Medical Preparations (Control of Sale) Regulations, 1966

• Jurisdiction: Ireland
• Citation: IR SI 261/1966
• Year: 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...