S.I. No. 261/1966 - Medical Preparations (Control of Sale) Regulations, 1966.

S.I. No. 261 of 1966.

MEDICAL PREPARATIONS (CONTROL OF SALE) REGULATIONS, 1966.

The Minister for Health, in exercise of the powers conferred on him by sections 5 and 65 of the Health Act, 1947 (No. 28 of 1947), hereby makes the following Regulations:—

1. These Regulations may be cited as the Medical Preparations (Control of Sale) Regulations, 1966.

2. In these Regulations—

" the Minister " means the Minister for Health;

" controlled preparation " means any of the substances specified in the First or Second Schedule to these Regulations and any preparation containing such a substance;

" sale " includes the offering or keeping for sale;

" sale by retail " means sale to a person buying otherwise than for the purpose of re-sale;

" wholesale dealing " means sale to a person buying for the purpose of re-sale.

3. These Regulations shall come into operation on the 2nd day of January, 1967.

4. (1) These Regulations shall not apply to the sale of a controlled preparation to—

(a) a pharmaceutical chemist, a dispensing chemist and druggist or a registered druggist;

(b) a hospital or similar institution on a written order signed by a registered medical practitioner, pharmaceutical chemist or dispensing chemist and druggist employed in the institution;

(c) an authority which is a local authority for the purposes of the Local Government Act, 1941 (No. 23 of 1941);

(d) a body engaged in medical, dental or veterinary education or research;

(e) a registered medical practitioner, a registered dentist or a registered veterinary surgeon;

(f) any person for the purpose of the business of wholesale dealing in medical preparations;

(g) any person authorised in that behalf by the Minister.

(2) Nothing in these Regulations shall affect—

(a) the supply of a controlled preparation by a registered medical practitioner to a person under his care,

(b) the supply, for dental purposes, of a controlled preparation by a registered dentist to a person under his care,

(c) the supply, for veterinary purposes, of a controlled preparation by a registered veterinary surgeon for animals under his care.

5. No person other than a pharmaceutical chemist, a dispensing chemist and druggist or a registered druggist shall sell a controlled preparation by retail.

6. (1) A pharmaceutical chemist or a dispensing chemist and druggist shall not sell by retail a controlled preparation which is or which contains a substance specified in the First Schedule to these Regulations except in the dispensing of a prescription, in accordance with article 7 of these Regulations.

(2) A registered druggist shall not sell by retail a controlled preparation which is or which contains a substance specified in the First Schedule to these Regulations except in the dispensing of a prescription issued by a registered veterinary surgeon in accordance with article 7 of these Regulations.

7. The following provisions shall be complied with by a pharmaceutical chemist, a dispensing chemist and druggist or a registered druggist in the dispensing of a prescription for the supply of a controlled preparation which is or which contains a substance specified in the First Schedule to these Regulations:—

(a) The prescription shall be in writing signed and dated by a registered medical practitioner or a registered dentist or a registered veterinary surgeon whose address is on the prescription;

(b) The prescription shall contain the name and address of the person to whom it is issued and shall prescribe the supply to such person of a specified quantity of a controlled preparation;

(c) Where the prescription is issued by a registered dentist, it shall be dispensed on one occasion only;

(d) Where neither the number of occasions on which nor the intervals at which a controlled preparation, which is or which contains a substance specified in Part A of the First Schedule to these Regulations, may be applied are specified in a prescription, the prescription may be dispensed on one occasion only;

(e) Where neither the number of occasions on which nor the intervals at which a controlled preparation, which is or which contains a substance specified in Part B of the First Schedule to these Regulations but which does not contain a substance specified in Part A of that Schedule, may be supplied are specified in a prescription issued by a registered medical practitioner or a registered veterinary surgeon, the prescription may be dispensed on such number of occasions within the period of six months after the date thereon as the person dispensing the prescription considers appropriate having regard to the rate of dosage specified therein;

(f) Where the intervals at which a controlled preparation, which is or which contains a substance specified in Part A of the First Schedule to these Regulations, may be supplied are specified in a prescription issued by a registered medical practitioner or by a registered veterinary surgeon but the number of occasions on which it may be supplied are not so specified, the prescription may be dispensed on not more than three occasions;

(g) Where the intervals at which a controlled preparation, which is or which contains a substance specified in Part B of the First Schedule to these Regulations but which does not contain a substance specified in Part A of that Schedule, may be supplied are specified in a prescription issued by a registered medical practitioner or by a registered veterinary surgeon, the prescription may be dispensed at those intervals within the period of six months after that date thereon;

(h) Where the number of occasions on which a controlled preparation, which is or which contains a substance specified in the First Schedule to these Regulations, may be supplied is specified in a prescription issued by a registered medical practitioner or a registered veterinary surgeon, but the intervals at which it may be supplied are not so specified, the prescription may be dispensed at such intervals (not being less than three days) as the person dispensing the prescription considers appropriate having regard to the rate of dosage specified therein;

(i) A pharmaceutical chemist, a dispensing chemist and druggist or a registered druggist who has completed the dispensing of a prescription shall forthwith write prominently on the prescription the word "dispensed" and the date on which it was dispensed and shall retain the prescription in his possession for two years and then destroy it;

(j) A pharmaceutical chemist, a dispensing chemist and druggist or a registered druggist who has dispensed in part the prescription shall forthwith record on the prescription the quantity of each controlled preparation supplied by him on foot of the prescription and the date on which he supplied each such quantity.

8. (1) Subject to the provisions of this article, no person shall sell by retail a controlled preparation which is or which contains a substance specified in the Second Schedule to these Regulations unless there is legibly written on the outside of the packet or container in which it is sold or on a label affixed thereto—

(a) the appropriate designation of the preparation or of each of the active constituents thereof or of each of the ingredients from which it has been compounded,

(b) where the appropriate designation of each of the active constituents or ingredients is written as aforesaid, the appropriate quantitative particulars of the constituents or ingredients,

(c) the name of the seller and the address of the premises on which it was sold, and

(d) whichever of the following cautionary notices is appropriate—

(i) on such a preparation which is intended solely for the prevention of motion sickness and is not made up by the person dispensing it:—

" Caution. This may cause drowsiness " or words to that effect,

or

(ii) on such a preparation (other than a preparation referred to in the foregoing sub-paragraph) which is intended for the internal treatment of human ailments and is not made up by the person dispensing it:—

" Caution. It is inadvisable to take this preparation. except under medical supervision " or words to that effect.

(2) Sub-article (1) of this article shall not apply in relation to the sale of a preparation made up and supplied for the use of a particular person, having been prescribed by reference to his needs.

(3) In this article—

(a) where the preparation, constituent or ingredient is described in any of the monographs contained in the current edition of the Irish Pharmacopoeia or in the current edition of the British Pharmaceutical Codex, the description, or any synonym or abbreviation of that description, set out at the head of the monograph and

(b) where the preparation, constituent or ingredient is not so described, the accepted scientific name or other name descriptive of the true nature of the preparation, constituent or ingredient;

"appropriate quantitative particulars" in relation to the active constituents of the ingredients of a preparation means the approximate percentage of each of the constituents or ingredients contained in the preparation or the approximate quantity of each of these constituents or ingredients contained in the packet or container in a specified quantity of the preparation.

(4) Article 6 of the Medical Preparations (Advertisement and Sale) Regulations, 1958 ( S.I. No. 135 of 1958 ), shall not apply in relation to a controlled preparation which is or which contains a substance specified in the Second Schedule to these Regulations.

9. (1) These Regulations shall be enforced and executed in each district by the health authority of the district and their authorised officers.

(2) A pharmaceutical chemist, a dispensing chemist and druggist and a registered druggist shall make available any prescriptions in his possession for inspection by authorised officers of the Minister and of a health authority and by inspectors of the Pharmaceutical Society of Ireland.

10. The following Regulations are hereby revoked :—

Medical Preparations (Cortisone and A.C.T.H.) Regulations, 1952, ( S.I. No. 324 of 1952 );

Medical Preparations (Barbiturates) Regulations, 1954, ( S.I. No. 30 of 1954 ) ;

Medical Preparations (Oral Diabetic Treatments) Regulations, 1956 ( S.I. No. 203 of 1956 );

Medical Preparations (Control of Sale) Regulations, 1963 ( S.I. No. 82 of 1963 ).

FIRST SCHEDULE.

PART A.

Allylisopropylacetylurea.

Amidopyrine; its salts; amidopyrine sulphonates; their salts.

B-Aminopropylbenzene, and B-aminoisopropylbenzene and any compound structurally derived from either of these substances by substitution in the side chain or by ring closure therein (or by both such substitution and such closure), except ephedrine, N-methylephedrine, N-diethylaminoe-thylephedrine, phenylpropanolamine, and prenylamine; any salt of any such substance.

Antibiotics, the following; their salts; their derivatives; salts of their derivatives except when intended for agricultural, horticultural or veterinary use or in feed supplements for veterinary use:—

Amphotericins

Bacitracin

Cephalosporin

Chloramphenicol

Colistin

Cycloserine

Dihydrostreptomycin

Erythromycin

Fusidic Acid

Griseofulvin

Kanamycin

Neomycin

Novobiocin

Eystatin

Oleandomycin

Paromomycin

Penicillins

Polymyxins

Ristocetins

Spiramycin

Streptomycin

Tetracyline

Vancomycin

Viomycin

Barbituric acid; its salts; derivatives of barbituric acid; their salts; compounds of barbituric acid (including its salts and derivatives and salts of its derivatives), with any other substance except (i) any of the substances comprised in this entry when in combination with any other active substance which is not a substance included in this Schedule and (ii) mixtures containing any of the said substances designed solely for veterinary use provided the words "not for human use" are distinctly written on the container in which the mixture is sold or on a label affixed thereto.

Busulpban; its salts.

Carbimazole.

Chlorisondamine; its salts.

Dimethylsulfoxide.

Ethyl Biscoumacetate.

Glutethimide; its salts.

Hexamethonium; its salts.

Iproniazid; its salts.

Methimazole.

Methocarbamol.

Methylthiouracil.

Mustine and any other N-substituted derivatives of di (2-chloroethyl) amine; their salts.

Nicoumalone.

Nitrofurantoin.

Oxphenbutazone.

Paramethadione.

Pempidine; its salts.

Pentolinium; its salts.

Phenindione.

Phenprocoumon.

Phenylbutazone; its salts.

Phenylcinchoninic acid, salicylcinchoninic acid, their salts, their esters. Pituitary gland; the active principles of; their salts, except when contained in preparations intended for external application only or in inhalants or rectal ointments or eye lotions or preparations intended for use as eye lotions.

Propylthiouracil.

Rauwolfia; alkaloids of; their salts derivatives of the alkaloids of rauwolfia; their salts.

Substances with adrenocortical or androgenic or oestrogenic or progestational activity, the following (not being a substance intended solely for external use or a progesterone preparation for use solely in the treatment of sheep fertility or stilboestral and its esters):—

Benzoestrol,

Derivatives of stilbene dibenzyl or naphthalene with oestrogenic activity; their esters,

Steroid compounds, with adrenocortical or androgenic or oestrogenic or progestational activity; their esters.

Sulphinpyrazone.

Thalidomide; its salts.

Thiouracil.

Troxidone.

Warfarin Sodium.

PART B.

Acetohexamide.

Acetylcarbromal.

P-Aminobenzenesulphonamide; its salts; derivatives of P-aminobenzenesulphonamide having any of the hydrogen atoms of the P-amino group or of the sulphonamide group substituted by another radical; their salts; except when contained in ointments or surgical dressings or when intended for the prevention and treatment of diseases in animals including poultry or in feeding stuffs containing not more than 0.5 per cent. of total sulphonamdies.

Amitriptyline; its salts.

Azacyclonol; its salts.

Barbituric acid (including its salts and derivatives and salts of its derivatives in combination with any other active substance not being a substance included in this Schedule.

Benactyzine; its salts.

Bretylium tosylate.

Bromvaletone.

Captodiame; its salts.

Carbromal.

Carbutamide.

Carisoprodol.

Chlordiazepoxide; its salts.

Chlorexolone.

Chlormethiazole; its salts.

Chlorothiazide and other derivatives of benzo 1, 2, 4-thiadiazine-7-sulphonamide 1, 1-dioxide, whether hydrogenated or not.

Chlorphentermine; its salts.

Chlorpropamide; its salts.

Chlorprothixene.

Chlorthalidone.

Desipramine; its salts.

Diazepam and other compounds containing the chemical structure or dihydro-1, 4-benzodiazepine substituted to any degree; their salts.

Emylcamate.

Ethchlorvynol.

Ethinamate.

Ethoheptazine; its salts.

Guanethidine; its salts.

Haloparidol and other 4 substituted derivatives of N-(3-p-fluorobensoylpropyl) piperidine.

Hydrazines, benzyl phenethyl and phenoxyethyl; their a-methyl derivatives; acyl derivatives of any of the foregoing substances comprised in this entry; salts of any compounds comprised in this entry.

Hydroxyzine; its salts.

Imipramine; its salts.

Indomethacin; its salts.

Mefenamic Acid.

Mephenesin; its esters.

Meprobamate.

Metformin; its salts.

Methaqualone; its salts.

Methylpentynol; its esters and other derivatives.

Methyprylone.

Nalidixic Acid.

Nortriptyline; its salts.

Orphenadrine; its salts.

Pargyline; its salts.

Pemoline; its salts.

Phenbutrazate.

Phenformin; its salts.

Phenothiazine; derivatives of; their salts; except dimethoxanate, its salts and promethazine, its salts and molecular componds (except any of foregoing substances when intended for the prevention and treatment of diseases in animals including poultry).

5 Phenylhydantoin; its alkyl and aryl derivatives; their salts.

Prothipendyl; its salts.

Quinethazone.

Styramate.

Tetrabenazine; its salts.

Thyroid gland; the active principles of; their salts.

Tolbutamide.

SECOND SCHEDULE.

The following; their salts; their molecular compounds; and preparations containing them:

Antazlonine

Bromodiphenydramine

Buclizine

Carbinozamine

Chlorcyclizine

Chlorpheniramine

Cinnarizine

Clemizole

Cyclizine

Cyproheptadine

3-Di-n-butylaminoniethyl-4: 5: 6-trihydroxyphthalide

Diphenhydramine

Diphenylpyraline

Doxylamine

Isothipendyl

Mebhydrolin

Meclozine

Phenindamine

Pheniramine

Phenlytoloxamine

Promethazine

Pyrrobutamine

Thenalidine

Tolpropamine

Triprolidine

Substances being tetra-substituted N-derivatives of ethylenediamine or propylenediamine.

GIVEN under the Official Seal of the Minister for Health this 30th day of November, 1966.

SEÁN FLANAGAN.

Minister for Health.

EXPLANATORY NOTE.

These Regulations provide for the revocation of four sets of regulations that control the retail sale of a number of scheduled substances and preparations containing them. These controls are reimposed together with similar controls on a number of additional substances with effect from the 2nd January, 1967.

These substances and preparations may, as from that date, be sold by retail only by pharmaceutical chemists, dispensing chemists and druggists and registered druggists. In addition, the prescription of a registered medical practitioner, dentist or veterinary surgeon will be required to purchase such of them as are in the First Schedule. In the case of those in Part A of that Schedule, the prescription may be dispensed on one occasion only, unless the prescription states otherwise; in the case of those in Part B, it may be dispensed at such intervals, over the six-month period following the date of issue of the prescription, as the dispenser deems appropriate, having regard to the dosage rate.

In addition to complying with the condition that they may be sold only by qualified pharmacists, containers and packets of substances, and preparations containing such substances, which are included in the Second Schedule, must, as from the date stated, be labelled with, inter alia, appropriate cautionary notices.