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(4) Any labeling, whether or not it is on or within a package from which the drug is to be dispenced, 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 contains:

(1) 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 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 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.

(5) All labeling bearing information for use of the drug also bears the date of the issuance of such labeling.

(d) Exemption for prescription devices. A device, which, because of any potentiality for harmful effect, or the method of its uses, 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 fcllowing conditions are met:

(1) The device is:

(i) (a) In the possession of a person (or his agents or employees) regularly and lawfully engaged in the manufacture, transportation, storage, or wholesale or retail distribution of such device; 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 (cther than surgical instruments) bears: (1) The statement "Cauti n: Fe eral law restricts this device to sale by or on the order of a "the blank to be filled with the word "physician," "entist," "veterinarian," or with the descriptive designation of any other practitioner licensed by the laws of the State in which he practices, to use or creer the use of the levice; an! (11) The method of its application or use.

(3) Labeling on or within the package from which the device is to be dispensed bears information for use, including in 'ications, effects, routes, methos, and frequency an 'uration of a ministration, and any relevant hazards, contraindications, sile effects, and precautions under which practitioners licensed by law to administer the device can use the levice anfely and for the purpose for which it is intence, including all pur

ses for which it is advertise or represented: Provided, however, That such information may be omitted from the 'ispensing package if, but only if, the article is a Levice for which 'irections, hazards, warnings, and ›ther information are commonly known to the ordinary practitioner. Upon written request, stating reasonable grounds therefor, the Commissioner

will offer an opinion on a proposal to omit such information from the di pensing package under this proviso.

(4) Any labeling, whether or not it is on or within a package fræ which the device is to be dispensed, distributed by or on behalf of the manufacturer, packer, or distributor of the device, that furnishes or pur ports to furnish information for use of the device contains adequate infor mation for its use, including indications, effects, routes, methods, and frequency and duration of administration and any relevant hazards, contraindications, side effects, and precautions, under which practitioners licensed by law to employ 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.

(5) All labeling bearing information for use of the device also bears the date of the issuance of such labeling.

b. By revoking § 1.106 (e).

2. It is proposed to amend § 130.4 Applications by changing items (6) (c), (d), and (e) and (9) in the new-drug application form set out in paragraph (c) to read: as set forth below and by adding to § 130.4 a DET paragraph (e), reading as indicated:

(c) * * *
(6) * *

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(c) If the drug is limited in its labeling to use under the professional supervision of a practitioner licensed by law to administer it, labeling on or within the package from which the drug is to be dispensed should bear information for use under which such practitioners can use the drug for the purposes for which it is intended, including all the purposes for which it is to be advertised or represented.

(d) Typewritten or other draft labeling copy may be accepted for conditional consideration of an application with the understanding that final printed labeling identical in content to the draft copy will be submitted as soon as available and prior to the marketing of the drug.

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(9) It is agreed that the labeling and advertising for the drug will prescribe, recommend, or suggest its use only under the conditions stated in the labeling which is part of this application, and if the article is a prescription drug, it is agreed that any labeling which furnishes or purports to furnish information for use or which prescribes, recommends, or suggests a dosage for use of the drug will also contain adequate information for its use, including indications, effects, dosages, routes, methods, and frequency and duration of administration, any relevant hazards, contraindica tions, side effects, and precautions, which is contained in the labeling on or within the package from which the drug is to be dispensed.

It is understood that all representations En this application regarding the components, composition, manufacturing methods, facilities, controls, and labeling apply to the drug produced until an effective supplement to the application provides for a change or the applicant is notified in writing by the Food and Drug Administration that a supplemental application is not required for the

change, or the article is no longer a new drug. It is further un-
derstood that a new drug for which an application is conditionally
effective may not be marketed until the stated conditions have been
met, including when such is a condition, the submission of final
printed labeling identical in content to the draft copy in the ap-
plication, and including, when such is a condition, notification
of the New Drug Branch when the first production batch of the drug
will be prepared, so that an inspection may be conducted to verify
the adequacy of the manufacturing methods, facilities, and controls.

(e) When in the judgment of the New Drug Branch, the description of the methods used in and the facilities and controls used for the manufacture, processing, and packaging of such drug appears adequate on its face, but it is not feasible to reach a conclusion as to the safety of the drug solely from consideration of this description, the New Drug Branch will notify the applicant that an inspection is required and the application will be made conditionally effective until such time that it is notified that the applicant is prepared to produce the first production batch, and the Administration is given an adequate opportunity to inspect the manufacturing methods, facilities, and controls to verify their adequacy. When an application is made conditionally effective under the conditions prescribed in this paragraph, the production and marketing of the drug without notification of the New Drug Branch or without offering an apportunity for an inspection to verify the adequacy of the manufacturing methods, facilities, and controls shall be regarded as the production and marketing of a drug for which no new-drug application is effective.

3. It is proposed to amend the first sentence of § 130.5(a)(3) to read as follows:

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(3) The specimens of labeling proposed for use upon or within the retail package do not expressly prescribe, recommend, or suggest the use of such drug under such conditions. *

4. It is proposed to amend § 130.9 to read as follows:

§ 130.9 Supplemental applications.

(a) After an application is effective, a supplemental application nay propose changes. The supplemental application may omit statements made in the effective application concerning which no change is proposed. A supplemental application should be submitted for any change beyond the variations provided for in the application, that may alter the conditions of use, the labeling, the safety, identity, strength, quality, or purity of the drug or the adequacy of manufacturing methods, facilities, or controls to preserve them. Labeling changes include deviations from the authorized brochure in any mailing or promotional piece used after the drug is placed on the market. When necessary for the safety of the drug, a supplemental application may be required to specify a period of time within which the proposed change will be made; and in such case the distribution of the drug after such time without such change constitutes distribution without an effective new-drug application. If a material change is made in labeling ɔr advertising from the representations in an effective application for a

new drug before a supplement is effective for such change, the application may be suspended under § 130.27, because the authorized labeling does not truly represent the intended uses of the drug.

(b) The submission of a supplemental new-drug application is not required for changes made in the new drug, or in its labeling, or in the manufacturing facilities or controls under which it is produced, that are not significant from the standpoint of the safety of the new drug as established by the original new-drug application. The holder of an effective new-drug application should submit to the New Drug Branch, in writing, full details of any proposed change or changes, and he will be notified in writing whether, in the Food and Drug Administrationės opinion, the submission of a supplemental application is required for such change or changes. This includes all mailing and promotional pieces that are to be used after the new drug has been placed on the market.

(c) A supplemental application is not required when the article is no longer a new drug, under the labeling submitted in the new-drug application, unless the proposed change itself causes it to become a new drug.

5. It is proposed to amend § 130.13 to read as follows:

§ 130.13 Insufficient information in application.

The information contained in an application may be insufficient for the New Drug Branch to determine whether a drug is safe for use if it fails to include (among other things) a statement showing whether the drug is to be limited to prescription sale and exempt under section 502(f)(1) of the act, from the requirement that its labeling bear adequate directions for use. If the drug is to be exempt, the information may also be insufficient if: (a) The specimen labeling proposed for use on or within the package from which the drug is to be dispensed fails to bear adequate information for 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 for the purposes for which it is intended, including all purposes for which it is to be advertised or represented.

(b) The application fails to show that the labeling and advertising of the drug will offer the drug for use only under those conditions for which it is offered in the labeling on or within the package from which the drug is to be dispensed,

(c) The application fails to show that all labeling which furnishes or purports to furnish information for use of the drug will contain adequate information for use, including indications, effects, dosages, routes, methods, and frequency and duration of administration, and any relevant hazards, contraindications, side effects, and precautions which is contained in the labeling on or within the package from which the drug is to be dispensed.

Dated: July 18, 1960.

Geo. P. Larrick, Commissioner of Food and Drugs.

OTHER MATERIAL

[COMMITTEE PRINT]

MAY 26, 1961

In order that the provisions of bill No. S. 1552 may be conveniently referred to the sections of present law which would be amended, those sections are set forth below with indication of deletions in, insertions in, and additions to such sections. Entirely new sections which would be added to present laws also are included.

Matter proposed to be omitted is printed in linetype. New matter is printed in italic. Matter in which no change is proposed is shown in roman.

PRINTED FOR THE USE OF THE COMMITTEE ON THE
JUDICIARY

SHERMAN ACT

Section 2 of the bill adds section 7 to the Sherman Act as

follows:

1 "SEC. 7. (a) For the purposes of sections 1 and 3 of 2 this Act, every contract, combination, or conspiracy whereby 3 any party thereto undertakes or has undertaken to (1) with4 draw or cause to be withdrawn any pending application for

73753 O 61-pt. 2- 29

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