CHAPTER I-FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH, EDUCATION AND WELFARE Part SUBCHAPTER A- GENERAL Regulations for the enforcement of the Federal Food, Drug, and Cosmetic Statements of general policy or interpretation. Official records and information. Color additives. Color certification. SUBCHAPTER B-FOOD AND FOOD PRODUCTS Definitions and standards for food. Cacao products; definitions and standards of identity. Cereal flours and related products; definitions and standards of identity. Milk and cream; definitions and standards of identity. Cheeses; processed cheeses; cheese foods; cheese spreads, and related foods; definitions and standards of identity. Frozen desserts; definitions and standards of identity. Food flavorings; definitions and standards of identity. Canned fruits and canned fruit juices; definitions and standards of identity; quality; and fill of container. Fruit butters, fruit jellies, fruit preserves, and related products; definitions and standards of identity. Shellfish. Fish; definitions and standards of identity; standards of fill of container. Eggs and egg products; definitions and standards of identity. Oleomargarine, margarine; definitions and standard of identity. Nut products; definitions and standards of identity. Canned vegetables; definitions and standards of identity; quality; and fill of container. Tomato products; definitions and standards of identity; quality; and fill of container. Part 85 120 121 125 Seafood inspection. Tolerances and exemptions from tolerances for pesticide cl on raw agricultural commodities. Food additives. Label statements concerning dietary properties of food pu or represented for special dietary uses. SUBCHAPTER C- -DRUGS 130 New drugs. 131 132 133 141 Interpretative statements re warnings on drugs and devices counter sale. Registration of producers of drugs. Drugs; current good manufacturing practice in manufactu packing or holding. Tests and methods of assay of antibiotic and antibiotic-contai 141a Penicillin and penicillin-containing drugs; tests and meth 141b Streptomycin (or dihydrostreptomycin) and streptomycinstreptomycin-) containing drugs; tests and methods of assay 141c Chlortetracycline (or tetracycline) and chlortetracycline- (or containing drugs; tests and methods of assay. 141d Chloramphenicol and chloramphenicol-containing drugs; test of assay. 141e Bacitracin and bacitracin-containing drugs; tests and meth 146 General regulations for the certification of antibiotic and taining drugs. 146a Certification of penicillin and penicillin-containing drugs. 146b Certification of streptomycin (or dihydrostreptomycin) and (or dihydrostreptomycin-) containing drugs. 146c Certification of chlortetracycline (or tetracycline) and chl (or tetracycline-) containing drugs. 147 146d Certification of chloramphenicol and chloramphenicol-contai 146e Certification of bacitracin and bacitracin-containing drugs. Antibiotics intended for use in the laboratory diagnosis of dise Certification of batches of drugs composed wholly or part Habit-forming drugs. 164 165 SUBCHAPTER D-HAZARDOUS SUBSTANCES 191 Hazardous substances: definitions and procedural and inte lations. SUBCHAPTER E-REGULATIONS UNDER SPECIFIC ACTS OF OTHER THAN THE FOOD, DRUG, AND COSMETIC 281 Enforcement of the Tea Importation Act. 285 Regulations under the Federal Caustic Poison Act. 290 Regulations for the enforcement of the Federal Import Milk preted or applied are cited to text in parentheses. § 1.2 Labeling; definition. Labeling includes all written, printed, or graphic matter accompanying an article at any time while such article is in interstate commerce or held for sale after shipment or delivery in interstate commerce. (Sec. 201, 52 Stat. 1041, as amended; 21 U. S. C. 321) § 1.3 Difference of opinion among experts. The existence of a difference of opinion, among experts qualified by scientific training and experience, as to the truth of a representation made or suggested in the labeling is a fact (among other facts) the failure to reveal which may render the labeling misleading, if there is a material weight of opinion contrary to such representation. (Sec. 201, 52 Stat. 1041, as amended; 21 U. S. C. 321) PROHIBITED ACTS AND PENALTIES AUTHORITY: §§ 1.4 to 1.6 issued under sec. 701, 52 Stat. 1055, as amended; 21 U. S. C. 871. Statutory provisions interpreted or applied are cited to text in parentheses. § 1.4 Guaranty. In case of the giving of a guaranty or undertaking referred to in section 303 (c) (2) or (3) of the act, each person signing such guaranty or undertaking shall be considered to have given it. (Sec. 301, 52 Stat. 1042, as amended; 21 U. S. C. 331) § 1.5 Guaranty; definition, and suggested forms. (a) A guaranty or undertaking referred to in section 303 (c) (2) of the act may be: (1) Limited to a specific shipment or other delivery of an article, in which case it may be a part of or attached to the invoice or bill of sale covering such shipment or delivery, or (2) General and continuing, in which case, in its application to any shipment or other delivery of an article, it shall be considered to have been given at the date such article was shipped or delivered by the person who gives the guaranty or undertaking. (b) The following are suggested forms of guaranty or undertaking under section 303 (c) (2) of the act: (1) Limited form for use on invoice or bill of sale. (Name of person giving the guaranty or undertaking) hereby guarantees that no article listed herein is adulterated or misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act, or is an article which may not, under the provisions of section 404 or 505 of the act, be introduced into interstate commerce. (Signature and post-office address of person giving the guaranty or undertaking) (2) General and continuing form. The article comprising each shipment or other delivery hereafter made by (name of person giving the guaranty or undertaking) to, or on the order of (name and post-office address of person to whom the guaranty or undertaking is given) is hereby guaranteed, as of the date of such shipment or delivery, to be, on such date, not adulterated or misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act, and not an article which may not, under the provisions of section 404 or 505 of the act, be introduced into interstate commerce. (Signature and post-office address of person giving the guaranty of undertaking) (c) The application of a guaranty or undertaking referred to in section 303 (c) (2) of the act to any shipment or other delivery of an article shall expire when such article, after shipment or delivery by the person who gave such guaranty or undertaking, becomes adulterated or misbranded within the meaning of the act, or becomes an article which may not, under the provisions of section 404 or 505 of the act, be introduced into interstate commerce. (d) A guaranty or undertaking referred to in section 303 (c) (3) of the act shall state that the shipment or other delivery of the color additive covered thereby was manufactured by a signer thereof. It may be a part of or attached to the invoice or bill of sale covering such color. If such shipment or delivery is from a foreign manufacturer, such guaranty or undertaking shall be signed by such manufacturer and by an agent of such manufacturer who resides in the United States. (e) The following are suggested forms of guaranty or undertaking under section 303 (c) (3) of the act: (1) For domestic manufacturers: (Name of manufacturer) hereby guarantees that all color additives listed herein were manufactured by him, and (where color additive regulations require certification) are from batches certified in accordance with the applicable regulations promulgated under |