Thursday, May 31, 2007

ADULTERATION OF DRUGS

Drug- Adulteration Cases. The author is indebted
to the Chemist and Druggist for the majority of the
following cases in illustration of the application of
the Food and Drugs Acts to the adulteration of
drugs. Many of the cases are only decisions of
Courts of Summary Jurisdiction, and therefore can-
not be quoted as authority. They serve, however, to
indicate what is the general trend of magisterial
opinion in the matters referred to.

Acetic Acid. In April, 1895, an Islington chemist
is reported to have been summoned for selling 117
per cent, acetic acid as "diluted acetic acid." This
acid was of higher strength than standard " diluted
acetic acid," and the question arose whether or not
such sale was "to the prejudice of the purchaser,"
since that supplied was in one sense of better quality
than that demanded. The magistrate held himself
bound by Knight v. Bowers, 1885, 14, Q.B.D., 845, in
which it was decided that if the article supplied, even
though unadulterated, was wholly different from that
demanded by the purchaser, an offence had been
committed. (C. and D., 16th. April, 1895.)

It cannot be said that a somewhat stronger
acetic acid is a wholly different article, but it must
be remembered that the standard to be applied
to drugs is a different one from that applied in
the case of food. It can scarcely be imagined that
any purchaser would feel himself prejudiced by the
sale of milk containing twice the usual quantity of
cream ; but if a drug be supplied of twice its proper
strength, its administration may be most harmful
instead of beneficial to the patient.

Arsenical Soap. There have been several prosecu-
tions for the sale of soap as " arsenical soap," which
contained little or no arsenic. At Brentford con-
victions were obtained on the ground that the soap
was a drug, and did not contain an essential quantity
of that which was represented as the actual con-
stituent. In the case of HougJiton v. Taplin, 1897,
13, Times L.R., 386, there was an appeal to the Court
of Queen's Bench. WEIGHT, J., held that the soap
was a compounded drug within the meaning of S. 6,
s.s. 3 of the Act, and therefore was within the proviso.
HAWKINS, J., held that the soap was not a drug per se.
The magistrates had refused to convict, and their
decision was therefore upheld on appeal.

British Pharmacopoeia as a Standard Drugs
asked for by popular names do not necessarily mean
the articles so designated in the British Pharmacopoeia,
but prima facie it is assumed by judges that they do
until the contrary is proved. The Acts lay down no
standards for drugs, but the majority of decided cases
favour application of British Pharmacopoeia standards
to articles sold under British Pharmacopoeia names.
The following are the more important High Court
(English) decisions:

White v. Bywater. The Sheffield Medical Officer of
Health bought 3 oz. of tincture of opium, which on
analysis was found to be deficient both in opium and
spirit when compared with that specified in the
British Pharmacopoeia. On appeal to the Queen's
Bench Division (Q.B.D.), it was Held that the re-
spondent ought to have been convicted although the
purchaser had not specifically asked for tincture of
opium prepared according to the British Pharmacopoeia
-(1887), 19, Q.B.D., 582.

Beardsley v. Walton & Co., Ltd. Camphorated oil
containing 8 per cent, of camphor was sold, and
W. & Co. were summoned under Section 6 of the
1875 Act. The justices found that the oil is a
"compounded drug" (Section 6, Sub-section 3), and
therefore that proceedings should have been taken
under Section 7. Held in the Q.B.D. that there is no
definition in the Act of what is a drug " compounded
as in this Act mentioned," so that no meaning can be
given to the words in Sub-section 3. Camphorated
oil is not a drug "compounded as in this Act
mentioned," and the prosecution was properly brought
under Section 6. (1900), 2, Q.B.D., 1.

Dickins v. Randerson. A chemist managing a branch
of Taylor's Drug Stores, Ltd., was asked for " mercury
ointment," and supplied an ointment containing 12'5
per cent, of mercury instead of 48*5 per cent., as in
the British Pharmacopoeia. He was convicted under
Section 6. On appeal to the K.B.D. it was Held that
the appellant was properly convicted under Section 6,
as, in the absence of a prescription by a medical
practitioner, he ought to have sold the article according
to the standard in the Pharmacopoeia ; and that he
might probably have also been convicted under Section
7 of selling a " compounded drug which is not com-
posed of ingredients in accordance with the demand
of the purchaser." (Section 15 of the Pharmacy
Act, 1868, as to compounding British Pharmacopoeia
medicines according to the formularies thereof was
held to be proof that there is no standard for mercury
ointment different from the Pharmacopoeia). (1901)
1, K.B.D., 437.

Hudson v. Bridge. Vinegar of squills was sold. It
contained less acetic acid than is prescribed in the
British Pharmacopoeia formula, and the seller was
convicted, although evidence proved that in the
vinegar, even if properly kept, a change! or decom-
position takes place which reduces the quantity of
acetic acid. On appeal it was Held that the justices
were wrong, as there was no evidence that the pur-
chaser in asking for vinegar of squills demanded the
proportion of acetic acid in new vinegar of squills,
and that the hypothetical standard set up by them
could not be supported. It was further held that as
the vinegar is liable to decomposition the public
analyst should have mentioned the fact in his cer-
tificate. (1903), 19, Times L.E., 369.

Boots Cash Chemists (Southern), Ltd., v. Cowling.
The appellants sold methylated soap liniment, and
were convicted under Section 6, the magistrate refusing
to receive evidence that there is a commercial standard
for liniment of soap different from that prescribed by
the British Pharmacopoeia. The magistrate relied on
Dickins v. Eanderson. The K.B.D. (ALVERSTONE, L.C.J.,
and WILLS and CHANNELL, J. J.) Held that the evidence
as to commercial standard is admissible, and that
PHILLIMORE, J., " never meant to lay down in that
case that nothing could be looked at except the
British Pharmacopoeia. On the other hand, if it was
the sale of some drug recognised by a special name in
the British Pharmacopoeia, a very strong prima facie
case would be made out as to what the drug ought to
contain." (1903), 19, Times L.E., 370.

Bandy v. Lewis. An unqualified assistant of
respondent was asked for 4 oz. of paregoric, and
supplied a liquid free from opium, striking out the
word " poison " on a paregoric label and replacing it
with " substitute." The purchaser (Bundy) observed
this when dividing the sample, but prosecuted under
Section 6, 1875, and the justices dismissed the sum-
mons on the grounds (1) that the sale was not to the
prejudice of the purchaser, and (2) that the respondent
was protected by Section 8, 1875, by the label dis-
closing the fact that the article was paregoric
substitute and not paregoric. On appeal, Held by the
K.B.D. that the sale was not to the prejudice of the
purchaser. (1908), 72, J.P., 489.

It is an interesting fact that when the Food and
Drugs Act, 1875, was drafted as a bill, it contained a
provision making the British Pharmacopoeia the
standard for the quality of drugs, but this provision
was eliminated from the bill before it became law.
Dr. J. Attfield, the editor of the British Pharmacopoeia,
pointed out at the Pharmaceutical Conference, July,
1899, that that work is not specified in the Sale of
Food and Drugs Acts as the standard for drugs.

Castor Oil Pills. A chemist was summoned for
selling as " castor oil pills," pills which were certified
by the public analyst to contain rhubarb, aloes, ginger,
&c., but no castor oil. In cross-examination the analyst
admitted that there might be 1*5 or 1'75 per cent, of
castor oil in the pills, but that he should call that
amount equivalent to none. For the defence it was
alleged that it was usual to name compound pills
from one of the ingredients, and that the name here
implied that the effects were similar to those of castor
oil. There could be no idea of fraud, because the
other ingredients were much the more expensive.
The magistrates convicted. (C. and D., 15th. April,
1879.)

A shopkeeper was summoned under Section 6 for
selling castor oil pills, certified by the analyst to
be composed of ingredients other than castor oil.
The pill boxes were wrapped in a handbill stating
that they " contained the finest cold-drawn castor oil,
together with the choicest Pharmacopoeia ingredients,
compounded so as to produce the effect as nearly
approaching that of castor oil itself as possible without
any of its unpleasantness. We wish it to be under-
stood that the purgative effects are not caused by
castor oil alone, as that would be impossible, but by
the choicest ingredients of the Pharmacopoeia." This
label was held to be a sufficient disclosure of the
composition of the pills to secure the dismissal of the
summons. (C. and D., 25th. May, 1895.)

Chewing-gum. This is a well-known American
confection, and consists of paraffin or wax, com-
pounded with sugar and various flavouring ingredients.
The object of the preparation is to provide something
that shall be chewed and not swallowed in the solid
state, the residual wax being finally spat out. In
Shortt v. Smith, the appellant purchased at the re-
spondent's shop three sticks of chewing-gum. These
were labelled " For chewing only ; not to be eaten."
Upon analysis it was proved to contain 35 per cent,
of paraffin wax. The public analyst gave evidence
that he was of opinion that the use of such a mixture
might prove injurious to the consumer. Gums equally
as insoluble as paraffin wax could be used. The
paraffin wax would not dissolve in the mouth, but
some portions might be swallowed, and, if so, it would
be injurious to health. The appellant contended that
during the chewing some portion would be swallowed
and the article thereby rendered an article of food.
The respondent argued that the article was regarded
by the public as a chewing-gum or wax, and sold
accordingly. Having regard to the label, and that
the wax would not dissolve in the mouth, the justices
decided that the article was neither a food nor a
drug, and dismissed the case. An appeal, CAVE and
WRIGHT, J.J., decided that the justices were right in
finding that this was not an article of food, and dis-
missed the appeal. (1895) 2, Times L.R., 325.

The case is of some interest because of the quibbling
around whether or not this was an article of food. If
gums equally as insoluble as paraffin wax were used,
they would equally be likely to cause injury to health
if swallowed. No doubt the chewing-gum contained
sugar in considerable quantity, and to that extent was
really a food. But what was sold in this case was an
article specially prepared to meet a particular require-
ment, that being a pleasant flavoured confection that
shall be capable of being chewed and yet remain in
the mouth. If, in response to a demand for chewing-
gum, a substance of the type of a gelatin lozenge
were sold, the sale would be in fact one to the pre-
judice of the purchaser, as the article would be unfit
for the purpose for which required.

Citrate of Magnesia. This is the popular name of
a well-known granular effervescent preparation, in
which little or no true magnesium citrate is present.
A Greenock chemist was prosecuted for selling as.
citrate of magnesia an article alleged to be adulterated
with carbonate of soda, tartaric acid, sugar, and
sulphate of soda. The defence proved that the sub-
stance sold was what is known commercially as-
" citrate of magnesia," and medical evidence was also-
given that when the witnesses prescribed citrate of
magnesia they meant the article as sold by the
defendant. On this evidence the magistrate found
the defendant not guilty. (C. and D., 15th. November?
1875.)

Dispensing, The price charged for making up a
prescription is usually governed by the skill requisite
in dispensing, rather than the actual cost of the
ingredients. Any gross inaccuracy in so dispensing
is an offence against Section 7 of the Act, whether the
ingredients be either in excess or in deficit of those
demanded by the purchaser. Where, however, the
drugs are expensive, occasions happen in which a.
deficiency in the actual drug may be a considerable
source of extra profit to the vendor. The following
are representative cases of prosecutions for incorrect
dispensing.

A chemist was fined for dispensing a mixture found
to contain 36 instead of 120 grains of iodide of
potassium. The defendant submitted that the medi-
cine as ordered was too strong, and that he had
reduced it in the exercise of his discretion. (0. & I).,
15th. June, 1885.)

A Buxton chemist was summoned for selling a
10-oz. potassium iodide mixture, which contained 142J
instead of 160 grains of the iodide. The defence was
that 160 grains had been put in and the bottle filled
up, so that it was possible that the analyst, taking a
small measured quantity, would find less in the
portion, although the whole was right (owing to bottle
inaccuracy). The medicine was to be given in parts.
Evidence in proof of this, and the purity of the iodide
was adduced. The magistrate dismissed the summons,
remarking that " the custom of filling the bottles up
from the tap is, to say the least of it, lax." (0. and D.,
12th. January, 1890.)

It is a well known custom in the dispensing of
medicines to direct that, say, "an eighth part is
to be taken" for a dose. To meet this form of
prescription, bottles are made in which one-eighth
divisions are shown by lines across the side. If
in the case in question the bottle taken had really
held 11 instead of 10 oz., then assuming 160 grains to
have been dispensed, each eighth part would still have
contained 20 grains of the iodide, although each 1| oz.
(the eighth part of 10 oz.) would only contain 18*2
grains. Eight times 18-2 is 147'6, so that if the error
in the bottle had been as much as 1 oz., the deficiency
would not thus be accounted for. It is exceedingly
doubtful whether any ordinary medicine bottle would
have an error of anything like an ounce in ten of its
nominal capacity. The analyst might have taken for
his analysis the measured quantity shown by the
divisions on the bottle, but it is extremely unlikely
that an analyst would adopt such a rough and ready
method of measurement. Where a medicine is directed
to be taken in eighths or other number of parts, it is
difficult to see what arrangements could conveniently
be made for dispensing, other than putting all the
ingredients in a bottle and then filling it with
water.

A chemist, who had contracted to supply medicines
to the local Union, was summoned and convicted for
dispensing a mixture which should have contained

2 grains of sulphate of quinine per oz., and was found
on analysis to contain only 0'64 grains per oz. (0.
and D. y 15th. May, 1881.)

A London chemist received a prescription for 66
grains of iodine and 99 grains of potassium iodide in

3 oz. of water. He dispensed it, and the analyst
reported that the solution showed a deficiency of 14*5
per cent, of iodine and an excess of 9*3 per cent, of
potassium iodide. The chemist was summoned, and
his defence was that the prescription was accurately
prepared. The reserve sample was referred to the
Government Chemists, who reported that the sample
contained iodine in the proportion of 924 grains, and
potassium iodide 103'8 grains per 3 fluid oz. (The
figures, it will be noticed, are considerably in excess of
the quantities prescribed.) The certificate suggested
that the iodine had not been fully dissolved before the
solution was divided, so that the three parts were
unequal in strength. On that ground the magistrate
dismissed the summons. (G. and D. y 18th. April, 1896.)
The medical officer of health for Fulham wrote the
following prescription, which was taken to most of the
chemists in the neighbourhood to be dispensed :

" Potassii iodidi, - - 3 i y -

Syr. aurantii, - j

Aq. ad, - vj.
M. Ft. mist."

Several of the dispensers were summoned, under
Section 7 of the Act of 1875. In one case the potassium
iodide was stated to be 16 grains in excess. Dr.
Attfield found only 2 grains in excess. The magistrate
dismissed the case, as he was not satisfied on the
evidence that the trifling amount over the prescription
mattered in the slightest, and Section 7 should be read
in the light of the preceding and succeeding lines of the
Act. (G. and Z>., 14th. October, 1899.)

Glycerin. A Birmingham chemist was summoned
and convicted for selling Id. bottles of glycerin which
was certified by the analyst to be adulterated with 45
per cent, of glucose syrup. (C. and D., Wth. February,
1897.)

There have been a few prosecutions for selling
glycerin containing small percentages of water. In
one such case the analyst certified to 9 per cent, of
water. The reserve sample was sent to the Govern-
ment chemists, who reported that the specific gravity at
60 Fahr. was 1*2492, and as the British Pharmacopoeia
standard was 1*25, they were of opinion that the sample
contained no excess of water. The summons was dis-
missed with costs. (0. and D., 10th. April, 1897.)

Glycerin and Lime-juice. There are a number of
preparations for the hair to which this generic name is
applied. Neither lime-juice nor glycerin is a very suit-
able component of a hair-wash or lotion, and if a mixture
were made of the two it would in practice be unusable
for such a purpose. Nevertheless these preparations
have a certain vogue, and the public well know the
kind of article they in fact require when they ask for a
hair- wash by this name. The actual preparations are
mostly oils and lime-water, with a little glycerin and
some perfume. No doubt the term lime-juice has been
applied as a misnomer for lime-water. Chemists as a
whole would probably prefer the use of some name
which was not so incorrect as lime-juice, but the public
have acquired the habit of asking for the particular
preparation they require under this name. There have
been a number of prosecutions for the sale of this
article, without any glycerin being present, and in many
cases convictions have followed. The following is one
of the most important, and was heard at Brentford.
The defendant deposed that his formula was

Nut oil, ... ... ... 4 oz.

Lime-water, ... ... ... 4 oz.

Saccharated lime solution, ... 40 drops.
Perfume (lemon and bergamot oils), 25 drops.
Glycerin, J dram.

It was sold as "lime-cream and glycerin," and the
analyst certified absence of glycerin. (Note. The pre-
ferable word lime-cream is substituted for lime-juice.)
The reserve sample was referred to the Government
chemists, whose analysis confirmed the defendant's
statement. The hearing was adjourned, and Mr. Eichard
Bannister, then of the Government Laboratory, described
his process of analysis, and admitted that he was assisted
in arriving at his declaration about the preparation
containing J dram of glycerin in 8 oz. by the report in
the Chemist and Druggist. It also transpired that the
reserve sample was the lower portion of the bottle, so
that it would contain more glycerin than the other
parts. The magistrates took the latter fact as the basis
for dismissing the summons. (C. and D., 27th. March,
24th. April, and 15th. May, 1897.)

It is curious that in the cases quoted the defence
was not advanced that the preparation is not a drug
at all.

Gregory's Powder. Dr. Gregory's original formula
was : Powdered rhubarb, 2 parts ; powdered ginger, 1
part ; light magnesia, 6 parts ; mix. Magnesia is the
oxide of the metal, and readily absorbs both water and
carbon dioxide gas from the atmosphere : the latter
converts the oxide into the carbonate. In one case a
chemist for the defence stated that he found Gregory's
powder to absorb 14 per cent, of carbon dioxide and
water in three days. (C. and D., 15th. October, 1898.)
For further experimental evidence in proof of this
absorption see a paper by Umney (C. and D., 24th.
September, 1898). In cases brought before the magis-
trates their decisions seem about equally divided.
Thus, the Guildford Bench Held, after hearing medical
evidence, that the sale of Gregory's powder made with
magnesium carbonate was not to the prejudice of the
purchaser. (C. and D., 23rd. and 30th. October, 1897.)
A London chemist was summoned for selling Gregory's
powder composed of rhubarb and ginger 3316, carbonate
of magnesia 32*41, and light magnesia 34*43 per cent.
The defence was that the powder was made with light
magnesia solely, and that the " carbonate " certified was
due to absorption of moisture and carbon dioxide from
the air. The magistrate convicted. (C. and D., 27th.
August, 1898.)

Olive Oil. This is one of the articles on the border
line, which may be used either in the arts or as a drug.
A chemist sold as " pure olive oil " an article which he
bought at 3s. 6d. per gallon. It was cotton-seed oil.
He was convicted, the magistrate remarking, " People
going to a chemist's shop ought to be able to get a pure
article, as their purchases are frequently required for
medicinal purposes." ( C. and D., 13th. October, 1888.)

A Battersea shopkeeper sold olive oil containing 80 per
cent, of seed oil. The prosecution was taken on the
ground that olive oil is both a food and a drug. The
defence was that it is neither; that the purchaser
should have stated when he asked for the oil what he
wanted it for. The magistrate strongly supported the
view taken by the defence, and in giving judgment said
that the oil was used also for machinery, and clearly
when so employed did not come within the Act. (C.
and />., 20th. October, 1894.)

Salad Oil. An inspector bought a pint of salad oil
from a chemist. Cotton seed oil was supplied and
labelled " Columba Salad Oil." The chemist was sum-
moned, and pleaded in defence that he asked the
purchaser if he wanted olive oil, but the inspector
indicated the kind which he got. The Bench dis-
missed the case, saying that the purchaser would have
got olive oil if he had asked for it. (C. and D., llth.
July, 1891.)

Spirit of Nitrous Ether and Sweet Spirit of Nitre.

By the British Pharmacopoeia of 1893, sweet spirit
of nitre is made a synonym for spirit of nitrous ether.
This substance is exceedingly volatile, and hence there
is a difficulty, amounting in practice almost to an
impossibility, in keeping the substance up to full
strength. Nevertheless, spirit of nitrous ether has
frequently been the subject of prosecutions. Thus at
Ashton-under-Lyne a chemist sold as spirit of nitrous
ether a spirit which was a sixth of the minimum
pharmacopoeia strength. For the defence, evidence
was called to prove the extreme difficulty of keeping
tiae spirit, and that the deficiency was the result of
natural deterioration. The Bench decided that the
purchaser had not been prejudiced, as " there was no
admixture and no attempt at cheating in any way."
(C. and D., 10th. March, 1888.) In a prosecution of a
company an interesting and successful defence was
that the divided sample was put into bottles so large
that the sample deteriorated below the minimum
standard between the time of purchase and analysis.
(C. and J)., 1st. April, 1899.)

Beeswax. In Fowle v. Fowle the respondent sold
some beeswax which on analysis was found to contain
about 50 parts of beeswax and 50 parts of paraffin.
The justices found that beeswax is not a drug within
the meaning of the Act. and dismissed the information.
On appeal, GRANTHAM, J., said that, speaking for him-
self, he could "not admit that beeswax was a drug. . . .
Everyone could think of instances where beeswax was
used not as a drug. It was sold by a grocer at a little
country shop. The grocer did not make it. He said
he did not know what its constituents were. The
justices were right." WRIGHT, J., concurred. The appeal
was dismissed. (1896) 13, Times, L.R. 12.

Importance was evidently here attached by the
Court to the kind of person from whom the beeswax
was bought. Given a substance which is commonly
used both as a drug and for some other purpose, e.g.,
castor oil : if bought from a chemist, the presumption
is that it is to be used as a drug ; but if bought by the
gallon from an oilman it is probably intended flubricating or other purposes in the arts.