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 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. regarding issuance, (t) Delegation regarding issuance of notices of filing of petitions and notices of proposed rulemaking pertaining to food standards, food additives, and color additives. The Director of the Bureau of Foods is authorized to perform all the functions of the Commissioner of Food and Drugs under sections 401, 409, and 706 of the Federal Food, Drug, and Cosmetic Act regarding the issuance of notices of filing of petitions and notices of proposed rulemaking pertaining tc food standards, food additives, and color additives. (Sec. 3(a) (1), 60 Stat. 238; 5 U.S.C. 552) [29 F.R. 471, Jan. 18, 1964. Redesignated, 31 F.R. 3008, Feb. 22, 1966 and 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. 4462, Mar. 13, 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; 36 F.R. 5842, Mar. 30, 1971; 36 F.R. 7128, Apr. 15, 1971; 36 F.R. 10728, June 2, 1971; 36 F.R. 14255, Aug. 3, 1971; 36 F.R. REGION VI Field Office: 3032 Bryan Street, Dallas, TX 75204. District Office: 3032 Bryan Street, Dallas, TX 75204. District Office: Room 222, 423 Canal Street, New Orleans, LA 70130. REGION VII Field Office: 1009 Cherry Street, Kansas City, MO 64106. REGION VIII Field Office: Room 513, 20th and California Streets, Denver CO 80202. REGION IX Field Office: Room 518, 50 Fulton Street, San Francisco, CA 94102. District Office: Room 518, 50 Fulton Street, San Francisco, CA 94102. District Office: 1521 West Pico Boulevard, Los Angeles, CA 90015. REGION X Field Office: Room 501, 909 First Avenue, Seattle, WA 98104. [36 F.R. 25222, Dec. 30, 1971] PART 3-STATEMENTS OF GENERAL POLICY OR INTERPRETATION Subpart A-Formal Statements of Policy or Interpretation 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. Sec. REGION II 8.1 Field Office: 850 Third Avenue, Brooklyn, NY 11232. District Office: 850 Third Avenue, Brooklyn, NY 11232. 3.2 District Office: 599 Delaware Avenue, Buffalo, NY 14202. 3.3 Sec. 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. 8.17 Labeling of oleomargarine or margarine. 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. 8.20 Tolerances for moldy and insect-infested cocoa beans. 8.21 Drug preparations intended for human use containing certain "coronary vasodilators.” 8.22 Suprarenal glands from hog carcasses prior to final inspection. 8.23 Notice to manufacturers and users of monosodium glutamate and other hydrolyzed vegetable protein products. 8.24 Notice to packers of comminuted tomato products. 8.25 Antibiotics used in food-producing animals. 3.26 Labeling exemptions for foods repackaged in retail food establishments. 8.27 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 3.62 3.63 Cosmetics containing bithionol. Use of secondhand containers for the Established names for drugs. 3.64 Stramonium preparations labeled with directions for use in self-medication regarded as misbranded. 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 Canned clams; canned fish roe; establishshrimp (dry and wet pack). 3.206 Whipped cream products containing flavoring or sweetening. DRUGS 3.501 Mailing of important information 3.502 3.503 3.505 3.506 about drugs. Use of term "infant" in drug labeling. label declaration on drug products. Estradiol labeling. Use of octadecylamine in steam lines of drug establishments. 3.507 Location of expiration date in drug labeling. 3.508 Significance of control numbers on drug labeling. 3.509 Labeling of drug preparations containing salicylates. 3.510 Over-the-counter drugs for minor sore throats; suggested warning. 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 (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 indi |