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.

(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 to 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.

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."

Pessaries for intracervical and intrauterine use.

3.50 Status of salt substitutes under the Federal Food, Drug, and Cosmetic Act.

(DMSO) preparations; clinical testing and investigational use.

Oral prenatal drugs containing fluorides intended for human use. Antibiotics used in veterinary medicine and for nonmedical purposes; required data.

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.

3.60 3.61

3.32 Label declarations of vitamin B1, and folic acid in foods for special dietary

3.62 3.63

Cosmetics containing bithionol.
Use of secondhand containers for the
shipment or storage of food and ani-
mal feed.

Established names for drugs.
Thyroid-containing drug preparations
intended for treatment of obesity in
humans.

3.64 Stramonium preparations labeled with directions for use in self-medication regarded as misbranded.

3.65 Status of foods and drugs containing calamus, as the root, oil, or extract. 3.67 Isoproterenol inhalation preparations (pressurized aerosols, nebulizers, powders) for human use; warnings. 3.68 Medicated feeds; approval of new-drug applications.

3.69 Artificially red-dyed yellow varieties of sweetpotatoes.

3.70 Labeling for food fish of the species Reinhardtius hippoglossoides. 3.71 Amyl nitrite inhalant as a prescription drug for human use.

Sec. 3.76

3.77

3.78

3.80 3.81

Contract facilities (including consulting laboratories) utilized as extramural facilities by pharmaceutical

manufacturers.

The use of methadone in the maintenance treatment of narcotic addicts.

Combinations of nutritive and nonnutritive sweeteners in canned fruits.

Red blood cells (human)-frozen. Disclosure of drug efficacy study evaluations in labeling and advertising. 3.82 Quantity of contents declaration on open basket type carrier for soft drinks.

3.84 Use of impact-resistant lenses in eyeglasses and sunglasses.

3.85 Revisions of procedures for recall of products from the market. 3.86 Fixed-combination prescription drugs for humans.

Subpart B-Informal Statements of General Policy or Interpretation FOODS

Lemon extract; orange extract
Malted milk.

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]

(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