The Drug Abuse Control Amendments of 1965 were a law passed by Congress and signed by the President, which modified the Food, Drug, and Cosmetics Act. They allowed the Secretary of Health, Education, and Welfare to designate certain "stimulant, depressant, or hallucinogenic" drugs as controlled, requiring licensing for sales and distribution. Possession for personal consumption or administration to animals was specifically allowed under this law. The law went into effect on or around Feb 1, 1966. After two years, President Lyndon Johnson issued an executive order creating the Bureau of Narcotics and Dangerous Drugs (BNDD) by merging the Bureau of Narcotics, in the Treasury Department, which was responsible for the control of marijuana and narcotics such as heroin, with the Bureau of Drug Abuse Control (BDAC), formerly responsible for handling depressants, stimulants, and hallucinogens.

See also a scanned PDF version of the DACA 1965.

             PUBLIC LAW 89-74-JULY 15, 1965        [79 STAT.

                            ADMINISTRATION

  SEC. 602. (a) In carrying out the purposes of this Act, the Secre-
tary of Health, Education, and Welfare is authorized to provide con-
sultative services and technical assistance to public or nonprofit private 
agencies, organizations, and institutions; to provide short-term train-
ing and technical instruction; to conduct research and demonstrations; 
and to collect, prepare, publish, and disseminate special educational or 
informational materials, including reports of the projects for which 
funds are provided under this Act.
  (b) In administering their respective functions under this Act, the 
Secretary of Health, Education, and Welfare is authorized to utilize 
the services and facilities of any agency of the Federal Government 
and of any other public or nonprofit private agency or institution, in 
accordance with agreements between the Secretary concerned and the 
head thereof, and to pay therefor, in advance or by way of reimburse-
ment, as may be provided in the agreement.

                   AUTHORIZATION OF APPROPRIATIONS

  SEC. 603. The Secretary shall carry out titles IV and V of this 
Act during the fiscal year ending June 30, 1966, and each of the four 
succeeding fiscal years. There are hereby authorized to be appro-
priated $1,500,000 for the fiscal year ending June 30, 1966, and 
$3,000,000 for the fiscal year ending June 30, 1967, and for the fiscal 
year ending June 30, 1968, and each of the two succeeding fiscal years, 
such sums may be appropriated as the Congress may hereafter author-
ize by law.
    Approved July 14, 1965.


Public Law 89-74

                                AN ACT

To protect the public health and safety by amending the Federal Food, Drug, 
  and Cosmetic Act to establish special controls for depressant and stimulant 
  drugs and counterfeit drugs, and for other purposes.

  Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled, That this Act may
be cited as the "Drug Abuse Control Amendments of 1965".

                       FINDINGS AND DECLARATION

  SEC. 2. The Congress hereby finds and declares that there is a wide-
spread illicit traffic in depressant and stimulant drugs moving in or 
otherwise affecting interstate commerce; that the use of such drugs, 
when not under the supervision of a licensed practitioner, often endan-
gers safety on the highways (without distinction of interstate and 
intrastate traffic thereon) and otherwise has become a threat to the 
public health and safety, making additional regulation of such drugs 
necessary regardless of the intrastate or interstate origin of such 
drugs; that in order to make regulation and protection of interstate 
commerce in such drugs effective, regulation of intrastate commerce 
is also necessary because, among other things, such drugs, when held 
for illicit sale, often do not bear labeling showing their place of origin 
and because in the form in which they are so held or in which they are 
consumed a determination of their place of origin is often extremely 
difficult or impossible; and that regulation of interstate commerce with-
out the regulation of intrastate commerce in such drugs, as provided 
in this Act, would discriminate against and adversely affect interstate 
commerce in such drugs.

              CONTROL OF DEPRESSANT AND STIMULANT DRUGS

  SEC. 3. (a) Section 201 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 321) is amended by adding at the end thereof the 
following
  "(v) The term 'depressant or stimulant drug' means——
     "(1) any drug which contains any quantity of (A) barbituric 
   acid or any of the salts of barbituric acid; or (B) any derivative 
   of barbituric acid which has been designated by the Secretary 
   under section 502(d) as habit forming;
     "(2) any drug which contains any quantity of (A) ampheta-
   mine or any of its optical isomers; (B) any salt of amphetamine 
   or any salt of an optical isomer of amphetamine; or (C) any sub-
   stance which the Secretary, after investigation, has found to be, 
   and by regulation designated as, habit forming because of its 
   stimulant effect on the central nervous system; or
     "(3) any drug which contains any quantity of a substance 
   which the Secretary, after investigation, has found to have, and 
   by regulation designates as having, a potential for abuse because 
   of its depressant or stimulant effect on the central nervous system 
   or its hallucinogenic effect; except that the Secretary shall not 
   designate under this paragraph, or under clause (C) of subpara-
   graph (2), any substance that is now included, or is hereafter 
   included, within the classifications stated in section 4731, and mar-
   ihuana as defined in section 4761, of the Internal Revenue Code of 
   1954 (26 U.S.C. 4731, 4761).
The provisions of subsections (e), (f), and (g) of section 701 shall 
apply to and govern proceedings for the issuance, amendment, or 
repeal of regulations under subparagraph (2)(C) or (3) of this 
paragraph."
  (b) Chapter V of such Act (21 U.S.C., chap. 9, subch. V) is amended 
by adding at the end thereof the following new section:

                   "DEPRESSANT AND STIMULANT DRUGS

  "SEC. 511. (a) No person shall manufacture, compound, or process
any depressant or stimulant drug, except that this prohibition shall
not apply to the following persons whose activities in connection with
any such drug are solely as specified in this subsection:
      "(1)(A) Manufacturers, compounders, and processors regis-
    tered under section 510 who are regularly engaged, and are other-
    wise qualified, in conformance with local laws, in preparing 
    pharmaceutical chemicals or prescription drugs for distribution 
    through branch outlets, through wholesale druggists, or by direct 
    shipment, (i) to pharmacies or to hospitals, clinics, public health 
    agencies, or physicians, for dispensing by registered pharmacists 
    upon prescriptions, or for use by or under the supervision of prac-
    titioners licensed by law to administer such drugs in the course of 
    their professional practice, or (ii) to laboratories or research or 
    educational institutions for their use in research, teaching, or 
    chemical analysis.
      "(B) Suppliers (otherwise qualified in conformance with local 
    laws) of manufacturers, compounders, and processors referred 
    to in subparagraph (A).
      "(2) Wholesale druggists registered under section 510 who 
    maintain establishments in conformance with local laws and are 
    regularly engaged in supplying prescription drugs (A) to phar-
    macies, or to hospitals, clinics, public health agencies, or physi-
    cians, for dispensing, by registered pharmacists upon prescriptions, 
    or for use by or under the supervision of practitioners licensed by 
    law to administer such drugs in the course of their professional 
    practice, or (B) to laboratories or research or educational insti-
    tutions for their use in research, teaching, or clinical analysis.
      "(3) Pharmacies, hospitals, clinics, and public health agencies, 
    which maintain establishments in conformance with any appli-
    cable 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 for patients under the care of such practitioners in the 
    course of their professional practice.
      "(4) Practitioners licensed by law to prescribe or administer 
    depressant or stimulant drugs, while acting in the course of their 
    professional practice.
      "(5) Persons who use depressant or stimulant drugs in research. 
    teaching, or chemical analysis and not for sale.
      "(6) Officers and employees of the United States, a State gov-
    ernment, or a political subdivision of a State. while acting in the 
    course of their official duties.
      "(7) An employee or agent of any person described in para-
    graph (1) through paragraph (5), and a nurse or other medical 
    technician under the supervision of a practitioner licensed by law 
    to administer depressant or stimulant drugs, while such employee, 
    nurse, or medical technician is acting in the course of his employ-
    ment or occupation and not on his own account.
  "(b) No person, other than——
      "(1) a person described in subsection (a), while such person
    is acting in the ordinary and authorized course of his business,
    profession, occupation, or employment, or
      "(2) a common or contract carrier or warehouseman, or an
    employee thereof, whose possession of any depressant or stimulant
    drug is in the usual course of his business or employment as such, 
shall sell, deliver, or otherwise dispose of any depressant or stimulant 
drug to any other person.
  "(c) No person, other than a person described in subsection (a) or 
subsection (b)(2), shall possess any depressant or stimulant drug 
otherwise than (1) for the personal use of himself or of a member of 
his household, or (2) for administration to an animal owned by him 
or a member of his household. In any criminal prosecution for pos-
session of a depressant or stimulant drug in violation of this subsection 
(which is made a prohibited act by section 301(q)(3)), the United 
States shall have the burden of proof that the possession involved does 
not come within the exceptions contained in clauses (1) and (2) of 
the preceding sentence.
  "(d)(1) Every person engaged in manufacturing, compounding, 
processing, selling, delivering, or otherwise disposing of any depres-
sant or stimulant drug shall, upon the effective date of this section, 
prepare a complete and accurate record of all stocks of each such drug 
on hand and shall keep such record for three years. On and after the 
effective date of this section, every person manufacturing, compound-
ing, or processing any depressant or stimulant drug shall prepare and 
keep, for not less than three years, a complete and accurate record of 
the kind and quantity of each such drug manufactured, compounded, 
or processed and the date of such manufacture, compounding, or 
processing; and every person selling, delivering, or otherwise dispos-
ing of any depressant or stimulant drug shall prepare or obtain, and 
keep for not less than three years, a complete and accurate record of 
the kind and quantity of each such drug received, sold, delivered, or 
otherwise disposed of, the name and address of the person, and the 
registration number, if any, assigned to such person by the Secretary 
pursuant to section 510(e), from whom it was received and to whom 
it was sold, delivered, or otherwise disposed of, and the date of such 
transaction. No separate records, nor set form or forms for any of 
the foregoing records, shall be required as long as records containing 
the required information are available.
  "(2)(A) Every person required by paragraph (1) of this subsec-
tion to prepare or obtain, and keep, records, and any carrier main-
taining records with respect to any shipment containing any depressant 
or stimulant drug, and every person in charge, or having custody, of 
such records, shall, upon request of an officer or employee designated by 
the Secretary permit such officer or employee at reasonable times to 
have access to and copy such records. For the purposes of verification 
of such records and of enforcement of this section, officers or employees
designated by the Secretary are authorized, upon presenting appro-
priate credentials and a written notice to the owner, operator, or agent 
in charge, to enter, at reasonable times, any factory, warehouse, estab-
lishment, or vehicle in which any depressant or stimulant drug is held, 
manufactured, compounded, processed, sold, delivered, or otherwise 
disposed of and to inspect, within reasonable limits and in a reasonable 
manner, such factory, warehouse, establishment, or vehicle, and all 
pertinent equipment, finished and unfinished material, containers and 
labeling therein, and all things therein (including records, files, papers, 
processes, controls, and facilities) bearing on violation of this section 
or section 301(q); and to inventory any stock of any such drug therein 
and obtain samples of any such drug. If a sample is thus obtained, 
the officer or employee making the inspection shall, upon completion 
of the inspection and before leaving the premises, give to the owner, 
operator, or agent in charge a receipt describing the sample obtained.
  "(B) No inspection authorized by subparagraph (A) shall extend 
to (i) financial data, (ii) sales data other than shipment data, (iii) 
pricing data, (iv) personnel data, or (v) research data, which are 
exempted from inspection under the third sentence of section 704(a) 
of this Act.
  "(3) The provisions of paragraphs (1) and (2) of this subsection 
shall not apply to a licensed practitioner described in subsection (a)(4) 
with respect to any depressant or stimulant drug received, prepared, 
processed, administered, or dispensed by him in the course of his pro-
fessional practice, unless such practitioner regularly engages in dis-
pensing any such drug or drugs to his patients for which they are 
charged, either separately or together with charges for other profes-
sional services.
  "(e) No prescription (issued before or after the effective date of 
this section) for any depressant or stimulant drug may be filled or 
refilled more than six months after the date on which such prescription 
was issued and no such prescription which is authorized to be refilled 
may be refilled more than five times, except that any prescription for 
such a drug after six months after the date of issue or after being 
refilled five times may be renewed by the practitioner issuing it either 
in writing, or orally (if promptly reduced to writing and filed by the 
pharmacist filling it).
  "(f)(1) The Secretary may by regulation exempt any depressant
or stimulant drug from the application of all or part of this section
when he finds that regulation of its manufacture, compounding, proc-
essing, possession, and disposition, as provided in this section or in such
part thereof, is not necessary for the protection of the public health.
  "(2) The Secretary shall by regulation exempt any depressant or
stimulant drug from the application of this section, if——
      "(A) such drug may, under the provisions of this Act, be sold 
    over the counter without a prescription ; or
      "(B) he finds that such drug includes one or more substances 
    not having a depressant or stimulant effect on the central nervous 
    system or a hallucinogenic effect and such substance or substances 
    are present therein in such combination, quantity, proportion, or 
    concentration as to prevent the substance or substances therein 
    which do have such an effect from being ingested or absorbed in 
    sufficient amounts or concentrations as, within the meaning of 
    section 201 (v), to——
          "(i) be habit forming because of their stimulant effect on 
        the central nervous system, or
          "(ii) have a potential for abuse because of their depressant 
        or stimulant effect on the central nervous system or their 
        hallucinogenic effect.
  "(g)(1) The Secretary may, from time to time, appoint a com-
mittee of experts to advise him with regard to any of the following 
matters involved in determining whether a regulation under subpara-
graph (2)(C) or (3) of section 201(v) should be proposed, issued, 
amended, or repealed: (A) whether or not the substance involved has 
a depressant or stimulant effect on the central nervous system or a 
hallucinogenic effect, (B) whether the substance involved has a poten-
tial for abuse because of its depressant or stimulant effect on the cen-
tral nervous system, and (C) any other scientific question (as deter-
mined by the Secretary) which is pertinent to the determination of 
whether such substance should be designated by the Secretary pur-
suant to subparagraph (2)(C) or (3) of section 201(v). The Secre-
tary may establish a time limit for submission of the committee's 
report. The appointment, compensation, staffing, and procedure of 
such committees shall be in accordance with subsections (b)(5)(D), 
and the admissibility of their reports, recommendations, and testi-
mony at any hearing involving such matters shall be determined in 
accordance with subsection (d)(2), of section 706. The appointment 
of such a committee after publication of an order acting on a proposal 
pursuant to section 701(e)(1) shall not suspend the running of the 
time for filing objections to such order and requesting a hearing unless 
the Secretary so directs.
  "(2) Where such a matter is referred to an expert advisory com-
mittee upon request of an interested person, the Secretary may, pur-
suant to regulations, require such person to pay fees to pay the costs, 
to the Department, arising by reason of such referral. Such fees, 
including advance deposits to cover such fees, shall be available, until 
expended, for paying (directly or by way of reimbursement of the 
applicable appropriations) the expenses of advisory committees under 
this subsection and other expenses arising by reason of referrals to 
such committees and for refunds in accordance with such regulations.
  "(h) As used in this section and in sections 301 and 304, the term 
'manufacture, compound, or process' shall be deemed to refer to 'manu-
facture, preparation, propagation, compounding, or processing' as 
defined in section 510(a), and the term 'manufacturers, compounders, 
and processors' shall be deemed to refer to persons engaged in such 
defined activities."

     REGISTRATION OF PRODUCERS AND WHOLESALERS OF DEPRESSANT AND
                           STIMULANT DRUGS

  SEC. 4. (a) Section 510(a) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360) is amended by redesignating paragraph (2) 
thereof as paragraph (3) and by inserting immediately after para-
graph (1) the following new paragraph:
      "(2) the term 'wholesaling, jobbing, or distributing of depres-
    sant or stimulant drugs' means the selling or distribution of any 
    depressant or stimulant drug to any person who is not the ultimate 
    user or consumer or such drug;"
  (b) Subsection (b) of section 510 of such Act is amended (1) by 
inserting immediately after "drug or drugs" the following: "or in the 
wholesaling, jobbing, or distributing of any depressant or stimulant 
drug", and (2) by adding at the end thereof the following: "If any 
such establishment is engaged in the manufacture, preparation, propa-
gation, compounding, or processing of any depressant or stimulant 
drug, such person shall, at the time of such registration, indicate such 
fact, in such manner as the Secretary may by regulation prescribe."
  (c) Subsection (c) of section 510 of such Act is amended (1) by 
inserting immediately after "drug or drugs" the following: "or in the 
wholesaling, jobbing, or distributing of any depressant or stimulant 
drug", and (2) by adding at the end thereof the following: "If such 
establishment is engaged in the manufacture, preparation, propaga-
tion, compounding, or processing of any depressant or stimulant drug 
such person shall, at the time of such registration, indicate such fact, 
in such manner as the Secretary may by regulation prescribe."
  (d) Subsection (d) of section 510 of such Act is amended by insert-
ing "(1)" immediately after "(d)" and by striking out the period at 
the end thereof and inserting in lieu thereof the following: "or the 
wholesaling, jobbing, or distributing of any depressant or stimulant 
drug. If any depressant or stimulant drug is manufactured, prepared, 
propagated, compounded, or processed in such additional establish-
ment, such person shall, at the time of such registration, indicate such 
fact, in such manner as the Secretary may by regulation prescribe.
  "(2) Every person who is registered with the Secretary pursuant to 
the first sentence of subsection (b) or (c) or paragraph (1) of this 
subsection, but to whom the second sentence of subsection (b) or (c) 
or of paragraph (1) of this subsection did not apply at the time of 
such registration, shall, if any depressant or stimulant drug is there-
after manufactured, prepared, propagated, compounded, or processed 
in any establishment with respect to which he is so registered, im-
mediately file a supplement to such registration with the Secretary 
indicating such fact, in such manner as the Secretary may by regula-
tion prescribe."
  (e) The heading of such section 510 is amended by inserting "and 
Certain Wholesalers" immediately after "of Producers".

                           PROHIBITED ACTS

  SEC. 5. 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:
  "(q)(1) The manufacture, compounding, or processing of a drug 
in violation of section 511(a); (2) the sale, delivery, or other disposi-
tion of a drug in violation of section 511(b); (3) the possession of a 
drug in violation of section 511(c); (4) the failure to prepare or 
obtain, or the failure to keep, a complete and accurate record with 
respect to any drug as required by section 511(d); (5) the refusal to 
permit access to or copying of any record as required by section 511(d); 
(6) the refusal to permit entry or inspection as authorized by section 
511(d); or (7) the filling or refilling of any prescription in violation 
of section 511(e)."

    GROUNDS AND JURISDICTION FOR JUDICIAL SEIZURE AND CONDEMNATION

  SEC. 6. (a) Subsection (a) of section 304 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 334) is amended by inserting "(1)"after 
"(a)" and redesignating clauses (1) and (2) of the proviso thereto 
as "(A)" and "(B)", respectively; and by adding at the end of such 
subsection the following new paragraph:
  "(2) The following shall be liable to be proceeded against at any 
time on libel of information and condemned in any district court of
the United States within the jurisdiction of which they are found:
(A) Any depressant or stimulant drug with respect to which a pro-
hibited act within the meaning of section 301 (p) or (q) by any person 
has occurred, (B) Any drug that is a counterfeit drug, (C) Any con-
tainer of such depressant or stimulant drug or of a counterfeit drug, 
(D) Any equipment used in manufacturing, compounding, or proc-
essing a depressant or stimulant drug with respect to which drug a 
prohibited act within the meaning of section 301 (p) or (q), by the 
manufacturer, compounder, or processor thereof, has occurred, and 
(E) Any punch, die, plate, stone, labeling, container, or other thing 
used or designed for use in making a counterfeit drug or drugs."
  (b)(1) The first sentence of subsection (b) of such section 304 is 
amended by inserting ", equipment, or other thing proceeded against" 
after "article".
  (2) Subsection (d) of such section 304 is amended by inserting "(1)" 
after "(d)" and redesignating clauses (1) and (2) of the second 
sentence of such subsection as "(A)" and "(B)", respectively; and by 
adding at the end of such subsection the following new paragraphs:
  "(2) The provisions of paragraph (1) of this subsection shall, to 
the extent deemed appropriate by the court, apply to any equipment 
or other thing which is not otherwise within the scope of such para-
graph and which is referred to in paragraph (2) of subsection (a).
  "(3) Whenever in any proceeding under this section, involving para-
graph (2) of subsection (a), the condemnation of any equipment or 
thing (other than a drug) is decreed, the court shall allow the claim 
of any claimant, to the extent of such claimant's interest, for remis-
sion or mitigation of such forfeiture if such claimant proves to the 
satisfaction of the court (i) that he has not committed or caused to 
be committed any prohibited act referred to in such paragraph (2) 
and has no interest in any drug referred to therein, (ii) that he has 
an interest in such equipment or other thing as owner or lienor or 
otherwise, acquired by him in good faith, and (iii) that he at no time 
had any knowledge or reason to believe that such equipment or other 
thing was being or would be used in, or to facilitate, the violation of 
laws of the United States relating to depressant or stimulant drugs or 
counterfeit drugs."

                              PENALTIES

  SEC. 7. (a) Section 303(a) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 333(a)) is amended by inserting after the final 
word "fine" and before the period the following: ": Provided, how-
ever, That any person who, having attained his eighteenth birthday, 
violates section 301(q)(2) by selling, delivering, or otherwise dispos-
ing of any depressant or stimulant drug to a person who has not 
attained his twenty-first birthday shall, if there be no previous con-
viction of such person under this section which has become final, be 
subject to imprisonment for not more than two years, or a fine of not 
more than $5,000, or both such imprisonment and fine, and for the 
second or any subsequent conviction for such a violation shall be sub-
ject to imprisonment for not more than six years, or a fine of not more 
than $15,000, or both such imprisonment and fine".
  (b) Section 303(b) of such Act (21 U.S.C. 333(b)) is amended by 
inserting after the word "shall" the following: "(except in the case 
of an offense which is subject to the provisions of the proviso to sub-
section (a) relating to second or subsequent offenses)".

            POWERS AND PROTECTION OF ENFORCEMENT PERSONNEL

  SEC. 8. (a) Section 702 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 372) is amended by adding at the end thereof the fol-
lowing new subsection:
  "(e) Any officer or employee of the Department designated by the 
Secretary to conduct examinations, investigations, or inspections under 
this Act relating to depressant or stimulant drugs or to counterfeit 
drugs may, when so authorized by the Secretary——
      "(1) carry firearms;
      "(2) execute and serve search warrants and arrest warrants;
      "(3) execute seizure by process issued pursuant to libel under 
    section 304;
      "(4) make arrests without warrant for offenses under this Act 
    with respect to such drugs if the offense is committed in his pres-
    ence or, in the case of a felony, if he has probable cause to believe 
    that the person so arrested has committed, or is committing, such 
    offense; and
      "(5) make, prior to the institution of libel proceedings under
    section 304(a)(2), seizures of drugs or containers or of equipment,
    punches, dies, plates, stones, labeling, or other things, if they are,
    or he has reasonable grounds to believe that they are, subject to
    seizure and condemnation under such section 304(a)(2). In the
    event of seizure pursuant to this paragraph (5), libel proceed-
    ings under section 304(a)(2) shall be instituted promptly and
    the property seized be placed under the jurisdiction of the court."
  (b) Section 1114 of title 18 of the United States Code is amended by 
striking out "or any security officer of the Department of State or the 
Foreign Service" and by inserting in lieu thereof the following: "any 
security officer of the Department of State or the Foreign Service, or 
any officer or employee of the Department of Health, Education, and 
Welfare designated by the Secretary of Health, Education, and Wel-
fare to conduct investigations or inspections under the Federal Food, 
Drug, and Cosmetic Act".

                       COUNTERFEITING OF DRUGS

  SEC. 9. (a) The Congress finds and declares that there is a substan-
tial traffic in counterfeit drugs simulating the brand or other identify-
ing mark or device of the manufacturer of the genuine article; that 
such traffic poses a serious hazard to the health of innocent consumers 
of such drugs because of the lack of proper qualifications, facilities, 
and manufacturing controls on the part of the counterfeiter, whose 
operations are clandestine; that, while such drugs are deemed mis-
branded within the meaning of section 502(i) of the Federal Food, 
Drug, and Cosmetic Act, the controls for the suppression of the traffic 
in such drugs are inadequate because of the difficulty of determining 
the place of interstate origin of such drugs and, if that place is dis-
covered, the fact that the implements for counterfeiting are not subject 
to seizure, and that these factors require enactment of additional con-
trols with respect to such drugs without regard to their interstate or 
intrastate origins.
  (b) Paragraph (g) of section 201 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321) is amended (1) by inserting "(1)" 
immediately after "(g)", (2) by redesignating clauses (1), (2), (3), 
and (4) thereof as clauses (A), (B), (C), and (D), respectively, 
(3) by striking out "clause (1), (2), or (3)" and inserting in lieu
thereof "clause (A), (B), or (C)", and (4) by adding at the end 
thereof the following:
  "(2) The term 'counterfeit drug' means a drug which, or the con-
tainer or labeling of which, without authorization, bears the trade-
mark, trade name, or other identifying mark, imprint, or device, or 
any likeness thereof, of a drug manufacturer, processor, packer, or 
distributor other than the person or persons who in fact manufac-
tured, processed, packed, or distributed such drug and which thereby 
falsely purports or is represented to be the product of, or to have 
been packed or distributed by, such other drug manufacturer, proc-
essor, packer, or distributor."
  (c) Paragraph (i) of section 301 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331(c)) is amended by inserting "(1)" 
immediately after "(i)" and by adding at the end thereof the following 
new subparagraphs:
  "(2) Making, selling, disposing of, or keeping in possession, control, 
or custody, or concealing any punch, die, plate, stone, or other thing 
designed to print, imprint, or reproduce the trademark, trade name, 
or other identifying mark, imprint, or device of another or any like-
ness of any of the foregoing upon any drug or container or labeling 
thereof so as to render such drug a counterfeit drug.
  "(3) The doing of any act which causes a drug to be a counterfeit 
drug, or the sale or dispensing, or the holding for sale or dispensing, 
of a counterfeit drug."
  (d) Section 303 of such Act (21 U.S.C. 333(c)) is amended by 
inserting immediately before the period at the end thereof the follow-
ing: "; or (5) for having violated section 301(i)(2) if such person 
acted in good faith and had no reason to believe that use of the punch, 
die, plate, stone, or other thing involved would result in a drug being 
a counterfeit drug, or for having violated section 301(i)(3) if the 
person doing the act or causing it to be done acted in good faith and 
had no reason to believe that the drug was a counterfeit drug".

                       APPLICATION OF STATE LAW

  SEC. 10. (a) Nothing in this Act shall be construed as authorizing 
the manufacture, compounding, processing, possession, sale, delivery, 
or other disposal of any drug in any State in contravention of the laws 
of such State.
  (b) No provision of this Act nor any amendment made by it shall be 
construed as indicating an intent on the part of the Congress to occupy 
the field in which such provision or amendment operates to the exclu-
sion of any State law on the same subject matter, unless there is a 
direct and positive conflict between such provision or amendment and 
such State law so that the two cannot be reconciled or consistently 
stand together.
  (c) No amendment made by this Act shall be construed to prevent 
the enforcement in the courts of any State of any statute of such State 
prescribing any criminal penalty for any act made criminal by any 
Such amendment.

                            EFFECTIVE DATE

  SEC. 11. The foregoing provisions of this Act shall take effect on 
the first day of the seventh calendar month following the month in 
which this Act is enacted; except that (1) the Secretary shall permit 
persons, owning or operating any establishment engaged in manu-
facturing, preparing, propagating, compounding, processing, whole-
saling, jobbing, or distributing any depressant or stimulant drug, as 
referred to in the amendments made by section 4 of this Act to section 
510 of the Federal Food, Drug, and Cosmetic Act, to register their 
names, places of business, and establishments, and other information 
prescribed by such amendments, with the Secretary prior to such 
effective date, and (2) sections 201(v) and 511(g) of the Federal 
Food, Drug, and Cosmetic Act, as added by this Act, and the provi-
sions of sections 8 and 10 shall take effect upon the date of enactment 
of this Act.
  Approved July 15, 1965.