PART III | REQUIREMENTS AS TO DOCUMENTATION AND RECORD KEEPING |
| Documents to be obtained by supplier of controlled drugs |
10.—(1) Where a person (referred to in this paragraph as the supplier), not being a practitioner, supplies a controlled drug otherwise than on a prescription, the supplier shall not deliver the drug to a person who —| (a) | purports to be sent by or on behalf of the person to whom it is supplied (referred to in this paragraph as the recipient); and | | (b) | is not authorised by any of these Regulations other than regulation 5(1)(d) to have that drug in his possession, [S 939/2021 wef 15/12/2021] |
| unless that person produces to the supplier a statement in writing signed by the recipient to the effect that he is empowered by the recipient to receive that drug on behalf of the recipient, and the supplier is reasonably satisfied that the document is a genuine document. |
(2) Where a person (referred to in this paragraph as the supplier) supplies a controlled drug, otherwise than on a prescription or by way of administration, to any of the persons specified in paragraph (5), the supplier shall not deliver the drug —| (a) | until he has obtained a requisition in writing which —| (i) | is signed by the person to whom the drug is supplied (referred to in this paragraph as the recipient); | | (ii) | states the name, address and profession or occupation of the recipient; and | | (iii) | specifies the purpose for which the drug supplied is required and the total quantity to be supplied; and |
| | (b) | unless he is reasonably satisfied that the signature is that of the person purporting to have signed the requisition and that that person is engaged in the profession or occupation specified in the requisition. |
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| (3) Where the recipient is a practitioner and he represents that he urgently requires a controlled drug for the purpose of his profession, the supplier may, if he is reasonably satisfied that the recipient so requires the drug and is by reason of some emergency, unable before delivery to furnish to the supplier a requisition in writing duly signed, deliver the drug to the recipient on an undertaking by the recipient to furnish such a requisition within the 24 hours next following. |
| (4) A person who has given such an undertaking shall deliver to the person by whom the controlled drug was supplied a signed requisition in accordance with the undertaking. |
(5) The persons referred to in paragraph (2) are —| (a) | a practitioner or a pharmacist; | | (b) | a researcher who is approved by the Director to carry out any scientific research or project approved by the Director that involves any controlled drug; [S 939/2021 wef 15/12/2021] | | (c) | a person who has charge or custody of the controlled drugs in a laboratory approved by the Director for the purpose of carrying out any scientific research or project mentioned in sub-paragraph (b); [S 939/2021 wef 15/12/2021] | | (d) | the master of a ship which does not carry a medical practitioner on board as part of the ship’s complement; and [S 939/2021 wef 15/12/2021] | | (e) | the master of a foreign ship in port. [S 939/2021 wef 15/12/2021] |
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(6) Where the person responsible for the dispensing and supply of medicines at any hospital supplies a controlled drug to —| (a) | a collaborative prescribing practitioner practising in accordance with the collaborative practice agreement applicable to him in that hospital; or | | (b) | the nurse for the time being in charge of any ward, theatre or other department in that hospital, |
| the person so responsible must — |
| (c) | obtain a requisition in writing, signed by the collaborative prescribing practitioner or nurse (as the case may be), which specifies the total quantity of the drug to be supplied; and | | (d) | mark the requisition in such manner as to show that it has been complied with. |
[S 939/2021 wef 15/12/2021] |
| (7) Any requisition obtained for the purposes of paragraph (6) shall be retained in the dispensary from which the drug was supplied and a copy of the requisition or a note of it shall be retained or kept by the recipient. |
| (8) Nothing in this regulation shall have effect in relation to the drugs specified in the First Schedule. |
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11.—(1) Subject to this regulation, a person shall not issue a prescription containing a controlled drug other than a drug specified in the First Schedule unless the prescription complies with the following requirements:| (a) | be in ink or otherwise so as to be indelible and be signed by the person issuing it with his usual signature and dated by him; | | (b) | insofar as it specifies the information required by sub‑paragraphs (d), (f) and (g), be written by the person issuing it in his own handwriting; | | (c) | have written thereon, if issued by a dentist, the words “for dental treatment only” and, if issued by a veterinary surgeon, the words “for animal treatment only”; | | (d) | specify the name and address of the person for whose treatment it is issued or, if it is issued by a veterinary surgeon, of the person to whom the controlled drug prescribed is to be delivered; | | (e) | specify the name and address of the person issuing the prescription; | | (f) | specify the dose to be taken and —| (i) | in the case of a prescription containing a controlled drug which is a preparation, the form and, where appropriate, the strength of the preparation, and either the total quantity (in both words and figures) of the preparation or the number (in both words and figures) of dosage units, as appropriate, to be supplied; and | | (ii) | in any other case, the total quantity (in both words and figures) of the controlled drug to be supplied; and |
| | (g) | in the case of a prescription for a total quantity intended to be dispensed by instalments, contain a direction specifying the amount of the instalments of the total amount which may be dispensed and the intervals to be observed when dispensing. |
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| (2) In the case of a prescription issued for the treatment of a patient in a hospital, it shall be a sufficient compliance with paragraph (1)(d) if the prescription is written on the patient’s bed card or case sheet. |
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| Provisions as to supply on prescription |
12.—(1) A person shall not supply a controlled drug other than a drug specified in the First Schedule on a prescription before the date specified in the prescription and later than 30 days after the date specified in the prescription and —| (a) | unless the prescription complies with regulation 11; | | (b) | unless the address specified in the prescription as the address of the person issuing it, is an address within Singapore; and | | (c) | unless he either is acquainted with the signature of the person by whom it purports to be issued and has no reason to suppose that it is not genuine, or has taken reasonably sufficient steps to satisfy himself that it is genuine. |
(2) A person dispensing a prescription containing a controlled drug other than a drug specified in the First Schedule shall —| (a) | at the time of dispensing it, mark thereon the date on which it is dispensed; and | | (b) | retain the prescription on the premises on which it was dispensed. |
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| Marking of bottles and other containers |
13.—(1) Subject to paragraph (2), no person shall supply a controlled drug otherwise than in a bottle, package or other container which is plainly marked —| (a) | in the case of a controlled drug other than a preparation, with the amount of the drug contained therein; and | | (b) | in the case of a controlled drug which is a preparation —| (i) | made up into tablets, capsules or other dosage units, with the amount of each component (being a controlled drug) of the preparation in each dosage unit and the number of dosage units in the bottle, package or other container; or | | (ii) | not made up as mentioned in sub-paragraph (i), with the total amount of the preparation in the bottle, package or other container and the percentage of each of its components which is a controlled drug. |
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| (2) Nothing in this regulation shall have effect in relation to the drugs specified in the First Schedule or in relation to the supply of a controlled drug by or on the prescription of a practitioner. |
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14.—(1) Every person authorised by or under these Regulations to supply any drug specified in the Second or Fourth Schedule shall comply with the following requirements:| (a) | he shall, in accordance with this regulation and regulation 15, keep a register and shall enter therein in chronological sequence in the form specified in Part I or II of the Fifth Schedule, as the case may require, particulars of every quantity of a drug specified in the Second or Fourth Schedule obtained by him and of every quantity of such a drug supplied (whether by way of administration or otherwise) by him whether to persons within or outside Singapore, except that the register if kept in a ward, theatre or other department in a hospital (other than the dispensary within the hospital) shall be in the form specified in the Sixth Schedule instead of the Fifth Schedule; and | | (b) | he shall use a separate register or separate part of the register for entries made in respect of each class of drugs, and each of the drugs specified in paragraphs 1, 3 and 6 of the Second Schedule and paragraphs 1 and 3 of the Fourth Schedule together with its salts and any preparation or other product containing it or any of its salts shall be treated as a separate class, so however that any stereoisomeric form of a drug or its salts shall be classed with that drug. |
| (2) Nothing in paragraph (1) shall be taken as preventing the use of a separate section within a register or separate part of a register in respect of different drugs or strengths of drugs comprised within the class of drugs to which that register or separate part relates. |
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| Requirement as to registers |
15. Any person required to keep a register under regulation 14 shall comply with the following requirements:| (a) | the class of drugs to which the entries on any page of any such register relate shall be specified at the head of that page; | | (b) | every entry required to be made under regulation 14 in such a register shall be made on the day on which the drug is obtained or, as the case may be, on which the transaction in respect of the supply of the drug by the person required to make the entry takes place or, if that is not reasonably practicable, on the day next following that day; | | (c) | no cancellation, obliteration or alteration of any such entry shall be made, and a correction of such an entry shall be made only by way of marginal note or footnote which shall specify the date on which the correction is made; | | (d) | every such entry and every correction of such an entry shall be made in ink or otherwise so as to be indelible; | | (e) | such a register shall not be used for any purpose other than for the purposes of these Regulations; | | (f) | the person so required to keep such a register shall on demand made by any person authorised in writing by the Minister in that behalf —| (i) | furnish such particulars as may be requested in respect of the obtaining or supplying by him of any drug specified in the Second or Fourth Schedule or in respect of any stock of the drugs in his possession; | | (ii) | for the purpose of confirming any such particulars, produce any stock of the drugs in his possession; and | | (iii) | produce the register and such other books or documents in his possession relating to any dealings in drugs specified in the Second or Fourth Schedule as may be requested; |
| | (g) | a separate register shall be kept in respect of each premises at which the person required to keep the register carries on his business or occupation, but subject to that not more than one register shall be kept at one time in respect of each class of drugs in respect of which he is required to keep a separate register, so, however, that a separate register may, with the approval of the Minister, be kept in respect of each department of the business carried on by him; and | | (h) | every such register in which entries are currently being made shall be kept at the premises to which it relates. |
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| Record keeping requirements in case of ship |
| 16. Where a drug specified in the Second Schedule is supplied in accordance with regulation 7(4) to a member of the crew of a ship, an entry in the official log book required to be kept under the Merchant Shipping Act (Cap. 179) or, in the case of a ship which is not required to carry such an official log book, a report signed by the master of the ship shall, notwithstanding anything in these Regulations, be a sufficient record of the supply if the entry or report specifies the drug supplied. |
| Preservation of registers, books and other documents |
17.—(1) All registers and books kept under regulation 14 or 16 shall be preserved for a period of 3 years from the date on which the last entry is made.| (2) Every requisition, order or prescription, on which a controlled drug is supplied under these Regulations, shall be preserved for a period of 3 years from the date on which the last delivery under it was made. |
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| Preservation of records relating to drugs in First Schedule |
18.—(1) A manufacturer of any drug specified in the First Schedule and a wholesale dealer in any such drug shall keep every invoice or other like record issued in respect of each quantity of that drug obtained by him and in respect of each quantity of the drug supplied by him.| (2) A retail dealer in any drug specified in the First Schedule shall keep every invoice or other like record issued in respect of each quantity of that drug obtained by him. |
| (3) Every document kept in pursuance of this regulation shall be preserved for a period of 3 years from the date on which it is issued. |
| (4) The keeping of a copy of the document made at any time during the period of 3 years shall be treated for the purposes of this regulation as if it were the keeping of the original document. |
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