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

S.I. No. 82 of 1963.

MEDICAL PREPARATIONS (CONTROL OF SALE) REGULATIONS, 1963.

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, 1963.

2. (1) 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 or any preparation containing such a substance ;

" medical prescription " means a written prescription for a controlled preparation (being a preparation which is or which contains a substance specified in the First Schedule to these Regulations) which is—

(a) signed and dated by a registered medical practitioner whose address is on the prescription, and

(b) issued by that medical practitioner to a person, whose address is recorded thereon, prescribing the supply to such person of either—

(i) a specified quantity of the controlled preparation on one occasion, or

(ii) a specified quantity of the controlled preparation on a specified number of occasions at specified intervals;

" dental prescription " means a written prescription for a controlled preparation (being a preparation which is or which contains a substance specified in the First Schedule to these Regulations) which is—

(a) signed and dated by a registered dentist whose address is on the prescription, and

(b) issued by that dentist for dental purposes to a person whose name and address is recorded thereon prescribing the supply to such person of a specified quantity of the controlled preparation;

" veterinary prescription " means a written prescription for a controlled preparation (being a preparation which is or which contains a substance specified in the First Schedule to these Regulations) which is—

(a) signed and dated by a registered veterinary surgeon whose address is on the prescription, and

(b) issued by that veterinary surgeon for veterinary purposes to a person whose name and address is recorded thereon, prescribing the supply to such person of either—

(i) a specified quantity of the controlled preparation on one occasion, or

(ii) a specified quantity of the controlled preparation on a specified number of occasions at specified intervals;

" sale " includes the offering or keeping for sale.

(2) Where neither the number of occasions on which nor the intervals at which a controlled preparation (being a preparation which is or which contains a substance specified in Part A of the First Schedule to these Regulations) may be supplied are mentioned in a prescription, the prescription shall be deemed to be a prescription for the supply of the specified quantity of that controlled preparation on one occasion.

(3) Where neither the number of occasions on which nor the intervals at which a controlled preparation (being a 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) are specified, the prescription shall be deemed to be a prescription for the supply of the specified quantity of that controlled preparation on such number of occasions within the period of six months following its issue as the person dispensing the prescription considers appropriate having regard to the dosage rate specified therein.

(4) Where the number of occasions on which a controlled preparation may be supplied is specified in a medical prescription or a veterinary prescription but the intervals at which it may be supplied are not so specified, such intervals (not being less than three days) as the person dispensing the prescription thinks proper shall be deemed to be specified in the prescription.

(5) Where the intervals at which a controlled preparation, being a preparation which is or which contains a substance specifiedin Part A of the First Schedule to these Regulations may be supplied are specified in a medical prescription or a veterinary prescription but the number of occasions on which it may be supplied are not so specified, three occasions shall be deemed to be specified in the prescription.

(6) Where the intervals at which a controlled preparation (being a 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) are specified in a medical prescription or a veterinary prescription, the prescription shall be deemed to be a prescription for the supply of the specified quantity of that controlled preparation at those intervals within the period of six months following the issue of the prescription.

3. These Regulations shall come into operation on the 27th day of May, 1963.

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) the Medical Research Council of Ireland, the Veterinary College of Ireland or the Veterinary Research Laboratory of the Department of Agriculture ;

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

(f) a person engaged in the business of wholesale dealing in medical preparations, or

(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, in accordance with its terms, of a medical prescription, a dental prescription, or a veterinary prescription.

(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, in accordance with its terms, of a veterinary prescription.

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

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

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

7. (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 Regulationsunless 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 a preparation containing a substance which is intended solely, and made up ready, for the prevention of motion sickness :—

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

or

(ii) on a preparation, other than a preparation referred to in the foregoing sub-paragraph, containing a substance which is made up ready for the internal treatment of human ailments :—

" 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 an unadvertised preparation for the use of a particular person, having been prescribed by reference to his needs.

(3) In this Article—

" appropriate designation " in relation to any preparation, constituent or ingredient means—

(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) As from the commencement of this Article, Article 6 of the Medical Preparations (Advertisement and Sale) Regulations, 1958 ( S.I. No. 135 of 1958 ), shall cease to apply in relation to a controlled preparation which is or which contains a substance specified in the Second Schedule to these Regulations.

FIRST SCHEDULE

PART A

Allylisopropylacetylurea

β-Aminopropylbenzene ; its salts

Glutethimide ; its salts

Iproniazid ; its salts

Phenmetrazine ; its salts, its molecular compounds

Thalidomide ; its salts

Substances with adrenocortical or androgenic or oestrogenic or progestational action, the following (except when contained in a preparation intended solely for external use) :—

Benzoestrol

Derivatives of stilbene (except stilboestrol and its esters), dibenzyl or naphthalene with oestrogenic activity ; their esters

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

Part B

Amitriptline

Azacyclonol ; its salts

Benactyzine ; its salts

Bromvaletone

Captodiame ; its salts

Carbromal

Chlordiazepoxide ; its salts

Chlorprothixene

Emylcamate

Ethchlorvynol

Ethinamate

Haloperidol

Hydroxyzine ; its salts

Imipramine ; its salts

Isocarboxazid ; its salts

Meprobamate

Methylpentynol ; its esters and other derivatives

Methyl phenidate ; its salts

Methyprylone

Phenelzine

Pheniprazine ; its salts

Phenothiazine, derivatives of, their salts ; except dimethoxanate, its salts, and promethazine, its salts and molecular compounds (except when contained in preparations for the prevention and treatment of diseases in animals, including poultry).

Phenoxypropazine ; its salts

Pipradol ; its salts

SECOND SCHEDULE

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

Antazoline

Bromodiphydramine

Buclizine

Chlorcyclizine

(p-Chlorophenylpyrid-2ylmethyl) 2-dimethylaminoethyl ether

Chlorpheniramine

Cinnarizine

Clemizole

Cyclizine

Cyproheptadine

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

Diphenhydramine

Diphenylpyraline

Doxylamine

Isothipendyl

Mebhydrolin

Meclozine

Phenindamine

Pheniramine

Phenyltoloxamine

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 fifteenth day of May, One Thousand Nine Hundred and Sixty-three.

SEÁN MacENTEE,

Minister for Health.

EXPLANATORY NOTE.

These Regulations provide for the introduction, as from 27th May, 1963, of controls over the retail sale of the substances, and preparations containing them, which are included in the First andSecond Schedules. 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.