BUREAU OF SCIENCE Division of Antibiotics and Insulin Certification. Division of Color Certification and Evaluation. Division of Color and Cosmetic Chemistry. Division of Food Standards and Additives. Division of Nutrition. Division of Pharmaceutical Sciences. Division of Toxicological Evaluation. BUREAU OF VETERINARY MEDICINE Division of Veterinary Medical Review. [31 F.R. 12018, Sept. 14, 1966, as amended at 31 F.R. 15088, Dec. 1, 1966, 32 F.R. 12714, Sept. 2, 1967; 32 F.R. 13807, Oct. 4, 1967] The District Offices of the Food and Drug Administration are located as follows: Atlanta: 60 Eighth Street NE., Atlanta, Ga. 30309. Baltimore: 900 Madison Avenue, Baltimore, Md. 21201. Boston: 585 Commercial Street, Boston, Mass. 02109. Buffalo: 599 Delaware Avenue, Buffalo, N.Y. 14202. Chicago: Room 1222, Main Post Office Building, 433 West Van Buren Street, Chicago, Ill. 60607. Cincinnati: 1141 Central Parkway, Cincinnati, Ohio 45202. Dallas: 3032 Bryan Street, Dallas, Tex. 75204. Denver: Room 5604, New Customhouse Build ing, 20th and California Streets, Denver, Colo. 80202. Detroit: 1560 East Jefferson Avenue, Detroit, Mich. 48207. Kansas City: 1009 Cherry Street, Kansas City, Mo. 64106. Los Angeles: 1521 West Pico Boulevard, Los Angeles, Calif. 90015. Minneapolis: 240 Hennepin Avenue, Minneapolis, Minn. 55401. New Orleans: Room 222, U.S. Customhouse Building, 423 Canal Street, New Orleans, La. 70130. New York: 700 Federal Office Building, 850 Third Avenue, Brooklyn, N.Y. 11232. Philadelphia: Room 1204, U.S. Customhouse Building, Second and Chestnut Streets, Philadelphia, Pa. 19106. San Francisco: Room 518, Federal Office Building, 50 Fulton Street, San Francisco, Calif. 94102. Seattle: Room 501, Federal Office Building, 909 First Avenue, Seattle, Wash. 98104. [32 F.R. 12714, Sept. 2, 1967] § 2.174 Bureau of Drug Abuse Control Field Offices. The Field Offices of the Bureau of Drug Abuse Control are located as follows: Atlanta: 1831 Peachtree Street NE., Atlanta, Ga. 30309. Baltimore: 401 Water Street, Baltimore, Md. 21202. 3.2 3.9 3.10 [32 F.R. 12714, Sept. 2, 1967] § 2.175 Regional representatives. Regional Assistant Commissioners represent the Food and Drug Administration in the Regional Offices of the Department of Health, Education, and Welfare. The Regional Offices are located as follows: Atlanta: 50 Seventh Street NE., Atlanta, Ga. 30323. Boston: John F. Kennedy Federal Building, Government Center, Boston, Mass. 02203. Charlottesville: 220 Seventh Street NE., Charlottesville, Va. 22901. Chicago: Room 712, New Post Office Building, 433 West Van Buren Street, Chicago, Ill. 60607. Dallas: 1114 Commerce Street, Dallas, Tex. 75202. 3.11 Termination of exemption for designated foods for which label declaration of ingredients has not been required pending standardization. Notice to packers and shippers of shelled peanuts. Notice to manufacturers, packers, and distributors of glandular preparations. Notice to manufacturers, packers, and distributors of drugs for internal use which contain mineral oil. Disposition of incubator reject eggs. Notice to importers of Peruvian canned fish. Potassium permanganate preparations as prescription drugs. prescription Amphetamine and methamphetamine Label declaration of vitamin E in food Notice to manufacturers and users in food products of monosodium glutamate. Notice to manufacturers, packers, and distributors of estrogenic hormone preparations. 3.12 Tannic acid and barium enema preparations. 3.13 Grain seed treated with poisonous substances; color identification to prevent adulteration of human and animal food. § 3.2 Notice to packers and shippers of shelled peanuts. Investigations by the Food and Drug Administration have shown that a number of interstate shipments of shelled peanuts in bags holding from approximately 100 to 125 pounds each have failed to bear labeling as required by the terms of the Federal Food, Drug, and Cosmetic Act. Shelled peanuts in sacks, whether or not shipped in carload lots, should bear the following information required by the law on food in package form: (a) The name of the product. (b) An accurate statement of net weight. (c) The name and place of business of the packer or distributor. This information should be conspicuously set forth. It may be printed or stenciled on each bag or, if desired, placed on tags which are securely attached to each bag. The net weight marked on the bags must be the correct net weight of the peanuts at the time they are delivered to the carrier for interstate shipment. The tare weight of the bag should not be included in the weight declaration. [20 F.R. 9541, Dec. 20, 1955] § 3.3 Notice to manufacturers, packers, and distributors of glandular preparations. Under date of December 4, 1941, in a notice to manufacturers of glandular preparations, the Food and Drug Administration expressed the opinion that preparations of inert glandular materials intended for medicinal use should, in view of the requirement of section 201 (n) of the Federal Food, Drug, and Cosmetic Act (52 Stat. 1041; 21 U.S.C. 321 (n)), be labeled with a statement of the material fact that there is no scientific evidence that the articles contain any therapeutic or physiologically active constituents. Numerous preparations of such inert glandular materials were subsequently marketed with disclaimers of the type suggested. The term "inert glandular materials" means preparations incapable of exerting an action or effect of some significant or measurable benefit in one way or another, i.e., in the diagnosis, cure, mitigation, treatment, or prevention of disease, or in affecting the structure or any function of the body. Manufacturers have heretofore taken advantage of § 1.106 (b) of this chapter, permitting omission of directions for use when the label bears the prescription legend. Section 1.106 (b) (3) of this chapter requires that the labeling of the drug, which may include brochures readily available to licensed practitioners, bear information as to the use of the drug by practitioners licensed by law to administer it. Obviously, information adequate for the use of an inert glandular preparation is not available to practitioners licensed by law. The Department of Health, Education, and Welfare is of the opinion that inert glandular materials may not be exempted from the requirements of section 502 (f) (1) of the act that they bear adequate directions for use; and, accordingly, that their labeling must include, among other things, representations as to the conditions for which such articles are intended to be used or as to the structure or function of the human body that they are intended to affect. Since any such representations offering these articles for use as drugs would be false or misleading, such articles will be considered to be misbranded if they are distributed for use as drugs. The amended regulations provide also that in the case of drugs intended for parenteral administration there shall be no exemption from the requirement that their labelings bear adequate directions for use. Such inert glandular materials for parenteral use are therefore subject to the same comment as applies to those intended for oral administration. [20 F.R. 9542, Dec. 20, 1955, as amended at 22 F.R. 10685, Dec. 25, 1957] § 3.4 Notice to manufacturers, packers, and distributors of drugs for internal use which contain mineral oil. In the past few years research studies have altered medical opinion as to the usefulness and harmfulness of mineral oil in the human body. These studies have indicated that when mineral oil is used orally near mealtime it interferes with absorption from the digestive tract of provitamin A and the fat-soluble vitamins A, D, and K, and consequently interferes with the utilization of calcium and phosphorus, with the result that the user is left liable to deficiency diseases. When so used in pregnancy it predisposes to hemorrhagic disease of the newborn. There is accumulated evidence that the indiscriminate administration of mineral oil to infants may be followed by aspiration of the mineral oil and subsequent "lipoid pneumonia." In view of these facts, the Department of Health, Education, and Welfare will regard as misbranded under the provisions of the Federal Food, Drug, and Cosmetic Act a drug for oral administration consisting in whole or in part of mineral oil, the labeling of which encourages its use in pregnancy or indicates or implies that such drug is for administration to infants. It is also this Department's view that the act requires the labelings of such drugs to bear a warning against consumption other than at bedtime and against administration to infants. The following form of warning is suggested: "Caution: To be taken only at bedtime. Do not use at any other time or administer to infants, except upon the advice of a physician.' This statement of interpretation does not in any way exempt mineral oil or preparations containing mineral oil from complying in all other respects with the requirements of the Federal Food, Drug, and Cosmetic Act. [20 F.R. 9542, Dec. 20, 1955] § 3.5 Disposition of incubator reject eggs. (a) Investigations by the Food and Drug Administration and a number of State regulatory agencies have revealed that incubator reject eggs, removed as infertile or otherwise unhatchable during hatching operations, are being diverted for human food use. Such eggs are regarded as adulterated within the meaning of section 402 (a) (3) of the Federal Food, Drug, and Cosmetic Act (52 Stat. 1046; 21 U.S.C. 342(a) (3) because they are unfit for food. (b) The introduction or delivery for introduction into interstate commerce of adulterated eggs is prohibited under section 301 (a) of the aforesaid act (52 Stat. 1042; 21 U. S. C. 331 (a) unless they have been broken, crushed, or smashed and then denatured with kerosene, creolin, or other suitable denaturant to preclude their diversion to human food channels. (Secs. 301, 402, 52 Stat. 1042, 1046; 21 U. S. C.. 331, 342) [23 F. R. 6834, Sept. 5, 1958] |