An Act to amend the Federal Food, Drug and Cosmetic Act to provide for a current listing of each drug manufactured, prepared, propagated, compounded, or processed by a registrant under that act, and for other purposes
PL 92-387 (H.R.9936), enacted 08/16/1972

86 STAT.] 
PUBLIC LAW 92-387-AUG. 16, 1972 
559 
"(f) The President shall conduct a thorough review of existing 
disaster relief legislation as it relates to emergency loans and housing 
loans administered by the Farmers Home Administration of the 
United States Department of Agriculture, and not later than Janu-
ary 31, 1973, he shall transmit to the Committee on Agriculture and 
Forestry of the Senate and the Committee on Agriculture of the 
House of Representatives a report containing specific legislative pro-
posals for the comprehensive revision of such legislation in order to— 
"(1) adjust the benefits and the coverage available to persons 
affected by disasters; 
" (2) improve the execution of the program by simplifying and 
eliminating unnecessary administrative procedures; and 
"(3) prevent the misuse of benefits made available under the 
program.-' 
SEC. 6. Section 231 of the Disaster Relief Act of 1970 is amended 
by— 
(1) inserting'' (a)" after "SEC. 231."; and 
(2) adding at the end of such section the following new 
subsection: 
"(b) Loans to which this section applies may also be made for the 
purpose of providing small business concerns with working capital, 
the payment of operating expenses, and any purpose for which loans 
may be made under section 7(a) of the Small Business Act (15 U.S.C. 
636(a))." 
Approved August 16, 1972. 
Disaster relief 
legislation, Presi-
dential review. 
Report to con-
gressional com-
mittees. 
84 Stat. 1752. 
42 u s e 4451. 
72 Stat. 387; 
81 Stat. 268. 
Public Law 92-386 
JOINT RESOLUTION 
To authorize the printing and binding of a revised edition of Senate Procedure 
and providing the same shall be subject to copyright by the author. 
August 16, 1972 
[S. J. Res. 254] 
Resolved hy the Senate and House of Representatives 
of the United 
States of America in Congress assemhled^ That there shall be printed dure ^"^*^ Proce-
and bound for the use of the Senate one thousand five hundred copies 
Revised edition, 
of a revised edition of Senate Procedure (originally prepared by p^i^ti^g-
Charles L. Watkins and Floyd M. Riddick), to be prepared by Floyd 
M. Riddick, Parliamentarian of the United States Senate, to be 
printed under the supervision of the author and to be distributed to 
the Members of the Senate. 
SEC. 2. That notwithstanding any provision of the copyright laws 
and regulations with respect to publications in the public domain, such 
revised edition of Senate Procedure shall be subject to copyright by 
the author thereof. 
Approved August 16, 1972. 
Public Law 92-387 
AN ACT 
To amend the Federal Food, Drug, and Cosmetic Act to provide for a current 
listing of each drug manufactured, prepared, propagated, compounded, or 
processed by a registrant under that Act, and for other purposes. 
August 16, 1972 
[H. R. 9936] 
Be it enacted hy the Senate and House of Representatives 
of the 
United States of America in Congress assembled^ 
^'•"g Listing 
SECTION 1. This Act may be cited as the J'Drug Listing Act of 1972". ^"^ °^ ^^'^'^• 
SEC. 2. The Federal Government which is responsible for regulating 
560 
PUBLIC LAW 92-387-AUG. 16, 1972 
[86 
STAT. 
52 Stat. 1040. 
21 u s e 301. 
76 Stat. 781. 
59 Stat. 463. 
21 u s e 355, 
357. 
Registration, 
drug list require-
ments. 
76 Stat. 794. 
52 Stat. 1050; 
76 Stat. 790. 
21 u s e 352. 
55 Stat. 851. 
82 Stat. 343. 
21 u s e 356, 
360b. 
65 Stat. 648. 
21 u s e 353. 
drugs has no ready means of determining what drugs are actually being 
manufactured or packed by establishments registered under the Fed-
eral Food, Drug, and Cosmetic Act except by periodic inspection of 
such registered establishments. Knowledge of which particular drugs 
are being manufactured or packed by each registered establishment 
would substantially assist in the enforcement oi Federal laws requir-
ing that such drugs be pure, safe, effective, and properly labeled. 
Information on the discontinuance of a particular drug could serve 
to alleviate the burden of reviewing and implementing enforcement 
actions against drugs which, although commercially discontinued, 
remain active for regulatory purposes. Information on the type and 
number of different drugs being manufactured or packed bj^ drug 
establishments could permit more effective and timely regulation by 
the agencies of the Federal Government responsible for regulating 
drugs, including identification of which drugs in interstate commerce 
are subject to section 505 or 507, or to other provisions of the Federal 
Food, Drug, and Cosmetic Act. 
SEC. 3. Section 510 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360) is amended by adding at the end of the following new 
subsection: 
"(j) (1) Every person who registers with the Secretary under sub-
section (b), (c), or (d) shall, at the time of registration under any 
such subsection, file with the Secretary a list of all drugs (by estab-
lished name (as defined in section 502(e)) and by any proprietary 
name) which are being manufactured, prepared, propagated, com-
pounded, or processed by him for commercial distribution and which 
he has not included in any list of drugs filed by him with the Secre-
tary under this paragraph or paragraph (2) before such time of reg-
istration. Such list shall be prepared in such form and manner as the 
Secretary may prescribe and shall be accompanied by— 
"(A) in the case of a drug contained in such list and subject to 
section 505, 506, 507, or 512, a reference to the authority for the 
marketing of such drug and a copy of all labeling for such drug; 
"(B) in the case of any other dru^ contained in such list— 
"(i) which is subject to section 503(b) (1), a copy of all 
labeling for such drug, a representative sampling of adver-
tisements for such drug, and, upon request made by the Secre-
tary for good cause, a copy of all advertisements for a 
particular drug product, or 
"(ii) which is not subject to section 503(b) (1), the label 
and package insert for such drug and a representative sam-
pling of any other labeling for such drug; 
"(C) in the case of any drug contained in such list which is 
described in subpararaph (B), a quantitative listing of its active 
ingredient or ingredients, except that with respect to a particular 
drug product the Secretary may require the submission of a quan-
titative listing of all ingredients if he finds that such submission 
is necessary to carry out the purposes of this Act; and 
"(D) if the registrant filing the list has determined that a par-
ticular drug product contained in such list is not subject to section 
7' 
505, 506, 507, or 512, a brief statement of the basis upon which the 
registrant made such determination if the Secretary requests such 
a statement with respect to that particular drug product. 
86 STAT. ] 
PUBLIC LAW 92-387-AUG. 16, 1972 
561 
"(2) Each person who registers with the Secretary under this sec- 
Reports. 
tion shall report to the Secretary once during the month of June of 
each year and once during the month of December of each year the 
,, 
,, ,^,., 
following information: 
"(A) A list of each drug introduced by the registrant for com-
mercial distribution which has not been included in any list pre- 
,,, 
,^ ,. 
viously filed by him with the Secretary under this subparagraph 
or paragraph (1) of this subsection. A list under this subpara-
graph shall list a drug by its established name (as defined in sec-
tion 502(e)) and by any proprietary name it may have and shall 
52 stat. loso; 
be accompanied by the other information required by paragraph ^%TvscVs2 
"(B) If since the date the registrant last made a report under 
this paragraph (or if he has not made a report under this para-
graph, since the effective date of this subsection) he has discon-
tinued the manufacture, preparation, propagation, compounding, 
or processing for commercial distribution of a drug included in a 
list filed by him under subparagraph (A) or paragraph (1) ; 
notice of such discontinuance, the date of such discontinuance, 
and the identity (by established name (as defined in section 502 
(e)) and by any proprietary name) of such drug. 
"(C) If since the date the registrant reported pursuant to 
subparagraph (B) a notice of discontinuance he has resumed 
the manufacture, preparation, propagation, compounding, or 
processing for commercial distribution of the drug with reSpect 
to which such notice of discontinuance was reported; notice of 
such resumption, the date of such resumption, the identity of 
such drug (by established name (as defined in section 502(e)) 
and by any proprietary name), and the other information 
required by paragraph (1), unless the registrant has previously 
• ^ --• -
reported such resumption to the Secretary pursuant to this 
subparagraph. 
"(D) Any material change in any information previously sub-
mitted pursuant to this paragraph or paragraph (1). 
"(3) The Secretary may also require each registrant under this sec- ,. ^'"^ product 
tion to submit a list of each drug product which (A) the registrant is 
manufacturing, preparing, propagating, compounding, or processing 
for commercial distribution, and (B) contains a particular ingredient. 
The Secretary may not require the submission of such a list unless he 
has made a finding that the submission of such a list is necessary to 
carry out the purposes of this Act." 
SEC. 4. (a) Section 510(e) of such Act is amended by adding at the 
end thereof the following: "The Secretary may also assign a listing 
number to each drug or class of drugs listed under subsection (j). Any 
number assigned pursuant to the preceding sentence shall be the same 
as that assigned pursuant to the National Drug Code.". 
(b) Section 510(f) of such Act is amended by inserting before the 
period the following: "; except that any list submitted pursuant to 
paragraph (3) of subsection (j) and the information accompanying 
any list or notice filed under paragraph (1) or (2) of that subsection 
shall be exempt from such inspection unless the Secretary finds that 
such an exemption would be inconsistent with protection of the public 
health". 
list. 
76 Stat. 794. 
21 u s e 360. 
Ante, p. 560. 
562 
PUBLIC LAW 92-388-AUG. 17, 1972 
[86 
STAT. 
76 Stat. 794. 
21 u s e 360. 
Ante, p. 560. 
76 Stat. 781. 
76 Stat. 795. 
Effective date. 
(c) The second sentence of section 510 (i) of such Act is amended 
b j inserting "shall require such establishment to provide the informa-
tion required by subsection (j) and" immediately before "shall 
include". 
(d) Clause (1) of the second sentence of section 505(e) of such 
Act (21 IJ.S.C. 355(e)) is amended by inserting "or to comply with 
the notice requirements of section 510(j) (2)" immediately after "sub-
section (j)". 
(e) Section 301 (p) of such Act (21 •IJ.S.C. 331 (p)) is amended 
to read as follows: 
"(p) The failure to register in accordance with section 510, the 
failure to provide any information required by section 510(j), or the 
failure to provide a notice required by section 510 (j) (2)." 
SEC. 5. The amendments made by this Act shall take effect on the 
first day of the sixth month beginning after the date of enactment of 
this Act. 
Approved August 16, 1972. 
August 17, 1972 
[H. R. 1462] 
Public Law 92-388 
AN ACT 
To provide for the establishment of the Puukohola Heiau National Historic Site, 
in the State of Hawaii, and for other purposes. 
Puukohola 
Heiau National 
Historic Site, 
Hawaii. 
Establishment. 
Limitation. 
Land acquisi-
tion. 
Be it enacted hy the Senate and House of Representatives 
of the 
United States of America in Congress assembled^ That in order to 
restore and preserve in public ownership the historically significant 
temple associated with Kamehameha the Great, who founded the his-
toric Kingdom of Hawaii, and the property of John Young who 
fought for Kamehameha the Great during the period of his ascend-
ancy to power, the Secretary of the Interior is authorized to acquire, 
by donation or purchase with donated funds, such lands and interests 
in lands, together with structures and improvements thereon, not to 
exceed one hundred acres, in the vicinity of Kawaihae, Hawaii, as 
f
enerally depicted on a map entitled "Boundary Map, Proposed 
*uukohola Heiau National Historic Site," numbered NHS-PK 20,002, 
dated February 1970, which shall be on file and available for public 
inspection in the offices of the National Park Service, Washington, 
District of Columbia. The Secretary of the Interior may from time 
to time revise the boundaries of the proposed historic site, but the total 
acreage of the site shall not exceed one hundred acres. 
SEC. 2. The Secretary of the Interior shall establish the area as the 
"Puukohola Heiau National Historic Site" at such time as he deems 
sufficient interests in lands have been acquired to constitute an admin-
istrable unit. Pending and after establishment, the Puukohola Heiau 
National Historic Site shall be administered, developed, preserved, 
and maintained in accordance with the provisions of the Act entitled 
"An Act to establish a National Park Service, and for other purposes", 
approved August 25, 1916 (39 Stat. 535), as amended and supple-
mented (16 U.S.C. 1 et seq.), and the Act entitled "An Act to provide 
for the preservation of historic American sites, buildings, objects, and 
antiquities of national significance, and for other purposes", approved 
August 21, 1935 (49 Stat. 666; 16 U.S.C. 461 et seq.). 
SEC. 3. Notwithstanding the acreage limitation contained in section 
1 of this Act, the Secretary of the Interior is authorized to acquire 
by donation, purchase, or exchange, such additional lands and inter-
ests therein outside the boundary of the site as he deems necessary to 
relocate portions of State and county roads which are currently within