contents. |
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| 201.63 |
Pregnancy/breast-feeding warning. |
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| 201.64 |
Sodium labeling.
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| 201.66 |
Format and content requirements for over-the-counter (OTC) drug product labeling.
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| 201.70 |
Calcium labeling. |
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| 201.71 |
Magnesium labeling. |
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| 201.72 |
Potassium labeling. |
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| 201.100 |
Prescription drugs for human use. |
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| 201.100 |
Prescription drugs for human use. |
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| 201.105 |
Veterinary drugs. |
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| 201.115 |
New drugs or new animal drugs. |
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| 201.116 |
Drugs having commonly known directions. |
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| 201.117 |
Inactive ingredients. |
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| 201.119 |
In vitro diagnostic products. |
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| 201.120 |
Prescription chemicals and other prescription components.
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| 201.122 |
Drugs for processing, repacking, or manufacturing.
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| 201.125 |
Drugs for use in teaching, law enforcement, research, and analysis. |
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| 201.127 |
Drugs; expiration of exemptions. |
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| 201.128 |
Meaning of ``intended uses''. |
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| 201.129 |
Drugs; exemption for radioactive drugs for research use. |
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| 201.150 |
Drugs; processing, labeling, or repacking. |
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| 201.161 |
Carbon dioxide and certain other gases. |
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| 201.200 |
Disclosure of drug efficacy study evaluations in labeling and advertising. |
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| 201.300 |
Notice to manufacturers, packers, and distributors of glandular preparations. |
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| 201.301 |
Notice to manufacturers, packers, and distributors of estrogenic hormone preparations. |
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| 201.302 |
Notice to manufacturers, packers, and distributors of drugs for internal use which contain mineral oil. |
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| 201.303 |
Labeling of drug preparations containing significant proportions of wintergreen oil. |
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| 201.304 |
Tannic acid and barium enema preparations. |
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| 201.305 |
Isoproterenol inhalation preparations (pressurized aerosols, nebulizers, powders) for human use; warnings. |
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| 201.306 |
Potassium salt preparations intended for oral ingestion by man.
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| 201.307 |
Sodium phosphates; package size limitation, warnings, and directions for over-the-counter sale. |
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| 201.308 |
Ipecac syrup; warnings and directions for use for over-the-counter sale. |
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| 201.309 |
Acetophenetidin (phenacetin)-containing preparations; necessary warning statement. |
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| 201.310 |
Phenindione; labeling of drug preparations intended for use by man. |
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| 201.312 |
Magnesium sulfate heptahydrate; label declaration on drug products. |
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| 201.313 |
Estradiol labeling. |
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| 201.314 |
Labeling of drug preparations containing salicylates. |
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| 201.315 |
Over-the-counter drugs for minor sore throats; suggested warning. |
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| 201.316 |
Drugs with thyroid hormone activity for human use; required warning. |
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| 201.317 |
Digitalis and related cardiotonic drugs for human use in oral dosage forms; required warning. |
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| 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. |
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| 201.320 |
Warning statements for drug products containing or manufactured with chlorofluorocarbons or other ozone-depleting substances. |
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| 201.322 |
Over-the-counter drug products containing internal analgesic/antipyretic active ingredients; required alcohol warning. |
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| 201.323 |
Aluminum in large and small volume parenterals used in total parenteral nutrition. |