86 THE ANALYST. IS THE BRITISH YHARMACOPCEIA THE LEGAL STANDARD FOR THE PREPARATIONS DESCRIBED THEREIN ? BY ALFRED H. ALLEN. (Read at the Meeting, February 5 , 1901.) PROBABLY the great majority of Public Analysts will have observed the rapidly increasing opposition which has existed of late in certain quarters to the claims made that, under the Sale of Food and Drugs Act, the British Pharmacopceia should be considered as a standard or guide for the articles therein mentioned, and the vigorous attempts made in certain quarters to degrade it from the position which it practically held till recently. Public Analysts owe it to Dr. James Bell that the Pharmacopceia was not made formally an authority under the Sale of Food and Drugs Act. The Select Committee of the House of Commons, upon whose report the Amendment Act of 1879 was based, called two witnesses on the pGnt.One was Mr. Thomas, of the Local Government Board, who expressed strongly the opinion that the British Pharmacopceia should be made the official standard under the Act for the drugs described therein. The second witness was Dr. James Bell, then Principal of the Somerset House Laboratory, who expressed the opinion that the Pharmacopceia was already in practice accepted as the standard for drugs, and that if it were made so more formally it might be trouble- some with respect to slight accidental variations. I make this statement from memory, as I have had no recent opportunity of referring to the evidence in question. Dr. Bell having expressed himself satisfied with the then position of the British Pharmacopceia, the question remained in abeyance until a Sheffield pharmacist supplied to the written prescription of a medical man some tincture of opium, which was found on analysis by me to contain only one-third of the opium and a little more than one-half the alcohol present in the British Pharmacopceia tincture.In the face of the evidence given by Mr. G. T. W. Newsholme, at that time the President of the Sheffield Pharmaceutical Society, by Dr. Sinclair White, then Medical Officer of Health for Sheffield, and by myself, the Sheffield stipendiary magistrate decided that, seeing the preparation contained alcohol and opium, it was a tincture of opium, and that deficiency of these ingredients had nothing to do with the question.That decision was not allowed to rest, and the opinion of the High Court of Justice was taken, with the result that the stipendiary’s decision was reversed, and the decision in White v. Bywater became one of the leading cases on record dealing with the question in point. It was heard before the High Court, Queen’s Bench Division, before Chief Justice Coleridge and Mr. Justice A. L. Smith, who decided that the article known as tincture of opium was a well-understood term in the trade as regards the proportion of ingredients; and though the druggist did not profess to sell it according to the British Pharmacopaeia, the sample supplied was not that which was asked for. But this decision was of a limited character ; and it has been forcibly contended that the Pharmacopceia is Dot, and never was, intended to apply to the articles named therein, except when used in dispensing a physician’s prescription, or when theTHE ANALYST.87 British Pharmacopoeia preparation was specifically demanded. This view has been recently endorsed by Dr. John Attfield, the editor of the British Pharmacopoeia, who at the Plymouth meeting of the Pharmaceutical Conference, held in 1899, expressed himself as follows: “ H e hoped that it would be realized by everyone that the Pharmacopoeia, notwithstanding the practice of tribunals and the principle on which barristers made speeches, was not a legal standard under the Sale of Food and Drugs Act ; and if anyone had the courage to test a case in the superior courts, he was not afraid to forecast that the judges in the superior courts would agree with what he had stated.” But the decision in the case of White v.Bywater was largely owing to the evidence brought forward that the British Pharmacopceia tincture of opium was the only one recognised in the trade. If the defence had succeeded in showing that half a dozen qualities of tincture of opium were listed by wholesale druggists, possibly the court might have taken a different view, and held that the purchaser should demand the British Pharmacopceia quality of the tincture. But I think the existing condition of the law leaves no loophole for an article purchased under the name of one of the preparations of the British Pharmacopoeia being otherwise than of British Pharmacopoeia quality. Queen Victoria in Council made an order on February 3, 1851, which required that : “ All and singular apothecaries and others, whose duty it is to compound medicines, or distil oils or waters, or make any other extracts within any part of ., . England . . . Wales, or Berwick-on-Tweed, they and every of them, immediately after the Pharmacopoeia Collegii Regalis Medicorum Londinensis shall be printed and published, do not compound or make any medicine or medicinal receipt or prescription, or distil any oil or waters, or make any extract, that are or shall be in the said Pharma- copceia . . . mentioned or named in any other manner or form than is or shall be directed, prescribed, or set down by the said book, and according to the weights and measures that are or shall be therein limited, except it shall be by the special direction or prescription of some learned physician in that behalf ; and Her Majesty doth hereby declare that the offenders to the contrary shall not only incur Her Najesty’s just displeasure, but be proceeded against for s6ch their contempt and offences to the utmost severity of the law.” This Order in Council is still in force.Further, by the Medical Act of 1862, it is provided that the General Medical Council shall cause to be published a British Pharmacopeia; and Section 3 of the same Act provides that ‘‘ the British Pharmacopoeia when published shall for all purposes be deemed to be substituted throughout Great Britain and Ireland for the several above-mentioned Pharmacopceias, and any Act of Parliament, Order in Council or Custom relating to any of such last-mentioned Pharmacopeias shall be deemed after the publication of the British Pharmacopoeia to refer to such Pharmacopceia.” any person who shall compound any medicines of the British Pharmacopceia, except according to the said Pharmacopceia, shall for every such offence be liable to pay a penalty or sum of $5 .. . but nothing in this Act contained shall prevent any person from being liable Again, according to the Pharmacy Act of 1868, Section 15,88 THE ANALYST. to any other penalty, damages, or punishment to which he would have been subject if this Act had not been passed.” This last passage appears to tie a pharmacist down to compound his medicines according to the Pharmacopoeia’s directions only, unless by special directions of a medical man.The foregoing statement represented my view of the question up to November last, when it was originally arranged that I should read a paper on the subject before this Society ; but only a few days ago the question has received a stronger and far more authoritative treatment than I could pretend to give it. A week since an appeal case was heard by Mr. Justice Phillimore and Mr. Justice Bruce, sitting in the King’s Bench Division of the High Court of Justice. I t was a, case in which a sample of mercurial ointment was purchased at Skipton, and on analysis by me was found to contain only 12.5 per cent. of mercury, whereas the mercurial ointment of the British Pharmacopoeia contains not less than 48.5 per cent. The vendor was convicted, and he appealed to the High Court of Justice on the ground that he could not be convicted under Section 6, as the article was a compounded drug ; and further con- tended that the usual practice was not to supply purchasers with ointment of British Pharmacopaeia quality unless ordered by medical prescription.I n a very full and lucid judgment Mr. Justice Phillimore held that the British Pharmacopaia was the legal authority for all preparations described therein. Unless those who sympathize with the appellant are prepared to take the case still higher, I presume the recent judgment will stand good for a time at least. Numerous as are the defects in the Pharmacopoeia, I have no sympathy with those who try to drag it down from its due position of authority, end degrade it to the standpoint of an irresponsible farrago of second-grade recipes.I t is a great misfortune that the Pharmacopoeia was not long ago formally recognised under the Adulteration Acts as the standard for drugs described in it ; it would then have been easy to have had a schedule appended to the Act specifying certain articles as excluded from the general provision relating t o drugs. The course thus suggested was adopted in the Bill laid by this Society before the Select Committee on Food Products Adulteration at their meeting in 1894, and if the advice of the’ Society had been accepted by the Government, much heart- burning and some injustice would have been prevented. At the present moment the position is most unsatisfactory, and I heartily sympathize with &hat large and respectable section of pharmacists who have habitually taken the British Phar- macopoeia as their guide.I n order to place the law on a more satisfactory basis than exists at the present, I would suggest that a representative committee, including analysts, medical men, pharmacists, manufacturing chemists, and others interested, should endeavour to obtain an interview with the British Medical Council or the Pharmacopoeia Committee of that body with the view of the immediate production of an appendix to the British Pharmacopceia, in which appendix titles and undesirable synonyms should be subjected to extensive correction. Subsequent steps would depend on the result of this interview. The present situation, to my mind, is very unsatisfactory.THE ANALYST.89 DISCUSSION. Mr. CHATTAWAY thought that, owing to the comparative infrequency of the publication of the Pharmacopaeia, its immediate revision would be very difficult to obtain, although such revision was undoubtedly .much to be desired. It was to be hoped, however, that the recent High Court decision would have the effect of placing the question upon a more reasonable basis. Mr. MARTIN PRIEST said that, although the High Court decision just referred to was distinctly a step forward, there still remained the question as to whether, for instance, a grocer selling camphorated oil or beeswax was bound to supply the Pharmacopaeia articles. I n the case of both camphorated oil and beeswax, it had been held in recent decisions that a grocer was not so bound.Now that the Pharmacopoeia was actually established as a legal standard, there would seem to be only two courses open to the compilers of the next edition, namely, either to omit mention of all the characters and tests of the final products, limiting themselves to directions 8s to quantities and modes of preparation, or to give efficient tests. The former would be a retrograde step, for much assistance was a,f€orded by those of the tests already given, which in justice must be said to be fairly correct. The adoption of the latter alternative would involve considerable research, but would be of very great advantage to all concerned. Dr. DYER inquired on what authority Mr. Priest contended that the position of a, grocer who sold adulterated camphorated oil was in any way different from that of a, pharmacist who sold a similar article.The case was quite different from that of beeswax, which was an article used not only as a drug, but for other purposes as well. As a matter of fact, over and over again grocers who had dabbled in selling drugs and had supplied articles not in accordance with the demand of the purchaser, had been properly punished. The case of paregoric afforded a somewhat amusing instance of the liability of grocers dealing in drugs. If a grocer sold paregoric con- taining no opium, he might be prosecuted under the Sale of Food and Drugs Act ; while if he sold paregoric containing opium he might be prosecuted under the Pharmacy Act. Mr. PRIEST said that a case in reference to camphorated oil was recorded in the Phawnaceutzcacl Jozmal for July 28, 1900, in which such a decision as he had referred to had been given by a magistrate.Mr. THOMAS TYRER said that it was desirable to distinguish between galenical and non-galenical preparations. There could be no question whatever that a tincture ought to be of the proper alcoholic strength, although the extractive matters might vary within reasonable limits. I n the case, however, of an article like Glauber’s salt, it would be reasonable enough to stipulate for a given percentage of sodium sulphate -99, 98, or whatever it might be ; but it really seemed absurd to covenant that it should have only the ‘‘ slightest quantity of chlorides, etc.” What was the meaning of the term ‘‘ slightest ” ? It was highly important that alkaloidal preparations should be what they were represented to be, and he could not imagine that, in the light of modern scientific and technical knowledge, any alkaloid manufacturer would send out articles which were otherwise.Still, it would be wise to stipulate that90 TEE ANALYST. preparations of quinine, for instance, should contain definite proportions of the alkaloid. But the rest might be omitted: one did not expect to find arsenic in quinine, or selenium or tellurium in Glauber’s salt. The essential question seemed to be as to whether there was any evidence of fraud, and for dealing with this a simple statement of the maximum that could be reasonably required under ordinary trade conditions was all that was necessary. As to mercury ointment, he had never made and had never been asked for the weaker kind, and he doubted whether much of it was sent out by the wholesale druggists.At any rate, it was in the vendor’s power and his duty to label it properly, and he ought to have done so in his own interest, just as a “poison ” label should be affixed to any article requiring it, whether such article was mentioned in the schedule or not. If, as had been suggested in the recent case, mercury ointment of full strength might produce therapeutical effects which were not contemplated, why not let the weaker article be prescribed in the Pharmacopceia ? I t would only be necessary to employ more of it in any given case. The presence of dangerous quantities of impurities such as arsenic in sodium phosphate was largely due to the prevailing craze for cheapness; but, on the other hand, it was manifestly impossible, in fairness to the purchaser, to insist that articles should be absolutely free from impurities of which, by the utmost refinements of analysis, small traces could be found in anything and everything.He therefore felt that the suggestion concluding the paper was most valuable ; but, having regard to the manner in which offers of good work from such bodies as the British Pharmaceutical Conference had been dealt with, he was afraid that its early realization was improbable. Mr. C. T. TYRER said that it seemed to him obvious that, if the Pharmacopceia was to be a standard, its own standards should be reasonable. Two points seemed likely to be productive of legal complications.The first was that manufacturers, while using the purest materials obtainable, often found themselves quite unable to meet the full requirements of the Pharmacopceia. Secondly, owing to the lack of definiteness which existed in regard to the determination of physical constants, the manufacturer tested in one way, the customer in another, and the analyst to whom the matter might be referred probably in another. He had lately compared certain articles with the standards laid down by seventeen different Pharmacopceias, and had found that, as regards strictness of definition, the British Pharmacopmia was con- siderably behind in the scale. Nobody would doubt the ability and good faith of its editor, but the system seemed to be radically at fault. Mr. HEHNER said that if anything were likely to lead to the production of a perfect British Pharmacopceia, it would be the recent legal decision which had been referred to.As long as the Pharmacopeia was not considered seriously, there was no real incentive to make it perfect ; but now that, as the resulf of a High Court decision, it had become definitely the standard by which the articles mentioned in it must be judged, it was to the interest of everybody-and it was bound to come to pass-that its standards should be made to meet the requirements of everybody. Mr. Chattaway had said that there was no chance of its immediate revision; but at the same time those who realized how much work was required to make it perfect would realize also that, if such a result was to be attained even within the next eight years, the work must be taken in hand soon.THE ANALYST.91 Mr. JOHN WHITE said that there had lately grown up a pernicious custom of using the official names or official synonyms of the Pharmacopoeia, but with some qualification. Not long ago he had met with a sample bought as camphorated oil, in the case of which the bottle was found to be labelled, in very small letters, with the words, ‘‘ Camphor Embrocation,” and underneath, in large type, ‘‘ Used as Camphor- ated Oil.” Another example was afforded by the use of the terms, “ Sweet Spirit OE Nitre, sp. gr. 0.850,’’ and ‘‘ Sweet Spirit of Nitre, sp. gr. 0.900.” Such articles could only be sold with a view to defrauding the public, and it seemed to him that when a new Pharmacopceia was issued this point ought to be properly dealt with.He under- stood Mr. Tyrer to say that he did not think proceedings should be instituted in respect of any sample of a drug, except in the case of an article which, by reason of some deficiency in strength or quality, was sold with a view to defrauding the public ; but surely Mr. Tyrer would admit that in many instances there must be, not only a minimum which ought to be reached, but also a maximum which should not be exceeded. If this principle were not admitted, purchasers of drugs would always be exposed to obvious and improper risks. Mr. J. B. HARRISON said that in the colony of British Guiana, with which he was intimately connected, the practice was to admit at low rates of duty certain articles when imported as articles of the Pharmacopoeia; but if, on analysis by the Government Analyst, such an article was found not to conform within reasonable limits to the requirements of the Pharmacopoeia, it was treated as not being in consonance with the Yharmacopmia, and a much higher rate of duty was charged on it.Under those circumstances, at any rate, there could be no advantage in the direction of cheapness from the importation of inferior articles. Mr. ALLEN said, in reply, in reference to Mr. Chattawag’s remark, that his suggestion was that a representative committee should at once obtain an interview with the General Nedical Council, or with the Pharmacopceia Committee of that body, urging the desirability of the immediate issue of a revised version of the Pharmacopmia, in which the titles and synonyms should be subjected to extensive correction; or, in the alternative, of ail appendix containing the necessary modifications. An appendix to the Pharmacopmia, in fact, was badly needed in any case.This might possibly set the ball rolling, and might be the nieans of obtaining mitigation of what, he was sure, would be a hardship for a great many classes of persons. It would be a much larger task to carry out the suggestion of Mr. C. T. Tyrer. The revision of the standards and tests of the Pharmacopozia would occupy a considerable period of time, and it wa8 to be hoped that the work involved would be suitably remunerated. He would certainly strongly protest against any unfortunate vendor being brought into a police court simply through a misunderstanding, or through having sold an article which he believed, but had no means of ascertaining, to be correct, as was the case with the unfortunate shopkeeper who sold sweet spirit of nitre without knowing that the strength OX the article was likely to diminish on keeping.At the same time, he was rather surprised at the attitude adopted by some speakers and writers on that subject. The vendor should be educated; or, if he could not be educated, the trade in such articles should, as far as possible, be put into the hands of the educated pharmacist, who had means of knowing whether the articles he sold were of the proper92 THE ANALYST. quality. To cry ‘‘ stinking fish ” was held to be no excuse for selling unsound meat ; and if sweet spirit of nitre was really to be valued by its proportion of nitrous ether, it ought to be kept reasonably up to its proper strength.Pharmacists were too much inclined to be a law unto themselves. One man said that, as far as possible, he took care that all the articles he sold were of British Pharmacopceia quality. Another thought it was sufficient if all the articles with which he made up prescrip- tions were of British Pharmacopoeia quality, the public being supplied with mixtures : and it was this latter class who sometimes got into trouble under the Sale of Food and Drugs Act. He sympathized very greatly with the majority of pharmacists, who, he believed, were doing their very best to maintain the honest traditions of their occupation. He could not help thinking that, if it were really desired, there ought to be a means for a united expression of views to the General Medical Council or its Pharmacopoeia Committee.Owing to the recent High Court decision, pharmacists would be in difficulties if it were held that such articles as hard soap were drugs, and must always be in accordance with the Pharmacopceia. Some such articles (such a s soda-water, vinegar, etc.) had been removed from the last edition. The time had come when pharmacists would begin to see that the contention that the Pharma- copceia was only intended for use in connection with physicians’ prescriptions, and not for everyday use, would not hold water; but he believed that by far the greater number of pharmacists would be only too glad to approach the Medical Council, and to have the assistance of public analysts in attempting to arrive at some reasonable understanding on the question. The PRESIDENT (Dr. Voelcker) observed that there seemed to be a general feeling of satisfaction that a decision had been given which recognised a certain authority in the matters referred to ; but it was clear that the feeling was also general that that authority needed considerable improvement. He agreed with Mr. White in thinking that it was not sufficient to take Mr. Tyrer’s view that a departure from the rules laid down should be regarded solely from the point of view of fraud. It certainly seemed very material that people should know the quality or strength of the drugs they used, and insure that the required effect would be adequately produced without being exceeded. I t did not seem to be sufficient to say that, if a drug were of half strength only, it was only necessary to use a double quantity of it, for the effect might be very different. I t would be much more satisfactory to know, not only that there had been no fraud, but that the production of the proper effect would be insured.