Antibiotics Act (Cap. 30:02)

1. Short title.

2. Interpretation.

3. Establishment of Antibiotics Control Committee.

4. Restriction on manufacture of antibiotics.

5. Restriction on importation of antibiotics.

6. Licences to import antibiotics.

7. Licences to store antibiotics.

8. Appointment of licensing officer.

9. Form of licence.

10. Cancellation of licences.

11. Restriction of sale or transfer of antibiotics.

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

13. Taking samples of antibiotics.

14. Further restriction on issue of antibiotics.

15. Administering of antibiotics.

16. Identification marks or numbers on containers.

17. Licence holder to keep records.

18. Examination of records.

19. Lists of approved pharmaceutical firms.

20. Variation of lists of approved pharmaceutical firms.

21. Minister may amend Schedule and impose restrictions.

22. Regulations.

23. Offences.

24. Penalty. SCHEDULE. UNOFFICIAL VERSION L.R.O. UPDATED TO 31ST DECEMBER 2016 LAWS OF TRINIDAD AND TOBAGO 4 Chap. 30:02 Antibiotics MINISTRY OF THE ATTORNEY GENERAL AND LEGAL AFFAIRS www.legalaffairs.gov.tt CHAPTER 30:02 ANTIBIOTICS ACT 1950 Ed. An Act to regulate the importation, storage, distribution, sale and use of antibiotics. Ch. 12. No. 8. 18 of 1948. Commencement. [1ST APRIL 1949] Short title. 1. This Act may be cited as the Antibiotics Act. Interpretation. 2. In this Act “antibiotic” means any of the substances specified in the Schedule and includes all compounds of, and all [20 of 1960]. Schedule. medicinal preparations containing, any of such substances. Establishment 3. (1) For the purposes of this Act, a Committee shall be established to be called the Antibiotics Control Committee of Antibiotics Control (hereinafter referred to as “the Committee”) consisting of the Chief Committee. [20 of 1960]. Medical Officer, who shall be Chairman of the Committee, one member to be appointed by the Council of the Medical Board of Trinidad and Tobago, two registered members of the Board and one other person to be appointed by the Minister, and two members to be appointed by the Branch Council of the British Medical Association constituted in Trinidad and Tobago. (2) The members of the Committee shall appoint one of their number to be Vice-Chairman of the Committee. (3) Three members of the Committee including the Chairman or the Vice-Chairman shall form a quorum at meetings of the Committee and the Chairman of the meeting shall have an original vote and also, whenever the votes are equal, a casting vote. (4) The Minister, the Council of the Medical Board of Trinidad and Tobago or the Branch Council of the British Medical Association, as the case may be, may, in the absence or inability to act of any member of the Committee appointed by him or them, appoint any other person to act in the place of the member. UNOFFICIAL VERSION UPDATED TO 31ST DECEMBER 2016 LAWS OF TRINIDAD AND TOBAGO Antibiotics Chap. 30:02 5 MINISTRY OF THE ATTORNEY GENERAL AND LEGAL AFFAIRS www.legalaffairs.gov.tt

4. No person shall manufacture any antibiotic in Trinidad Restriction on and Tobago unless he is the holder of a licence granted by the antibiotics. manufacture of Committee to manufacture the antibiotic.

5. No person shall import into Trinidad and Tobago any Restriction on antibiotic other than an antibiotic manufactured by a antibiotics. importation of pharmaceutical firm approved by the Minister. [20 of 1960].

6. No person shall import any antibiotic into Trinidad and Licences to Tobago unless he is the holder of a licence granted by the antibiotics. import Committee to import the antibiotic.

7. No person shall store any antibiotic for the purpose of sale Licences to unless he is the holder of a licence granted by the Committee to store antibiotics. store the antibiotic; 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.

8. The Committee may appoint a fit and proper person to be Appointment of a licensing officer under this Act. licensing officer.

9. Licences issued under this Act shall be in such form as the Form of licence. Committee may approve.

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

11. No importer of antibiotics shall sell or transfer any Restriction of antibiotic to any person other than a person registered as a of antibiotics. sale or transfer member of the Medical Board of Trinidad and Tobago (hereinafter referred to as a “medical practitioner”) or as a dentist under the Medical Board Act (hereinafter referred to as a “dentist”) or as a Ch. 29:50. veterinary surgeon under the Veterinary Surgeons (Registration) Ch. 67:04. Act (hereinafter referred to as a “veterinary surgeon”) unless such person is the holder of a licence to store antibiotics granted under the provisions of this Act. UNOFFICIAL VERSION L.R.O. UPDATED TO 31ST DECEMBER 2016 LAWS OF TRINIDAD AND TOBAGO 6 Chap. 30:02 Antibiotics MINISTRY OF THE ATTORNEY GENERAL AND LEGAL AFFAIRS www.legalaffairs.gov.tt Right of entry 12. (1) Any person authorised in writing by or on behalf of the Committee may at any time between the hours of 6.00 a.m. on premises to ensure and 6.00 p.m. enter any premises in which he has reason to believe compliance with provisions of Act. that any antibiotic is kept which has been acquired or is being kept in contravention of any of the provisions of this Act or of any Regulations hereunder and may carry out such inspection of the premises as he considers necessary, and may require the occupier or person in charge of the premises to furnish him with such information in connection with such antibiotic as he considers necessary. (2) Any antibiotic in respect of which there has been a breach of any of the provisions of this Act or of any Regulations hereunder may be seized by such person authorised as aforesaid and on conviction of the offender shall be forfeited to the Committee. Taking samples 13. (1) Any person authorised in writing by or on behalf of the Committee may require the holder of a licence to store of antibiotics. antibiotics granted under the provisions of this Act to produce samples of any antibiotic 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 to be destroyed the entire stock of the antibiotic in the possession of the licensee which bears the same batch identification number as the sample. Further 14. (1) Subject to the provisions of this Act, no antibiotic shall be issued to any person except on the prescription of a restriction on issue of medical practitioner, dentist or veterinary surgeon. antibiotics. UNOFFICIAL VERSION UPDATED TO 31ST DECEMBER 2016 LAWS OF TRINIDAD AND TOBAGO Antibiotics Chap. 30:02 7 MINISTRY OF THE ATTORNEY GENERAL AND LEGAL AFFAIRS www.legalaffairs.gov.tt (2) Every such prescription as is referred to in subsection (1) 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 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 instructions for its use. (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); (b) if the prescription contains a direction that it may be dispensed a stated number of times or at stated intervals, it shall not be dispensed otherwise than in accordance with the direction; (c) there 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 last time of dispensing, be retained for a period of two years by the person last dispensing UNOFFICIAL VERSION L.R.O. UPDATED TO 31ST DECEMBER 2016 LAWS OF TRINIDAD AND TOBAGO 8 Chap. 30:02 Antibiotics MINISTRY OF THE ATTORNEY GENERAL AND LEGAL AFFAIRS www.legalaffairs.gov.tt it on the premises on which it was last dispensed and be made available for inspection by any person authorised by or on behalf of the Committee; (e) if the prescription may not be dispensed more than once it shall be retained for a period of two years by the person dispensing it on the premises on which it was dispensed and be made available for inspection by any person authorised by or on behalf of the Committee. Administering 15. An antibiotic shall not be administered to any person except by or under the direction of a medical practitioner or of antibiotics. dentist except that in any case of emergency it may be administered by a nurse who is a state registered nurse in Trinidad and Tobago or has passed the final examination for nurses at the Port of Spain or San Fernando General Hospital. Identification 16. (1) Every container of an antibiotic shall carry a batch identification mark or number and the date of manufacture of the marks or numbers on containers. 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 the antibiotic. Licence holder 17. Every holder of a licence under this Act shall keep records showing— to keep records. (a) the quantities of antibiotics which he has imported into Trinidad and Tobago and the identification marks or numbers of the consignments; (b) the date of importation into Trinidad and Tobago of any antibiotic which he has imported or has in stock; UNOFFICIAL VERSION UPDATED TO 31ST DECEMBER 2016 LAWS OF TRINIDAD AND TOBAGO Antibiotics Chap. 30:02 9 MINISTRY OF THE ATTORNEY GENERAL AND LEGAL AFFAIRS www.legalaffairs.gov.tt (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.

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

19. It is the function of the Committee to submit to the Lists of Minister lists of pharmaceutical firms for approval as pharmaceutical approved manufacturing firms from whom antibiotics may be imported into [20 of 1960]. firms. Trinidad and Tobago; and the names of the firms so approved shall be published in the Gazette.

20. The Minister may, on the recommendation of the Variation of lists Committee, add to or delete from the list of approved firms, and pharmaceutical of approved every such addition or deletion shall be published in the Gazette. [20 of 1960]. firms.

21. The Minister may, on the recommendation of the Minister may Committee, by Order— amend Schedule and impose (a) amend the Schedule by adding or deleting any [4 of 1988]. restrictions. antimicrobial organic substance produced by living organisms; (b) attach conditions to the use of any substance listed in the Schedule. Schedule.

22. The Minister may make Regulations— Regulations. [20 of 1960]. (a) defining the powers and duties of the Committee; (b) providing for 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. UNOFFICIAL VERSION L.R.O. UPDATED TO 31ST DECEMBER 2016 LAWS OF TRINIDAD AND TOBAGO 10 Chap. 30:02 Antibiotics MINISTRY OF THE ATTORNEY GENERAL AND LEGAL AFFAIRS www.legalaffairs.gov.tt Offences. 23. Any person who obstructs any person authorised in writing by or on behalf of the Committee in the performance of any duty imposed by or under this Act or refuses to give any information lawfully demanded by any such authorised person or otherwise contravenes any of the provisions of this Act is guilty of an offence against this Act. Penalty. 24. Any person found guilty of an offence against this Act is liable on summary conviction to a fine of three thousand dollars and to imprisonment for six months. Sections 2, 21. *SCHEDULE 190/1950. Aureomycin, all compounds of Aureomycin, and all medicinal preparations containing Aureomycin. Chloromycetin, all compounds of Chloromycetin, and all medicinal preparations containing Chloromycetin. 178/1951. Terramycin, all compounds of Terramycin, and all preparations containing Terramycin. 219/1951. Bacitracin, all compounds of Bacitracin, and all medicinal preparations containing Bacitracin. Tyrothricin, all compounds of Tyrothricin, and all medicinal preparations containing Tyrothricin. 59/1954. Tetracycline, all compounds of Tetracycline, and all medicinal preparations containing Tetracycline. 71/1954. Fumagillin, all compounds of Fumagillin, and all medicinal preparations containing Fumagillin. 147/1954. Erythromycin, all compounds of Erythromycin, and all medicinal preparations containing Erythromycin. Neomycin, all compounds of Neomycin, and all medicinal preparations containing Neomycin. 76/1955. The Polymyxins, all compounds of the Polymyxins, and all medicinal 128/1955. preparations containing the Polymyxins other than Aerosporin Otic Solution and Polyfax Ointment. 173/1955. Nystatin, all compounds of Nystatin, and all medicinal preparations containing Nystatin. * The Schedule has been amended by the following GNs 190/1950, 178/1951, 219/1951, 123/1952, 59/1954, 71/1954, 147/1954, 76/1955, 128/1955, 173/1955, 174/1956, 17/1957, 48/1957, 49/1957, 106/1958, 13/1960; 20/1960; 31/1961, 46/1964, 55/1964, 9/1965, 34/1965, 47/1965; 113/1968; LNs 55/2003; 12/2005; 213/2005; 154/2008; 188/2008; 88/2009; 147/2009; 26/2011; 40/2011. UNOFFICIAL VERSION UPDATED TO 31ST DECEMBER 2016 LAWS OF TRINIDAD AND TOBAGO Antibiotics Chap. 30:02 11 MINISTRY OF THE ATTORNEY GENERAL AND LEGAL AFFAIRS www.legalaffairs.gov.tt SCHEDULE—Continued Novobiocin, all compounds of Novobiocin, and all medicinal preparations 174/1956. containing Novobiocin. Spiramycin, all compounds of Spiramycin and all medicinal preparations 17/1957. containing Spiramycin. Viomycin, all compounds of Viomycin, and all medicinal preparations 48/1957. containing Viomycin. Oleandomycin, all compounds of Oleandomycin, and all medicinal 49/1957. preparations containing Oleandomycin. Framycetin, all compounds of Framycetin, and all medicinal preparations 13/1960. containing Framycetin. Amphothericin B Neomycin 20 of 1960. Bacitracin Novobiocin Chloramphenicol Nystatin Cycloserine Penicillins Erythromycin Polymixins Framycetin Spiramycin Fumagillin Streptomycins Griseofulvin Tetracyclines Oleandomycin Tyrothricin Viomycin Amphomycin 31/1961. Carbomycin Gramicidin Hygromycin B Paromomycin Puromycin Xanthocillin Kanamycin, all compounds of Kanamycin, and all medical preparations 46/1964. containing Kanamycin Pimaricin 55/1964. Fucidin 9/1965. Ritamycin also called Rifomycin Cephaloridine also called Ceporin 34/1965. Methacycline also called Rondomycin Lincomycin 47/1965. Colistin 113/1968. Gentamicin Mitomycin 55/2003. Telithromycin 12/2005. Cefixime 213/2005. Cefdinir 154/2008. Tigecycline 188/2008. Ertapenem 88/2009. Retapamulin 147/2009. Tulathromycin 26/2011. Linezolid 40/2011. UNOFFICIAL VERSION L.R.O. UPDATED TO 31ST DECEMBER 2016