hearing shall be filed in the office of the hearing clerk. The record of the hearing shall include the transcript of the testimony, including any exhibits and together with any written arguments that may have been filed with the presiding officer.

§ 1.711 Copies of the record of the hearing.

The Department will make provisions for a stenographic record of the testimony and for such copies of the transcript thereof as it requires for its own purposes. Any person desiring a copy of the record of the hearing or of any part thereof shall be entitled to the same upon application to the hearing clerk and upon payment of the costs thereof. Suggested corrections to transcripts of the testimony shall be considered only if offered within a period (to be fixed by the presiding officer) of not more than 3 days following the completion of the testimony, for which purpose the record shall be kept open for such additional period. The presiding officer shall have authority to act upon such suggested corrections.

The Secretary, within a reasonable time after the filing of the record of the hearing, will issue his proposed order, which shall be served upon the interested persons whose appearances were entered at the hearing by publication in the FEDERAL REGISTER or by mailing a copy of the proposed order to each of such persons by registered mail: Provided, however, That if, after examination of the record of the hearing, the Secretary finds that no controversy with respect to the subject of the hearing exists between the persons who appeared thereat, and that such action will promote the purposes of the act, the Secretary will issue a final order in lieu of issuing a proposed order in accordance with this section.

§ 1.713 Exceptions.

Within a reasonable time, which shall be specified in the proposed order but shall not exceed 20 days from the time of the issuance of such order, any interested person whose appearance was filed at the hearing may file exceptions to the proposed order. The exceptions shall point out with particularity the alleged errors in said proposed order, and shall contain a specific reference to the page

of the transcript of the testimony or to the exhibit on which each exception is based. Such exceptions may be accompanied by a memorandum or brief in support thereof.

§ 1.714 Final order.

The Secretary thereafter will issue his final order. A duplicate original thereof shall thereupon be filed with the Archivist of the United States and published in the FEDERAL REGISTER. A duplicate original thereof shall also be filed with the hearing clerk for public inspection.

PUBLIC NOTICE OF REGULATIONS

§ 1.715 Public notice of regulations.

Public notice of the issuance of the foregoing rules of practice for hearings in §§ 1.701-1.714 shall be given by publishing the same in the FEDERAL REGISTER.

Sec.

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.

3.22 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

3.505 3.506

Use of octadecylamine in steam lines of food and drug establishments. 3.507 Location of expiration date in drug labeling.

3.508 Significance of control numbers o drug labeling.

3.509 Labeling of drug preparations con taining salicylates.

3.510 Over-the-counter drugs for minor sor throats; suggested warning. 3.511 Injectable iron preparations for vet erinary use.

3.512 New-drug status of timed-release dos age forms of drugs.

3.513 Supplying pharmacists with indica tions and dosage of drugs.

3.514 Statement of dosage on prescriptio drug labels.

3.515 Exemption from certain drug-labelin requirements.

3.516 Gelsemium-containing

preparation regarded as prescription drugs. COSMETICS

3.651 Shampoo preparations containing e as one of the ingredients.

3.652 Labeling of detergent substance other than soap, intended for u in cleansing the body.

CAUSTIC POISON

by man.

Subpart A-Formal Statements of

1

Policy or Interpretation 1

AUTHORITY: §§ 3.1 to 3.51 issued under sec. 701, 52 Stat. 1055, as amended; 21 U. S. C. 371. Statutory provisions interpreted or applied are cited to text in parentheses. §3.1 Termination of exemption for designated foods for which label declaration of ingredients has not been required pending standardization.

(a) 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 shrimp (dry and wet pack).

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.

Jnmixed 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.

(b) The exemption from label declaraion of ingredients requirements of secion 403 (i) (2) of the Federal Food, Drug, nd Cosmetic Act as applied to nonalcotolic carbonated beverages is continued ntil the effective date of a final order ssued as a result of the proceedings tarted by the publication in the FEDERAL EGISTER Of September 14, 1963, of a otice proposing to establish a definition nd standard of identity for this class of Dod.

Sec. 403, 52 Stat. 1047; 21 U.S.C. 343) [26 R. 5369, June 15, 1961, as amended at 28 R. 9982, Sept. 14, 1963]

3.2 Notice to packers and shippers of shelled peanuts.

Investigations by the Food and Drug dministration have shown that a numer of interstate shipments of shelled eanuts in bags holding from approxiately 100 to 125 pounds each have failed bear labeling as required by the terms the Federal Food, Drug, and Cosmetic ct.

122 F.R. 9593, Nov. 30, 1957.

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 gland

ular 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, 19571

§ 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

(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, o smashed and then denatured with kero sene, creolin, or other suitable denatur ant to preclude their diversion to human food channels.

(Secs. 301, 402, 52 Stat. 1042, 1046; 21 U. S. 331, 342) [23 F. R. 6834, Sept. 5, 1958] § 3.6 Notice to importers of Peruvia canned fish.

In collaboration with the Unite States Department of State and official of the Government of Peru, the Foo and Drug Administration of the Depart ment of Health, Education, and Welfa has made a study in Peru of the cannin of bonito and tuna packed for exports tion to the United States. The fis known in Peru as bonito constitutes major portion of the pack. Represent tive specimens of Peruvian bonito ha been identified as the species Sar chilensis. This confirms previous info

mation that the species of fish constituting the commercial bonito fishery in Peru is the same species of bonito that has been packed in this country in small quantities and sold as bonito, for many years. Minor quantities of another bonito, Sarda velox, are apparently caught in Peruvian waters but do not enter the commercial pack to any significant degree. The bonitos, Sarda chilensis and Sarda velox, are not classified as tuna and under the provisions of the Federal Food, Drug, and Cosmetic Act have never been legally labeled as tuna, but must be labeled as "bonito" or "bonito fish."

Two species of tuna, "skipjac” (Katsuwonus pelamis) and "yellowfin" (Thunnus macropterus), are commercially canned in Peru but constitute a relatively small proportion of the Peruvian pack of canned fish exported to the United States.

Information developed during the investigation in Peru shows that the bonito (Sarda chilensis) can be readily distinguished from the tunas. Consequently no difficulty should be encountered by packers in keeping separate the fish in the two classifications and in properly labeling the canned product before shipment.

The provisions of the Federal Food, Drug, and Cosmetic Act require that importations of canned bonito and canned tuna, when offered for entry into the United States, must bear labels designating the product as "bonito" or as "tuna”, as the case may be. Shipments that are unlabeled or mislabeled when offered for entry must be detained and are subject to refusal of admission, with consequent exportation or destruction. [20 F.R. 9542, Dec. 20, 1955]

$3.7 Potassium permanganate preparations as prescription drugs.

(a) There have been a number of reports in the medical literature of serious injuries to women resulting from the misuse of potassium permanganate in an effort to induce abortion. Reports from physicians who have treated such cases show that the injuries are commonly caused by introducing tablets or crystals of potassium permanganate into the vagina. Experience with these cases shows that such use of potassium permanganate is not effective in producing abortion, but that instead the drug produces serious and painful injury to the walls of the vagina, causing ulcers, massive hemorrhage, and infection. Such

dangerous and useless employment of potassium permanganate is apparently encouraged among the misinformed by the mistaken idea that the vaginal bleeding caused by the corrosive action of the drug indicates a termination of pregnancy, which it does not.

(b) Potassium permanganate is a strong oxidizing agent, a highly caustic, tissue-destroying chemical, and a poison. There are no circumstances under which crystals and tablets of potassium permanganate constitute safe dosage forms for use in self-medication. It is the consensus of informed medical opinion that the only dosage forms of potassium permanganate known to be safe for use in self-medication are aqueous solutions containing not more than 0.04 percent potassium permanganate. Such solutions are safe for use in self-medication only by external application to the skin.

(c) In view of the very real potentiality for harmful effect, and the actual injuries caused by the misuse of potassium permanganate, the Food and Drug Administration believes that in order adequately to protect the public health:

(1) Potassium permanganate and potassium permanganate tablets intended for human use are drugs subject to section 503 (b) (1) of the Federal Food, Drug, and Cosmetic Act and should be restricted to prescription sale. Such drugs will be regarded as misbranded if at any time prior to dispensing the label fails to bear the legend, "Caution: Federal law prohibits dispensing without prescription."

(2) Potassium permanganate labeled for use as a prescription component in human drugs under the exemption provided in § 1.106 (k) of this chapter or labeled for manufacturing use under the exemption provided in § 1.106 (1) will be regarded as misbranded unless the label bears the statement, "Caution: Federal law prohibits dispensing without prescription."

(3) These drugs will be regarded as misbranded when intended for veterinary use unless the label bears the legend, "Caution: Federal law restricts this drug to sale by or on the order of a licensed veterinarian"; Provided, however, That this shall not apply to a drug labeled and marketed for veterinary use if such drug contains not more than 50 percent of potassium permanganate and includes other ingredients which make it unsuitable for human use and unlikely