No. IV, effective June 30, 1940, and Reorganization Plan No. 1 of 1953, sections 1 to 9, effective April 11, 1953. (3) Duly appointed and authorized inspectors of the Food and Drug Administration and all officers and employees of the Food and Drug Administration who have been issued the official credential denominated as Form FD-200C entitled "Specification of Special Authority," bearing the signature of the Commissioner of Food and Drugs and containing authorization to copy or verify sections 505 (i) and (j) and 507 (d) and (g) records and reports, have been designated as officers and employees having the authority to request and the authority to have access to and copy and verify records and reports required by sections 505(i) and (j) and 507(d) and (g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335(i) and (j), 357 (d) and (g)). (4) The official credentials denominated as Form FD-200A, Form FD-200B, Form FD-200C, and Form FD-200D, described in subparagraphs (2), (3), and (5) of this paragraph are all superimposed with the seal of the Department of Health, Education, and Welfare, with blue imprint. (5) Duly appointed and authorized agents of the Food and Drug Administration and all officers and employees of the Food and Drug Administration who have been issued the official credentials denominated as Form FD-200A entitled "Identification Record," which bears the description and photograph of the bearer, his signature, identification number, and the date of issuance, and Form FD-200D entitled "Specification of Agent Authority," which contains the name of and describes the general authority of the bearer, and the signature of the Commisisoner of Food and Drugs: (i) Have been designated by the Commissioner of Food and Drugs to conduct examinations, inspections, and investigations; to collect and obtain samples; to have access to and to copy and verify records; and to supervise compliance operations, for the enforcement of the Federal Food, Drug, and Cosmetic Act, as amended. Further, they are specifically designated in accordance with section 702(e) of said act (21 U.S.C. 372(e)) to carry firearms, make arrests, execute seizures, and to perform certain other functions, all as set forth in said section. (ii) Have been designated by the Commissioner of Food and Drugs to admin 66-039-67- 4 ister oaths and affirmations, under the Act of January 31, 1925, Chapter 124, section 1, 43 Stat. 803 (5 U.S.C. 521) and sections 12 to 15 of Reorganization Plan No. IV, effective June 30, 1940, and Reorganization Plan No. 1 of 1953, sections 1 to 9, effective April 11, 1953. (c) Authorization of officials to request samples of imports. (1) The Director of the Bureau of Regulatory Compliance may authorize officials to request, pursuant to section 801(a) of the Federal Food, Drug, and Cosmetic Act, and section 14 of the Hazardous Substances Act, from the Secretary of the Treasury samples of foods, drugs, devices, cosmetics, or hazardous substances imported or offered for import, in order to determine whether such articles are in compliance with those acts. (2) The Director of the Bureau of Drug Abuse Control may authorize officials to request, pursuant to section 801 (a) of the Federal Food, Drug, and Cosmetic Act, from the Secretary of the Treasury samples of depressant or stimulant drugs imported or offered for import, in order to determine whether such articles are in compliance with that act. (d) Certification of true copies and use of Department seal. The Director of the Bureau of Regulatory Compliance and the Director of the Bureau of Drug Abuse Control may certify true copies of documents and cause the seal of the Department of Health, Education, and Welfare to be affixed to such copies. (e) Delegations regarding disclosure of official records. The Director of the Bureau of Regulatory Compliance, the Director of the Division of Case Supervision of that Bureau, the Director of the Bureau of Drug Abuse Control, and the Directors of the Division of Case Assistance and the Division of Investigations of that Bureau are authorized to make determinations to disclose official records and information in accordance with § 4.1 of this chapter. (f) Delegations regarding certification of color additives. The Director of the Bureau of Science and the Director of the Division of Color Certification and Evaluation of that Bureau are authorized to certify batches of color additives for use in food, drugs, or cosmetics, pursuant to section 706 of the Federal Food, Drug, and Cosmetic Act. (g) [Reserved] (h) Delegations regarding certification of insulin. The Director of the Bureau of Science and the Director of the Division of Antibiotics and Insulin Certification of that Bureau are authorized to exercise the functions and duties of the Commissioner under the regulations insofar as such duties and functions involve the certification of batches of drugs containing insulin as contemplated by § 164.3 (a) and (c) of this chapter or approval of the use of materials as contemplated by § 164.2 (j) and (k) of this chapter. (i) Delegations regarding certification of antibiotic drugs. The Director of the Bureau of Science and the Director of the Division of Antibiotics and Insulin Certification of that Bureau are authorized to certify or reject batches of antibiotic drugs, or any derivative of these drugs, pursuant to section 507(a) of the Federal Food, Drug, and Cosmetic Act. (j) Delegations regarding approved new-drug applications for medicated feeds. The Director of the Bureau of Veterinary Medicine is authorized to notify applicants of approved new-drug applications for medicated feeds, pursuant to § 130.10 of this chapter. (k) Delegations regarding approved new-drug application supplements involving only changes in manufacturing processes or controls. The Director of the Bureau of Medicine, the Director of the Division of New Drugs, and the Director of the Bureau of Veterinary Medicine are authorized to notify applicants of supplements to approved new-drug applications involving only changes in manufacturing processes or controls pursuant to § 130.9 of this chapter. (Sec. 3(a) (1), 60 Stat. 238; 5 U.S.C. 1002) [29 F.R. 471, Jan. 18, 1964, as amended at 31 F.R. 8953, June 29, 1966; 31 F.R. 12018, Sept. 14, 1966; 31 F.R. 16564, Dec. 28, 1966. Redesignated, 31 F.R. 3008, Feb. 22, 1966] Subparts I-L-[Reserved] Subpart M-Organization 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] § 2.172 Food and Drug Division, Office of the General Counsel, Department of Health, Education, and Welfare. Office of the Assistant General Counsel for Food and Drugs, Room 5342, Health, Education, and Welfare Building, North, Washington, D.C., 20201. Hearing Clerk, Room 5440, Health, Education, and Welfare Building, North, Washington, D.C., 20201. [29 F.R. 472, Jan. 18, 1964. Redesignated, 31 F.R. 3008, Feb. 22, 1966] § 2.173 District offices. Food and Drug Administration, 60 Eighth Food and Drug Administration, 900 Madison Food and Drug Administration, Room 501, Federal Office Building, 909 First Avenue, Seattle, Wash., 98104. [29 F.R. 14223, Oct. 16, 1964, as amended at 30 F.R. 11279, Sept. 2, 1965; 31 F.R. 8953, June 29, 1966. Redesignated, 31 F.R. 3008, Feb. 22, 1966] § 2.174 Bureau of Drug Abuse Control field offices. Food and Drug Administration, 1831 Peach- Food and Drug Administration, John F. Ken- Food and Drug Administration, 1114 Commerce Street, Dallas, Tex. 75202. Food and Drug Administration, 1814 California Street, Denver, Colo. 80202. Food and Drug Administration, U.S. Courthouse, 811 Grand Avenue, Kansas City, Mo. 64106. Food and Drug Administration, 714 West Olympic Boulevard, Los Angeles, Calif. 90015. Food and Drug Administration, 346 Broadway, New York, N.Y. 10013. [31 F.R. 15088, Dec. 1, 1966] Food and Drug Administration, Room 573, 3.2 3.3 3.4 3.5 3.6 Canal 3.7 3.8 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. Amphetamine and methamphetamine inhalers regarded as drugs. prescription Label declaration of vitamin E in food for special dietary use. 3.10 Notice to manufacturers and users in food products of monosodium glutamate. 3.11 Notice to manufacturers, packers, and distributors of estrogenic hormone preparations. 8.12 Tannic acid and barium enema preparations. Sec. 3.13 Grain seed treated with poisonous substances; color identification to prevent adulteration of human and animal food. 3.14 Notice to manufacturers and distributors of foods and drugs containing artificial sweeteners. 3.15 Potassium salt preparations intended for oral ingestion by man. 3.16 Use of ox bile from condemned livers from slaughtered animals in the manufacture of drugs. 3.17 Labeling of oleomargarine or margarine. 3.18 Drugs for use in milk-producing animals; labeling. 3.19 Notice to manufacturers, packers, and distributors of pasteurized process cheese, pasteurized blended cheese, pasteurized process cheese food, pasteurized process cheese spread, and related foods. 3.20 Tolerances for moldy and insect-infested cocoa beans. 3.21 Drug preparations intended for human use containing certain "coronary vasodilators." 3.22 Suprarenal glands from hog carcasses prior to final inspection. 3.23 Notice to manufacturers and users of monosodium glutamate and other hydrolyzed vegetable protein products. 3.24 Notice to packers of comminuted tomato products. 3.25 Notice to manufacturers and labelers of antibiotic drugs for veterinary use. 3.26 Labeling exemptions for foods repackaged in retail food establishments. 3.27 Status of fluoridated water and foods prepared with fluoridated water under the Federal Food, Drug, and Cosmetic Act. 3.28 Ophthalmic solutions and dispensers. 3.29 Chlorcyclizine, cyclizine, meclizine; warnings; labeling requirements. 3.30 Ipecac syrup; warnings and directions for use for over-the-counter sale. 3.31 Label declaration of salt in frozen vegetables. 8.32 Label declarations of vitamin B1, and folic acid in foods for special dietary uses. 8.33 Status of foods containing added coumarin. 8.34 Labeling of imported crabmeat. 3.35 Labeling of drug preparations containing significant proportions of wintergreen oil. Sec. 3.41 Status of articles offered to the general public for the control or reduction of blood cholesterol levels and for the prevention and treatment of heart and artery disease under the Federal Food, Drug, and Cosmetic Act. 3.42 Status of pteroylglutamic acid (folic acid) in foods for special dietary use and as a drug. 3.43 Phenindione; labeling of drug preparations intended for use by man. 3.44 Aminopyrine or dipyrone drug preparations for human use; directions and warnings. 3.45 3.46 Sterilization of drugs by irradiation. Interpretation of orders relating to dietary supplements; vitamin and mineral-fortified foods; foods for special dietary use. 3.47 DMT, LSD, mescaline and its salts, psilocybin, and psilocyn; conditions for investigational use. 3.48 Cobalt preparations intended for use by man. 3.49 Pessaries for intracervical and intrauterine use. 3.50 Status of salt substitutes under the Federal Food, Drug, and Cosmetic Act. 8.51 Label declaration of D-erythroascorbic acid when it is an ingredient of a fabricated food. 3.52 Dimethylsulfoxide 3.53 (DMSO) prepara tions; clinical testing and investigational use. Oral prenatal drugs containing fluorides intended for human use. 3.54 Epinephrine injection 1:000 in 10-milliliter containers for emergency treatment of anaphylactoid shock in cattle, horses, sheep, and swine. Antibiotics used in veterinary medicine and for nonmedical purposes; required data. 3.55 3.56 Imported canned heat-processed milk products under the Federal Import Milk Act. Subpart B-Informal Statements of General Policy or Interpretation FOODS 8.201 Declaration of pyroligneous acid in food. 3.502 3.503 3.39 Use of vegetable fat in products which are imitations of ice cream. 3.40 Preparations for the treatment of pernicious anemia. 3.505 3.506 Use of octadecylamine in steam lines of food and drug establishments. Use of term "infant" in drug labeling. Magnesium sulfate heptahydrate; label declaration on drug products. Estradiol labeling. sugar or both, but with no other added substance. (Sec. 403, 52 Stat. 1047; 21 U.S.C. 343) [26 F.R. 5369, June 15, 1961] § 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 prep arations. 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, |