An Act to protect the public health by amending the Federal Food, Drug, and Cosmetic Act to assure the safety, effectiveness, and reliability of drugs, authorize standardization of drug names, and clarify and strengthen existing inspection authority; and for other purposes
PL 87-781 (S.1552), enacted 10/10/1962

780 
PUBLIC LAW 87-781-.OCT. 10,1962 
[76 STAT. 
October 10, 1962 
[S.1552] 
Drug Amend-
ments of 1962. 
52 Stat. 1049. 
Public Law 87-781 
^ 
AN A C T 
To protect the public health by amending the Federal Food, Drug, and Cosmetic 
Act to assure the safety, effectiveness, and reliability of drugs, authorize 
standardization of drug names, and clarify and strengthen existing inspection 
authority; and for other purposes. 
Be it enacted hy the Seriate and House of Representatives 
of the 
United States of America in Congress assembled^ That this Act, 
divided into titles and sections according to the following table of 
contents, may be cited as the "Drug Amendments of 1962". 
TABLE OF CONTENTS 
TITLE 
I—DRUGS 
PART A 
AMENDMENTS TO ASSURE SAFETY, B^FECTIVENESS, AND RELIABIUTY 
Sec. 101. Requirement of adequate controls in manufacture. 
Sec. 102. Effectiveness and safety of new drugs. 
Sec. 103. Records and reports as to experience on new drugs. 
Sec. 104. New drug clearance procedure. 
Sec. 105. Certification of antibiotics. 
Sec. 1,06. Records and reports as to experience on antibiotics. 
Sec. 107. Effective dates and application of part A. 
PART B 
STANDARDIZATION OF DRUG NAMES 
Sec. 111. Review and designation of official names. 
Sec. 112. Name to be used on drug label. 
Sec. 113. Exclusion of cosmetics. 
Sec. 114. Information to physicians. 
PART C 
AMENDMENTS AS TO ADVERTISING 
Sec. 131. Prescription drug advertisements. 
TITLE II—FACTORY INSPECTION AND EFFECT ON STATE LAWS 
Sec. 201. Factory inspection. 
Sec. 202. Effect on State laws. 
Sec. 203. Effective date. 
TITLE III—^REGISTRATION OF DRUG ESTABLISHMENTS AND PATENT INFORMATION 
Sec. 301. Findings and declaration. 
Sec. 302. Registration of producers of drugs. 
Sec. 303. Transitional provisions. 
Sec. 304. Failure to register. 
Sec. 305. Drugs from nonregistered establishments misbranded. 
Sec. 306. Samples of imported drugs. 
Sec. 307. Definitions. 
Sec. 308. Information on patents for drugs. 
TITLE I—DRUGS 
PART A—AMENDMENTS T O ASSURE SAFETY, EFFECTIVENESS, AND 
RELJABIUTY 
REQUIREMENT OF ADEQUATE CONTROLS IN MANUFACTURE 
SEC. 101. Clause (2) of section 501(a) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 351(a)) is amended to read as follows: 
" (2) (A) if it has been prepared, packed, or held under insanitary con-
ditions whereby it may have been contaminated with filth, or whereby 
it may have been rendered injurious to health; or (B) if it is a drug 
and the methods used in, or the facilities or controls used for, its manu-
facture, processing, packing, or holding do not conform to or are not 
76 STAT.] 
PUBLIC LAW 87-781-OCT. 10, 1962 
781 
operated or administered in conformity with current good manu-
facturing practice to assure that such drug meets the requirements of 
this Act as to safety and has the identity and strength, and meets the 
quality and purity characteristics, which it purports or is represented 
to possess;". 
EFFECTIVENESS AND SAFETY OF N E W DRUGS 
SEC. 102. (a) (1) Section 201 (p) (1) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321 (p) (1)), defining the term "new drug", is 
52 stat. i04i. 
amended by (A) inserting therein, immediately after the words "to 
evaluate the safety", the words "and effectiveness", and (B) inserting 
therein, immediately after the words "as safe", the words "and 
(2) Section 201 (p) (2) of such Act (21 U.S.C. 321 (p) (2)) is 
amended by inserting therein, immediately after the word "safety", 
the words and effectiveness". 
(b) Section 505(b) of such Act (21 U.S.C. 355(b)) is amended by 
S2 stat. 1052. 
inserting therein, immediately after the words "is safe for use", the 
words "and whether such drug is effective in use". 
(c) Section 505(d) of such Act (21 U.S.C. 355(d)) is amended to 
read as follows: 
"(d) If the Secretary finds, after due notice to the applicant in 
Grounds for re-
accordance with subsection (c) and giving him an opportunity for a ^i^«^"s appiica-
hearing, in accordance with said subsection, that (1) the investiga-
tions, reports of which are required to be submitted to the Secretary 
pursuant to subsection (b), do not include adequate tests by all 
methods reasonably applicable to show whether or not such drug is 
safe for use under the conditions prescribed, recommended, or sug-
gested in the proposed labeling thereof; (2) the results of such tests 
show that such drug is unsafe for use under such conditions or do not 
show that such drug is safe for use under such conditions; (3) the 
methods used in, and the facilities and controls used for, the manu-
facture, processing, and packing of such drug are inadequate to pre-
serve its identity, strength, quality, and purity; (4) upon the basis of 
the information submitted to him as part of the application, or upon 
the basis of any other information before him with respect to such 
drug, he has insufficient information to determine whether such drug 
is safe for use under such conditions; or (5) evaluated on the basis 
of the information submitted to him as part of the application and 
any other information before him with respect to such drug, there 
is a lack of substantial evidence that the drug wdll have the effect it 
purports or is represented to have under the conditions of use pre-
scribed, recommended, or suggested in the proposed labeling thereof; 
or (6) based on a fair evaluation of all material facts, such labeling is 
false or misleading in any particular; he shall issue an order refusing 
to approve the application. 
If, after such notice and opportunity 
Approval of ap-
for hearing, the Secretary finds that clauses (1) through (6) do not pii*=«'io"-
apply, he shall issue an order approving the application. 
As used 
in this subsection and subsection (e), the term 'substantial evidence' 
means evidence consisting of adequate and well-controlled investiga-
tions, including clinical investigations, by experts qualified by scien-
tific training and experience to evaluate the effectiveness of the drug 
involved, on the basis of which it could fairly and responsibly be con-
cluded by such experts that the drug will have the effect it purports 
or is represented to have under the conditions of use prescribed, 
recommended, or suggested in the labeling or proposed labeling 
thereof." 
(d) Section 505(e) of such Act (21 U.S.C. 355(e)) is amended to 
52 stat. 1052. 
read as follows: 
782 
PUBLIC LAW 87-781-OCT. 10, 1962 
[76 STAT. 
Suspension of 
" (e) The Secretary shall, after due notice and opportunity for hear-
approvai. 
jj^g ^^ ^j^^ applicant, withdraw approval of an application with respect 
to any drug under this section if the Secretary finds (1) that clinical 
or other experience, tests, or other scientific data show that such drug 
is unsafe for use under the conditions of use upon the basis of which 
the application was approved; (2) that new evidence of clinical expe-
rience, not contained in such application or not available to the Secre-
tary until after such application was approved, or tests by new 
methods, or tests by methods not deemed reasonably applicable when 
such application was approved, evaluated together with the evidence 
available to the Secretary when the application was approved, shows 
that such drug is not shown to be safe for use under the conditions of 
use upon the basis of which the application was approved; or (3) on 
the'basis of new information before him with respect to such dru^, 
evaluated together with the evidence available to him when the appli-
cation was approved, that there is a lack of substantial evidence that 
the drug will have the effect it purports or is represented to have 
under the conditions of use prescribed, recommended, or suggested in 
the labeling thereof; or (4) that the application contains any untrue 
statement of a material fact: Provided, That if the Secretary (or in his 
absence the officer acting as Secretary) finds that there is an imminent 
hazard to the public health, he may suspend the approval of such 
application immediately, and give the applicant prompt notice of his 
action and afford the applicant the opportunity for an expedited 
hearing under this subsection; but the authority conferred by this 
proviso to suspend the approval of an application shall not be dele-
gated. The Secretary may also, after due notice and opportunity for 
hearing to the applicant, withdraw the approval of an application 
with respect to any drug under this section if the Secretary finds (1) 
that the applicant has failed to establish a system for maintaining 
required records, or has repeatedly or deliberately failed to maintain 
such records or to make required reports, in accordance with a regula-
tion or order under subsection (j), or the applicant has refused to 
permit access to, or copying or verification of, such records as required 
by paragraph (2) of such subsection; or (2) that on the basis of new 
information before him, evaluated together with the evidence before 
him when the application was approved, the methods used in, or the 
facilities and controls used for, the manufacture, processing, and pack-
ing of such drug are inadequate to assure and preserve its identity, 
strength, quality, and purity and were not made adequate within a 
reasonable time after receipt of written notice from the Secretary 
specifying the matter complained of; or (3) that on the basis of new 
information before him, evaluated together with the evidence before 
him when the application was approved, the labeling of such drug, 
based on a fair evaluation of all material facts, is false or misleading 
in any particular and was not corrected within a reasonable time after 
receipt of written notice from the Secretary specifying the matter 
complained of. Any order under this subsection shall state the find-
ings upon which it is based." 
^' 
RECORDS AND REPORTS AS TO EXPERIENCE ON N E W DRUGS 
SEC. 103. (a) Section 505 of the Federal Food, Drug, and Cosmetic 
52 Stat. 1052. 
Act (21 U.S.C. 355) is amended by adding at the end thereof the 
following new subsection: 
"(j) (1) In the case of any drug for which an approval of an appli-
cation filed pursuant to this section is in effect, the applicant shall 
establish and maintain such records, and make such reports to the 
Secretary, of data relating to clinical experience and other data or 
76 STAT.] 
PUBLIC LAW 87-781-OCT. 10, 1962 
783 
information, received or otherwise obtained by such applicant with 
respect to such drug, as the Secretary may by general regulation, or 
by order with respect to such application, prescribe on the basis of a 
finding that such records and reports are necessary in order to enable 
the Secretary to determine, or facilitate a determination, whether there 
is or may be ground for invoking subsection (e) of this section: 
Provided^ however, That regulations and orders issued under this sub-
section and under subsection (i) shall have due regard for the profes-
sional ethics of the medical profession and the interests of patients 
and shall provide, where the Secretary deems it to be appropriate, 
for the examination, upon request, by the persons to whom such regu-
lations or orders are applicable, of similar information received or 
otherwise obtained by the Secretary. 
"(2) Every person required under this section to maintain records. 
Access to rec-
and every person in charge or custody thereof, shall, upon request of °'"'*^-
an officer or employee designated by the Secretary, permit such officer 
or employee at all reasonable times to have access to and copy and 
verify such records." 
(b) Section 505(i) of such Act (21 U.S.C. 355(i)) is amended (1) 
52 stat. 1052. 
by inserting "the foregoing subsections of" immediately after "opera-
tion of"; 
(2) by inserting "and effectiveness" immediately after 
"safety"; and (3) by adding at the end thereof the following new 
sentences: "Such regulations may, within the discretion of the Secre- 
Regulations per-
tary, among other conditions relating to the protection of the public *?|"*"^ *° exemp-
health, provide for conditioning such exemption upon— 
f 
" (1) the submission to the Secretary, before any clinical testing 
of a new drug is undertaken, of reports, by the manufacturer or 
the sponsor of the investigation of such drug, of preclinical tests 
(including tests on animals) of such drug adequate to justify the 
proposed clinical testing; 
"(2) the manufacturer or the sponsor of the investigation of a 
f 
new drug proposed to be distributed to investigators for clinical 
testing obtaining a signed agreement from each of such investiga-
tors that patients to whom the drug is administered will be under 
his personal supervision, or under the supervision of investigators 
i 
responsible to him, and that he will not supply such drug to any 
other investigator, or to clinics, for administration to human 
* 
beings; and 
"(3) the establishment and maintenance of such records, and 
the making of such reports to the Secretary, by the manufacturer 
or the sponsor of the investigation of such drug, of data (includ-
ing but not limited to analytical reports by investigators) 
obtained as the result of such investigational use of such drug, 
as the Secretary finds will enable him to evaluate the safety and 
effectiveness of such drug in the event of the filing of an applica- 
'"^' 
' -
tion pursuant to subsection (b). 
Such regulations shall provide that such exemption shall be condi-
tioned upon the manufacturer, or the sponsor of the investigation, 
requiring that experts using such drugs for investigational purposes 
certify to such manufacturer or sponsor that they will inform any 
human beings to whom such drugs, or any controls used in connection 
therewith, are being administered, or their representatives, that such 
drugs are being used for investigational purposes and will obtain the 
consent of such human beings or their representatives, except where 
they deem it not feasible or, in their professional judgment, contrary 
to the best interests of such human beings. Nothing in this subsection 
shall be construed to require any clinical investigator to submit directly 
to the Secretary reports on the investigational use of drugs." 
784 
PUBLIC LAW 87-781-OCT. 10, 1962 
[76 STAT. 
52 Stat. 1042. 
(c) Sectioii 301(e) of such Act (21 U.S.C. 331(e)) is amended to 
read as follows: 
"(e) The refusal to permit access to or copying of any record as 
21 use 373. 
required by section 703; or the failure to establish or maintain any rec-
21 use 355. 
ord, or make anj^ report, required under section 505 (i) or (j), or the 
Ante, p. 782. 
refusal to permit access to or verification or copying of any such 
required record." 
(d) Section 302(a) of such Act (21 U.S.C. 332(a)) is amended by 
striking out "(e),". 
52 Stat. 1043. 
N E W DRUG CLEARANCE PROCEDURE 
SEC. 104. (a) Section 505(a) of the Federal Food, Drug, and Cos-
52 Stat. 1052. 
metic Act (21 U.S.C. 355(a)), is amended to read as follows: 
"(a) No person shall introduce or deliver for introduction into 
interstate commerce any new drug, unless an approval of an applica-
tion filed pursuant to subsection (b) is effective with respect to such 
drug." 
(b) Section 505(c) of such Act (21 U.S.C. 355(c)) is amended to 
read as follows: 
"(c) Within one hundred and eighty days after the filing of an 
application under this subsection, or such additional period as may be 
agreed upon by the Secretary and the applicant, the Secretary shall 
either— 
"(1) approve the application if he then finds that none of the 
grounds for denying approval specified in subsection (d) applies, 
or 
" (2) give the applicant notice of an opportunity for a hearing 
before the Secretary under subsection (d) on the question whether 
such application is approvable. If the applicant elects to accept 
the opportunity for hearing by written request within thirty days 
after such notice, such hearing shall commence not more than 
ninety days after the expiration of such thirty days unless the 
Secretary and the applicant otherwise agree. Any such hearing 
shall thereafter be conducted on an expedited basis and the Secre-
tary's order thereon shall be issued within ninety days after the 
date fixed by the Secretary for filing final briefs." 
(c) Section 505(f) of such Act (21 U.S.C. 355(f)) is amended to 
read as follows: 
"(f) Whenever the Secretary finds that the facts so require, he shall 
revoke any previous order under subsection (d) or (e) refusing, with-
drawing, or suspending approval of an application and shall approve 
such application or reinstate such approval, as may be appropriate." 
Appeal. 
(d) (1) The first four sentences of section 505(h) of such Act (21 
52 Stat. 1052. 
U.S.C. 355(h)) are amended to read as follows: "An appeal may be 
taken by the applicant from an order of the Secretary refusing or 
withdrawing approval of an application under this section. 
Such 
appeal shall be taken by filing in the United States court of appeals 
for the circuit wherein such applicant resides or has his principal place 
of business, or in the United States Court of Appeals for the District 
of Columbia Circuit, within sixty days after the entry of such order, 
a written petition praying that the order of the Secretary be set aside. 
A copy of such petition shall be forthwith transmitted by the clerk of 
the court to the Secretary, or any officer designated by him for that 
purpose, and thereupon the Secretary shall certify and file in the 
court the record upon which the order complained of was entered, as 
72 Stat. 941. 
provided in section 2112 of title 28, United States Code. Upon the 
filing of such petition such court shall have exclusive jurisdiction to 
affirm or set aside such order, except that until the filing of the record 
the Secretary may modify or set aside his order." 
76 STAT.] 
PUBLIC LAW 8 7 - 7 8 1 - O C T . 10, 1962 
785 
(2) The ninth sentence of such section 505 (h) is amended to read as 
21 use 355. 
follows: "The judgment of the court affirming or setting aside any such 
order of the Secretary shall be final, subject to review by the Supreme 
Court of the United States upon certiorari or certification as provided 
in section 1254 of title 28 of the United States Code." 
62 stat. 928. 
(3) The amendments made by this subsection shall not apply to any 
appeal taken prior to the date of enactment of this Act. 
(e) (1) Section 301(1) of such Act (21 U.S.C. 331(1)) is amended 
52 stat. 1042. 
by (1) inserting "approval of" before "an application", and (2) 
striking out "effective" and inserting in lieu thereof "in effect". 
(2) Clause (C) of section 503(b) (1) of such Act (21 U.S.C. 353(b) 
52 stat. losi. 
(1.)) is amended by striking out "effective" and inserting in lieu 
thereof "approved". 
(f)(1) Clause (A) of paragraph (3) of section 409(c) of such Act 
(21 U.S.C/ 348 (c)) is amended by inserting before the semicolon at the 
72 stat. i78S. 
end thereof the following: ", except that this proviso shall not apply 
with respect to the use of a substance as an ingredient of feed for 
animals which are raised for food production, if the Secretary finds 
(i) that, under the conditions of use and feeding specified in proposed 
labeling and reasonably certain to be followed in practice, such addi-
tive will not adversely affect the animals for which such feed is 
intended, and (ii) that no residue of the additive will be found (by 
methods of examination prescribed or approved by the Secretary by 
regulations, which regulations shall not be subject to subsections (f) 
and (g)) in any edible portion of such animal after slaughter or in 
any food yielded by or derived from the living animal". 
(2) Subparagraph (B) of paragraph (5) of section 706(b) of such 
Act (21 U.S.C. 376(b)) is amended by inserting before the period at 
74 stat. 399. 
the end of the subparagraph a colon and the following proviso: "Fro-
vide'd, That clause (i) of this subparagraph (B) shall not apply with 
respect to the use of a color additive as an ingredient of feed for ani-
mals which are raised for food production, if the Secretary finds that, 
under the conditions of use and feeding specified in proposed labeling 
and reasonably certain to be followed in practice, such additive will 
not adversely affect the animals for which such feed is intended, and 
that no residlue of the additive will be found (by methods of examina-
tion prescribed or approved by the Secretary by regulations, which 
regulations shall not be subject to subsection (d)) in any edible portion 
of such animals after slaughter or in any food yielded by or derived 
from the living animal". 
CERTIFICATION OF ANTIBIOTICS 
SEC. 105. (a) Section 507(a) of such Act (21 U.S.C. 357(a)) is 
59 stat. 453. 
amended by adding at the end thereof the following new sentence: 
"For purposes of this section and of section 502(1), the term 'anti-
biotic drug' means any drug intended for use by man containing any 
quantity of any chemical substance which is produced by a micro-
organism and which has the capacity to inhibit or destroy micro-
organisms in dilute solution (including the chemically synthesized 
equivalent of any such substance)." 
(b) Section 507(a) of such Act (21 U.S.C. 357(a)) is further 
amended by striking the word "or" preceding the word "bacitracin" 
and by adding after the word "bacitracin" a comma and the following: 
"or any other antibiotic drug,". 
(c) Section 502(1) of such Act (21 U.S.C. 352(1)) is amended by 
59 stat. 463. 
striking the word "or" preceding the word "bacitracin" and by adding 
immediately after "bacitracin," the following: "or any other anti-
biotic drug,". 
78135 0-63—53 
786 
PUBLIC LAW 87-781-OCT. 10, 1962 
[76 STAT. 
59 Stat. 464. 
(d) Section 507(c) of such Act (21 U.S.C. 357(c)) is amended by 
E»««"p"°"' '**- adding at the end thereof the following: "In deciding whether an 
enn a ons. 
antibiotic drug, or class of antibiotic drugs, is to be exempted from 
the requirement of certification the Secretary shall give consideration, 
among other relevant factors, to— 
" (1) whether such drug or class of drugs is manufactured by a 
person who has, or hereafter shall have, produced fifty consecu-
, 
.., r- 
tive batches of such drug or class of drugs in compliance with 
the regulations for the certification thereof within a period of 
not more than eighteen calendar months, upon the application by 
such person to the Secretary; or 
"(2) whether such drug or class of drugs is manufactured by 
any person who has otherwise demonstrated such consistency in 
the production of such drug or class of drugs, in compliance with 
the regulations for the certification thereof, as in the judgment of 
the Secretary is adequate to insure the safety and efficacy of use 
thereof. 
When an antibiotic drug or a drug manufacturer has been exempted 
from the requirement of certification, the manufacturer may still 
obtain certification of a batch or batches of that drug if he applies for 
and meets the requirements for certification. Nothing in this Act shall 
be deemed to prevent a manufacturer or distributor of an antibiotic 
drug from making a truthful statement in labeling or advertising of 
the product as to whether it has been certified or exempted from the 
requirement of certification." 
(e) The first sentence of section 507^e) of such Act (21 U.S.C. 
59 Stat.464. 
357(e)) is amended to read as follows: No drug which is subject to 
section 507 shall be deemed to be subject to any provision of section 
21 use 355. 
505 except a new drug exempted from the requirements of this section 
and of section 502(1) pursuant to regulations promulgated by the 
Secretary: Provided., That, for purposes of section 505, the initial 
request for certification, as thereafter duly amended, pursuant to 
section 507, of a new drug so exempted shall be considered a part of 
the application filed pursuant to section 505(b) with respect to the 
person filing such request and to such drug as of the date of the 
exemption." 
59 Stat. 463; 
(f) Section 507 of such Act (21 U.S.C. 357) is further amended by 
Post, p. 787. 
adding at the end of such section the following new subsection: 
"(h) In the case of a drug for which, on the daj immediately pre-
ceding the effective date of this subsection, a prior approval of an 
21 use 355. 
application under section 505 had not been withdrawn under section 
505(e), the initial issuance of regulations providing for certification 
or exemption of such drug under this section 507 shall, with respect 
to the conditions of use prescribed, recommended, or suggested in the 
labeling covered by such application, not be conditioned upon an 
affirmative finding of the efficacy of such drug. 
Any subsequent 
amendment or repeal of such regulations so as no longer to provide for 
such certification or exemption on the ground of a lack of efficacy of 
such drug for use under such conditions of use may be effected only on 
or after that effective date of clause (3) of the first sentence of section 
505(e) which would be applicable to such drug under such conditions 
of use if such drug were subject to section 505(e), and then only if 
(1) such amendment or repeal is made in accordance with the pro-
cedure specified in subsection (f) of this section (except that such 
amendment or repeal may be initiated either by a proposal of the 
Secretary or by a petition of any interested person) and (2) the 
Secretary finds, on the basis of new information with respect to such 
drug evaluated together with the information befoi-e him when the 
application under section 505 became effective or was approved, that 
76 STAT.] 
PUBLIC LAW 87-781-OCT. 10, 1962 
787 
there is a lack of substantial evidence (as defined in section 505(d)) 
that the drug has the effect it purports or is represented to have under 
such conditions of use." 
RECORDS AND REPORTS AS TO EXPERIENCE ON ANTIBIOTICS 
SEC. 106. (a) Section 507 of such Act (21 U.S.C. 357) is amended 
59 stat. 463. 
by adding at the end thereof the following new subsection: 
"(g)(1) Every person engaged in manufacturing, compounding, or 
processing any drug within the purview of this section with respect to 
which a certificate or release has been issued pursuant to this section 
shall establish and maintain such records, and make such reports to 
the Secretary, of data relating to clinical experience and other data 
or information, received or otherwise obtained by such person with 
respect to such drug, as the Secretary may by general regulation, or by 
- 
, ^ 
order with respect to such certification or release, prescribe on the 
basis of a finding that such records and reports are necessary in order 
to enable the Secretary to make, or to facilitate, a determination as to 
whether such certification or release should be rescinded or whether 
any regulation issued under this section should be amended or 
repealed: Provided^ however^ That regulations and orders issued 
under this subsection and under clause (3) of subsection (d) shall 
1 
have due regard for the professional ethics of the medical profession 
and the interests of patients and shall provide, where the Secretary 
deems it to be appropriate, for the examination, upon request, by the 
persons to whom such regulations or orders are applicable, of similar 
information received or otherwise obtained by the Secretary. 
"(2) Every person required under this section to maintain records. 
Access to rec-
and every person having charge or custody thereof, shall, upon request °'"^^-
of an officer or employee designated by the Secretary, permit such 
officer or employee at all reasonable times to have access to and copy 
and verify such records." 
(b) Section 507(d) of such Act (21 U.S.C. 357(d)) is amended by 
59 stat. 463. 
adding at the end thereof the following new sentences: "Such regula- 
Regulations per-
tions may, within the discretion of the Secretary, among other condi- taining to exemp-
tions relating to the protection of the public health, provide for con-
ditioning the exemption under clause (3) upon— 
"(1) the submission to the Secretary, before any clinical test-
ing of a new drug is undertaken, of reports, by the manufacturer 
or the sponsor of the investigation of such drug, of preclinical 
tests (including tests on animals) of such drug adequate to 
justify the proposed clinical testing; 
I 
"(2) the manufacturer or the sponsor of the investigation of 
a new drug proposed to be distributed to investigators for clinical 
testing obtaining a signed agreement from each of such investi-
gators that patients to whom the drug is administered will be 
under his personal supervision, or under the supervision of investi-
gators responsible to him, and that he will not supply such drug 
=
- 
to any other investigator, or to clinics, for administration to 
human beings; and 
"(3) the establishment and maintenance of such records, and 
. 
the making of such reports to the Secretary, by the manufacturer 
or the sponsor of the investigation of such drug, of data (includ-
ing but not limited to analytical reports by investigators) 
obtained as the result of such investigational use of such drug, 
as the Secretary finds will enable him to evaluate the safety and 
effectiveness of such drug in the event of the filing of an applica-
tion for certification or release pursuant to subsection (a). 
tion. 
788 
PUBLIC LAW 87-781-OCT. 10, 1962 
[76 STAT. 
Ante, 
p. 784. 
LAnte, pp. 783, 
782, 787. 
" Enactment 
date.»» 
" B a s i c Act.»» 
52 Stat. 104 0. 
21 u s e 301. 
52 Stat. 1052. 
21 u s e 355. 
Ante, 
p. 781. 
Ante, 
p. 781. 
Ante, 
p.782. 
Such regulations shall provide that such exemption shall be condi-
tioned upon the manufacturer, or the sponsor of the investigation, 
requiring that experts using such drugs for investigational purposes 
certify to such manufacturer or sponsor that they will inform any 
human beings to whom such drugs, or any controls used in connec-
tion therewith, are being administered, or their representatives, that 
such drugs are being used for investigational purposes and will obtain 
the consent of such human beings or their representatives, except 
where they deem it not feasible or, in their professional judgment, 
contrary to the best interests of such human beings. Nothing in this 
subsection shall be construed to require any clinical investigator to 
submit directly to the Secretary reports on the investigational use of 
drugs." 
(c) Section 301(e) of such Act (21 U.S.C. 331(e)), as amended by 
section 103(c) of this Act, is further amended by striking out "505 (i) 
or (j)" and inserting in lieu thereof "505 (i) or (j), or 507 (d) or (g)". 
EFFECTIVE DATES AND APPLICATION OF PART A 
SEC. 107. (a) Except as otherwise provided in this section, the 
amendments made by the foregoing sections of this part A shall take 
effect on the date of enactment of this Act. 
(b) The amendments made by sections 101,103,105, and 106 of this 
part A shall, with respect to any drug, take effect on the first day of the 
seventh calendar month following the month in which this Act is 
enacted. 
(c) (1) As used in this subsection, the term "enactment date" means 
the date of enactment of this Act; and the term "basic Act" means the 
Federal Food, Drug, and Cosmetic Act. 
(2) An application filed pursuant to section 505 (b) of the basic Act 
which was "effective" within the meaning of that Act on the day imme-
diately preceding the enactment date shall be deemed, as of the enact-
ment date, to be an application "approved" by the Secretary within 
the meaning of the basic Act as amended by this Act. 
(3) In the case of any drug with respect to which an application 
filed under section 505 (b) of the basic Act is deemed to be an approved 
application on the enactment date by virtue of paragraph (2) of this 
subsection— 
(A) the amendments made by this Act to sectioja 201 (p), and 
to subsections (b) and (d) of section 505, of the basic Act, inso-
far as such amendments relate to the effectiveness of drugs, shall 
not, so long as approval of such application is not withdrawn or 
suspended pursuant to section 505(e) of that Act, apply to such 
drug when intended solely for use under conditions prescribed, 
recommended, or suggested in labeling covered by such approved 
application, but shall apply to any changed use, or conditions of 
use, prescribed, recommended, or suggested in its labeling, includ-
ing such conditions of use as are the subject of an amendment or 
supplement to such application pending on, or filed after, the 
enactment date; and 
(B) clause (3) of the first sentence of section 505(e) of the 
basic Act, as amended by this Act, shall not apply to such drug 
when intended solely for use under conditions prescribed, recom-
mended, or suggested in labeling covered by such approved appli-
cation (except with respect to such use, or conditions of use, as 
are the subject of an amendment or supplement to such approved 
application, which amendment or supplement has been approved 
after the enactment date under section 505 of the basic Act as 
amended by this Act) until whichever of the following first 
76 STAT.] 
PUBLIC LAW 87-781-OCT. 10, 1962 
78^ 
occurs: (i) the expiration of the two-year period beginning with 
the enactment date; (ii) the effective date of an order under 
section 505(e) of the basic Act, other than clause (3) of the first Ante, p. 781. 
sentence of such section 505(e), withdrawing or suspending the 
approval of such application. 
(4) In the case of any drug which, on the day immediately preceding 
the enactment date, (A) was commercially used or sold in the United 
States, (B) was not a new drug as defined by section 201 (p) of the 
21 use 321. 
basic Act as then in force, and (C) was not covered by an effective 
application under section 505 of that Act, the amendments to section 
21 use 355. 
201 (p) made by this Act shall not apply to such drug when intended 
Ante, p. 78i. 
solely for use under conditions prescribed, recommended, or suggested 
in labeling with respect to such drug on that day. 
PART B-—STANDARDIZATION OF DRUG NAMES 
REVIEW AND DESIGNATION OF OFFICIAL NAMES 
SEC. 111. (a) The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
351 et seq.), as amended by this Act, is further amended by adding at 
the end of chapter V the following new section: 
" A U T H O R I T Y TO D E S I G N A T E OFFICIAL NAMES 
"SEC. 508. (a) The Secretary may designate an official name for any 
drug if he determines that such action is necessary or desirable in the 
interest of usefulness and simplicity. Any official name designated 
under this section for any drug shall be the only official name of that 
drug used in any official compendium published after such name has 
been prescribed or for any other purpose of this Act. In no event, 
however, shall the Secretary establish an official name so as to infringe 
a valid trademark. 
"(b) Within a reasonable time after the effective date of this sec-
tion, and at such other times as he may deem necessary, the Secretary 
shall cause a review to be made of the official names by which drugs 
Review of 
are identified in the official United States Pharmacopeia, the official "^mes. 
Homoeopathic Pharmacopoeia of the United States, and the official 
National Formulary, and all supplements thereto, to determine 
whether revision of any of those names is necessary or desirable in the 
interest of usefulness and simplicity. 
"(c) Whenever he determines after any such review that (1) any 
such official name is unduly complex or is not useful for any other 
reason, (2) two or more official names have been applied to a single 
drug, or to two or more drugs which are identical in chemical struc-
ture and pharmacological action and which are substantially identical 
in strength, quality, and purity, or (3) no official name has been applied 
to a medically useful drug, he shall transmit in writing to the com-
piler of each official compendium in which that drug or drugs are 
identified and recognized his request for the reco;nmendation of a 
single official name for such drug or drugs which will have usefulness 
and simplicity. 
Whenever such a single official name has not been 
recommended within one hundred and eighty days after such request, 
or the Secretary determines that any name so recommended is not use-
ful for any reason, he shall designate a single official name for such 
drug or drugs. Whenever he determines that the name so recom-
mended is useful, he shall designate that name as the official name of 
such drug or drugs. 
Such designation shall be made as a regulation 
upon public notice and in accordance with the procedure set forth in 
section 4 of the Administrative Procedure Act (5 U.S.C. 1003). 
eo stat. 23a. 
790 
PUBUC LAW 87-781-OCT. 10, 1962 
[76 STAT. 
"(d) After each such review, and at such other times as the Secre-
tary may determine to be necessary or desirable, the Secretary shall 
cause to be compiled, published, and publicly distributed a list which 
shall list all revised official names of drugs designated under this 
section and shall contain such descriptive and explanatory matter as 
the Secretary may determine to be required for the effective use of 
those names. 
"(e) Upon a request in writing by any compiler of an oflEicial com-
pendium that the Secretary exercise the authority granted to him 
under section 508(a), he shall upon public notice and in accordance 
with the procedure set forth in section 4 of the Administrative Pro-
60 Stat. 238. 
ccdure Act (5 U.S.C. 1003) designate the official name of the drug 
for which the request is made." 
(b) This section shall take effect on the date of its enactment. 
NAME TO BE USED ON DRUG l A B E L 
52 Stat. 1050. 
SEC. 112. (a) Scction 502(e) of such Act (21 U.S.C. 352(e)) is 
amended by— 
(1) inserting the subparagraph designation " (1)" after "(e)"; 
(2) striking out the words "If it is a drug and is not designated 
solely by a name recognized in an official compendium unless its 
label bears (1) the common or usual name of the drug, if such 
there be; and (2), in case it is fabricated from two or more 
ingredients, the common or usual name of each active ingredient", 
and inserting in lieu thereof "If it is a drug, unless (A) its label 
bears, to the exclusion of any other nonproprietary name (except 
the applicable systematic chemical name or the chemical formula), 
(i) the established name (as defined in subparagraph (2)) of the 
drug, if such there be, and (ii), in case it is fabricated from two or 
more ingredients, the established name and quantity of each active 
ingredient"; 
(3) striking out the words "the name" and inserting in lieu 
thereof the words "the established name"; 
(4) inserting therein, immediately after the colon following 
the words "contained therein", the following: ''^Provided^ That 
the requirement for stating the quantity of the active ingredients, 
other than the quantity of those specifically named in this para-
graph, shall apply only to prescription drugs; and (B) for any 
prescription drug the established name of such drug or ingredient, 
as the case may be, on such label (and on any labeling on which 
a name for such drug or ingredient is used) is printed promi-
nently and in type at 
least half as large as that used thereon for 
^ 
any 
proprietary 
name or 
designation 
for 
such drug 
or 
ingredient:"; 
(5) striking out the words "clause (2) of this paragraph" in 
the proviso to such paragraph and inserting in lieu thereof "clause 
(A) (ii) or clause (B) of this subparagraph"; and 
(6) adding at the end of such paragraph the following new 
subparagraph: 
"(2) As used in this paragraph (e), the term 'established name', 
with respect to a drug or ingredient thereof, means (A) the applicable 
Ante. p. 789. 
official name designated pursuant to section 508, or (B), if there is no 
such name and such drug, or such ingredient, is an article recognized 
in an official compendium, then.the official title thereof in such com-
pendium, or (C) if neither clause (A) nor clause (B) of this subpara-
graph applies, then the common or usual name, if any, of such drug or 
of such ingredient: Provided further^ That where clause (B) of this 
subparagraph applies to an article recognized in the United States 
76 STAT.] 
PUBLIC LAW 87-781-OCT. 10, 1962 
791 
Pharmacopeia and in the Homoeopathic Pharmacopoeia under differ-
ent official titles, the official title used in the United States Pharma-
copeia shall apply unless it is labeled and offered for sale as a homoe-
opathic drug, in which case the official title used in the Homoeopathic 
Pharmacopoeia shall apply." 
(b) Section 502(g) of such Act (21 U.S.C. 352(g)) is amended by 
inserting immediately before the period at the end thereof a colon 
and the following proviso: '''•Provided further^ That, in the event of 
inconsistency between the requirements of this paragraph and those 
of paragraph (e) as to the name by which the drug or its ingredients 
shall be designated, the requirements of paragraph (e) shall prevail". 
(c) This section shall take effect on the first day of the seventh 
calendar month following the month in which this Act is enacted. 
52 Stat. 1050. 
EXCLUSION OF COSMETICS 
SEC. 113. Chapter V of the Federal Food, Drug, and Cosmetic Act, 
as amended by section 111 of this Act, is further amended by adding at 
the end thereof the following: 
(( 
NONAPPLICABILITY TO COSMETICS 
"SEC. 509. This chapter, as amended by the Drug Amendments of 
1962, shall not apply to any cosmetic unless such cosmetic is also a 
drug or device or component thereof." 
Ante, p. 789. 
INFORMATION TO PHYSICIANS 
SEC. 114. (a) Section 301 of the Federal Food, Drug, and Cosnietic 
Act (21 U.S.C. 331), as amended by this Act, is further amended by 
adding at the end thereof the following new paragraph: 
" (o) In the case of a prescription drug distributed or offered for sale 
in interstate commerce, the failure of the manufacturer, packer, or 
distributor thereof to maintain for transmittal, or to transmit, to any 
practitioner licensed by applicable State law to administer such drug 
who makes written request for information as to such drug, true and 
correct copies of all printed matter which is required to be included 
in any package in which that drug is distributed or sold, or such other 
printed matter as is approved by the Secretary. Nothing in this para-
graph shall be construed to exempt any person from any labeling 
requirement imposed by or under other provisions of this Act." 
(b) This section shall take effect on the first day of the seventh 
calendar month following the month in which this Act is enacted. 
PART C—AMENDMENTS AS TO ADVERTISING 
52 Stat. 1042. 
PRESCRIPTION DRUG ADVERTISEMENTS 
SEC. 131. (a) Section 502 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 352) is further amended by adding at the end thereof 
52 stat. 1050. 
the following new paragraph: 
"(n) In the case of any prescription drug distributed or offered for 
sale in any State, unless the manufacturer, packer, or distributor 
thereof includes in all advertisements and other descriptive printed 
matter issued or caused to be issued by the manufacturer, packer, or 
distributor with respect to that drug a true statement of (1) the estab-
lished name as defined in section 502(e), printed prominently and in 
Ante, p. 790. 
type at least half as large as that used for any trade or brand name 
thereof, (2) the formula showing quantitatively each ingredient of 
such drug to the extent required for labels under section 502(e), and 
(3) such other information in brief summary relating to side effects. 
792 
PUBLIC LAW 87-781-OCT. 10, 1962 
[76 STAT. 
contraindications, and effectiveness as shall be required in regulations 
which shall be issued by the Secretary in accordance with the procedure 
70 Stat. 919. 
specified in section 701(e) of this Act: Provided, That (A) except 
21 use 371. 
jjj extraordinary circumstances, no regulation issued under this para-
graph shall require prior approval by the Secretary of the content of 
any advertisement, and (B) no advertisement of a prescription drug, 
published after the effective date of regulations issued under this 
paragraph applicable to advertisements of prescription drugs, shall, 
with respect to the matters specified in this paragraph or covered 
by such regulations, be subject to the provisions of sections 12 through 
17 of the Federal Trade Commission Act, as amended (15 U.S.C. 
52 Stat. 114. 
52-57). 
This paragraph (n) shall not be applicable to any printed 
matter which the Secretary determines to be labeling as defined in 
52 Stat. 1041. 
section 201 (m) of this Act." 
21 use 321. 
(b) No drug which was being commercially distributed prior to the 
date of enactment of this Act shall be deemed to be misbranded under 
paragraph (n) of section 502 of the Federal Food, Drug, and Cosmetic 
Act, as added by this section, until the earlier of the following dates: 
(1) the first day of the seventh month following the month in which 
this Act is enacted; or (2) the effective date of regulations first issued 
under clause (3) of such paragraph (n) in accordance with the proce-
dure specified in section 701(e) of the Federal Food, Drug, and Cos-
metic Act. 
TITLE II—FACTORY INSPECTION AND E F F E C T ON 
STATE LAWS 
FACTORY INSPECTION 
SEC. 201. (a) Section 704(a) of the Federal Food, Drug, and Cos-
67 Stat. 477. 
mctic Act (21 U.S.C. 374(a)) is amended to read as follows: 
" (a) For purposes of enforcement of this Act, officers or employees 
'duly designated by the Secretary, upon presenting appropriate creden-
tials and a written notice to the owner, operator, or agent in charge, 
are autliorized (1) to enter, at reasonable times, any factory, ware-
house, or establishment in which food, drugs, devices, or cosmetics are 
manufactured, processed, packed, or held, for introduction into inter-
state commerce or after such introduction, or to enter any vehicle 
being used to transport or hold such food, drugs, devices, or cosmetics 
in interstate commerce; and (2) to inspect, at reasonable times and 
within reasonable limits and in a reasonable manner, such factory, 
warehouse, establishment, or vehicle and all pertinent equipment, 
finished and unfinished materials; containers, and labeling therein. 
In the case of any factory, warehouse, establishment, or consulting 
laboratory in which prescription drugs are manufactured, processed, 
packed, or held, the inspection shall extend to all things therein^ 
(including records, files, papers, processes, controls, and facilities) 
bearing on whether prescription drugs which are adulterated or mis-
branded within the meaning of this Act, or which may not be manu-
factured, introduced into interstate commerce, or sold, or offered for 
sale by reason of any provision of this Act, have been or are being 
manufactured, processed, packed, transported, or held in any such 
place, or otherwise bearing on violation of this Act. No inspection 
authorized for prescription drugs by the preceding sentence shall 
extend to (A) financial data, (B) sales data other than shipment 
data, (C) pricing data, (D) personnel data (other than data as to 
qualifications of technical and professional personnel performing 
functions subject to this Act), and (E) research data (other than 
data, relating to new drugs and antibiotic drugs, subject to reporting 
76 STAT.] 
PUBLIC LAW 87-781-OCT. 10, 1962 
793 
and inspection under regulations lawfully issued pursuant to section 
505 (i) or (j) or section 507 (d) or (g) of this Act, and data, relating 
Ante, pp.783, 
to other drugs, which in the case of a new drug would be subject to '*^' ''^^* 
reporting or inspection under lawful regulations issued pursuant to 
section 505 (j) of this Act). A separate notice shall be given for each 
such inspection, but a notice shall not be required for each entry made 
during the period covered by the inspection. Each such inspection 
shall be commenced and completed with reasonable promptness. The 
provisions of the second sentence of this subsection shall not apply to— 
"(1) pharmacies which maintain establishments in conform-
ance with any applicable local laws regulating the practice of 
pharmacy and medicine and which are regularly engaged in 
dispensing prescription drugs, upon prescriptions of practitioners 
licensed to administer such drugs to patients under the care of 
such practitioners in the course of their professional practice, and 
which do not, either through a subsidiary or otherwise, manu-
facture, prepare, propagate, compound, or process drugs for sale 
other than in the regular course of their business of dispensing 
or selling drugs at retail; 
"(2) practitioners licensed by law to prescribe or administer 
drugs and who manufacture, prepare, propagate, compound, or 
process drugs solely for use in the course of their professional 
practice; 
" (3) persons who manufacture, prepare, propagate, compound, 
or process drugs solely for use in research, teaching, or chemical 
analysis and not for sale; 
" (4) such other classes of persons as the Secretary may by regu-
lation exempt from the application of this section upon a finding 
that inspection as applied to such classes of persons in accord-
ance with this section is not necessary for the protection of the 
public health." 
(b) Section 704(b) of such Act (21 U.S.C. 374(b)) is amended by 
e? stat. 477. 
inserting after "warehouse," the words "consulting laboratory,". 
(c) Section 302(a) of such Act (21 U.S.C. 332(a)) is amended by 
52 stat. 1043. 
striking out "(f),". 
(d) Nothing in the amendments made by subsections (a) and (b) 
of this section shall be construed to negate or derogate from any 
authority of the Secretary existing prior to the enactment of this Act. 
EFFECT ON STATE LAWS 
SEC. 202. Nothing in the amendments made by this Act to the 
Federal Food, Drug, and Cosmetic Act shall be construed as invali- 
52 stat. 1040. 
dating any provision of State law which would be valid in the 
^^ "^^ ^°^-
absence of such amendments unless there is a direct and positive con-
flict between such amendments and such provision of State law. 
EFFECTIVE DATE 
SEC. 203. The amendments made by this title shall take effect on 
the date of enactment of this Act. 
TITLE III—REGISTRATION OF DRUG ESTABLISHMENTS 
AND PATENT INFORMATION 
FINDINGS AND DECLARATION 
SEC. 301. The Congress hereby finds and declares that in order to 
make regulation of interstate commerce in drugs effective, it is neces-
sary to provide for registration and inspection of all establishments 
in which drugs are manufactured, prepared, propagated, compounded, 
794 
PUBLIC LAW 87-781-OCT. 10, 1962 
[76 STAT. 
or processed; that the products of all such establishments are likely 
to enter the channels of interstate commerce and directly affect such 
commerce; and that the regulation of interstate commerce in drugs 
without provision for registration and inspection of establishments 
that may be engaged only in intrastate commerce in such drugs would 
discriminate against and depress interstate commerce in such drugs, 
and adversely burden, obstruct, and affect such interstate commerce. 
REGISTRATION OF PRODUCERS OF DRUGS 
SEC. 302. Chapter V of the Federal Food, Drug, and Cosmetic Act 
Ante, pp. 789, 
(21 U.S.C. 351 ct scq.) is amended by adding at the end thereof the 
following section: 
791 
u 
REGISTRATION OF PRODUCERS OF DRUGS 
"SEC. 510. (a) As used in this section— 
"(1) the term 'manufacture, preparation, propagation, com-
pounding, or processing' shall include repackaging or otherwise 
changing the container, wrapper, or labeling of any drug package 
in furtherance of the distribution of the drug from the original 
place of manufacture to the person who makes final delivery or 
sale to the ultimate consumer; 
"(2) the term 'name' shall include in the case of a partnership 
the name of each partner and, in the case of a corporation, the 
name of each corporate officer and director, and the State of 
incorporation, 
"(b) On or before December 31 of each year every person who owns 
or operates any establishment in any State engaged in the manu-
facture, preparation, propagation, compounding, or processing of a 
drug or drugs shall register with the Secretary his name, places of 
business, and all such establishments. 
" (c) Every person upon first engaging in the manufacture, prepara-
tion, propagation, compounding, or processing of a drug or drugs in 
any establishment which he owns or operates in any State shall 
immediately register with the Secretary his name, place of business, 
and such establishment. 
"(d) Every person duly registered in accordance with the foregoing 
subsections of this section shall immediately register with the Secre-
tary any additional establishment which he owns or operates in any 
State and in which he begins the manufacture, preparation, propaga-
tion, compounding, or processing of a drug or drugs. 
"(e) The Secretary may assign a registration number to any person 
or any establishment registered in accordance with this section. 
"(f) The Secretary shall make available for inspection, to any per-
son so requesting, any registration filed pursuant to this section. 
"(g) The foregoing subsections of this section shall not apply to— 
"(1) pharmacies which maintain establishments in conform-
ance with any applicable local laws regulating the practice of 
pharmacy and medicine and which are regularly engaged in dis-
pensing prescription drugs, upon prescriptions of practitioners 
licensed to administer such drugs to patients under the care of 
such practitioners in the course of their professional practice, and 
which do not manufacture, prepare, propagate, compound, or 
process drugs for sale other than in the regular course of their 
business of dispensing or selling drugs at retail; 
"(2) practitioners licensed by law to prescribe or administer 
drugs and who manufacture, prepare, propagate, compound, or 
process drugs solely for use in the course of their professional 
practice; 
;.^ t.i,-ti:- 
-./,>. 
',•;; : » i ^ : ^ i - i 
^i:""'^>J'H 
. - f ' i J ' u : 
r^ii:t. 
*•""•(» n ' i ' i ^ ?> i l * 
76 STAT.] 
PUBLIC LAW 87-781-OCT. 10, 1962 
795 
" (3) persons who manufacture, prepare, propagate, compound, 
or process drugs solely for use in research, teaching, or chemical 
analysis and not for sale; 
"(4) such other classes of persons as the Secretary may by 
regulation exempt from the application of this section upon a find-
ing that registration by such classes of persons in accordance 
with this section is not necessary for the protection of the public 
health. 
" (h) Every establishment in any State registered with the Secre-
tary pursuant to this section shall be subject to inspection pursuant 
to section 704 and shall be so inspected by one or more officers or 
employees duly designated by the Secretary at least once in the two-
year period beginning with the date of registration of such establish-
ment pursuant to this section and at least once in every successive two-
year period thereafter. 
"(i) Any establishment within any foreign country engaged in the 
manufacture, preparation, propagation, compounding, or processing 
of a drug or (drugs shall be permitted to register under this section 
pursuant to regulations promulgated by the Secretary. Such regula-
tions shall include'provisions for registration of any such establish-
ment upon condition that adequate and effective means are available, 
by arrangement with the government of such foreign country or other-
wise, to enable the Secretary to determine from time to time whether 
drugs manufactured, prepared, propagated, compounded, or processed 
in such establishment, if imported or offered for import into the 
United States, shall be refused admission on any of the grounds set 
forth in section 801 (a) of this Act." 
67 Stat. 477; 
Ante, 
p. 792. 
21 u s e 374. 
Post, 
p. 796. 
TRANSITIONAL PROVISIONS 
SEC. 303. Any person who, on the day immediately preceding the 
date of enactment of this Act, owned or operated any establishment in 
any State (as defined in section 201 of the Federal Food, Drug, and 
Cosmetic Act as amended by this Act) engaged in the manufacture, 
preparation, propagation, compounding, or processing of a drug or 
drugs, shall, if he first registers in accordance with subsection (b) of 
section 510 of that Act (as added thereto by this Act) prior to the first 
day of the seventh calendar month following the month in which this 
Act is enacted, be deemed to have complied with that subsection for 
the calendar year 1962. Such registration, if made within such period 
and effected in 1963, shall also be deemed to be in compliance with 
such subsection for that calendar year. 
Post, 
p. 796. 
Ante, 
p. 794. 
FAILURE TO REGISTER 
SEC. 304. Section 301 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 331) is amended by adding at the end thereof the following 
new paragraph: 
"(p} The failure to register as required by section 510." 
Ante, 
p. 791. 
DRUGS FROM NONREGISTERED ESTABLISHMENTS MISBRANDED 
SEC. 305. Section 502 of such Act (21 U.S.C. 352) is amended by 
adding at the end thereof the following new paragraph: 
"(o) If it is a drug and was manufactured, prepared, propagated, 
compounded, or processed in an establishment m any State not duly 
registered under section 510." 
Ante, 
p. 791. 
796 
PUBLIC LAW 87-782-OCT. 10, 1962 
[76 STAT. 
52 Stat. 1058. 
Ante, 
p. 795. 
52 Stat. 1041. 
SAMPLES OF IMPORTED DRUGS 
SEC. 306. Section 801 (a) of such Act (21 U.S.C. 381 (a)) is amended 
by inserting, after the first sentence thereof, the following new sen-
tence : "The Secretary of Health, Education, and Welfare shall furnish 
to the Secretary of the Treasury a list of establishments registered 
pursuant to subsection (i) of section 510 and shall request that if any 
drugs manufactured, prepared, propagated, compounded, or processed 
in an establishment not so registered are imported or offered for 
import into the United States, samples of such drugs be delivered to 
the Secretary of Health, Education, and Welfare, with notice of such 
delivery to the owner or consignee, who may appear before the Secre-
tary of Health, Education, and Welfare and have the right to introduce 
testimony." 
DEFINITIONS 
SEC. 307. (a) Section 201(a) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 321(a)) is amended to read as follows: 
"(a)(1) The term 'State', except as used in the last sentence of 
section 702(a), means any State or Territory of the United States, the 
District of Columbia, and the Commonwealth of Puerto Rico. 
"(2) The term 'Territory' means any Territory or possession of the 
United States, including the District of Columbia, and excluding the 
Commonwealth of Puerto Rico and the Canal Zone." 
(b) The second sentence of section 702(a) of such Act (21 U.S.C. 
372(a)) is amended by inserting before the words "a Territory" the 
words "the Commonwealth of Puerto Rico or". 
INFORMATION ON PATENTS FOR DRUGS 
SEC. 308. Section 702 of the Federal Food, Drug, and Cosmetic Act 
52 Stat. 1056. 
(21 U.S.C. 372) is amended by adding at the end thereof the following 
new subsection: 
"(d) The Secretary is authorized and directed, upon request from 
the Commissioner of Patents, to furnish full and complete information 
with respect to such questions relating to drugs as the Commissioner 
may submit concerning any patent application. 
The Secretary is 
further authorized, upon receipt of any such request, to conduct or 
cause to be conducted, such research as may be required." 
Approved October 10, 1962. 
October 10, 1962 
[S.3396] 
Public Law 87-782 
AN ACT 
To amend section 511(h) of the Merchant Marine Act, 1936, as amended, in 
order to extend the time for commitment of construction reserve funds. 
Merchant Marine 
Act, 1936, amend-
ment. 
Construction re-
serve funds. 
75 Stat. 661. 
46 u s e 1161. 
Effective date. 
Be it enacted hy the Senate and House of Representatives 
of the 
United States of America in Congress assembled^ That the proviso at 
the end of section 511(h) of the Merchant Marine Act, 1936, as 
amended, is amended to read as follows: '•'•Provided^ That until Janu-
ary 1, 1963, in addition to the extensions hereinbefore permitted, 
further extensions may be granted ending not later than December 31, 
1963." 
SEC. 2. The amendment made by the first section of this Act shall 
take effect December 31,1962, or on the date of enactment of this Act, 
whichever date first occurs. 
Approved October 10, 1962.