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
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.
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
(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.
(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—
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(a) monitor, supervise and control special stocks and stocks, in collaboration with the Drug Enforcement Commission and other appropriate authorities, to ensure compliance with this Act and any other written law;
(b) regulate and control the manufacture, importation, exportation, distribution and sale of a controlled substance;
(c) issue a licence to deal in, import, export, store, manufacture and use, a controlled substance;
(d) collaborate with national, regional and international organisations on matters relating to controlled substances;
(e) co-ordinate the assessment on a psychoactive substance with an appropriate authority and recommend to the Minister possible control measures under international agreements; and
(f) advise the Minister on a matter relating to a controlled substance.
PART III
LICENSING FOR CONTROLLED SUBSTANCES
5. Non-application of Part III
(1) This part shall not apply to a controlled substance that is listed under the Sixth Schedule.
(2) A person who intends to manufacture, import, export, deal in or advertise a controlled substance set out under the Sixth Schedule shall apply for a licence to manufacture, import, export, deal in or advertise the controlled substance in accordance with the Environmental Management Act, 2011.
(3) Despite sub-section (2), a person who intends to import a controlled substance set out in the Sixth Schedule shall, in addition to the licence under sub-section (2), apply to the Authority for authorisation to import the controlled substance in the prescribed manner and form.
(4) The Authority shall, within 30 days of receipt of an application under sub-section (3), approve or reject the application.
(5) The Authority shall, where the Authority—
(a) approves an application under sub-section (4), notify the applicant, in writing; or
(b) rejects an application under sub-section (4), notify the applicant, in writing, stating the reasons for the rejection.
6. Prohibition of manufacturing, importing, exporting, dealing in or advertising of controlled substance
(1) A person shall not manufacture, import, export, deal in or advertise a controlled substance without a licence issued by the Authority.
(2) A person who contravenes sub-section (1) commits an offence and is liable, on conviction, to imprisonment for a term not exceeding twenty-five years but the term of imprisonment shall not be less than two years.
(1) A person who intends to manufacture, import, export, deal in or advertise a controlled substance set out in the Schedules shall apply to the Authority for a licence in a prescribed manner and form, on payment of a prescribed fee.
(2) The Authority shall, within 90 days of receipt of an application under sub-section (1), approve or reject the application.
(3) Despite sub-section (2), the Authority shall approve or reject an application to import or export a controlled substance within 14 days of the date of receipt of the application.
(4) The Authority shall, where the Authority rejects an application, inform the applicant of the Authority’s decision in a prescribed manner and form stating the reasons for the rejection.
(5) The Authority shall, where the applicant meets the prescribed requirements issue the applicant with an applicable licence in a prescribed manner and form.
(6) A licence granted under sub-section (5) shall be valid for—
(a) one year, for an import and export licence;
(b) two years, for a manufacturing licence;
(c) the duration of the advert for a controlled substance for an advertising licence; and
(d) a period as stated on the licence for other licences dealing in controlled substances.
(1) A licensee who intends to renew a licence shall, within 90 days before the expiration of the licence, apply to the Authority for renewal of the licence in a prescribed manner and form, on payment of a prescribed fee.
(2) The Authority shall, within 14 days of receipt of an application under sub-section (1), approve or reject the application.
(3) The Authority shall, where the Authority rejects an application, inform the applicant of the Authority’s decision in a prescribed manner and form stating the reasons for the rejection.
(4) The Authority shall, where the applicant meets the prescribed requirements, renew the licence.
(5) The licensee shall, where a licensee does not intend to renew the licence, within 90 days before the expiry of the licence, submit to the Authority a status report relating to the licensed activity in a prescribed manner and form.
(6) Despite sub-section (1), a licence to import or export a controlled substance, is not renewable.
9. Suspension or revocation of licence
(1) The Authority shall suspend or revoke a licence where the licensee—
(a) obtained the licence by fraud, misrepresentation or concealment of a material fact;
(b) is legally disqualified to undertake the activity for which the licence was issued;
(c) fails to take corrective measures following the suspension of the licence;
(d) changes business premises without authorisation; or
(e) is convicted of an offence under the Act or any other written law and sentenced to a term of imprisonment exceeding six months without the option of a fine.
(2) The Authority shall, before suspending or revoking a licence, notify the licensee in a prescribed manner and form of the Authority’s intention to suspend or revoke the licence and—
(a) give reasons for the intended suspension or revocation; and
(b) require the licensee to show cause, within a period as the Authority may determine, why the licence should not be suspended or revoked.
(3) The Authority shall not suspend or revoke a licence under this section if the licensee takes remedial measures to the satisfaction of the Authority within the period specified under sub-section (2).
(4) The Authority may suspend or revoke a licence if the licensee, after being notified under sub-section (2), fails to show cause or does not take any remedial measures to the satisfaction of the Authority.
(5) The Authority shall, where a licence is revoked under this Act, inform the licensee, in writing, of the revocation of the licence and the licensee shall surrender that licence to the Authority.
(1) A licensee who intends to amend a licence shall apply to the Authority for an amendment of that licence in a prescribed manner and form, on payment of a prescribed fee.
(2) The Authority shall within 14 days of receipt of an application under sub-section (1)—
(a) approve or reject the amendment; and
(b) notify the licensee of the approval of the amendment or rejection thereof.
11. Submission of quarterly returns
(1) A licensee shall submit to the Authority a quarterly return on a controlled substance in a prescribed manner and form.
(2) A quarterly return referred to under sub-section (1) shall be submitted not later than 14 days of the next quarter.
(3) A licensee who fails to submit a quarterly return within the prescribed period commits an offence.
(1) A licence issued under this Part shall not be transferred to a third party without prior authorisation of the Authority.
(2) A licensee who intends to transfer a licence shall apply to the Authority in a prescribed manner and form, on payment of a prescribed fee.
(3) The Authority shall, within 30 days of receipt of an application under sub-section (2), approve or reject the application.
(4) The Authority shall, where the Authority rejects the application, inform the applicant in the prescribed manner and form stating the reasons for the rejection.
(5) The Authority shall, where the person to whom a licensee intends to transfer the licence meets the prescribed requirements, transfer the licence to that person for the remainder of the validity of the licence on terms and conditions that the Authority may determine.
(6) Despite sub-section (2), an import or export licence is not transferable.
13. Notice of cessation of activity by licensee
(1) A licensee who intends to cease conducting a licensed activity under this Act shall notify the Authority in a prescribed manner and form.
(2) A licensee shall, 30 days prior to the cessation of the activity for which the licence was issued, submit to the Authority a detailed report of the licensed activity in a prescribed manner and form.
(3) A licensee shall, where the licensed activity ceases before the expiry of the licence, surrender the licence to the Authority and the Authority shall, on terms and conditions that the Authority may determine, cancel that licence.
PART IV
MANUFACTURING, SUPPLY, DISTRIBUTION, SELLING, USING, PRESCRIBING AND DISPENSING OF CONTROLLED SUBSTANCES
14. National annual requirements for controlled substances
The Authority shall determine the total quantity, and establish national annual requirements, for each class of a controlled substance in order to provide for—
(a) requirements for medicinal, scientific and research purposes;
(b) lawful export requirements;
(c) maintenance of reserve stocks;
(d) limitation or reduction of individual production quotas to the extent necessary to prevent the aggregate of individual quotas from exceeding the amount prescribed;
(e) revision of quotas for each class of a controlled substance, where applicable; and
(f) determination of the process of fixing the production quota, taking into account—
(i) the average estimated disposal, inventory and other requirements of the manufacturing sector for the year;
(ii) the trend of the national disposal rate during the preceding year;
(iii) the average production cycle and inventory position of the manufacturing sector;
(iv) the economic availability of raw materials, yield and stability problems;
(v) national emergencies and disasters; or
(vi) any other factor that the Authority considers necessary.
15. Prohibition of placing on market, etc., controlled substance used as medicine without pharmaceutical licence
A person shall not place on the market, advertise, promote, manufacture, sell, import, supply or deal with a controlled substance used as a medicine without a pharmaceutical licence issued by the Authority in accordance with the Medicines and Allied Substances Act, 2013.
16. Application for pharmaceutical licence
A person who intends to place on the market, advertise, promote, manufacture, sell, import, supply or deal with a controlled substance used as a medicine shall apply to the Authority for a pharmaceutical licence in accordance with the Medicines and Allied Substances Act, 2013, and shall meet the requirements prescribed under this Act.
17. Authorisation for certain classes of persons
(1) The following classes of persons are authorised for the practice or exercise of that person’s profession, function or employment, to be in possession of, dispose, use, prescribe or dispense, a controlled substance—
(a) health practitioner;
(b) veterinary surgeon;
(c) nurse or midwife specified under section 51 of the Nurses and Midwives Act, 2019;
(d) a person in charge of a laboratory used for the purpose of research or education and attached to—
(i) a higher education institution;
(ii) a health facility; or
(iii) any research institution or registered business entity; and
(e) an authorised officer.
(2) A person referred to under sub-section (1) who is in possession of a medicine containing a controlled substance, shall, except when required by the practice of a profession, function or employment, keep the medicine in a locked immovable receptacle which shall be opened only by that person or another person authorised by virtue of this section, to be in possession of a controlled substance.
18. Prescribing or dispensing controlled substances
(1) An authorised prescriber may prescribe a controlled substance for treatment in accordance with guidelines issued by the Authority.
(2) An authorised dispenser may dispense a controlled substance for treatment in accordance with guidelines issued by the Authority.
(3) Guidelines issued under this section shall include matters relating to—
(a) security of stocks of controlled substances;
(b) the maintenance of prescribed records on controlled substances; and
(c) the quantities of controlled substances which may be provided without supervision for use by an individual in treatment.
19. Withdrawal and restoration of authorisation
(1) The Authority may, by notice in the Gazette, revoke the authorisation of any person under section 16, where that person—
(a) commits an offence under this Act, or attempts to solicit, incite, aid or abet, any other person to commit any offence under this Act;
(b) has that person’s licence or certificate of practice suspended or revoked;
(c) is legally disqualified from, being in possession of, disposing, using, prescribing or dispensing, a controlled substance; or
(d) is proved, to the satisfaction of a medical doctor, to be a drug addict.
(2) A person whose authorisation is revoked in accordance with sub-section (1) may apply to the Authority in a prescribed manner and form, on payment of a prescribed fee for the restoration of that person’s authorisation.
(3) The Authority may, where the authorisation of a person is revoked in accordance with this section, restore the authorisation where the reasons for revocation cease to exist.
(4) The Authority may, where the Authority revokes the authorisation of a person, seize and take custody of the controlled substance at the cost of the person whose authorisation has been revoked.
20. Sell or supply without prescription
A person shall not sell or supply a controlled substance which requires a prescription without a prescription.
21. Sell or supply by partial filling of prescription
(1) Despite section 20 and any other written law governing controlled substances, a person may sell or supply a controlled substance for medicinal purposes on partial filling of a prescription for a controlled substance set out in the First, Second, Third, Fourth and Fifth Schedules if the—
(a) partial filling is requested by the patient or the authorised prescriber that prescribed the controlled substance; and
(b) total quantity for the partial filling does not exceed the total quantity prescribed.
(2) Except as provided in this section, remaining portions of a partially filled prescription for a controlled substance set out in the First, Second, Third, Fourth and Fifth Schedules may be filled not later than 30 days after the date on which the prescription was written.
22. Emergency sell or supply of controlled substance
(1) An authorised seller of a controlled substance who is reasonably satisfied that a person requesting a controlled substance is an authorised prescriber and by reason of some emergency is unable to furnish a prescription immediately, may, in the absence of a prescription, sell or supply the controlled substance requested in accordance with the directions of the authorised prescriber, except that the authorised prescriber shall undertake to furnish the authorised seller with a prescription, within seven days of the delivery of the controlled substance.
(2) A person who fails to provide a prescription within the period specified under sub-section (1) commits an offence.
23. Retail of precursor chemicals
A retailer shall ensure that the sale of a product containing precursor chemicals set out in the Fifth Schedule is made in accordance with the guidelines issued by the Authority.
24. Consignment of controlled substance in transit
(1) Where a controlled substance is permitted under the law of any foreign country to be exported to another country, and is transited through the Republic as provided in the Customs and Excise Act, the exporter shall—
(a) notify the Authority, the Drug Enforcement Commission and the Zambia Revenue Authority in the prescribed manner and form; and
(b) not cause, or procure, the controlled substance to be diverted to any destination within the Republic without authorisation.
(2) A person who contravenes sub-section (1) commits an offence and is liable, on conviction, to a fine not exceeding five hundred thousand penalty units or to imprisonment for a term not exceeding five years, or to both.
25. Prohibition of diversion of controlled substance within Republic
(1) A person shall not without authorisation cause a controlled substance to be diverted within the Republic to a destination other than that which it was originally assigned.
(2) A person who contravenes sub-section (1) commits an offence and is liable, on conviction, to a fine not exceeding five hundred thousand penalty units or to imprisonment for a term not exceeding five years, or to both.
26. Use of controlled substances in health research
(1) A person who intends to carry out health research on a controlled substance set out in the First, Second, Third, Fourth, Fifth and Sixth Schedules shall do so in accordance with the National Health Research Act, 2013, and the Medicines and Allied Substances Act, 2013.
(2) The Authority and the National Health Research Authority shall, in setting the criteria for assessing the merits of a research protocol using a controlled substance, ensure that they are effective procedures to adequately safeguard against diversion of a controlled substance from legitimate medicinal, scientific or research purposes.
(3) The Authority and the National Health Research Authority shall, in setting the criteria for assessing the merits of a research protocol using a controlled substance under sub-section (2), take into account—
(a) a person’s experience with respect to a controlled substance;
(b) previous convictions relating to a controlled substance;
(c) relevant written laws relating to a controlled substance;
(d) medical and research experience of the person; and
(e) any other conduct which may threaten public health and safety.
PART V
CLASSIFICATION AND EXEMPTION OF CONTROLLED SUBSTANCES
27. Classification of controlled substances
(1) The Minister may, by statutory instrument and on the recommendation of the Authority, and in consultation with appropriate authorities, classify a controlled substance in the First, Second, Third, Fourth, Fifth or Sixth Schedule.
(2) The Authority shall, in making the recommendation under sub-section (1), ensure that the classification is in accordance with the following levels of potential abuse—
(a) in the case of a controlled substance classified in the First Schedule, the controlled substance—
(i) has a high potential for abuse or poses a serious threat to public health; or
(ii) is limited or has no use for research, medicinal or scientific purposes;
(b) in the case of a controlled substance classified in the Second Schedule, the controlled substance—
(i) has major stimulant and addictive properties;
(ii) has high potential for abuse or poses a serious threat to public health;
(iii) has an approved medicinal or scientific purpose; or
(iv) may lead to severe psychological or physical dependence due to abuse;
(c) in the case of a controlled substance classified in the Third Schedule, the controlled substance includes—
(i) preparations containing narcotic drugs that are intended for legitimate medical use and are compounded in such a way that the preparation is unlikely to be abused and that the base narcotic drug cannot be easily extracted; or
(ii) psychotropic substances which have legitimate medical use, and poses a serious risk to public health;
(d) in the case of a controlled substance classified in the Fourth Schedule, the controlled substance—
(i) is rarely used in medical practice and may be subject to special control measures; or
(ii) includes psychotropic substances which have legitimate use and poses a minor risk to public health; and
(e) in the case of a controlled substance classified in the Fifth and Sixth Schedule, the controlled substance is a precursor chemical.
28. Exemptions for certain purposes
(1) Subject to section 31, the Authority shall, where the Authority considers that a controlled substance does not have a significant potential for abuse, recommend to the Minister to exempt the controlled substance from the application of any provisions of this Act.
(2) The Minister may, on the recommendation of the Authority and in consultation with an appropriate authority, exempt, by statutory instrument, a controlled substance from the application of any provisions of this Act.
(3) The Minister may, on the recommendation of the Authority and in consultation with an appropriate authority, by statutory instrument, exempt any compound, mixture or preparation containing a controlled substance from the application of any provisions of this Act if the Authority finds that the compound, mixture or preparation contains—
(a) a controlled substance which is not for administration to a human being or animal, and which is packaged in a form or concentration, or with adulterant or denaturants, and it does not present any significant potential for abuse; or
(b) an anabolic steroid, which is intended for administration to a human being or an animal and which, because of its concentration, preparation, formulation or delivery system, does not present any significant potential for abuse.
(4) The Minister shall, by statutory instrument, revoke the exemption of a controlled substance that the Authority finds is being diverted from the purposes specified in sub-section (2) or (3).
(5) The Minister shall, in revoking an exemption of a controlled substance under this section, consider—
(a) the scope, duration and significance of the diversion;
(b) whether the controlled substance is formulated in a manner that it cannot easily be used in the illicit production of another controlled substance;
(c) whether a precursor can be readily recovered from the controlled substance;
(d) the evidence of the diversion of the controlled substance; and
(e) any other relevant issue that contravenes this Act and any other written law.
(6) Subject to sub-section (8), the Minister shall, on the recommendation of the Authority and in consultation with an appropriate authority, on an application by a licensee of a controlled substance, whose exemption is revoked by statutory instrument, reinstate the exemption of that controlled substance, where the Minister is satisfied that the controlled substance shall be manufactured, imported, exported and dealt with in a manner that prevents diversion.
(7) The Minister shall, on the recommendation of the Authority, in reinstating an exemption of a controlled substance, as specified under sub-section (6), consider—
(a) the package sizes and manner of packaging of the controlled substance;
(b) the manner of distribution and advertising of the controlled substance;
(c) any action taken by the manufacturer to prevent diversion of the controlled substance; and
(d) other factors that are relevant to, and consistent with, public health and safety, including the factors specified in sub-section (3).
(8) A person shall not divert a controlled substance without authorisation from the Authority as prescribed.
(9) A person who contravenes sub-section (8) commits an offence and is liable, on conviction, to a penalty specified under the Narcotic Drugs and Psychotropic Substances Act, 2021.
29. Non-prescription preparation containing controlled substance
Subject to the Medicines and Allied Substances Act, 2013, the Minister may, by statutory instrument, exempt a preparation containing a controlled substance from the application of this Act, if the preparation containing a controlled substance may be sold over the counter without a prescription.
30. Temporary classification of controlled substances to avoid imminent hazards to public safety
(1) Despite sections 28 and 29, the Minister may, on the recommendation of the Authority, by statutory instrument, order the temporary classification of a controlled substance to avoid an imminent hazard to the public.
(2) The Minister may, on the recommendation of the Authority, by statutory instrument, remove a controlled substance from a Schedule on a temporary basis, where reasons advanced for the grant of the temporary classification cease to exist.
31. Temporary and permanent classification of anabolic steroids
(1) The Minister may, on the recommendation of the Authority, by statutory instrument, order the temporary classification of an anabolic steroid as a controlled substance, if the Authority finds that the classification shall assist in preventing abuse or misuse of the anabolic steroid.
(2) The Minister may, on the recommendation of the Authority, by statutory instrument, remove an anabolic steroid from a Schedule on a temporary basis, where the reasons advanced for the grant of the temporary classification cease to exist.
(3) The Minister may, on the recommendation of the Authority, by statutory instrument, permanently include an anabolic steroid as a controlled substance in the appropriate Schedule.
PART VI
REPORTS, RECORDS, INVENTORIES AND REGISTERS
32. Records or inventory of licensed activity
(1) A licensee shall establish and maintain a complete and accurate record or inventory of each controlled substance manufactured, imported, exported, advertised or dealt in.
(2) A health facility or animal health facility shall establish and maintain a complete and accurate record or inventory of each controlled substance in the health facility or animal health facility’s possession, disposed of, used, prescribed or dispensed by a person authorised under section 16.
(3) In the case of a person in charge of a laboratory used for the purpose of research or education and attached to a higher education institution, research institution or registered business entity, that higher education institution, research institution and registered business entity shall establish and maintain a complete and accurate record or inventory of each controlled substance.
(4) The record or inventory referred to in this section shall be kept and maintained in a prescribed manner and form.
(5) A person who contravenes this section commits an offence.
33. Registers by other person or institution
(1) The Authority may require a person or institution, other than a person or institution referred to under section 32, in possession of a controlled substance for disposal, use, prescribing or dispensing to keep and maintain a register of the controlled substances in that person or institution’s possession in a prescribed manner and form.
(2) A person who contravenes this section commits an offence.
(1) A licensee, a health facility, animal health facility, higher education institution, research institution, registered business entity or other person or institution so required by the Authority shall preserve registers, records, inventories, books, prescriptions, orders in writing and other documents issued or made for the purposes of this Act for a period of five years from the date on which the last entry was made or issued, as prescribed.
(2) A person who contravenes this section commits an offence.
PART VII
INSPECTIONS
35. Power of authorised officer
(1) An authorised officer may, for the purpose of enforcing the provisions of this Act, with a warrant, at any reasonable time—
(a) enter any premises, pharmacy, agro veterinary shop, container, vessel, vehicle, aircraft or other conveyance that the authorised officer has reasonable grounds to believe is used for the commission of an offence or for purposes contrary to the provisions of this Act;
(b) search any premises where any activity in relation to controlled substances is being undertaken, including a pharmacy, an agro veterinary shop, a container, vessel, vehicle, an aircraft or other conveyance, or the premises of a manufacturer, importer, exporter or dealer of any controlled substances or any person licensed or regulated under this Act, including a private dwelling, where information or documents which may be relevant to an inspection may be kept or which are being used for the commission of an offence under this Act;
(c) search any person on the premises if the authorised officer has reasonable grounds to believe that the person has possession of an article, document, record or controlled substance that has a bearing on an investigation, except that a person shall only be searched by a person of the same sex;
(d) examine any document, record, book, article or controlled substance found on the premises that has a bearing on an inspection or investigation;
(e) require information to be given about any document, record, book, article or controlled substance in any premises by—
(i) the owner of the premises;
(ii) the person in control of the premises;
(iii) any person who has control of the document, record, book, article or controlled substance; or
(iv) any other person who may have the information;
(f) seize any document, book, record, article, computer or other electronic storage device or controlled substance that has a bearing on an inspection or investigation or is used for purposes contrary to the provisions of this Act;
(g) take samples of any controlled substance as may be necessary for the purposes of testing, examination or analysis;
(h) take extracts from, or make copies of, any book, record or document found on the premises that has a bearing on an inspection or investigation; or
(i) use any computer system or any other electronic device on the premises, or require the assistance of any person on the premises to use that computer system or electronic device, to—
(i) search any data contained in, or available to, the computer system or electronic device;
(ii) reproduce any record from the data;
(iii) seize any output from the computer or electronic device for examination and copying; and
(iv) attach and, if necessary, remove from the premises for examination and safeguarding any document, record, book or article that has a bearing on an inspection or investigation.
(2) An authorised officer who removes any document, book, record or article from any premises under sub-section (1) shall—
(a) issue a receipt for the document, book, record or article to the owner of, or person in control of, the premises; and
(b) return the document, book, record or article as soon as practicable after achieving the purpose for which it was removed.
(3) A person commits an offence if that person—
(a) delays, assaults, threatens or obstructs an authorised officer in the performance of the authorised officer’s functions;
(b) refuses to give an authorised officer reasonable assistance that the authorised officer may require for the purpose of exercising the authorised officer’s powers;
(c) gives an authorised officer false or misleading information in answer to an inquiry made by the authorised officer; or
(d) impersonates an authorised officer or presents oneself to be an authorised officer.
(4) A person convicted of an offence under sub-section (3) is liable, on conviction, to a fine not exceeding two hundred thousand penalty units or to imprisonment for a term not exceeding two years, or to both.
(5) An authorised officer shall furnish a written report and any other information relating to an inspection to an appropriate authority, as the Authority may require.
(6) Nothing in this section requires a person to disclose or produce information or a document, if the person would in an action in a court be entitled to refuse to disclose or produce the information or document.
(1) An authorised officer may arrest a person, without warrant, where the authorised officer has reasonable grounds to believe that the person—
(a) is committing or has committed an offence under this Act;
(b) is about to commit an offence under this Act and there is no other way to prevent the commission of the offence;
(c) shall, unless arrested—
(i) escape or cause unreasonable delay, trouble or expense in being made answerable to justice;
(ii) interfere with the witnesses; or
(iii) tamper with or destroy relevant evidence or material; or
(d) is wilfully obstructing the authorised officer in the execution of the authorised officer’s duties.
(2) An authorised officer shall, where the authorised officer arrests a person under sub-section (1), handover the person to a police officer, or surrender that person to a police post or station within 24 hours of the arrest.
(3) An authorised officer who makes an arrest under sub-section (1) shall, without undue delay, have the person so arrested brought before a court of competent jurisdiction to be dealt with accordingly.
PART VIII
OFFENCES AND PENALTIES
37. Maintaining controlled substances involved premises
(1) Except as authorised by this Act, a person commits an offence if that person—
(a) knowingly opens, leases, rents, uses or maintains any place, whether permanently or temporarily, for the purpose of manufacturing, distributing or using any controlled substance; or
(b) manages or controls any place, whether permanently or temporarily, either as an owner, lessee, agent, employee, occupant or mortgagee, or knowingly and intentionally rents, leases, profits from, or makes available for use, with or without compensation, the place for the purpose of unlawfully manufacturing, storing, distributing or using a controlled substance.
(2) A person convicted of an offence under sub-section (1) is liable, on conviction, to imprisonment for a term not exceeding five years.
38. Sale of controlled substance to children
(1) Except as provided in this Act, a person who deals in a controlled substance with a child commits an offence and is liable, on conviction, to a fine not exceeding two million penalty units or to imprisonment for a term not exceeding fifteen years, or to both.
(2) Where the controlled substance referred to under sub-section (1) is set out in the Fifth and Sixth Schedules, the person referred to under sub-section (1) is liable, on conviction, to a fine not exceeding one million penalty units or imprisonment for a term not exceeding ten years, or to both.
39. Employing, hiring, using, persuading, inducing, enticing or coercing children to distribute drugs
(1) Despite any other written law, a person commits an offence if that person knowingly—
(a) employs, hires, uses, persuades, induces, entices or coerces a child to contravene this Act; or
(b) employs, hires, uses, persuades, induces, entices or coerces a child to assist in avoiding detection or apprehension for any offence under this Act.
(2) A person convicted of an offence under sub-section (1) is liable, on conviction, to a fine not exceeding one million penalty units or to imprisonment for a term not exceeding ten years, or to both.
40. Prohibition of possession of controlled substance
(1) A person shall not possess a controlled substance without authorisation under this Act or any other written law.
(2) A person who contravenes sub-section (1) commits an offence and is liable, on conviction, to imprisonment for a term not exceeding fifteen years.
(3) This section shall not apply to an appropriate authority procuring a controlled substance in accordance with the requirements of any written law.
41. Offence of import, export, manufacture, possession and use of prepared opium
(1) A person who intends to import, export, manufacture or use prepared opium shall apply for authorisation from the Authority.
(2) A person commits an offence if that person—
(a) imports into, or exports from the Republic any prepared opium;
(b) manufactures or otherwise deals in prepared opium;
(c) has in that person’s possession any prepared opium;
(d) being the occupier of any premises, permits the premises to be used for the purpose of the preparation of prepared opium for smoking, or the sale or smoking, of prepared opium;
(e) is concerned in the management of any premises used for purposes of paragraph (d);
(f) has in that person’s possession any pipes or other utensils for use in connection with the smoking of prepared opium or any utensils used in connection with the prepared opium for smoking; or
(g) smokes, or otherwise uses, prepared opium.
(3) A person who commits an offence under sub-section (1) is liable, on conviction, to a fine not exceeding one million penalty units or to imprisonment for a term not exceeding ten years, or to both.
A person who commits an offence under this Act for which a specific penalty is not provided for is liable, on conviction, to a fine not exceeding three hundred thousand penalty units or to imprisonment for a term not exceeding three years, or to both.
43. Offences by principal officer, shareholder or partner of body corporate or unincorporate body
Where an offence under this Act is committed by a body corporate or unincorporate body, with the knowledge, consent or connivance of the director, manager shareholder or partner, that director, manager, shareholder or partner of the body corporate or unincorporate body commits an offence and is liable, on conviction, to the penalty specified for that offence.
PART IX
GENERAL PROVISIONS
The Authority may waive certain requirements under this Act for the purposes of an importation or exportation of a controlled substance where a national or global disaster or health emergency is declared.
(1) A person who is aggrieved by a decision made under this Act may appeal to the Minister within 30 days of the date of the decision.
(2) The Minister shall hear and determine an appeal referred to under sub-section (1) within 90 days from the date of appeal.
(3) A person aggrieved with the decision of the Minister under sub-section (1), may appeal to the High Court.
46. Disposal of controlled substance
The Authority shall, in collaboration with the Zambia Environmental Management Agency and any other appropriate authority, dispose of expired, obsolete or unwanted controlled substances.
47. Requirements in respect of cessation of practise
(1) A person in lawful possession of a controlled substance shall, before ceasing to practise in a profession or being in employment—
(a) where that person is being succeeded by another person authorised—
(i) physically check with, and hand over to the successor all controlled substances;
(ii) submit to the licensee a signed statement, including the signature of the successor, certifying that the controlled substances have been physically checked and handed over in accordance with sub-paragraph (i);
(iii) after handing over the controlled substance, rule off each page of the register on which an entry is made, and both the person and the successor shall, when satisfied that it is a true record of the controlled substances on hand, sign each page; and
(iv) if either person is not satisfied that an entry, under sub-paragraph (iii), is a true record, that person shall refuse to sign the page and shall immediately inform the licensed entity of the reason for the refusal; or
(b) where that person is not succeeded by another authorised person—
(i) inform the Authority of the arrangements made for the disposal of the controlled substances; and
(ii) immediately after disposing of the controlled substances, that person shall notify the Authority of the disposal of the controlled substances and shall, at the same time, forward the register and the supporting prescriptions and written orders to the Authority who shall retain them for a period of five years from the latest date of entry.
(2) Where the arrangements under sub-section (1)(b), are not made or are not to the satisfaction of the Authority, the controlled substances shall be disposed of in the manner that the Authority may determine, in consultation with the Zambia Environmental Management Agency.
Subject to the Forfeiture of Proceeds of Crime Act, 2010, a person convicted of an offence under this Act shall forfeit to the Republic all articles in respect of which the offence was committed, and the court before which that person is convicted may order those articles to be destroyed or otherwise disposed of as the court thinks fit at the cost of the convicted person.
(1) The Authority may, in the exercise of the Authority’s functions under this Act, issue guidelines as are necessary for the better carrying out of the provisions of this Act.
(2) The Authority shall publish the guidelines issued under this Act in the Gazette and any other electronic media that the Authority may determine.
(3) The guidelines shall take effect on the date of publication and shall bind all persons licensed or authorised under this Act.
50. Power of Minister to amend Schedules
(1) The Minister may, by statutory instrument, on the recommendation of the Authority and in consultation with the Drug Enforcement Commission and any other appropriate authority, amend the Schedules where it is found that a controlled substance—
(a) has a potential for abuse as categorised in section 27; or
(b) fails to meet the requirements for inclusion in any of the Schedules.
(2) The Minister shall, in amending a Schedule under sub-section (1), take into consideration the—
(a) actual or relative potential for abuse;
(b) scientific evidence of its pharmacological effect, if known;
(c) state of current scientific knowledge regarding a controlled substance;
(d) history and current pattern of abuse;
(e) scope, duration and significance of abuse;
(f) potential risk to public health;
(g) psychic or physiological dependence liability; or
(h) possibility of the substance being a precursor chemical of a substance already controlled as specified in this Act.
(3) The Authority shall, in making the recommendation under sub-section (1), consider the decision of the Commission on Narcotic Drugs on categorisation of a controlled substance.
(1) The Minister may, on the recommendation of the Authority, by statutory instrument, make Regulations for the better carrying out of the provisions of this Act and for anything required to be prescribed as specified in this Act.
(2) Despite the generality of sub-section (1), Regulations made under sub-section (1) may—
(a) provide for measures to prevent diversion of controlled substances;
(b) provide for the provision of emergency medical services, a public health emergency or a mass casualty event using controlled substances, consistent with this Act;
(c) prescribe fees or charges payable in respect of any matter arising and provided for, or authorised by this Act;
(d) prescribe the forms for applications, licences, approvals, registers, notices, orders and any other documents required for the purposes of this Act;
(e) provide for the supply and monitoring of special stocks and stocks; and
(f) prescribe the information to be given in returns and other documents submitted or made for the purposes of this Act.
52. Repeal of Act No. 42 of 1967 and savings and transitional provisions
(1) The Dangerous Drugs Act, 1967 is repealed.
(2) Despite sub-section (1)—
(a) a licence issued under the repealed Act shall be considered as having been issued under this Act; and
(b) an application for a licence under the repealed Act shall be considered and issued in accordance with this Act.
[Sections 2, 21, 26 and 27]
[Sections 2, 21, 26 and 27]
[Sections 2, 21, and 27]
[Sections 2, 21, and 27]
[Sections 2, 21, 23, 26 and 38]
[Sections 2, 5, 26 and 38]
{/mprestriction}