10

1 of a drug in violation of section 511 (a); (2) the sale, 2 delivery, or other disposition of a drug in violation of section. 3 511(b); (3) the possession of a drug in violation of section 4 511 (c); (4) the failure to prepare or obtain, or the failure 5 to keep, a complete and accurate record with respect to

6

7

any drug as required by section 511 (d); (5) the refusal to

permit access to or copying of any record as required by 8 section 511 (d); or (6) the refusal to permit entry or in

9 spection as authorized by section 511 (d).”

GROUNDS AND JURISDICTION FOR JUDICIAL SEIZURE AND

10

11

12

CONDEMNATION

13

14

SEC. 5. The first sentence of section 304 (a) of such Act is amended by inserting before ": Provided, however,”

the following: ", and any such drug which is a psychotoxic 15 drug within the meaning of section 201 (v) and which has 16 been manufactured, compounded, processed, sold, delivered, 17 disposed of, or is possessed in violation of section 511, or 18 with respect to which there is a failure to prepare, obtain, or 19 keep any record required by such section, shall be liable to be 20 proceeded against at any time on libel of information and 21 condemned in any district court of the United States within 22 the jurisdiction of which the article is found".

1

2

11

PENALTIES

SEC. 6. (a) Section 303 (a) of such Act (21 U.S.C. 3 333 (a)) is amended by inserting after the final word "fine" 4 and before the period the following: ": Provided, however, 5 That any person who, having attained his eighteenth birth6 day, violates section 301 (q) (2) by selling, delivering, or 7 otherwise disposing of any psychotoxic drug (as defined in 8 section 511) to a person who has not attained his eighteenth 9 birthday shall, if there be no previous conviction of such 10 person under this section which has become final, be subject to imprisonment for not more than two years, or a fine of 12 not more than $2,000, or both such imprisonment and fine, 13 and for the second or any subsequent conviction for such a 14 violation shall be subject to imprisonment for not more than 15 six years, or a fine of not more than $15,000, or both such 16 imprisonment and fine”.

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17

(b) Section 303 (b) of such Act (21 U.S.C. 333 (b)) 18 is amended by inserting after the word "shall" the following: 19 "(except in the case of an offense which is subject to the 20 provisions of the proviso to subsection (a) relating to second or subsequent offenses)".

21

2 SEC. 7. The first sentence of section 701 (e) (1) of the

Federal Food, Drug, and Cosmetic Act is amended by insert

4 ing "201 (v)," immediately before "401".

5

6

AUTHORITY OF INSPECTORS TO CARRY FIREARMS

SEC. 8. Section 702 of such Act (21 U.S.C. 372) is 7 amended by inserting at the end thereof the following new 8 subsection:

9

"(g) Officers or employees of the Department desig10 nated by the Secretary to conduct examinations, investigations, or inspections under section 511 of this Act may, when 12 authorized by the Secretary, carry firearms."

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13

APPLICATION OF STATE LAW

14 SEC. 9. Nothing in this Act shall be construed as au15 thorizing the manufacture, compounding, processing, posses16 sion, sale, delivery, or other disposal of any drug in any 17 State in contravention of the laws of such State.

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EFFECTIVE DATE

SEC. 10. The foregoing provisions of this Act shall take 20 effect on the first day of the seventh calendar month follow21 ing the month in which this Act is enacted; except that the 22 Secretary shall permit manufacturers, compounders, and processors referred to in paragraph (1) of subsection (a) of 24 section 511 of the Federal Food, Drug, and Cosmetic Act, as added by this Act, to list their names and places of busi

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25

36-249-64- 3

13

1 ness with the Secretary prior to such effective date, and 2 except that the definitions of terms in subsection (v) of sec3 tion 201, as added by this Act, and the provisions of section 4 7 shall take effect upon the date of enactment of this Act. REPORT FROM THE DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE JULY 20, 1964.

Hon. LISTER HILL,

Chairman, Committee on Labor and Public Welfare,
U.S. Senate, Washington, D.C.

DEAR MR. CHAIRMAN: This letter is in response to your request of March 13, 1964, for a report on S. 2628, a bill to protect the public health by amending the Federal Food, Drug, and Cosmetic Act to regulate the manufacture, compounding, processing, distribution, delivery, and possession of habit-forming barbiturate drugs, and amphetamine, and other habit-forming central nervous system stimulant drugs, and other drugs that have a potential for abuse resulting in psychotoxic effects or antisocial behavior.

This bill, to be known as the Psychotoxic Drug Control Act of 1964, is a revision of S. 553 on which we submitted a report to your committee on February 24 recommending enactment with certain modifications. The present bill embodies the changes recommended in our report on the earlier bill-i.e., to expand its scope of coverage, and to authorize food and drug inspectors engaged in enforcement of the bill to carry firearms for self-protection-as well as certain additional technical amendments.

The earlier bill, it will be recalled, covered barbiturates and amphetamines, and in addition any drug (or drug component) which the Secretary, after investigation, finds to be and by regulation designates as habit forming because of its stimulant effect on the central nervous system. The present bill has added to this (in line with our recommendation based on the final report of the President's Advisory Commission on Narcotic and Drug Abuse) any other drug or drug component that the Secretary, after investigation, finds to have a potential for abuse that may result in psychotoxic effects or antisocial behavior. And there has been appropriately added to section 2 (Findings and Declaration) a finding that the use of drugs covered by the bill, when not medically supervised, may cause a wide variety of acute and chronic changes in psychological functioning, social behavior, or personality, such as difficulties in judgment and coordination, disordered thinking, disturbances in mood, bizarre and abnormal perceptual experiences, and more severe behavior disburbances such as attempted suicide and antisocial activities.

For the reasons set forth at length in our report on the earlier bill, we recommend enactment of S. 2628. (We would, however, suggest that the committee, in addition to making certain technical corrections enclosed herewith, consider deletion of section 7 (not contained in the earlier version) which would have the effect of requiring formal rulemaking proceedings, with plenary hearing, before issuance of a regulation that would include under the bill any psychotoxic drug other than one containing a barbiturate or amphetamine. We believe that in view of the judgmental nature of these regulations, the procedure of section 4 of the Administrative Procedure Act, requiring prior public notice of proposed rulemaking and opportunity for comment and suggestions by all interested persons, coupled with the conference method in cases in which we find it appropriate, is better suited to the purpose and that plenary hearing requirements would tend to result in inordinate delay.)

We are advised by the Bureau of the Budget that there is no objection to the presentation of this report from the standpoint of the administration's program.

Sincerely,

ANTHONY J. CELEBREZZE,

Enclosure.

Secretary.

TECHNICAL CORRECTIONS FOR S. 2628

Page 2, line 3, strike out "barbiturates, in psy-" and insert in lieu thereof "barbiturates, amphetamines and other habit-forming central nervous system stimulant drugs, and other psy-". If this detailed enumeration is not acceptable, then simply strike out "in barbiturates," and do not insert anything.

Page 7, lines 5-7, the phrase "shall sell, deliver, or otherwise dispose of any psychotoxic drug to any other person." should be flush with the outer margin instead of being indented.

Page 8, line 7, strike out "rate" and insert "date".

Page 10, line 17, insert a comma after "possessed”.

Page 11, line 8, strike out "511" and insert in lieu thereof "201(v)".

Page 13, line 4, strike out "7" and insert in lieu thereof "9".

(NOTE.-If, as recommended in the Secretary's report, section 7 of the bill is deleted, with consequent redesignation of subsequent sections, the figure "7" on page 13, line 4, should be replaced by the figure "8".)

Senator YARBOROUGH. S. 2628 is a revision of S. 553 that was introduced last year. I was privileged to be a cosponsor of that bill and I am delighted to have the opportunity to conduct these hearings. I want to take this opportunity to pay tribute to Senator Dodd, the senior Senator from Connecticut. All of us know of his pioneering work and great interest in combating the illegal traffic in dangerous drugs. Senator Dodd has performed a great public service in bringing to the attention of the Nation the illegal traffic in dangerous drugs and its consequences, just as he did in the matter of the wide distribution of cheap imported automatic rifles over the country, and as he has in so many other phases of the growth of criminal activity in this country. Through the various types of hearings he has conducted in combating, not only crime, but also the underlying causes of juvenile delinquency. He has endeavored to aid in the creation of a plan in which life and property are made safer in America, but in which opportunities for young people are preserved.

The bill we are considering, S. 2628, would carry out the recommendations of the President's Advisory Commission on Narcotic and Drug Abuse. The Commission submitted its final report in November 1963 and one of its recommendations was the enactment of legislation to control the illegal traffic in amphetamines, habit-forming barbiturates, habit-forming central nervous system stimulant drugs, and other drugs that have a potential for abuse resulting in psychotoxic effects or antisocial behavior.

S. 2628 would enable the Food and Drug Administration to combat the illegal traffic in barbiturates, amphetamines, and certain other dangerous drugs by regulating their manufacture and controlling their distribution. The maintenance of records, factory inspections, and penalties for violations are provided for in the legislation.

Senator Dodd will be with us to testify today, but his plane has been delayed.

The first witness on the list this morning is Mr. George P. Larrick, Commissioner of Food and Drug Administration, Department of Health, Education, and Welfare.

Commissioner Larrick, please come forward to the witness table. Commissioner Larrick, if you have staff associates with you and you desire to introduce them, please proceed.