tions, under which practitioners licensed by law to employ the device can use the device safely and for the purposes for which it is intended, including all purposes for which it is advertised or represented. This information will not be required on so-called reminder-piece labeling which calls attention to the name of the device but does not include indications or other use information.

(5) All labeling, except labels and cartons, bearing information for use of the device also bears the date of the issuance or the date of the latest revision of such labeling.

(e) [Reserved]

(f) Retail exemption for veterinary drugs and prescription devices. A drug or device subject to paragraph (c) or (d) of this section shall be exempt at the time of delivery to the ultimate purchaser or user from section 502(f) (1) of the act if it is delivered by a licensed practitioner in the course of his professional practice or upon a prescription or other order lawfully issued in the course of his professional practice, with labeling bearing the name and address of such licensed practitioner and the directions for use and cautionary statements, if any, contained in such order.

(g) Exemption for new drugs. A new drug shall be exempt from section 502 (f) (1) of the act:

(1) To the extent to which such exemption is claimed in an approved application with respect to such drug under section 505 of the act; or

(2) If no application under section 505 of the act is approved with respect to such drug but it complies with section 505 (i) and regulations thereunder.

No exemption shall apply to any other drug which would be a new drug if its labeling bore representations for its intended uses.

(h) Exemption for drugs or devices when directions are commonly known. A drug or device shall be exempt from section 502 (f) (1) of the act insofar as adequate directions for common uses thereof are known to the ordinary individual.

(i) Exemptions for inactive ingredients. A harmless drug that is ordinarily used as an inactive ingredient, such as a coloring, emulsifier, excipient, flavoring, lubricant, preservative, or solvent, in the preparation of other drugs shall be exempt from section 502 (f) (1) of the act.

This exemption shall not apply to any substance intended for a use which results in the preparation of a new drug, unless an approved new-drug application provides for such use.

(j) Exemption for diagnostic reagents. A drug intended solely for use in the professional diagnosis of disease and which is generally recognized by qualified experts as useful for that purpose shall be exempt from section 502 (f) (1) of the act if its label bears the statement "Diagnostic reagent-For professional use only."

(k) Exemption for prescription chemicals and other prescription components. A drug prepared, packaged, and primarily sold as a prescription chemical or other component for use by registered pharmacists in compounding prescriptions or for dispensing in dosage unit form upon prescriptions shall be exempt from section 502 (f) (1) of the act if all the following conditions are met:

(1) The drug is an official liquid acid or official liquid alkali, or is not a liquid solution, emulsion, suspension, tablet. capsule, or other dosage unit form; and (2) The label of the drug bears: (i) The statement "For prescription compounding"; and

(ii) If in substantially all dosage forms in which it may be dispensed it is subject to section 503 (b) (1) of the act, the statement "Caution: Federal law prohibits dispensing without prescription"; or

(iii) If it is not subject to section 503 (b) (1) of the act and is by custom among retail pharmacists sold in or from the interstate package for use by consumers, "adequate directions for use" in the conditions for which it is so sold. Provided, however, That the information referred to in subdivision (iii) of this subparagraph may be contained in the labeling on or within the package from which it is to be dispensed.

(3) This exemption shall not apply to any substance intended for use in compounding which results in a new drug, unless an approved new-drug application covers such use of the drug in compounding prescriptions.

(1) Exemption for processing, repacking, or manufacture. A drug in a bulk package (except tablets, capsules, or other dosage unit forms) or a device intended for processing, repacking, or use in the manufacture of another drug or device shall be exempt from section 502 (f) (1) of the act if its label bears the

statement "Caution: For manufacturing, processing, or repacking"; and, if in substantially all dosage forms in which it may be dispensed it is subject to section 503 (b) (1), the statement "Caution: Federal law prohibits dispensing without prescription." This exemption and the exemption under paragraph (k) of this section may be claimed for the same article. But the exemption shall not apply to a substance intended for a use in manufacture, processing, or repacking which causes the finished article to be a new drug, unless:

(1) An approved new-drug application held by the person preparing the dosage form or drug for dispensing covers the production and delivery to him of such substance; or

(2) If no application is approved with respect to such new drug, the label statement "Caution: For manufacturing, processing, or repacking" is immediately supplemented by the words "in the preparation of a new drug limited by Federal law to investigational use," and the delivery is made for use only in the manufacture of such new drug limited to investigational use as provided in § 130.3 of this chapter.

(m) Exemption for drugs and devices for use in teaching, law enforcement, research, and analysis. A drug or device subject to paragraph (b), (c), or (d) of this section shall be exempt from section 502 (f) (1) of the act if shipped or sold to, or in the possession of, persons regularly and lawfully engaged in instruction in pharmacy, chemistry, or medicine not involving clinical use, or engaged in law enforcement, or in research not involving clinical use, or in chemical analysis, or physical testing, and is to be used only for such instruction, law enforcement, research, analysis, or testing.

(n) Expiration of exemptions. (1) If a shipment or delivery, or any part thereof, of a drug or device which is exempt under the regulations in this section is made to a person in whose possession the article is not exempt, or is made for any purpose other than those specified, such exemption shall expire, with respect to such shipment or delivery or part thereof, at the beginning of that shipment or delivery. The causing of an exemption to expire shall be considered an act which results in such drug or device being misbranded unless it is disposed of under circumstances in which it ceases to be a drug or device.

(2) The exemptions conferred by paragraphs (1), (j), (k), (1), and (m) of this section shall continue until the drugs or devices are used for the purposes for which they are exempted, or until they are relabeled to comply with section 502 (f) (1) of the act. If, however, the drug is converted, compounded, or manufactured into a dosage form limited to prescription dispensing, no exemption shall thereafter apply to the article unless the dosage form is labeled as required by section 503 (b) and paragraph (b), (c), or (d) of this section.

(0) Intended uses. The words "intended uses" or words of similar import in paragraphs (a), (g), (i), (j), (k), and (1) of this section refer to the objective intent of the persons legally responsible for the labeling of drugs and devices. The intent is determined by such persons' expressions or may be shown by the circumstances surrounding the distribution of the article. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives. It may be shown by the circumstances that the article is, with the knowledge of such persons or their representatives, offered and used for a purpose for which it is neither labeled nor advertised. The intended uses of an article may change after it has been introduced into interstate commerce by its manufacturer. If, for example, a packer, distributor, or seller intends an article for different uses than those intended by the person from whom he received the drug, such packer, distributor, or seller is required to supply adequate labeling in accordance with the new intended uses. But if a manufacturer knows, or has knowledge of facts that would give him notice, that a drug or device introduced into interstate commerce by him is to be used for conditions, purposes, or uses other than the ones for which he offers it, he is required to provide adequate labeling for such a drug which accords with such other uses to which the article is to be put.

(Sec. 502(f), 52 Stat. 1051; 21 U.S.C. 352(f)) [20 F.R. 9532, Dec. 20, 1955, as amended at 21 F.R. 2326, Apr. 11, 1956, 23 F.R. 7909, Oct. 14, 1958, 25 FR. 12593, Dec. 9, 1960, 26 F.R. 295, Jan. 14, 1961, 26 F.R. 8389, Sept. 6, 1961, 27 F.R. 1317, Feb. 13, 1962, 28 F.R. 5719, June 12, 1963, 29 F.R. 18055, Dec. 19, 1964; 33 F.R. 15023, Oct. 8, 1968; 34 F.R. 12885, Aug. 8, 1969]

§ 1.107

Drugs and devices; exemptions. (a) Except as provided by paragraphs (b) and (c) of this section, a shipment or other delivery of a drug or device 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 and packaging requirements of sections 501 (b) and 502 (b), (d), (e), (f), and (g) of the act if:

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

(2) In case such person is not such operator, such shipment or delivery is made to such establishment under a written agreement, signed by and containing the post-office addresses of such person and such operator, and containing such specifications for the processing, labeling, or repacking, as the case may be, of such drug or device in such establishment as will insure, if such specifications are followed, that such drug or device will not be adulterated or misbranded within the meaning of the act upon completion of such processing, labeling, or repacking. Such person and such operator shall each keep a copy of such agreement until 2 years after the final shipment or delivery of such drug or device from such establishment, and shall make such copies available for inspection at any reasonable hour to any officer or employee of the Department who requests them.

(b) An exemption of a shipment or other delivery of a drug or device under paragraph (a) (1) of this section shall, at the beginning of the act of removing such shipment or delivery, or any part thereof, from such establishment, become void ab initio if the drug or device comprising such shipment, delivery, or part is adulterated or misbranded within the meaning of the act when so removed.

(c) An exemption of a shipment or other delivery of a drug or device under paragraph (a) (2) of this section shall become void ab initio with respect to the person who introduced such shipment or

delivery into interstate commerce upon refusal by such person to make available for inspection a copy of the agreement, as required by such subparagraph.

(d) An exemption of a shipment or other delivery of a drug or device under paragraph (a) (2) of this section shall expire:

(1) At the beginning of the act of removing such shipment or delivery, or any part thereof, from such establishment if the drug or device comprising such shipment, delivery, or part is adulterated or misbranded within the meaning of the act when so removed; or

(2) Upon refusal by the operator of the establishment where such drug or device is to be processed, labeled, or repacked, to make available for inspection a copy of the agreement, as required by such clause.

(e) Except as provided in paragraphs (g) and (h) of this section, a shipment or other delivery of a drug which is subject to section 507 of the act and which is, in accordance with the practice of the trade, to be processed or repacked in a substantial quantity at an establishment other than that where originally processed or packed shall be exempt from compliance with the labeling requirements of section 502 (f) of the act during the time such drug is also exempt from the requirements of section 502 (1) of the act under the provisions of § 144.5 or § 144.6 of this chapter.

(f) Except as provided by paragraphs (g) and (h) of this section, a shipment or other delivery of a drug which is subject to section 507 of the act and which is, in accordance with the practice of the trade, to be labeled in substantial quantity at an establishment other than that where originally processed or packed shall be exempt from compliance with the labeling requirements of section 502 (b), (e) and (f) of the act during the time such drug is also exempt from the requirements of section 502 (1) of the act under § 144.3 of this chapter, if the words, statements, and other information required by section 502 (b) and (e) of the act appear on each shipping container of such drug.

(g) In case the person who introduced such shipment or other delivery into interstate commerce is the operator of the establishment where such drug is to be processed, labeled, or repacked, an exemption of such shipment

or delivery under paragraph (e) or (f) of this section shall become void at the beginning of the act of removing such shipment or delivery or any part thereof from such establishment if the drug comprising such shipment, delivery, or part is adulterated or misbranded within the meaning of the act when so removed.

(h) In case the person who introduced such shipment or delivery into interstate commerce is not the operator of the establishment where such drug is to be processed, labeled, or repacked, an exemption of a shipment or other delivery of such drug under paragraph (e) or (f) of this section shall expire at the beginning of the act of removing such shipment or delivery or any part thereof from such establishment if the drug comprising such shipment, delivery, or part is adulterated or misbranded within the meaning of the act when so removed.

(Sec. 503, 52 Stat. 1051, as amended; 21 U.S.C. 353) [20 F.R. 9534, Dec. 20, 1955, as amended at 22 F.R. 891, Feb. 13, 1957] § 1.108 Drugs and devices; statement of policy re Spanish-language versions of required labeling statements. An increasing number of medications restricted to prescription use only are being labeled solely in Spanish for distribution in the Commonwealth of Puerto Rico where Spanish is the predominant language. Such labeling is authorized under § 1.103(c). Two required warnings, the wording of which is fixed by law in the English language, are presently being translated in various ways, from literal translation to loose interpretation. The statutory nature of these two statements requires that the translation must convey the meaning properly, in order to avoid confusion and dilution of the purposes of the warnings. The Commissioner of Food and Drugs hereby adopts the following Spanishlanguage versions as the accepted equivalents of the English wording of the following:

(a) Section 503(b) (4) of the Federal Food, Drug, and Cosmetic Act requires the statement "Caution: Federal law prohibits dispensing without prescription." The Spanish version of this shall be: "Precaucion: La ley Federal prohibe su despacho sin prescripcion facultativa."

(b) Section 502(d) of the Federal Food, Drug, and Cosmetic Act requires the statement "Warning-May be habit

forming" on habit-forming drugs. The Spanish version of this shall be: "Aviso— Puede formar habito o vicio."

(Secs. 502, 503; 53 Stat. 854, 65 Stat. 648; 21 U.S.C. 352, 353) [28 F.R. 5719, June 12, 1963]

§ 1.115

Definition of term "insulin." For the purposes of sections 502(k) and 506 of the act:

(a) The term "insulin" as used therein means the active principle of pancreas which affects the metabolism of carbohydrate in the animal body and which is of value in the treatment of diabetes mellitus.

(b) The following substances, when they are intended for use in the manufacture of insulin-containing drugs that will subsequently be submitted for certification, shall not be considered to be subject to certification as "drugs composed wholly or partly of insulin":

(1) Pancreas glands; and

(2) Materials prepared from pancreas glands, such as "salt cake" and "isoelectric precipitate," which materials must be subjected to further purification in order to meet the standards of purity established by Part 164 of this chapter. (Sec. 506, 55 Stat. 851; 21 U.S.C. 356) [24 FR. 5367, July 2, 1959]

COSMETICS

AUTHORITY: §§ 1.201 to 1.204 issued under sec. 701, 52 Stat. 1055, as amended; 21 U.S.C. 371, unless otherwise noted.

§ 1.201 Cosmetic; labeling; misbranding.

(a) Among representations in labeling of a cosmetic which render such cosmetic misbranded is a false or misleading representation with respect to another cosmetic or a food, drug, or device.

(b) The labeling of a cosmetic which contains two or more ingredients may be misleading by reason (among other reasons) of the designation of such cosmetic in such labeling by a name which includes or suggests the name of one or more but not all such ingredients, even though the names of all such ingredients are stated elsewhere in the labeling. (Sec. 602, 52 Stat. 1054, as amended; 21 U.S.C. 362) [20 F.R. 9536, Dec. 20, 1955] § 1.201a Cosmetics in package form; principal display panel.

The term "principal display panel" as it applies to cosmetics in package form

and as used in this part, means the part of a label that is most likely to be displayed, presented, shown, or examined under customary conditions of display for retail sale. The principal display panel shall be large enough to accommodate all the mandatory label information required to be placed thereon by this part with clarity and conspicuousness and without obscuring designs, vignettes, or crowding. Where packages bear alternate principal display panels, information required to be placed on the principal display panel shall be duplicated on each principal display panel. For the purpose of obtaining uniform type size in declaring the quantity of contents of all packages of substantially the same size, the term "area of the principal display panel" means the area of the side or surface that bears the principal display panel, which area shall be:

(a) In the case of a rectangular package where one entire side properly can be considered to be the principal display panel side, the product of the height times the width of that side;

(b) In the case of a cylindrical or nearly cylindrical container, 40 percent of the product of the height of the container times the circumference; and

(c) In the case of any other shape of container, 40 percent of the total surface of the container: Provided, however, That where such container presents an obvious "principal display panel" such as the top of a triangular or circular package, the area shall consist of the entire top surface.

In determining the area of the principal display panel, exclude tops, bottoms, flanges at the tops and bottoms of cans, and shoulders and necks of bottles or jars. In the case of cylindrical or nearly cylindrical containers, information required by this part to appear on the principal display panel shall appear within that 40 percent of the circumference which is most likely to be displayed, presented, shown, or examined under customary conditions of display for retail sale.

[33 F.R. 9485, June 28, 1968] § 1.202

form;

Cosmetics in package labeling re identity. (a) The principal display panel of a cosmetic in package form shall bear as one of its principal features a statement of the identity of the commodity.

(b) Such statement of identity shall be in terms of:

(1) The common or usual name of the cosmetic; or

(2) An appropriately descriptive name or, when the nature of the cosmetic is obvious, a fanciful name understood by the public to identify such cosmetic; or

(3) An appropriate illustration or vignette representing the intended cosmetic

use.

(c) The statement of identity shall be presented in bold type on the principal display panel, shall be in a size reasonably related to the most prominent printed matted on such panel, and shall be in lines generally parallel to the base on which the package rests as it is designed to be displayed.

[33 F.R. 9485, June 28, 1968]

§ 1.202a Cosmetics in package form; labeling re name and place of business of manufacturer, packer, or distrib

utor.

(a) The label of a cosmetic in package form shall specify conspicuously the name and place of business of the manufacturer, packer, or distributor.

(b) The requirement for declaration of the name of the manufacturer, packer, or distributor shall be deemed to be satisfied in the case of a corporation only by the actual corporate name, which may be preceded or followed by the name of the particular division of the corporation. Abbreviations for "Company," "Incorporated," etc., may be used and "The" may be omitted. In the case of an individual, partnership, or association, the name under which the business is conducted shall be used.

(c) Where the cosmetic is not manufactured by the person whose name appears on the label, the name shall be qualified by a phrase that reveals the connection such person has with such cosmetic; such as, "Manufactured for ""Distributed by

or any other wording that expresses the facts.

(d) The statement of the place of business shall include the street address, city, State, and ZIP Code; however, the street address may be omitted if it is shown in a current city directory or telephone directory. The requirement for inclusion of the ZIP Code shall apply only to consumer commodity labels developed or revised after the effective date of this section. In the case of noncon