An Act to protect the public health by amending the Federal Food, Drug, and Cosmetic Act to consolidate certain provisions assuring the safety and effectiveness of new animal drugs, and for other purposes
PL 90-399 (H.R.3639), enacted 07/13/1968

342 
PUBLIC LAW 90-398-JULY 11, 1968 
[82 STAT. 
July 11,1968 
[S.2837] 
Public Law 90-398 
AN ACT 
To authorize the Secretary of Agriculture to establish the Cradle of Forestry in 
America in the Pisgah National Forest in North Carolina, and for other 
purposes. 
Cradle of For-
estry in America, 
Pisgah National 
Forest, N.C. 
Establishment. 
Publication in 
Federal Register. 
Be it enacted hy the Senate and House of Representatives 
of the 
United States of America In Congress assembled^ That, in order to 
preserve, develop, and make available to this and future generations 
the birthplace of forestry and forestry education in America and to 
promote, demonstrate, and stimulate interest in and knowledge of the 
management of forest lands under principles of multiple use and sus-
tained yield and the development and progress of management of 
forest lands in America, the Secretary of Agriculture is hereby author-
ized to establish the Cradle of Forestry in America in the Pisgah 
National Forest, North Carolina. As soon as possible after this Act 
takes effect, the Secretary of Agriculture shall publish notice of the 
designation thereof in the Federal Register together with a map show-
ing the boundaries which shall be those shown on the map entitled 
"Cradle of Forestry in America" dated April 12,1967, which shall be 
on file and available for public inspection in the office of the Chief, 
Forest Service, Department of Agriculture. 
SEC. 2. The area designated as the Cradle of Forestry in America 
shall be administered, protected, and developed w'ithin and as a part 
of the Pisgah National Forest by the Secretary of Agriculture in 
accordance with the laws, rules, and regulations applicable to national 
forests in such manner as in his judgment will best provide for the 
purposes of this Act and for such management, utilization, and dis-
posal of the natural resources as in his judgment wnll promote or is 
compatible with and does not significantly impair the purposes for 
which the Cradle of Forestry in America is established. 
SEC. 3. The Secretary of Agriculture is hereby authorized to coop-
ei-ate with and receive the cooperation of public and private agencies 
and organizations and individuals in the development, administration, 
and operation of the Cradle of Forestry in America. The Secretary of 
Agriculture is authorized to accept contributions and gifts to be used 
to further the purposes of this Act. 
Approved July 11, 1968. 
July 13, 1968 
[H. R. 3639] 
Public Law 90-399 
AN ACT 
To protect the public health by amending the Federal Food, Drug, and Cosmetic 
Act to consolidate certain provisions assuring the safety and effectiveness of 
new animal drugs, and for other purposes. 
Animal Drug 
Amendments of 
1968. 
Be it enacted hy the Senate and House of Representa.tives of the 
United States of America in Congress assembled^ That this Act may 
be cited as the "Animal Drug Amendments of 1968." 
82 STAT. ] 
PUBLIC LAW 90-399-JULY 13, 1968 
343 
N E W ANIMAL DRUGS 
SEC. 101. (a) Section 501(a) of the Federal Food, Drug, and Cos-
metic Act, as amended, is amended by inserting before the period at 
the end thereof a semicolon and the following: "or (5) if it is a new 
animal drug which is unsafe within the meaning of section 512; or (6) 
if it is an animal feed bearing or containing a new animal drug, and 
such animal feed is unsafe within the meaning of section 512". 
(b) Chapter V of such Act is amended by adding at the end thereof 
the following: 
aeoa 
"NEW ANIMAL DRUGS 
52 Stat. 1049. 
21 u s e 351. 
In Ira. 
79 Stat. 227. 
21 u s e 351-
"SEC. 512. (a)(1) A new animal drug shall, with respect to any par-
ticular use or intended use of such drug, be deemed unsafe for the pur-
poses of section 501(a) (5) and section 402(a) (2) (D) unless— 
^^^^^- ^^.^ 
"(A) there is in effect an approval of an application filed pur-
suant to subsection (b) of this section with respect to such use or 
intended use of such drug, 
"(B) such drug, its labeling, and such use conform to such ap-
proved application, and 
"(C) in the case of a new animal drug subject to subsection (n) 
of this section and not exempted therefrom by regulations it is 
from a batch with respect to which a certificate or release issued 
pursuant to subsection (n) is in effect with respect to such drug. 
A new animal drug shall also be deemed unsafe for such purposes in 
the event of removal from the establishment of a manufacturer, packer, 
or distributor of such drug for use in the manufacture of animal feed 
in any State unless at the time of such removal such manufacturer, 
packer, or distributor has an unrevoked written statement from the 
consignee of such drug, or notice from the Secretary, to the effect that, 
with respect to the use of such drug in animal feed, such consignee— 
"(i) is the holder of an approved application under subsection 
(m) of this section; or 
"(ii) will, if the consignee is not a user of the drug, ship such 
drug only to a holder of an approved application under subsection 
(m) of this section. 
"(2) An animal feed bearing or containing a new animal drug 
shall, with respect to any particular use or intended use of such ani-
mal feed, be deemed unsafe for the purposes of section 501(a)(6) 
^^P'^-
unless— 
"(A) there is in effect an approval of an application filed pur-
suant to subsection (b) of this section with respect to such drug, 
as used in such animal feed, 
"(B) there is in effect an approval of an application pursuant 
to subsection (m) (1) of this section with respect to such animal 
feed, and 
"(C) such animal feed, its labeling, and such use conform to 
the conditions and indications of use published pursuant to sub-
section (1) of this section and to the application with respect 
thereto approved under subsection (m) of this section. 
344 
PUBLIC LAW 90-399-JULY 13, 1968 
[82 STAT. 
"(8) A new nnimjil drug or an animal feed bearing or containing 
a new animal drug shall not be deemed unsafe for tne purj^oses oi 
Ante, p. 343. 
scc'tiou 501 (a) (5) Or (6) if such article is for investigational use and 
conforms to the terms of an exemption in effect with respect thereto 
under section 512(j). 
"(b) Any person may file with the Secretary an application with 
respect to any intended use or uses of a new animal drug. Such person 
.shall submit to the Secretary as a part of the application (1) full 
reports of investigations which have been made to show" whether or 
not such drug is safe and effective for use; (2) a full list of the articles 
used as components of such drug; (3) a full statement of the composi-
tion of such drug; (4) a full description of the methods used in, and 
the facilities and controls used for, the manufacture, processing, and 
packing of such drug; (5) such samples of such drug and of the arti-
cles used as components thereof, of any animal feed for use in or on 
which such drug is intended, and of the edible portions or products 
(before or after slaughter) of animals to which such drug (directly or 
in or on animal feed) is intended to be administered, as the Secretary 
may require; (6) specimens of the labeling proposed to be used for 
such drug, or in case such drug is intended for use in animal feed, 
I>roposed labeling appropriate for such use, and specimens of the 
labeling for the drug to be manufactured, packed, or distributed by 
the applicant; (7) a description of practicable methods for determin-
ing the quantity, if any, of such drug in or on food, and any substance 
formed in or on food, because of its use; and (8) the proposed toler-
ance or withdrawal period or other use restrictions for such drug if 
any tolerance or withdrawal period or other use restrictions are 
required in order to assure that the proposed use of such drug will 
be safe. 
hearkT'*""'*^ ^°' 
"(^) Within one hundred and eighty days after the filing of an 
application pursuant to subsection (b), or such additional period as 
may be agreed upon by the Secretary and the applicant, the Secretary 
shall either (1) issue an order approving the application if he then 
finds that none of the grounds for denying approval specified in sub-
section (d) applies, or (2) give the applicant notice of an opportunity 
for a hearing before the Secretary under subsection (d) on the ques-
tion whether such application is approvable. If the applicant elects 
to accept the opportunity for a 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 Secretary's 
order thereon shall be issued within ninety days after the date fixed 
by the Secretary for filing final briefs. 
"(d) (1) If the Secretary finds, after due notice to the applicant in 
accordance with subsection (c) and giving him an opportunity for a 
hearing, in accordance with said subsection, that— 
"(A) the investigations, 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 condi-
tions prescribed, recommended, or suggested in the proposed 
labeling thereof; 
"(B) 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; 
"(C) the methods used in, and the facilities and controls used 
for, the manufacture, processing, and packing of such drug are 
inadequate to preserve its identity, strength, quality, and pvirity; 
"(D) upon the basis of the information submitted to him as 
82 STAT. ] 
PUBLIC LAW 90-399-JULY 13, 1968 
345 
part of the application, or upon the basis of any other informa-
tion before him with respect to such drug, he has insufficient 
information to determine whether such drug is safe for use under 
such conditions; 
"(E) evakiated 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 will have the effect it purports or is rep-
resented to have under the conditions of use prescribed, recom-
mended, or suggested in the proposed labeling thereof; 
"(F) upon the basis of the information submitted to him as 
part of the application or any other information before him with 
respect to such drug, the tolerance limitation proposed, if any, 
exceeds that reasonably required to accomplish the physical or 
other technical effect for which the drug is intended; 
"(G) based on a fair evaluation of all material facts, such 
labeling is false or misleading in any particular; or 
"(H) such drug induces cancer when ingested by man or 
animal or, after tests which are appropriate for the evaluation of 
the safety of such drug, induces cancer in man or animal, except 
that the foregoing provisions of this subparagraph shall not apply 
with respect to such drug if the Secretary finds that, under the 
conditions of use specified in proposed labeling and reasonably 
certain to be followed in practice (i) such drug will not adversely 
affect the animals for which it is intended, and (ii) no residue of 
such drug will be found (by methods of examination prescribed 
or approved by the Secretary by regulations, which regulations 
shall not be subject to subsections (c), (d), and (h)), in any 
edible portion of such animals after slaughter or in any food 
yielded by or derived from the living animals; 
he shall issue an order refusing to approve the application. If, after 
such notice and opportunity for hearing, the Secretary finds that 
subparagraphs (A) through (H) do not apply, he shall issue an order 
approving the application. 
"(2) In determining whether such drug is safe for use under the 
conditions prescribed, recommended, or suggested in the proposed 
labeling thereof, the Secretary shall consider, among other relevant 
factors, (A) the probable consumption of such drug and of any 
substance formed in or on food because of the use of such drug, (B) 
the cumulative effect on man or animal of such drug, taking into 
account any chemically or pharmacologically related substance, (C) 
safety factors which in the opinion of experts, qualified by scientific 
training and experience to evaluate the safety of such drugs, are 
appropriate for the use of animal experimentation data, and (D) 
whether the conditions of use prescribed, recommended, or suggested 
in the proposed labeling are reasonably certain to be followed in 
practice. Any order issued under this subsection refusing to approve 
an application shall state the findings upon which it is based. 
"(3) As used in this subsection and subsection (e), the term 'sub- 
"substantial 
stantial evidence' means evidence consisting of adequate and well-
controlled investigations, including field investigation, by experts 
qualified by scientific training and experience to evaluate the effec-
tiveness of the drug involved, on the basis of which it could fairly and 
reasonably be concluded 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. 
"(e) (1) The Secretary shall, after due notice and opportunity for 
hearing to the applicant, issue an order withdrawing approval of an 
evidence." 
346 
PUBLIC LAW 90-399-JULY 13, 1968 
[82 STAT. 
application filed pursuant to subsection (b) with respect to any new 
annnal drug if the Secretary finds— 
"(A) that experience or scientific data show that such drug is 
unsafe for use under the conditions of use upon the basis of which 
the application was approved; 
"(B) that new evidence not contained in such application or 
not available to the Secretary until after such application was 
approved, or tests by new methods, or tests by methods not deemed 
reasonably applicable w^hen • 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 that subparagraph 
(H) of paragraph (1) of subsection (d) applies to such drug; 
"(C) on the basis of new information before him with respect 
to such drug, evaluated together with the evidence available to 
him when the application was approved, that there is a lack of 
substantial evidence that such 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; 
"(I)) that the application contains any untrue statement of a 
material fact; or 
"(E) that the applicant has made any changes from the ^stand-
point of safety or effectiveness beyond the variations provided for 
in the application unless he has supplemented the application by 
filing with the Secretary adequate information respecting all such 
changes and unless there is in effect an approval of the supple-
mental application. The supplemental application shall be treated 
in the same manner as the original application. 
If the Secretary (or in his absence the officer acting as Secretary) 
finds that there is an imminent hazard to the health of man or of the 
animals for which such drug is intended, 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 sen-
tence to suspend the approval of an application shall not be delegated. 
"(2) The Secretary may also, after due notice and opportunity for 
hearing to the applicant, issue an order withdraw^ing the approval of 
an application with respect to any new animal drug under this section 
if the Secretary finds— 
"(A) 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 regulation or order under subsection (1), or 
the applicant has refused to permit access to, or copying or veri-
fication of, such records as required by paragraph (2) of such 
subsection; 
"(B) that on the basis of new information before him, ev^alu-
ated 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 packing of such 
drug are inadequate to assure and preserve its identity, strength, 
(uiality, and purity and were not made adequate within a reason-
able time after receipt of written notice from the Secretary speci-
fying the matter complained of; or 
"(C) that on the basis of new information before him, evalu-
ated together with the evidence before him when the application 
was approved, the labeling of such drug, based on a fair evalua-
tion of all material facts, is false or misleading in any particular 
82 
STAT. ] 
PUBLIC LAW 90-399-JULY 13, 1968 
347 
and was not corrected within a reasonable time after receipt of 
written notice from the Secretary specifying the matter com-
plained of. 
"(3) Any order under this subsection shall state the findings upon 
which it is based. 
"(f) Whenever the Secretary finds that the facts so require, he 
shall revoke any previous order under subsection (d), (e), or (m) 
refusing, withdrawing, or suspending approval of an application and 
shall approve such application or reinstate such approval, as may be 
appropriate. 
"(g) Orders of the Secretary issued under this section (other than 
orders issuing, amending, or repealing regulations) shall be served 
(1) in person by any officer or employee of the department designated 
by the Secretary or (2) by mailing the order by registered mail or by 
certified mail addressed to the applicant or respondent at his last 
known address in the records of the Secretary. 
"(h) An appeal may be taken by the applicant from an order of 
the Secretary refusing or withdrawing approval of an application 
filed under subsection (b) or (m) of this section. The provisions of 
subsection (h) of section 505 of this Act shall govern any such appeal. 
52 stat. 1052; 
"(i) When a new animal drug application filed pursuant to sub- '^^ ^*^'- 784, 785. 
section (b) is approved, the Secretary shall by notice, which upon 
Publication in 
publication shall be effective as a regulation, publish in the Federal Federal Register. 
Register the name and address of the applicant and the conditions and 
indications of use of the new animal drug covered by such application, 
including any tolerance and withdrawal period or other use restric-
tions and, if such new animal drug is intended for use in animal feed, 
appropriate purposes and conditions of use (including special labeling 
requirements) applicable to any animal feed for use in which such 
drug is approved, and such other information, upon the basis of which 
such application was approved, as the Secretary deems necessary to 
assure the safe and effective use of such drug. Upon withdrawal of 
approval of such new animal drug application or upon its suspension, 
the Secretary shall forthwith revoke or suspend, as the case may be, 
the regulation published pursuant to this subsection (i) insofar as it is 
based on the approval of such application. 
"(j) To the extent consistent with the public health, the Secretary 
shall promulgate regulations for exempting from the operation of 
this section new animal drugs, and animal feeds bearing or containing 
new animal drugs, intended solely for investigational use by experts 
qualified by scientific training and experience to investigate the safety 
and effectiveness of animal drugs. Such regulations may, in the dis-
cretion of the Secretary, among other conditions relating to the pro-
tection of the public health, provide for conditioning such exemption 
upon 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 article, of data (including but 
not limited to analytical reports by investigators) obtained as a result 
of such investigational use of such article, as the Secretary finds will 
enable him to evaluate the safety and effectiveness of such article in 
the event of the filing of an application pursuant to this section. Such 
regulations, among other things, shall set forth the conditions 
(if any) upon which animals treated with such articles, and any 
products of such animals (before or after slaughter), may be mar-
keted for food use. 
"(k) While approval of an application for a new animal drug is 
effective, a food shall not, by reason of bearing or containing such 
drug or any substance formed in or on the food because of its use in 
accordance with such application (including the conditions and indi-
Exemptions 
348 
PUBLIC LAW 90-399-JULY 13, 1968 
[82 STAT. 
cations of use i)i'eseribed pursuant to subsection (i)), be considered 
21 us^c 3
^
°
2
*
^ 
adulterated within the meanin*^ of chiuse (1) of section 402(a). 
Recordkeeping. 
"(1) (1) lu the case of auj new animal drug for which an approval 
of an application filed pursuant to subsection (b) is in effect, the 
applicant shall establish and maintain such records, and make such 
reports to the Secretary, of data relating to experience and other 
data or information, received or otherwise obtained by such applicant 
with respect to such drug, or with respect to animal feeds bearing 
or containing 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) or sub-
section (m) (4) of this section. Such regulation or order shall pro-
vide, where the Secretary deems it to be appropriate, for the examina-
tion, upon request, by the pereons to whom such regulation or order is 
applicable, of similar information received or otherwise obtained by 
the Secretary. 
"(2) Every person required under this subsection to maintain 
7'ecords, and every person in charge or custody thereof, shall, upon 
request of an officer or employee designated by the Secretary, permit 
such officer oc employee at all reasonable times to have access to and 
copy and verify such records. 
'•(m) (1) Any person may file with the Secretary an application 
with respect to any intended use or uses of an animal feed bearing or 
containing a new animal drug. Such person shall submit to the Secre-
tary as part of the application (A) a full statement of the composition 
of such animal feed, (B) an identification of the regulation or regula-
tions (relating to the new animal drug or drugs to be used in such 
feed), published pursuant to subsection (i), on which he relies as a 
basis for approval of his application with respect to the use of such 
drug in such feed, (C) a full description of the methods used in, and 
the facilities and controls used for, the manufacture, processing, and 
])acking of such animal feed, (D) specimens of the labeling proposed 
to be used for such animal feed, and (E) if so requested by the 
Secretary, samples of such animal feed or components thereof. 
"(2) Within ninety days after the filing of an application pursuant 
to subsection (m) (1), or such additional period as may be agreed 
upon by the Secretary and the applicant, the Secretary shall either 
(A) issue an order approving the application if he then finds that 
none of the grounds for denying approval specified in paragraph (3) 
applies, or (B) give the applicant notice of an opportunity for a 
hearing before the Secretary under paragraph (8) on the question 
whether such application is approvable. The procedure governing 
such a hearing shall be the procedure set forth in the last two sentences 
of subsection (c). 
"(3) If the Secretary, after due notice to the applicant in accord-
ance with paragraph (2) and giving him an opportunity for a hearing 
in accordance with such paragraph, finds, on the basis of information 
submitted to him as part of the application or on the basis of any 
other information before him— 
"(A) that there is not in effect a regulation under subsection 
(i) (identified in such application) on the basis of which such 
application may be approved; 
"(B) that such animal feed (including the proposed use of any 
new animal drue therein or thereon) does not conform to an 
applicable regulation published pursuant to subsection 
(i) 
referred to in the application, or that the purposes and conditions 
or indications of use prescribed, recommended, or suggested in 
the labeling of such feed do not conform to the applicable pur-
82 STAT. ] 
PUBLIC LAW 90-399-JULY 13, 1968 
349 
poses and conditions or indications of use (including warnings) 
published pursuant to subsection (i) or such labeling omits or 
fails to conform to other applicable information published pur-
suant to subsection (i); 
"(C) that the methods used in, and the facilities and controls 
used for, the manufacture, processing, and packing of such ani-
mal feed are inadequate to preserve the identity, strength, quality, 
and purity of the new animal drug therein; or 
"(D) that, 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 for hearing, the Secretary finds that 
subparagraphs (A) through (D) do not apply, he shall issue an 
order approving the application. An order under this subsection 
approving an application with respect to an animal feed bearing or 
containing a new animal drug shall be effective only while there is 
in effect a regulation pursuant to subsection (i), on the basis of which 
such application (or a supplement thereto) was approved, relating 
to the use of such drug in or on such feed. 
"(4) (A) The Secretary shall, after due notice and opportunity 
for hearing to the applicant, issue an order withdrawing approval of 
an application with respect to any animal feed under this subsection 
if the Secretary finds— 
"(i) that the application contains any untrue statement of a 
material fact; or 
"(ii) that the applicant has made any changes from the stand-
point of safety or effectiveness beyond the variations provided 
for in the application unless he has supplemented the application 
by filing with the Secretary adequate information respecting all 
such changes and unless there is in effect an approval of the 
supplemental application. The supplemental application shall 
be treated in the same manner as the original application. 
If the Secretary (or in his absence the officer acting as Secretary) 
finds that there is an imminent hazard to the health of man or of 
the animals for which such animal feed is intended, 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 sentence shall not be delegated. 
"(B) The Secretary may also, after due notice and opportunity 
for hearing to the applicant, issue an order withdrawing the approval 
of an application with respect to any animal feed under this subsection 
if the Secretary finds— 
"(i) 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 regulation or order under paragraph (5) (A) 
of this subsection, or the applicant has refused to permit access 
to, or copying or verification of, such records as required by sub-
paragraph (B) of such paragraph; 
"(ii) that on the basis of new information before him, eval-
uated together with the evidence before him when such applica-
tion was approved, the methods used in, or the facilities and con-
trols used for, the manufacture, processing, and packing of such 
animal feed are inadequate to assure and preserve the identity, 
strength, quality, and purity of the new animal drug therein, and 
were not made adequate within a reasonable time after receipt 
of written notice from the Secretary, specifying the matter com-
plained of; or 
350 
PUBLIC LAW 90-399-JULY 13, 1968 
[82 STAT. 
"(iii) that on the basis of new information before him, eval-
uated together with the evidence before him when the application 
was approved, the labeling of such animal feed, based on a fair 
evaluation of all material facts, is false or misleading in any par-
ticular and was not corrected within a reasonable time after re-
ceipt of written notice from the Secretary specifying the matter 
complained of. 
"(C) Xny order under paragraph (4) of this subsection shall state 
the findings upon which it is based. 
Recordkeeping. 
u^^>^ jj^ ^|-^g ^.^^^ ^f .^^^^ animal feed for which an approval of a,n 
application filed pursuant to this subsection is in effect— 
"(A) the applicant shall establish and maintain such records, 
and make such reports to the Secretary, or (at the option of the 
Secretary) to the appropriate person or persons holding an 
approved application filed under subsection (b), as the Secretary 
may by general regulation, or by order with respect to such appli-
cation, prescribe on the basis of a finding that such records and 
reports are necessary in order to enable the Secretary to deter-
mine, or facilitate a determination, whether there is or may be 
ground for invoking subsection (e) or paragraph (4) of this 
subsection. 
"(B) every person required under this subsection to maintain 
records, and every person in charge or custody thereof, shall, upon 
request of an officer or employee designated by the Secretary, per-
mit such officer or employee at all reasonable times to have access 
to and copy and verify such records. 
Certification. 
" ( n ) ( l ) The Secretary, pursuant to regulations promulgated by 
him, shall provide for the certification of batches of a new animal 
drug composed wholly or partly of any kind of penicillin, strepto-
mycm, chlortetracycline, chloramphenicol, or bacitracin, or any deriv-
ative thereof. A batch of any such drug shall be certified if an 
approval of an application filed pursuant to subsection (b) is effective 
with respect to such drug and such drug has the characteristics of 
identity and such batch has the characteristics of strength, quality, 
and purity upon the basis of which the application was approved, but 
shall not otherwise be certified. Prior to the effective date of such 
regulations the Secretary, in lieu of certification, shall issue a release 
for any batch which, in his judgment, may be released without risk 
as to the safety and efficacy of its use. Such release shall prescribe the 
date of its expiration and other conditions under which it shall cease 
to be effective as to such batch and as to portions thereof. 
"(2) Regulations providing for such certifications shall contain 
such provisions as are necessary to carry out the purposes of this sub-
section, including provisions prescribing— 
"(A) tests and methods of assay to determine compliance with 
applicable standards of identity and of strength, quality, and 
purity; 
"(B) effective periods for certificates, and other conditions 
under which they shall cease to be effective as to certified batches 
and as to portions thereof; 
"(C) administration and procedure; and 
"(D) such fees, specified m such regulations, as are necessary 
to provide, equip, and maintain an adequate certification service. 
Such regulations shall prescribe only such tests and methods of assay 
as will provide for certification or rejection wnthin the shortest time 
consistent with the purposes of this subsection. 
82 STAT. ] 
PUBLIC LAW 90-399-JULY 13, 1968 
351 
"(3) Whenever, in the judgment of the Secretary, the requirements 
of this subsection with respect to any drug or class of drugs are not 
necessary to insure that such drug conforms to the standards of iden-
tity, strength, quality, and purity applicable thereto under paragraph 
(1) of this subsection, the Secretary shall promulgate regulations 
exempting such dru^ or class of drugs from such requirements. The 
provisions of subsection (c) of section 507 of this Act (other than the 
59 stat. 464; 
first sentence thereof) shall apply under this paragraph. 
'^^2rusc 357. 
"(4) The Secretary shall promulgate regulations exempting from 
Exemptions. 
any requirement of this subsection— 
"(A) drugs which are to be stored, processed, labeled, or 
repacked at establishments other than those where manufactured, 
on condition that such drugs comply with all such requirements 
upon removal from such establishments; and 
"(B) drugs which conform to applicable standards of identity, 
strength, quality, and purity prescribed pursuant to this subsec-
tion and are intended for use in manufacturing other drugs. 
"(5) On petition of any interested person for the issuance, amend-
ment, or repeal of any regulation contemplated by this subsection, the 
procedure shall be in accordance with subsection (f) of section 507 
of this Act. 
" (6) Where any drug is subject to this subsection and not exempted 
therefrom by regulations, the compliance of such drug with sections 
501(b) and 502(g) shall be determined by the application of the 
jius^cs^^' 
standards of strength, quality, and purity applicable under para- 352. 
graph (1) of this subsectionj the tests and methods of assay applicable 
under provisions of regulations referred to in paragraph (2) (A) of 
this subsection, and the requirements of packaging and labeling on 
the basis of which the application with respect to such drug filed 
under subsection (b) of this section was approved." 
DEFINITIONS 
SEC. 102. Section 201 of the Federal Food, Drug, and Cosmetic Act, 
as amended, is amended by— 
(a) inserting "(except a new animal drug or an animal feed 
bearing or containing a new animal drug)" after "Any drug" in 
subparagraph (1) of paragraph (p) ; 
2ius^c32°r' 
(b) inserting "(except a new animal drug or an animal feed 
bearing or containing a new animal drug)" after "Any drug" in 
subparagraph (2) of paragraph (p); 
(c) striking out the period at the end of subparagraph (4) of 
paragraph (s) and inserting in lieu thereof "; or", and by adding 
^^ ^*^* ^^^'*' 
a new subparagraph (5) to read as follows: "(5) a new animal 
drug."; 
(d) inserting ". 512," after "409" in paragraph (u) ; and 
(e) adding at the end of such section the following new para- 
79 stat. 227. 
graphs: 
"(w) The term 'new animal drug' means any drug intended for use 
"New animai 
for animals other than man, including any drug intended for use in '^'^"^"" 
animal feed but not including such animal feed,— 
"(1) the comf)Osition of which is such that such drug is not 
generally recognized, among experts qualified by scientific train-
ing and experience to evaluate the safety and effectiveness of 
animal drugs, as safe and effective for use under the conditions 
prescribed, recommended, or suggested in the labeling thereof; 
352 
PUBLIC LAW 90-399-JULY 13, 1968 
[82 STAT. 
Exception. 
except that such a drug not so recognized shall not be deemed 
to be a 'new animal drug' if at any time prior to June 25, 1938, 
it was subject to the Food and Drug Act of June 30, 1906, as 
52^stat°\o59^' 
amended, and if at such time its labeling contained the same 
21 use 1-15 
representations concerning the conditions of its use; or 
"°'^^- 
"(2) the composition of which is such that such drug, as a 
result of investigations to determine its safety and effectiveness 
for use under such conditions, has become so recognized but which 
has not, otherwise than in such investigations, been used to a 
material extent or for a material time under such conditions; or 
"(3) which drug is composed wholly or partly of any kind of 
penicillin, streptomycin, chlortetracycline, chloramphenicol, or 
bacitracin, or any derivative thereof, except when there is in 
effect a published order of the Secretary declaring such drug not 
to be a new animal drug on the grounds that (A) the require-
ment of certification of batches of such drug, as provided for in 
Ante, p. 350. 
sectiou 512(u), is not necessary to insure that the objectives 
specified in paragraph (3) thereof are achieved and (B) that 
neither subparagraph (1) nor (2) of this paragraph (w) applies 
to such drug. 
"Animal feed." 
"(x) The term 'animal feed', as used in paragraph (w) of this 
^^Anfe, pp. 351, 
scction, lu sectiou 512, and in provisions of this Act referring to such 
paragraph or section, means an article which is intended for use for 
food for animals other than man and which is intended for use as 
a substantial source of nutrients in the diet of the animal, and is not 
limited to a mixture intended to be the sole ration of the animal." 
rROIIIBlTED ACTS AND PENALTIES 
SEC. 103. Section 301 of the Federal Food, Drug, and Cosmetic Act, 
as amended, is amended by— 
(1) striking out "or" before "507," and inserting ", or 512 (j), 
788^ ^*^*' ^^'*' 
C^)?"!" (m)" after "507 (d) or (g)" in paragraph (e),and 
21 use 331. 
(2) adding "512," after "507," in paragraph (j). 
52 Stat. 1042; 
61 Stat. 11. 
ANIMAL DRUGS I N FEEDS AND RESIDUES THEREOF I N OTHER FOOD 
SEC. 104. Section 402 of the Federal Food, Drug, and Cosmetic Act, 
as amended, is amended by— 
(1) striking out the word "or" before "(iii)" in clause (A) of 
77stat^397^^^' 
Subparagraph (2) of paragraph (a) and inserting "; or (iv) a 
21 use 342. 
new animal drug" after the words "color additive" therein; and 
(2) adding before the semicolon following "commodity" at the 
end of the proviso to clause (C) of subparagraph (2) of para-
graph (a) the following: "; or (D) if it is, or it bears or contains, 
a new animal drug (or conversion product thereof) which is un-
safe within the meaning of section 512". 
ANTIBIOTIC DRUGS FOR 
ANIMALS 
SEC. 105. (a) Section 502 of the Federal Food, Drug, and Cosmetic 
Act, as amended, is amended by inserting "(except a drug for use in 
animals other than man)" after "represented as a drug" in para-
2??se352- 
gr^Ph(l)-
21 use 357! 
(b) Section 507 of such Act is amended by inserting "(except drugs 
for use in animals other than man)" after "drugs" in the first sentence 
of subsection (a). 
82 STAT. ] 
PUBLIC LAW 90-399-JULY 13, 1968 
353 
ANIMAL DRUGS FOR 
EXPORT 
SEC. 106. Section 801(d) of the Federal Food, Drug, and Cosmetic 
Act, as amended, is amended by adding at the end thereof the follow- 
52 stat. loss. 
ing: "Nothing in this subsection shall authorize the exportation of 
^^ "^^ ^
^
^
^
• 
any new animal drug, or an animal feed bearing or containing a new 
animal drug, which is unsafe within the meaning of section 512 of 
t h i s 
A c t . " 
An^e, p. 343. 
AMENDMENT WITH RESPECT TO VIRUS, SERUM, TOXIN, AND 
ANAL0(i0US PRODUCTS ACTS 
21 u s e 392. 
21 u s e 151-158. 
Definitions. 
SEC. 107. Section J>02(c) of the Federal Food, Drug, and Cosmetic 
Act is amended by striking out "the virus, serum, and toxin Act of 
July 1,1902 (U.S.C, 1934 ed., title 42, chap. 4 ) ; " and inserting in lieu 
thereof the following: "section 351 of Public Health Service Act 
42 us^c 2
^
6
2
^ 
(relating to viruses, serums, toxins, and analogous products applicable 
to man); the virus, serum, toxin, and analogous products provisions, 
applicable to domestic animals, of the Act of Congress approved 
March 4, 1913 (37 Stat. 832-833) ;•'. 
EFFECTIVE DATE AND TRANSITIONAL 
PROVISIONS 
SEC. 108, (a) Except ?s otherwise provided in this section, the 
amendments made by the foregoing sections shall take effect on the 
first day of the thirteenth calendar month whicli begins after the date 
of enactment of this Act. 
(b) (1) As used in this subsection, the term "effective date" means 
the effective date specified in subsection (a) of this section; the term 
"basic Act" means the Federal Food, Drug, and Cosmetic Act; and 
other terms used both in this section and the basic Act shall have the 
same meaning as they have, or had, at the time referred to in the con-
text, under the basic Act. 
(2) Any approval, prior to the effective date, of a new animal drug 
or of an animal feed bearing or containing a new animal drug, whether 
granted by approval of a new-drug application, master file, antibiotic 
regulation, or food additive regulation, sliall continue in effect, and 
shall be subject to change in accordance with the provisions of the 
basic Act as amended by this Act. 
(3) In the case of any drug (other than a drug subject to section 
512(n) of the basic Act as amended by this Act) intended for use in 
^"^^' P- ^^O. 
animals other tlian man which, on October 9, 1962, (A) was commer-
cially used or sold in the United States, (B) was not a new drug as 
defined by section 201 (p) of the basic Act as then in force, and (C) 
was not covered by an effective application under section 505 of that 
Act, the words "effectiveness" and "effective" contained in section 201 
(w) as added by this Act to the basic Act sliall not apply to such drug 
when intended solely for use under conditions prescribed, recom-
mended, or suggested in labeling with respect to such drug on tliat day. 
(4) Rpjxulations providing tor fees (and advance deposits to cover 
fees) which on the day preceding the effective date applicable under 
subsection (a) of this section were in effect pursuant to section 507 
of the basic Act shall, except as the Secretary may otherwise l)re- 
59 stat^ 463; 
scribe, be deemed to apply also under section 512(n) of the basic Act, 
and appropriations of fees (and of advancs deposits to cover fees) 
available for the purposes specified in such section 507 as in effect 
prior to the effective date shall also be available for the purposes 
specified in section 512(n), including preparatory work or proceed-
ings prior to that date. 
Approved July 13, 1968. 
52 Stat. 
21 use 
76 Stat. 
785. 
21 use 
Ante, 
p. 
1041 
321. 
781-
355. 
351. 
76 Stat. 785-78S 
21 u s e 357.