CONTROLLED SUBSTANCES ACT

Arrangement of Sections

    Section

PART I
PRELIMINARY PROVISIONS

    1.    Short title and commencement

    2.    Interpretation

PART II
ADMINISTRATION

    3.    Administration of Act

    4.    Functions of Authority

PART III
LICENSING FOR CONTROLLED SUBSTANCES

    5.    Non-application of Part III

    6.    Prohibition of manufacturing, importing, exporting, dealing in or advertising of controlled substance

    7.    Application for licence

    8.    Renewal of licence

    9.    Suspension or revocation of licence

    10.    Amendment of licence

    11.    Submission of quarterly returns

    12.    Transfer of licence

    13.    Notice of cessation of activity by licensee

PART IV
MANUFACTURING, SUPPLY, DISTRIBUTION, SELLING, USING, PRESCRIBING AND DISPENSING OF CONTROLLED SUBSTANCES

    14.    National annual requirements for controlled substances

    15.    Prohibition of placing on market, etc., controlled substance used as medicine without pharmaceutical licence

    16.    Application for pharmaceutical licence

    17.    Authorisation for certain classes of persons

    18.    Prescribing or dispensing controlled substances

    19.    Withdrawal and restoration of authorisation

    20.    Sell or supply without prescription

    21.    Sell or supply by partial filling of prescription

    22.    Emergency sell or supply of controlled substance

    23.    Retail of precursor chemicals

    24.    Consignment of controlled substance in transit

    25.    Prohibition of diversion of controlled substance within Republic

    26.    Use of controlled substances in health research

PART V
CLASSIFICATION AND EXEMPTION OF CONTROLLED SUBSTANCES

    27.    Classification of controlled substances

    28.    Exemptions for certain purposes

    29.    Non-prescription preparation containing controlled substance

    30.    Temporary classification of controlled substances to avoid imminent hazards to public safety

    31.    Temporary and permanent classification of anabolic steroids

PART VI
REPORTS, RECORDS, INVENTORIES AND REGISTERS

    32.    Records or inventory of licensed activity

    33.    Registers by other person or institution

    34.    Preservation of documents

PART VII
INSPECTIONS

    35.    Power of authorised officer

    36.    Powers of arrest

PART VIII
OFFENCES AND PENALTIES

    37.    Maintaining controlled substances involved premises

    38.    Sale of controlled substance to children

    39.    Employing, hiring, using, persuading, inducing, enticing or coercing children to distribute drugs

    40.    Prohibition of possession of controlled substance

    41.    Offence of import, export, manufacture, possession and use of prepared opium

    42.    General penalty

    43.    Offence by principal officer, shareholder or partner of body corporate or unincorporate body

PART IX
GENERAL PROVISIONS

    44.    Waiver by Authority

    45.    Appeals

    46.    Disposal of controlled substance

    47.    Requirements in respect of cessation of practise

    48.    Forfeiture

    49.    Guidelines

    50.    Power of Minister to amend Schedules

    51.    Regulations

    52.    Repeal of Act No. 42 of 1967 and savings and transitional provisions

        FIRST SCHEDULE

        SECOND SCHEDULE

        THIRD SCHEDULE

        FOURTH SCHEDULE

        FIFTH SCHEDULE

        SIXTH SCHEDULE

AN ACT

to provide for the granting of a licence to deal in, manufacture, import and export a controlled substance; regulate the use, dispensing, manufacture, wholesale, transfer, supply, sell, distribution and possession of a controlled substance for medicinal, scientific and research purposes; provide for procedures and criteria for classification of controlled substances; provide for the functions of the Zambia Medicines and Regulatory Authority relating to controlled substances; repeal and replace the Dangerous Drugs Act, 1967; and provide for matters connected with, or incidental to, the foregoing.

[On Notice]

Act 2 of 2023.

PART I
PRELIMINARY PROVISIONS

1.    Short title and commencement

This Act may be cited as the Controlled Substances Act, and shall come into operation on the date that the Minister may appoint, by statutory instrument.

2.    Interpretation

In this Act, unless the context otherwise requires—

"administer" has the meaning assigned to the word in the Medicines and Allied Substances Act, 2013;

"adulterant" means a substance found within a controlled substance that compromises the quality, safety or effectiveness of that controlled substance;

"agent" means a person who acts on behalf, or on the direction, of a licensed entity when carrying out the licensed entity’s business;

"anabolic steroid" includes a hormonal substance, chemical or pharmacological substance related to testosterone;

"animal health facility" has the meaning assigned to the words in the Veterinary and Veterinary Para-Professions Act, 2010;

"appropriate authority" means a relevant public body, statutory corporation or person having powers or regulatory functions under any other written law;

"authorised dispenser" means a pharmacist, veterinary surgeon or any other person authorised by the Authority to dispense a controlled substance;

"authorised officer" means a person assigned to carry out the duties of a law enforcement authority for the purposes of this Act and includes—

    (a)    an officer appointed under the Narcotic Drugs and Psychotropic Substances Act, 2021;

    (b)    an inspector appointed under the Medicines and Allied Substances Act, 2013; and

    (c)    an inspector appointed under the Environmental Management Act, 2011;

"authorised prescriber" has the meaning assigned to the words in the Medicines and Allied Substances Act, 2013;

"authorised seller" means a registered pharmacist in a pharmacy or veterinary surgeon in an agro veterinary shop of a specified class, who is authorised to sell controlled substances as prescribed and any other person authorised by the Authority;

"Authority" means the Zambia Medicines Regulatory Authority established under the Medicines and Allied Substances Act, 2013;

"child" has the meaning assigned to the word in the Constitution;

"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;

"Commission on Narcotic Drugs" means the United Nations Commission on Narcotic Drugs established by the Economic and Social Council in 1946, to assist the Economic and Social Council in supervising the application of the international drug control treaties;

"controlled substance" means a narcotic drug, psychotropic substance or precursor chemical set out in the First, Second, Third, Fourth, Fifth and Sixth Schedules, but does not include distilled spirits, wine, malt beverages or tobacco as defined in the Customs and Excise Act;

"Convention on Psychotropic Substances" means the Convention on Psychotropic Substances which entered into force on 16th August 1976, and was acceded to by the Republic on 28th May, 1993;

"deal" has the meaning assigned to the word in the Medicines and Allied Substances Act, 2013 and includes research for medicinal and scientific purposes and "dealt" shall be construed accordingly;

"denaturant" means a substance which renders a controlled substance unfit for consumption without destroying the usefulness in other applications;

"dispense" means to count, measure or decant a controlled substance from a bulk supply or to prepare, mix, dissolve or supply a controlled substance but does not include the administration of medicine;

"distribute" means the division and movement of controlled substances from the premises of a manufacturer, or from another central point to an intermediate point, or to an end user, by means of any method of transport;

"distributor" means a person who distributes a controlled substance;

"diversion" means a change of the intended use or destination of a controlled substance;

"drug addict" means a person addicted to a narcotic drug or psychotropic substance;

"Drug Enforcement Commission" means the Drug Enforcement Commission established under the Constitution;

"health facility" has the meaning assigned to words in the Health Professions Act, 2009;

"health practitioner" means a medical doctor, medical licentiate, pharmacist, dental surgeon or other person as the Minister may, on the advice of the Authority, by statutory instrument, designate;

"health research" has the meaning assigned to the words in the National Health Research Act, 2013;

"higher education institution" has the meaning assigned to the word in the Higher Education Act, 2013;

"international agreements" means the United Nations Single Convention on Narcotic Drugs, 1961, or any other agreement relating to, or impacting on, controlled substances to which the Republic is a party to;

"legally disqualified" means the absence of legal capacity as provided in section 4 of the Mental Health Act, 2019;

"licence" means a licence issued under section 6;

"licensee" means a person licensed in accordance with this Act;

"manufacture" in relation to a controlled substance, includes any process carried out in the course of making that controlled substance but does not include dissolving or dispensing a product in, or diluting or mixing it with, some other substance for purposes of administering it;

"medicine" has the meaning assigned to the word in the Medicines and Allied Substances Act, 2013;

"medical doctor" means a person registered as a medical doctor under the Health Professions Act, 2009;

"medicinal purposes" means the use of a controlled substance for the treatment or prevention of a disease or for some other definite curative or therapeutic purpose, but excludes the satisfaction or relief of a habit or craving for the controlled substance;

"narcotic drug" means a narcotic drug set out in the First, Second, Third and Fourth Schedules;

"National Health Research Authority" means the National Health Research Authority established under the National Health Research Act, 2013;

"pharmacist" means a person registered as a pharmacist under the Health Professions Act, 2009;

"possess" includes to keep or store a controlled substance, or to have a controlled substance in custody or under control or supervision;

"precursor chemical" has the meaning assigned to the words in the Narcotic Drugs and Psychotropic Substances Act, 2021;

"premises" includes any building, dwelling, shop, office or tent together with the land on which the building, dwelling, shop, office or tent is situated and the adjoining land used in connection with that land, and includes any vehicle, conveyance or vessel;

"preparation" means a solution or mixture in whatever physical state containing a controlled substance;

"prescription" has the meaning assigned to the word in the Medicines and Allied Substances Act, 2013;

"prepared opium" means opium prepared for smoking, and includes dross and any other residues remaining after opium has been smoked, and opium, for whatever purpose prepared, which is capable of being smoked;

"psychoactive substance" means a narcotic drug or psychotropic substance that has potential to affect how the brain functions and causes changes in mood, awareness, thoughts, feelings, or behaviour;

"psychotropic substance" has the meaning assigned to the words in the Narcotic Drugs and Psychotropic Substances Act, 2021 and includes the psychotropic substances set out in the First, Second, Third and Fourth Schedule;

"register" means a register of controlled substances provided for under section 32;

"repealed Act" means the repealed Dangerous Drugs Act;

"sell" has the meaning assigned to the word in the Medicines and Allied Substances Act, 2013;

"Single Convention" means the Single Convention on Narcotic Drugs which entered into force on 8th August, 1975, and was ratified by the Republic on 13th May, 1998;

"special stocks" means an amount of controlled substances held by the Government for purposes determined by the Government;

"stocks"means the amount of controlled substances held in the Republic for medicinal, scientific and research purposes, manufacture or export;

"temporary classification" means a temporary removal of a controlled substance from or an addition to the First, Second, Third or Fourth Schedule;

"veterinary surgeon" means a person registered as a veterinary surgeon under the Veterinary and Veterinary Para-Professions Act, 2010;

"Zambia Environmental Management Agency" means the Zambia Environmental Management Agency established under the Environmental Management Act, 2011; and

"Zambia Revenue Authority" means the Zambia Revenue Authority established under the Zambia Revenue Authority Act.

PART II
ADMINISTRATION

3.    Administration of Act

    (1) The Act shall be administered by the Authority.

    (2) The seal of the Authority kept in terms of the Medicines and Allied Substances Act, 2013, shall be used for the purposes of this Act and the impression made for that purpose shall be judicially noticed.

4.    Functions of Authority Act

    (1) The Authority shall, in addition to the functions under the Medicines and Allied Substances Act, 2013, perform the functions conferred on the Authority under this Act.

    (2) The functions of the Authority are to—