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[PUBLIC LAW 360-81ST CONGRESS]

[CHAPTER 696-1ST SESSION]

[H. R. 160]

AN ACT

To amend section 801 of the Federal Food, Drug, and Cosmetic Act, as amended.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, That subsection (a) of section 801 of the Federal Food, Drug, and Cosmetic Act, as amended (21 U. S. C. 381 (a)), is amended by striking out the period at the end of the second sentence and inserting in lieu thereof: ", except as provided in subsection (b) of this section. The Secretary of the Treasury shall cause the destruction of any such article refused admission unless such article is exported, under regulations prescribed by the Secretary of the Treasury, within ninety days of the date of notice of such refusal or within such additional time as may be permitted pursuant to such regulations."

SEC. 2. Subsection (b) of such section is amended to read:

"(b) Pending decision as to the admission of an article being imported or offered for import, the Secretary of the Treasury may authorize delivery of such article to the owner or consignee upon the execution by him of a good and sufficient bond providing for the payment of such liquidated damages in the event of default as may be required pursuant to regulations of the Secretary of the Treasury. If it appears to the Administrator that an article included within the provisions of clause (3) of subsection (a) of this section can, by relabeling or other action, be brought into compliance with the Act or rendered other than a food, drug, device, or cosmetic, final determination as to admission of such article may be deferred and, upon filing of timely written application by the owner or consignee and the execution by him of a bond as provided in the preceding provisions of this subsection, the Administrator may, in accordance with regulations, authorize the applicant to perform such relabeling or other action specified in such authorization (including destruction or export of rejected articles or portions thereof, as may be specified in the Administrator's authorization). All such relabeling or other action pursuant to such authorization shall in accordance with regulations be under the supervision of an officer or employee of the Federal Security Agency designated by the Administrator, or an officer or employee of the Department of the Treasury designated by the Secretary of the Treasury.

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SEC. 3. Subsection (c) of such section is amended to read:

"(c) All expenses (including travel, per diem or subsistence, and salaries of officers or employees of the United States) in connection with the destruction provided for in subsection (a) of this section and the supervision of the relabeling or other action authorized under the provisions of subsection (b) of this section, the amount of such

expenses to be determined in accordance with regulations, and all expenses in connection with the storage, cartage, or labor with respect to any article refused admission under subsection (a) of this section, shall be paid by the owner or consignee and, in default of such payment, shall constitute a lien against any future importations made by such owner or consignee."

Approved October 18, 1949.

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To amend sections 303 (c) and 503 (b) of the Federal Food, Drug, and Cosmetic
Act, as amended.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, That subsection Federal Food, (b) of section 503 of the Federal Food, Drug, and Cosmetic Act, Drug, and Cosas amended, is amended to read as follows:

"(b) (1) A drug intended for use by man which

or

66

metio Act,
amendments.
52 Stat. 1051.

"(A) is a habit-forming drug to which section 502 (d) applies; 21 U.S.C. 353(b).

Conditions for

"(B) because of its toxicity or other potentiality for harmful dispensation of effect, or the method of its use, or the collateral measures neces- certain drugs. sary to its use, is not safe for use except under the supervision

of a practitioner licensed by law to administer such drug; or

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“(C) is limited by an effective application under section 505 to 21 U.S.C. § 355. use under the professional supervision of a practitioner licensed by law to administer such drug,

65 Stat. 648.

shall be dispensed only (i) upon a written prescription of a prac- 65 Stat. 649.
titioner licensed by law to administer such drug, or (ii) upon an oral
prescription of such practitioner which is reduced promptly to writing
and filed by the pharmacist, or (iii) by refilling any such written or
oral prescription if such refilling is authorized by the prescriber either
in the original prescription or by oral order which is reduced promptly
to writing and filed by the pharmacist. The act of dispensing a drug
contrary to the provisions of this paragraph shall be deemed to be an
act which results in the drug being misbranded while held for sale.

"(2) Any drug dispensed by filling or refilling a written or oral Exemption from prescription of a practitioner licensed by law to administer such drug certain labeling shall be exempt from the requirements of section 502, except para- 21 U.S.C. § 352. requirements. graphs (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 to a drug dispensed in violation of paragraph (1) of this subsection.

"(3) The Administrator may by regulation remove drugs subject to Exemption from section 502 (d) and section 505 from the requirements of paragraph prescription (1) of this subsection when such requirements are not necessary for requirements. the protection of the public health.

"(4) A drug which is subject to paragraph (1) of this subsection Drugs deemed shall be deemed to be misbranded if at any time prior to dispensing to be misits label fails to bear the statement 'Caution: Federal law prohibits branded. dispensing without prescription'. A drug to which paragraph (1) of this subsection does not apply shall be deemed to be misbranded if

at any time prior to dispensing its label bears the caution statement quoted in the preceding sentence.

"(5) Nothing in this subsection shall be construed to relieve any Compliance with person from any requirement prescribed by or under authority of narcotics or law with respect to drugs now included or which may hereafter be marihuana laws. included within the classifications stated in section 3220 of the Internal

Revenue Code (26 U. S. C. 3220), or to marihuana as defined in section 53 Stat. 382. 3238 (b) of the Internal Revenue Code (26 U. S. C. 3238 (b)).” 53 Stat. 387.

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All 65 Stat. 649. 21 U.S.C. 333.

Effective date.

SEC. 2. Subsection (c) of section 303 of the Federal Food, Drug, and Cosmetic Act, as amended, is amended by striking out the period at the end of clause (3) and inserting in lieu thereof a semicolon and the following: "or (4) for having violated section 301 (b), (c) or (k) by failure to comply with section 502 (f) in respect to an article received in interstate commerce to which neither section 503 (a) nor section 503 (b) (1) is applicable, if the delivery or proffered delivery was made in good faith and the labeling at the time thereof contained the same directions for use and warning statements as were contained in the labeling at the time of such receipt of such article."

SEC. 3. The provisions of this Act shall take effect six months after the date of its enactment.

Approved October 26, 1951.

42-474 0-70-4

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To amend sections 502 (1) and 507 of the Federal Food, Drug, and Cosmetic Act in order to identify the drug known as aureomycin by its chemical name, chlortetracycline.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, That section 502 (1)

of the Federal Food, Drug, and Cosmetic Act (21 U. S. C., sec. 352 63 Stat. 409. (1)) is amended by striking out "aureomycin" and inserting in lieu thereof "chlortetracycline".

SEC. 2. (a) The heading of section 507 of such Act (21 U. S. C., sec. 357) is amended by striking out "AUREOMYCIN" and inserting in lieu thereof "CHLORTETRACYCLINE".

(b) The first sentence of subsection (a) of such section 507 is amended by striking out "aureomycin" and inserting in lieu thereof "chlortetracycline".

Approved August 5, 1953.

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