Antibiotics Act (Cap. 33)

1. Short title.

2. Interpretation. PART II Establishment, Powers and Functions, etc., of the Antibiotics Control Committee

3. Establishment of Antibiotics Control Committee.

4. Restriction on manufacture of antibiotics.

5. Restriction on importation of antibiotics.

6. Licences to store antibiotics.

7. Form of licence.

8. Cancellation of licences.

9. Restriction on sale or transfer of antibiotics.

10. Right of entry on premises to ensure compliance with provisions of Act.

11. Taking sample of antibiotics.

12. Further restriction on issue of antibiotics.

13. Administering of antibiotics.

14. Identification marks or numbers on containers.

15. Licence holder to keep records.

16. Examination of record.

17. Lists of approved pharmaceutical firms.

18. Variation of lists of approved pharmaceutical firms. THE SUBSTANTIVE LAWS OF BELIZE REVISED EDITION 2020 [ ] Printed by Authority of the Government of Belize 4 [CAP. 33 Antibiotics PART III Miscellaneous

19. Regulations.

20. Offences.

21. Penalty.

22. Saving. THE SUBSTANTIVE LAWS OF BELIZE REVISED EDITION 2020 [ ] Printed by Authority of the Government of Belize Antibiotics [CAP. 33 5 CHAPTER 33 ANTIBIOTICS Ch. 86, [1st May, 1948] R. L., 1958. CAP. 26, R.E. 1980-1990. 40 of 1963. PART I Preliminary

1. This Act may be cited as the Antibiotics Act. Short title.

2. In this Act, unless the context otherwise requires, Interpretation. “antibiotic” means penicillin, all compounds of penicillin and all medicinal preparations containing penicillin, streptomycin, all compounds of streptomycin and all medicinal preparations containing streptomycin, and any other antimicrobial organic substance produced by living organisms which the Minister may, by order published in the Gazette, declare to be an antibiotic to which the Act shall apply; “Committee” means the “Antibiotic Committee” constituted under section 3 of this Act; “Minister” means the Minister responsible for health; “regulations” means regulations made under section 19 of this Act. THE SUBSTANTIVE LAWS OF BELIZE REVISED EDITION 2020 [ ] Printed by Authority of the Government of Belize 6 [CAP. 33 Antibiotics PART II Establishment, Powers and Functions, etc., of the Antibiotics Control Committee Establishment of 3.-(1) For the purposes of this Act, there shall be established an Antibiotics Control “Antibiotics Control Committee” consisting of the Director of Committee. Health Services who shall be Chairperson, and four other 40 of 1963. persons to be appointed by, and hold office at the pleasure of, the Minister. (2) The Chairperson and two other members of the Committee shall form a quorum at meetings of the Committee. (3) In case of an equality of votes, the Chairperson shall be entitled to a casting vote. Restriction on 4. No person shall manufacture any antibiotic in Belize manufacture of antibiotics. unless he is the holder of a licence to manufacture such antibiotic granted by the Minister on the recommendation of the Committee. Restriction on 5. No person shall import into Belize, importation of antibiotics. (a) any antibiotic whatever unless he is the holder of a licence to import such antibiotic, granted by the Committee; 40 of 1963. (b) any antibiotic, other than an antibiotic manufactured by a pharmaceutical firm approved by the Minister. Licences to store 6. No person shall store any antibiotic for the purpose of antibiotics. sale unless he is the holder of a licence to store such antibiotic granted by the Committee and no such licence shall be granted except on proof to the satisfaction of the Committee that the storage facilities of the applicant are adequate. THE SUBSTANTIVE LAWS OF BELIZE REVISED EDITION 2020 [ ] Printed by Authority of the Government of Belize Antibiotics [CAP. 33 7

7. Licences issued under this Act shall be in such form as Form of licence. the Committee may from time to time approve.

8. The Committee may cancel any licence issued under Cancellation of licences. this Act if the holder thereof fails to comply with any of the provisions of this Act or the regulations.

9. An importer of antibiotics shall not sell or transfer any Restriction on sales or transfer antibiotic except to, of antibiotics. (a) a medical practitioner registered in Belize, hereinafter referred to as a “medical practitioner”; (b) a dentist registered in Belize under the Dentists Act, Cap. 316, herein-after referred to as a “dentist”; (c) a Government veterinary surgeon, hereinafter referred to as a “veterinary surgeon”; (d) any person who is the holder of a licence to store antibiotics granted under this Act.

10.-(1) A person authorised in writing by or on behalf of the Right of entry on premises to Committee may at any time between the hours of six in the ensure morning and six in the evening enter any premises in which he compliance with provisions of has reason to believe that any antibiotic is being kept which Act. has been acquired or is being kept in contravention of any of the provisions of this Act or of the regulations, and may carry out such inspection of the premises as he may consider necessary. (2) Such authorised person may require the occupier or person in charge of the premises to furnish him with such information in connection with such antibiotics as he may consider necessary. THE SUBSTANTIVE LAWS OF BELIZE REVISED EDITION 2020 [ ] Printed by Authority of the Government of Belize 8 [CAP. 33 Antibiotics (3) Any antibiotic, in respect of which there has been a breach of any of the provisions of this Act or the regulations, may be seized by a person authorised under this section and on conviction of the offender shall be forfeited to the Committee. Taking sample of 11.-(1) A person authorised in writing by or on behalf of the antibiotics. Committee may require the holder of a licence to store antibiotics granted under this Act to produce samples of any antibiotic which may be in his possession and, on payment of the current market value of any sample, may require that it be delivered to him for purposes of assay. (2) If any such sample is found on assay to have deteriorated to an extent or to contain toxic substances in amounts which, in the opinion of the Committee, render it ineffective or unfit for use as a therapeutic substance, or not to contain the antibiotic or to contain the antibiotic in a lesser degree of potency than it purports to possess, the Committee may require the person who produced the sample to destroy the whole or any part of the stock of the antibiotic in the possession of the licensee which bears the same batch identification number as the sample. Further 12.-(1) Subject to section 6, no antibiotic shall be issued to any restriction on issue of person except on the prescription of a medical practitioner, antibiotics. dentist or veterinary surgeon. (2) Every prescription referred to in subsection (1) of this section shall, (a) be in indelible writing or typescript and be signed by the person giving it with his usual signature in indelible writing and be dated by him; (b) specify the address of the person giving it; (c) specify the name and address of the person for whose treatment it is given or, if it is THE SUBSTANTIVE LAWS OF BELIZE REVISED EDITION 2020 [ ] Printed by Authority of the Government of Belize Antibiotics [CAP. 33 9 given by a veterinary surgeon, of the person to whom the medicine is to be delivered; (d) have written or typed thereon, if given by a dentist, the words “for dental treatment only”, and, if given by a veterinary surgeon, the words “for animal treatment only”; (e) indicate the total quantity of the antibiotic to be supplied and the dose to be taken and shall not contain a direction for dispensing more than twice. (3) Every person dispensing any such prescription shall comply with the following requirements, (a) the prescription shall not be dispensed otherwise than in accordance with the prescription or more than once unless the prescription contains a direction in accordance with the provisions of paragraph (b) of this subsection; (b) if the prescription contains a direction that it may be dispensed twice or at stated intervals, it shall not be dispensed otherwise than in accordance with such direction; (c) here must be noted on the prescription, at the time of dispensing, immediately above the signature of the person giving the prescription the name and address of the person supplying the antibiotic and the date on which the prescription is dispensed; (d) if the prescription may be again dispensed it shall, on the second time of dispensing, be retained for a period of two years by the person last dispensing it on the premises on THE SUBSTANTIVE LAWS OF BELIZE REVISED EDITION 2020 [ ] Printed by Authority of the Government of Belize 10 [CAP. 33 Antibiotics which it was last dispensed and be made available for inspection by any person authorised by or on behalf of the Committee. Administering of 13.-(1) Subject to subsection (2) of this section, an antibiotic antibiotics. shall not be administered to any person except by or under the direction of a medical practitioner or dentist. (2) In a case of emergency an antibiotic may be administered by a nurse who is a state registered nurse in the United Kingdom or who has received her certificate after a course of training in a Government Hospital in Belize or in a Government Hospital of any other country approved by order of the Minister. 40 of 1963. (3) The Chairperson of the Committee may, on the advice of the Committee and with the approval of the Minister, give to a nurse who has received her training in a country other than one specified in this section, authority in writing to administer an antibiotic in any case of emergency. Identification 14.-(1) Every container of an antibiotic shall carry a batch marks or numbers on identification mark or number and the date of manufacture of containers. such antibiotic, and the contents of any such containers, supplied by any person and bearing the same identification marks or numbers, shall be deemed to have been manufactured at the same time and under identical conditions until the contrary is proved. (2) No person shall sell, transfer or dispense any antibiotic after the date of expiry endorsed on the container thereof, except to a medical practitioner, dentist or veterinary surgeon, who has been informed in writing of such date by the person selling, transferring or dispensing such antibiotic. Licence holder to 15. Every holder of a licence under this Act shall keep keep records. records showing, THE SUBSTANTIVE LAWS OF BELIZE REVISED EDITION 2020 [ ] Printed by Authority of the Government of Belize Antibiotics [CAP. 33 11 (a) the quantities of antibiotics which he has imported into Belize and the identification marks or numbers of the consignments; (b) the date of importation into Belize of any antibiotic which he has imported or has in stock; (c) the names of the manufacturers of any such antibiotic; (d) the names and addresses of the persons to whom any such antibiotic has been issued by him and the quantity and date of every such issue.

16. Any person authorised in writing by or on behalf of the Examination of record. Committee may, at any time during business hours enter the premises of any holder of a licence under this Act and call for and examine any records required to be kept by such holder.

17. It shall be the function of the Committee to submit to Lists of approved pharmaceutical the Minister lists of pharmaceutical firms for approval as firms. manufacturing firms from whom antibiotics may be imported into Belize, and the names of the firms so approved shall be published in the Gazette.

18. The Minister may, on the recommendation of the Variation of lists of approved Committee, add to or delete from the list of approved firms, pharmaceutical and every such addition or deletion shall be published in the firms. Gazette. PART III Miscellaneous

19. The Minister may make regulations, Regulations. 40 of 1963. THE SUBSTANTIVE LAWS OF BELIZE REVISED EDITION 2020 [ ] Printed by Authority of the Government of Belize 12 [CAP. 33 Antibiotics (a) defining the powers and duties of the Committee; (b) regulating the storage and transport of any antibiotic; (c) controlling or prohibiting any process which may affect the potency, sterility or toxicity of any antibiotic. Offences. 20. Every person who, (a) obstructs any person authorised in writing by or on behalf of the Committee in the performance of any duty imposed on the Committee by or under this Act; or (b) refuses to give any information lawfully demanded by any such authorised person; or (c) otherwise contravenes any of the provisions of this Act, is guilty of an offence. Penalty. 21. Every person guilty of an offence against this Act is liable on summary conviction to a fine not exceeding five hundred dollars or to imprisonment for a term not exceeding six months, or to both such fine and term of imprisonment. Saving. 22. This Act shall be in addition to and not in derogation of the provisions of the Chemists and Druggists Act, Cap. 311. THE SUBSTANTIVE LAWS OF BELIZE REVISED EDITION 2020 [ ] Printed by Authority of the Government of Belize