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COMMITTEE ON INTERSTATE AND FOREIGN COMMERCE

ROBERT CROSSER, Ohio, Chairman
LINDLEY BECKWORTH, Texas

CHARLES A. WOLVERTON, New Jersey
J. PERCY PRIEST, Tennessee

CARL HINSHAW, California
OREN HARRIS, Arkansas

LEONARD W. HALL, New York
DWIGHT L. ROGERS, Florida

JOSEPH P. O'HARA, Minnesota
ARTHUR G. KLEIN, New York

WILSON D. GILLETTE, Pennsylvania
THOMAS B. STANLEY, Virginia

ROBERT HALE, Maine
WILLIAM T. GRANAHAN, Pennsylvania JAMES I. DOLLIVER, Iowa
JOHN A. MCGUIRE, Connecticut

JOHN W. HESELTON, Massachusetts
F. ERTEL CARLYLE, North Carolina

HUGH D. SCOTT, JR., Pennsylvania
JOHN BELL WILLIAMS, Mississippi

JOHN B. BENNETT, Michigan
PETER F. MACK, JR., Illinois

RICHARD W. HOFFMAN, Illinois
HOMER THORNBERRY, Texas

J. EDGAR CHENOWETH, Colorado
LOUIS B. HELLER, New York

JOHN V. BEAMER, Indiana
KENNETH A. ROBERTS, Alabama
MORGAN M. MOULDER, Missouri
HARLEY O. STAGGERS, West Virginia

ELTON J. LAYTON, Clerk

B

CONTENTS

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Text of H. R. 3298.

Report of-

Administrative Office of the United States Courts.

Federal Security Agency--

Justice Department--

Statement of-

Clutter, Raymond O., representing Eli Lilly & Co., Indianapolis, Ind.

Dunn, Charles Wesley, representing American Pharmaceutical Manu-

facturers' Association.

Durham, Hon. Carl T., a Representative in Congress from the State

of North Carolina.

Ewing, Hon. Oscar R., Administrator, Federal Security Agency -

Fischelis, Robert P., secretary and general manager, American

Pharmaceutical Association.

Harrop, Leslie D., general counsel, American Drug Manufacturers

Association.-

Hoge, James F., representing Proprietary Association-

Kelly, Robert E., Chicago, Ill_-

Larrick, George B., Associate Commissioner, Food and Drug Admin-

istration, Federal Security Agency--

Sibley, George H., vice president and general counsel, E. R. Squibb

& Sons...

Stephens, Hon. Harold M., Chief Judge United States Court of

Appeals for the District of Columbia Circuit

Waller, Herman S., Counsel, National Association Retail Druggists-

Warnack, Roy S., retail druggist, Los Angeles, Calif..

Additional information submitted for the record by-

Abbott Laboratories, statement of Paul Gerdən, general attorney and

assistant secretary-

American Drug Manufacturers Association:

Members of...

Proposed amended bill.
American Medical Association, letter from Ernest B. Howard.
American Pharmaceutical Association:

Correspondence with Federal Security Agency concerning pro-

posed ruling-
Statement of Hugo H. Schaefer, chairman, committee on legis-

lation..

Supplemental statement of Hugo H. Schaefer.

District of Columbia Pharmaceutical Association, statement of Horace

Walker, executive secretary--

Eli Lilly & Co.:

Prescription refills, article by_Walton M. Wheeler, Jr., secretary

and general counsel, from Food Drug Cosmetic Law Journal,

November 1950...

Federal Security Agency:

Regulations (sec. 1.106)

State laws relating to the dispensing of drugs on prescription,

table..

Terminations of over-the-counter and unauthorized refill cases as

of April 1, 1951, table..

National Association of Retail Druggists, supplemental statement of

Herman S. Waller, legal counsel

New York Board of Trade, statement of James G. Flanagan, counsel

and legislative chairman, durg, chemical, and allied trades section..
Parke, Davis & Co., telegram from Kenneth D. McGregor, secretary

and general attorney.
Pierce's Proprietaries, Inc., letter from R. V. Pierce, president.
Sterling Drug, Inc., telegram from..

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08/94 53-005-00

FEDERAL FOOD, DRUG, AND COSMÉTIC ACT

,

TUESDAY, MAY 1, 1951

HOUSE OF REPRESENTATIVES,
COMMITTEE ON INTERSTATE AND FOREIGN COMMERCE,

Washington, D. C. The committee met at 10 a. m., Hon. Robert Crosser (chairman) presiding

The CHAIRMAN. The committee will please be in order. The hearing this morning will be on H. R. 3298, by Mr. Durham, who will be the first witness. A copy of the bill and the reports received thereon, will be made a part of the record. (H. R. 3298 is as follows:)

(H. R. 3298, 82d Cong., 1st sess.) A BILL To amend section 503 (b) of the Federal Food, Drug, and Cosmetic Act Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, That subsection (b) of section 503 of the Federal Food, Drug, and Cosmetic Act, as amended, is amended to read as follows:

“(b) A drug dispensed by filling or refilling a written or oral prescription of a practitioner licensed by law to administer such drug shall be exempt from the requirements of section 502, except paragraphs (a), (i) (2) and (3), (k), and (1), and the packaging requirements of paragraphs (g) and (h), if the drug bears a label containing the name and address of the dispenser, the serial number and date of the prescription, or of its filling, the name of the prescriber, and, if stated in the prescription, the name of the patient, and the directions for use and cautionary statements, if any, contained in such prescription. This exemption shall not apply to any drug dispensed in the course of the conduct of a business of dispensing drugs pursuant to diagnosis by mail or otherwise without examination of the patient. If the drug is intended for use by man and

"(1) is a habit-forming drug subject to the regulations prescribed under section 502 (d);

“(2) has been found by the Administrator, after investigation and opportunity for public hearing, to be unsafe or ineffective for use without the professional diagnosis or supervision of a practitioner licensed by law;

"(3) if an effective application under section 505 limits it to use under the professional supervision of a practitioner licensed by law, such exemption shall apply only if such drug is dispensed upon a written prescription of a practitioner licensed by law to administer such drug or upon an oral prescription of such practitioner which is reduced to writing and filed by the pharmacist, or is dispensed by refilling a prescrption if such refilling is authorized by the prescriber in the original prescription or by oral order and such order is reduced to writing and filed by the pharmacist. "The Administrator may by regulation remove drugs subject to section 502 (d) and section 505 from the provision of this subsection when such requirements are not necessary for the protection of the public health.

“A drug which is subject to clause (1), (2), or (3) of this subsection shall be deemed to be misbranded if at any time prior to dispensing its label fails to bear the statement 'Caution: Federal law prohibits sale or dispensing without prescription.'

"The act of dispensing a drug contrary to the provisions of this subsection shall be deemed to be an act which results in the drug's being misbranded while held for sale.

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