CROSS-REFERENCE: See § 1.108 for the Spanish-language version of the required labeling statement in § 1.106 (b) (2) (i), (c) (2)(i), (d) (2) (i), (k) (2) (ii), and (1).

(3)(i) Labeling on or within the package from which the drug is to be dispensed bears adequate information for its use, including indications, effects, dosages, routes, methods, and frequency and duration of administration, and any relevant hazards, contraindications, side effects, and precautions under which practitioners licensed by law to administer the drug can use the drug safely and for the purposes for which it is intended, including all purposes for which it is advertised or represented; and

(ii) If the article is subject to section 505, 506, or 507 of the act, the labeling bearing such information is the labeling authorized by the effective new-drug application or required as a condition for the certification or the exemption from certification requirements applicable to preparations of insulin or antibiotic drugs: Provided, however, That the information required by subdivision (i) of this subparagraph may be omitted from the dispensing package if, but only if, the article is a drug for which directions, hazards, warnings, and use information are commonly known to practitioners licensed by law to administer the drug. Upon written request, stating reasonable grounds therefor, the Commissioner will offer an opinion on a proposal to omit such information from the dispensing package under this proviso.

(4) Any labeling, as defined in section 201 (m) of the act, whether or not it is on or within a package from which the drug is to be dispensed, distributed by or on behalf of the manufacturer, packer, or distributor of the drug, that furnishes or purports to furnish information for use or which prescribes, recommends, or suggests a dosage for the use of the drug (other than dose information required by subparagraph (2) (ii) of this paragraph and paragraph (c) (2) (ii) of this section) contains:

(i) Adequate information for such use, including indications, effects, dosages, routes, methods, and frequency and duration of administration and any relevant hazards, contraindications, side effects, and precautions, under which practitioners licensed by law to administer the drug can use the drug safely and for the purposes for which it is intended, including all conditions for which it is advertised or represented;

and if the article is subject to section 505, 506, or 507 of the act, the labeling providing such information is substantially the same as the labeling authorized by the effective new-drug application or required as a condition for its certification or exemption from certification; and

(ii) The same information concerning the ingredients of the drug as appears on the label and labeling on or within the package from which the drug is to be dispensed;

Provided, however, That the information required by subdivisions (i) and (ii) of this subparagraph is not required on the so-called reminder-piece labeling which calls attention to the name of the drug but does not include indications or dosage recommendations for use of the drug.

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

(c) Exemption for veterinary drugs A drug intended for veterinary us which, because of toxicity or other po tentiality for harmful effect, or th method of its use, is not safe for anima use except under the supervision of licensed veterinarian, and hence fo which "adequate directions for use” can not be prepared, shall be exempt from section 502(f)(1) of the act if all th following conditions are met:

(1) The drug is:

(i) In the possession of a person ( his agents or employees) regularly an lawfully engaged in the manufactur transportation, storage, or wholesale retail distribution of veterinary dru and is to be sold only to or on the pr scription or other order of a license veterinarian for use in the course of h professional practice; or

(ii) In the possession of a license veterinarian for use in the course of h professional practice.

(2) The label of the drug bears:

(1) The statement "Caution: Feder law restricts this drug to sale by or the order of a licensed veterinarian and

(ii) The recommended or usual do age; and

(iii) The route of administration, if is not for oral use; and

(iv) The quantity or proportion each active ingredient as well as the i

formation required by section 502(e) of the act; and

(v) If it is for other than oral use, the names of all inactive ingredients, except that:

(a) Flavorings and perfumes may be designated as such without naming their components.

(b) Color additives may be designated as coloring without naming specific color components unless the naming of such components is required by a color additive regulation prescribed in Part 8 of this chapter.

(c) Trace amounts of harmless substances added solely for individual product identification need not be named. If it is intended for administration by parenteral injection, the quantity or proportion of all inactive ingredients, except that ingredients added to adjust the pH or to make the drug isotonic may be declared by name and a statement of heir effect; and if the vehicle is water for injection, it need not be named.

(vi) An identifying lot or control number from which it is possible to deermine the complete manufacturing history of the package of the drug;

Provided, however, That in the case of Containers too small or otherwise unable o accommodate a label with sufficient pace to bear all such information, but which are packaged within an outer ontainer from which they are removed or dispensing or use, the information equired by subdivisions (ii), (iii), and v) of this subparagraph may be conained in other labeling on or within the ackage from which it is to be so disensed, and the information referred to n subdivision (1) of this subparagraph may be placed on such outer container nly, and the information required by ubdivision (vi) of this subparagraph may be on the crimp of the dispensing ube.

(3) (i) Labeling on or within the packge from which the drug is to be disensed bears adequate information for ts use, including indications, effects, Hosages, routes, methods, and frequency and duration of administration, and any elevant hazards, contraindications, side ffects, and precautions under which vetrinarians licensed by law to administer he drug can use the drug safely and for he purposes for which it is intended, inluding all purposes for which it is dvertised or represented; and

(ii) If the article is subject to section 505 or 507 of the act, the labeling bearing such information is the labeling authorized by the effective new-drug application or required as a condition for the certification or the exemption from certification requirements applicable to preparations of antibiotic drugs: Provided, however, That the information required by subdivision (i) of this subparagraph may be omitted from the dispensing package if, but only if, the article is a drug for which directions, hazards, warnings, and use information are commonly known to veterinarians licensed by law to administer the drug. Upon written request, stating reasonable grounds therefor, the Commissioner will offer an opinion on a proposal to omit such information from the dispensing package under this proviso.

(4) Any labeling, as defined in section 201(m) of the act, whether or not it is on or within a package from which the drug is to be dispensed, distributed by or on behalf of the manufacturer, packer, or distributor of the drug, that furnishes or purports to furnish information for use or which prescribes, recommends, or suggests a dosage for the use of the drug (other than dose information required by paragraph (b)(2) (ii) of this section and subparagraph (2) (ii) of this paragraph) contains:

(i) Adequate information for such use, including indications, effects, dosages, routes, methods, and frequency and duration of administration, and any relevant hazards, contraindications, side effects, and precautions, and including information relevant to compliance with the food additive provisions of the act, under which veterinarians licensed by law to administer the drug can use the drug safely and for the purposes for which it is intended, including all conditions for which it is advertised or represented; and if the article is subject to section 505 or 507 of the act, the labeling providing such information is substantially the same as the labeling authorized by the effective new-drug application or required as a condition for its certification or exemption from certification; and

(ii) The same information concerning the ingredients of the drug as appears on the label and labeling on or within the package from which the drug is to be dispensed;

Provided, however, That the information required by subdivisions (i) and (ii) of this subparagraph is not required on the so-called reminder-piece labeling which calls attention to the name of the drug but does not include indications or dosage recommendations for use of the drug.

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

(6) A prescription drug intended for both human and veterinary use shall comply with paragraph (b) of this section and subparagraphs (4) and (5) of this paragraph.

(d) Exemption for prescription devices. A device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which "adequate directions for use" cannot be prepared, shall be exempt from section 502 (f) (1) of the act if all the following conditions are met:

or

(b) In the possession of a practitioner, such as physicians, dentists, and veterinarians, licensed by law to use or order the use of such device; and

(ii) Is to be sold only to or on the prescription or other order of such practitioner for use in the course of his professional practice.

(2) The label of the device (other than surgical instruments) bears:

(i) The statement "Caution: Federal law restricts this device to sale by or on the order of a

"the blank

to be filled with the word "physician," "dentist," "veterinarian," or with the descriptive designation of any other practitioner licensed by the law of the State in which he practices to use or order the use of the device; and

(ii) The method of its application or

tion, and any relevant hazards, contrain dications, side effects, and precautions under which practitioners licensed by law to administer the device can use the device safely and for the purpose for which it is intended, including all purposes for which it is advertised or represented: Provided, however, That such information may be omitted from the dispensing package if, but only if, the article is a device for which direc tions, hazards, warnings, and other information are commonly known to practitioners licensed by law to use the device, Upon written request, stating reasonable grounds therefor, the Commissioner will offer an opinion on a proposal to omit such information from the dispensing package under this proviso.

(4) Any labeling, as defined in section 201(m) of the act, whether or not it is on or within a package from which the device is to be dispensed, distributed by or on behalf of the manufacturer, packer or distributor of the device, that furnishes or purports to furnish information for use of the device contains ade quate information for such use, includ ing indications, effects, routes, methods and frequency and duration of administration and any relevant hazards, con traindications, side effects, and precau tions, under which practitioners license by law to employ the device can use the device safely and for the purposes fo which it is intended, including all pur poses for which it is advertised or repre sented. This information will not b required on so-called reminder-piec labeling which calls attention to th name of the device but does not includ indications or other use information.

(5) All labeling, except labels and car tons, bearing information for use of th device also bears the date of the issuan or the date of the latest revision of suc labeling.

(e) [Reserved]

(f) Retail exemption for veterina drugs and prescription devices. A dru or device subject to paragraph (c) or (c of this section shall be exempt at t time of delivery to the ultimate purchas or user from section 502(f) (1) of the a if it is delivered by a licensed pract tioner in the course of his profession practice or upon a prescription or oth order lawfully issued in the course of professional practice, with labeling bea ing the name and address of such censed practitioner and the directio

or use and cautionary statements, if ny, contained in such order.

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

(1) To the extent to which such exmption is claimed in an effective appliation with respect to such drug under ection 505 of the act; or

(2) If no application under section 05 of the act is effective with respect to uch drug but it complies with section 05 (i) and regulations thereunder.

o exemption shall apply to any other rug which would be a new drug if its abeling bore representations for its inended uses.

(h) Exemption for drugs or devices hen directions are commonly known. A rug or device shall be exempt from secon 502 (f) (1) of the act insofar as dequate directions for common uses hereof are known to the ordinary inividual.

(i) Exemptions for inactive ingrediits. A harmless drug that is ordinarily ed as an inactive ingredient, such as a loring, emulsifier, excipient, flavoring, bricant, preservative, or solvent, in the reparation of other drugs shall be exnpt from section 502 (f) (1) of the act. his exemption shall not apply to any bstance intended for a use which relts in the preparation of a new drug, less an effective new-drug application rovides for such use.

(j) Exemption for diagnostic reagents. drug intended solely for use in the prossional diagnosis of disease and which generally recognized by qualified exerts as useful for that purpose shall be tempt from section 502 (f) (1) of the t if its label bears the statement "Diagreagent-For professional use

stic aly."

(k) Exemption for prescription chemals and other prescription components. drug prepared, packaged, and primarily ld as a prescription chemical or other mponent for use by registered pharmasts in compounding prescriptions or dispensing in dosage unit form upon escriptions shall be exempt from secin 502 (f) (1) of the act if all the folwing conditions are met:

(1) The drug is an official liquid acid official liquid alkali, or is not a liquid ution, emulsion, suspension, tablet, psule, or other dosage unit form; and (2) The label of the drug bears: (i) The statement "For prescription mpounding"; 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 effective 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 effective 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 effective 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 (i), (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 F.R. 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]

§ 1.107

Drugs and devices; exemptions

(a) Except as provided by paragraphs (b) and (c) of this section, a shipmen or other delivery of a drug or device which is, in accordance with the prac tice of the trade, to be processed, labeled or repacked in substantial quantity at a establishment other than that wher originally processed or packed, shall b exempt, during the time of introduction into and movement in interstate com merce and the time of holding in suc establishment, from compliance with th labeling and packaging requirements sections 501 (b) and 502 (b), (d), (e), (f) and (g) of the act if:

(1) The person who introduced suc shipment or delivery into interstate com merce is the operator of the establish ment where such drug or device is to b processed, labeled, or repacked; or

(2) In case such person is not su operator, such shipment or delivery made to such establishment under written agreement, signed by and co taining the post-office addresses of su person and such operator, and contai ing such specifications for the processin labeling, or repacking, as the case may! of such drug or device in such establis ment as will insure, if such specificatio are followed, that such drug or devi will not be adulterated or misbrand within the meaning of the act upon co