(i) Delegations regarding certification of antibiotic drugs. The Director of the Office of Certification Services, a unit within the Office of the Associate Commissioner for Compliance, is 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 animal drug applications and approved new animal drug application supplements for new animal drugs. The Director of the Bureau of Veterinary Medicine is authorized to perform all the functions of the Commissioner of Food and Drugs with regard to the approval of new animal drug applications, and new animal drug application supplements, for new animal drugs submitted pursuant to section 512 of the Federal Food, Drug, and Cosmetic Act. The Director of the Division of Veterinary Medical Review of the Bureau of Veterinary Medicine is authorized to perform the functions of the Commissioner with regard to the approval of applications for animal feeds containing new animal drugs. (k) Delegations regarding approved new-drug applications and approved new-drug application supplements for drugs for human use. The Director of the Bureau of Medicine is authorized to notify applicants, pursuant to §§ 130.9 and 130.10 of this chapter, of approved new-drug applications and approved new-drug application supplements, for drugs for human use. (1) Delegation regarding review of denials of requests for records made pursuant to § 5.53 (45 CFR 5.53). The Chief, Press Relations Staff, Office of Assistant Commissioner for Education and Information, is authorized to review under § 5.82 (45 CFR 5.82) denials by the Information Center Officer of the Food and Drug Administration of written requests for inspection or copying of records of the Administration. Such requests are made pursuant to the Public Information Act (Public Law 90-23). (m) [Reserved] (n) Delegation regarding designation of official master and working standards for antibiotic drugs. The Director of the Bureau of Drugs is authorized to designate official Food and Drug Administration master and working standards for antibiotic drugs under § 145.3 of this chapter. (0) Delegations regarding emergency functions. Each Regional Food and Drug Director is authorized, during any period when normal channels of direction are disrupted between the Food and Drug Administration headquarters and his region, to fully represent the Food and Drug Administration within his region in consonance with the Department of Health, Education, and Welfare regional emergency plans and to exercise the authority of the Commissioner for supervision of and direction to all Food and Drug Administration activities and use of resources within his region for continuity and for Federal Emergency Health Service operations. These same officials are authorized to provide in Regional Emergency Plans for the delegation of Food and Drug Administration regional authorities to heads of field activities when such activities are cut off from national and regional headquarters. (p) Delegations regarding enforcement activities. (1) Duly appointed and authorized inspectors, officers, and employees of the Food and Drug Administration who have been issued the Food and Drug Administration official credentials consisting of FD Form 200a entitled "Identification Record" and FD Form 200b entitled "Specification of General Authority" are designated by the Commissioner of Food and Drugs: (i) 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, the Fair Packaging and Labeling Act, the Federal Caustic Poison Act, the Federal Hazardous Substances Act, the Import Milk Act, the Filled Milk Act, the Tea Importation Act, and section 361 of the Public Health Service Act. (ii) To administer oaths and affirmations under section 1 of the Act of January 31, 1925 (Ch. 124, 43 Stat. 803); sections 12 to 15 of Reorganization Plan No. IV, effective June 30, 1940; and Reorganization Plan No. 1 of 1953, effective April 11, 1953. (2) Duly appointed and authorized inspectors, officers, and employees of the Food and Drug Administration who have been issued the Food and Drug Administration official credentials consisting of FD Form 200a entitled "Identification Record" and FD Form 200c entitled "Specification of General and Special Authority" are designated by the Commissioner of Food and Drugs: (i) To perform the duties enumerated in subparagraph (1) (i) and (ii) of this paragraph. (ii) 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), 507 (d) and (g), and 512 (1) and (m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355 (i) and (j), 357 (d) and (g), and 360b (1) and (m)). (3) The Food and Drug Administration official credentials referred to in subparagraphs (1) and (2) of this paragraph are described as follows: (i) FD Form 200a entitled "Identification Record" bears a color photograph, description, and signature of the bearer, an identification number, an expiration date, the Department of Health, Education, and Welfare seal with blue imprint centered to the left of the photograph and the Food and Drug Administration symbol centered to the right of the photograph. (ii) FD Form 200b entitled "Specification of General Authority" bears the holder's name, his general authority, an identification number, an expiration date, and the Commissioner's signature. (iii) FD Form 200c entitled "Specification of General and Special Authority" bears the holder's name, his general and special authority, an identification number, an expiration date, and the Commissioner's signature and is superimposed in the lower right corner with a red, white, and blue stripe imprint. (iv) Both FD Form 200b and FD Form 200c bear the name of the Department of Health, Education, and Welfare, Public Health Service, and Food and Drug Administration and are superimposed with the Department seal with blue imprint. (q) Delegations regarding certification following inspections. Regional Food and Drug Directors and Deputy Regional Food Food and Drug Directors are authorized to issue certificates of sanitation pursuant to § 72.181 (42 CFR 72.181). (r) Delegations regarding awarding grants and fellowships. The Associate and Deputy Associate Commissioner for Science are authorized to award grants and fellowships pursuant to sections 301, 311, and 314 of the Public Health Service Act. (s) Delegation regarding issuance, amendment, or repeal of regulations pertaining to antibiotic drugs for human use. The Director of the Bureau of Drugs is authorized to perform all the functions of the Commissioner of Food and Drugs under section 507 of the Federal Food, Drug, and Cosmetic Act regarding the issuance, amendment, or repeal of regulations pertaining to antibiotic drugs for human use. (Sec. 3(a)(1), 60 Stat. 238; 5 U.S.C. 552) [29 F.R. 471, Jan. 18, 1964, as amended at 31 F.R. 12018, Sept. 4, 1966; 32 F.R. 712, Jan. 21, 1967; 32 F.R. 13187, Sept. 16, 1967; 33 F.R. 3111, Feb. 17, 1968; 33 F.R. 4462, Mar. 13, 1968; 33 F.R. 9608, July 2, 1968; 33 F.R. 15652, Oct. 23, 1968; 35 F.R. 7068, May 5, 1970; 35 F.R. 13196, Aug. 19, 1970; 35 F.R. 13644, Aug. 27, 1970; 35 F.R. 15749, Oct. 7, 1970; 35 F.R. 15912, Oct. 9, 1970. Redesignated, 31 F.R. 3008, Feb. 22, 1966] Subparts I-L-[Reserved] Subpart M-Organization SOURCE: The provisions of this Subpart M appear at 35 F.R. 19993, Dec. 31, 1970, unless otherwise noted. safety functions to the Bureau of Product Safety effective October 21, 1970, and the transfer of certain pesticides functions to the Environmental Protection Agency effective December 2, 1970. BUREAU OF PRODUCT SAFETY BUREAU OF VETERINARY MEDICINE Division of Compliance. Division of New Animal Drugs. Division of Veterinary Medical Review. § 2.172 Food, Drug, and Environmental Health Division, Office of the General Counsel, Department of Health, Education, and Welfare. Office of the Assistant General Counsel for Food, Drugs, and Environmental Health, Room 6-57, 5600 Fishers Lane, Rockville, Maryland 20852. Hearing Clerk, Room 6-62, 5600 Fishers Lane, Rockville, Maryland 20852. § 2.173 Regional Offices. The Regional Offices of the Food and Drug Administration are located as Dallas: 3032 Bryan Street, Dallas, Texas 75204. Denver: 513 New Customhouse, Denver, Colorado 80202. Detroit: 1560 East Jefferson Avenue, Detroit, Michigan 48207 Kansas City: 1009 Cherry Street, Kansas City, Missouri 64106 Los Angeles: 1521 West Pico Boulevard, Los Angeles, California 90015 Minneapolis: 240 Hennepin Avenue, Minneapolis, Minnesota 55401 New Orleans: Room 222, 423 Canal Street, New Orleans, Louisiana 70130 New York: 850 Third Avenue, Brooklyn, New York 11232 Philadelphia: Room 1204, Second and Chestnut Streets, Philadelphia, Pennsylvania 19106 San Francisco: Room 518, 50 Fulton Street, San Francisco, California 94102 Seattle: 909 First Avenue, Room 5003, Seattle, Washington 98104 PART 3-STATEMENTS OF GENERAL POLICY OR INTERPRETATION Subpart A-Formal Statements of Policy or Interpretation Atlanta: 60 Eighth Street, NE., Atlanta, Georgia 30309. 8.1 Boston: 585 Commercial Street, Boston, Massachusetts 02109. Chicago: Room 1222, 433 West Van Buren Street, Chicago, Illinois 60607. 3.2 Dallas: 3032 Bryan Street, Dallas, Texas 75204. 8.3 Denver: 513 New Customhouse, Denver, Colo 3.4 rado 80202. Kansas City: 1009 Cherry Street, Kansas City, Missouri 64106. New York: 850 Third Avenue, Brooklyn, New York 11232. 3.5 3.6 Philadelphia: Room 1204, Second and Chestnut Streets, Philadelphia, Pennsylvania 19106. 3.7 San Francisco: Room 518, 50 Fulton Street, 3.8 3.9 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 prescription drugs. Label declaration of vitamin E in food for special dietary use. Notice to manufacturers and users in food products of monosodium glutamate. 3.11 Notice to manufacturers, packers, and distributors of estrogenic hormone preparations. 3.12 Tannic acid and barium enema preparations. Maryland 21201. 3.13 Boston: 585 Commercial Street, Boston, Mas Grain seed treated with poisonous substances: color identification to prevent adulteration of human and animal food. Notice to manufacturers and distributors of foods and drugs containing artificial sweeteners. 3.15 Potassium salt preparations intended for oral ingestion by man. Sec. 3.16 Use of ox bile from condemned livers from slaughtered animals in the manufacture of drugs. 8.17 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 Antibiotics used in food-producing animals. 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. 3.32 Label declarations of vitamin B1, and folic acid in foods for special dietary uses. 3.48 3.49 Cobalt preparations intended for use by man. Pessaries for intracervical and intrauterine use. 3.50 Status of salt substitutes under the Federal Food, Drug, and Cosmetic Act. 3.51 Label declaration of D-erythroascorbic acid when it is an ingredient of a fabricated food. 3.52 Dimethylsulfoxide (DMSO) preparations; clinical testing and investigational use. 3.53 Oral prenatal drugs containing fluorides intended for human use. 3.54 Epinephrine injection 1:1000 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 Labeling of articles intended for lay use in the repairing and/or refitting of dentures. 3.57 Stocks of packages and labels not complying with section 4 of the Fair Packaging and Labeling Act. 3.58 3.59 3.35 Labeling of drug preparations containing significant proportions of wintergreen oil. 3.36 Thorium dioxide for drug use. 3.37 Acetophenetidin (phenacetin) containing preparations; necessary warning statement. 3.38 Declaration of quantity of contents on labels for canned oysters. 3.39 Use of vegetable fat in products which are imitations of ice cream. 3.40 Preparations for the treatment of pernicious anemia. 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. 3.62 3.63 Animal feeds contaminated with Sal- Use of poultry litter as animal feed. Use of secondhand poultry crates as Established names for drugs. 3.64 Stramonium preparations labeled with directions for use in self-medication regarded as misbranded. 3.502 3.503 3.505 Use of term "infant" in drug labeling. label declaration on drug products. Estradiol labeling. 3.506 Use of octadecylamine in steam lines of drug establishments. 8.507 Location of expiration date in drug labeling. 3.508 Significance of control numbers on drug labeling. 8.509 Labeling of drug preparations containing salicylates. 3.510 Over-the-counter drugs for minor sore throats; suggested warning. 3.511 Injectable iron preparations for veterinary use. 3.512 New-drug status of timed-release dosage forms of drugs. 3.513 Supplying pharmacists with indications and dosage of drugs. 3.514 Statement of dosage on prescription drug labels. 3.515 Exemption from certain drug-labeling requirements. 8.516 Gelsemium-containing preparations regarded as prescription drugs. 3.517 New animal drugs; transitional provisions re section 512 of the act. 3.518 Labeling exemption for carbon dioxide, cyclopropane, ethylene, helium, and nitrous oxide gases for drug use. 3.700 Definition of ammonia under Federal Caustic Poison Act. AUTHORITY: The provisions of this Part 3 issued under sec. 701, 52 Stat. 1055; 21 U.S.C. 371, unless otherwise noted. Subpart A-Formal Statements of Policy or Interpretation § 3.1 Termination of exemption for designated foods for which label declaration of ingredients has not been required pending standardization. Effective September 17, 1959, the exemption from the label declaration of ingredients requirements of section 403 (i) (2) of the Federal Food, Drug, and Cosmetic Act is terminated for the following foods: Canned clams; canned fish roe; canned Olives in brine. Sauerkraut. Unmixed canned fruits, properly prepared and in sugar solution of not less than 20° Brix, not in excess of the amount necessary for proper processing, but with no other added substance. Unmixed immature canned vegetables, properly prepared and with water not in excess of the amount necessary for proper processing, with or without added salt or 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] |