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					                                                                           Food and Drug Administration, HHS                                                               § 201.319

                                                                             (b) Drugs for human use with thyroid                    § 201.319 Water-soluble gums, hydro-
                                                                           hormone activity are misbranded with-                          philic   gums,    and     hydrophilic
                                                                           in the meaning of section 502 of the                           mucilloids (including, but not lim-
                                                                           Federal Food, Drug, and Cosmetic Act                           ited to agar, alginic acid, calcium
                                                                           unless their labeling bears the fol-                           polycarbophil,
                                                                                                                                          carboxymethylcellulose         sodium,
                                                                           lowing boxed warning at the beginning                          carrageenan,                 chondrus,
                                                                           of the ‘‘Warnings’’ section:                                   glucomannan       ((B-1,4       linked)
                                                                                                                                          polymannose acetate), guar gum,
                                                                               Drugs with thyroid hormone activity,
                                                                                                                                          karaya gum, kelp, methylcellulose,
                                                                             alone or together with other therapeutic
                                                                                                                                          plantago       seed         (psyllium),
                                                                             agents, have been used for the treatment
                                                                                                                                          polycarbophil tragacanth, and xan-
                                                                             of obesity. In euthyroid patients, doses
                                                                                                                                          than gum) as active ingredients; re-
                                                                             within the range of daily hormonal re-
                                                                                                                                          quired warnings and directions.
                                                                             quirements are ineffective for weight re-                  (a) Reports in the medical literature
                                                                             duction. Larger doses may produce seri-                 and data accumulated by the Food and
                                                                             ous or even life-threatening manifesta-                 Drug Administration indicate that
                                                                             tions of toxicity, particularly when                    esophageal obstruction and asphyxia-
                                                                             given       in      association     with
                                                                             sympathomimetic amines such as those
                                                                                                                                     tion have been associated with the in-
                                                                             used for their anorectic effects.                       gestion of water-soluble gums, hydro-
                                                                                                                                     philic      gums,     and      hydrophilic
                                                                                                                                     mucilloids including, but not limited
                                                                           [43 FR 22009, May 23, 1978]                               to,    agar,   alginic    acid,     calcium
                                                                                                                                     polycarbophil, carboxymethylcellulose
                                                                           § 201.317 Digitalis     and    related                    sodium,       carrageenan,        chondrus,
                                                                               cardiotonic drugs for human use in                    glucomannan          ((B–1,4         linked)
                                                                               oral dosage forms; required warn-                     polymannose acetate), guar gum,
                                                                               ing.                                                  karaya gum, kelp, methylcellulose,
                                                                             (a) Digitalis and related cardiotonic                   plantago          seed          (psyllium),
                                                                           drugs for human use in oral dosage                        polycarbophil, tragacanth, and xan-
                                                                           forms have been promoted for, and con-                    than gum. Esophageal obstruction and
                                                                           tinue to be dispensed and prescribed                      asphyxiation due to orally-adminis-
                                                                           for, use in the treatment of obesity, al-                 tered drug products containing water-
                                                                           though their safety and effectiveness                     soluble gums, hydrophilic gums, and
                                                                           for that use have never been estab-                       hydrophilic mucilloids as active ingre-
                                                                           lished.                                                   dients are significant health risks
                                                                             (b) Digitalis and related cardiotonic                   when these products are taken without
                                                                           drugs for human use in oral dosage                        adequate fluid or when they are used
                                                                           forms are misbranded within the mean-                     by individuals with esophageal nar-
                                                                           ing of section 502 of the Federal Food,                   rowing or dysfunction, or with dif-
                                                                           Drug, and Cosmetic Act unless their la-                   ficulty in swallowing. Additional label-
                                                                           beling bears the following boxed warn-                    ing is needed for the safe and effective
                                                                           ing at the beginning of the ‘‘Warnings’’                  use of any OTC drug product for human
                                                                           section:                                                  use containing a water-soluble gum,
                                                                                                                                     hydrophilic     gum,    or     hydrophilic
                                                                                                                                     mucilloid as an active ingredient when
                                                                               Digitalis alone or with other drugs has               marketed in a dry or incompletely hy-
                                                                             been used in the treatment of obesity.                  drated form to include, but not limited
                                                                             This use of digoxin or other digitalis
                                                                                                                                     to, the following dosage forms: Cap-
                                                                             glycosides is unwarranted. Moreover,
                                                                             since they may cause potentially fatal                  sules, granules, powders, tablets, and
                                                                             arrhythmias or other adverse effects,                   wafers. Granular dosage forms con-
                                                                             the use of these drugs in the treatment                 taining psyllium are not generally rec-
                                                                             of obesity is dangerous.                                ognized as safe and effective as OTC
                                                                                                                                     laxatives (see § 310.545(a)(12)(i)(B) of
                                                                             (c) This section does not apply to dig-                 this chapter) and may not be marketed
                                                                                                                                     without an approved new drug applica-
WReier-Aviles on DSKGBLS3C1PROD with CFR




                                                                           oxin products for oral use, which shall
                                                                           be labeled according to the require-                      tion because the warnings and direc-
                                                                           ments of § 310.500 of this chapter.                       tions in paragraph (b) of this section
                                                                                                                                     have been found inadequate for these
                                                                           [43 FR 22009, May 23, 1978]                               products.

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                                                                           § 201.320                                                               21 CFR Ch. I (4–1–11 Edition)

                                                                             (b) Any drug products for human use                     graph (b) or (c) of this section, bear the
                                                                           containing a water-soluble gum, hydro-                    following warning statement:
                                                                           philic gum, or hydrophilic mucilloid as
                                                                                                                                        Warning: Contains [or Manufactured with,
                                                                           an active ingredient in an oral dosage                    if applicable] [insert name of substance], a sub-
                                                                           form when marketed in a dry or incom-                     stance which harms public health and the
                                                                           pletely hydrated form as described in                     environment by destroying ozone in the
                                                                           paragraph (a) of this section are mis-                    upper atmosphere.
                                                                           branded within the meaning of section
                                                                           502 of the Federal Food, Drug, and Cos-                     (2) The warning statement shall be
                                                                           metic Act unless their labeling bears                     clearly legible and conspicuous on the
                                                                           the following warnings (under the sub-                    product, its immediate container, its
                                                                           heading ‘‘Choking’’) and directions:                      outer packaging, or other labeling in
                                                                                                                                     accordance with the requirements of 40
                                                                             ‘‘ ‘Choking’ [highlighted in bold
                                                                                                                                     CFR part 82 and appear with such
                                                                           type]: Taking this product without
                                                                                                                                     prominence and conspicuousness as to
                                                                           adequate fluid may cause it to swell
                                                                                                                                     render it likely to be read and under-
                                                                           and block your throat or esophagus and
                                                                                                                                     stood by consumers under normal con-
                                                                           may cause choking. Do not take this
                                                                                                                                     ditions of purchase.
                                                                           product if you have difficulty in swal-
                                                                           lowing. If you experience chest pain,                       (b)(1) For prescription drug products
                                                                           vomiting, or difficulty in swallowing or                  for human use, the following alter-
                                                                           breathing after taking this product,                      native warning statement may be used:
                                                                           seek immediate medical attention;’’                         NOTE: The indented statement below is re-
                                                                           and                                                       quired by the Federal government’s Clean
                                                                             ‘‘ ‘Directions’ [highlighted in bold                    Air Act for all products containing or manu-
                                                                           type]:’’ (Select one of the following, as                 factured with chlorofluorocarbons (CFC’s)
                                                                                                                                     [or name of other class I substance, if appli-
                                                                           appropriate: ‘‘Take’’ or ‘‘Mix’’) ‘‘this
                                                                                                                                     cable]:
                                                                           product (child or adult dose) with at
                                                                           least 8 ounces (a full glass) of water or                   This product contains [or is manufactured
                                                                           other fluid. Taking this product with-                    with, if applicable] [insert name of substance],
                                                                           out enough liquid may cause choking.                      a substance which harms the environment by
                                                                                                                                     destroying ozone in the upper atmosphere.
                                                                           See choking warning.’’
                                                                                                                                       Your physician has determined that this
                                                                             (c) After February 28, 1994, any such                   product is likely to help your personal
                                                                           OTC drug product initially introduced                     health. USE THIS PRODUCT AS DIRECTED,
                                                                           or initially delivered for introduction                   UNLESS INSTRUCTED TO DO OTHERWISE
                                                                                                                                     BY YOUR PHYSICIAN. If you have any ques-
                                                                           into interstate commerce, or any such                     tions about alternatives, consult with your
                                                                           drug product that is repackaged or re-                    physician.
                                                                           labeled after this date regardless of the
                                                                           date the product was manufactured,                          (2) The warning statement shall be
                                                                           initially introduced, or initially deliv-                 clearly legible and conspicuous on the
                                                                           ered for introduction into interstate                     product, its immediate container, its
                                                                           commerce, that is not in compliance                       outer packaging, or other labeling in
                                                                           with this section is subject to regu-                     accordance with the requirements of 40
                                                                           latory action.                                            CFR part 82 and appear with such
                                                                                                                                     prominence and conspicuousness as to
                                                                           [58 FR 45201, Aug. 26, 1993, as amended at 64             render it likely to be read and under-
                                                                           FR 13292, Mar. 17, 1999; 72 FR 14674, Mar. 29,            stood by consumers under normal con-
                                                                           2007]
                                                                                                                                     ditions of purchase.
                                                                           § 201.320 Warning statements for drug                       (3) If the warning statement in para-
                                                                               products containing or manufac-                       graph (b)(1) of this section is used, the
                                                                               tured with chlorofluorocarbons or                     following warning statement must be
                                                                               other ozone-depleting substances.                     placed on the package labeling in-
                                                                             (a)(1) All drug products containing or                  tended to be read by the physician
                                                                           manufactured                        with                  (physician package insert) after the
                                                                           chlorofluorocarbons, halons, carbon                       ‘‘How supplied’’ section, which de-
WReier-Aviles on DSKGBLS3C1PROD with CFR




                                                                           tetrachloride, methyl chloride, or any                    scribes special handling and storage
                                                                           other class I substance designated by                     conditions on the physician labeling:
                                                                           the Environmental Protection Agency                         NOTE: The indented statement below is re-
                                                                           (EPA) shall, except as provided in para-                  quired by the Federal government’s Clean

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