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219 Part 331—Antacid Products for Over-The Food and Drug Administration, HHS § 331.10 publish a notice of proposed rule- PART 331—ANTACID PRODUCTS making to include the condition in FOR OVER-THE-COUNTER (OTC) § 310.502 of this chapter. HUMAN USE (5) Interested parties will have an op- portunity to submit comments and new Subpart A—General Provisions data. The agency will subsequently publish a final rule (or reproposal if Sec. 331.1 Scope. necessary) in the FEDERAL REGISTER. (h) Marketing. A condition submitted Subpart B—Active Ingredients under this section for consideration in the OTC drug monograph system may 331.10 Antacid active ingredients. 331.11 Listing of specific active ingredients. be marketed in accordance with an ap- 331.15 Combination with nonantacid active plicable final OTC drug monograph(s) ingredients. only after the agency determines that the condition is generally recognized as Subpart C—Testing Procedures safe and effective and includes it in the 331.20 Determination of percent contribu- appropriate OTC drug final mono- tion of active ingredients. graph(s), and the condition complies 331.21 Test Modifications. with paragraph (i) of this section. When an OTC drug monograph has not Subpart D—Labeling been finalized and finalization is not 331.30 Labeling of antacid products. imminent, after the agency has evalu- 331.80 Professional labeling. ated the comments to a proposed rule AUTHORITY: 21 U.S.C. 321, 351, 352, 353, 355, to include a new condition in a ten- 360, 371. tative final monograph as generally SOURCE: 39 FR 19874, June 4, 1974, unless recognized as safe and effective and the otherwise noted. agency has not changed its position as a result of the comments, and the con- Subpart A—General Provisions dition complies with paragraph (i) of this section, the agency may publish a § 331.1 Scope. notice of enforcement policy that al- An over-the-counter antacid product lows marketing to begin pending com- in a form suitable for oral administra- pletion of the final monograph subject tion is generally recognized as safe and to the risk that the agency may, prior effective and is not misbranded if it to or in the final monograph, adopt a meets each of the following conditions different position that could require re- and each of the general conditions es- labeling, recall, or other regulatory ac- tablished in § 330.1 of this chapter. tion. (i) Compendial monograph. Any active Subpart B—Active Ingredients ingredient or botanical drug substance included in a final OTC drug mono- § 331.10 Antacid active ingredients. graph or the subject of an enforcement (a) The active antacid ingredients of notice described in paragraph (h) of the product consist of one or more of this section must be recognized in an the ingredients permitted in § 331.11 official USP-NF drug monograph that within any maximum daily dosage sets forth its standards of identity, limit established, each ingredient is in- strength, quality, and purity. Sponsors cluded at a level that contributes at must include an official or proposed least 25 percent of the total acid neu- compendial monograph as part of the tralizing capacity of the product, and safety and effectiveness data submis- the finished product contains at least 5 sion listed in § 330.10(a)(2) under item meq of acid neutralizing capacity as VII of the outline entitled ‘‘OTC DRUG measured by the procedure provided in the United States Pharmacopeia 23/Na- REVIEW INFORMATION.’’ tional Formulary 18. The method es- [67 FR 3074, Jan. 23, 2002] tablished in § 331.20 shall be used to de- termine the percent contribution of each antacid active ingredient. 219 VerDate Nov<24>2008 14:36 Jun 03, 2009 Jkt 217069 PO 00000 Frm 00229 Fmt 8010 Sfmt 8010 Y:\SGML\217069.XXX 217069 § 331.11 21 CFR Ch. I (4–1–09 Edition) (b) This section does not apply to an (6) Magnesium hydroxide. antacid ingredient specifically added as (7) Magnesium oxide. a corrective to prevent a laxative or (8) Magnesium trisilicate. constipating effect. (h) Milk solids, dried. [39 FR 19874, June 4, 1974, as amended at 61 (i) Phosphate-containing active in- FR 4822, Feb. 8, 1996] gredients: (1) Aluminum phosphate; maximum § 331.11 Listing of specific active in- daily dosage limit 8 grams. gredients. (2) Mono or dibasic calcium salt; (a) Aluminum-containing active in- maximum daily dosage limit 2 grams. gredients: (3) Tricalcium phosphate; maximum (1) Basic aluminum carbonate gel. daily dosage limit 24 grams. (2) Aluminum hydroxide (or as alu- minum hydroxide-hexitol stabilized (j) Potassium-containing active in- polymer, aluminum hydroxide-magne- gredients: sium carbonate codried gel, aluminum (1) Potassium bicarbonate (or car- hydroxide-magnesium trisilicate bonate when used as a component of an codried gel, aluminum-hydroxide su- effervescent preparation); maximum crose powder hydrated). daily dosage limit 200 mEq. of bicar- (3) Dihydroxyaluminum amino- bonate ion for persons up to 60 years acetate and dihydroxyaluminum ami- old and 100 mEq. of bicarbonate ion for noacetic acid. persons 60 years or older. (4) Aluminum phosphate gel when (2) Sodium potassium tartrate. used as part of an antacid combination (k) Sodium-containing active ingre- product and contributing at least 25 dients: percent of the total acid neutralizing (1) Sodium bicarbonate (or carbonate capacity; maximum daily dosage limit when used as a component of an effer- is 8 grams. vescent preparation); maximum daily (5) Dihydroxyaluminum sodium car- dosage limit 200 mEq. of sodium for bonate. persons up to 60 years old and 100 mEq. (b) Bicarbonate-containing active in- of sodium for persons 60 years or older, gredients: Bicarbonate ion; maximum and 200 mEq. of bicarbonate ion for per- daily dosage limit 200 mEq. for persons sons up to 60 years old and 100 mEq. of up to 60 years old and 100 mEq. for per- sons 60 years or older. bicarbonate ion for persons 60 years or (c) Bismuth-containing active ingre- older. That part of the warning re- dients: quired by § 330.1(g), which states, ‘‘Keep (1) Bismuth aluminate. this and all drugs out of the reach of (2) Bismuth carbonate. children’’ is not required on a product (3) Bismuth subcarbonate. which contains only sodium bicarbon- (4) Bismuth subgallate. ate powder and which is intended pri- (5) Bismuth subnitrate. marily for other than drug uses. (d) Calcium-containing active ingre- (2) Sodium potassium tartrate. dients: Calcium, as carbonate or phos- (l) Silicates: phate; maximum daily dosage limit 160 (1) Magnesium aluminosilicates. mEq. calcium (e.g., 8 grams calcium (2) Magnesium trisilicate. carbonate). (m) Tartrate-containing active ingre- (e) Citrate-containing active ingredi- dients. Tartaric acid or its salts; max- ents: Citrate ion, as citric acid or salt; imum daily dosage limit 200 mEq. (15 maximum daily dosage limit 8 grams. grams) of tartrate. (f) Glycine (aminoacetic acid). (g) Magnesium-containing active in- [39 FR 19874, June 4, 1974, as amended at 51 gredients: FR 27763, Aug. 1, 1986; 55 FR 19859, May 11, (1) Hydrate magnesium aluminate ac- 1990] tivated sulfate. (2) Magaldrate. § 331.15 Combination with nonantacid (3) Magnesium aluminosilicates. active ingredients. (4) Magnesium carbonate. (a) An antacid may contain any gen- (5) Magnesium glycinate. erally recognized as safe and effective 220 VerDate Nov<24>2008 14:36 Jun 03, 2009 Jkt 217069 PO 00000 Frm 00230 Fmt 8010 Sfmt 8010 Y:\SGML\217069.XXX 217069 Food and Drug Administration, HHS § 331.30 nonantacid laxative ingredient to cor- submitted will be subject to the disclo- rect for constipation caused by the ant- sure rules in part 20 of this chapter. acid. No labeling claim of the laxative [61 FR 4823, Feb. 8, 1996] effect may be used for such a product. (b) An antacid may contain any gen- erally recognized as safe and effective Subpart D—Labeling analgesic ingredient(s), if it is indi- cated for use solely for the concurrent § 331.30 Labeling of antacid products. symptoms involved, e.g., headache and (a) Statement of identity. The labeling acid indigestion, and is marketed in a of the product contains the established form intended for ingestion as a solu- name of the drug, if any, and identifies tion. the product as an ‘‘antacid.’’ (c) An antacid may contain any gen- (b) Indications. The labeling of the erally recognized as safe and effective product states, under the heading ‘‘In- antiflatulent ingredient if it is indi- dications,’’ the following: ‘‘For the re- cated for use solely for the concurrent lief of’’ (optional, any or all of the fol- symptoms of gas associated with heart- lowing:) ‘‘heartburn,’’ ‘‘sour stomach,’’ burn, sour stomach or acid indigestion. and/or ‘‘acid indigestion’’ (which may be followed by the optional statement:) Subpart C—Testing Procedures ‘‘and upset stomach associated with’’ (optional, as appropriate) ‘‘this symp- § 331.20 Determination of percent con- tom’’ or ‘‘these symptoms.’’ Other tribution of active ingredients. truthful and nonmisleading state- ments, describing only the indications To determine the percent contribu- for use that have been established and tion of an antacid active ingredient, listed in this paragraph (b), may also place an accurately weighed amount of be used, as provided in § 330.1(c)(2) of the antacid active ingredient equal to this chapter, subject to the provisions the amount present in a unit dose of of section 502 of the act relating to the product into a 250-milliliter (mL) misbranding and the prohibition in sec- beaker. If wetting is desired, add not tion 301(d) of the act against the intro- more than 5 mL of alcohol (neutralized duction or delivery for introduction to an apparent pH of 3.5), and mix to into interstate commerce of unap- wet the sample thoroughly. Add 70 mL proved new drugs in violation of sec- of water, and mix on a magnetic stirrer tion 505(a) of the act.
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