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March 15, 2004

THE PHYSICIAN AND THE FEDERAL NARCOTIC LAW

H.J. Anslinger - United States Commissioner of Narcotics.

From: Tulane Law Review, Vol. XX No. 3, March 1946 pp. 309-332

1. Types of Narcotic Drugs Covered.

Narcotic drugs covered by the law are those included within the classification

opium, coca leaves, and any compound, salt, derivative or preparation

thereof.(1) They include, for instance, all of the alkaloids and salts of opium,

whether of the phenanthrene or isoquinoline groups. By an amendment approved

July 1, 1944, to the Federal law, isonipecaine, a synthetic substitute for

morphine, was added to this classification and is therefore subject to the

operation of the Federal narcotic law in the same manner as is morphine for

which it is substituted. Isonipecaine is defined as

1-methyl-4-phenyl-piperidine-4-carboxylic acid ethyl ester, or any salt thereof,

by whatever trade name designated.(2)

2. International Action.

Modern narcotic drug legislation is the result of the efforts of our government

to give full effect to its obligations under the international conventions to

which it is a party.(3) The first of these important international agreements is

known as the International Opium Convention of 1912.(4) Under this convention

the contracting powers assumed the obligation, among others, to enact pharmacy

laws or regulations to limit exclusively to medical and legitimate purposes the

manufacture, sale and use of morphine, cocaine, and their respective salts

unless laws or regulations on the subject were already in existence. The

contracting powers were obligated to cooperate with one another to prevent the

use of these drugs for any other purpose.

In 1925 the second international convention on the subject of narcotic drugs was

signed at Geneva on behalf of a number of World Powers, not including the United

States, this agreement being described as the International Opium Convention

adopted by the Second Opium Conference, (League of Nations) signed at Geneva

February 19, 1925.(5) This Convention sought to make more specific the

obligations of the 1912 Convention, notably in the control of international

trade in narcotics, and established a Permanent Central Board with certain

functions in connection with the supply and international movement of narcotic

drugs. Our government did not sign or ratify this convention at the time,

because it did not give effect to the principle, advanced by the United States,

of direct control of production of the source raw material (the opium poppy and

the coca leaf). However, in Article 31 it was provided that the present (1925)

Convention replaces, as between the contracting parties, the provisions of

Chapters I, III and V of the Convention signed at The Hague on January 23, 1912,

which provisions remain in force as between the contracting parties and any

States parties to the said Convention which are not parties to the present

Convention. The United States fully cooperated with the contracting powers which

had ratified the 1925, as well as with those which had merely ratified the 1912,

Convention, in international action looking toward control of the narcotic drug

traffic. Our government, as a matter of fact, had already adopted legislative

measures which gave effect to the provisions of the 1925 Convention, pursuant to

the obligations assumed under the 1912 Convention.

A third international agreement, concluded at Geneva July 13, 1931, was the

Convention for Limiting the Manufacture and Regulating the Distribution of

Narcotic Drugs.(6) The ratification by the United States of this Convention was

deposited at Geneva on April 28, 1932, and was proclaimed by the President July

10, 1933. The outstanding feature of this Convention is that it obligates each

High Contracting Party to furnish annual estimates to a Supervisory Body of its

requirements for narcotic drugs, based solely on the medical and scientific

requirements of the country, and limits manufacture of the drugs to the total

requirements thus estimated. The Convention incorporates and therefore in effect

adopts certain provisions of the preceding 1925 Convention. It further obligates

the High Contracting Parties to take all necessary legislative or other measures

in order to give effect within their countries to the provisions of the

Convention. Another important and interesting feature of the Convention is the

imposition of a special obligation upon each of the High Contracting Parties to

create a special administration for the purpose of (a) applying the provisions

of the Convention; ( regulating, supervising and controlling the trade in the

drugs; and © organizing the campaign against drug addiction, by taking all

useful steps to prevent its development and to suppress the illicit traffic.

3. Federal Narcotic Statutes.

The two principal Federal narcotic statutes are the Act of May 26, 1922, known

as the Narcotic Drugs Import and Export Act, as amended,(7) and the so-called

on Narcotic Law, now incorporated in the Internal Revenue Code.(8) The

Narcotic Drugs Import and Export Act authorizes the importation of such

quantities only of opium and coca leaves as the Commissioner of Narcotics shall

find to be necessary to provide for medical and scientific needs. Importation of

any form of narcotic drug, except such limited quantities of crude opium and

coca leaves, is prohibited. Exportation of manufactured drugs and preparations

is permitted under a rigid system of control designed to assure their use for

medical needs only in the country of destination.

The on Narcotic Law as reenacted in the Internal Revenue Code is designed

to direct the manufacture and distribution of narcotic drugs through medical

channels to consumption use for medical purposes only. This statute and the

regulations promulgated thereunder (9) more directly affect the practicing

physician and will be the basis of the following discussion.

4. Registration

(a) Qualification Prerequisite.

A physician who intends to practice medicine and to administer or dispense

narcotic drugs in the course of such practice must apply for registration under

the on Law with the Collector of Internal Revenue of the district in which

he proposes to practice, and must pay the appropriate occupational tax for the

fiscal year applicable. Before being entitled to such registration, however, he

must be lawfully entitled under the laws of the State or Territory or district

wherein he intends to practice, to distribute, dispense, give away or administer

narcotic drugs to patients upon whom he, in the course of his professional

practice, is in attendance.(10) In the case of a medical practitioner, this

requirement usually means that the applicant is a physician who holds an

unrevoked and unrestricted license to practice medicine in the particular State,

Territory or district. To be entitled to registration, however, in the case of

any type of practitioner of the healing art, it must appear that he is entitled

under the State laws to distribute, administer or dispense narcotic drugs to

patients upon whom he, in the course of his professional practice, is in

attendance. " The right to register and pay tax under the Federal statute depends

on the right to dispense under the State laws. " (11)

( Inventory Required.

Every person making application for registry or re-registry as a physician

shall, as of December 31st preceding the date of his application, or any date

between December 31st and the date of applying for such registry or re-registry,

prepare under oath or affirmation, in duplicate, an inventory of all narcotic

drugs and preparations on hand at the time of making such inventory. The

inventory shall be prepared on Form 713, copies of which may be obtained from

Collectors of Internal Revenue upon request. The original inventory shall be

forwarded to the Collector with the application for registration, and the

duplicate shall be kept on file by the maker for a period of two years.

Upon approval of the application for registration the Collector of Internal

Revenue will assign a registry number to the applicant and will issue him a

special tax stamp in Class IV as a practitioner. This special tax stamp must be

kept posted conspicuously on the premises covered by the registration, i.e., the

physician's office.

(d) Change of Location of Office.

A physician registrant who changes the location of his, office shall, within

thirty days, execute a new return on Form 678-A, marking it " Revise Registry. "

The return shall set forth the date of change and the new name or address. The

return shall be forwarded with the special tax stamp to the Collector who issued

the stamp for recording the change. If the removal is to another State,

Territory or district, the physician must, of course, be qualified in the new

location to administer, dispense or distribute narcotic drugs to patients, which

usually means, of course, that he must also be licensed to practice medicine in

the new location.

5. Dispensing and Prescribing -- in General.

(a) Direct Dispensing or Administration.

A physician may obtain narcotic drugs for direct dispensing or administration to

patients only on official order forms. He may not obtain narcotic drugs on a

so-called prescription for general office use. Official order forms are

obtainable from the Collector of Internal Revenue in a book of ten originals and

duplicates for ten cents. The form is to be prepared in duplicate and signed by

the physician, the original copy being forwarded to a qualified manufacturer or

wholesaler, and the duplicate retained by the physician for a period of two

years subject to inspection by a duly authorized Federal or State narcotic

officer. The order form may be prepared in typewriting, ink or indelible pencil,

but not by the use of an ordinary lead pencil.

( Prescribing.

A physician may issue for a bona fide patient, for medical purposes only, a

prescription for narcotic drugs which may be filled by a qualified retail dealer

(druggist).

6. Prescriptions.

(a) Formal Requirements.

A prescription for narcotic drugs shall be dated as of and signed on the date

when issued and shall bear the full name and address of the patient and the

name, address, and registry number of the practitioner. A physician may sign a

prescription in the same manner as he would sign a check or legal document, as,

for instance, J. H. , H. , or Henry . Prescriptions

should be written with ink or indelible pencil or typewriter; if typewritten,

they shall be signed by the practitioner. The refilling of a prescription for

taxable narcotic drugs is prohibited.

( Misuse of Prescription Form as an Order Form,

A physician must not use his prescription form to obtain narcotic drugs for

general office practice. Narcotic drugs desired for general office practice are

obtainable on official order form, as above described, from a qualified

manufacturer or wholesale dealer. An order for narcotic drugs for general office

practice, written on a prescription blank, is not a lawful prescription within

the meaning of the law and can have no effect to validate the sale which is

illegal.

(e) Fictitious Names.

When the names of fictitious patients are discovered on narcotic drug

prescriptions filed with a druggist it is usually a clear indication of wilful

catering to drug addiction, whether or not the so-called prescriptions are also

discovered to be forged. Sometimes the physician will insert a fictitious

patient's name, however, because he wishes to conceal from the druggist the fact

that the real patient is consuming drugs, notwithstanding that the real patient

is claimed to have a bona fide medical need therefor. The law does not permit

the use of a fictitious patient's name upon a prescription.

(d) Telephone Orders.

The furnishing of narcotic drugs pursuant to telephone advice of practitioners

is prohibited, whether prescriptions covering such orders are subsequently

received or not, except that in an emergency a druggist may deliver narcotic

drugs through his employee or responsible agent pursuant to a telephone order,

provided the employee or agent is supplied with a properly prepared prescription

before delivery is made, which prescription shall be turned over to the druggist

and filed by him as required by law.

(e) Safeguarding Blanks for Narcotic Drugs.

A physician's prescription blanks should be most carefully safeguarded and never

left where persons who may be drug addicts will have opportunity to take them,

and to prepare and have filled forged narcotic prescriptions. A physician's

official order forms should be likewise safeguarded, and great care should be

exercised by the physician in keeping his stock of narcotic drugs secure from

robbery or pilfering. The medicine case of morphine tablets should never be left

in an unattended automobile.

7. Professional Practice in Prescribing or Dispensing Narcotic Drugs.

(a) Constitutionality of the on Narcotic Law.

The constitutionality of the on Narcotic Law was first challenged before

the United States Supreme Court in 1919 by Dr. C.T. Doremus of Texas. Dr.

Doremus had been indicted under section 2 of the Act (now section 2554 of Title

26 of the United States Code). The Supreme Court sustained the constitutionality

of section 2 as having reasonable relation to the raising of revenue, and stated

that the Act " may not be declared unconstitutional because its effect may be to

accomplish another purpose as well as the raising of revenue.(12)

In 1927, the constitutional validity of section 1 of the Act (now section 2553

of Title 26 of the United States Code) was questioned by a defendant, not a

physician, who had been convicted of purchasing narcotic drugs not in or from

the original tax stamped packages. The Supreme Court affirmed the

constitutionality of the challenged section.(13)

In 1928, a defendant who was not a physician again challenged the constitutional

validity of section 2 of the Act, notwithstanding the previous Doremus decision,

and the Supreme Court reaffirmed the constitutionality of this section.(14)

( Professional Practice as Applied to Drug Addiction.

In a leading case decided March 3, 1919, the Supreme Court enunciated an

important principle in connection with the meaning of the words " professional

practice " as used in section 2 of the on Act.(15) In this case Webb was a

practicing physician and Goldbaum a retail druggist in Memphis. It was Webb's

regular custom and practice to prescribe morphine for habitual users upon their

application to him therefor. He furnished these prescriptions not after

consideration of the applicant's individual case and in such quantities and with

such direction as, in his judgment, would tend to cure the habit, or as might be

necessary or helpful in an attempt to break the habit, but with such

consideration and in such quaritities as the applicant desired for the sake of

continuing his accustomed use. Goldbaum was familiar with such practice and

habitually filled such prescriptions. Within a period of eleven months Goldbaum

purchased from wholesalers in Memphis thirty times as much morphine as was

bought by the average retail druggist doing a larger general business, and he

sold narcotic drugs in 6,500 instances. It was also shown that during the same

period Webb had issued and Goldbaum had filled over 4,000 such narcotic

prescriptions, and that a certain user of the drugs had applied to Webb for

morphine and was given at one time ten so-called prescriptions for one gram

each, which prescriptions were filled at one time by Goldbaum although each was

made out in a separate fictitious name. The United States Circuit Court of

Appeals, upon this statement of fact, propounded the following question to the

United States Supreme Court:

" If a practicing and registered physician issues an order for morphine to an

habitual user thereof, the order not being issued by him in the course of

professional treatment in the attempted cure of the habit, but being issued for

the purpose of providing the user with morphine sufficient to keep him

comfortable by maintaining his customary use, is such order a physician's

prescription under exception ( of section 2 (of the on Act) ? "

To this question the Supreme Court answered, " To call such an order for the use

of morphine a physician's prescription would be so plain a perversion of meaning

that no discussion of the subject is required. That question should be answered

in the negative. "

The Supreme Court emphasized this rule in a later case involving the prescribing

of narcotics by a practitioner for an addict by holding in part as follows:

" Manifestly the phrases 'to a patient' and 'in the course of his professional

practice only' are intended to confine the immunity of a registered physician,

in dispensing the narcotic drugs mentioned in the Act, strictly within the

appropriate bounds of a physician's professional practice, and not to extend it

to include a sale to a dealer or a distribution intended to cater to the

appetite or satisfy the craving of one addicted to the use of the drug. A

'prescription' issued for either of the latter purposes protects neither the

physician who issues it nor the dealer who knowingly accepts and fills it. " (16)

In the Dr. Behrman case (17) decided by the Supreme Court in 1922, the

defendant was charged with unlawfully selling to an addict by means of three

so-called prescriptions, 150 grains of heroin, 360 grains of morphine, and 210

grains of cocaine, with the intent that the addict would use the same by

self-administration in divided doses over a period of several days. The

indictment did not in terms challenge the good faith of the physician and did

not contain the allegation that the prescriptions were not issued in the course

of professional practice only. A demurrer to the indictment was sustained in the

district court and the case was appealed to the United States Supreme Court. The

Supreme Court pointed out that the quantities of narcotics named in the

indictment were charged to have been entrusted to a person known by the

physician to be an addict, without restraint upon him in its administration or

disposition by anything more than his own weakened and perverted will. Such

so-called prescriptions, said the court, could only result in the gratification

of a diseased appetite for these pernicious drugs, or result in an unlawful

parting with them to others, in violation of the Act as heretofore interpreted

in this court, within the principles laid down in the Webb and Jin Fuey Moy

cases. Notwithstanding the omissions in the indictment, therefore, the court

held that the acts charged constituted offenses within the terms and meaning of

the Act, and the judgment of the district court to the contrary was reversed.

The effect of the decision of the Supreme Court in the Dr. C. 0. Linder case(18)

has been misunderstood by some physicians, who evidently regarded the decision

as authority to cater to drug addiction as such notwithstanding previous

decisions of the court which declared this activity not within the course of

professional practice of a physician. Dr. C. 0. Linder was charged with the

unlawful sale to an addict of one tablet of morphine and three tablets of

cocaine for self administration in divided doses over a period of time. Here, as

in the Behrman case, the indictment did not specifically challenge the good

faith of the physician, or negative that the sale was in the course of

professional practice only. The quantity of drugs sold was, of course, far less

than the quantity prescribed by Dr. Behrman. Dr. Linder was convicted but when

his case reached the Supreme Court the judgment of conviction was reversed.

In the course of the opinion there was discussion that direct control of medical

practice in the States is beyond the power of the Federal Government, and that

incidental regulation of such practice by Congress through a taxing act cannot

extend to matters plainly inappropriate and unnecessary to reasonable

enforcement of a revenue measure. But the court had first significantly noted

that the indictment " does not question the doctor's good faith nor the wisdom or

propriety of his action according to medical standards, " and that " it does not

allege that he dispensed the drugs otherwise than to a patient in the course of

his professional practice or for other than medical purposes. " In concluding the

opinion, therefore, the court stated:

" We find no facts alleged in the indictment sufficient to show that petitioner

had done anything falling within definite inhibitions or sufficient materially

to imperil orderly collection of revenue from sale. * * * The unfortunate

condition of the recipient certainly created no reasonable probability that she

would sell or otherwise dispose of the few tablets entrusted to her; and we

cannot say that by so dispensing them the doctor necessarily transcended the

limits of that professional conduct with which Congress never intended to

interfere. "

All that the Linder case holds, therefore, is that in the absence of an

allegation in the indictment negativing good faith and professional practice,

the court cannot supply the omission by holding as a matter of law that the sale

of four tablets of narcotics necessarily transcends the limits of professional

practice. The court could so hold in the Behrman case because the quantities

were so large as to preclude any possibility that they were prescribed

professionally.

It follows, therefore, that where the indictment challenges the good faith and

professional practice of a physician who prescribes or directly sells narcotic

drugs for the purpose of merely gratifying and perpetuating narcotic drug

addiction as such and if convicted of such an offense, the judgment of

conviction will stand and a number of United States Circuit Courts of Appeal

have so held in cases involving convictions of physicians which reached these

intermediate appellate courts after the Linder case was decided, and in which

the Linder decision was urged as exculpating the convicted physician.(19)

(d) The A. W. Boyd Case.

One year after its decision in the Linder case, the Supreme Court rendered its

decision in the case of Dr. A. W. Boyd(20), in which the physician had been

convicted on six counts of an indictment charging unlawful sales by means of

prescriptions issued.not in good faith and not in the course of his professional

practice. These prescriptions were issued for from 30 to 48 grains each to two

named drug addicts. It was established that the physician purchased and

distributed over 15,000 grains of morphine during a period from May lst to

September 30th, and that he issued prescriptions on much the same scale during

that period. The court pointed out that the disputed question was whether the

defendant'issued the prescriptions in good faith in the course of his

professional practice. The Government's evidence tended strongly to show that

the prescriptions were for quantities many times in excess of what, according to

any fair medical standards, reasonably could be put into the possession of

confirmed addicts, even when treating them for the addiction or endeavoring to

relieve them from suffering incident to it. Much of the defendant's evidence

tended to show that he issued the prescriptions in good faith in the course of

professionally treating the recipients for their addiction and endeavoring to

relieve them from its incidents, but the court noted that some of the evidence

submitted in behalf of the defendant was pronouncedly corroborative of that for

the Government. The court, in sustaining the judgment of conviction, quoted with

implied approval the charge to the jury which had been made at the request of

the defendant's counsel, as follows:

" I am requested to say to you, gentlemen, that in determining whether or not the

defendant in prescribing morphine to his patients was honestly seeking to cure

them of the morphine habit while applying his curative remedies, it is not

necessary for the jury to believe that the defendant's treatment would cure the

morphine habit, but it is sufficient if defendant honestly believed his remedy

was a cure for this disease.

" I instruct you that if this is true, regardless of whether the course of

treatment given by this defendant is a cure, the question is, was he honestly

and in good faith in the course of his professional practice and in an effort to

cure disease issuing these prescriptions .

This charge certainly was as fair as the defendant could have wished, but the

jury, under all the evidence submitted, could hardly have done otherwise than

convict.

(e) The Young Case.(21)

Dr. Young had been convicted on eight counts of an indictment charging

sales of quantities of certain conditionally exempt narcotic preparations(22)

without having kept a record of the sales. Actually the total quantities of

these narcotic preparations sold by the physician were large but unfortunately,

from the standpoint of a proper presentation of the merits of the case, the

indictment did not question the good faith or professional propriety of the

unlawful sales charged. When this case reached the Supreme Court, it was

necessarily considered on the theory that the physician dispensed or

administered preparations to patients whom he personally attended, and the

question of whether the dispensing or administration was in the course of

professional practice was not before the court. Thus considered, the court

reversed the judgment of conviction holding that physicians administering the

preparations to patients whom they personally attended were not required to keep

records of the preparations so administered.

(f) The Professional Practice Rule in Intermediate Appellate Courts.

Subsequent to the decision of the Supreme Court in the A. W. Boyd case, the

several circuit courts of appeals have applied the principle enunciated in that

case in rendering decisions appealed to them by physicians who have been

convicted under the on Narcotic Law.(23) In the DuVall case the Circuit

Court of Appeals for the Ninth Circuit quoted with approval the following

instruction to the jury which applies and interprets the principle:

" If the prescriptions were issued in good faith and according to fair medical

standards, in the curing of disease, and not merely to satisfy the cravings of

the said persons for such drugs, then they may be said to have been issued in

the course of the defendant's professional practice only; but if the

prescriptions were not issued in good faith, but were issued to enable such

person to obtain morphine sulphate to satisfy his appetite and cravings for such

drugs only, and not in the treatment of his patient, then the issuance of such

prescriptions would not be in good faith nor in the course of the defendant's

professional practice as a physician, and the sale and dispensing upon such

prescriptions would not be lawful. "

8. Ambulatory Treatment for Drug Addiction.

(a) Legal and Medical Views.

The ambulatory treatment for the cure of drug addiction has always been

disapproved by the United States Bureau of Narcotics because its observation and

experience have shown that the object of the treatment is practically never

achieved. The average drug addict who purports to undergo this treatment will

invariably seek other sources of supply as his dosage is reduced. It will be

recalled that the Supreme Court in the Behrman(24) case called attention to the

danger of entrusting quantities of narcotic drugs to a known addict " without

restraint upon him in its administration or disposition by anything more than

his own weakened and perverted will. " The Supreme Court in the Behrman case at

least impliedly disapproved the procedure which is applied in pursuing the

so-called ambulatory treatment for the cure of drug addiction, and in 1924 in a

case involving the conviction of Dr. Addison D. Hobart(25) the Circuit Court of

Appeals for the Sixth Circuit construed the Behrman decision as condemning the

ambulatory treatment as unlawful, as follows:

" The case of United States v. Behrman, 258 U. S. 280, destroys the theory of the

defense upon the present trial. Since that decision, there is no possibility

that conduct such as Hobart admitted, could be lawful. The patient was not under

restraint. Hobart furnished to him at frequent intervals and for

self-administration, large quantities of morphine, though in quantities

diminishing from one time to another; but the patient was at liberty to apply to

other doctors and get as many other similar prescriptions as he could. In the

case cited, the Supreme Court declared that this conduct by a physician was ipso

facto violation of the law * * *. "

Scientific medical opinion appears to be in harmony with the opinion of the

court that disapproved the ambulatory treatment for cure of drug addiction. In

1924, the Reference Committee on Legislation and Public Relations recommended

that the House of Delegates of the American Medical Association approve

Recommendation No. 8 of the Committee on Narcotic Drugs of the Council on Health

and Public Instruction.(26) The report of the Reference Committee was adopted as

presented. Recommendation No. 8 of the Report of the Committee on Narcotic Drugs

of the Council on Health and Public Instruction submitted by the Council to the

House of Delegates at the Boston session, 1921, is as follows:

" 8. Your committee desires to place on record its firm conviction that any

method of treatment for narcotic drug addiction, whether private,

institutioiial, official or governmental, which permits the addicted person to

dose himself with the habit-forming narcotic drugs placed in his hands for

self-administration, is an unsatisfactory treatment of addiction, begets

deception, extends the abuse of habit-forming narcotic drugs, and causes an

increase in crime. Therefore, your committee recommends that the American

Medical Association urge both federal and state governments to exert their full

powers and authority to put an end to all manner of such so-called ambulatory

methods of treatment of narcotic drug addiction, whether practiced by the

private physician or by the so-called 'narcotic clinic' dispensary.

" In the opinion of your committee, the only proper and scientific method of

treating narcotic drug addiction is under such conditions of control of both the

addict and the drug, that any administration of a habit-forming narcotic drug

must be by, or under the direct personal authority of the physician, with no

chance of any distribution of the drug of addiction to others, or opportunity

for the same person to procure any of the drug from any source other than from

the physician directly responsible for the addict's treatment. "

( Recognized (Institutional) Treatment.

The most practicable plan of applying the only proper and scientific method of

treating narcotic drug addiction under the conditions laid down by the Committee

on Narcotic Drugs of the Council on Health and Public Instruction, is to

establish an institution properly staffed and equipped for the purpose.. By the

Act of Congress approved January 19, 1929,(27) provision was made for, and there

were later constructed and put into operation, two institutions located at

Lexington, Kentucky and Fort Worth, Texas, respectively, for the treatment and

rehabilitation of narcotic drug addicts, under the supervision of the United

States Public Health Service. The facilities of these two institutions,

available primarily for prisoner-addicts, are also made available for voluntary

applicants, even if they are unable to pay a nominal sum representing part of

the cost of the treatment. A large number of drug addicts, including some

physicians, have received treatment and rehabilitation in these institutions.

9. Federal Investigative Procedure.

(a) Primary Purpose.

The primary purpose of Federal investigative procedure, as far as the physician

is concerned, is to prevent diversion of narcotic drugs from medical channels to

abusive use. Thus it becomes necessary to investigate, and to resort to legal

procedure to penalize that physician who wilfully prescribes or directly sells

narcotic drugs merely for the gratification and perpetuation of narcotic drug

addiction.

( Prerequisite to Investigation of a Physician.

No investigation of a criminal violation on the part of a physician is permitted

to be made by an officer of the Bureau of Narcotics unless such investigation is

based on well-founded suspicion, strong circumstances, or trustworthy and

reliable information that such violation is being committed. Furthermore, no

field officer of the Bureau of Narcotics is permitted to initiate any such

investigation as above described except upon written instructions from his

superior officer, the District Supervisor of the District.

(e) Rule Established by Federal Courts.

A defense quite frequently sought to be interposed by a physician indicted for

unlawful sales of narcotic drugs is that he was illegally entrapped by the

officers into committing the offenses charged against him. The United States

Circuit Courts of Appeals have consistently rejected such claims on the part of

defendant physicians, holding in effect that it does not constitute illegal

entrapment for the officer to afford an opportunity for the physician to sell

narcotic drugs if the sale was the defendant's free voluntary act.(28) The rule

which was applied by the United States Circuit Court of Appeals for the Eighth

Circuit in the case of W. V. v. United States is even more liberal than

the procedure outlined by the Bureau limiting its field officers in making

investigations of violations on the part of physicians. The Circuit Court of

Appeals in the W. V. case quoted with approval the following charge to the

jury in that case:

" It is no enticement to ask a physician to write an illegal prescription, if you

suspect that he might do it, and you want to find out if he does it, nor to ask

a druggist to sell narcotics illicitly, because both of them know better, and if

they are going to obey the law, why they won't do that in response to any form

of petition or inducement, and it is perfectly within the rights of

investigating officers to determine, by means that have been here disclosed,

whether a party, or parties, are engaged in violation of the law, and if they

are, to take steps accordingly, so that I wish to disabuse your minds of all

this confusion that this, in itself, was such an unwarrantable offense on the

part of Federal officers that it relieves this offense charged, if you find any

offense was committed, of its character as such offense. "

10. Uniform State Narcotic Law.

The National Conference of Commissioners on Uniform State Laws after several

years' study completed in 1932 the final draft of a Uniform Drug Act which it

thereupon recommended for enactment in all the States. This Act has been

adopted, in some cases with a few changes, by 42 States, by Congress for the

District of Columbia, and by the Territories of Alaska, Hawaii, and Puerto Rico.

The States of California and Pennsylvania, which have not adopted the Uniform

State Narcotic Law, nevertheless have in effect other State narcotic legislation

which the Bureau of Narcotics considers of comparable effectiveness. The States

of Massachusetts, New Hampshire, Kansas, and Washington have not adopted the

Uniform State Narcotic Law but have in effect State narcotic legislation which

the Bureau of Narcotics does not consider comparable in effectiveness to the

Uniform Law.

The Uniform State Narcotic law provides a comprehensive plan for intrastate

control of the narcotic drug traffic, and is designed generally to restrict

narcotic drugs to medical channels from the manufacturer or distributor within

the State to the consumer for bona fide medical purposes. The Act differs from

the Federal law in some respects. For instance, it requires manufacturers of and

wholesale dealers in narcotic drugs to obtain a license from the appropriate

State agency and prescribes certain qualifications for these licensees, and it

directly and specifically penalizes the forgery or alteration of a narcotic

prescription. In so far as the professional use of narcotic drugs is concerned,

however, the statutory standard is practically the same as that provided by

theFederal narcotic law. Thus, under the Uniform Act, a physician in good faith

and in the course of his professional practice only is permitted to prescribe,

administer and dispense narcotic drugs, or may cause the same to be administered

by a nurse or interne under his direction and supervision.

11. ation with the States.

Under section 8 of the Act of June 14, 1930(29) the Secretary of the Treasury is

directed to cooperate with the several States in the suppression of the abuse of

narcotic drugs in their respective jurisdictions and to this end he is

authorized (1) to cooperate in the drafting of such legislation as may be needed

and (2) to arrange for the exchange of information concerning the use and abuse

of narcotic drugs in said States and for cooperation in the institution and

prosecution of cases in the courts of the United States and before licensing

boards and courts of the several States. The Secretary of the Treasury has

authorized the Commissioner of Narcotics to furnish to State Licensing Boards

such information in the possession of the Bureau of Narcotics as the

Commissioner may deem appropriate to the enforcement of any State law or

regulation or municipal ordinance relating to the granting, withholding,

suspension, or revocation of State licenses or permits.(30) The Commissioner is

also authorized to direct the attendance, as a witness, in hearings held by such

boards or agencies, of any officer, agent, or employee of the Bureau of

Narcotics, and the production of pertinent records or copies thereof. Pursuant

to this authority, the Commissioner reports to the several State Medical

Licensing Boards a statement of the facts in the cases of practitioners

convicted of offenses against the narcotic laws or who are shown to be narcotic

drug addicts. If the State Licensing Board decides to institute action under its

Medical Practice Act looking toward suspension or revocation of the

practitioner's license and desires the attendance of the Federal investigating

officer as a witness at the hearing, the Commissioner arranges the attendance of

such officer at the hearing and the production of such pertinent records as may

be necessary.

12. Conclusion.

Dr. Fishbein in his introductions(31) to a series of articles printed in

the Journal of the American Medical Association in 1931 on the Indispensable Use

of Narcotic Drugs has presented to the medical profession some excellent

suggestions dealing with the general professional use of narcotic drugs. If all

physicians would accept and conscientiously follow these suggestions, which are

quoted below, irregularities in prescribing and dispensing narcotic drugs by

physicians would be reduced to a minimum.

" The problem of narcotic addiction merits the attention of physicians for many

reasons. The control by statute of the prescribing of alcohol, and the definite

limitations of the amount prescribed, indicates that the medical profession must

do everything possible to minimize the prescribing of narcotics in order to make

unnecessary further restrictive measures. Physicians should give more serious

consideration to the materia medica, pharmacology and therapeutics of narcotics.

" Physicians may, by the exercise of more thought in practicing, do much to avoid

censure in relation to narcotic addiction. They may substitute, whenever

possible, non-habit-forming drugs in the place of morphine or other opium

alkaloids. When narcotics are indispensable, however, as shown in this series of

articles, no more should be administered than is necessary to achieve the

desired end. Patients requiring daily administration should be seen often by the

doctor and the amount of drugs ordered or supplied should not exceed that

required by the patient until seen again. Independence of administration on the

part of nurses should be strictly limited to prescription and any change in

treatment should be in writing. "

--------------------------------------------------------------------------------

*NOTES*

[As printed, this note appeared on the first page (p309) of the article]

This is an article from the National Symposium. series dealing with " Scientific

Proof and Relations of Law and Medicine " (2nd series). The Symposium contains

fifty or more studies prepared by legal and medical scholars on problems of

joint interest to the two professions. The papers will be published in the pages

of participating legal and medical journals during the spring and summer of

1946. The intent of the effort is to muster up legal and scientific learning

relevant to various type problems which need illumination from both sources for

their proper solution. The scientific writers have undetaken, under editorial

direction, to prepare their studies in a basic style comprehensible to lawyers,

without, however, any sacrifice of scientific authority.

The new Symposium is a continuation of the first series, published by leading

law reviews and medical journals in the spring of 1943. As before, the general

editor of the Symposium is Hubert Winston , A. B., M. B. A., LL. B., M. D.

(at the time of the first Symposium, Professor was Research Associate on

the faculties of Harvard Law School and Harvard Medical School), who holds an

appointment, under the Distinguished Professorship fund of the University of

Illinois, as Professor of Legal Medicine affiliated with the College of Law and

with the College of Medicine. Readers interested in procuring a master index

containing citations to the studies published in both the first and second

series of " Scientific Proof and Relations of Law and Medicine, " may do so by

remitting cost price (20c) in coin or stamps to Professor , College of Law,

University of Illinois, Urbana, Illinois; he expects that copies so reserved

will be ready for mailing between May 15 and June 1, 1946.

--------------------------------------------------------------------------------

*FOOTNOTES*

[As printed, footnotes appeared at the bottom of each page]

(1)Act of December 17, 1914, c. 1, * 1, 38 Stat. at L 785 as amended by Act of

February 26, 1926, c. 27, *703, 44 Stat. at L. 97, 2 6 U. S. C. * 2550.

(2) Act of July 1, 1944, c. 377, * 7, 58 Stat. at L. 721,- 26 U. S. C. A. * 3228

(e).

(3) Foreign Relations of the United States (1914) 931.

(4)38 Stat. at L. 1912, 1930.

(5)81 League of Nations Treafy Series (No. 1845) 319.

(6) 48 Stat. at L. 1543.

(7)Act of May 26, 1922, c. 202, 42 Stat. at L. 596, 21 U. S. C. A. ** 171-185.

(8)Act of February 10, 1939, c. 2, **2550-2565, 3220-3228, 53 Stat. at L. 269,

382, 26 U. S. C. A. **2550-2565, 3220-3228.

(9)26 Code of Federal Regulations (1939) **151.1-151.205, pp. 1158-1205; 26 Code

of Federal Regulations Cum. Supp. (1944) **151.4-151.185, pp. 7158-7162.

(10) Act of February 10, 1939, c. 2, *3220(d), 53 Stat. at L 382, 26 U.S.C.A.

*3220(d).

(11) v. Larson, 104 F. (2d) 728 (C. C. A. 5th 1939) ; Burke v. Kansas State

Osteopathic Association, Inc., 111 F. (2d) 250 (C. C. A. 10th 1940) ; Georgia

Ass'n of Osteopathic Physicians and Surgeons, Inc. v. , 112 F. (2d) 52 (C.

C. A. 5th 1940); Kavanagh v. Fowler, 146 F. (2d) 961 (C. C. A. 6th 1945) ; Waldo

v. Poe, 14 F. (2d) 749P (D. C. Wash. 1926); Bruer v. Woodworth, 22 F. (2d) 577

(D. C. Mich. 1927).

(12) United States v. Doremus, 249 U. S. 86, 39 Sup. Ct. 214, 63 L. Ed. 493

(1919).

(13) Alston v. United States, 274 U. S. 289, 47 Sup. Ct. 634, 71 Ed. 1052

(1927).

(14) Nigro v. United States, 276 U. S. 332, 48 Sup. Ct. 388, 72 L. Ed. 400

(1928).

(15) Webb v. United States, 249 U. S. 96, 39 Sup. Ct. 217, 63 L. Ed. 497 (1919).

(16) Jin Fuey Moy v. United States, 254 U. S. 189, 41 Sup. Ct. 98, 65 L. Ed. 214

(1920).

(17) United States v. Behrman, 258 U. S. 280, 42 Sup Ct. 303, 66 L. Ed.619

(1922).

(18) Linder v. United States, 268 U. S. 5, 45 Sup. Ct. 446, 69 L. Ed. 819

(1926).

(19)Boehm v. United States, 21 F. (2d) 283 (C. C. A. 8th 1927); Nelms v. United

States, 22 F. (2d) 79 (C. C. A. 9th 1927); Freeman v. United States, 86 F. (2d)

243 (C. C. A. 5th 1936); Hawldas v. United States, 90 F. (2d) 551 (C. C. A. 5th

19-97).

(20)Boyd v. United States, 271 U. S. 104, 46 Sup. Ct. 442, 70 L. Ed. 857 (1926).

(21)Young V. United States, 315 U. S. 257, 62 Sup. Ct. 510, 86 L. Ed. 834

(1942).

(22)Act of February 10, 1939, c. 2, *2551 (a), 53 Stat. at L. 270, 26 U. S. C.

*2551 (a).

(23)DuVall v. United States, 82 F. (2d) 382 (C. C. A. 9th 1936); United States

v. Lindenfield, 142 F. (2d) 829 (C. C. A. 2d 1944); United States v. Aladallah,

149 F. (2d) 219 (C. C. A. 2d 1945).

(24)Supra note 17.

(25)Hobart v. United States, 299 Fed. 784 (C. C. A. 6th 1924).

(26)82 Jour. Am. Med. Assn. 1967 (1924).

(27)Act of January 19, 1929, c. 82, 45 Stat. at L. 1085-1089, Act of June 23,

1936, c. 725, * 1, 49 Stat. at L. 1840, Act of March 28, 1938, c. 55, * 1, 52

Stat. at L. 134, 21 U. S. C. A. **221-237.

(28) v. United States, 284 Fed. 673 (C. C. A. 8th 1923) ; Ratigan v. United

States, 88 F. (2d) 919 (C. C. A. 9th 1937); v. United States, 143 F.

(2d) 953 (C. C. A. 10th 1944) United States v. Abdallah, supra note 23; cf.

Newman v. United States, 299 Fed. 128 (C. C. A. 4th 1924).

(29)Act of June 14, 1930, c. 488, *8, 46 Stat. at L. 58,, 21 U. S. C. A. *198.

(30)2l Code of Federal Regulations (1939) **201.8-201.12, pp. 1063-1064

(31)96 Jour. Am. Med. Assn. 856 (1931).

I hope this finds you and yours well

Mark E. Armstrong

casca@...

www.top5plus5.com

PAI NW Rep

ICQ #59196115

Mark, If you have this answer on 5plus 5 I'll buy you

a steak!

Is there a limit in the number of pills a physician can write a

prescription for a particular narcotic drug at one given time? In

other words, is there a limit in the quantity of a narcotic that can

be despensed at one time? FDA red flags or basic pharmacopea

standards of practice.

Just curious really but I would much prefer getting enough pain med

to last a month or so; and I will spring for the steak but I cant

grill worth a hoot!

Hope you and the family are doing well.

Warmly

March 15, 2004

Okay .....you owe me a steak......lol...as a matter of fact...you bring

the steak over and I will supply the lobster and I will even marinade the steak

and cook it for us.....hope you are well...the link on the bottom is the link to

the page where I found the info...so as you can see..it is up to the Dr to

decide how much to prescribe...hope that helps...talk to you soon...please let

me know if there is anything else I can do to help. I hope this finds you and

yours well......Mark

THE FEDERAL FOOD, DRUG, AND COSMETIC ACT

The Food and Drug Administration (FDA) has approved opioids, stimulants, and

sedative hypnotics as safe and effective for medical use and commercial

marketing under the Federal Food, Drug, and Cosmetic Act of 1962. This act does

not restrict a physician's prescribing either to labeled indications or to

recommended doses. This policy is clearly stated in the foreword to the

Physician's Desk Reference (1993). Once a product has been approved under the

Federal Food, Drug, and Cosmetic Act for marketing, a physician may prescribe it

for uses, in treatment regimens, or in patient populations that are not included

in the approved labeling (Federal Register 1983). Appropriate medical practice

and patient interest require that physicians be free to administer drugs

according to their best knowledge and judgment (Federal Register 1975).

http://www.medsch.wisc.edu/painpolicy/publicat/94appcs.htm

I hope this finds you and yours well

Mark E. Armstrong

casca@...

www.top5plus5.com

PAI NW Rep

ICQ #59196115

Mark, If you have this answer on 5plus 5 I'll buy you

a steak!

Is there a limit in the number of pills a physician can write a

prescription for a particular narcotic drug at one given time? In

other words, is there a limit in the quantity of a narcotic that can

be despensed at one time? FDA red flags or basic pharmacopea

standards of practice.

Just curious really but I would much prefer getting enough pain med

to last a month or so; and I will spring for the steak but I cant

grill worth a hoot!

Hope you and the family are doing well.

Warmly

March 15, 2004

This is the complete article.....talk to you soon.....Mark

Controlled Substances, Medical Practice, and the Law

E. Joranson, M.S.S.W.

Gilson, M.S.

The development of drug control policy in the United States has been

characterized by vacillation between tolerance and intolerance toward drugs

(Musto 1987). Today's war on drugs is distinguished by intense media coverage of

drug-related crime, new antidrug laws, and efforts to educate schoolchildren and

the public to " just say no " to drugs. The message is clear: Drugs are dangerous

and must be avoided. The United States continues to have significant drug abuse

problems that must be addressed, but we should be careful not to reject the

medical benefits of drugs or restrict the ability of physicians to care for

patients.

Antidrug efforts are directed not only at the illegal controlled substances such

as marijuana, heroin, and cocaine, but also at the legal controlled substances

that have important medical uses: the opioids (narcotics), stimulants, and

sedative hypnotics. These efforts involve media campaigns against perceived

overprescribing (Safer and Krager 1992), vigorous enforcement efforts against

suspect prescribers (Benton 1993; Hill 1989; McIntosh 1991a, 1991b; Nowak 1992),

regulations to increase restrictions on prescribing (Weintraub et al. 1991), and

federal proposals to monitor all prescribing to patients of all controlled

substances (Stark 1990).

When controlled substances are used for medical purposes, they can provide great

improvements in the quality of life for millions of people with debilitating

diseases and conditions, including pain, severe anxiety, narcolepsy, and

epilepsy. However, when diverted from the legitimate distribution system, the

nonmedical use of controlled substances can lead to serious public health

problems. For example, there are a small percentage of practitioners who abuse

their privilege to prescribe and are a source of drugs for addicts and the

illicit market. Consequently, it is in the public interest to protect the

medical uses of controlled substances while at the same time preventing their

diversion and abuse. Public policy should recognize the dual effect of

controlled substances on public health to obtain the broadest medical benefit

while reducing the risks of diversion and abuse.

There is troubling evidence that some controlled substances laws and regulations

and their enforcement interfere with medical practice and patient care. In this

chapter we explore whether controlled substances laws and regulations achieve an

appropriate balance between controlling abuse and protecting medical use. The

primary focus is on the opioids (narcotics) that are used in the somatic

treatment of pain, in particular pain due to cancer.

Tragically, cancer pain is often undertreated. Several factors impede pain

management, including inadequate preparation of health care professionals, the

low priority given to pain management, and the effects of antidrug policies.

Although most, if not all, cancer pain can be relieved (Foley 1985; Takeda

1987), it is estimated that one-half to three-quarters of cancer patients with

pain are inadequately treated and that nearly 25% die with severe unrelieved

pain (Daut and Cleeland 1982). The mainstay of cancer pain management is opioid

therapy (World Health Organization 1986). Efforts to improve pain management and

eradicate misuse and abuse of prescription controlled substances take place in a

medical and regulatory environment characterized by misinformation about

opioids. Misinformation about opioids and exaggerated fears of addiction are

prevalent among the professions and medical regulators and are partly

responsible for the undertreatment of pain (Ferrell et al. 1992; Jaffe 1989;

Jasinski 1989; Joranson et al. 1992; 1986).

The Framework of Controlled Substances Policy

Three tiers of law establish the policy framework that governs the medical use

and diversion of controlled substances: 1) international treaties, 2) federal

laws and regulations, and 3) state laws and regulations. As will be seen,

international and federal laws clearly recognize the principle that a balance

should be maintained between controlling drug abuse and ensuring that controlled

substances are available for medical use. However, most state laws do not

achieve this balance and, in some instances, interfere with medical practice.

International Treaties, Drug Control, and Medical Use

Treaties provide the basic legal framework for controlling international and

domestic production and distribution of drugs that have been determined to have

an abuse liability. The principal treaties recognize that many controlled

substances are indispensable to public health and that their availability for

legitimate medical and scientific purposes must be ensured. These treaties are

the Single Convention on Narcotic Drugs, 1961 (United Nations 1977b), and the

Convention on Psychotropic Substances, 1971 (United Nations 1977a). In becoming

a party to a treaty, a government agrees to ensure the availability of

controlled substances for medical purposes. Most, but not all, of the

governments of the world have acceded to these treaties (International Narcotics

Control Board 1991).

The International Narcotics Control Board, the United Nations agency responsible

for monitoring governments' compliance with the treaties, has reported that

opioids are not sufficiently available for legitimate medical purposes

throughout the world and that this is due in part to antidrug abuse laws and

regulations that unduly restrict the availability of opioids for medical use

(International Narcotics Control Board 1989).

A World Health Organization expert committee has also expressed concern that the

fear of drug abuse has curtailed appropriate medical use of opioids,

particularly for the treatment of cancer pain (World Health Organization 1990);

laws are so strict in some countries that physicians cannot prescribe morphine

for cancer pain. The expert committee commented on " multiple copy prescription

programs " that are used in several countries as well as in several states in the

United States.

The extent to which these programmes restrict or inhibit the prescribing of

opioids to patients who need them should be questioned.... Health care workers

may be reluctant to prescribe, stock or dispense opioids if they feel that there

is a possibility of their professional licenses being suspended or revoked by

the governing authority in cases where large quantifies of opioids are provided

to an individual, even though the medical need for such drugs can be proved.

(World Health Organization 1990, p. 39)

Thus, although the purpose of the international treaties is to ensure

availability of drugs for medical use, restrictive laws in some countries limit

the use of opioids for the treatment of pain. To what extent do laws and

regulations in the United States maintain a balance between the control of drug

abuse and the appropriate medical use of opioid analgesics or other controlled

substances?

Federal Law and Medical Practice