INTERNAL CONTROL OF DANGEROUS DRUGS RULES

SUBSIDIARY LEGISLATION 101.02

INTERNAL CONTROL OF DANGEROUS DRUGS

RULES

1st September, 1939

GOVERNMENT NOTICE 292 of 1939, as amended by Government

Notices 449 of 1942 and 545 of 1957; Legal Notices 4 of 1974, 40 of 1984,

23 of 1985, 64 of 1986, 33 of 1989 , 426 of 2012 and 234 of 2018.

The title of these Rules is Internal Control of Dangerous

Drugs Rules.

Substituted by

L.N. 40 of 1984.

Amended by

(Rules 6 and 7)

L.N. 23 of 1985.

PRESCRIPTION FOR NARCOTIC AND PSYCHOTROPIC DRUGS

(Only one item may be prescribed on this Form)

A. TO BE FILLED BY PRESCRIBER

C. TO BE FILLED BY

DISPENSING APOTHECARY

PATIENT

Name and Surname .................................................................

PATIENT

Address ...................................................................................

Surname

Name

ITEM

Quantity

(incl. Form& Dose)

I.D

Directions for use

Additional information in respect of Prescriptions for METHADONE

Male

Female

ITEM

Expected Duration of Treatment ....................

Quantity Supplied

Medical Indication ........................................

Total Quantity

in Units ...............................................................

PRESCRIBER

Total Quantity

Med Council Reg. No.

in Weight/Measure ...............................................

Name and Surname ..........................................................

PRESCRIPTION ORIGIN

Address ..........................................................................

Hospitals .............................................................

Signature ............................................... Date ....................

Govt. Clinics

..

Private

..

B. FOR OFFICIAL USE ONLY

DISPENSER

To be filled by Government Dispenser

Signature................................................................

.

PRESCRIPTION TYPE

Pharmacy Board Reg. No

Dispensary Address

Pink Form

Schedule III

Others

Direct

Postal

LOCATION DISPENSER

Dispensary

To be filled by Coder

DH Licence No.

Date

Item No.

Prescription Origin

Serial No.

INTERNAL CONTROL OF DANGEROUS DRUGS

REQUEST FOR PRESCRIPTION FORMS FOR NARCOTIC AND

PSYCHOTROPIC DRUGS

I request .................... booklet/s by .................. prescription forms.

Name and surname of prescriber ....................................................

( IN BLOCK LETTERS)

Private address .....................................................................................................

( IN BLOCK LETTERS)

Signature ..................

Med. Council Reg. No.

FOR OFFICIAL USE

Supplied ................... booklet/s by ................... prescription forms.

Serial No. ........................ to ........................

(a)

If withdrawn personally by prescriber.

Signature of Prescriber

Date

(b)

If forwarded by mail.

Forwarded by .................................... on ...........................

A.R. Card to be attached.

INTERNAL CONTROL OF DANGEROUS DRUGS

Amended by

L.N. 40 of 1984;

(1) For the purposes of these Rules, unless the context

otherwise requires -

"medical practitioner", "dental surgeon", "dentist", "veterinary

surgeon", "apothecary" mean in each case a person holding a

licence to practice in Malta the profession indicated;

"Ordinance" means the Dangerous Drugs Ordinance;

"prescription" means any medicinal prescription issued by a

professional person qualified to prescribe medicinal products by or

under the Medicines Act, including manual prescriptions, computer

generated prescriptions and eprescriptions;

"register" means a bound book and does not include any form of

loose-leaf register or card index.

(2) The drugs to which these Rules apply are those to which

Part V of the Ordinance applies, unless the context otherwise

requires.

L.N. 23 of 1985.

(Rule 11)

A.Register of Drugs to which Part V of the Dangerous Drugs Ordinance applies

Purchased or otherwise obtained

Name of

Name of

Address of

Date on

substance

person, body

person, body

which

Form in which

purchased or

or firm from

or firm from

Amount

supply

obtained

otherwise

whom

whom

obtained

received

obtained

obtained

obtained

B.Register of Drugs to which Part V of the Dangerous Drugs Ordinance applies

Sold or supplied.

When sale is

on

prescription,

Address

specify the

of person, Authority of

Name of

ingredients or

Name of

Date on

person, body body or person, body

Form in

Amount

the

substance

which the

firm to or firm to bein

which

or firm to

sold or

prescriptions

sold or

transaction

whom sold whom or possession of

sold or

supplied

and insert the

supplied

was effected or supplied

which the substances

supplied

official serial

sold or

number

supplied

printed on the

prescription

form

INTERNAL CONTROL OF DANGEROUS DRUGS

No person shall manufacture or carry on any process in the

manufacture of any of the drugs -

(a) unless he is licensed by the Minister responsible for

Health or is authorised by these Rules or by any

authority granted by the Minister responsible for

Health to do so;

(b) except on premises licensed for the purpose by the

Minister responsible for health;

(c) otherwise than in accordance with the terms and

conditions of such licence or authority.

Substituted by

L.N. 4 of 1974.

(Rule 14)

The Medical Council constituted under article 20 of the Department of Health

(Constitution) Ordinance shall be the tribunal for the purposes mentioned in sub-rule

(3) of rule 14 of these Rules.

No person shall supply or procure, or offer to supply or

procure, the drugs to or for any person and whether in these Islands

or elsewhere, or advertise the drugs for sale -

(a) unless he is licensed by the Minister responsible for

Health or is authorised by these Rules or by authority

granted by the Minister responsible for Health to

supply the drugs, or unless he is in possession of an

import or export authorisation issued by the Chief

Government Medical Officer in pursuance of the

provisions of Part VI of the Ordinance, or unless he is

licensed or otherwise authorised to manufacture the

drug or (but so far only as regards procuring) unless he

is licensed to procure the same;

(b) otherwise than in accordance with the terms and

conditions of such licence or authority.

(Rule 17)

Preparations exempt from the Rules

Cereoli Idoformi et Mophineae, B.P.C. ’23

Elixir Diamorph. et Terpin. c. Apomorph., B.P.C.

Emp. Opii, B.P. ’98.

Linctus Diamorph. Camph., B.P.C.

Linctus Diamorph. c. Ipecac., B.P.C.

Linctus Diamorph. et Scill., B.P.C.

Lin. Opii, B.P. ’14.

Lin. Opii Ammon., B.P.C. ’23.

Pasta Arsenicals, B.P.C.

Pil. Digitalis et Opii Co., B.P.C. ’23.

Pil. Hydrarg. c. Cret. et Opii, B.P.C.

Pil. Hydrag. c. Opio, B.P.C. ’23.

Pil. Ipecac. c. Scill., B.P. ’14.

Pil. Plubi c.Opio. B.P. ’14.

Pulv. Cret. Aromat. c. Opio, B.P.

Pulv. Ipecac. et Opii, B.P (Dover’s Powder).

Pulv. Kino Co. B.P., ’14.

Suppos. Plumbi c. Opio, B.P.

Tabellae Plumbi c Opio, B.P.C.

Ung. Gallae c. Opio, B.P.C. (Ung. Gallae Co.).

Mixtures of Emp. Opii, B.P. ’98 with other plasters of the British Pharmacopoeia

1914 and 1932, and of the British Pharmaceutical Codex.

Mixtures of Lin. Opii, B.P. ’14 with other liniments of the British Pharmacopoeia

1914 and 1932, and of the British Pharmaceutical Codex.

Mixtures of Pulv. Ipecac. Co., B.P. ’14 and of Pulv. Ipecac. et Opii, B.P. with any of

the following

Hydrarg. c. Cret., B.P.

INTERNAL CONTROL OF DANGEROUS DRUGS

Acetysalicylic Acid.

Phenacetin.

Quinine and its Salts.

Sodium Bicarbonate

Mixtures of Ung. Gallae c. Opio, B.P.C. (Ung. Gallae Co.) with other ointments and

plasters of the British Pharmacopoeia 1914 and 1932, and of the British

Pharmaceutical Codex.

Mixtures of Lin. Opii Ammon., B.P.C. ’23 with other liniments of the British

Pharmacopoeia 1914 and 1932, and of the British Pharmaceutical Codex.

Except when the drugs are lawfully dispensed in pursuance

of a prescription given by a medical practitioner, dental surgeon,

dentist, or veterinary surgeon, in accordance with the conditions

hereinafter in these Rules specified, no person shall supply or

procure, or offer to supply or procure, any of the drugs to or for any

person in these Islands who is not licensed or otherwise authorised

to be in possession of the drug nor to any person so licensed or

authorised except in accordance with the terms and conditions of

such licence or authority

Provided that the administration of the drug by or under the

direct personal supervision of a medical practitioner, or by a dental

surgeon or by a dentist in dental treatment, or by, or under the

direct personal supervision of a, veterinary surgeon in the treatment

of any animal, shall not be deemed to be supplying the drug within

the meaning of these Rules.

Added by

L.N. 64 of 1986.

(Rule 8)

Amended by

L.N. 33 of 1989;

L.N. 426 of 2012.

DEPARTMENT OF HEALTH

DRUGS (CONTROL) REGULATIONS AND DANGEROUS DRUGS (INTERNAL CONTROL) RULES

CONTROL CARD FOR NARCOTIC/PSYCHOTROPIC DRUGS

Name and Surname of Patient ....................................

Address ................................................

Legally valid identification document number (where

available, or Passport No., in case of non-Maltese

citizens who do not hold a legally valid identification

document)

Date of Issue of Card ..........

Valid till ........................

Superintendent of Public Health

(Columns 1 - 4 to be filled by Prescriber)

(Columns 5 - 8 to be filled by Dispensing Apothecary)

Signature of

Name of

Medical

Signature of D.H.

Licence

Date of

Drug.

Amount

Practitioner

Amount

Date of

No. of

Prescription

Form and

Prescribed

and Medical

Dispensed

Dispensing

Apothecary

Dispensary

Dose

Council Reg.

No.

INTERNAL CONTROL OF DANGEROUS DRUGS

(1) Every manual prescription for the supply of the drugs

shall be written in ink or in other indelible material on the form set out

in the First Schedule to these Rules. In the case of computer generated

prescriptions and eprescriptions, the medical practitioner shall use the

official prescription as approved by the Superintendent of Public

Health.

(2) A medical practitioner issuing a prescription for drugs

shall fill in a clear and legible hand Part A of the form set out in the

First Schedule, and to supply all the details and give all the

information (including additional information in the case of

prescriptions for methadone or for any salt or ester thereof); the

medical practitioner shall further add his signature in full and the

date when the prescription was issued

Provided that in the case of a medical practitioner

authorised to practise the medical profession under article 4 of the

Medical and Kindred Professions Ordinance but who is not yet

registered with the Medical Council, such practitioner shall insert

the number given to him by the Superintendent of Public Health

instead of the Medical Council registration number on the said

prescription.

(3) Subject to the provisions of sub-rule (11) of this rule, no

medical practitioner shall issue a prescription for the supply of the

drugs unless the prescription complies with the provisions of sub-

rules (1) and (2) of this rule, and unless the drugs are required for

the purpose of medical treatment

Provided that a medical practitioner may, subject to the

other provisions of these Rules, issue a prescription for

professional use for an amount not in excess of ten phials for

injection or of twenty tablets or capsules

Provided further that -

(i)

in the case of a dental surgeon or a dentist a

prescription may only be issued for the purposes

of dental treatment and such prescription shall

be marked "for dental treatment only"; and

(ii) in the case of a veterinary surgeon a prescription

shall only be issued for the purposes of

treatment of animals and shall be marked "for

animal treatment only".

(4) Every medical practitioner who obtains the drugs for

professional use as provided for in the first proviso to sub-rule (3),

shall keep, in accordance with, and without prejudice to the

provisions of rule 11, a record in an appropriate register, of the

name and surname, the age and address of the patient to whom the

drug has been administered and the date of administration and the

medical indication for administering the drug.

(5) No medical practitioner shall issue a prescription for the

drugs to any person unless such person is well known to him or

unless the medical practitioner has ascertained the identity of such

person through a legally valid identification document.

(6) No medical practitioner shall issue a prescription for the

drugs to any person unless the said medical practitioner has taken

reasonably sufficient steps to ascertain that such person is not at the

time of issuing the prescription, receiving treatment from another

medical practitioner in respect of addiction to any of the drugs or

otherwise, and that such person has not been supplied with any of

such drugs on a prescription issued by that other medical

practitioner.

(7) A medical practitioner shall use a separate form in respect

of every drug prescribed by him under these Rules, and no drug

other than a drug to which the provisions of the Ordinance or of the

Drugs (Control) Regulations, apply, may be prescribed on these

forms.

(8) When issuing a manual prescription a medical practitioner

shall in prescribing the drugs use only prescription forms from the

booklets of forms in serial number issued to him by the

Superintendent of Public Health upon a request made on the form

set out in the First Schedule and it shall be the duty of a medical

practitioner, whether for the purpose of his private practice or for

carrying out his duties in an official capacity as a result of his

employment with Government, with a view to meeting the needs of

his patients, to make a request for such prescription booklets on the

said form; such request form shall be correctly filled in all respects

and signed by the practitioner, and shall be either handed in

personally to the Chief Pharmacist at the Government Medical

Stores, Gwardamangia or sent by post to the Superintendent of

Public Health at the Department of Health in Valletta; when sent by

post the envelope may be marked "Public Health Notifications" for

the purpose of exemption from postage.

(9) It shall be the duty of a medical practitioner to report in

writing forthwith to the Superintendent of Public Health any case of

theft or loss of such booklet or unauthorised access to his electronic

profile, and it shall not be lawful for a medical practitioner to use any

prescription form from any booklet of forms issued to another medical

p r a c t i t i o n e r, o r i s s u e c o m p u t e r g e n e r a t e d p r e s c r i p t i o n s o r

eprescriptions from the electronic profile of another medical

practitioner.

(10) For the purpose of this rule, the expression "medical

practitioner" includes a dental surgeon, a dentist and a veterinary

surgeon.

(11) The provisions of sub-rules (1), (2), (7), (8) and (9) shall

not apply to the prescription of the drugs for administration to ward

patients in Government hospitals, which prescription shall be

controlled by the hospital internal rules.

Added by

L.N. 64 of 1986.

(Rule 8)

DRUGS (CONTROL) REGULATIONS AND DANGEROUS DRUGS

(INTERNAL CONTROL) RULES

REQUEST FOR THE ISSUE/RENEWAL OF A CONTROL CARD FOR

NARCOTIC AND PSYCHOTROPIC DRUGS

Superintendent of Public Health

I hereby request that Mr/Ms ................................... aged .............

I. D. No. * ............................... residing at ....................................

(i)

be issued with a control card for narcotic/psychotropic drugs (§)

(ii)

have the control card for narcotic/psychotropic drugs renewed.(§)

(§) Delete whatever is inapplicable.

Signature of Medical Practitioner ...................................................

Name and Address of

Medical Practitioner

Medical Council Reg. No. ...............................................

Date .......................................

*

In case of non-Maltese citizens not holding an I.D. Card, the Passport No., is to be inserted; in the

case of a minor the particulars inserted are to be in relation to the I. D. Card or passport of the father,

mother or guardian.

(1) No person other than an apothecary shall dispense a

prescription for the drugs.

(2) No apothecary shall dispense a prescription for the drugs

unless -

(a) he is acquainted with the signature of the person by

whom it purports to have been issued, and he has no

reason to suppose that it is not genuine and he has

taken reasonable steps to satisfy himself that it is

genuine; and

(b) the prescription complies with the provisions of rule 6.

(3) The drugs shall not be supplied more than once on the

same prescription.

(4) An apothecary dispensing a prescription for the drugs shall

fill in a clear and legible hand in ink or other indelible material Part

C of the form set out in the First Schedule, supply all the details

and give all the information as therein required, and the apothecary

shal l add hi s signat ure in ful l an d th e dat e, an d shal l af ter

dispensing the prescription, retain it.

(5) For the purpose of sub-rule (4), an apothecary dispensing a

prescription for the drugs shall request the legally valid identification

document of the person in respect of whom the prescription has

been issued, the person who intends to acquire the drugs whether for

himself or on behalf of the person to whom the drugs have been

prescribed shall present the said identification document as well as his

own legally valid identification document together with the

prescription

Provided that the provision of this sub-rule, and the

relative part of the provision of sub-rule (4) shall not apply in

respect of a person who has not yet been issued with a legally valid

identification document.

(6) Every managing apothecary of a licensed dispensary shall

send to the Superintendent of Public Health in a sealed envelope on

the first day of every month all the prescriptions for the drugs

dispensed from that dispensary during the preceding month. That

envelope shall be addressed "Superintendent of Public Health,

Department of Health, Valletta" and may be marked "Public Health

Notifications" for the purpose of exemption from postage.

(7) (a) In the case of eprescriptions, the pharmacist shall

access the electronic system by the applicable official verification.

(b) The pharmacist must ensure that the prescription was sent

by the official electronic system and fill in the details specified by

these rules in the manner that is required by the electronic system.

(1) (a) No medical practitioner may prescribe any drug to

any person unless such person is in possession of a control card, as

per the Fifth Schedule, issued for the purpose by the

Superintendent of Public Health.

(b) In prescribing any drug to any person, the prescriber

shall enter in a clear, indelible and legible manner all the details set

out in columns 1 to 4 of the control card, and shall then return the

card to such person together with the prescription

Provided that a medical practitioner may, in making the

application on behalf of a person on the request form as set out in

the Sixth Schedule, also issue a prescription for a supply of a drug

to such person and may attach the prescription to such request

form

Provided further that such prescription shall only become

valid when the provisions of the proviso to sub-rule (2) have been

complied with.

(2) The Superintendent shall issue such control card to the

person concerned on receipt of a request, from a medical

practitioner to this effect, made on the form as set out in the Sixth

Schedule

Provided that in the case of a prescription for a supply of a

drug as provided for in the provisos to sub-rule (1), the

Superintendent shall enter the details of the relative prescription in

columns 1 to 4 of the control card.

(3) No control card shall be valid in excess of a period of one

year from the date on which it is issued, unless it is renewed by the

Superintendent of Public Health following a request by a medical

practitioner, on the form set out in the Sixth Schedule.

(4) No apothecary shall dispense any drug to any person who

is not in possession of a control card as set out in sub-rule (1).

(5) On dispensing a drug, the apothecary shall, in addition to

other duties laid down by these Rules or by any law, enter in a

clear, indelible and legible manner all the details set out in columns

5 to 8 on the card, and shall then return the card to the person

presenting the prescription.

(6)

(a) Notwithstanding the provisions of this rule, it shall be

lawful for a medical practitioner to prescribe in urgent

cases a drug to a patient who is not in possession of a

control card provided that

(i) the prescription is labelled "URGENT";

(ii) the amount prescribed does not exceed seven

days’ supply;

(iii) it complies with other requirements of these

Rules; and

(iv)

the prescriber notifies the Superintendent of

Public Health within forty-eight hours of issuing

such prescription, giving full particulars of the

patient, the name, form and dose and amount of

drug prescribed and reasons for the urgency.

(b) It shall be lawful for an apothecary to dispense such a

prescription complying with sub-paragraphs (i), (ii)

and (iii) of paragraph (a).

(7) The provisions of this rule shall not apply to the

prescription of a drug by a medical practitioner employed in a

Government hospital, for administration to ward patients at that

time under his care in such hospital, which prescription shall be

controlled by hospital internal rules.

(8) Any request or notification in terms of this rule may be

made in person or sent by post in a sealed envelope addressed to the

Superintendent of Public Health, Department of Health, Valletta,

and marked "Public Health Notification - Confidential" for the

purpose of exemption from postage.

(9) For the purpose of this rule, the expression "medical

practitioner" includes a dental surgeon and a dentist but does not

include a veterinary surgeon.

(10) The Superintendent may withdraw the control card of a

person who is suspected of abusing of a drug prescribed to him, or

who is in any other way abusing of the control card system.

(11) The Superintendent may include on the control card such

guidelines as he may deem necessary regarding the prescription of

any drugs.

No person shall be in possession of or attempt to obtain

possession of any of the drugs unless -

(a) he is in possession of an import or export authorisation

issued by the Chief Government Medical Officer in

pursuance of the provisions of Part VI of the

Ordinance; or

(b) he is licensed or otherwise authorised to manufacture

or supply such drug; or

(c) he is otherwise licensed by the Minister responsible

for the Department of Health or authorised by these

Rules or by any authority granted by the Minister

responsible for health to be in possession of the drug;

or

(d) he proves that the drug was supplied for his use in

accordance with such a prescription

Provided that the qualification contained in paragraph (d)

shall not apply in the case of any drug supplied to a person for his

use in accordance with a prescription if that person was at the time

of the supply in course of receiving treatment from another medical

practitioner in respect of addiction to any of the drugs or otherwise,

and of being supplied with any of the drugs on a prescription given

by that last-mentioned practitioner and did not disclose that fact to

the first-mentioned practitioner before the drug was supplied to

him.

(1) No person shall supply any of the drugs unless the

package or bottle is plainly marked in ink or in other indelible

manner with the nature and amount of the drug contained therein.

(2) No person shall supply any preparation, admixture, extract

or other article containing any of the drugs unless the package or

bottle is plainly marked in ink or other indelible manner-

(a) in the case of a powder, solution or ointment with the

total amount thereof in the package or bottle and the

percentage of the drug in the powder, solution or

ointment; and

(b) in the case of tablets or other articles with the amount

of the drug in each article and the number of articles in

the package or bottle

Provided that this rule shall not apply to any preparation

supplied in accordance with the prescription of a medical

practitioner, dental surgeon, dentist or veterinary surgeon.

(1) Every person who supplies any of the drugs shall

comply with the following provisions

(a) he shall enter or cause to be entered in a register kept

for this sole purpose all supplies of the drug purchased

or otherwise obtained by him and all dealings in the

drug effected by him (including sales or supplies to

persons outside these Islands) in the form, with such

variations as circumstances may require, and

containing the particulars shown in the Second

Schedule;

(b) he shall make the entry with respect to any of the drugs

purchased or otherwise obtained by him on the day on

which the drug is received, and with respect to any

sale or supply by him of the drug on the day on which

the transaction is effected; or, where that is not

reasonably practicable, on the day next following the

day on which the drug is received or the transaction is

effected;

(c) where he carries on business at more than one set of

premises he shall keep a separate register or registers

in respect of each set of premises;

(d) he shall keep the register or registers in some part of

the premises to which it relates, so that it or they shall

at all times be available for inspection in accordance

with the provisions of the Ordinance;

(e) he shall not cancel, obliterate or alter any entry in the

register or make therein any entry which is untrue in

any particular; any mistake in an entry may be

corrected by a marginal note or footnote giving the

correct particulars and dated;

(f)

every entry required to be made and every correction

of such an entry must be made in ink or otherwise so

as to be indelible;

(g) he shall furnish to the Chief Government Medical

Officer such particulars as the said Chief Government

Medical Officer may require in regard to any

purchases by him of the drugs, all stocks held by him

of the drugs, and all transactions effected by him in the

drugs.

(2) A drug or preparation administered by, or under the direct

supervision and in the presence of, a medical practitioner or dental

surgeon or dentist shall not be deemed to have been supplied by

him.

(3) With the approval of the Chief Government Medical

Officer, separate registers may be kept for separate departments of

a business.

(1) An apothecary is hereby authorised -

(a) to manufacture in the ordinary course of his retail

business any preparation, admixture or extract of any

of the drugs; and

(b) to carry on the business of retailing, dispensing or

compounding the drugs, but subject always to the

provisions of these Rules.

(2) Every drug in the actual custody of a person authorised by

virtue of this rule shall be kept in a locked receptacle which can be

opened only by him.

(3) Where under the provisions of article 9(2) of the Ordinance

any such authorisati on has b een w ithdrawn, notice of such

withdrawal shall be published in the Gazette.

Notwithstanding anything to the contrary contained in

these Rules, any medical practitioner, dental surgeon, dentist,

veterinary surgeon or apothecary, or any person in charge of a

laboratory used for research or instruction and attached to any

public hospital or other institution approved by the Minister

responsible for Health for the purpose, is hereby authorised, so far

as may be necessary for the practice of his profession or

employment in such capacity and in accordance with the provisions

of any law relative to such profession or employment, to be in

possession of and to supply the drugs.

(1) If any person authorised by these Rules or by an

authority granted by the Minister responsible for Health to

manufacture, supply or possess the drugs or any of them is

convicted of an offence against the Ordinance or these Rules, the

Minister responsible for Health may, if he is of opinion that that

person ought not to be allowed to manufacture, supply or possess

the drugs, withdraw the authority of such person and notice of such

withdrawal shall be published in the Gazette

Provided that nothing in this rule shall be taken to prejudice

any power otherwise vested in the Minister responsible for Health

of withdrawing any authority previously given by him.

(2) Where the person whose authority is withdrawn under sub-

rule (1) of this rule is a medical practitioner, dental surgeon, dentist

or veterinary surgeon, it shall not be lawful, if the Minister

responsible for Health so directs, for that person to give

prescriptions for the purposes of these Rules, and notice of any

such direction shall be given to the person affected thereby and

shall be published in the Gazette.

(3) If the Minister responsible for Health has reason to suspect

that a medical practitioner or dental surgeon or dentist is supplying

or prescribing drugs to or for either himself or any other person

otherwise than is properly required for the purpose of medical or

dental treatment of himself or that of any other person, the Minister

responsible for Health may refer the matter to the Tribunal

constituted in the manner specified in the Third Schedule, and, if

the Tribunal so recommends, the Minister responsible for Health

may withdraw the authority of the practitioner or dental surgeon or

dentist to supply, procure or possess the drugs and give the like

direction with respect to him as may be given under sub-rule (2) of

this rule, and notice of any such withdrawal or direction shall be

given to the person affected thereby and shall be published in the

Gazette.

(1) No person shall deliver any of the drugs to any person

not licensed or otherwise authorised to be in possession of the

drugs who purports to be sent by or on behalf of a person so

licensed or authorised unless such person produces an authority in

ink or in other indelible manner, signed by the person so licensed or

authorised, to receive the drug on his behalf, and unless the person

supplying the drug is satisfied that the authority is genuine. This

rule shall not be deemed to apply to medicines dispensed in

accordance with the provisions of these Rules.

(2)

A person to whom a drug is lawfully delivered in the

circumstances mentioned in sub-rule (1) shall be deemed to be a

person authorised to be in possession thereof, but for such period

only as in the circumstances of the case is reasonably sufficient to

enable the delivery to the recipient to be effected.

Any of the drugs in the order or disposition of any person

shall be deemed to be in his possession.

These Rules shall not apply to the preparations named in

the Fourth Schedule, nor to any such preparations when mixed with

an inert substance required to render the medicament suitably

coherent.

Prescriptions, records, registers or other documents

required to be retained or kept in pursuance of the Ordinance or of

any of these Rules shall be preserved for not less than two years

from the date of the prescription or document or the last entry in the

record register, as the case may be, and shall be kept at all times

available for inspection in accordance with the provisions of the

Ordinance.

INTERNAL CONTROL OF DANGEROUS DRUGS

INTERNAL CONTROL OF DANGEROUS DRUGS

Added by

G.N. 545 of 1957.