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Home , Magaldrate

Pt. 331 21 CFR Ch. I (4–1–12 Edition)

imminent, after the agency has evalu- AUTHORITY: 21 U.S.C. 321, 351, 352, 353, 355, ated the comments to a proposed rule 360, 371. to include a new condition in a ten- SOURCE: 39 FR 19874, June 4, 1974, unless tative final monograph as generally otherwise noted. recognized as safe and effective and the agency has not changed its position as Subpart A—General Provisions a result of the comments, and the con- dition complies with paragraph (i) of § 331.1 Scope. this section, the agency may publish a notice of enforcement policy that al- An over-the-counter 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 REVIEW INFORMATION.’’ the United States Pharmacopeia 23/Na- 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 PART 331—ANTACID PRODUCTS each antacid active ingredient. FOR OVER-THE-COUNTER (OTC) (b) This section does not apply to an HUMAN USE antacid ingredient specifically added as a corrective to prevent a laxative or Subpart A—General Provisions constipating effect.

Sec. [39 FR 19874, June 4, 1974, as amended at 61 331.1 Scope. FR 4822, Feb. 8, 1996]

Subpart B—Active Ingredients § 331.11 Listing of specific active in- gredients. 331.10 Antacid active ingredients. (a) Aluminum-containing active in- 331.11 Listing of specific active ingredients. gredients: 331.15 Combination with nonantacid active ingredients. (1) Basic aluminum carbonate gel. (2) Aluminum hydroxide (or as alu- Subpart C—Testing Procedures minum hydroxide-hexitol stabilized polymer, aluminum hydroxide-magne- 331.20 Determination of percent contribu- sium carbonate codried gel, aluminum tion of active ingredients. hydroxide- trisilicate 331.21 Test Modifications. codried gel, aluminum-hydroxide su- crose powder hydrated). Subpart D—Labeling (3) Dihydroxyaluminum amino- 331.30 Labeling of antacid products. acetate and dihydroxyaluminum ami- 331.80 Professional labeling. noacetic acid.

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(4) Aluminum phosphate gel when (k) -containing active ingre- used as part of an antacid combination dients: product and contributing at least 25 (1) (or carbonate percent of the total acid neutralizing when used as a component of an effer- capacity; maximum daily dosage limit vescent preparation); maximum daily is 8 grams. dosage limit 200 mEq. of sodium for (5) Dihydroxyaluminum sodium car- persons up to 60 years old and 100 mEq. bonate. of sodium for persons 60 years or older, (b) Bicarbonate-containing active in- and 200 mEq. of bicarbonate ion for per- gredients: Bicarbonate ion; maximum sons up to 60 years old and 100 mEq. of daily dosage limit 200 mEq. for persons bicarbonate ion for persons 60 years or up to 60 years old and 100 mEq. for per- older. That part of the warning re- sons 60 years or older. quired by § 330.1(g), which states, ‘‘Keep (c) Bismuth-containing active ingre- this and all drugs out of the reach of dients: children’’ is not required on a product (1) Bismuth aluminate. which contains only sodium bicarbon- (2) Bismuth carbonate. ate powder and which is intended pri- (3) Bismuth subcarbonate. marily for other than drug uses. (4) Bismuth subgallate. (2) Sodium potassium tartrate. (5) Bismuth subnitrate. (l) Silicates: (d) -containing active ingre- (1) Magnesium aluminosilicates. dients: Calcium, as carbonate or phos- (2) Magnesium trisilicate. phate; maximum daily dosage limit 160 (m) Tartrate-containing active ingre- mEq. calcium (e.g., 8 grams calcium dients. Tartaric acid or its salts; max- carbonate). imum daily dosage limit 200 mEq. (15 (e) Citrate-containing active ingredi- grams) of tartrate. ents: Citrate ion, as citric acid or salt; [39 FR 19874, June 4, 1974, as amended at 51 maximum daily dosage limit 8 grams. FR 27763, Aug. 1, 1986; 55 FR 19859, May 11, (f) Glycine (aminoacetic acid). 1990] (g) Magnesium-containing active in- gredients: § 331.15 Combination with nonantacid (1) Hydrate magnesium aluminate ac- active ingredients. tivated sulfate. (a) An antacid may contain any gen- (2) Magaldrate. erally recognized as safe and effective (3) Magnesium aluminosilicates. nonantacid laxative ingredient to cor- (4) . rect for caused by the ant- (5) Magnesium glycinate. acid. No labeling claim of the laxative (6) . effect may be used for such a product. (7) . (b) An antacid may contain any gen- (8) Magnesium trisilicate. erally recognized as safe and effective (h) Milk solids, dried. analgesic ingredient(s), if it is indi- (i) Phosphate-containing active in- cated for use solely for the concurrent gredients: symptoms involved, e.g., headache and (1) Aluminum phosphate; maximum acid indigestion, and is marketed in a daily dosage limit 8 grams. form intended for ingestion as a solu- (2) Mono or dibasic calcium salt; tion. maximum daily dosage limit 2 grams. (c) An antacid may contain any gen- (3) Tricalcium phosphate; maximum erally recognized as safe and effective daily dosage limit 24 grams. antiflatulent ingredient if it is indi- (j) Potassium-containing active in- cated for use solely for the concurrent gredients: symptoms of gas associated with heart- (1) Potassium bicarbonate (or car- burn, sour stomach or acid indigestion. bonate when used as a component of an effervescent preparation); maximum Subpart C—Testing Procedures daily dosage limit 200 mEq. of bicar- bonate ion for persons up to 60 years § 331.20 Determination of percent con- old and 100 mEq. of bicarbonate ion for tribution of active ingredients. persons 60 years or older. To determine the percent contribu- (2) Sodium potassium tartrate. tion of an antacid active ingredient,

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