cylate (wintergreen oil) should bear a conspicuous warning such as: "Warning: Do not use otherwise than as directed. Keep out of the reach of children to avoid accidental poisoning."

(2) If the preparation is a counterirritant or rubefacient, it should also bear a caution such as, "Caution: Discontinue use if excessive irritation of the skin develops. Avoid getting into the eyes or on mucous membranes." (See also § 3.35.)

(Sec. 502, 52 Stat. 1051; 21 U. S. C. 352) [23 F. R. 5880, July 16, 1958]

§ 3.510

Over-the-counter drugs for minor sore throats; suggested warning.

The Food and Drug Administration has studied the problem of the labeling of lozenges or troches containing antibiotics and a local anesthetic, chewing gum containing aspirin, various mouth washes and gargles and other articles sold over the counter for the relief of minor irritations of the mouth or throat. It will not object to the labeling of suitable articles of this type "For the temporary relief of minor sore throats," provided this is immediately followed in the labeling with a warning statement in prominent type essentially as follows: "Warning-Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by physician." (Sec. 502, 52 Stat. 1051; 21 U. S. C. 352) [23 FR. 5380, July 16, 1958, 27 F.R. 4418, May 9, 1962]

§ 3.511 Injectable iron preparations for veterinary use.

There has been an increasing interest in the use of injectable iron compounds for the prevention or treatment of irondeficiency anemia in animals. Although some such preparations have been shown to be safe, such articles are regarded as new drugs within the meaning of the Federal Food, Drug, and Cosmetic Act. Accordingly, an effective new-drug application is required prior to the marketing of such preparations within the jurisdiction of the act. In addition to the need for demonstrating the safety of such articles, we are concerned that the labeling of such preparations not only recommends appropriate dosages of iron

but also declares the amount (in milligrams) of available iron (Fe) per milliliter of the subject product.

(Secs. 201(p), 502(f), 505(a), 52 Stat. 1041, 1042, 1051, 1052; 21 U.S.C. 321(p), 355(a)) [24 F.R. 1177, Feb. 17, 1959]

§ 3.512 New-drug status of timed-release dosage forms of drugs.

(a) Many drugs are now being offered in dosage forms that are designed to release the active ingredients over a prolonged period. There is a possibility of unsafe overdosage if such products are improperly made and the active ingredients are released at one time or over too short a time interval. Any such dosage form that contains per dosage unit (for examples, capsule, or tablet), a quantity of active drug ingredients which is not generally recognized as safe for administration as a single dose under the conditions suggested in its labeling, is regarded as a new drug within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act.

(b) The fact that the labeling of this type of drug may claim delayed or prolonged release of all or some of the active ingredients does not affect the new-drug status of such articles. A new-drug application is required in any such case to demonstrate that the drug is in fact safe because it is properly made and controlled to release the total dose at a safe rate. It should be noted particularly that such dosage forms are regarded as new drugs even when the total daily dosage recommended in the labeling is generally recognized as safe. For example, a capsule containing 50 milligrams of pyrilamine maleate and 15 milligrams of phenylephrine hydrochloride, offered for sale without prescription, is regarded as a new drug for which the distributor should have an effective new-drug application, even though the directions call for taking no more than two capsules daily. While the daily intake under such directions is within the range regarded as safe for use in self-medication, the single dose is too high for such use unless the release of the drug is sufficiently prolonged. It is obvious that, in filing a newdrug application for such an article, particular attention should be given to data which establish that the active ingredients are released over a period of time, as represented in the labeling.

(Sec. 201 (p), 52 Stat. 1042; 21 U.S.C. 321(p)) [24 F.R. 3756, May 9, 1959]

§ 3.513 Supplying pharmacists with indications and dosage of drugs.

There are presently no regulations under the Federal Food, Drug, and Cosmetic Act that prevent a manufacturer of prescription drugs from sending the pharmacist data he needs on indications and dosage in exercising his important professional function of checking against possible mistakes in a prescription. The Food and Drug Administration believes manufacturers should be encouraged to supply such printed matter to the pharmacist for his professional information. Obviously, such printed matter should not be displayed to prospective purchasers to promote over-the-counter sale of prescription drugs.

(Secs. 502(1)(1), 503(b) (1) (B), 52 Stat. 1051, 52 Stat. 1052, as amended 65 Stat. 648, 649; 21 U.S.C. 352(1)(1), 353(b)(1)(B)) [24 F.R. 4376, May 30, 1959]

§ 3.514 Statement of dosage on prescription drug labels.

Section 1.106(b) (2) (ii) of this chapter requires that labels for prescription drugs bear a statement of the recommended or usual dosage. Since the dosage for some prescription drugs varies within extremely wide limits, depending upon the conditions being treated, it may not be possible in all cases to present an informative or useful statement of the recommended or usual dosage in the space available on the label or carton of the package. It is the view of the Food and Drug Administration that when such a situation prevails, compliance with this requirement would be met by a statement such as "See package insert for dosage information," where the detailed information is contained in such insert. However, if an informative, realistic, recommended or usual dosage can readily be set forth on the label, it should appear thereon.

[26 F.R. 12518, Dec. 27, 1961]

§ 3.515 Exemption from certain druglabeling requirements.

(a) Section 1.106(b) (3) of this chapter provides that in the case of certain drugs for which directions, hazards, warnings, and use information are commonly known to practitioners licensed by law, such information may be omitted from the dispensing package. Under this proviso, the Commissioner of Food and Drugs will offer an opinion, upon written

request, stating reasonable grounds therefor, on a proposal to omit such information from the dispensing package.

(b) The Commissioner of Food and Drugs has considered submitted material covering a number of drug products and has offered the opinion that the following drugs, when intended for those human uses for which they are now generally employed by the medical profession, should be exempt from the requirements of § 1.106 (b) (3) of this chapter, provided that they meet the conditions prescribed in this paragraph. Preparations that are not in dosage unit form (for example, solutions) will be regarded as meeting the conditions with respect to the maximum quantity of drug per dosage unit if they are prepared in a manner that enables accurate and ready administration of a quantity of drug not in excess of the stated maximum per dosage unit:

Aminophylline. For oral use, not in ex

cess of 200 milligrams per dosage unit, with or without not in excess of 33 milligrams of phenobarbital. Atropine methyl nitrate. For oral use, not in excess of 1.0 milligram per dosage unit.

Atropine sulfate. For oral use, not in excess of 0.54 milligram per dosage unit; for injection, not in excess of 0.54 milligram (120-grain) per dosage unit.

Barbiturates. For oral use, not in excess of 100 milligrams per dosage unit; for use as suppositories, not in excess of 130 milligrams per suppository.

Chloral hydrate. For oral use, not in excess of 500 milligrams per dosage unit; for use as suppositories, not in excess of 1.0 gram per suppository. Codeine phosphate. For oral use, not in excess of 65 milligrams per dosage unit; for injection, not in excess of 65 milligrams per dosage unit. Codeine sulfate. For oral use, not in excess of 65 milligrams per dosage unit; for injection, not in excess of 65 milligrams per dosage unit. Digitalis. Preparations of whole leaf digitalis including forms such as digitalis tincture. For oral use, containing the equivalent of not more than 1 U.S.P. digitalis unit per dosage unit. Dihydrocodeinone bitartrate. For oral use, not in excess of 10 milligrams per dosage unit.

use, not in excess of 1 milligram per dosage unit.

Hyoscyamine sulfate. For oral use, not in excess of 1 milligram per dosage unit.

Hyoscyamus tincture. For oral use, not in excess of 2 milliliters per dosage unit.

Mannitol hexanitrate. For oral use, not in excess of 32 milligrams per dosage unit. Methenamine. For oral use, not in excess of 1 gram per dosage unit. Morphine phosphate. For oral use, not in excess of 33 milligrams per dosage unit; for injection, not in excess of 33 milligrams per dosage unit.

Morphine sulfate. For oral use, not in excess of 33 milligrams per dosage unit; for injection, not in excess of 33 milligrams per dosage unit. Nitroglycerin. For oral use, not in excess of 0.65 milligram per dosage unit. Pentaerythritol tetranitrate. For oral use, not in excess of 20 milligrams per dosage unit.

Pentaerythritol tetranitrate with phenobarbital. For oral use, not in excess of 20 milligrams of pentaerythritol tetranitrate and 35 milligrams of phenobarbital.

Quinidine sulfate. For oral use, not in excess of 325 milligrams per dosage unit.

Scopolamine methylbromide. For oral use, not in excess of 2.5 milligrams per dosage unit.

Sodium chloride injection.

Sodium nitrite. For oral use, not in excess of 60 milligrams per dosage unit.

Theobromine. For oral use, not in excess of 325 milligrams per dosage unit. Thyroid. For oral use, not in excess of 220 milligrams per dosage unit. Water for injection, sterile.

(c) The Commissioner of Food and Drugs has considered submitted material covering a number of drug products and has offered the opinion that the following drugs, when intended for those vet

erinary uses for which they are now generally employed by the veterinary medical profession, should be exempt from the requirements of § 1.106 (c) (3) of this chapter, provided that they meet the conditions prescribed in this paragraph. Preparations that are not in dosage unit form (for example, solutions) will be regarded as meeting the conditions with respect to the maximum quantity of drug per dosage unit if they are prepared in a manner that enables accurate and ready administration of a quantity of drug not in excess of the stated maximum per dosage unit:

Atropine sulfate. As an injectable for cattle, goats, horses, pigs, and sheep, not in excess of 15 milligrams per dosage unit; as an injectable for cats and dogs, not in excess of 0.6 milligram per dosage unit.

Barbital sodium. For oral use in cats and dogs, not in excess of 300 milligrams per dosage unit.

Epinephrine injection, 1:1,000. For cats, dogs, cattle, goats, horses, pigs, and sheep.

Morphine sulfate. As an injectable for dogs, not in excess of 15 milligrams per dosage unit. Pentobarbital sodium. For oral use in cats, and dogs, not in excess of 100 milligrams per dosage unit. Phenobarbital sodium. For oral use in cats and dogs, not in excess of 100 milligrams per dosage unit.

Procaine hydrochloride injection. Containing not in excess of 2 percent procaine hydrochloride, with or without epinephrine up to a concentration of 1:50,000. For use in cats, dogs, cattle, goats, horses, pigs, and sheep. Thyroid. For oral use in dogs, not in

excess of 60 milligrams per dosage unit. [26 F.R. 12563, Dec. 28, 1961, as amended at 27 F.R. 5428, June 8, 1962]

§ 3.516 Gelsemium-containing preparations regarded as prescription drugs. It is the consensus of informed medical opinion that the margin of safety between the therapeutic and toxic concentration of gelsemium is narrow and it is difficult to predict the point at which the dose will be toxic. Very small doses may cause toxic symptoms. It is therefore the view of the Food and Drug Administration that gelsemium is not a proper ingredient in any product that is to be sold without prescription. Accordingly, any drug containing gelsemium will be regarded as misbranded under

section 503(b) (4) of the Federal Food, Drug, and Cosmetic Act if its label fails to bear in a prominent and conspicuous fashion the statement "Caution: Federal law prohibits dispensing without prescription."

[28 F.R. 7673, July 27, 1963]

COSMETICS

§ 3.651 Shampoo preparations containing egg as one of the ingredients. The present views of the Food and Drug Administration concerning the status of shampoo preparations containing egg as one of the ingredients are as follows:

(a) An article designated as "egg shampoo" should contain one egg (or the equivalent amount of dried whole egg) in that quantity of the article which would be used in one shampooing of the hair.

(b) An article that contains less than one egg per "shampoo" should not be referred to as an “egg shampoo," and the word "egg" should not be used as part of the name of the article. At the present time, the Administration is not raising objection to the marketing of an article containing less than one egg per "shampoo," provided the word "egg" does not appear in the name of the article, the reference to the egg ingredient, such as "plus egg," appears in a subordinate position on the label and is in type which is substantially reduced in size in comparison with the title of the article, and the reference to the presence of egg reveals the amount of the egg ingredient.

(c) In the case of an article containing less than 2 percent egg, the amount of egg is so small as to be insignificant, and it is therefore considered that it would be misleading for the labeling to make any mention of the presence of egg in such a product.

(Sec. 602, 52 Stat. 1054; 21 U. S. C. 362) [23 F. R. 5380, July 16, 1958]

§ 3.652 Labeling of detergent

substances, other than soap, intended for use in cleansing the body.

(a) In its definition of the term "cosmetic," the Federal Food, Drug, and Cosmetic Act specifically excludes soap. The term "soap” is nowhere defined in the act. In administering the act, the Food and Drug Administration interprets the term "soap” to apply only to articles that meet the following conditions:

(1) The bulk of the nonvolatile matter in the product consists of an alkali

salt of fatty acids and the detergent properties of the article are due to the alkali-fatty acid compounds; and

(2) The product is labeled, sold, and represented only as soap.

(b) Products intended for cleansing the human body and which are not "soap" as set out in paragraph (a) of this section are "cosmetics," and accordingly they are subject to the requirements of the act and the regulations thereunder. For example, such a product in bar form is subject to the requirement, among others, that it shall bear a label containing an accurate statement of the weight of the bar in avoirdupois pounds and ounces, this statement to be prominently and conspicuously displayed so as to be likely to be read under the customary conditions of purchase and

use.

(Secs. 201, 602, 52 Stat. 1041, 1054; 21 U.S.C. 321, 362) [23 F.R. 7483, Sept. 26, 1958] CAUSTIC POISON

§ 3.700 Definition of ammonia under Federal Caustic Poison Act.

For the purpose of determining whether an article containing ammonia is subject to the Federal Caustic Poison Act, the ammonia content is to be calculated as NH..

(Sec. 9, 44 Stat. 1409, as amended; 15 U. S. C. 409. Interprets or applies sec. 2, 44 Stat. 1406; 15 U.S.C. 402) [22 F.R. 9594, Nov. 30. 1957]

PART 4 OFFICIAL RECORDS AND INFORMATION

§ 4.1

Disclosure of official records and information.

(a) No officer or employee of the Food and Drug Administration or of any other office or establishment in the Department of Health, Education, and Welfare-except as otherwise specifically authorized in accordance with paragraph (c) of this section or except in the discharge of his official duties under the laws administered by the Food and Drug Administration-shall produce or disclose to any person, or before any tribunal, directly or indirectly, whether in response to a subpoena or otherwise, any record (including any file, letter, application, report, work sheet, or other paper or document) pertaining to the functions of the Food and Drug Administration, or any information acquired from any such record or otherwise acquired in the discharge of his official duties.

(b) Whenever a subpoena or a subpoena duces tecum, in appropriate form, has been lawfully served upon an officer or employee of the Food and Drug Administration commanding the production of any such record or the giving of any such information, such officer or employee will, unless otherwise specifically authorized in accordance with paragraph (c), appear in response thereto and respectfully decline to produce the record or information specified therein, on the ground that disclosure of such record or information is prohibited by this section.

(c) A person who desires the disclosure of any such record or information may make written request therefor, verified by oath, directed to the Commissioner of Food and Drugs, setting forth his interest in the matter sought to be disclosed and specifically designating the use to which such records or information will be put in the event of compliance with such request; Provided, That a written request therefor made by a health, food or drug officer, prosecuting attorney or member of the judiciary of any State, Territory or political subdivision thereof, acting in his official capacity, need not be verified by oath. If it is determined by the Commissioner, or any other officer or employee of the Food and Drug Administration whom he may designate to act on his behalf for the purpose, that disclosure of any such record or information for the use so specifically designated will not be incompatible with the public interest and will not result in revealing confidential matters the request will be granted, and if testimony relating thereto is requested one or more employees of the Food and Drug Administration will be designated and directed to appear, in response to a subpoena or a subpoena duces tecum, and testify with respect thereto.

(Sec. 10, 29 Stat. 607, as amended, sec. 8, 44 Stat. 1102, sec. 9, 44 Stat. 1409, sec. 4, 49 Stat. 885, sec. 701, 52 Stat. 1055; 15 U. S. C. 409, 21 U. S. C. 50, 64, 143, 371) 9554, Dec. 20, 1955]

[20 F. R.

5.8

Markers.

Wrapped fish fillets.

Bananas, wrapped clusters (consumer units).

5.9 Labeling of foods in which salt containing anticaking agents or other substances is an ingredient.

AUTHORITY: The provisions of this Part 5 issued under sec. 403, 701(a), 52 Stat. 1047, 1055 as amended, 21 U.S.C. 343, 371(a).

SOURCE: The provisions of this Part 5 appear at 29 F.R. 15285, Nov. 14, 1964, unless otherwise noted.

§ 5.1 Open containers.

(a) An open container is a container of rigid or semirigid construction, which is not closed by lid, wrapper, or otherwise.

(b) An open container of a fresh fruit or fresh vegetable, the quantity of contents of which is not more than one dry quart, shall be exempt from the labeling requirements of subsections (e), (g) (2) (with respect to the name of the food specified in the definition and standard), and (i) (1) of section 403 of the act; but such exemption shall be on the condition that if two or more such containers are enclosed in a crate or other shipping package, such crate or package shall bear labeling showing the number of such containers enclosed therein and the quantity of the contents of each. § 5.2

Repacked, reprocessed, and relabeled foods.

Except as provided by §§ 5.3 and 5.4, a shipment or other delivery of a food which is, in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantity at an establishment other than that where originally processed or packed, shall be exempt, during the time of introduction into and movement in interstate commerce and the time of holding in such establishment, from compliance with the labeling requirements of section 403 (c), (e), (g), (h), (i), (j) and (k) of the act if:

(a) The person who introduced such shipment or delivery into interstate commerce is the operator of the establishment where such food is to be processed, labeled, or repacked; or

(b) In case such person is not such operator, such shipment or delivery is