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Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)

22A. Control of medicines, Scheduled substances, medical devices and IVDs

[Section 22A heading substituted by section 14(a) of Act No. 14 of 2015]

 

(1) Subject to this section, no person shall sell, have in his or her possession or manufacture any medicine, Scheduled substance, medical device or IVD, except in accordance with the prescribed conditions.

[Subsection (1) substituted by section 14(b) of Act No. 14 of 2015]

 

(2) The Minister may, on the recommendation of the Authority, prescribe the Scheduled substances referred to in this section.

[Subsection (2) substituted by section 22(a) of Act No. 72 of 2008]

 

(3) Any Schedule 0 substance may be sold in an open shop.

 

(4) Any Schedule 1 substance shall not be sold—
(a) by any person other than—
(i) a pharmacist, or a pharmacist intern or pharmacist's assistant acting under the personal supervision of a pharmacist;
(ii) a manufacturer of or wholesale dealer in pharmaceutical products for sale to any person who may lawfully possess such substance;
(iii) a medical practitioner or dentist, who may—
(aa) prescribe such substance;
(bb) compound and dispense such substance only if he or she is the holder of a licence as contemplated in section 22C(1)(a);
(iv) a veterinarian who may prescribe, compound or dispense such substance;
(v) a practitioner, nurse or a person registered under the Health Professions Act, 1974, other than a medical practitioner or dentist, who may—
(aa) prescribe only the Scheduled substances identified in the Schedule for that purpose;
(bb) compound and dispense the Scheduled substances referred to in item (aa) only if he or she is the holder of a licence contemplated in section 22C(1)(a);
(b) to any person apparently under the age of 12 years except upon a prescription issued by an authorised prescriber and dispensed by a pharmacist, pharmacist intern or pharmacist's assistant or by a veterinarian or a person who is the holder of a licence as contemplated in section 22C(1)(a), or on a written order disclosing the purpose for which such substance is to be used and bears a signature known to the seller as the signature of a person known to such seller and who is apparently over the age of 12 years;

[Subsection (4)(b) substituted by section 22(b) of Act No. 72 of 2008]

(c) unless the seller, other than a manufacturer or wholesale dealer in pharmaceutical products, enters in a prescription book required to be kept in the prescribed manner, the prescribed particulars of such sale.

 

(5) Any Schedule 2, Schedule 3, Schedule 4, Schedule 5 or Schedule 6 substance shall not be sold by any person other than—
(a) a pharmacist, pharmacist intern or a pharmacist's assistant acting under the personal supervision of a pharmacist, who may sell only Schedule 2 substances without a prescription;
(b) a pharmacist or a pharmacist intern or pharmacist's assistant acting under the personal supervision of a pharmacist, upon a written prescription issued by an authorised prescriber or on the verbal instructions of an authorised prescriber who is known to such pharmacist;
(c) a manufacturer of or wholesale dealer in pharmaceutical products for sale to any person who may lawfully possess such substance;
(d) a medical practitioner or dentist, who may—
(i) prescribe such substance;
(ii) compound or dispense such substance only if he or she is the holder of a licence as contemplated in section 22C(1)(a);
(e) a veterinarian who may prescribe, compound or dispense such substance;
(f) a practitioner, a nurse or a person registered under the Health Professions Act, 1974, other than a medical practitioner or dentist, who may—
(i) prescribe only the Scheduled substances identified in the Schedule for that purpose;
(ii) compound and dispense the Scheduled substances referred to in subparagraph (i) only if he or she is the holder of a licence contemplated in section 22C(1)(a):

 

(6) Any sale under subsection (5) shall only take place on condition that—
(a) all the prescribed particulars of every sale shall be recorded in the prescribed manner in a prescription book or other permanent record required to be kept in the prescribed manner;
(b) the authorised prescriber who has given verbal instructions to a pharmacist to dispense a prescription shall within seven days after giving such instructions furnish such pharmacist with a prescription confirming such instructions;
(c) in the case of verbal instructions the treatment period shall not exceed seven days;
(d) if a prescription is not presented for dispensing within 30 days of issue it shall not be dispensed;
(e) in the case of a Schedule 2 substance, such substance may not be supplied to any person apparently under the age of 12 years except upon a prescription issued by an authorised prescriber and dispensed by a pharmacist, pharmacist intern or pharmacist's assistant or by a veterinarian or a person who is the holder of a licence as contemplated in section 22C(1)(a), or on a written order disclosing the purpose for which such substance is to be used and bears a signature known to the seller as the signature of a person known to such seller and who is apparently over the age of 12 years;

[Subsection (6)(e) substituted by section 22(c) of Act No. 72 of 2008]

(f) in the case of a Schedule 2, Schedule 3 or Schedule 4 substance, such sale may be repeated if the person who issued the prescription has indicated thereon the number of times it may be dispensed, but not for longer than six months;
(g) in the case of a Schedule 5 substance, such sale shall not be repeated for longer than six months, and then only if the authorised prescriber has indicated on the prescription the number of times and the intervals at which it may be dispensed;
(h) where a Schedule 5 substance is used for—
(i) its anxiolytic, antidepressant or tranquillising properties it shall not be prescribed for longer than six months unless the authorised prescriber has consulted a registered psychiatrist, or, in the case of a psychiatrist, another psychiatrist before issuing a new prescription;
(ii) its analgesic properties it shall not be prescribed for longer than six months unless the authorised prescriber has consulted another medical practitioner, before issuing a new prescription;
(i) in the case of a Schedule 6 substance, it shall not be repeated without a new prescription being issued;
(j) in an emergency in which the health or life of a patient is at stake, a pharmacist engaged in wholesale practice may, on receipt of a telephonic or telefaxed or other electronic request, supply a Schedule 6 substance to a pharmacist, medical practitioner, dentist, veterinarian, practitioner, nurse or other person registered under the Health Professions Act, 1974, without a written order: Provided that—
(i) it shall be the responsibility of such pharmacist, medical practitioner, dentist, veterinarian, practitioner, nurse or other person to ensure that such pharmacist receives a written order within seven days.
(ii) the Schedule 6 substance shall be supplied in the smallest unit sales pack available;
(iii) a permanent record is made and kept of such supply.
(k) in an emergency a pharmacist may sell any Schedule 5 or Schedule 6 substance in a quantity not greater than that required for continuous use for a period of 48 hours, on the verbal instructions of a medical practitioner, dentist, veterinarian, practitioner, nurse or other person registered under the Health Professions Act, 1974, who is known to such pharmacist, but the prescriber who has given such verbal instructions shall within 72 hours after giving such instructions furnish to such pharmacist a written prescription confirming the instructions;
(l) in an emergency a pharmacist may sell a Schedule 2, Schedule 3 or Schedule 4 substance on a non-recurring basis for a period not exceeding 30 days in accordance with the original prescription in order to ensure that therapy is not disrupted if he or she is satisfied that an authorised prescriber initiated the therapy, with the intention that the therapy be continued, and that the particulars of such sale are recorded in a prescription book or other prescribed permanent record;
(m) a pharmacist may sell a greater or a lesser quantity of a Schedule 1, Schedule 2, Schedule 3 or Schedule 4 substance than the quantity prescribed or ordered, according to the therapeutic pack in the original container of such substance as supplied to him or her, but the quantity so sold shall not exceed or be less than, 25 per cent of the quantity specified in the prescription or order in question;
(n) any seller referred to in this subsection shall retain the prescription or order concerned for a period of not less than five years as from the date of such sale;
(o) a Schedule 6 substance may only be sold if the course of treatment does not exceed 30 consecutive days;
(p) the sale of a specified Schedule 5 or Schedule 6 substance by a manufacturer of or wholesale dealer in pharmaceutical products shall be recorded in a register which shall be kept in the prescribed manner, and shall be balanced so as to show clearly the quantity of every specified Schedule 5 or Schedule 6 substance remaining in stock as on the last day of March, June, September and December of each year, and such balancing shall be completed within the 14 days following each of the said dates;

[Subsection (6)(p) substituted by section 5(a) of Act No. 59 of 2002]

(q) a pharmacist shall endorse on the prescription the date of sale and the quantity of the substance sold, and when it is repeated, the date of sale and the quantity of the said substance sold, and the last seller shall retain the prescription for a period of not less than five years as from the date of the last sale;
(r) any Schedule 1, Schedule 2, Schedule 3 or Schedule 4 substance for the treatment of any animal may be supplied by any person practising a para-veterinary profession within the meaning of the Veterinary and Para-Veterinary Professions Act, 1982 (Act No. 19 of 1982), upon a written prescription issued by a veterinarian or on the verbal instructions of a veterinarian.

 

(7)
(a) No person, other than a pharmacist, pharmacist intern or pharmacist's assistant acting under the personal supervision of a pharmacist, shall sell or export a Schedule 1, Schedule 2, Schedule 3, Schedule 4, Schedule 5 or Schedule 6 substance for analytical purposes, manufacture of foods, cosmetics, educational or scientific purposes, unless a permit, issued in accordance with the prescribed conditions has, subject to paragraph (b), been obtained from the Director-General for such purpose.
(b) The Director-General may revoke any permit referred to in paragraph (a) if the conditions on which such permit was issued, are not complied with or if it is not in the public interest that the particular action be continued.

 

(8) Subject to subsection (9), a Schedule 8 substance shall not be acquired by any person other than the Director-General for the purpose of providing a medical practitioner therewith, on the prescribed conditions, for the treatment of a particular patient of that medical practitioner upon such conditions as the Director-General, on the recommendation of the council, may determine.

[Subsection (8) substituted by section 5(b) of Act No. 59 of 2002]

 

(9)
(a) No person shall—
(i) acquire, use, possess, manufacture, or supply any Schedule 7 or Schedule 8 substance, or manufacture any specified Schedule 5 or Schedule 6 substance unless he or she has been issued with a permit by the Director-General for such acquisition, use, possession, manufacture, or supply: Provided that the Director-General may, subject to such conditions as he or she may determine, acquire or authorise the use of any Schedule 7 or Schedule 8 substance in order to provide a medical practitioner, analyst, researcher or veterinarian therewith on the prescribed conditions for the treatment or prevention of a medical condition in a particular patient, or for the purposes of education, analysis or research;

[Section (9)(a)(i) substituted by section 5(c) of Act No. 59 of 2002]

(ii) manufacture, use or supply any Schedule 5 or Schedule 6 substance for other than medicinal purposes, unless he or she has been issued by the Director-General with a permit for such manufacture, use or supply upon the prescribed conditions.
(b) Notwithstanding paragraph (a), the Director-General may at any time revoke any permit issued in terms of that paragraph if any condition on which the permit was issued is not being complied with.
(c) A permit issued in terms of this subsection shall be valid for a period of 12 calendar months after the date of issue thereof.

 

(10) Notwithstanding anything to the contrary contained in this section, no person shall sell or administer any Scheduled substance or medicine for other than medicinal purposes: Provided that the Minister may, subject to the conditions or requirements stated in such authority, authorise the administration outside any hospital of any Scheduled substance or medicine for the satisfaction or relief of a habit or craving to the person referred to in such authority.

 

(11)
(a) No person shall import or export any specified Schedule 5, Schedule 6, Schedule 7 or Schedule 8 substance or other substance or medicine prescribed for that purpose unless a permit has been issued to him or her by the Director-General in the prescribed manner and subject to such conditions as may be determined by the Director-General;

[Subsection (11)(a) substituted by section 5(d) of Act No. 59 of 2002]

(b) A permit referred to in paragraph (a) may be issued for any purpose other than the satisfaction or relief of a habit or craving in respect of such substance or medicine.
(c) The issue of a permit referred to in paragraph (a) may be refused if—
(i) the Director-General is not convinced that the applicant is capable of keeping or storing the substance or medicine in a satisfactory manner in order to prevent the loss thereof;
(ii) the use of such substance or medicine has not been authorised in terms of this Act;
(iii) the Director-General is of the opinion that the annual importation quota for such substance has been exceeded or will be exceeded;
(iv) the Director-General is of the opinion that such substance or medicine, of an acceptable quality, is already available in the Republic; or
(v) the applicant did not comply with the conditions under which a previous permit was issued to him or her.
(d) If an application is refused, the applicant shall be furnished with the reasons for such refusal.
(e) A permit issued in terms of this subsection shall be valid for a period of six months from the date of issue thereof.

 

(12)
(a) The control on the importation of Scheduled substances shall relate to—
(i) any specified Schedule 5, Schedule 6, Schedule 7 or Schedule 8 substance;

[Subsection (12)(a)(i) substituted by section 5(e) of Act No. 59 of 2002]

(ii) such substances irrespective of the scheduling status allocated thereto, as the Minister may prescribe;
(iii) any other substance which becomes subject to international control in terms of the 1961 Single Convention on Narcotic Drugs or the 1971 Convention on Psychotropic Substances entered into by the Republic.
(b) The obtaining of import or export permits as required in terms of subsection (11) shall not apply to any preparation which contains a substance as prescribed which is specifically exempted from all control measures for the obtaining of such import or export permits by the 1961 Single Convention on Narcotic Drugs referred to in paragraph (a).

[Subsection (12)(b) substituted by section 5(f) of Act No. 59 of 2002]

(c) Notwithstanding paragraph (b), no such importation or exportation shall take place unless authorised by the Director-General.

[Subsection (12)(c) substituted by section 5(g) of Act No. 59 of 2002]

 

(13) Any permit issued under subsection (11) shall be subject—
(a) to the applicant's furnishing the Chief Executive Officer annually with the prescribed information;

[Subsection (13)(a) substituted by section 22(d) of Act No. 72 of 2008]

(b) to the requirement that there shall be no deviation from the particulars reflected on the permit: Provided that if the quantity of such substance or medicine to be imported is less than that provided for in the permit, the Director-General shall be informed in writing thereof within 10 days after the importation of such substance or medicine; and
(c) to the conditions, as detailed on the permit, having been complied with, the triplicate copy of the permit having been certified by a customs officer or an employee of the S.A. Post Office Limited.

 

(14) Notwithstanding anything to the contrary contained in this section—
(a) a pharmacist's assistant shall not handle any specified Schedule 5 or Schedule 6 substance except as contemplated in subsection (5)(a) and (b); and

[Subsection (14)(a) substituted by section 5(h) of Act No. 59 of 2002]

(b) no nurse or a person registered under the Health Professions Act, 1974, other than a medical practitioner or dentist, may prescribe a medicine or Scheduled substance unless he or she has been authorised to do so by his or her professional council concerned.

 

(15) Notwithstanding anything to the contrary contained in this section, the Director-General may, after consultation with the South African Pharmacy Council as referred to in section 2 of the Pharmacy Act, 1974 (Act No. 53 of 1974), issue a permit to any person or organisation performing a health service, authorising such person or organisation to acquire, possess, use or supply any specified Schedule 1, Schedule 2, Schedule 3, Schedule 4 or Schedule 5 substance, and such permit shall be subject to such conditions as the Director-General may determine.

[Subsection (15) substituted by section 22(d) of Act No. 72 of 2008]

 

(16) Notwithstanding anything to the contrary contained in this section—
(a) any person may possess a Schedule 0, Schedule 1 or Schedule 2 substance for medicinal purposes;
(b) any person may possess a Schedule 3, Schedule 4, Schedule 5 or Schedule 6 substance if he or she is in possession of a prescription issued by an authorised prescriber;

[Subsection (16)(b) substituted by section 5(i) of Act No. 59 of 2002]

(c) any medicine or scheduled substance may be possessed by a medical practitioner, dentist, veterinarian, practitioner, nurse or other person registered under the Health Professions Act, 1974, or under the Veterinary and Para-Veterinary Professions Act, 1982, for the purposes of administering it in accordance with his or her scope of practice;
(d) any medicine or scheduled substance may be possessed for sale by a pharmacist, a person licenced to own a pharmacy in terms of the Pharmacy Act, 1974, or a person who is the holder of a licence as contemplated in section 22C.

 

(17) For the purposes of this section—
(a) 'authorised prescriber' means a medical practitioner, dentist, veterinarian, practitioner, nurse or other person registered under the Health Professions Act, 1974; and
(b) 'medicinal purpose' means for the purposes of the treatment or prevention of a disease or some other definite curative or therapeutic purpose, but does not include the satisfaction or relief of a habit or craving for the substance used or for any other such substance, except where the substance is administered or used in a hospital or similar institution maintained wholly or partly by the Government or a provincial government or approved for such purpose by the Minister.

 

[Section 22A substituted by section 13 of Act No. 90 of 1997]