CHAPTER 95 - DANGEROUS DRUGS ACT: SUBSIDIARY LEGISLATION

INDEX TO SUBSIDIARY LEGISLATION

Dangerous Drugs Regulation

Dangerous Drugs (Part III) (Application) Notice

Dangerous Drugs (Section 10) (Exemption) Notice

Dangerous Drugs (Section 13) (Exemption) Notice

Dangerous Drugs (Modification of Schedule) Order

DANGEROUS DRUGS REGULATIONS

[Section 6]

[Currency mentioned in this regulation should be re-denominated as stipulated under S 4 of Re-denomination Act, 2012, read with S 29 of Bank of Zambia Act, 1996.]

Arrangement of Regulations

   Regulation

PART I
PRELIMINARY

   1.   Short title

   2.   Interpretation

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 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
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 license 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 license or authority

   38.   Movement license

   39.   Form of application for license

   40.   Revocation of GN 59 of 1956 and savings

      FIRST SCHEDULE

      SECOND SCHEDULE

      THIRD SCHEDULE

[Regulations by the Minister]

Act 13 of 1994,

SI 128 of 1971,

SI 50 of 1976,

SI 65 of 1993.

PART I
PRELIMINARY

1.   Short title

These Regulations may be cited as the Dangerous Drugs Regulations.

2.   Interpretation

In these Regulations, unless the context otherwise requires—

“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;

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

“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 license 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 “license ” 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;

“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;

“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;

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

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

“Pharmacy Act book” means either of the books required to be kept by sub-section (2) of section 21 and sub-section (3) of section 24 of the Pharmacy and Poisons Act.

“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;

“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;

“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.

3.   Application

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 “drug” means any such drug, resin or preparation as aforesaid.

4.   Supply, procuring, and advertising, of drugs

   (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 license or group authority.

   (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 license or group authority.

5.   Possession of drugs

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 license or group authority.

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

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

      (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.   Cultivation of plants

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

   (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 license .

8.   Clearing of plants from land by owner or occupier

   (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.

   (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.   Keeping of register

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.

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

10.   Application

   (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.

   (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.   Manufacture of drugs

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 license .

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

   (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.

   (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 license 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.   Possession of drugs and preparations

   (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 license or group authority.

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

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

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

   (1) The Permanent Secretary may at his discretion license —

      (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 license 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.   Special provisions in respect of midwives

   (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.

   (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.   Special provisions in respect of operators of aircraft

   (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.

   (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;

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