CHAPTER 95 THE DANGEROUS DRUGS ACT

 

 

CHAPTER 95 THE DANGEROUS DRUGS ACTCHAPTER 95

THE DANGEROUS DRUGS ACT

 

 

ARRANGEMENT OF SECTIONS

 

 

PART I PRELIMINARYPART I

PRELIMINARY

 

 

Section

  1.         Short title

  2.         Interpretation

 

 

PART II RAW OPIUM, COCA LEAVES, POPPY-STRAW, CANNABIS, ETC.PART II

RAW OPIUM, COCA LEAVES, POPPY-STRAW, CANNABIS, ETC.

 

 

  3.         Drugs to which Part II applies

  4.         Restriction of importation of drugs to which Part II applies

  5.         Restriction of exportation of drugs to which Part II applies

  6.         Power to control production, sale, etc., of drugs to which Part II applies

  7.         Penalisation of permitting premises to be used for smoking cannabis, etc.

  8.         Penalisation of intentional cultivation of cannabis plant

 

 

PART III PREPARED OPIUMPART III

PREPARED OPIUM

 

 

  9.         Prohibition of importation and exportation of prepared opium

10.         Penalisation of manufacture, sale, use, etc., of prepared opium

11.         Meaning of "prepared opium"

 

 

PART IV OTHER DRUGS AND INTERMEDIATE PRODUCTS OF SYTHESIS THEREOFPART IV

OTHER DRUGS AND INTERMEDIATE PRODUCTS OF SYTHESIS THEREOF

 

 

12.         Restriction of importation and exportation of substances specified in Part I, but falling within Part II, of Schedule

13.         Power to control manufacture, sale, etc., of substances specified in Part I of Schedule

14.         Power of Minister to amend Schedule

 

 

 

PART V GENERALPART V

GENERAL

 

 

Section

15.         Miscellaneous offences

16.         Appointment of inspectors

17.         Powers of entry and inspection

18.         Power of arrest

19.         Penalties and forfeiture

19A.       Penalty for trafficking

20.         Attempts, etc., to commit offences

21.         Offences by companies

22.         Licences and authorities

 

 

SCHEDULE-Substances dealings in which are subject to control under Part IV

 

 

 

CHAPTER 95

 

 

DANGEROUS DRUGS

An Act to control the importation, exportation, production, possession, sale, distribution and use of dangerous drugs; and to provide for matters incidental thereto.

[26th August, 1967]

42 of 1967
19 of 1985
2 of 1989
13 of 1994

 

PART I PRELIMINARYPART I

PRELIMINARY

 

 

1.    This Act may be cited as the Dangerous Drugs Act.

Short title

 

2.  (1)  In this Act, unless the context otherwise requires-

"cannabis" (except where used in the expression "cannabis resin") means the flowering or fruiting tops of any plant of the genus cannabis from which the resin has not been extracted, by whatever name they may be designated;

"cannabis resin" means the separated resin, whether crude or purified, obtained from any plant of the genus cannabis;

"coca leaves" means the leaves of any plant of the genus of the erythroxylaceae from which cocaine can be extracted, either directly or by chemical transformation;

"the Commission" means the Commission on Narcotic Drugs of the Economic and Social Council of the United Nations;

"corresponding law" means a law stated in a certificate purporting to be issued by or on behalf of the government of a country outside Zambia to be a law providing for the control and regulation in that country of the manufacture, sale, use, export and import of drugs and other substances in accordance with the provisions of the Single Convention, or a law providing for the control and regulation in that country of the manufacture, sale, use, export and import of drugs in accordance with the provisions of the Hague Convention, the Geneva Convention (No. 1) and the Geneva Convention (No. 2) as respectively amended by the Protocol;

"the Geneva Convention (No. 1)" means the international Opium Convention signed at Geneva on the 19th February, 1925;

"the Geneva Convention (No. 2)" means the Convention signed at Geneva on the 13th July, 1931, being the Convention for the purpose of supplementing the Geneva Convention (No. 1) and the Hague Convention;

"the Hague Convention" means the International Opium Convention signed at the Hague on the 23rd January, 1912;

"inspector" means a person appointed as an inspector under section sixteen;

"medicinal opium" means raw opium which has undergone the processes necessary to adapt it for medicinal use, whether it is in the form of powder or is granulated or is in any other form, and whether it is or is not mixed with neutral substances;

"opium poppy" means the plant of the species Papaver somniferum L;

"the Organisation" means the World Health Organisation;

"poppy-straw" means all parts except the seeds of the opium poppy, after mowing;

"the Protocol" means the Protocol on Narcotic Drugs signed at Lake Success, New York, on the 11th December, 1946;

"raw opium" includes powdered or granulated opium, but does not include medicinal opium;

"the Single Convention" means the Single Convention on Narcotic Drugs signed at New York on the 30th March, 1961.

Interpretation

 

(2)  In any certificate referred to in the definition of "corresponding law" in subsection (1), a statement as to the effect of the law mentioned in such certificate or a statement in any such certificate that any facts constitute an offence against that law shall be conclusive.

 

 

(3)  The specification in paragraph 1 of the Schedule of a substance shall, if the existence of isomers of that substance is possible within the specific chemical designation thereof, be taken to comprehend the specification of any isomer of that substance whose existence is possible as aforesaid; and references in paragraphs 2, 3, 8, 13 and 14 of the Schedule to a substance for the time being specified in the said paragraph 1 shall be construed accordingly.

 

 

(4)  For the purposes of this Act, an article shall be deemed to be imported under licence or exported under licence if the importer or exporter, as the case may be, is the holder of a licence issued under this Act authorising the importation or exportation, as the case may be, of the article and complies with the conditions, if any, of the licence, but not otherwise.

 

 

PART II RAW OPIUM, COCA LEAVES, POPPY-STRAW, CANNABIS, ETC.PART II

RAW OPIUM, COCA LEAVES, POPPY-STRAW, CANNABIS, ETC.

 

 

3.    The drugs to which this Part applies are raw opium, coca leaves, poppy-straw, cannabis, cannabis resin and all preparations of which cannabis resin forms the base.

Drugs to which Part II applies

 

4.    It shall not be lawful for a person to import into Zambia a drug to which this Part applies except under a licence granted by the Minister.

Restriction of importation of drugs to which Part II applies

 

5.  (1)  It shall not be lawful for a person to export from Zambia a drug to which this Part applies except under a licence granted by the Minister.

Restriction of exportation of drugs to which Part II applies

 

(2)  If at any time the importation into a foreign country of a drug to which this Part applies is prohibited or restricted by the laws of that country, there shall, while that prohibition or restriction is in force, be attached to every licence which is issued by the Minister under this Act authorising the export of that drug from Zambia such conditions as appear to him necessary for preventing or restricting, as the case may be, the exportation of that drug from Zambia to that country during such time as the importation of that drug into that country is so prohibited or restricted, and any such licence issued before the prohibition or restriction came into force shall, if the Minister by order so directs, be deemed to be subject to the like conditions.

 

 

6.    The Minister may by regulations-

(a)       provide for controlling or restricting the production, possession, sale and distribution of drugs to which this Part applies;

(b)       provide for prohibiting the production, possession, sale or distribution of any drug to which this Part applies except by persons licensed or otherwise authorised in that behalf by the Minister, and the cultivation of plants from which such drugs are derived;

(c)       prescribe measures to be taken for the eradication of plants, to which regulations made under paragraph (b) apply, found to be growing wild.

Power to control production, sale, etc., of drugs to which Part II applies

 

7.    If a person-

(a)       being the occupier of any premises, permits those premises to be used for the purpose of smoking cannabis or cannabis resin or of dealing in cannabis resin (whether by sale or otherwise); or

(b)       is concerned in the management of any premises used for any such purpose as aforesaid;

he shall be guilty of an offence against this Act.

Penalisation of permitting premises to be used for smoking cannabis, etc.

 

8.    A person who, except under a licence granted by the Minister, knowingly cultivates any plant of the genus cannabis shall be guilty of an offence against this Act.

Penalisation of intentional cultivation of cannabis plant

 

PART III PREPARED OPIUMPART III

PREPARED OPIUM

 

 

9.    It shall not be lawful for a person to import into, or to export from, Zambia, any prepared opium.

Prohibition of importation and exportation of prepared opium

 

10.    If a person-

(a)       manufactures, sells or otherwise deals in prepared opium; or

(b)       has in his possession any prepared opium; or

(c)       being the occupier of any premises, permits those premises to be used for the purpose of the preparation of opium for smoking or the sale or smoking of prepared opium; or

(d)       is concerned in the management of any premises used for any such purpose as aforesaid; or

(e)       has in his possession any pipes or other utensils for use in connection with the smoking of opium or any utensils used in connection with the preparation of opium for smoking; or

(f)        smokes or otherwise uses prepared opium or frequents a place used for the purpose of opium smoking;

he shall be guilty of an offence against this Act.

Penalisation of manufacture, sale, use, etc., of prepared opium

 

11.    In this Part, "prepared opium" means opium prepared for smoking, and includes dross and any other residues remaining after opium has been smoked.

Meaning of "prepared opium"

 

PART IV OTHER DRUGS AND INTERMEDIATE PRODUCTS OF SYNTHESIS THEREOFPART IV

OTHER DRUGS AND INTERMEDIATE PRODUCTS OF SYNTHESIS THEREOF

 

 

12.    It shall not, except under a licence granted by the Minister, be lawful for a person to import into, or to export from, Zambia a substance for the time being specified in Part I of the Schedule other than a preparation or other substance for the time being falling within Part II of the Schedule.

Restriction of importation and exportation of substances specified in Part I, but falling within Part II, of Schedule

 

13.  (1)  For the purpose of preventing the improper use of the substances for the time being specified in Part I of the Schedule, the Minister may by regulations provide for controlling the manufacture, sale, possession and distribution of those substances, and in particular, but without prejudice to the generality of the foregoing power, for-

Power to control manufacture, sale, etc., of substances specified in Part I of Schedule

 

(a)       prohibiting the manufacture of a substance for the time being so specified except on premises licensed for the purpose by the Minister and subject to any conditions specified in the licence;

 

 

(b)       prohibiting the manufacture, sale or distribution of a substance for the time being so specified except by persons licensed or otherwise authorised under the regulations by the Minister and subject to any conditions specified in the licence or authority;

 

 

(c)       regulating the issue by any medical practitioner, dental surgeon or veterinary surgeon of prescriptions containing a substance for the time being so specified and the dispensing of any such prescriptions; and

 

 

(d)       requiring persons engaged in the manufacture, sale or distribution of a substance for the time being so specified to keep such books and furnish such information either in writing or otherwise as may be prescribed by the regulations.

 

 

(2)  The regulations under this section shall provide for authorising a person lawfully carrying on business in accordance with the provisions of the Pharmacy and Poisons Act as an authorised seller of poisons-

Cap. 299

 

(a)       in the ordinary course of his retail business to manufacture, at any premises duly registered under Part II of the Pharmacy and Poisons Act, any preparation, admixture, or extract of a substance for the time being specified in Part I of the Schedule; or

Cap. 299

 

(b)       to carry on at any such premises as aforesaid the business of retailing, dispensing or compounding any such substance;

subject to the power of the Minister to withdraw the authorisation in the case of a person who has been convicted of an offence against this Act and who cannot, in the opinion of the Minister, properly be allowed to carry on the business of manufacturing or selling or distributing, as the case may be, any such substance as aforesaid.

 

 

(3)  Nothing in any regulations made under this section shall be taken to authorise the sale by retail of poisons by a person who is not qualified in that behalf under, or otherwise than in accordance with, the provisions of the Pharmacy and Poisons Act or to be in derogation of the provisions of the said Act for prohibiting, restricting or regulationg the sale of poisons.

Cap. 299

 

14.    If-

(a)       it appears to the Minister that a decision of the Commission or Organisation to alter any of the Schedules to the Single Convention or to apply to a substance measures of control applicable under that Convention to substances specified in the First Schedule thereto, requires the addition of a substance to, or the removal of a substance from, Part I or Part II of the Schedule to this Act or both the removal of a substance from Part I of that Schedule and the removal of a substance from Part II thereof; or

(b)       it appears to the Minister probable that there will be taken such a decision as aforesaid of the Commission or of the Organisation as will require the addition of a substance to Part I of the Schedule to this Act and that, in the circumstances of the case, it is expedient to anticipate the decision;

the Minister may, by statutory order, make the requisite modifications in the said Schedule.

Power of Minister to amend Schedule

 

PART V GENERALPART V

GENERAL

 

 

15.    A person-

(a)       who acts in contravention of, or fails to comply with, a regulation made under this Act; or

(b)       who acts in contravention of, or fails to comply with the conditions of a licence issued or authority granted under, or in pursuance of, this Act; or

(c)       who for the purpose of obtaining, whether for himself or for any other person, the issue, grant or renewal of any such licence or authority as aforesaid, makes a declaration or statement which is false in any particular, or knowingly utters, produces or makes use of any such declaration or statement or a document containing the same; or

(d)       who in Zambia aids, abets, counsels or procures the commission in a place outside Zambia of an offence punishable under the provisions of a corresponding law in force in that place, or does an act preparatory to, or in furtherance of, an act which if committed in Zambia would constitute an offence against this Act;

shall be guilty of an offence against this Act.

Miscellaneous offences

 

16.  (1)  Subject to the provisions of subsection (2), the Minister may appoint inspectors for the purposes of this Act.

Appointment of inspectors

 

(2)  No person shall be appointed as an inspector unless he is a person authorised to compound or dispense poisons or drugs under the Pharmacy and Poisons Act.

Cap. 299

 

17.  (1)  An inspector shall, for the purpose of the execution of Parts II, III and IV, have power to enter the premises of a person carrying on the business of a producer, manufacturer, seller or distributor of any drugs to which Part II or III applies or any substances for the time being specified in Part I of the Schedule and to demand the production of, and to inspect, any books or documents relating to dealings in any such drugs or substances and to inspect any stocks of any such drugs or substances.

Powers of entry and inspection

 

(2)  If a magistrate is satisfied by information on oath that there is reasonable ground for suspecting-

 

 

(a)       that any drugs to which Part II or III applies or any substances for the time being specified in Part I of the Schedule are, in contravention of the provisions of this Act or any regulations made thereunder, in the possession or under the control of a person in any premises, place, receptacle, aircraft, boat, train or other vehicle of whatever description; or

 

 

(b)       that a document directly or indirectly relating to, or connected with, a transaction or dealing which was, or an intended transaction or dealing which would if carried out be, an offence against this Act, or in the case of a transaction or dealing carried out or intended to be carried out in a place outside Zambia, an offence against the provisions of a corresponding law in force in that place, is in the possession or under the control of a person in any premises, place, receptacle, aircraft, boat, train or other vehicle of whatever description:

he may grant a search warrant authorising any inspector, customs officer or police officer named in the warrant, at any time or times within one month from the date of the warrant, to enter, if need be by force, such premises, place, receptacle, aircraft, boat, train or other vehicle, as the case may be, and to search the same and any persons found therein and, if there is reasonable ground for suspecting that an offence against this Act has been committed in relation to any such drugs or substances as aforesaid which may be found in such premises, place, receptacle, aircraft, boat, train or other vehicle or in the possession of any such persons, or that a document which may be so found is such a document as is mentioned in paragraph (b), to seize and detain those drugs or substances or that document, as the case may be.

 

 

(3)  If a person wilfully delays or obstructs a person in the exercise of his powers under this section or fails to produce, or, conceals or attempts to conceal, any such books, stocks, drugs, substances or documents as aforesaid, he shall be guilty of an offence against this Act.

 

 

18.    A police officer may arrest without warrant a person who has committed or attempted to commit, or is reasonably suspected by the police officer of having committed or attempted to commit an offence against this Act, if he has reasonable ground for believing that that person will abscond unless arrested, or if the name and address of that person are unknown to, and cannot be ascertained by, him.

Power of arrest

 

19.  (1)  Every person guilty of an offence against this Act shall, in respect of each offence, be liable (subject to subsection (2)) on conviction to a fine not exceeding five thousand penalty units or to imprisonment for a period not exceeding three years, or to both.

Penalties and forfeiture

 

(2)  No person shall, on conviction for an offence against this Act consisting in a contravention of, or failure to comply with, a regulation under this Act relating to the keeping of books or the issuing or dispensing of prescriptions containing drugs to which Part II or III applies or substances for the time being specified in Part I of the Schedule, be sentenced to imprisonment without the option of a fine or to pay a fine exceeding three thousand two hundred penalty units, if the court is satisfied that the offence was committed through inadvertence, and was not preparatory to, or committed in the course of, or in connection with, the commission or intended commission of any other offence against this Act.

 

 

(3)  A person convicted of an offence against this Act shall forfeit to the Republic all articles in respect of which the offence was committed, and the court before which he is convicted may order those articles to be destroyed or otherwise disposed of as the court thinks fit.

(As amended by Acts No. 19 of 1985, No. 2 of 1989
and No. 13 of 1994)

 

 

19A.    Notwithstanding the penalties provided for in section nineteen, where a person is convicted of an offence under this Act, and the court is satisfied that the offence relates to trafficking in any drug to which Part II, III or IV of the Act applies, the offender shall be liable to an unlimited fine of not less than five hundred penalty units or to imprisonment for a period not exceeding fifteen years or to both, such fine and imprisonment.

(As amended by Acts No.19 of 1985 and No. 13 of 1994)

Penalty for trafficking

 

20.    If a person attempts to commit an offence against this Act, or solicits or incites another person to commit such an offence, he shall, without prejudice to any other liability, be liable on conviction to the same punishment and forfeiture as if he had committed an offence against this Act.

Attempts, etc., to commit offences

 

21.    Where a person convicted of an offence against this Act is a company, the chairman and every director and every officer concerned in the management of the company shall be guilty of the like offence unless he proves that the act constituting the offence took place without his knowledge or consent.

Offences by companies

 

22.    A licence or authority issued or granted for the purposes of this Act by the Minister may be issued or granted on such terms and subject to such conditions (including, in the case of a licence, the payment of a fee) as the Minister thinks proper.

Licences and authorities

 


 

SCHEDULE

 

 

(Sections 12, 13 and 14)

 

 

SUBSTANCES DEALINGS IN WHICH ARE SUBJECT TO CONTROL UNDER PART IV

 

 

PART I

 

 

SUBSTANCES DEALINGS IN WHICH ARE SUBJECT TO CONTROL EXCEPT, IN THE CASE OF ANY SPECIFIED IN PART II, AS REGARDS IMPORTATION AND EXPORTATION

 

 

1.     Acetorphine (M 183)

Acetyldihydrocodeine

Allylprodine

Alphacetylmethadol

Alphameprodine

Alphamethadol

Alphaprodine

Amphetamine

Anileridine

Benzethidine

Benzylmorphine (3-benzylmorphine)

Betacetylmethadol

Betameprodine

Betamethadol

Betaprodine

Clonitszene

Cocaine

Codeine

Desomorphine

Dexamphetamine

Dextromoramide

Diamorphine

Diampromide (n-(2-(N-methylphenethylamino)propyl)propionanilide

Diethylthiambutene

Dihydrocodeine

Dihydromorphine

Dimenoxadole

Dimepheptanol

Dimethylthiambutene

Dioxaphetyl butyrate

Diphenoxylate

Dipipanone

Eegonine

Ethylmethylthiambutene

Ethylmorphine (3-ethylmorphine)

Eticyclidine

Etonitazene

Etorphine (M99)

Etoxeridine

Fentanyl

Furethidine

Hydrocodone (dihydrocodsinone)

Hydromorphinol

Hydromorphone

Hydroxypethidine

Hydroxy-7,8,9,10-tetrahydro 6,6,9-trimethyl-dibenzo (b,d) pyran

Isomethadone

Ketobemidone

Levomethorphan

Levomoramide

Levophenacylmorphan

Levorphanol

Mecloqualone

*Metaqualone

Metazocine

Methadone

Methadyl acctate

Methamphetamine

Methyldesorphine

Methyldihydromorphine (6-methyldihydromorphine)

Methypheridase

Metapon

Morpheridine

Morphine

Morphine methobromide, morphine-N-oxide and other pentavalent nitrogen morphine derivatives

Myrophine

Nicocodine

Nicodicodine

Nicomorphine (3,6-dinicotinoylmorphine)

Noracymethadol

Norcodeine

Norlevorphanol

Normethadone

Normorphine

Norpipanone

Oxycodone

Oxymorphone

Pethidine

Phenadoxone

Phenampromide

Phenazocine

Phencyclindine

Phenmentrazine

Phenomorphan

Phenoperidine

Pholcodine

Piminidono

Piritramide

Proheptazine

Properidine (1-methyl-4-phenylpiperidine-4-carboxylic acid isopropyl ester)

Psilocybine

Racemethorphan

Racemoramide

Racemorphan

Rolicyclindine

Tenocyclindine

Thebacon

Thebaine

Trimeperidine

4-Cyano-2-dimethylamine-4, 4-diphenylbutane

1-(3-cyano-3,3-diphenylpropyl) 4(1-piperidine) piperidine-4-carboxylic acid amide and its salts, and any preparation, admixture, extract or other substance containing any proportion of 1-(3-cyano-3, 3-diphenylpropyl-4-(1-piperidine) piperidine,4-carboxylic acid amide

4-Cyano-1-methyl-4-phenylpiperidine

3-(1,2-dimethylheptyl-1)

1-Methyl-4-phenylpiperidine-4-carboxylic acid

2-Methyl-3-morpholine-1,1-diphenylpropane-carboxylic acid

4 Phenylpiperidine-4-carboxylic acid ethyl ester

(+)-Lysergide

N,N-diethyltryptamine

N,N-dimethyltryptamine

2.   Any ester (other than one expressly mentioned in paragraph 1) or other (other than one so mentioned) of a substance for the time being specified in that paragraph.

3.     Any salt of a substance for the time being specified in paragraph 1 or 2.

4.     Any derivative of cegonine which is convertible to cegonine or to, cocaine.

5.    Concentrate of poppy-straw (that is to say, the material arising when poppy-straw has entered into a process for the concentration of its alkaloride).

6.      Medicinal opium.

7.      Any extract or tincture of cannabis.

8.    Any preparation, admixture, extract or other substance containing any proportion of a substance for the time being specified in paragraph 1 or in any of paragraphs 2 to 7.

(As amended by S.I. 144 of 1985)

 

 


 

PART II

 

 

PREPARATIONS AND OTHER SUBSTANCES FALLING WITHIN PART I WHOSE IMPORTATION AND EXPORTATION IS EXCEPTED FROM CONTROL

 

 

9.  (1)  A preparation of not more than one of the substances to which this paragraph applies, when compounded with one or more other ingredients and containing not more than 100 milligrammes of the substance per dosage unit and with a concentration of not more than 2.5 per centum in undivided preparations.

(2)  The substances to which this paragraph applies are acetydihydro-eodeine, codeine, dihydroecodeine, ethylmorphine (3-ethylmorphine), norcodeine, pholeodine and their respective salts.

10.    A preparation of cocaine containing not more than 0.1 per centum of cocaine calculated as cocaine base, being a preparation compounded with one or more other ingredients in such a way that the cocaine cannot be recovered by readily applicable means or in a yield which would constitute a risk to health.

11.    A preparation of medicinal opium or morphine containing (in either case) not more than 0.2 per centum of morphine calculated as anhydrous morphine base, being a preparation compounded with one or more other ingredients in such a way that the opium or, as the case may be, the morphine, cannot be recovered by readily applicable means or in a yield which would constitute a risk to health.

12.  Preparations of diphenoxylate containing, per dosage unit, not more than 2.5 milligrammes of diphenoxylate calculated as base and not less than 25 microgrammes of atropine sulphate.

13.    Pulvis Ipecacuanhae et Opii Compositus:

   10 per centum opium, in powder,

   10 per centum lpecacuanha root, in powder, well mixed with

   80 per centum of any other powdered ingredient containing neither a drug to which Part II or III of this Act applies nor a substance for the time being specified in paragraph 1 of this Schedule or in any of paragraphs 2 to 8 thereof.

14.   Mixtures containing not more than one of the preparations specified in paragraphs 9 to 13, being mixtures whereof none of the other ingredients is either a drug to which Part II or III of this Act applies or a substance for the time being specified in paragraph 1 of this Schedule or in any of paragraphs 2 to 8 thereof.

 

 

 

SUBSIDIARY LEGISLATION

 

 

THE DANGEROUS DRUGS REGULATIONS

 

 

ARRANGEMENT OF REGULATIONS

 

 

PART I PRELIMINARYPART I

PRELIMINARY

 

 

Regulation

  1.         Title

  2.         Interpretation

 

 

PART II CONTROL OF RAW OPIUM, ETC.PART II

CONTROL OF RAW OPIUM, ETC.

 

 

  3.         Application

  4.         Supply, procuring, and advertising of drugs

  5.         Possession of drugs

  6.         General authority for certain classes of persons to possess and supply drugs

  7.         Cultivation of plants

  8.         Clearing of plants from land by owner or occupier

  9.         Keeping of register

 

 

PART III CONTROL OF SUBSTANCES IN PART I OF THE SCHEDULE TO THE ACTPART III

CONTROL OF SUBSTANCES IN PART I OF THE SCHEDULE TO THE ACT

 

 

10.         Application

11.         Manufacture of drugs

12.         Supply, procuring, and advertising of drugs and preparations

13.         Possession of drugs and preparations

14.         General authority for certain classes of persons to possess and supply drugs and preparations

15.         Special provisions in respect of certain public officers, etc.

16.         Special provisions in respect of midwives

17.         Special provisions in respect of operators of aircraft

18.         General authority for authorised sellers of poisons to manufacture preparations and to retail drugs and preparations

19.         Form of prescription

20.         Provisions as to supply on prescription

21.         Report of cases to Permanent Secretary

22.         Treatment of drug addicts

23.         Markings of packets and bottles

24.         Production of order in writing to supplier

25.         Keeping of register

 

 

PART IV GENERALPART IV

GENERAL

 

 

26.         Definition of "drug"

27.         Definition of "possession"

28.         Supply otherwise than on prescription

29.         Withdrawal of authority

30.         Consignment between places outside Zambia

31.         Revocation or amendment of licence or group authority

32.         Requirements as to registers

33.         Preservation of documents

34.         Exemption of police officers and carriers

35.         Exemption of certain classes of agents

36.         Requirements in respect of cessation of practice, etc.

37.         Construction of licence or authority

38.         Movement licence

39.         Form of application for licence

40.         Revocation of F.G.N. No. 59 of 1956 and savings

 

 

FIRST SCHEDULE-Midwives' Supply Order

 

 

SECOND SCHEDULE-Form of Register

 

 

THIRD SCHEDULE-Prescribed Fees preparation,

 

 

 

DANGEROUS DRUGS

 

 

SECTION 6-DANGEROUS DRUGS REGULATIONS

Regulations by the Minister

Statutory Instrument
128 of 1971
50 of 1976
65 of 1993
Act No.
13 of 1994

 

PART I PRELIMINARYPART I

PRELIMINARY

 

 

1.    These Regulations may be cited as the Dangerous Drugs Regulations.

Title

 

2.    In these Regulations, unless the context otherwise requires-

Interpretation

 

"authorised as a member of a group" means authorised by virtue of being a member of a class in respect of which the Permanent Secretary has granted an authority under and for the purpose of regulation 4, 5, 12 or 13 which is in force;

 

 

"group authority" means such an authority so granted, and "his group authority", in relation to a person who is a member of such a class, means the authority so granted to that class;

 

 

"authorised seller of poisons" means an authorised seller of poisons within the meaning of the Pharmacy and Poisons Ordinance;

Cap. 299

 

"dental surgeon" means a person registered as a dental surgeon under the Medical and Allied Professions Act, 1965;

Cap. 297

 

"generally authorised" in relation to any person, means authorised by, as the case may be, regulation 6, 11, 14, 16, 17 or 18 by virtue of being a member of a class specified in that regulation, or of being a person of a description so specified, and "general authority" means the authority possessed by a person as aforesaid;

 

 

"licensed" means duly licensed by a licence issued by the Permanent Secretary to the person named therein, or, as the case may be, in respect of premises named therein, under and for the purposes of regulation 4, 5, 7, 11, 12, 13, 15 or 30, and "licence" and "licensed premises" shall be construed accordingly;

 

 

"medical practitioner" means a person registered as a medical practitioner under the Medical and Allied Professions Act, 1965;

Cap. 297

 

"midwife" means a person registered as a midwife under the Medical and Allied Professions Act 1965, or any written law amending or replacing that Act, which provides for registration of midwives;

Cap. 297

 

"nurse" means a person registered as a nurse under the Medical and Allied Professions Act, 1965, or any written law amending or replacing that Act, which provides for registration of nurses;

Cap. 297

 

"Permanent Secretary" means the Permanent Secretary responsible for the Department of the Government for the time being administering the Dangerous Drugs Act, 1967;

Cap. 95

 

"pharmacist" means a person registered as a pharmacist under the Medical and Allied Professions Act, 1965;

Cap. 297

 

"Pharmacy Act book" means either of the books required to be kept by subsection (2) of section twenty-one and subsection (3) of section twenty-four of the Pharmacy and Poisons Act.

Cap. 299

 

"prescription" means a prescription for a single individual given by a medical practitioner for the purposes of medical treatment, by a dental surgeon for the purposes of dental treatment, or by a veterinary surgeon for the purposes of animal treatment;

 

 

"register" means a bound book and does not include any form of loose leaf register or card index;

 

 

"registered premises" means premises registered in terms of the Pharmacy and Poisons Act;

Cap. 299

 

"retail business" means the business of retailing, dispensing, or compounding drugs carried on at a shop;

 

 

"retail dealer" means a person who carries on a retail business;

 

 

"veterinary surgeon" means a person registered as a veterinary surgeon under the Veterinary Surgeons Act;

Cap. 243

 

"wholesale dealer" means any person who carries on the business of selling drugs to persons who buy to sell again.

 

 

PART II CONTROL OF RAW OPIUM, ETC.PART II

CONTROL OF RAW OPIUM, ETC.

 

 

3.    This Part of these Regulations shall apply to any drug, resin or preparation, other than poppy straw and extract or tincture of cannabis, to which Part I of the Act applies, and hereafter in this Part the expression "drrug" means any such drug, resin or preparation as aforesaid.

Application

 

4.  (1)  A person shall not supply, procure, offer to supply or procure, to or for any person, including himself, whether in Zambia or elsewhere, or advertise for sale a drug unless he is generally authorised, or, under this regulation, licensed or authorised as a member of a group so to do, nor otherwise than in accordance with the provisions of these Regulations, and, in the case of a person licensed or authorised as a member of a group, with the terms and conditions of his licence or group authority.

Supply, procuring, and advertising, of drugs

 

(2)  A person shall not supply, procure, or offer to supply or procure a drug to, or for, any person in Zambia unless that person is generally authorised, or, under regulation 5, licensed or authorised as a member of a group to be in possession of the drug and the drug is to be supplied or procured in accordance with the provisions of these Regulations, and, in the case of a person licensed or authorised as a member of a group, with the terms and conditions of his licence or group authority.

 

 

5.    A person shall not be in possession of a drug unless he is generally so authorised or, under this regulation, so licensed or authorised as a member of a group, nor otherwise than in accordance with the provisions of these Regulations and, in the case of a person licensed or authorised as a member of a group with the terms and conditions of his licence or group authority.

Possession of drugs

 

6.  (1)  Subject to the provisions of these Regulations, a person who is a member of any of the following classes, that is to say-

General authority for certain classes of persons to possess and supply drugs

 

(a)       medical practitioners;

 

 

(b)       veterinary surgeons;

 

 

(c)       authorised sellers of poisons;

 

 

(d)       registered pharmacists employed or engaged at a hospital, clinic, dispensary, like institution administered by the Government, or by a local authority, in any other hospital, clinic, dispensary or like institution approved by the Minister, or in any Government medical store;

 

 

(e)       a person in charge of a laboratory used for the purpose of research or instruction and attached to-

(i)        the University of Zambia or other educational institution approved by the Minister;

(ii)       any hospital referred to in paragraph (d);

 

 

(f)        a Government analyst;

 

 

(g)       persons duly appointed inspectors under the Act

shall be authorised so far as may be necessary for the practice or exercise of his profession, function, or employment, and in his capacity as a member of his said class, to be in possession of, and to supply, drugs.

 

 

(2)  Every drug in the actual custody of a person authorised by virtue of this regulation to be in possession thereof, shall, except when the necessities of the practice of the profession, function, or employment, by virtue of which that person is authorised as aforesaid, otherwise require, be kept in a locked receptacle which can be opened only by him or some other person authorised by virtue of this regulation to be in possession of the drug.

 

 

7.  (1)  No person who is not a person licensed under this regulation shall cultivate any plant from which a drug is derived.

Cultivation of plants

 

(2)  No person licensed under this regulation shall cultivate any plant from which a drug is derived otherwise than in accordance with the terms and conditions of his licence.

 

 

8.  (1)  Every owner or occupier of land shall clear or cause to be cleared from his land any plant from which a drug is derived, which is found to be growing wild or which is being cultivated in contravention of the provisions of these Regulations.

Clearing of plants from land by owner or occupier

 

(2)  The owner or occupier of land who has cleared or caused to be cleared from his land any plants from which a drug is derived shall destroy the plants so cleared by fire.

 

 

9.    Every person generally authorised, licensed, or authorised as a member of a group, to supply any drugs shall comply with the following provisions, that is to say-

(a)       he shall, in accordance with the provisions of this regulation and regulation 32, keep a register and enter therein, in chronological sequence in the form specified in the Second Schedule to these Regulations, true particulars with respect to every quantity of any drug obtained by him, and with respect to every quantity of any drug supplied by him whether to persons within or to persons outside Zambia;

(b)       he shall use a separate register or separate part of the register with respect to each of the following classes of drugs, that is to say-

(i)        raw opium;

(ii)       coca leaves;

(iii)      cannabis and cannabis resin and all preparations (other than extract or tincture of cannabis) of which cannabis resin forms the base.

Keeping of register

 

PART III CONTROL OF SUBSTANCES SPECIFIED IN PART I OF THE SCHEDULE TO THE ACTPART III

CONTROL OF SUBSTANCES SPECIFIED IN PART I OF THE SCHEDULE TO THE ACT

 

 

10.  (1)  This Part of these Regulations shall apply to any substance for the time being specified in Part I of the Schedule to the Act.

Application

 

(2)  In the following provisions of this Part the expression "drug" means any substance to which this Part applies other than a preparation as defined for the purpose of this Part in sub-regulation (3).

 

 

(3)  In this Part the expression "preparation" means any preparation, admixture, extract or other substance, containing any proportion of a substance to which this Part applies.

 

 

11.    A person shall not manufacture, or carry on any process in the manufacture of, a drug-

(a)       unless he is generally authorised, or licensed under this regulation, so to do:

            Provided that no person shall be licensed under this regulation with respect to diamorphine;

(b)       except on premises on which he is permitted by his general authority so to do, or on premises licensed for the purpose under this regulation;

(c)       otherwise than in accordance with the provisions of these Regulations, and, in the case of a person licensed, with the terms and conditions of his licence.

Manufacture of drugs

 

12.  (1)  A person shall not supply, procure, or offer to supply or procure, to or for any person, including himself, whether in Zambia or elsewhere, or advertise for sale a drug or preparation, unless he is generally authorised, or, under this regulation, licensed or authorised as a member of a group so to do, nor otherwise than in accordance with the provisions of these Regulations, and, in the case of a person licensed or authorised as a member of a group, with the terms and conditions of his license or group authority.

Supply, procuring, and advertising of drugs and preparations

 

(2)  A person shall not supply, procure, or offer to supply or procure a drug or preparation to, or for, any person in Zambia, unless that person is generally authorised, or, under regulation 13, licensed or authorised as a member of a group to be in possession of the drug or preparation and the drug or preparation is to be supplied or procured in accordance with the provisions of these Regulations, and, in the case of a person licensed or authorised as a member of a group, with the terms and conditions of his licence or group authority:

 

 

Provided that for the purposes of this sub-regulation the administration of a drug or preparation-

 

 

(a)       by or under the direct supervision, and in the presence, of a medical practitioner;

 

 

(b)       by or under the direct personal supervision, and in the presence, of a dental surgeon;

 

 

(c)       by a nurse in charge of a ward, theatre, or outpatients department, in a hospital;

 

 

(d)       by a midwife under, and, in accordance with regulation 16;

 

 

(e)       by a person authorised as a member of a group to supply that drug or preparation acting under or in accordance with the terms and conditions of his group authority;

shall not be deemed to be the supplying of the drug or preparation.

 

 

13.  (1)  A person shall not be in possession of a drug or preparation, unless he is generally so authorised or, under this regulation, so licensed or authorised as a member of a group, nor otherwise than in accordance with the provisions of these Regulations and, in the case of a person licensed or authorised as a member of a group, with the terms and conditions of his licence or group authority.

Possession of drugs and preparations

 

(2)  For the purposes of these Regulations-

 

 

(a)       a person to whom a drug or preparation is lawfully supplied by a medical practitioner or veterinary surgeon;

 

 

(b)       a person to whom a drug or preparation is lawfully supplied on a prescription given by a medical practitioner, a dental surgeon, or veterinary surgeon;

 

 

(c)       a person to whom a drug or preparation is lawfully supplied by an authorised seller of poisons;

shall be deemed to be a person generally authorised to be in possession of the drug or preparation so supplied:

 

 

Provided that a person supplied with a drug or preparation by, or on a prescription given by, a medical practitioner shall be deemed not to be a person generally authorised to be in possession of the drug or preparation if-

 

 

(i)        he was then being supplied with a drug or preparation by, or on a prescription given by, another medical practitioner in the course of treatment, and did not disclose the fact to the first mentioned medical practitioner before obtaining the supply from that practitioner or on the said practitioner's prescription; or

 

 

(ii)       he or any other person on his behalf made a declaration or statement for the purpose of obtaining the supply or prescription, and the declaration or statement was false in any particular.

 

 

14.  (1)  Subject to the provisions of these Regulations, a person who is a member of any of the following classes, that is to say-

General authority for certain classes of persons to possess and supply drugs and preparations

 

(a)       medical practitioners;

 

 

(b)       dental surgeons;

 

 

(c)       veterinary surgeons;

 

 

(d)       pharmacists who are employed or engaged at a hospital, clinic, dispensary, or like institution, administered by the Government or by a local authority or in any other hospital, clinic, dispensary, or like institution approved by the Minister, or in any Government medical store;

 

 

(e)       a nurse in charge of a ward, theatre, or outpatients department, in a hospital;

 

 

(f)        a person in charge of a laboratory used for the purposes of research or instruction and attached to-

(i)        the University of Zambia or other educational institution, or such a hospital as aforesaid approved for the purposes of this regulation by the Minister; or

(ii)       any hospital referred to in paragraph (d);

 

 

(g)       Government analyst; or

 

 

(h)       persons appointed as inspectors under the Act;

shall be authorised, so far as may be necessary for the practice or exercise of his said profession, function, or employment, and in his capacity as a member of his said class, to be in possession of, and to supply, drugs and preparations:

 

 

Provided that nothing in this sub-regulation shall-

 

 

(i)        authorise a dental surgeon to supply drugs or preparations unless the drugs or preparations are administered by him, or under his direct supervision and in his presence, to persons receiving treatment by him; or

 

 

(ii)       authorise a nurse in charge of a ward, theatre, or outpatients department, in a hospital-

A.        to procure a drug or preparation, except from a person employed or engaged in dispensing medicines at the hospital or infirmary, and except upon a written order therefor signed by her; or

B.        to supply a drug or preparation, except in accordance with the directions of a medical practitioner in charge of any patients in the ward, theatre or outpatients department, as the case may be.

 

 

(2)  A written order, signed by a nurse to which paragraph A of proviso (ii) to sub-regulation (1) relates, shall be marked in such a way as to show that it has been fulfilled, by the person employed or engaged in dispensing medicines who fulfils that order, and be kept in the dispensary, and a copy of the order shall be kept by the nurse in charge of that hospital department, for which the drug or preparation to which the order relates was procured.

 

 

(3)  The matron of any hospital referred to in paragraph (d) of sub-regulation (1), in which no pharmacist is employed or engaged in dispensing medicines, is authorised in her capacity as a matron and so far as is necessary for the purposes of that hospital and the exercise of her duties, to procure drugs and preparations on the order, in writing, of a medical practitioner employed or engaged in that hospital, and to be in possession of, and to supply, drugs and preparations so procured.

 

 

(4)  Every drug or preparation in the actual custody of a person authorised by virtue of this regulation, or procure, administer, possess, or supply the said drug or preparation, shall, except when the necessities of the practice of the profession, function, or employment, by virtue of which that person is authorised as aforesaid, otherwise require, be kept in a locked receptacle which can be opened only by him or by some other person authorised by virtue of this regulation, to be in possession of that drug or preparation.

 

 

15.  (1)  The Permanent Secretary may at his discretion licence-

Special provisions in respect of certain public officers, etc.

 

(a)       any Government officer in charge of a station at which no Government medical officer is stationed, or from which a Government medical officer is for the time being absent;

 

 

(b)       any Government officer who undertakes a journey on duty during which he will be more than twenty-four hours' distance from any Government station;

 

 

(c)       any person in charge of a mission station of a missionary society;

 

 

(d)       a police officer in charge of a police station; or

 

 

(e)       a first-aid worker in the employ of any mining company;

to procure, possess, and administer, drugs and preparations, subject to the provisions of sub-regulation (2) and such terms and conditions as the Permanent Secretary may fix.

 

 

(2)  The following provisions shall apply to the supply to, and the possession, and administration by, a person licensed in terms of sub-regulation (1), that is to say-

 

 

(a)       on each occasion that he procures a drug or preparation, he shall, in addition to a signed order referred to in regulation 24, produce his licence to the supplier;

 

 

(b)       on each occasion that he procures a drug or preparation he shall enter in a drugs register to be kept by him and used solely for the purpose of this sub-regulation, the name and the amount of the drug or preparation, the form in which it is procured, the date, and the name and address of the supplier;

 

 

(c)       he shall, when he administers a drug or preparation, as soon as practicable thereafter, enter in his drugs register the name of the drug or preparation administered, the name and address of the person to whom it was administered, the amount administered, and the form in which it was administered.

 

 

(d)       he shall, except when a drug or preparation, is to be administered, kept every drug or preparation in his custody, in a locked receptacle which can be opened only by him or another licensed person; and

 

 

(e)       he shall not administer a drug or preparation procured in terms of this regulation otherwise than for strictly medical purposes.

 

 

16.  (1)  In this regulation, the expression "midwives' supply order" means an order in the form prescribed in the first Schedule to these Regulations, specifying the name of the midwife obtaining a supply of the drug or preparation, stating the fact that she is a midwife and giving the following particulars in regard to the drug or preparation to be procured, that is to say, its name, the purpose for which it is required and the total quantity to be procured, or, when the drug or preparation is packed in ampoules, either the said total quantity or the total quantity intended to be administered or
injected.

Special provisions in respect of midwives

 

(2)  A midwife is hereby authorised, so far as is necessary for the practice of her profession or employment as a midwife, to be in possession of tincture of opium and pethidine, which she has procured upon furnishing to the supplier thereof a midwives' supply order, and to administer those drugs or preparations.

 

 

(3)  An application for a midwives' supply order shall be made in writing to the Permanent Secretary.

 

 

(4)  A midwives' supply order will be valid until the thirty-first day of December in the year it is issued.

 

 

(5)  The following provisions shall apply to the supply to a midwife, and the possession and administration by a midwife, of drugs or preparations, that is to say-

 

 

(a)       on each occasion a midwife procures a drug or preparation she shall, in addition to a signed order referred to in regulation 24, produce her midwives' supply order;

 

 

(b)       the supplier shall note on the midwives' supply order the date on which the drugs or preparations are supplied, the name and quantity of the drugs or preparations supplied, and his name and address;

 

 

(c)       on each occasion a midwife procures a drug or preparation she shall enter in a drugs register, to be kept by her and used solely for the purpose of this regulation, the name and amount of the drug or preparation, the form in which it is procured, the date, and the name and address of the supplier;

 

 

(d)       a midwife shall, when she administers a drug or preparation or as soon as practicable thereafter, enter in the drugs register the name of the drug or preparation administered, the amount administered, and the form in which it is administered;

 

 

(e)       a midwife shall not in any one year procure a quantity of a drug or preparation greater than the total amount of that drug or preparation specified in her midwives' supply order; and

 

 

(f)        a midwife shall, except when the necessities of the practice of her profession or employment as a midwife otherwise require, keep every drug in her possession in a locked receptacle which can be opened only by her.

 

 

17.  (1)  In this regulation-

"aircraft" means any aircraft in which passengers are carried for hire or reward;

"Air Navigation Regulations" means the Air Navigation Regulations made under the Aviation Act or any Act amending or replacing the same;

"Director of Civil Aviation" has the meaning assigned to it in the Air Navigation Regulations;

"operator" means any person who is the owner or operator of any aircraft;

"passengers carried for hire or reward" has the meaning assigned to it in the Air Navigation Regulations.

Special provisions in respect of operators of aircraft
Cap. 444

 

(2)  Subject to the provisions of sub-regulation (8) all operator is authorised to procure and possess drugs and preparations, for the purposes of regulation 34 of the Air Navigation Regulations (which relates to first-aid equipment).

 

 

(3)  The following provisions shall apply to the supply to, and the possession by, an operator, of drugs and preparations, that is to say-

 

 

(a)       an order referred to in regulation 24, for the supply of drugs and preparations, shall be made in duplicate on the official note paper of the operator, and shall be signed and dated by the operator or his authorised representative;

 

 

(b)       it shall be stated in the order whether the order is for the initial supply or for replacement of any drugs or preparations previously supplied in terms of this regulation and, if for replacement, the reason therefor;

 

 

(c)       the order shall be countersigned by the Director of Civil Aviation, who shall send the duplicate to the Permanent Secretary;

 

 

(d)       drugs and preparations shall be in single dose ampoule-syringe form or in the form of an ampoule with a sterile disposable syringe needle and an ampoule file, and shall be kept in a sealed container adequately labelled to indicate the method of use and the quantity and nature of the contents and kept in the first-aid kit of the aircraft;

 

 

(e)       the quantity of drugs and preparations carried in any aircraft shall not amount to more than the equivalent of 15 mg of morphine for each person who may lawfully be on board that aircraft at any one-time;

 

 

(f)        a responsible official appointed by the operator shall-

(i)        satisfy himself at intervals not exceeding one month, that the drugs and preparations carried in each aircraft have not been removed from the first-aid kit for any unauthorised purpose;

(ii)       inspect and check at intervals not exceeding six months, the drugs and preparations carried in each aircraft;

 

 

(g)       the operator shall keep a permanent record, at his principal place of business in Zambia, of the receipt, distribution, and disposal, of all drugs and preparations obtained in terms of this regulation;

 

 

(h)       drugs and preparations procured by an operator in terms of this regulation shall not be transferred, on the change of ownership of any of his aircraft, to another person without the permission of the Permanent Secretary.

 

 

(4)  Any person who ceases to be an operator shall-

 

 

(a)       notify the Permanent Secretary of the fact; and

 

 

(b)       dispose of the drugs and preparations in his possession in accordance with the directions of the Permanent Secretary.

(As amended by S.I. No. 50 of 1976)

 

 

18.  (1)  An authorised seller of poisons shall be authorised-

General authority for authorised sellers of poisons to manufacture preparations and to retail drugs and preparations.

 

(a)       in the ordinary course of his retail business, to manufacture at any premises registered under section fifteen of the Pharmacy and Poisons Act-

(i)        any extract or tincture of cannabis; and

(ii)       any preparation;

Cap. 299

 

(b)       subject to the provisions of these Regulations, to carry on at any such premises the business of retailing, dispensing, and compounding, drugs and preparations; and

 

 

(c)       to supply drugs and preparations otherwise than by way of wholesale dealing:

 

 

Provided that nothing in this regulation shall be construed as authorising any such person to be in possession of any drug or preparation except on premises registered under the said section fifteen.

 

 

(2)  Every drug or preparation, other than a preparation for the time being specified in Part I of the Schedule to the Act, in the actual custody of a person authorised by virtue of this regulation to be in possession thereof, shall be kept in a locked receptacle which can be opened only by him or by some assistant of his who is a registered pharmacist and is not a person whose authority has been withdrawn under regulation 29.

 

 

19.  (1)  In this regulation the expression "recognised preparation" means a preparation contained in the British Pharmacopoeia, the British Pharmaceutical Codex, or the British National Formulary a publication issued jointly by the British Medical Association and the Pharmaceutical Society of Great Britain and used, for the purposes of those Regulations, to serve the usual requirements of persons prescribing preparations whether in hospitals or in general practice.

Form of prescription

 

(2)  The following provisions shall apply to prescriptions prescribing a drug or preparation, that is to say-

 

 

(a)       a prescription shall be in writing and shall be signed by the person giving it, with his usual signature, and dated by him;

 

 

(b)       a prescription shall be written in ink or otherwise so as to be indelible;

 

 

(c)       a prescription shall specify the name and address of the person for whose treatment it is given or, if it is given by a veterinary surgeon, the name and address of the person to whom the drug or preparation prescribed is to be delivered;

 

 

(d)       a prescription shall have written thereon, if given by a dental surgeon, the words "for local dental treatment only" and, if given by a registered veterinary surgeon, the words "for animal treatment only";

 

 

(e)       if the preparation prescribed is a recognised preparation, or if all the preparations contained therein are recognised preparations, specify the total amount of the preparation or, as the case may be, of each preparation or, when the preparation is packed in ampoules, either specify as aforesaid or specify the total amount of the preparation or, as the case may be, of each preparation intended to be administered or injected;

 

 

(f)        if the preparation prescribed is not a recognised preparation, specify the total amount of the drug to be supplied or, when the preparation is packed in ampoules, either the said total amount or the total amount intended to be administered or injected; and

 

 

(g)       in the case of a cancellation, obliteration, or alteration in a prescription, each cancellation, obliteration, or alteration shall be signed by the person giving it with his usual signature.

 

 

(2)  In the case of a prescription given for the treatment of a patient in a hospital, sub-regulation (1) shall be deemed to have been complied with if the prescription is written on a patient's bed-card or case-sheet, and in such a case the initials of the person giving the prescription shall be deemed to be a sufficient signature for the purposes of this regulation.

 

 

20.  (1)  A person shall not supply a drug or preparation on a prescription-

Provisions as to supply on prescription

 

(a)       unless the Prescription complies with the provisions of these Regulations relating to prescriptions;

 

 

(b)       unless, he either is acquainted with the signature of the person by whom it purports to be given and has no reason to suppose that it is not genuine, or has taken reasonably sufficient steps to satisfy himself that it is genuine;

 

 

(c)       before the date specified in the prescription.

 

 

(2)  If a prescription prescribing a drug or preparation expressly states that it may, subject to the lapse of an interval or intervals specified by the prescriber in the prescription, be dispensed a second or third time, the drug or preparation thereby prescribed may, as the case may be, be supplied a second or third time after the specified interval or intervals but not more; but, subject as aforesaid, a prescription shall not for the purposes of these Regulations be taken as enabling the drug or preparation prescribed to be supplied more than once.

 

 

(3)  A person dispensing a prescription prescribing a drug or preparation shall, at the time of dispensing it, mark thereon the date on which it is dispensed and, in the case of a prescription which may be dispensed a second or third time, the date of each occasion on which it is dispensed, and shall retain and keep it on the promises where it is dispensed and so as to be at all times available for inspection.

 

 

(4)  No person shall make or supply a copy of any prescription prescribing a drug or preparation, other than a copy of a prescription for submission to the Government or a medical aid society for the purpose of receiving payment for such a drug or preparation supplied thereon, unless he is requested to do so by the Permanent Secretary, an inspector, a police officer of the rank of Sub-Inspector or above, or any other police officer authorised in writing by a magistrate or by a police officer of the rank of Sub-Inspector or above, and such copy of a prescription shall be clearly and indelibly marked "Copy only. Not to be dispensed".

 

 

(5)  Notwithstanding anything contained in these Regulations, where an authorised seller of poisons is reasonably satisfied that a person ordering any drug or preparation is a medical practitioner who is by reason of some emergency unable to furnish a prescription immediately, he may, notwithstanding that no prescription has been given, if the said person undertakes to furnish him, within seven days next following, with a prescription, deliver the drug or preparation ordered in accordance with the directions of the said person, so however, that notwithstanding anything in the said directions, the supply shall not be repeated unless a prescription has been given.

 

 

(6)  If any person by whom an undertaking, referred to in sub-regulation (5) has been given, fails to deliver to the seller a prescription in accordance with the undertaking, or if any person, for the purpose of obtaining delivery of any drug or preparation under the provisions of this regulation, makes a statement which is to his knowledge false, he shall be deemed to have contravened the provisions of sub-regulation (5).

 

 

21.    Any medical practitioner who considers it necessary, for the purpose of the treatment by him of any patient, to prescribe a drug or preparation for a period exceeding four months, shall report the case to the Permanent Secretary.

Report of cases to Permanent Secretary

 

22.  (1)  Save as otherwise provided in this regulation no medical practitioner shall supply or administer to, or prescribe for, any person, a drug or preparation merely for the purpose of addiction.

Treatment of drug addicts

 

(2)  A medical practitioner who considers it necessary, for the purpose of the treatment or care of a patient who is a drug addict, that he should receive rational supplies of a drug or preparation, shall report the case to the Permanent Secretary.

 

 

(3)  When a case is reported in terms of sub-regulation (2), the Permanent Secretary may at his discretion permit, in writing, a medical practitioner to supply, and additionally or alternatively administer, and additionally or alternatively prescribe, such quantities of the drug or preparation to which the patient is addicted as the Permanent Secretary may in the circumstances consider necessary.

 

 

(4)  No medical practitioner shall supply or prescribe, for the treatment of a drug addict, a drug or preparation in excess of the quantity permitted by the Permanent Secretary.

 

 

(5)  No person generally authorised, licensed, or authorised as a member of a group to have in his possession a drug or preparation, shall use that drug or preparation by way of self-administration, otherwise than in accordance with these Regulations.

 

 

23.  (1)  Subject to the provisions of this regulation, no person shall-

Markings of packages and bottles

 

(a)       supply a drug unless the package or bottle in which it is contained is plainly marked with the amount of the drug contained therein; or

 

 

(b)       supply a preparation unless the package or bottle in which it is contained is plainly marked-

(i)        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 contained in the powder, solution, or ointment; or

(ii)       in the case of cachets, single dose injections, lozenges, suppositories, pills, tablets, or other similar articles, with the amount of the drug in each article, and the number of articles in the package or bottle.

 

 

(2)  Nothing in this regulation shall apply in a case where a drug or preparation is lawfully supplied in accordance with this Part, by, or on a prescription lawfully given by, a medical practitioner.

 

 

24.    A person generally authorised, licensed, or authorised as a member of a group, shall not procure a drug or preparation unless he produces to the supplier an order in writing signed and dated by him, in which it is stated-

(a)       the name and address of the person by whom the drug or preparation is required, or the institution for which it is ordered;

(b)       the name and quantity of the drug or preparation required; and

(c)       the name and address and profession or qualification of the person signing the order.

Production of order in writing to supplier

 

25.  (1)  Every person generally authorised, licensed or authorised as a member of a group, to supply drugs or preparations, other than a preparation for the time being specified in Part I of the Schedule to the Act, except a nurse who is generally so authorised by virtue of regulation 14 (1) (e), shall comply with the following provisions, that is to say-

Keeping of register

 

(a)       he shall, in accordance with the provisions of this regulation and of regulation 32, keep a register and enter therein, in chronological sequence in the form specified in the Second Schedule to these Regulations, true particulars with respect to every quantity of any drug or preparation obtained by him, and with respect to every quantity of any drug or preparation supplied by him, whether to persons within or outside Zambia;

 

 

(b)       he shall use a separate register or separate part of the register for entries made with respect to each of the substances for the time being specified in paragraph 1 of the Schedule to the Act, or in paragraphs 2, 3, 4, 5, 6, or 7 thereof; and for this purpose each substance shall be deemed to comprise its salts and any preparation, admixture, extract, or other substance containing any proportion of it or its salts, and any isomer of a substance the existence of which is possible within its specific chemical designation, shall be deemed to be identical with that substance.

 

 

(2)  Notwithstanding the provisions of sub-regulation (1)-

 

 

(a)       a separate section within a register, or a separate part of a register, may be used with respect to different drugs, preparations, or strengths of preparations, comprised within the class of drugs or preparations to which that register or separate part of a register relates;

 

 

(b)       so much of sub-regulation (1) as requires a person to enter in the register required to be kept under that sub-regulation, particulars with respect to drugs or preparations supplied by him, shall not apply to a medical practitioner if he enters in a book in which he records patients' case histories, hereinafter called "the day book", true particulars of every drug or preparation supplied by him to any person, together with the name and address of that person, and the date of the supply, and enters in a separate book kept for the purposes of this regulation, a proper reference to each entry in the day book which relates to the supply of any drug or preparation, and if paragraphs (c) and (d) of this sub-regulation are complied with;

 

 

(c)       references in the said separate book shall be made in chronological sequence, and the book shall be kept in separate parts relating respectively to the several classes of drugs and preparations specified in, and under, paragraph (b) of sub-regulation (1), and shall not be used for any purpose other than the purposes of this sub-regulation;

 

 

(d)       the entries in the day book, and in the separate book, shall be made on the day on which, but for this sub-regulation, an entry would under regulation 32 have been required to be made in the said register, and paragraph (c) of regulation 32 shall apply as respects any such entry as aforesaid as if it were an entry in the register;

 

 

(e)       in this sub-regulation, the expression "a proper reference" means a reference which is entered in the said separate book under the same date as that on which the entry in the said day book or in the Pharmacy Act book was made, and is otherwise such as to enable that entry to be easily identified.

 

 

(3)  Where a medical practitioner, dental surgeon or veterinary surgeon obtains, or supplies, any drug or preparation packed in ampoules he shall be deemed to have complied with the requirements-

 

 

(a)       of sub-regulation (1), in regard to entry in the register required to be kept under the said sub-regulation, of true particulars with respect to every quantity of every drug or preparation obtained or supplied; or

 

 

(b)       in the case of a medical practitioner supplying drugs or preparations to any person, of sub-regulation (2), in regard to entry in the day book referred to in sub-regulation (2), of particulars of any drug or preparation supplied by him;

if he enters the amount which he has obtained or supplied, as the case may be, or true particulars as to either the total quantity of the drug or preparation, or the total quantity thereof intended to be administered or injected.

 

 

(4)  Every separate book kept under sub-regulation (2), every day book in which any entry is made under sub-regulation (2), and every Pharmacy Act book containing an entry which is referred to in such a separate book as aforesaid, shall be kept on the premises to which the register or book relates and, in the case of a book referring to a prescription, shall be kept on the premises on which the prescription was dispensed so as to be at all times available for inspection.

 

 

(5)  For the purposes of the preceding sub-regulations, a drug or preparation administered by, or under the direct supervision and in the presence of, a medical practitioner, or dental surgeon shall be deemed not to have been supplied by him.

 

 

(6)  A manufacturer of any preparation for the time being specified in Part I of the Schedule to the Act, and a wholesale dealer in any such preparation, shall keep every invoice or other like record issued in respect of each quantity of any such preparation obtained by him, and in respect of each quantity of any such preparation supplied by him.

 

 

(7)  A retail dealer in any preparation, for the time being specified in Part I of the Schedule to the Act, shall keep every invoice or other like record issued in respect of each quantity of any such preparation obtained by him.

 

 

(8)  Notwithstanding the provisions of paragraph (a) of sub-regulation (1), an authorised seller of poisons may use drugs or preparations for the dispensing of medicines containing such amount of drugs and preparations as is sufficient to make the medicine a drug to which Part III of the Act applies, but only if the transaction and the date of the transaction are recorded in his register.

 

 

PART IV GENERALPART IV

GENERAL

 

 

26.    In this Part of these Regulations, the expression "drug" means a drug to which Part II of these Regulations or a substance to which Part III of these Regulations applies.

Definition of "drug"

 

27.    For the purposes of these Regulations, a person shall be deemed to be in possession of a drug, if it is in his actual custody, or is held, by some other person subject to his control, for him or on his behalf.

Definition of "possession"

 

28.  (1)  Where a drug other than a substance specified in Part I of the Schedule to the Act, is to be lawfully supplied to any person (hereinafter in this regulation referred to as "the recipient"), otherwise than by, or on a prescription given by, a medical practitioner, the person supplying the drug (hereinafter in this regulation referred to as "the supplier") shall not deliver it to the person who purports to be sent by, or on behalf of the recipient, unless that person either-

Supply otherwise than on prescription

 

(a)       is generally authorised, licensed, or authorised as a member of a group, to be in possession of that drug; or

 

 

(b)       produces to the supplier a statement in writing signed by the recipient to the effect that he is empowered by the recipient to receive the drug in question on behalf of the recipient, and the supplier is reasonably satisfied that the document is a genuine document.

 

 

(2)  A person to whom a drug is lawfully delivered in the circumstances mentioned in sub-regulation (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 delivery to the recipient to be effected.

 

 

29.  (1)  Where any person generally authorised

Withdrawal of authority

 

(a)       is or has been convicted of an offence against the Act, or these Regulations, or of attempting to commit any such offence or of soliciting, inciting, aiding or abetting, any other person to commit any such offence;

 

 

(b)       is adjudged, certified, or otherwise lawfully proved to be mentally disordered or defective under any law relating to mental disorders;

 

 

(c)       is undergoing treatment as a temporary or voluntary patient in terms of any law referred to in paragraph (b) above; or

 

 

(d)       is proved, to the satisfaction of the Minister, to have become a drug addict;

the Minister may, if he is of the opinion that that person cannot properly be allowed to remain a person generally authorised, by notice in the Gazette, withdraw the authority of that person.

 

 

(2)  Where the general authority of any person has been withdrawn under these Regulations, the Minister may at any time restore it, or may suspend the withdrawal and, while the withdrawal is so suspended, the person shall be a person generally authorised in the same manner as if the authority had never been withdrawn, so however, that the Minister may at any time cancel the suspension.

 

 

30.  (1)  If any drugs permitted under the law of any country outside Zambia to be exported therefrom to any destination outside Zambia, are brought into Zambia, no person shall cause or procure those drugs to be diverted to any other destination, unless he is licensed under this regulation by the Permanent Secretary and otherwise than in accordance with the terms and conditions of his licence.

Consignment between places outside Zambia

 

(2)  For the purposes of this regulation the destination to which any drugs are permitted to be exported shall be taken to be the destination stated in the permission for the export thereof from the country of export.

 

 

31.    The Minister may revoke or amend, at any time, a licence or group authority given under these Regulations.

Revocation or amendment of licence of group authority

 

32.    The following requirements shall be complied with by any person required to keep a register under, as the case may be, regulation 9 or 25, that is to say-

(a)       the class of drugs to which the entries on any page of any such register as aforesaid, relate, shall be specified at the head of that page;

(b)       every entry required to be made, under the said regulations 9 and 25, in the register shall be made on the day on which the drug is received or, as the case may be, on which the transaction with respect to the supplying of the drug by the person required to make the entry takes place; but if that is not reasonably practicable, on the day next following the said day;

(c)       no cancellation, obliteration, or alteration of any entry shall be made, and every correction of an entry shall be made only by way of a marginal note or footnote which shall specify the date on which the correction is made;

Requirements as to registers

 

(d)       every entry required to be made as aforesaid in every register, and every correction of an entry, shall be made in ink or otherwise so as to be indelible;

(e)       a register shall not be used for any purpose other than the purposes of these Regulations;

(f)        the person required, as aforesaid, to keep a register shall, on demand made by the Permanent Secretary or by any person empowered in writing by the Permanent Secretary in that behalf-

 

 

(i)        furnish such particulars as may be required with respect to the obtaining or supplying by him of any drug, or with respect to any stock of drugs in his possession;

 

 

(ii)       for the purpose of confirming any such particulars as aforesaid, produce any stock of drugs in his possession; and

 

 

(iii)      produce the register and such other books or documents in his possession, relating to any dealings in drugs as may be required;

(g)       a separate register shall be kept in respect of each set of premises at which the person required to keep the register carries on business; but save as aforesaid not more than one register shall be kept at one time, in respect of each class of drug for which he is required to keep a separate register or part of a register, so however, that a separate register may, with the approval of the Permanent Secretary, be kept in respect of each department of the business carried on by him;

(h)       every such register shall be kept at the premises to which it relates, so as to be at all times available for inspection.

 

 

33.  (1)  All registers, records, books, prescriptions, orders in writing, and other documents which are kept, issued, or made in pursuance of the requirements, or for the purposes of these Regulations, shall be preserved, in the case of a register, book, or other like record for a period of two years from the date on which the last entry therein is made, and in the case of any other document, for a period of two years from the date on which it is issued or made.

Preservation of documents

 

(2)  In the case of any document kept in pursuance of sub-regulations (6) and (7) of regulation 25, the keeping of a copy thereof made at any time during the said period of two years, shall be treated for the purposes of sub-regulation (1) as if it were the keeping of the original document.

 

 

34.    Nothing in these Regulations as respects the possession of a drug shall apply to-

(a)       a police officer acting in the course of his duty as such; or

(b)       a person carrying on the business of a carrier, or to any servant of such a person, acting in the course of that business.

Exception of police officers and carriers

 

35.    For the purposes of these Regulations, a person shall not be treated as procuring or offering to procure a drug for any person by reason only that he, in the course of his business as agent for another, offers for transfer, or acts in the transfer of, a business and stock-in-trade therewith which comprises a drug.

Exemption of certain classes of agents

 

36.  (1)  Any person lawfully in possession of drugs shall, before ceasing to practice or exercise his profession, function, or employment, at any place-

Requirements in respect of cessation of practice, etc.

 

(a)       where he is being succeeded by a person generally authorised, authorised as a member of a group, or a licensed person-

(i)        physically check with, and hand over to his successor all drugs in his possession;

(ii)       submit to the Permanent Secretary a statement signed by himself and by his successor, certifying that the said drugs have been physically checked and handed over in accordance with sub-paragraph (i);

(iii)      after handing over the drugs, rule off each page of the register on which an entry has been made, and both he and his successor shall, when satisfied that it is a true record of the drugs on hand, sign each page; and

(iv)      if either person is not satisfied that any entry referred to in sub-paragraph (iii) is a true record, he shall refuse to sign the page and shall immediately inform the Permanent Secretary of the reason for his refusal;

 

 

(b)       where he is not being succeeded by a person generally authorised, authorised as a member of a group, or a licensed person-

(i)        inform the Permanent Secretary of the arrangements he has made for the disposal of the drugs in his possession; and

(ii)       immediately after disposing of the drugs in accordance with those arrangements or an Order made under sub-regulation (2), as the case may be, he shall notify the Permanent Secretary that he has done so and shall, at the same time, forward the register and the supporting prescriptions and written orders to the Permanent Secretary who shall retain them for a period of two years from the latest date of entry.

 

 

(2)  Where the arrangements referred to in paragraph (b) of sub-regulation (1) have not been made or are not to the satisfaction of the Permanent Secretary, the drugs shall be disposed of in such manner as the Permanent Secretary shall order.

 

 

37.    For the purposes of these Regulations, but subject in each case to the express terms of the regulation by which he is generally authorised or, as the case may be, to any limitation attached to his licence, or group authority-

(a)       a person generally authorised or licensed to manufacture a drug shall be deemed to be generally authorised or, as the case may be, licensed to supply that drug;

(b)       a person generally authorised, licensed, or authorised as a member of a group, to supply a drug, shall be deemed to be generally authorised or, as the case may be, licensed or authorised as a member of a group to be in possession of, to procure, to offer to supply or procure, and to advertise for sale, that drug.

Construction of licence or authority

 

38.  (1)  No person shall in the course of supplying a drug to a person in Zambia consign that drug, by road or rail, by a route which entails the carriage of that drug beyond the borders of Zambia, unless he is in possession of a movement licence issued by the Permanent Secretary for the purposes of this regulation.

Movement licence

 

(2)  The holder of a movement licence shall-

 

 

(a)       in the case of a drug which is to be supplied in one package, place the duplicate of his movement licence inside the outer wrapper of that package; or

 

 

(b)       in the case of a drug which is to be supplied in more than one package-

(i)        place the duplicate of his movement licence inside the outer wrapper of one package;

(ii)       consecutively number on the outer wrapper all the packages in which the drug is contained; and

(iii)      indicate on each package the number of the package in which the duplicate of his movement licence is to be found.

 

 

39.    Application for a licence under the Act or for a licence or permit under these Regulations shall be-

(a)       made in such form as the Permanent Secretary may determine;

(b)       accompanied, if the application is for a licence to export any drug from Zambia, by the original copy of the certificate of the country of importation officially approving the import of that drug; and

(c)       accompanied by the appropriate fee, if any, prescribed in the Third Schedule.

Form of application for licence

 

40.  (1)  The Dangerous Drugs Regulations, 1956, are hereby revoked.

Revocation of F.G.N. No. 59 of 1956 and savings

 

(2)  Nothing in sub-regulation (1) shall render invalid any licence, authority, certificate or order, issued, granted or given, or other -thing done, under the Dangerous Drugs Act, 1955, or the Regulations revoked by these Regulations, and any such licence, authority, certificate, order, or other thing which could have been issued, granted or given or other thing done, under any provision in these Regulations, and which is in force at the date when these Regulations come into operation, shall be deemed to have been issued, granted or given, or done, under that provision.

Cap. A.L. 28

 

(3)  Any register, record, book, prescription, or other document, which is required to be kept under any regulation revoked by these Regulations, shall be kept in the same manner and for the same period, and every person shall be subject to the same requirements in regard thereto, as if these Regulations had not been made.

 

 

 


 

FIRST SCHEDULE

 

 

THE DANGEROUS DRUGS REGULATIONS, 1971

 

 

(Regulation 16)

 

 

MIDWIVES' SUPPLY ORDER

 

 

    I hereby certify that             
of          
 is a practising midwife and is authorised in pursuance of sub-regulation (2) of regulation 16 of the Dangerous Drugs Regulations, to procure during the period of validity of this supply order and for the purpose of her profession, tincture of opium, and pethidine preparations not exceeding the quantities stated below.

           
           

    This supply order shall remain valid until the 31st December of the year in which it is issued, and shall be returned to me immediately on becoming invalid.

Place --------------------------------------------             Signed ---------------------------

                                                                                                            Permanent Secretary

Date of Issue -----------------------------------

 

 

MIDWIVES' SUPPLY ORDER

 

 

(To be printed on the reverse)

    (1)  This supply order shall be produced to the person from whom the drugs are procured.

    (2)  The supplier shall at the time the transaction takes place, note under the appropriate heading in this order the date on which the drugs are supplied, the name and quantity of the drugs supplied, and his name and registered address.

 

 

 


 

PETHIDINE PREPARATIONS


Date Supplied

Details of Preparation (Strength of Tablets,
Ampoules, etc.)

Quality
Supplied

Total Supplied
to Date

Name and
Address of Supplier

 

 

 

 

 

 

 

 

 

 


 

TINCTURE OF OPIUM

Date Supplied

Quantity Supplied

Total Supplied to Date

Name and Address of Supplier

 

 

 

 

 

 

 

 

 

 


 

SECOND SCHEDULE

 

 

THE DANGEROUS DRUGS REGULATIONS, 1971

 

 

(Regulations 9, 25 and 32)

 

 

 

 

 

FORM OF REGISTER


Name of Drug or Preparation .....................................................................................................



Margin for Notes


Date on which Acquired,
Supplied or Used


Name and Address of Person from whom
Acquired or to whom Supplied



Reference


Amount
Acquired

Amount
Supplied
or Used


Amount
on Hand

 

 

 

 

 

 

 

 

Carried forward from page ...........................

 

 

 

 

Continued on page ........................................

 


 

THIRD SCHEDULE

 

 

THE DANGEROUS DRUGS REGULATIONS, 1971

 

 

(Regulation 39)

 

 

PRESCRIBED FEES

 

 

                                                                                                     Fee units

Licence to import                                  . .       . .       . .       . .       . .     5

Licence to export                                  . .       . .       . .       . .       . .     3

(As amended by Act No. 13 of 1994)

 

 

NOTICES MADE UNDER THE DANGEROUS DRUGS ACT-CHAPTER A.L. 28 OF THE 1965 EDITION OF THE APPLIED LAWS

 

(Section 15 of the Interpretation and General Provisions Act)

Federal Goverment Notices
57 of 1956
226 of 1956
4 of 1959
96 of 1960
144 of 1961
222 of 1961
249 of 1963
251 of 1963
Goverment Notices
360 of 1963
497 of1964
507 of 1964
Statutory Instruments
220 of 1966
221 of 1966

 

THE DANGEROUS DRUGS (PART III) (APPLICATION) NOTICE

 

 

1.    This Notice may be cited as the Dangerous Drugs (Part III) (Application) Notice.

Title

 

2.    In pursuance of subsection (2) of section ten of the Act, Part III of the Act is hereby applied to the drugs and products specified in the First Schedule in the same manner as it applies to drugs specified in the Schedule to the Act.

Application in pursuance of section 10 (2) of Act

 

3.    In pursuance of section fourteen of the Act, Part III of the Act is hereby applied to the drugs and products specified in the Second Schedule without any modification.

Application in pursuance of section 14 of Act

 

4.    In pursuance of subsection (3) of section ten and section fourteen of the Act, Part III of the Act is hereby applied to the drugs and products and their preparations specified in the Third Schedule, with the modifications that-

(a)       those drugs and products and their preparations shall not be treated as drugs to which Part III of the Act applies for the purposes of Part III of the Dangerous Drugs Regulations;

(b)       the provisions of section eleven of the Act shall not apply to the import into or the export from Zambia of Syrup of Codeine Phosphate B.P.C. 1954 or to any preparation containing not more than 2.5 per centum of methylmorphine, ethylmorphine or morpholinyl-ethylmorphine calculated as a pure drug, associated with other medicinal substances.

(As amended by G.N. No. 360 of 1963)

Application in pursuance of section 10 (3) and 14 of Act

 

FIRST SCHEDULE

 

 

(Paragraph 2)

    1.    The following substances and their salts, and any preparation, admixture, extract or other substance containing any proportion of any of the substance or salts;

Allylprodine (3-allyl-l-methyl-4 phenyl-4-propionyloxypiperidine);

Alphameprodine;

Anileridine (1-[2-(p-aminophenyl)-ethyl]-4-phenylpiperidine-4-carboxylic acid ethyl ester);

Benzethidine (ethyl)-1(2-benzyloxyethyl)-4-phenylpiperidine-4-carboxylate);

Clonitazene (2-p-chlorobenzyl-1-1-(2-diethylaminoethyl)-5-nitrobenzimidazole);

Dextromoramide, levomoramide and racemoramide 1-(3-methyl-4-morpholine-2: 2-diphenylbutryl)-pyrrolidine;

Dimenoxadole (2-dimethylamineothyl)-2-ethoxy-2:2-diphenylacetate);

Diphenoxylate (ethyl 1-(3-cyano-3:3-diphenylpropyl)-4-phenylpiperidine-4-carboxylate);

Etonitazene (1-(2-diethylaminoethyl)-2-p-ethoxybenzyl-5-pitrobenzimidazole);

Etoxeridine (1-[2-(2-hydroxyethoxy)-ethyl]-4-phenylpiperidine-4-carboxylic acid ethyl ester);

Fenanyl;

Furethidine (ethyl)-1(2-tetrahydrofurfuryloxyethyl)-4-phenylpiperidine-4- carboxylate);

Hydromorphinol (14-hydroxydihydromorphine);

Levophenacylmorphan ( (-)-3-hydroxy-N-phenacylmorphinan);

Metazocine (2-hydroxy-2:5:9-trimethyl-6:7-benzomorphan);

1-Methyl-4-phenylpiperidine-4-carboxylic acid;

Morpheridine (1-(2-morpholinoethyl)-4-phenylpiperidine-4-carboxylic acid ethyl ester);

Myreophine (myristyl ester of benzylmorphine);

Noracymethadol (ce-dl-3 acetoxy-6 methylamino-4:4-diphonylheptane);

N-[2-(N-methylphenethylamino) propyl] propionanilide;

Norcodeine;

Norlevorphanol ( (-)-3-hydroxymorphinan);

Normorphine;

Norpipanone;

Oxymorphone (dihydro-14-hydroxymorphinone);

Phenampromide (N-(1-methyl-2-piperidinoethyl) propionanilide);

Phenazocine (21-hydroxy-5:9-dimethyl-2-(2-phenylethyl)-6:7-benzomorphan);

Phenoperidine (ethyl 1(3-hydroxy-3-phenylpropyl)-4-phenylpiperidine-4-carboxylate);

Piminodine (ethyl 1-(3-anilinopropyl)-4-phenylpiperidine-4-carboxylate);

Trimeperidine (1:2:5-trimethyl-4-phenyl-4-propionyloxypiperidine).

  2.  The esters of 1-methyl-4-phenylpiperidine-4-carboxylic acid (other than pethidine) and their salts, and any preparation, admixture, extract or other substance containing any proportion of the esters of 1-methyl-4-phenylpiperidine-4-carboxylic acid (other than pethidine) or their salts.

  3.  4,4-Diphenyl-6-dimenthylamino-3-hexanone and its salts, and any preparation, admixture, extract or other substance containing any proportion of 4,4-diphenyl-6-dimethylamino-3-hexanone or its salts.

    4.    4,4-Diphenyl-8-piperidino-3-heptatone and its salts, and any admixture, extract or other substance containing any proportion of 4,4-diphenyl-8-piperidine-3-heptanone or its salts.

    5.    beta-Methadol and its salts, and any preparation, admixture, extract or other substance containing any proportion of beta-methadol and its salts.

  6.   3-Diethylamino-1, 1-di-(2'-thienyl)-1-butane (diethylthiambutene) and its salts, and any preparation, admixture, extract or other substance containing any proportion of 3-diethylamino-1,1-di-(2'-thienyl)-1-butene or its salts.

  7.    1,3-Dimethyl-4-phenyl-4-propionyloxyhexamethyleneimine, its salts and any preparation, admixture, extract or other substance containing any proportion of 1,3-dimethyl-4-phenyl-4-propionyloxyhexamethyleneimine.

    8.    3-Hydroxy-N-phenethylmorphinan, its salts and any preparation, admixture, extract or other substance containing any proportion of 3-hydroxy-N-phenethylmorphinan.

  9.   4-Morpholino-2:2-diphenyl ethyl butyrate, its salts and any preparation, admixture, extract or other substance containing any proportion of 1-morpholino-2:2-diphenyl ethyl butyrate.

10.  1-(3-cyano-3, 3-diphenyl)propyl)-4-(1-piperidino) piperidine-4-carboxylic acid amide and its salts, and any preparation, admixture, extract or other substance containing any proportion of 1-(3-cyano-3, 3-diphenylpropyl)-4-(1-piperidino) piperidine-4-carboxylic acid amide.

(As amended by F.G.N. No. 226 of 1956, F.G.N. No. 4 of 1959, F.G.N. No. 96 of 1960, F.G.N. Nos. 144 and 222 of 1961, F.G.N. No. 219 of 1963, G.N. No. 507 of 1964
and S.I. No. 220 of 1966)

 

 

SECOND SCHEDULE

 

 

(Paragraph 3)

   1.    Methyldesomorphine (6-methyl-Delta 6-desoxymorphine) and its salts, and any preparation, admixture, extract or other substance containing any proportion of methyldesomorphine or its salts.

   2.    Dihydrodesoxymorphine and its salts, and any preparation, admixture, extract or other substance containing any proportion of dihydrodesoxymorphine or its salts.

    3.    6-Methyldihydromorphine and its salts, and any preparation, admixture, extract or other substance containing any proportion of 6-methyl-dihydromorphine or its salts.

   4.    Methyldihydromorphinone and its salts, and any preparation, admixture, extract or other substance containing any proportion of methyl-dihydromorphinone or its salts.

 

 

*THIRD SCHEDULE


*The drugs and products specified in the Third Schedule are the drugs and products defined as "partially controlled drugs" for the purposes of the Dangerous Drugs Regulations.

 

 

(Paragraph 4)

1.    Acetyldihydrocodeine;

2.    Dihydrocodeine;

3.    Ethylmorphine;

4.    Methylmorphine (commonly known as codeine);

5.    Merpholinylethylmorphine;

6.    Nicoeodine;

and their salts.

(As amended by F.G.N. No. 144 of 1961, F.G.N. No. 251 of 1963
and S.I. No. 221 of 1966)

 

 

*The drugs and products specified in the Third Schedule are the drugs and products defined as "partially controlled drugs" for the purposes of the Dangerous Drugs Regulations.

 

 

THE DANGEROUS DRUGS (SECTION 10) (EXEMPTION) NOTICE

Federal Government Notices
58 of 1956
223 of 1961
Statutory Instrument
221 of1966

 

1.    This Notice may be cited as the Dangerous Drugs (Section 10) (Exemption) Notice.

(As amended by F.G.N. No. 223 of 1961)

Title

 

2.    The provisions of Part III of the Act shall not apply to the preparations specified in the First Schedule.

Application

 

3.    The provisions of Part III of the Act shall, as from the 30th June, 1961, cease to apply to the preparations specified in the Second Schedule.

Cessation of application

 

4.    The provisions of Part III of the Act shall, as from the 4th June, 1966, cease to apply to the preparations specified in the Third Schedule.

Cessation of application

 

FIRST SCHEDULE

 

 

(Paragraph 2)

A.-MORFINE PREPAARATIONS:

             Substance                                            Formula

  1.  Cercoli iodoformi et morphinae              Iodoform                            . .  . .                           0.320 gramme

                                                          Morphine hydrochloride                                             0.016 gramme

                                                          Oil of theobroma, sufficient to fill a
                                                          1-gramme mould,

  2.  Emplastrum opii              . .       . .  Elemi          . .       . .                     . .  20 grammes

                                                          Terebinthina   . .       . .              30 grammes

                                                          Cera flora                 . .                     . .  15 grammes

                                                          Olibanum pulvis       . .                     . .  18 grammes

                                                          Benzoes pulvis . .       . .              10 grammes

                                                          Opii pulvis                . .                     . .  5 grammes

                                                          Balsamum peruvanum                      . .  2 grammes

  3. Emplastrum opii               . .       . . Extract of opium                           . .  25 grammes

                                                          Refined clemi . .       . .              25 grammes

                                                          Diachylon plaster with gum                  50 grammes

  4. Emplastrum opii      . .       . .       . .  Elemi          . .       . .                     . .  8 grammes

                                                          Terebinthinae communis                       15 grammes

                                                          Ceroe florae    . .       . .                5 grammes

                                                          Olibani pulvertae                             . .  8 grammes

                                                          Benzoes pulvertae                            . .  4 grammes

                                                          Opii pulverati . .       . .                2 grammes

                                                          Balsami peruviani                            . .  1 grammes

  5.  Emplastrum opii              . .       . . Opium, in very fine powder               10 grammes

                                                          Resin plaster   . .       . .              90 grammes

  6.  Eplastrum opii (see formula under 5) mixed with other plasters contained in the British Pharmacopoeia or British Pharmaceutical Codex.

  7.  Linimentum opii              . .       . . Tincture of opium                         . .  500 millilitres

                                                          Liniment of soap                              . .  500 millilitres

  8.  Linimentum opii (see formula under 7) mixed with any other liniment of the British Pharmacopoeia or of the British Pharmaceutical Codex.

  9.  Linimentum opii ammoniatum Ammoniated liniment of camphor 30

                                                          Tincture of opium    . .       . .       30

                                                          Liniment of belladonna     . .         5

                                                          Strong solution of ammonia             . .  5

                                                          Liniment of soap to  ..        . .     100

             Substance                                            Formula

10.  Linimentum opii ammoniatum (see formula under 9) mixed with any other British Pharmacopoeia or British Pharmaceutical Codex liniment.

11.  Caustic "Nerve Pastes"    . .       . . Preparations containing, in addition to morphine salts, or morphine and cocaine salts, at least 25 per centum of arsenious acid, and made up with the requisite proportion of creosote or phenol to produce the consistency of a        paste.

12.  Diarrhoea pills                 . .       . . Camphor                . .                     . .                           0.0648 gramme

                                                          Lead acctate    . .       . .           0.013 gramme

                                                          Bismuth submitrate                          . .                           0.162 gramme

                                                          Tannic acid               . .                     . .                           0.0648 gramme

                                                          Opium powder         . .                     . .                           0.026 gramme

13.  Pilulac digitals et Opii compositae Digitalis leaves, in powder  0.31 gramme

                                                          Opium, in powder                            . .  0.19 gramme

                                                          Ipecacuanha root, in powder    0.13 gramme

                                                          Quinine sulphate                              . .  0.78 gramme

                                                          Syrup of glucose, a sufficient quantity to make 12 pills.

14.  Pilulae hydrargyri cum Opio     . .           Mercury pill                            . .                             . .     3.89 gramme

                                                          Opium, in powder                            . .  0.19 gramme

                                                          To make 12 pills.

15.  Pilulac hydrargyri cum Creta et Opii      Mercury with chalk                . .                           0.78 gramme

                                                          Compound powder of
                                                          *ipecacnanha* . .       . .             0.78 gramme

*The formula of this powder is given under 21.

                                                          Milk sugar, a sufficient quantity

                                                          Syrup of glucose, a sufficient quantity to make 12 pills.

16.  Pilulae ipecncuanhae cum                       . . Compound powder of
                                                             *ipecacuanha*       . .                     . .  30 grammes

*The formula of this powder is given under 21.

                                                          Squill, in powder                              . .  10 grammes

                                                          Ammoniacum, in powder                     10 grammes

                                                          Syrup of glucose, a sufficient quantity.

17.  Pilulae hydrargyri bichlorati cum Opii Bichloride of mercury
       extracto                                          triturated               . .                     . .  10 centigrammes

                                                          Extract of opium                              . .  20 centigrammes

                                                          Extract of couchgrass                       . .  20 centigrammes

                                                          Liquorice root in powder, q.s. for 10 pills.

18.  Pilulae hydrargyri iodati cum   Hydrargyrum iodatum
Opin pulvere                                         freshly prepared                           . .  50 centigrammes

                                                          Opium powder         . .                     . .  20 centigrammes

                                                          Powdered liquorice                          . .  30 centigrammes

                                                          White honey, q.s. for 10 pills.

19.  Pilula plumbi cum Opio            . . Lead acetate, in powder                     80 grammes

                                                          Opium, in powder                            . .  12 grammes

                                                          Syrup of glucose      ..                      . .  8 grammes
                                                                  (or a sufficient quantity).

20.  Pilulae terebinthinae compositae             Opium        . .                     . .  . .                           0.50 grammes

                                                          Chinina sulfas . .       . .                2 grammes

                                                          Styrax liquidus         . .                     . .  2 grammes

                                                          Terebenthina laricina                       . .  8 grammes

                                                          Mamesii subcarbonas, a sufficient quantity to make 100 pills.

21.  Pulvis Ipecacuanhae et Opii      Powdered ipecacuanha                     . .  100 grammes

       (Dover's Powder)                      Powdered opium                              . .  100 grammes

                                      Potassium sulphate in powder     . .                     . .  800 grammes

22.  Mixtures of Dover's Powder (see formula under 21) with mercury and chalk, aspirin, phenacetin, quinine and its salts, and sodium bicarbonate.

23.  Pulvis kine compositus             . . Kino, in powder    . .                     . .  75 grammes

                                                          Opium, in powder                            . .  5 grammes

                                                          Cinnamon bark, in powder                   20 grammes

* The formula of this powder is given under 21.

             Substance                                            Formula

24.  Suppositoria plumbi composita               Lead acetate, in powder     . .  2.4 grammes

       Syn.: Suppositoria plumbi cum Opio      Opium, in powder                   . .                           0.8 grammes

                                                          Oil of theobroma, a sufficient quantity for 12
                                                          suppositories, each weighing about 1 gramme.

25.  Coryna Tablets, No. 2               . . Powdered opium                           . .                           0.0043 gramme

                                                          Quinine sulph. . .       . .         0.022   gramme

                                                          Ammon. chlor.         . .                     . .                           0.022   gramme

                                                          Camphor                   . .                     . .                           0.022   gramme

                                                          Ext. belladonna leaves                     . .                           0.0043 gramme

                                                          Ext. aconite root       . .                     . .                           0.0043 gramme

26.  Dierrhoea Tablets, No. 2           . . Powdered opium                           . .                           0.016 gramme

                                                          Camphor                   . .                     . .                           0.016 gramme

                                                          Powdered ipecacuanha                     . .                           0.008 gramme

                                                          Lead acetate    . .       . .           0.011 gramme

27. Dysentery Tablets             . .       . . Powdered opium                           . .                           0.013   gramme

                                                          Powdered ipecacuanha                     . .                           0.0648 gramme

                                                          Powdered calomel                            . .                           0.0324 gramme

                                                          Lead acetate    . .       . .         0.0324 gramme

                                                          Bismuth betanaphthol                      . .                           0.1944 gramme

28.  Tabella hydrargyri cum Opio    Mercurous chloride powder                                        0.065 gramme

                                                          Antimony oxide powder                                             0.065 gramme

                                                          Ipecacuanha-root powder                                            0.065 gramme

                                                          Powdered opium                              . .                           0.065 gramme

                                                          Milk sugar                . .                     . .                           0.065 gramme

                                                          Gelatine solution, a sufficient quantity to make one tablet.

29. Tabella plumbi cum Opio          . . Sugar of lead         . .                     . .                           0.195 gramme

                                                          Powdered opium                              . .                           0.065 gramme

                                                          Gelatine solution, a sufficient quantity to make one tablet.

30. Tablettae plumbi cum Opio                      . . Lead acetate, in fine
                                                              powder        .                                                          19.44 grammes

                                                          Opium, in powder                            . .  3.24 grammes

                                                          Refined sugar, in powder                      6.48 grammes

                                                          Ethercal solution of
                                                              thoobroma                             3.60 mils.

                                                          Alcohol . .       . .       . .              0.90 mil.s

31.  Ungentum gallae compositum  Galls, in very fine powder                . .  20
                                                          Extract of opium      ..        . .           . .  4

                                                          Distilled water . .       . .       . .       16

                                                          Wool fat ..        . .       . .       . .       10

                                                          Soft paraffin, yellow          . .           ..   50

32.  Ungentum gallae composition (see formula under 31) mixed with other ointments and plasters contained in the British Pharmacopoeia or British Pharmaceutical Codex.

33.  Unguentum gallae cum Opio    Gall ointment  . .       . .           92.5 grammes

                                                          Opium in powder                             . .  7.5 grammes

34.  Unguentum gallae cum Opio (see formula under 33) mixed with other ointments and plasters contained in the British Pharmacopoeia or British Pharmaceutical Codex.

35.  Yatren-105 (Iodooxyquinoline-sulphonic acid) with 5 per centum opium admixture.

B.-COCAINE PREPARATIONS:

             Substance                                            Formula

1. Bernatzik's Injections                   . .           (a)  Hydrargyrum
                                                         
       bicayanatum                              . .  0.03 gramme

                                                                 Cocainum          . .             0.02 gramme

                                                          (b)  Hydrargyrum succinatum  0.03 gramme

                                                                 Cocainum . .       . .             0.01 gramme

2.  Stila's injections                 . .       . . (a)  Hydrargyrum
                                                         
       succinatum        . .                     . .  0.03 gramme

                                                                 Cocainum muriaticum                   0.01 gramme

                                                          (b)  Hydrargyrum
                                                         
       succinatum        . .                     . .  0.05 gramme

                                                                 Cocainum muriaticum                   0.03 gramme

             Substance                                            Formula

  3.  Natrium biboracicum compositum          In tablets, compressed tablets, lozenges,

       cum Cocaine                              pastilles and the like, difficult to break up, and
                                                          containing not more than 0.2 per centum of cocaine
                                                          salts in conjunction with not less than 20 per
                                                          centum borax and not less than 20 per centum
                                                          antipyrine, or some similar analgesic, and not more
                                                          than 40 per centum of flavoring matter. Maximum
                                                          weight of each tablet, etc., 1 gramme.

  4.  Caustic "Nerve Pastes"    . .       Preparations containing, in addition to ocaine salts
                                                          or cocaine and morphine salts, at least 25 per
                                                          centum of arsenious acid, and made up with the
                                                          requisite proportion of creosote or phenol to
                                                          produce the consistency of a paste.

  5.  Cocaine and Atropine Tablets, with a     Atropium sulphuricum                                  0.0003 gramme

content of not morec than 0.0003 gramme Cocainum hydrochloricum                               0.0003 gramme

of cocaine salts and not less than      Mannite          . .       . .                     . .                           0.003 gramme

0.0003 gramme of atropine salts to                                                                      _________

each tablet                                        Weight of one tablet                         . .                           0.0036 gramme

                                                          Cocaine content, 8.3 per centum.

C.-DICODIDE PREPARATIONS:

  1.  Cardiazol-Dicodide Solutions   . . Solutions containing not less than 10 per centum
                                                          of cardiazol and not more than       0.5 per centum of dicodide salts.

D.-EUCODAL PREPARATIONS:

  1.  Anti-Opium Tablets                  . .           . . Encodal   . .                     . .  . .                           1 gramme

                                                          Pulvis gentianae                               . .  35 grammes

                                                          Pulvis ipecacuanhae . .              20 grammes

                                                          Quinine sulphate                              . .  20 grammes

                                                          Caffeine          . .       . .                5 grammes

                                                          Sugar of milk  . .       . .              25 grammes

                                                          Mix up and make up 5-grain tablets.

  2.  Tablets B.B. Compound            . Berberis vulgaris powder                                           0.0324 gramme

                                                          Nux vomica               . .                     . .                           0.013   gramme

                                                          Eucodal           . .       . .         0.0032 gramme

                                                          Ipecacuanha    . .       . .         0.0648 gramme

                                                          Rhubarb          . .       . .         0.013   gramme

                                                          Pulvis cinnamoni compo-
                                                          situs       . .      
. .       . .         0.0324 gramme

                                                          Aromatic chalk         . .                     . .                           0.0032 gramme

 

 

 

SECOND SCHEDULE

 

 

(Paragraph 3)

    1.  Tablets each weighing 0.8 grammes and containing 2.5 milligrammes of diphenoxylate hydrochloride and 0.025 milligrammes of atropine sulphate.

    2.  Preparations containing 2.5 milligrammes of diphenoxylate hydrochloride, 0.025 milligrammes of atropine sulphate, 85 milligrammes of lactose, 7 milligrammes of sugar, 21.6 milligrammes of starch, 3 milligrammes of talc, 1 milligramme of magnesium stearate and 0.7 milligrammes of tartrazine.

(F.G.N. No. 223 of 1961)

 

 

THIRD SCHEDULE

 

 

(Paragraph 4)

    4-Dimethylamino-1; 2-diphenyl-3-methyl-2-propionyloxybutane, its salts and any preparation, admixture, extract or other substance containing any proportion of 4-dimethylamino-1; 2-diphenyl-3-methyl-2-propionyloxybutane.

(S.I. No. 221 of 1966)

 

 

THE DANGEROUS DRUGS (SECTION 13) (EXEMPTION) NOTICE

Federal Government Notices
3 of 1959
97 of 1960
224 of 1961
252 of 1963

 

1.    This Notice may be cited as the Dangerous Drugs (Section 13) (Exemption) Notice.

Title

 

2.    The provisions of section thirteen of the Act shall cease to apply to the products specified in the Schedule, being products obtained from morphine, one of the phenanthrene alkaloids of opium.

Cessation of application

 

SCHEDULE

 

 

(Paragraph 2)

 

 

EXEMPTED PRODUCTS

 

 

  1.       Methyldesomorphine.

  2.       Dihydrodesoxymorphine.

  3.       6-Methyldihydromorphine.

  4.       Methyldihydromorphinone.

  5.       Nallylnormorphine.

  6.       Diacetyl-N-allylnormorphine.

  7.       Myrophine (myristyl ester of benzylmorphine).

  8.       Oxymorphone (dihydro-14-hydroxymorphinone).

  9.       Hydromorphinol (14-hydroxydihydromorphine).

10.       Nicocodine.

11.       Norcodeine.

12.       Normorphine.

(As amended by F.G.N. No. 97 of 1960, F.G.N. No. 224 of 1961
and F.G.N. No. 252 of 1963)

 

 

SECTION 14-THE DANGEROUS DRUGS (MODIFICATION OF SCHEDULE) ORDER.

Statutory Instruments
144 of 1985

 

Order by the Minister

 

 

1.    This Order may be cited as the Dangerous Drugs (Modification of Schedule) Order, and shall be read as one with the Schedule to the Act, hereinafter referred to as the principal Schedule.

Title
Cap. 95 p. 12

 

2.    The principal Schedule is amended in Part I by the insertion in the appropriate places in paragraph 1 of the following new substances:

Amendment of Schedule

 

3-(1, 2-dimethylheptyl-1)-

 

 

hydroxy-7, 8, 9, 10-tetrahydro-

 

 

6, 6, 9-trimethyl-6H-dibenzo

 

 

(b, d) pyran

 

 

Amphetamine

 

 

Dexamphetamine

 

 

Eticyclidine

 

 

(+)-Lysorgide

 

 

Mecloqualone

 

 

Methamphetamine

 

 

Methaqualone

 

 

Methylphenidate

 

 

N, N-diethyltryptamine

 

 

N, N-dimethyltryptamine

 

 

Phencyclidine

 

 

Phenmetrazine

 

 

Psilocybine

 

 

Rolicyclidine

 

 

Tenocyclidine

(As amended by S.I. No. 144 of 1985)

 

 

 

 

 


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