The text of the bill below is as of Oct 26, 1951 (Passed Congress).
You are reading a bill enacted 26,148 days ago. In the intervening time subsequent legislation may have amended or repealed the provisions below.
Summary of this bill
Source: Wikipedia
The Durham-Humphrey Amendment explicitly defined two specific categories for medications, legend (prescription) and over-the-counter (OTC). This amendment was co-sponsored by then Senator (and later Vice President) Hubert H. Humphrey Jr., who was a pharmacist in South Dakota before beginning his political career. The other sponsor of this amendment was Carl Durham, a pharmacist representing North Carolina in the House of Representatives.
The bill requires any drug that is habit-forming or potentially harmful to be dispensed under the supervision of a health practitioner as a prescription drug and must carry the statement, "Caution: Federal law prohibits dispensing without a prescription."
Until this law, there was no requirement that any drug be …
648 PUBLIC LAW 216—OCT. 26, 1951 [65 STAT.
1947, (ii) on or after April 6, 1917, and prior to November 11,
1918, or (iii) on or after June 27, 1950, and prior to such date
thereafter as shall be determined by the President, and who shall
have been discharged or released therefrom under conditions other
"Serviceman." than dishonorable. The term 'serviceman' shall mean a pei-son in
the active military or naval service of the United States who has
served therein at any time (i) on or after September 16, 1940,
and prior to July 26,1947, (ii) on or after April 6,1917, and prior
to November 11,1918, or (iii) on or after J u n e 27,1950, and prior
to such date thereafter as shall be determined by the President."
SEC. 2. The Act of October 14,1940, as amended (54 Stat. 1125, as
amended; 42 U. S. C. 1521), is hereby amended (i) by striking out in
Stat el!**' ^°^^' ^ paragraph (c) of section 505 and in paragraph (c) of section 602 the
42U.S. c. §§1575, phrase "of World W a r I I " wherever such phrase occurs; and (ii) by
^^2U. s. c. § 1581. striking out in paragraph (b) of section 601 the phrase "during World
W a r I I " , and substituting therefor the words "at any time on or after
September 16,1940, and prior to July 26,1947, or on or after June 27,
1950, and prior to such date thereafter as shall be determined by the
President".
SEC. 3. Public Law 65, Eighty-first Congress (63 Stat. 68), is hereby
amended by adding, after the phrase "July 26, 1947,", in section 2
thereof, the phrase "or on or after J u n e 27, 1950, and prior to such
date thereafter as shall be determined by the President,".
SEC. 4. The National Housing Act, as amended, is amended by strik-
ing out the phrase "of World W a r I I " wherever it occurs in paragraph
^ u^^s^c. § i7i6e (^) of section 213, and by adding the following proviso before the
(b). ' period at the end of said paragraph: " : Provided^ That for purposes
of this section the word 'veteran' shall mean a person who has served
in the active military or naval service of the United States at any time
on or after September 16, 1940, and prior to July 26, 1947, or on or
after June 27, 1950, and prior to such date thereafter as shall be
determined by the President".
Approved October 26, 1951.
Public Law 215 CHAPTER 578
AN ACT
October 26,1951
[H. R. 3298] To amend sections 303 (c) and 503 (b) of the Federal Food, Drug, and Ck»smetic
Act, as amended.
Be it enacted hy the Senate and House of Representatives of the
an^^^cosmetfc^Act' United States of America in Congress assembled^ That subsection
amendments. ' (b) of scction 503 of the Federal Food, Drug, and Cosmetic Act,
21 U.V c^ § 353. as amended, is amended to read as follows:
p e S o r o f Srtafn " ( b ) (1) A drug intended for use by man w h i c h -
drugs. " ( A ) is a habit-formmg drug to which section 502 (d) applies;
^^ • • • • o r
" ( B ) because of its toxicity or other potentiality for harmful
effect, or the method of its use, or the collateral measures neces-
sary to its use, is not safe for use except under the supervision
of a practitioner licensed by law to administer such drug; or
21 u. s. c. § 365. " ( C ) is limited by an effective application under section 505 to
use under the professional supervision of a practitioner licensed
by law to administer such drug,
65 STAT.] PUBLIC LAW 215—OCT. 26, 1961 649
shall be dispensed only (i) upon a written prescription of a prac-
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 b ^ 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 cer-
tain labeling reqoire-
prescription of a practitioner licensed by law to administer such drug ments.
2 1 U . 8 . C. j362.
shall be exempt from the requirements of section 502, except para-
graphs ( a ) , (i) (2) and (3), ( k ) , a n d (1), and the packaging require-
ments 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 prescrip-
tion. 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 E x e m p t i o n from
prescription require-
section 502 (d) and section 505 from the requirements of paragraph ments.
21 U. S. C. }} 352,,
(1) of this subsection when such requirements are not necessary for 355.
the protection of the public health.
"(4) A drug which is subject to paragraph (1) of this subsection Drugs deemed to be
misbranded.
shall be deemed to be misbranded if at any time prior to dispensing
its label fails to bear the statement 'Caution: Federal law prohibits
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,
n a r c o t i c s or mari-
person from any requirement prescribed by or under authority of huana laws.
law with respect to drugs now included or which may hereafter be
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.
53 Stat. 387.
3238 (b) of the Internal Revenue Code (26 U. S. C. 3238 ( b ) ) . "
SEC. 2. Subsection (c) of section 303 of the Federal Food, Drug, and
21 U. 8. C. { 333.
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
folio wing: "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 Effective date.
the date of its enactment.
Approved October 26, 1951.
