Pharmacy Regulations, 1995 (S.I. No. 45 of 2012)

600-4.11 ANTIGUA AND BARBUDA THE PHARMACY REGULATIONS, 2012 STATUTORY INSTRUMENT 2012, No. 45 [Published in the Official Gazette Vol. XXXIJI No. 23 dated 25th March, 2013) Printed at the Government Printing Office, Antigua and Barbuda, by Ralph George, Government Printer By Authority, 2013. [Price $42.50) The Pharmacy Regulations, 2012 2 2012, No. 45 2012, No. 45 3 The Pharmacy Regulations, 2012 THE PHARMACY REGULATIONS, 2012 ARRANGEMENT Regulations PART I PRELIMINARY 1. Short title. 2. Interpretation. PARTH APPLICATION FOR REGISTRATION 3. Application. 4. Registration as a pharmacy student. 5. Registration as a pharmacist. 6. Other registration, pharmacy technician. 7. Notification. 8. Particulars of registration. 9. Registration certificate. PART III LICENSING OF PREMISES AND SALE OF POISONS 10. Application for licence for pharmacy. 11. Registration of wholesalers. 12. Application for licence to sell poisons. 13. Inspection of licensed premises. 14. Registration of licensed premises. 15. Register of pharmacies and wholesalers. PART IV PROFESSIONAL MISCONDUCT 16. Complaints. 17. Professional misconduct. 18. Board to investigate complaint. 19. Notification where evidence is insufficient. The Pharmacy Regulations, 2012 20. Procedure where evidence is sufficient. 21. Rights of accused. 22. Expenses. 23. Ex parte hearings. 24. Council's decision. 25. Notification of decision. 26. Right of appeal. 27. Removal of convicted pharmacist from register. PARTV AUTHORIZED SELLERS OF POISONS 28. Schedule of poisons. 29. Seller of poisons. 30. Registration as authorized seller of poisons. 31 . Certificate of registration. 32. Register of authorized sellers. 33. Display of certificate. 34.Annual fee. 35. Cancellation ofregistration. 36. Sale and labelling of poisons. 37. Handling of poisons. 38. Transport of poisons. 39. Sale of Arsenic. 40. Prescription. 41. Compounding and dispensing. 42. Number of times of dispensing. 43. Prescription verbal communication. 44. Prescription record. 45. Arranged storage. 46. Opium Tincture. PARTVI DISPENSING 4 2012, No. 45 2012, No. 45 5 47. Repeat prescriptions. 48. Sale of therapeutic substances. 49. Emergency prescriptions. 50. Public notification and recovery of drugs. PART VII MISCELLANEOUS 51. Certificate lost or destroyed. 52. Fees paid into the consolidated fund 53. Penalty. Schedules SCHEDULE 1 SCHEDULE2 SCHEDULE3 SCHEDULE4 The Pharmacy Regulations, 2012 The Pharmacy Regulations, 2012 6 ANTIGUA AND BARBUDA THE PHARMACY REGULATIONS, 2012 2012, No. 45 2012, No. 45 THE PHARMACY REGULATIONS made in exercise of the powers contained in section 28 of the Pharmacy Act, 1995. PARTJ PRELIMINARY 1. Short title. These Regulations may be cited as the Pharmacy Regulations, 2012. 2. Interpretation. In these Regulations "Act" means the Pharmacy Act, 1995; "approved" means approved by the Council; "Board of Inspectors" means the Board of Inspectors constituted under section 16 of the Act; "College" means the Antigua State College, or any other institution approved by the Council for the training of pharmacists; "Community" means the Caribbean Community including the CARICOM Single Market and Economy established by the Treaty; "Council" means the Council established under section 3 of the Act; "generic drug" means any unpatented drug and includes a drug whose patent has expired or one that has never been patented; "generic name" means the official name or international non-proprietary nomenclature; "Member State" means a Member State of the Community listed in Schedule 1; "pharmacy programme" means the programme for pharmacy studies offered at the College; "registered medical practitioner" means a person registered under the Medical Practitioners Act, 2009 No. 3 of2009; "Treaty" means the Revised Treaty of Chaguaramus establishing the Caribbean Community including the CARI COM Single Market and Economy signed at Nassau, The Bahamas on the 5th day of July, 2001 ; and "University" means an institution, at which a person may read for a degree in pharmacy, that 2012, No. 45 7 The Pharmacy Regulations, 2012 is approved by the Council. PART IT APPLICATION FOR REGISTRATION 3. Application. An application under the Act shall be made in the prescribed form and accompanied by the pre scribed fees. 4. Registration as a pharmacy student. The Council shall approve the registration ofan applicant as a pharmacy student where the applicant (a) has been accepted for the phannacy programme of a College for a course of studyin pharmacy; and (b) has made an application in Form A of Schedule 3 and paid the prescribed fee. S. Registration as a pharmacist. (I) The Council shall approve the registration of an applicant as a pharmacist where the applicant (a) is the holder of a degree or diploma in Pharmacy from a University or College recognized by the Council; (b) has produced a Medical Certificate offitness from a registered medical practitioner stating that he is physically fit and mentally sound to perform the duties of a phar macist; (c) has satisfied the requirements of section 7 of the Act; (d) has produced the documents required under section 8 (2) of the Act; (e) has made an application in Form B of Schedule 3 and paid the prescribed fee; and (I) in the case of a newly trained applicant has satisfied a period of internship for six months supervised by the Council. (2) A person registered as a pharmacist shall pay the annual licence fee as prescribed in Schedule 2. (3) After the initial licence is granted and prior to the issue of each licence thereafter, a pharmacist applying for a licence is required to complete twelve (12) hours of a continuing educa tion programme approved by or facilitated by the Council. The Pharmacy Regulations, 2012 8 2012, No. 45 6. Registration as a pharmacy technician. (I) The Council shall approve the registration of an applicant as a pharmacy technician, if the Council is satisfied that the applicant (a) has a qualification that entitles him to be registered as a pharmacy technician from an institution approved by the Council; (b) has undergone a period of practical training approved by the Council; and · (c) has produced a Medical Certificate offitness from a registered medical practitioner stating that he is physically fit and mentally sound to perform the duties of a phar macy technician; (d) has produced the documents required under section 8 (2) of the Act; (e) has made an application in Form D and paid the prescribed fee. (2) A person registered as a pharmacy technician shall pay the annual licence fee as pre scribed in Schedule 2. 7. Notification. (1) The Council shall, within forty five days of receipt of an application for registration, notify the applicant whether his application has been approved. (2) An applicant, upon being notified of the approval of bis application shall pay the fee prescribed for registration in Schedule 2. 8. Particulars of registration. (1) The Registrar shall cause the following particulars of every pharmacist to be entered in the Register of Pharmacists (a) his name and address; (b) his age, date of birth and country of origin; (c) his qualification and the institution from which he received his training; and (d) the date of his registration in Antigua and Barbuda; (2) The Registrar shall cause (a) a notice of the registration of each pharmacist, who is being registered for the first time in Antigua and Barbuda, to be published in the Gazette within one month after the date of registration; and 2012, No. 45 9 The Pharmacy Regulations, 2012 (b) a complete list of the Register of Pharmacists, containing the names and the dates of registration of each pharmacist registered in Antigua and Barbuda, to be pub lished in the Gazette once in the first quarter of each calendar year. 9. Registration certificate and Licence. (1) The certificate of registration issued by the Council (a) for a pharmacist shall be that prescribed in Form C of Schedule 3; (b) for pharmacy technician shall be that prescribed in Form E of Schedule 3; and (2) The licence issued by the Council to operate a wholesale pharmaceutical business shall be that prescribed in Form K of Schedule 3. (3) The licence issued by the Minister (a) for premises to be used to operate a pharmacy shall be that prescribed in Fonn L of Schedule 3; (b) to be an authorised seller of poisons shall be that prescribed in Form Hof Schedule 3. PART III LICENSING OF PREMISES AND SALE OF POISONS 10. Application for licence for pharmacy. An application for a licence to use premises to operate a pharmacy on any premises shall be made to the Registrar in Form F by the owner of the pharmacy or where a body corporate or partnership is making the application, by an officer of the body corporate or a partner and shall be accompanied by (a) two passport sized photographs of the applicant taken within the six month period immediately prior to the submission of the application, which are duly certified by an attorney at law registered to practice law in Antigua and Barbuda, or Notary Public to be a true photograph of the applicant; and (b) the prescribed fees. 11. Application for licence for wholesale pharmaceutical business. An application for a licence to operate a wholesale pharmaceutical business on any premises shall be made to the Registrar in Form J of Schedule 3 by the owner of the wholesale pharmaceutical business and where the owner of the wholesale pharmaceutical business is a body corporate or part nership, by a partner or officer of the body corporate and shall be accompanied by The Pharmacy Regulations, 20 I 2 10 2012, No. 45 (a) two recently taken passport sized photographs of the applicant, duly certified by an attorney at law registered to practice law in Antigua and Barbuda, or notary public to be a true photograph of the applicant; and (b) the prescribed fees . 12. Application for licence to sell poison. ( l) An application lo be licensed as an authorised seller of poisons shall be made to the Council in Form M of Schedule 3 by a person registered to sell poisons in accordance with regula tion 30 and shall be accompanied by (a) two recently taken passport sized photographs of the applicant, duly ce1tified by an attorney at law registered to practice law in Antigua and Barbuda, or notary public to be a true photograph of the applicant; and (b) the prescribed fees. (2) Where the applicant under regulation 12(1) is a body corporate or partnership the application shall be made by a partner or officer of the body corporate. 13. Inspection of premises. (1) The Registrar shall, within thirty days ofreceipt of an application for a licence to operate a pharmacy or wholesale business or to sell poisons containing all the necessary particulars, cause to be forwarded to the Board of Inspectors the application so that an inspection can be conducted to determine whether the premises may be licensed for the operation of a pharmacy or wholesale pharmaceutical business or to sell poisons. (2) The Board of Inspectors shall within forty-five days of receipt of an application under paragraph ( l) visit the premises and carry out all necessary inspections and shall submit to the Coun cil a written report indicating its findings. 14. Licensing of premises. (I) If the report of the Board of Inspectors indicates that the premises satisfy the require ments to be licensed as a pharmacy or to sell poisons, the Council shall notify the Minister of the report and Recommend that the Minister may approve the licence. (2) If the report of the Board of Inspectors indicates that the premises satisfy the require ments to be licensed as a wholesale pharmaceutical business, the Registrar shall notify the Council of the report and the Council shall approve the licence. (3) A certificate issued by the Minister under this Regulation shall be in Form L of Schedule 3. 2012, No. 45 11 The Pharmacy Regulations, 2012 15. Register of pharmacies. The Registrar shall, where premises have been approved for use as a pharmacy or wholesale phar maceutical business, enter the following particulars on the Register of Pharmacies (a) the name and address and occupation of the applicant; (b) the business name and address of the premises; (c) the nature of business conducted on the premises, and all purposes for which the premises are used or intended to be used; (d) the name and address and registration particulars of any registered pharmacist employed on the premises; and any changes thereto (e) the registration number of the premises; (f) the date of first registration and any records; and (g) the expiry date of the current registration. 16. Complaints. PART IV PROFESSIONAL MISCONDUCT (1) A person who alleges that a registered pharmacist, pharmacy student or phannacy technician is guilty of professional misconduct may make a complaint to the Registrar in writing setting out the full circumstances giving rise to the complaint and shall include his name, address and telephone number. (2) On receipt of a complaint the Registrar shall within twenty one days thereafter, forward the details of the complaint to the Council and the Council shall direct the Board of Inspectors to investigate the complaint. (3) The Board oflnspectors shall conduct all investigations, as directed by the council with in three months of receipt of those directions and shall submit for the consideration of the Council a written report of its findings of the investigations. 17. Professional misconduct. ( I) Professional misconduct includes the following (a) stealing or being in unlawful possession of drugs or poisons; (b) conspiring to procure or unlawfully procuring or attempting to procure an abortion; The Pharmacy Regulations, 2012 12 2012, No. 45 (c) being under the influence of drugs or alcohol while performing the duties of a pharmacist, pharmacy student or a pharmacy technician; (d) tampering with, altering or causing to be altered in any way the prescription of a registered medical practitioner, a registered dentist, a registered veterinary surgeon or veterinary practitioner; (e) entering into an arrangement with a registered practitioner for the sharing of profits derived from the filling of prescriptions issued by the practitioner; (I) the wilful or grossly negligent failure to comply with substantial provisions of any laws, rules or regulations governing the practice of the pharmacy profession; (g) exercising undue influence on a patient or client by promoting the sale of services, goods, appliances or drugs in such manner so as to exploit the patient or client for the financial gain of a pharmacist or of a third party; (h) permitting a person to share in the fees for professional services, other than: a partner, employee or associate in a professional firm or corporation, professional subcontractor or consultant authorized to practice as a pharmacist, or a pharmacy student, or pharmacy technician; (i) wilfully making or filing a false report, failing to file a report required to be filed by law or wilfully impeding or obstructing such filing, or inducing another person to impede or obstruct such filing; 0) failing to make available to a patient or client, upon request, copies of documents in the possession or under the control of the licensee which have been prepared for and paid for by the patient or client; (k) revealing of personally identifiable facts, data or information obtained in a professional capacity without the prior consent of the patient or client, except as authorized or required by law; (!) practicing or offering to practice beyond the scope permitted by law, accepting the task of performing professional responsibilities or performing professional re sponsibilities which the licensee has not the competence to perfonn or without adequate supervision performing professional services which the licensee is au thorized to perform only under the supervision of a licensed professional, except in an emergency situation where a person's life or health is in danger; (m) delegating professional responsibilities to an unlicensed person or a person who by virtue of insufficient training or insufficient experience is not qualified to per form those responsibilities; 2012, No. 45 13 The Pharmacy Regulations, 2012 (n) performing professional services which have not been duly authorized by the patient or client or his legal representative; (o) dispensing a written prescription which does not bear the name of the patient for whom it is intended; the date on which it was written; the name and strength of the drug prescribed, the quantity of the drug prescribed and the directions for use; (p) failing to maintain a current form which provides for ready retrieval of prescriptions, the patient for whom the prescription is intended, the signature or readily identifiable initials of the pharmacist who filled the prescription, and the number assigned to the prescription ; (q) holding for sale, offering for sale, or selling (i) any drug later than the date marked upon the label as indicative of the date beyond which the contents cannot be expected to be safe and effective; pro vided, however, that when the drug is identified as an outdated drug by segre gation from regular stock or by other means, the holding of that drug beyond its expiration date shall not be deemed a violation of this paragraph; or (ii) any drug, the nature of which requires storage under special conditions of temperature control as indicated either on the labelling, in the directions for storage of said drug contained in an official compendium, or as directed by common prudence, unless the special condition of temperature control shall have been complied with during the entire period of time in which that drug has been held for sale; (r) aiding and abetting an unlicensed person to dispense drugs provided that an unlicensed person may assist a pharmacist in the dispensing of drugs by ( i) receiving written, verbal or electronically transmitted prescriptions, except that in the case of electronically transmitted prescriptions the pharmacists shall review the prescription to determine whether in his professional judg ment it shall be accepted by the pharmacy, and if accepted, the pharmacist shall enter his initials into the records of the pharmacy; (ii) typing prescription labels; (iii) keying prescription data for entry into a computer-generated file or retrieving prescription data from the file, provided that the computer-generated file shall provide for verification of all information needed to fill the prescription by a pharmacist prior to the dispensing of the prescription, meaning that the pharmacist shall review and approve the information and enter his initials or other personal identifier into the record-keeping system prior to the dispens ing of the prescription or of the prescription refill; (iv) getting drugs from stock and returning them to stock; • I The Pharmacy Regulations, 2012 14 2012, No. 45 (v) getting prescription files and other manual records from storage and locating prescriptions; (vi) counting dosage units of drugs; (vii) placing dosage units of drugs in appropriate containers; (viii) affixing the prescription label to the containers; (ix) preparing manual records of dispensing for the signature or initials of the pharmacist; or (x) handing or delivering completed prescriptions to the patient or the person authorized to act on behalf of the patient after the pharmacist has handled the prescription in accordance with the Act and these regulations; (s) aiding and abetting an unlicensed person to ( i) receive oral prescriptions from prescribers; (ii) interpret and evaluate a prescription for conformance with legal requirements, authenticity, accuracy and interaction of the prescribed drug with other known prescribed and over-the-counter drugs; (iii) make determinations of the therapeutic equivalency as such determinations apply to generic substitution; (iv) measure, weigh, compound or mix ingredients; (v) sign or initial a record of dispensing required to be maintained by law; (vi) counsel patients; or (vii) perform any other function involving the exercise of professional judgment. (2) Where the expiration date on a drug is expressed by month and year, the expiration date shall be the last day of the month indicated. (3) Notwithstanding regulation (1 )(q)(i), in the event that a drug is not available, a registered medical practitioner may in writing request from a registered pharmacist an out of date drug but the drug shall not be outdated for more than three months and in the case of a registered veterinary practioner the drug shall not be outdated more than six months ( 4) A complaint of professional misconduct may not be made against a registered pharmacist who, in good faith, complies with regulation (3). 18. Board to investigate complaint. ( 1) The Board oflnspectors in investigating a complaintshal 1 provide the pharmacist, pharmacy student or pharmacy technician with a written statement of the complaint and all the allegations therein and shall invite the Pharmacist, student, or technician to furnish the Board within thirty days 2012, No. 45 15 The Pharmacy Regulations, 2012 of receipt the particulars of complaint a statement in writing relating to the allegations. (2) Upon receipt of a written statement from the pharmacist, student, or technician the Board of Inspectors shall consider the matter and shall submit a report of its findings to the Council, within thirty days. (3) The Board of Inspectors in investigating a complaint may at any stage consult with an attorney-at-law appointed by the Council for the purpose. (4) The Board of Inspectors may at any stage of its investigation decline to proceed further with the investigation if it determines that the allegations are fraudulently made or where the alle gations cannot be substantiated and where the Board oflnspectors so determines, it shall include a statement of its reason for the termination in its report to the Council. 19. Notification when evidence is insufficient. (1) The Council shall consider the findings of the Board of Inspectors and shall determine within forty five days whether there is sufficient evidence to institute disciplinary proceedings against pharmacist or student, or pharmacy technician. (2) Where the Council determines that there is insufficient evidence to institute disciplinary proceedings the Council shall forthwith direct the Registrar to notify the complainant and the phar macist or student, or phannacy technician, in writing, of the findings of the Council. 20. Procedure where evidence is sufficient. (1) The Council shall, where the report of the Board of Inspectors recommends that disciplinary action be taken, constitute a committee pursuant to sections 24 and 25 of the Act and fix a date for the hearing and may direct an attorney-at-law retained for the purpose (a) to take all steps as may be relevant, (b) to take steps as may be necessary to obtain or verify any documentary or other evidence that may be relevant, and (c) to take steps to ensure the attendance of witnesses at the hearing. (2) On fixing of a hearing date by the Council, the Registrar shall notify the complainant and the pharmacist, student or pharmacy technician of the date and shall specify in the notice (a) the nature of the charge to be determined including full particulars of the complainant; and (b) the time and place of the hearing. (3) A notice from the Registrar shall also include a statement informing the phannacist or The Pharmacy Regulations, 2012 16 2012, No. 45 student, or technician of the right to be represented by an attorney or other person at the hearing. ( 4) Notices under this regulation shall be posted or delivered no later than one month before the date set for the hearing and shall be sent by registered post to the address or to the last known address of the pharmacist or student or technician entered in the register or in the student records or technician records. 21. Rights of accused. A party against whom disciplinary proceedings have been instituted (a) may give evidence, call witnesses and may make submissions orally or in writing on his own behalf; (b) shall be allowed access to any documentary evidence used in the proceedings and shall upon payment of reasonable costs of copying be entitled to obtain copies of all relevant documents; (c) shall upon reasonable request having regard to all the circumstances be entitled to an adjournment provided that exceptional circumstances the Council shall per mit no more than three adjournments before detennining any disciplinary matter before it; and (d) is entitled to be represented by legal counsel. 22. Expenses. Where a finding is made against a pharmacist or student or technician as a result of disciplinary pro ceedings the Council may order the pharmacist or student or technician to cover expenses incurred in connection with the investigation of an allegation or complaint against him or in connection with any disciplinary proceedings. 23. Ex parte Hearings. Where the Council is satisfied that notice of a hearing has been duly served on the pharmacist or student or technician, it may proceed with the hearing in the absence of the pharmacist or student or technician. 24. Council's decision. (1) The Council at the conclusion of a hearing shall consider all evidence given at the hear ing and after due deliberation may decide (a) that the evidence given at the hearing is insufficient to support the charge; (b) that the charge has not been proven; or 2012, No. 45 17 The Pharmacy Regulations, 2012 (c) that the charge has been proven. (2) Where the Council decides that the charge has been proven, the Council may impose any of the sanctions or penalties specified in Section 25 (2) of the Act. 25. Notification of decision. The Council sha ll within fourteen days, upon making a determination notify the complainant and the pharmacist or student or technician in writing of its findings and the reasons therefore, and shall where the charge is proven indicate in the notice the sanction or penalty that may have been imposed. 26. Right of appeal. A person who is aggrieved by a decision of the Council in disciplinary proceedings shall have the right to appeal that decision to a judge in chambers within three months of being notified of the Council's decision. 27. Removal of convicted Pharmacist from register. Where a complaint against a pharmacist includes a charge of a criminal offence involving dishon esty, fraud or moral turpitude the Council, upon written confirmation under the hand of the Registrar of the High Court, or the Chief Magistrate that the person was convicted of such an offence and that the conviction was not subsequently quashed, may without further inquiry direct the Registrar to remove the name of the pharmacist from the register. PARTY AUTHORIZED SELLERS OF POISONS 28. Schedule of Poisons. The substances in Part II of Schedule 4 are poisons for the purposes of the Act. 29. Seller of poisons. A person shall not sell any poison unless that person is a registered phannacist or a person duly authorized by these regulations to sell poison. 30. Registration as seller of poison. (I) A person other than a registered pharmacist may apply to be registered as an authorized seller of poisons by submitting an application to the Council in Form G of Schedule 3. (2) An application under regulation ( I) may be registered as an authorized seller of poisons ifhe satisfies the Council that he is over twenty one years and that he is of good character and that The Pharmacy Regulations, 2012 18 2012, No. 45 (a) the fee prescribed has been paid; and (b) he is able to comply with the provisions of the Act relating to the sale of poisons. (3) For the purposes ofregulation (2) an applicant shall submit to the Council documentaf) evidence proving of his age as well as two recent photographs of the applicant and two testimonials of bis good character. 31. Certificate of Registration. (1) Where satisfied that an applicant has met the requirements to be an authorized seller o { poisons, the Council shall recommend to the Minister that a Certificate be issued to the applicant. (2) A certificate issued by the Minister pursuant to regulation 31(1) shall be in Form H. 32. Register of authorized sellers. The Council shall cause the Registrar to keep a register of authorized seller of poisons and shall in clude in the register particulars including the name, address of the authorized seller, and the premis es from which he operates, as the Council thinks fit. 33. Display of certificate and licence. (1) A registered seller of poisons shall display the certificate of registration and licence at all times in a conspicuous place on the premises where poisons are sold. (2) A register of poisons in Form I shall be maintained by the seller of poisons in such a manner that the same may be produced when requested by the Registrar or the Council and a request may be made without notice. 34. Annual fee. An authorized seller of poisons shall pay the annual licence fee prescribed in Schedule 2. 35. Cancellation of registration. ( 1) The Council may at any time cancel or suspend for such time as it thinks fit, a certificate of registration, if it is satisfied that the holder of the certificate has failed to comply with provisions of the Act or with these Regulations. (2) The holder of a certificate of registration which has been cancelled or suspended shall forthwith return the certificate to the Council and shall cease forthwith to engage in the business of selling poisons. 2012, No. 45 19 The Pharmacy Regulations, 2012 36. Sale and labelling of poisons. ( 1) A person shall not sell, dispense or deliver to any other person any poison unless the bottle, vessel, box, wrapper or cover in which the poison is contained is labelled, in addition to the requirements of subsection (1) {d) of section 18 of the Act with (a) adequate directions for use and words of caution in respect of the poison; and (b) where the poison is an ingredient of a preparation, proportion of poison in that preparation. (2) Before the sale, dispensing or delivery of any poison, the person selling, dispensing or delivering the poisons, shall ensure that the words of caution in paragraph (1) (a) of regulation 18 are understood by the person receiving the poison, and shall cause the person receiving the poison to sign his name beside the relevant entry in a register in which shall be recorded the following (a) the date of the transaction; (b) the name, address and occupation of the person to whom the poison is being sold, dispensed or delivered; (c) the name and quantity of poisons sold, dispensed or delivered, or where the poison is an ingredient of a preparation, the proportion, of poison; (d) the purpose for which the poison is required; (e) where the person to whom the poison is being delivered is not known to the person selling, dispensing or delivering same, the name and address of a witness to the transaction, and where there is no witness to the transaction, the name and address of person giving a recommendation in respect of the transaction; and (I) the signature of the person receiving the poison, and signature of the person selling, dispensing or delivering the poison. 37. Handling of poisons. (!) A person shall not sell, dispense or deliver any liniment embrocation, lotion or similar caustic substances containing poison unless that substance is in a container (a) which is so constructed as to prevent leakage arising from the ordinary risks of handling, and which is impervious to poison; and (b) to which is affixed a label giving notice that the contents shall not be taken orally. (2) Where a person sells, dispenses or delivers any substance mentioned in paragraph (1) in a bottle ofnot more than 120 fluid ounces, that substance shall be in ribbed or grooved bottles which The Pharmacy Regulations, 2012 are easily discemable by touch. 38. Transport of poisons. (1) A person shall not transport any poison unless 20 2012, No. 45 (a) it is adequately packed to avoid leakage arising from the ordinary risks of handling; (b) the outside of the package containing the poison is labelled conspicuously with the name and description of the poison and with a notice indicating that it is to be kept separate from food and food containers; and (c) adequate precautions are taken to prevent the risk of contaminating food. 39. Sale of Arsenic. ( 1) A person shall not sell arsenic unless (a) that person is authorised under the Act to sell arsenic; and (b) before sale, the arsenic is mixed with soot or indigo in the proportion of at least an ounce of soot or half an ounce of indigo to one pound of arsenic, and so in propor tion for any greater or lesser quantity. (2) This provision shall not apply (a) when arsenic is an ingredient of any medicine required to be made up or compounded in accordance with the prescription of a of a registered medical prac titioner, a registered dentist or a registered veterinary surgeon; (b) to wholesale pharmaceutical businesses supplying arsenic upon orders in writing in the ordinary course of wholesale pharmaceutical business dealing; or (c) where arsenic is stated by the person receiving same to be required for some purpose other than use in agriculture, and it is established that the mixture would render the arsenic unfit for the purpose for which it is obtained and the arsenic is delivered in quantities of not less than ten pounds on each occasion. 40. Prescription. Every prescription for a poison shall be in writing and shall include the following (a) the date; (b) the name and address of the person for whom the prescription is issued; (c) the name and quantity of the substance to be supplied; 2012, No. 45 2 1 The Pharmacy Regulations, 2012 (d) adequate directions for the use of the substance prescribed; (e) legible signature of the prescriber; and (I) where the prescription is given by a dentist or registered veterinary surgeon, the words "for dental treatment only" or "for the treatment of animals only" as the care may be. 41. Compounding and dispensing. PART VI DISPENSING ( I) A person who dispenses compounds and retails or supplies a drug other than in accordance with the prescription of a registered medical practitioner, registered dentist or registered veterinary surgeon, shall deliver that drug in a container labelled with (a) the name of the drug; (b) the pharmaceutical form and strength; (c) quantity; (d) adequate directions for use; and (e) words of caution respecting the drug, if necessary. (2) A person who dispenses, compounds, retails or supplies a drug whether over the coun ter or in accordance with the prescription of a registered dentist, registered medical practitioner or registered veterinary surgeon shall, where there is ava ilable a bioequivalent generic drug which is interchangeable with the named drug and which is less costly, inform the person requesting the drug those facts, and shall supply the generic equivalent instead of the named drug except where the per son objects or declines to accept the generic form. (3) A person who dispenses, retails or supplies an over-the-counter drug which carries a brand name shall erect and maintain a prominent sign informing persons of the availability of the generic drug which is the bioequivalent of the drug carrying the brand name. 42. Number of times of dispensing. (1) No prescription shall be dispensed more than once unless it is dispensed in accordance with the directions of the prescriber included in the prescription to the effect that it may be dispensed at a stated number of times or wherever necessary. (2) Where a prescription The Pharmacy Regulations, 2012 22 2012, No. 45 (a) includes a direction that it may be dispensed a stated number ohimes but does not include any direction as to the intervals at which it may be dispensed that prescrip tion shall not be dispensed before the stated duration except where the pharmacist is satisfied that the patient has a legitimate reason; (b) includes a direction that it may be dispensed at stated intervals but does not include any direction as to the number of times it may be dispensed, that prescription shall not be dispensed more than three times; (c) has not been dispensed after the period of six months from the date that the pre scription was issued, the prescription will cease to be valid. 43. Prescription verbal, or electronic communication. (1) A prescription for a drug may be communicated verbally by a registered practitioner, registered dentist or registered veterinary surgeon. (2) A person to whom a prescription for a drug has been verbally or electronically com municated shall forthwith reduce the prescription, after it has been validated by a practitioner under regulation 43(1 ), into writing and shall, upon the filling thereof, retain that validated prescription for a period of not less than two years from the date of filling same. (3) A prescription communicated verbally or electronically under regulation 43(2) shall be reduced into writing within thirty-six hours of the verbal or electronic communication. ( 4) A person selling a drug pursuant to a written prescription shall retain the prescription for at least two years from the date of filling thereof. (5) Every prescription for a drug shall include the following (a) the date; (b) the name, age, and address of the person for whom the prescription is issued; (c) the name, the generic name, pharmaceutical form and strength and the quantity of the substance to be supplied; (d) adequate directions for the use of the substance prescribed; (e) the usual signature of the prescriber and his name in legible print form; (f) the address, telephone number and registration number of the prescriber; and (g) where the prescription is given by a registered practitioner, registered dentist or registered veterinary surgeon, the words, "for dental treatment or "for treatment of animals only as the case may require". (6) A person filling a prescription shall note on the prescription at the time of dispensing, the date of dispensing, prescription number and the signature of the person by whom it was dispensed, 2012, No. 45 23 The Pharmacy Regulations, 2012 an indication of the items dispensed and the prescription shall be retained by the person in charge of the phannacy in which the prescription was filled for a period ofnot less than two years from the date on which the prescription was last dispensed. 44. Prescription record. A person filling a prescription shall (a) number each prescription; (b) file the prescription, or a true copy thereof the person for whom the prescription was given desires to retain the original prescription and the prescription does not contain a controlled substance or quantity of a substance which would make it inadvisable for the pharmacist to part with the same, and (c) record in a prescription register the number and date of each prescription, the name of the persons for whom it is prescribed, age and address and the name of the regis tered medical practitioner, registered dentist and registered veterinary surgeon, by whom the same was given, the particulars of every prescription and the directions which accompanied the medicine 45. Arranged storage. Every antibiotic and other drug or poison which requires special storage arrangements shall be stored in accordance with the temperature and other storage requirements specified by the manufac turer in respect of the antibiotic, drug or poison. 46. Opium Tincture. (I) A person who sells, dispenses or delivers Tincture Opie Carmph (Camphorated Opium Tincture), shall not sell more than four ounces of that drug at any one time unless the transaction is (a) to a registered medical practitioner, registered dentist or registered veterinary surgeon for the purposes of his profession; (b) for use in a hospital or other medical institution; or (c) to a registered pharmacist for use in a registered pharmacy. (2) Every sale, dispensing or delivery of camphorated Opium Tinch1re shall be recorded by the person making the sale, dispensing or delivery in a book kept for the purpose, in which shall be entered the following particulars (a) the date and quantity of the drug taken in stock; The Pharmacy Regulations, 20 I 2 24 2012, No. 45 (b) the date and quantity of any sale, dispensing or delivery of the drug; (c) the name, address and occupation of the person who acquired the drng; (d) the purpose for which the drug was acquired; and (e) the name of the person authorizing the transaction, if any. 47. Repeat prescriptions. (1) A repeat prescription shall not be dispensed after the period of six months from the date that the prescription was issued. (2) A repeat prescription that has not been dispensed within six months of the date when it was issued, ceases to be valid. 48. Sale of therapeutic substances. (I) Subject to paragraph (2), a person shall not sell any therapeutic substance by retail, ex cept by prescription. (2) Paragraph (1) shall not apply (a) to the supply of a therapeutic substance which is an antibiotic where it is made on production of a written requisition from one pharmacist to another; or (b) to a therapeutic substance sold (i) by a wholesale pharmaceutical business; (ii) for export; (iii) to an authorised person; (iv) to the owner or master of a ship or aircraft for medical use on board; (v) to any institution or business which proves to the satisfaction of the Board that it carries on scientific education or research; (vi) to Government; or (vii) to a person in charge of a hospital, clinic or nursing home, or of any other institution which is approved by the Board and provides medical, dental, surgical or veterinary treatment. 49. Emergency prescriptions. (1) A dmg may be dispensed by a pharmacist in case of emergency where the supply is made at the request oftbe patient and the following conditions apply 2012, No. 45 25 The Pharmacy Regulations, 2012 (a) the pharmacist under whose supervision the prescription only medicine is to be sold or supplied has interviewed the person requesting the medicine and shall sat isfy himself ( i) that there is an immediate need for the prescription only medicine requested to be sold or supplied and that it is impracticable in the circumstances to obtain a prescription without undue delay; (ii) that treatment with prescription only medicine requested has been prescribed previously by a doctor for the person requesting it; and (iii) as to the dose which in the circumstances it would be appropriate for that person to take. (b) that the pharmacist provides no more than 5 days' treatment of the presription only medicine in question except, where the medicine in question is an ointment, a cream or a preparation in an aerosol dispenser for the relief of asthma, which has been made up for sale in a container elsewhere than at the place of sale or supply, the smallest pack that the pharmacist has available for sale or supply; (c) that the pharmacist by or under whose supervision the medicine is sold or supplied ensures that an entry in the prescription only register is made stating ( i) the date on which the prescription only medicine was sold or supplied; (ii) the name, quantity and, except where it is apparent from the name, the phannaceutical form and strength of the medicine; (iii) the name, age and address of the person requiring the medicine and, (iv) the nature of the emergency. (d) that the container or package of the medicine is labelled with (i) the date on which the prescription only medicine was sold or supplied; (ii) the name, quantity and, except where it is apparent from the name, the phar maceutical fonn and strength of the prescription only medicine; (iii) the name of the person requiring the prescription only medicine; (iv) the name and address of the registered pharmacy from which the prescrip tion only medicine was sold or supplied; and (v) the words "Emergency Supply". (e) that the prescription only medicine (i) is not a controlled drug specified in Schedule 3 Section 5, or in the Mis use of Drugs Regulation; (ii) is restricted in relation to the Psychotropic Substances, in which case record The Pharmacy Regulations, 2012 26 2012, No. 45 of these shall be kept according to the provisions of the Misuse of Drugs Act and its Regulations; or (iii) is not an antibiotic. (2) An emergency sale or supply of prescription only medicine which contains or consists of Phenobarbitone or Phenobarbitone Sodium is permitted to be prescribed under regulation ( 1) if it is for use in the treatment of epilepsy and does not contain any of the substances in Schedule 3 relative to the Controlled Drugs and Psychotropic Substances. (3) The prescription only medicine to which this regulation applies should not contain one or more of the following substances (a) Ammonium Bromide; (b) Calcium Bromide; (c) Calcium Bromidolactobionate; (d) Embutramide; (e) Fencamfamin Hydrochloride; (f) Fluanisone; (g) Hydrobromic Embutramide; (h) Fencamfamin Phydrochloride; (i) Methohexitone Sodium; 0) Pemoline; or (k) Phenobarbitone. 50. Public notification and recovery of drugs. ( 1) The Chief Drug Inspector may, by notice in writing, impose requirements relating to any drug regulated by the Act, on a person registered to sell, supply or distribute drugs where (a) the dmg does not conform with a standard applicable to the drug or have been found or suspected to be tainted; (b) the manufacturing principles have not been observed in the manufacture of the drug; or (c) the drug is supplied in contravention of any law or enactment. l~/ 1uc uurn;c; u11uc;1 paragrapn llJ may spectty one or more ot the tollowmg requirements (a) the steps to be taken to recover the drugs; (b) the manner in which the steps are to be taken; or (c) a reasonable period within which the steps are to be taken. (3) The Chief Drug Inspector shall, as soon as practicable after giving the notice, cause particulars of it to be published in the Gazette. (4) The requirements that may be imposed upon a person under this regulation may include one or more of the following (a) to take specified steps, in the specified manner and within period specified, to re cover drugs that have been distributed; (b) to inform the public or a specified class of persons, in the specified manner and within the period specified, to the effect that the circumstances referred to in para graph (I )(a) have occurred in relation to drugs; or (c) to publish, in the specified manner and within the period specified, specified infor mation, or information of a specified kind, relating to the manufacture or distribu tion of drugs. (5) If the circumstances referred to in paragraph (l) apply only to a batch of drugs, the Chief Drug Inspector may limit the imposition of the requirements to the drugs included in that batch. (6) A requirement to recover drugs under this regulation does not apply to drugs that cannot be recovered because they have been administered to, or applied in the treatment of, a person. (7) A person commits an offence if (a) he does not comply with a notice under this regulation from the Chief Drug In spector; or (b) as a result of his failure to comply with the requirements imposed by the Chief Drug Inspector, the use of the drugs for which the requirements were imposed result in or will result in harm or injury to any person. (8) A person who commits and offence under subparagraph (7) is liable to a fine of fifty thousand dollars and to imprisonment for 4 years or to both. The Pharmacy Regulations, 2012 51. Certificate lost or destroyed. PART VII MISCELLANEOUS 28 2012, No. 45 (1) Where a certificate of registration or authorization issued under the Act is Jost, destroyed or defaced, the person to whom that certificate was originally issued may apply to the Council for a duplicate certificate. (2) An application for a duplicate certificate shall be made in the relevant application form set out in Schedule 2 in respect of an application for registration or authorization as the case may be required, and shall be accompanied by (a) an explanation as to why the duplicate certificate is required; and (b) the same number of photographs (if any) required in the case of an application for an original certificate. (3) The Registrar may issue to a person applying for a duplicate certificate, a certificate in the relevant form set out in Schedule 2, clearly marked in bold lettering with the word "DUPLI CATE". ( 4) A fee of one hundred fifty dollars shall be paid for a duplicate certificate issued under this regulation. (5) All records and books required by these regulations to be kept by any person, shall be open to inspection by the Board of Inspectors, at all reasonable times and it shall be lawful for the inspectors to make a copy or extract from any record or books. 52. Fees paid into the consolidated fund. Monies collected from fees prescribed under the Act and these Regulations shall be paid into the Consolidated Fund. 53. Penalty. A person who contravenes any provision of these Regulations commits an offence and shall be li able, on summary conviction to a fine often thousand dollars or to imprisonment for three years or to both. 2012, No. 45 29 (i) Antigua and Barbuda (ii) Bahamas (iii) Barbados (iv) Belize (v) Commonwealth of Dominica (vi) Grenada (vii) Guyana (viii) Haiti (ix) Jamaica (x) Montserrat (xi) St. Kitts; Nevis and Anguilla (xii) St. Lucia (xiii) St. Vincent and the Grenadines (xiv) Trinidad and Tobago SCHEDULE 1 SCHEDULE2 FEES 1. Annual Licence fee for the operation of a Pharmacy 2. Annual Licence fee for the operation of a wholesale pharmaceutical business 3. Registration of authorized seller of poisons and annual fee 4. Registration of Pharmacy Student 5. Registration of Pharmacist and annual licence fee 6. Registration of Pharmacy Technician and annual licence fee FORMSA-G The Pharmacy Regulations, 2012 $ 1000.00 $2000.00 $250.00 $50.00 $350.00 $100.00 1. Application for registration as a Pharmacy Student............................. ............. .. .......... Form A 2. Application for Registration as a Pharmacist .. .. .... ... .. .. . .. . . . .. . . . . . . . . .. . .. .. .. ..... .. .. . .. . .. . . . .. ... . Fonn B 3. Certificate of Registration as a Pharmacist... .. ............................ ................................. .. Form C The Pharmacy Regulations, 2012 30 2012, No. 45 4. Application for Registration as a Pharmacy Technician .. ............ ...... .................. ......... . 5. Certificate of Registration as a Pharmacy Technician .. ..................... ............. .. .... .. ..... . 6. Application for Licence to operate a Pharmacy ............. ............................. .......... .. 7. Application for registration as an authorized seller of poisons .. .. .. ... ... ... ...... .... .......... . 8. Certificate of Registration of Authorized seller of poisons ...................... ... ............ .... . 9. Register of Poisons ... .... ........ ... ... .. ..... ...... .. ........ ....... ....... .. ..... ........ ..................... ... .... . 10. Application for licence to operate a wholesale pharmaceutical business ........... .. ........ . 11. Licence to operate wholesale pharmaceutical business ....... ...... ............ .. .......... ... ...... .. 12. Licence to operate pharmacy ...... ........ ............. .......................... .... ........... .............. ...... . 13. Application for licence to sell poisons .............. .. ............ .. ... .................. .......... .. ....... .. . FormD FormE FormF FormG FormH Form I FormJ FormK FormL FormM 14. Licence to sell poisons ...... .... .................. ......... ................ .. ............................. .. ........ .... From N 2012, No. 45 31 The Pharmacy Regulations, 2012 SCHEDULE3 FORMA The Pharmacy Act Regulation 4 APPLICATION FOR REGISTRATION AS A PHARMACY STUDENT TO: The Pharmacy Council Name of Applicant ................ ........................ .. ................... ......... ................... ...... ....... ..... .. .. . (Block Letters) Date of Application ..... ........... .. ..... .. .... ......................................... .. ....... ............................... . Address of Applicant ....................................... .......... ........................ .. .. ....... ..... .................. . (Block Letters) Age of Applicant ................ ................... .. .. ..................................................... .. ........ .. ........ .. . (certified copy of Birth Certificate should be attached) Qualification of Applicant ........ .. ............................. .. ..................................... ..................... . ( copies of certificate to be attached) Testimonials (3 to be attached) Name of Parent/Guardian (if under 2 1) ........... .. ................ .......................... ... ... .. ... ............ . (Block Letters) Address of Parent/Guardian (if applicable) (Block Letters) The Pharmacy Regulations, 2012 32 2012, No. 45 Address of Parent/Guardian (if applicable) ............. .... .... .... .... .................................. ............ .... .... .... .. (Block etters) L Signature of Applicant To be completed by the College at which applicant has been admitted as pharmacy student Date of Admission ........................... .............. .... ........... .. ................ .... .. ............... ... ..... .. .............. ....... . Recommendation .... ...... ................. ..... ..... ...... .. ................ ... .. .. .. .. ........ ........ ............... .............. ........... . To be completed by the Registrar Date approved/refused by the Council ............... ........ ................ .. ..................... .. ......... .. ...... .... ........... . Date Registered, if registered .... .. ............. ............ ...... ........ .... ..... ........... ... ...................... .... ..... ........... . Reason for refusal, if refused ........... ............ ...................... ......... .. .. .................. .. ......... ... ... ................ .. Signature of Registrar 2012, No. 45 33 The Pharmacy Regulations, 2012 FORMB Regulation 5 THE PHARMACY ACT APPLICATION FOR REGISTRATION AS A PHARMACIST To the Pharmacy Council Applicant's Surname .... ............ ........ ........................... .................................. ............. ...... .... . (Block Letters) Applicant's Christian Name(s) ......... ....... .......................... ....... ............. ........ ....... ...... .......... . (Block Letters) Gender: Male D Female D Date of Application ...... ....... ..... ....... .. ................................. ........ ...... ..... ...................... ...... ... . Address of Applicant. .. ........ ...... .................... .. .......................... ............ ....... ........................ . (Block Letters) Telephone contact infonnation: e-mail address: Date of Birth: Country of birth: EMPLOYMENT RECORD Present Employer (if applicable) .... .... . ....... .. . .......... ...... .... . .. . ....... . ....... . . . . . . ........ . Employer's address ............. . .. .... . . . . . . . .... . .. . . .. ..... .. . . ...... .. . ... . ...... ......... ...... .. . .. . The Pharmacy Regulations, 2012 34 2012, No. 45 Phone / Fax . . . . . . .. . .. . .. ... .. . . . .. .. . . . . .. ... . .. . . . .. . . . . . .. . . . .... . . . . .. . .... ... .. . . .... .. . . .. . . En1ail address ..... . .... . . ..... . . .......... . . .. . . . ... .. . . . . .. .. . . . . . . ... . . . . .. .... .. . . . .. . .. ..... . 0-2 11-15 26-30 PharmD BSc D D D D D YEARS OF EXPERIENCE 3-5 D 16-20 D >31 D QUALIFICATIONS MSc D DipPham1 D 6-10 D 21 -25 D Ass. Degree D Other (please specify) .. .. .. . .. .. . .. . . ..... .. . . . . .... .. . . . .. . No. of Credits . . . . . . . .. . .. .. . . . .. ... . . . . . . .. . . .. . . .. . .. . . . . . .... .. . (copies of Diplomas and Certificates to be attached) Testimonials (2) (to be attached) Names of Referees (2): Present or Proposed Employment: .. .. .. .. ... ... . . . .. . .... . .. .. . . . .. . . .. . . . . .. . .. .......... . . . ... .. . DECLARATION I declare that the infonnation provided herein is a truthful, complete and accurate representation of the information required. Date 2012, No. 45 35 The Pharmacy Regulations, 2012 Signature of Applicant To be completed by the Registrar Date registered or refused ............................................. .. .. ................... .. .............. ..................... . Registration No: .................. ........ ............................................. ....... ............................... ........... . Date and No. of Gazette Notice in which registration is published .............................. ............ . Proof of payment: Receipt No. Reason refused, if refused ............................... ..................... ........... ...... ... ............. .. ................. . . Signature of Registrar The Pharmacy Regulations, 2012 36 2012, No. 45 FORMC Regulation 9 THE PHARMACY ACT CERTIFICATE OF REGISTRATION AS A PHARMAClST Kegistrat.ioo !-Jo: ... ......................... .... ...... ......... ........ .... ...... .... ................ ............. . This is to ceitify that ... .. .... ........ ... ..... ....... .. .... .. ...... ...... .... .. ... .... ...... .. .. .......... ....... . of ......... .. ... .. ............. ............. ... .. ........ ... .. ....................... ..... .... ........................... ... . has been duly registered as a pharmacist under the Phannacy Act. Given under my hand this day of 20 President, Pharmacy Council Registered Registrar 2012, No. 45 37 The Pharmacy Regulations, 2012 FORMD Regulation 6 THE PHARMACY ACT 1995 APPLICATION FOR REGISTRATION AS A PHARMACY TECHNICIAN To the Pharmacy Council Name of Applicant ...... .... ....... . . ... .. ... .. . . .......... .. ..... ... . ........ .. . . . . (Block Letters) Date of Application: .. ... . .... . .................... .. . ...... ... . ... . .... . .. . ..... ... . Address of Applicant .... .. . . . . .. .. . ... . ... . . . ..... . .. . .. .. .... ... . ...... . . . ........ .. Age of Applicant . . .. . ..... .. . .... . ..... ... .... . ........ . . . ... . .. . ... .... . ... . . . .. ... . (copies of Diploma to be attached) Testimonials (2) (to be attached) Signature of Applicant To be completed by the Registrar Date registered or refused .... .. . .. ... . . . ...... ... . .. ... .. .... ... ..... ... ... ... . . .. . . Registration No: .......... .... . ....... ... ............. . .... . . . ............... . ....... . Reason refused, if refused ... . .. . . . ... . ........ . .. .. ... . .... .. .. . ... . .... .. ... . .. .. . ... . Signature of Registrar The Pharmacy Regulations, 2012 38 2012, No. 45 FORME Regulation 9 THE PHARMACY ACT 1995 CERTIFICATE OF REGISTRATION AS A PHARMACY TECHNICIAN Registration No. THIS IS TO CERTIFY THAT NAME Of ..... .. ...... . .. .. .. . ........... . .. .... .. .. .. . . . ... .... . . . ... ............. . . .. .. ... .. has been duly registered as a Pharmacist Technician under the Pharmacy Act Given under my hand this day of 20 Expired Date: .... .. ........................ . President, Council Registrar 2012, No. 45 39 The Pharmacy Regulations, 2012 FORMF Regulation 10 THE PHARMACY ACT 1995 APPLICATION FOR LICENCE TO OPERATE A PHARMACY APPLICATION IS HEREBY MADE FOR A CERTIFICATE OF REGISTRATION OF A PHAR MACY, PARTICULARS OF WHICH ARE AS FOLLOWS: APPLICANT IS A CORPORATION? OWNER OF PHARMACY: (OR CORPORATION) ADDRESS OF OWNER: (OR CORPORATION) NAME OF PHARMACIST: ADDRESS OF PHARMACIST: PHARMACIST REGISTRATION#: YES NO - ------------ - PHARMACIST TELEPHONE#: PHARMACIST HOURS OF WORK: FROM (AM/PM)TO (AM/PM) FROM (AM/PM) TO (AM/PM) FROM (AM/PM) TO (AM/PM) (IF MORE THAN ONE PHARMACIST IS EMPLOYED, PLEASE WRITE THE NAME(S) NEXT TO THEIR RESPECTIVE WORKING HOURS). TRADING NAME OF PHARMACY: (AS KNOWN TO THE PUBLIC) ADDRESS OF PHARMACY: The Pharmacy Regulations, 2012 40 2012, No. 45 TEL#: FAX#: --------- E-MAIL ADDRESS: THE PHARMACY IS: (A) (B) A NEW OPENING BEING ACQUIRED (C) BEING RELOCATED (D) ALREADY IN OPERATION (TICK THE CORRECT RESPONSE) STATE DATE OF PURCHASE AND/ OR COMMENCEMENT OF OPERATION: STATE DATE THAT PHARMACY WILL BE READY FOR INSPECTION, PRIOR TO COM MENCEMENT OF OPERATION: THE OWNER(S) OR A DIRECTOR OF THE CORPORATION OPERATING THE ABOVE MENTIONED IS REQUIRED TO SIGN THE FORM. NAME: PHARMACY REGISTRATION # (IF REGISTERED BEFORE) POSITION WITH CORPORATION: SIGNATURE: DATE: FOR OFFICIAL USE ONLY 2012, No. 45 41 The Pharmacy Regulations, 2012 FORM G Regulation 30 THE PHARMACY ACT APPLICATION FOR REGISTRATION AS AN AUTHORIZED SELLER OF POISONS To the Pharmacy Council I the undersigned Name of Applicant of Address of Applicant hereby make application for registration as an authorized seller of poisons. I hereby certify that I am over twenty-one years of age and that the particulars of the Business where the selling of poisons will be carried out as follows: Name of Business ................. ................................ .................................... ............................. . Address of Business .. .................................................. ....................................................... .... . 3. If partnership, give names and titles of all active partners: 4. If individually owned, give name and address of owner: 6. Phone Number ... . .. . .... . ... .. .. . ..... . .. . ............ . .. .. . .. ....... . 8. I enclose two testimonials from the following persons : !. 2. and enclose The Pharmacy Regulations, 2012 42 2012, No. 45 (i) a fee of ................. .......... ...... .......... .......... .. ...... ............... ............ .. ....... ... .. ..... ......... . (ii) a certified copy of my birth certificate (iii) two recent photographs of myself Dated this .... ....... ..................... day of ...... .. .......................... ... ....... 20 ....... .. .... . Signature of Applicant 2012, No. 45 43 The Pharmacy Regulations, 2012 FORMH Regulations 9 & 3 I THE PHARMACY ACT 1995 No. THIS IS TO CERTIFY THAT Name IS Registered as an authorized Seller of Poisons in Antigua and Barbuda Dated: . . ...... . .. . ..... . . . . ..... ...... . .. . President, Council Expired Date: .. ... ....... . .......... .... . Registrar The Pharmacy Regulations, 2012 44 DATE Name and quantity of Poison sold FORM I THE PHARMACY ACT 1995 Register of Poison Purpose Name and Address of Signature of for which purchaser Purchaser it is sold 2012, No. 45 Regulation 33 Comments Made by the Pharmacy Council this day of 20 President 2012, No. 45 45 l'l,e h iarmacy Regulations, 2012 FORMJ THE PHARMACY ACT, 1995 APPLICATION FOR LICENCE TO OPERATE A WHOLESALE PHARMACEUTICAL BUSINESS Regulation 11 APPLICATION IS HEREBY MADE FOR A LICENCE TO OPERATE A WHOLESALE PHAR MACEUTICAL BUSINESS, PARTICULARS OF WHICH ARE AS FOLLOWS: NAME OF APPLICANT: ...... ..... .... .... ....... ... .... .. .......... . . . ....... .. . . ADDRESS OF APPLICANT: .. .. .... .. .. . ... .. ... ... . . .. ... ............ .. . . .. .... . . TEL# . . . . . . . . . . . . . . . . . . . . . FAX # ......... ......... ... EMAIL ................ .... . IF BUSINESS IS A COMPANY: NAME OF COMPANY: .. . .. .......... ............................. ...... ....... . . CHAIRMAN OF COMPANY: .. .... ............. .. ....... . .... ... . .. .. . . ....... . GENERAL MANAGER OF COMPANY: . ..... . . . . .. . ...... .. ....... . .......... . MANAGING DIRECTOR OR CEO (IF ANY): .. . .. ......... .. .... ... .. .. .. ... ... . IF INDIVIDUAL OR FAMILY OWNED: GENERAL MANAGER: . . . ... .. ... . .... ...... ..... ... ... . ..... .. .. ... . .... . .. . ... .. . OWNER(S): .... . ..... . ........ . . . .. .... .. .. ... ... . . ........ . ..... . .. ... .. .... . .. . . .. ... . PHARMACIST NAME: ... . .. . . ..... ..... ............. . .... . ..... . . ... . ... . . . ........ . SIGNATURE OF PHARMACIST: .......... ... .. ... .. . .. . ... .. ...... . .... . .... .. ... . PHARMACIST REGISTRATION #: . . ........ ... DATE: .......... . ......... ... . EMPLOYMENT - FULL TIME: . .. . .. .. ... ... .. . PART TIME: ........ . .. ..... . HOURS OF WORK: . . . . . .. .. . .. . . TRADING NAME OF WHOLESALE BUSINESS: ....... .... . . ... .... . ................ .. ... .... . . . .. . .. . (AS KNOWN TO THE PUBLIC) The Pharmacy Regulations, 2012 46 2012, No. 45 NORMAL BUSINESS HOURS: .......... . .................. . ...... . .. . ............... . .. . .... . ADDRESS OF WHOLE SALE BUSINESS ACTrYITY: ............ .. ....... .... ................ . THIS WHOLE SALE IS: (A) A NEW OPENING { } (B) BEING ACQUIRED { } (C) BEING RELOCATED { } (D) ALREADY IN OPERATION { } (TICK THE CORRECT RESPONSE) STATE DATE THAT THIS UNIT WILL BE READY FOR INSPECTION, PRIOR TO COM MENCEMENT OF OPERATION: ...... . .. ............ .... ... ...... ..... .. .... .. .. ...... .. .. STATE DATE OF COMMENCEMENT OF OPERATION: .... ... ..... . .. .... .. . .. .. THE OWNER (S) OR A DIRECTOR OF THE COMPANY OPERATING THE ABOVE MEN TIONED IS REQUIRED TO SIGN THIS FORM. NAME: ........ ............ .. .......... .. ... REGISTRATION # OF BUSINESS .. ...... .. .. POSITION WITH COMPANY: . . . ... . ..... ..... .. ... .. .... . .. . . ... ... . . .. .... . SIGNATURE: .. .. . .... .. .. ...... .. . .... . .. .. . . .... ....... .. ... . ........ . . . .... . DATE: ............ . . ...... . ... . .. .. .. ... . ... .. . ... ...... .. . . .. ... .... ... .. . . .... .. FOR OFFICIAL USE ONLY 2012, No. 45 47 The Pharmacy Regulations, 2012 No. - - - FORMK THE PHARMACY ACT, 1995 THIS IS TO CERTIFY THAT NAME IS Regulation 9 LICENSED TO OPERATE A WHOLESALE PHARMACEUTICAL BUSINESS IN ANTIGUA AND BARBUDA DATED ... . .... . ..... . . . ..... ... . ..... . President, Council EXPIRED DATE . .. ...... . . ... .. . . . .. . Registrar This Certificate of License is for the purpose of the Pharmacy Act 1995 and is the property of the Pharmacy Council of Antigua and Barbuda. The Pharmacy Regulations, 2012 48 FORML THE PHARMACY ACT, 1995 No. THIS IS TO CERTIFY THAT NAME IS LICENSED TO OPERATE A PHARMACY IN ANTIGUA AND BARBUDA DATED .. . .. .. ........ . ........ .. .... . EXPIRED DATE . ... . . . .. . ... ...... . . Minister with responsibility for the administration of the Pharmacy Act, 1995 Registrar This Certificate of License is for the purpose of the Pharmacy Act 1995 and is the property of the Pharmacy Council of Antigua and Barbuda. 2012, No. 45 Regulation 14 2012, No. 45 49 The Pharmacy Regulations, 2012 FORMM Regulation 12 THE PHARMACY ACT, 1995 APPLICATION FOR LICENCE TO SELL POISONS APPLICATION IS HEREBY MADE FOR A LICENCE TO SELL POISONS, PARTICULARS OF WHICH ARE AS FOLLOWS: NAME OF APPLICANT: . . . . . . .. . ... ... .. ... .... . .. . ... .... . .. .... . . ... ..... . .. . .. . ADDRESS OF APPLICANT: ..... ...... . . ... . .. . .. .... . . .. .............. . ....... . . . TEL# ..... .......... . . . .. . FAX# ....... .. . ... . . ... . . . EMAIL .. . .. ... .. ..... .... . . IF BUSINESS IS A COMPANY: NAME OF COMPANY: . . . . . . .. .. ... . .... .... . .... .... ..... ...... . . ...... .. . . .... . CHAIRMAN OF COMPANY: ..... . .. . .. . ... . . ... . . . .... .... ........ . ....... .. . . GENERAL MANAGER OF COMPANY: .. .... . .... . ... ... .. ..... .. . . ......... . . MANAGING DIRECTOR OR CEO (IF ANY): . ...... . .... .. ..... .. . ........ .. ... . IF INDIVIDUAL OR FAMILY OWNED: GENERAL MANAGER: . . . ...... .. .. . .... . ... . .... . . .. . ... .. .... ... ... ........ . ... . . OWNER(S): .. ... . ... ..... ... .... ... ... . . . . ... .. .. .. . . ...... . . .. .. ... ..... ... . . .. .. ..... . PHARMACIST NAME: .. .. .... . ... . ... . .. .. .. .. .. .. . . . ... . ... . ...... .. ..... .. .. . .. . . . SIGNATURE OF PHARMACIST: . ..... ..... ... .. . . . ..... ... ................ .. ..... . PHARMACIST REGISTRATION #: ...... . ... .. . DATE: ........ .. . ............ . EMPLOYMENT - FULL TIME: .. . . .... . .. . . . . . . PART TIME: .... .. ... . . ... .. . HOURS OF WORK: ......... . . .. . TRADING NAME OF WHOLESALE BUSINESS: ....... ..... . .. . .. .. .. .. . .... .... . .. .................. . (AS KNOWN TO THE PUBLIC) The Pharmacy Regulations, 2012 50 2012, No. 45 NORMAL BUSINESS HOURS: .. . ...... . . .. ... .. .... ....... ... ... . . .. . . . ..... . .... ... .. .. . . . . . ADDRESS OF WHOLE SALE BUSINESS ACTIVITY: ... .................. ....... ............. . THIS WHOLE SALE IS: (A) A NEW OPENING (B) BEING ACQUIRED (C) BEING RELOCATED { } { } { } (D) ALREADY IN OPERATION { } (TICK THE CORRECT RESPONSE) STATE DATE THAT THIS UNIT WILL BE READY FOR INSPECTION, PRIOR TO COM MENCEMENT OF OPERATION: . .. .. .... .. .... .. .. ... .. ... . ..... .. ...... ... ......... .. ... . STATE DATE OF COMMENCEMENT OF OPERATION: . . .... .............. . .. .. . THE OWNER (S) OR A DIRECTOR OF THE COMPANY OPERATING THE ABOVE MEN TIONED IS REQUIRED TO SIGN THIS FORM. NAME: . . ........... ... .. ... . . .. . . .. . . . ..... REGISTRATION# OF BUSINESS .. . .... . . . . . POSITION WITH COMPANY: .. ... . . . ... ... ... . ..... . . .... . .. . .. ............ . SIGNATURE: .. .. ... . ... . .... ... .. .. . .. ... . . ..... .. . .... . .... .. .. . ..... . . .. . . . . DATE: . .. .. .. .. .. . .. .. ... .... .. .. ... .... . ..... . .. ..... . . .. .. ............. . . ... . .. . FOR OFFICIAL USE ONLY 2012, No. 45 51 The Pharmacy Regulations, 2012 FORMN THE PHARMACY ACT, 1995 No. THIS IS TO CERTIFY THAT NAME IS LICENSED TO SELL POISONS IN ANTIGUA AND BARBUDA DATED ......... .. . .. . .. .. . .. ... . Minister with responsibility for the administration of the Pharmacy Act, 1995 EXPIRED DATE ........ .. .. .... . Registrar This Certificate of License is for the purpose of the Pharmacy Act 1995 and is the property of the Pharmacy Council of Antigua and Barbuda. Regulation 14 The Pharmacy Regulations, 2012 52 :2012, No. 45 SCHEDULE4 Subject to the provisions made under sections 13, 18, 19 and 20 of the Pharmacy Act, the sale or supply of drugs and poisons for the purpose of the Act falls into 2 parts: Part I - divided into 6 Sections: Section 1 - deals with sale of vitamins in Supermarkets, Health Food Stores and Shops Section 2 - Drugs restricted to Phannacies only. Section 3 - deals with Prescription only Drugs. Section 4 - deals with Controlled drugs and Psychotropic substances. Section 5 - deals with General Sales. Section 6 - deals with Chemical Precursors. Part II - deals with poisons which may be sold by authorized sellers of poisons. PART I Section 1 Vitamins - Persons already operating a Health Food Store, Supermarket, or Shop may sell vitamins and minerals as Vitamin Supplements but only in un-opened bottles or containers, suitably labelled as to the therapeutic effect of its contents. Vitamins are any of the following: Vitamins A, B 1, B2, 86, C, D and E, biotin, nicotinamide, nicotinic acid, pantothenic acid and its salts, biflavanoids, in ositol, choline, para-aminobenzoic acid, cyanocobalamin or folic acid. Vitamin preparations mean any medicinal product, the active ingredients of which consist only of vitamins, or vitamins and minerals salts, that is, salts of any one or more of the following: iron, iodine, calcium, phosphorus, fluorine, copper, potassium, manganese, magnesium or zinc. Vitamins for oral use as follows: Thiamine or Vitamin B 1 Riboflavin or Vitamin B2 Ascorbic Acid or Vitamin C Vitamin D, no more than 1,000 international units or less per oral dosage form (1,000 i.u.) 2012, No. 45 53 The Pharmacy Regulations, 2012 Vitamin E, Alpha tocopherol, no more than 200 international units (200 i.u.) Any vitamin preparation for oral administration as a food in relation to which there are no written particulars or direction as to dosage. Any medicinal product for oral administration as a food, not being a vitamin preparation to which one or more of the ingredients has been added: - Vitamin A or D, folic acid or cyanocobalamin, and in rel<1ti .)'.1 to which product there are written particulars or directions as to the recommended use of that substance which involves a daily intake in excess of the quantities and ingredients specified. Any vitamin preparation for oral administration as a food in relation to which there are written particulars or directions specifying a recommended daily dosage for adults involving a daily intake in excess of: vitamin A, 2500 units; or antirachitic activity, 250 units; or folic acid, 25 micrograms; or cyanocobalamin, 5 micro grams. Exemptions: No Supermarket, Health Food Store, or Shop may sell the vitamins as listed below: Vitamin A, any preparation for internal and parenteral use in humans containing or represented as containing more than 10,000 i.u. in each oral dosage form, or if the largest recommended daily dosage shown on the label thereof, if consumed would furnish more than 10,000 i.u. Vitamin B 12 or Cyanocobalamin. Vitamin B5 or Panthothenic Acid. Vitamin B3 or Niacin or Niacinamide Vitamin E dosage over 200 i.u. Vitamin D dosage over 1,000 i.u., any preparation for internal or parenteral use in humans containing or represented as containing more than 1,000 i.u. in each oral dosage form, or if the largest recommended daily dosage shown on the label thereof, if consumed would furnish more than I ,000 i.u. Vitamin K. Vitamin B6 or Pyridoxine Acid. FolicAcid Section 2 Narcotic controlled Drugs and Psychotropic substances are restricted to prescriptions only. Record of these must be kept according to the provisions of the Misuse of Drugs Act and the Dangerous Drugs Rules. The drugs which fall under this section are subject to control and should be guided by the following particu The Pharmacy Regulations, 2012 54 2012, No. 45 lars. Under this section, penalties may be determined for offences under the Misuse of Drug Act. Doctors, pharmacists and persons lawfully conducting retail pharmacy businesses may be called upon to give particulars of the quantities of any of these drugs which have been prescribed, admin istered or supplied over a period of time. It is an offence to fail, without reasonable excuse, to give the information required or to give false information. Control Drug Registers Records must be kept by all person(s) or businesses authorized to possess Control Drugs (CD). The following particulars are to be recorded a) date on which received; b) name and address of person or firm from whom received; c) amount received; d) form in which received. For CD supplied the following must be recorded a) date on which the supply was made; b) name and address of person or finn to whom supplied; c) particulars as to licence or authority of the person of film supplied to be in possession of Controlled Drngs; d) amount supplied; e) form in which supplied. NB: The following points are important in relation to the keeping of CD registers a) entries must be in chronological sequence; b) a separate part of the register must be used for each class of drugs. Separate sec tions are required for amphetamines (which includes dexamphetarnine) and me htylamphetmines; c) If desired, separate parts of the register can be used for different drugs or strengths of drugs comprised within a class of drugs; d) The class of drugs must be specified at the head of each page; 2012, No. 45 55 The Pharmacy Regulations, 2012 e) entries must be made on the day of the transaction; j) No cancellation, obliteration or alteration may be made; correction must be dated by marginal note or footnote; g) entries must be in ink or otherwise indelible; h) the register must not be used for other purposes; i) the register must be kept at the premises to which it is related and a separate register must be kept for each premises of the business; j) particulars of stock receipts and supplies must be - furnished to any authorized person on request (this includes drug inspectors and police officers during any investigation). Other documents and stocks of drugs must also be produced if required; k) no entry need to be made in the prescription-only register, but it is good practice to make these entries. CD Lie: The possession, production and supplies of these are restricted in the public inter est, to purposes of research or any other purpose designated by the Ministry of Health. A licence is required from the Ministry of National Security for possession. CD POM: A licence is needed to import, or export these drugs. A pharmacist may supply them to a patient only on the authority of a prescription issued by a registered medical practitioner. Requirement as to safe custody applies. CD No Register (CD NO Reg): The control that applies to CD POM applies to CD NO REG. However, records in the register of control drugs need not be kept in respect of these drugs. CD Benz: are mainly benzodiazepines and some adrenoreceptor stimulants. An import and export licence is required. There are no restrictions on possession once obtained in accordance with a prescription written by a duly registered physician. Recording of their sale in a control drug register is not required and there are no safe custody requirements. CD Anab: are mainly anabolic and androgenic steroids. An import and export licence is required. There are no restrictions on possession once obtained in accordance with a prescription written by a duly registered physician. Recording of their sale in a control drug register is not re quired and there are no safe custody requirements. CD Inv: contains preparations of certain controlled drugs, for e.g. Codeine, pholcodine and morphine, which are exempt from full control when, presented in medicinal products of low strength. There are no restrictions on the import, export, possession or administration of these preparations, and safe custody requirements do not apply for duly authorized person(s) or pharma cies. Invoice is required to be kept for two years. The Pharmacy Regulations, 2012 List l CD A Amphetamine; its salts Acetylsalicylic acid (aspirin)/ Papaveretum CD Inv POM Alfentanil CD Allylprodine CD POM Alphacetylmethadol; its salts esters & ethers CD POM Alphameprodine; its salt CD POM Alprazolam CD Benz POM Aminorex CD Benz POM Amylobarbitone CD No Reg. POM Amylobarbitone Na CD No Reg. POM Anileridine; its salts CD POM Amytal tablets CD No reg. POM Aspirin 500mg/Codeine 8mg P 56 Aspirin 250mg/Meprobamate 150mg/Ethoheptazine citrate 75mg CD POM Aspav tablets CD Inv POM Atamestane CD anab POM B Barbitone CD NO Reg Barbitone Na CD No Reg Benzethidine; its salts CD Benzphetamine; its salts CD No Reg Benzylmorphine; its salts CD POM Betacetylmethadol; its salts CD POM Betameprodine; its salts CD POM Betamethadol; its salts, esters and ethers CD POM Betaprodine CD POM Bezitramide; its salts CD POM 2012, No. 45 2012, No. 45 57 Bolandiol CD anab POM Bolasterone CD anab POM Bolazine CD anab POM Boldenone CD anab POM Bolenol CD anab POM Bolrnantalate CD anab POM Bromazeparn CD Benz POM Brotizalom CD Benz POM Buprenorphine CD No Reg POM Bufotenine; its salts, esters and ethers CD lie Butalbital CD No Reg POM Butobarbitone CD No Reg POM Butobarbitone Na CD No Reg POM C Calusterone CD anab POM Carnazeparn CD Benz Porn Camphorated Opium Tincture CD inv POM Cannabinol derivatives CD inv POM Cannabis and Cannabis resin CD lie Carfentanil; its stereoisomers, salts, esters and ethers CD POM The Pharmacy Regulations, 2012 Cathine its salts, stereoisomers (other than phenylpropanolamine) CD No Reg POM Cathinone; its stereoisomers, salts, esters and ethers CD lie Chloroform/Morphine Tincture CD inv POM Chlordiazepoxide CD Benz POM Chlophenterrnine; its salts CD No Reg POM Chorionic gonadotrophin CD anab POM Choragon inj. CD anab POM Clenbuterol CD anab POM Clobazam CD Benz POM Clonazepam CD Benz POM Clonitazene; its salts CD POM The Pharmacy Regulations, 2012 Clorazepic or Clorazepate dipotassium CD Benz POM Clostebol CD anab POM Clotiazepam CD Benz POM Coca leaf CD lie Cocaine; its salts CD lie Codeine; its salts CD POM Codeine/Paracetamol CD inv P Codeine/ Aspirin/Paracetamol tablets CD inv P Codeine 8mg/Paracetamol 500mg tablet CD inv P Codeine 60mg/Paracetamol lg CD inv POM Codeine 8mg/Aspirin 400mg tablet CD inv P Codeine/Diphenhydramine/Menthol cough CD inv P Codeine/Diphenhydramine/Na citrate/Menthol CD inv P Codeine/Pseudoephedrine/Guaifenesin CD inv P Codeine 20mg/Ibuprofen 300mg CD inv POM 58 Codeine or hydrocodone/Brompheniramine maleate/Pseudoephedrine inv P Codeine/Creosote CD inv P Codeine Linctus 10mg/5ml CD inv P Codeine Paediatric Linctus P Codeine/Kaolin CD inv POM Codeine/Paracetamol/Caffeine/Hyoscine POM Codeine/Promthazine/Ephedrine cough and cold inv P Codeine/Paracetamol/Caffeine/Diphenhydramine P Codeine/Guaiacol POM Codeine/Paracetamol/Caffeine POM Codeine/Paracetamol/Caffeine/Doxylamine CD inv P Cyclobaritone Ca CD No Reg POM Cyclobaritone CD No ~eg POM D Danazol CD anab POM Desomorphine; its salts, esters and ethers CD POM 2012, No. 45 2012, No. 45 59 Dextropropoxyphene HCI 32.5mg/Paracetamol 325mg inv POM Dexamphetarnine CD POM Dextropropoxphene 32.5rng/Paracetamol 325rng CD inv POM Dextropropoxpbene; its salts, esters and ethers CD POM Dextromoramide CD POM Diazepam CD Benz POM Diamorphine CD POM Dibydrocodeine/Paracetamol CD No Reg Porn Dihyrocodeine!Parcetamol CD Inv P Dihyrocodeine/Grindelia/altbaea cough inv P Dihyrocodeine; its salts CD POM The Pharmacy Regulations, 2012 Dibyrocodeineone O-carboxymethyloxirne; its salts, esters and ethers CD POM Dihydrornorphine; its salts, esters and ethers CD POM Dirnepheptanol; its salts, esters and ethers CD POM Dirnenoxadole, its salt, CD POM Dipipanone HCI 1 0mg/Cyclizine 30mg injection CD POM Dipipanone; its salts CD POM Dietbylpropion; its salt CD No Reg POM Diethylthiambutene; its salts CD POM Difenoxin CD POM . Dioxaphetyl butyrate; its salts CD POM Diphenoxylate CD POM Dronabinol CD POM Drotebanol; its salts, esters and ethers CD POM Drostanolone; its salts CD anab POM Drotebanol; its salts, esters ethers CD POM E Ergonine and its derivatives CD POM Enestebol CD anab POM Epitiostanol CD anab POM Estazolam CD Benz POM The Pharmacy Regulations, 2012 . Ethchlorvynol CD No Reg POM Ethirunate CD No Reg POM Ethyl loflazepate CD Benz POM Ehtyleostenol CD anab POM Eticyclidine CD lie Etonitazene; its salts POM Etorphine; its salts, esters and ethers CD POM Etryptamine CD lie Ethylmethylthiambutene; its salts CD POM F Fencamfamin; its salt, stereoisomers CD .Benz POM Fenethylline; its salts and stereoisomers CD POM Fenproporex; its salts and stereoisomers CD Benz POM Fentanyl CD Fluoxymestrone anab POM Formebolone POM Flurazepam CD Benz POM Fludiazepam CD Benz POM Flunitrazepam CD Benz No Reg POM Fluoxymesterone CD anab POM Formebolone CD anab POM Furazabol CD anab POM Furethidine; its salts CD POM G Genotropin prep CD anab POM Glutethimide; its salts and stereoisomers; CD POM Growth Hom1one CD anab POM H Halazepam CD Benz POM Haloxazolam CD Benz POM Heptabarbitone CD No Reg POM 60 2012, No. 45 2012, No. 45 61 Hexabarbitone CD No Reg POM Hexabarbitone Na CD No Reg POM Hydrornorphinol; its salts, esters and ethers CD POM Hydrornorphone; its salts, esters and ethers CD POM Hydroxypethidine; its salts, esters and ethers CD POM I Iso-lysergamide CD lie Isomethadone K Ketazolam CD Benz POM Ketobemidone; its salts, K.itamine L Lysergide (LSD); its salts, esters and ethers CD POM Lefetarnine; its salts CD POM Levomethorphan; its salts CD POM Levomoramide; its salts CD POM Levophenacylmorphan; its salts, esters and ethers CD POM Levorphanol; its salts, esters and ethers CD POM Lofentanil; its salts, esters, ethers and stereoisomers CD POM Loprazolam CD Benz POM Lometazepam CD Benz POM Lysergamide; its salt CD lie M Mazindol CD No Reg POM Mecloqualone CD POM Mefenorex: its salts and stereoisomers CD Benz POM Medazepam CD Benz POM Meprobamate CD No Reg POM Mebolazine CD anab POM Mepitiostane CD anab POM The Pharmacy Regulations, 2012 The Pharmacy Regulations, 2012 . Mesabolone CD anab POM Mesterolone CD anab POM Methadone CD POM Methandienone CD anab POM Methandriol CD anab POM Methenolone CD anab POM Methaqualone; its salts CD POM Methcathinone CD Lie Methytestosterone CD anab POM Methylamphetamine; its salt CD POM Methyldesorphine; its salts, esters and ethers CD POM Methyldihyromorphine; its salts, esters and ethers CD POM · Methylphenobarbitone CD No Reg POM Methyprylone CD anab POM Metribolone CD anab POM Metopon; its salts, esters and ethers CD POM Metazocine; its salts, esters and ethers CD POM Methyl Phenobarbital POM Methadyl acetate; its CD POM Mesterolone CD anab POM Methylphenidate CD POM Milbolerone CD Anab POM Midazolam Benz POM Morphine 1 0mg/Cyclizine 50mg injection CD POM Morphine; its salts, esters and ethers CD POM Morphine/Kaolin/Belladonna CD P Morphine Kaolin Mixture CD P Morphine/Belladonna/ Aluminium/Kaolin CD inv P Myrophine; its salt CD POM · N N,N-Diethyltryptamine; its salt CD lie 62 2012, No. 45 2012, No. 45 · 63 N,N-Dimethyltryptamine; its salt CD lie Nandrolene; its salts, esters and ethers CD anab POM N-etbylampbetamine; its salts, esters and ethers CD POM N-Hydroxy-tenampbetamine CD lie Nicocodine CD POM Nicodicodine CD POM Nicomorphine; its salt CD POM Nimetrazepam CD Benz POM Nitrazepam POM Norboletone CD anab POM Norclostebol CD anab POM Nordazepam CD Benz POM Norditropin CD anab POM Norethandrolone CD anab POM Norlevorphanol; its salt, esters and ethers CD POM Normethadone; its salt CD POM Normorphine; its salt, esters and ethers CD POM Norpipanone; its salts CD POM Naloxone CD POM 0 Opium medicinal CD POM Ovandrontone CD anab POM Oxabolone CD anab POM Oxandrolone CD anab POM Oxycodeine; its salt CD Oxymesterone CD anab POM Oxymetbolone·CD anab POM Oxycodone/Aspirin CD No Reg POM Oxycodone; its salt CD p Pemoline CD POM The Pharmacy Regulations, 2012 The Pharmacy Regulations, 2012 Pentazocine/Paracetamol CD POM Pentazocine; its salts, esters and ethers CD POM Pethidine CD POM Pethidine/Promethazine HCI CD POM Pethidine/Scopolamine CD POM Phenadoxone; its salts CD POM Phenampromide; its salts CD POM Phenazocine; its salts, esters and ethers and their salts CD POM Phendimetrazine; its salts CD No Reg POM Phencyclidine; its salts, esters and ethers and their salts CD POM 64 2012, No. 45 Phenethylamine; its salts, esters, ethers its derivatives and their salt esters, ethers CD lie Phenmetrazine; its salts CD POM Phenobarbital; its salts CD No Reg POM Phenobarbital Na CD No Reg POM Phenomorphan; its salts, esters and ethers and their salts CD POM Phenoperdine; its salts, esters and ethers and their salts CD POM Phentermine CD No Reg POM Phenymethylbarbituric acid CD No Reg POM Pholcodine CD POM Pholcodine Linctus CD inv P Pholcodine Linctus strong CD inv P Pholcodine/Promthazine/Pseudoephedrine cough and cold CD inv P Pholcodine/Menthol cough syrup CD inv P Pholcodine/Chlorphenirrupine/Pseudoephedrine cough and cold Linctus CD inv P Piminodine; its salts CD POM Pinazepam CD Benz POM Pipradol; its salts CD No Reg POM Piritramide; its salts CD POM Potassium Clorazepate CD Benz POM Prasterone CD anab POM Prazepam CD Benz POM 2012, No. 45 65 Properidine; its salts CD Proheptazine; its salts CD POM Propetandrol CD anab POM Propiram; its salts CD POM The Pharmacy Regulations, 2012 Psilocin; its salts, its esters and ethers and their salts CD Lie Pyrovalerone; its salts its stereoisomers; their salts CD Benz POM Q Quinalbarbitone CD POM Quinalbarbitone Na CD POM Quinalbolone CD anab POM R Racemethorphan; its salts CD POM Racemoramide; its salts CD POM Racemorphan; its salts, esters and ethers and their salts CD POM Raw Opium CD lie Rolicyclidine CD lie Roxibolone CD anab POM s Saizen inj. CD Anab POM Secbutobarbitone CD No Reg POM Secbutobarbitone Na CD No Reg POM Secobarbital Na; Amobarbital Na CD POM Sevredol oral solution CD Inv. POM Sevredol concentrated oral solution CD POM Sevredol tablets or capsule CD POM mandrone CD anab POM ;odium amytal prep CD No Reg POM fomatropin CD anab POM ,omatotropin CD anab POM ;omnite preparations CD Benz. POM :oneryl tablets or capsules CD no Reg POM The Pharmacy Regulations, 2012 Squill linctus opiate CD inv P Stanolone CD anab POM Stanozolol CD anab POM Stenbolone CD anab POM Stesolid rectal tubes CD Benz. POM Stromba preparation CD Anab. POM Sublimaze injection CD POM Subutex CD No Reg. POM Sufentanil; its salts, esters and ethers and their salts CD POM T Temazepam CD No reg POM Temazepam Gelthix CD No reg POM Temgesic injection CD No reg POM Temgesic sublingual tablets CD No reg POM Tenocyclidine CD lie Tercolix CD inv POM Terpoin CD Inv. POM Testoderm patches CD Anab POM Testosterone; its salts, esters and ethers POM Tetrazepam CD Benz POM Thebacon; its salts CD POM Thebaine, its salts CD POM Thiomesterone CD anab POM Tilidate; its salts, esters and ethers and their salts CD POM Trenbolone CD anab POM Triazolam CD Benz POM Trimeperidine; its salts CD POM Tixylix cough & cold linctus CD Inv P Tixylix Daytime linctus CD Inv P Tixylix night time linctus CD Inv P Tropium preparations CD Benz POM 66 2012, No. 45 2012, No. 45 67 Tylex capsules CD inv POM u Ultramol soluble tablets CD inv. P Uorazepam CD Benz POM V Veganin tablets CD inv P Vrrormone injection CD Anab POM z Zipeprol CD POM Zomacton CD Anab POM Zomorph tablet or capsules CD POM The Pharmacy Regulations, 2012 NB : Any derivative(s) of a list 1 drug or drug or new drugs which are not mentioned are considered Control drugs unless otherwise classified by the Pharmacy Council (the Minister of health). Section 3 Prescription only medicines. This means that a medicinal product which may be sold or supplied by retail shall be given in accordance with a prescription given by a duly registered medical practi tioner, dental surgeon or veterinary surgeon as described accordingly. Prescription only medicines as listed are Medicinal products containing one or more of the substances listed; Medicinal products that are controlled drugs; Medicinal products that are for parental administration whether or not they contain any substance included in the Prescription Only List; Cyan genetic substances other than preparations for external use; and Medicinal products which include certain steroids. Listl Prescription only medicines (POM) for human use. A Abiciximab Acarbose tabs Accuretic tabs Abelcet infusion Acamprosate tabs Accusite inject. Gel Acamprosate tabs Accupro tabs Acetolol HCI The Pharmacy Regulations, 2012 68 2012, No. 45 Aceclofenac tabs Acemetacin Acepril tabs Acepromazine maleate Acepromazine Acetanilide Acetarsol Acetazolarnide Acetazolarnide Na. Acetohexarnide Acetycholine Cl Acetycysteine prep Acitak tabs Aciclovir Acipimox Acitretin Aclacin Aclarubicin HCI Aconite Acrivastine Acrosoxacin ACTH inject ACT-HIBDTP ACT-HIB Actilyse Actinomycin C Actinomycin D inj Actinomycin D Actonel Abacavir Adrenocortical ext *Aspirin Adapalene Adenosine sol Adenosine prep Addiphos sol Adrenaline inject · Adrenaline eye drops Adrenaline prep Alglucerase Asparaginase Adapalene Alclofenac Alclometasone dipropionate Anistreplase Allantoin prep. Arniloride/frusernide Amoxapine Albendazole Albumin Hwnan prep. Aldosterone Allopurintol tabs Alendronic prep Alginic acid prep Almotriptan Aloxiprin Alphaglobin Alprazolam Alprenolol Alprostadil Altiplase Amantadine Ambenonium Arnidopyrine Amcinonide Amethocaine eye Amcinonide Amethocaine Arnifostine infusion Amikacin Amikacin inject Arnlodipine prep Amiloride/HCTZ Arniloride HCI Arninogluthethirnide Arninocaproic acid Arninophylline Arninoplex prep Arninopterin Arniphenazole HCI Arnisulpride tabs Ammonium Br Amodiaquine HCI Arnitriptyline Arniodarone HCI Ampicilline prep Amorolfine HCI Amphotericin prep Amsacrine Amoxicillin Amphotericin B Amprenavir Amylbarbitone 2012, No. 45 69 Amygdalin Amyl nitrate Anastrazole tabs Ancrod Anectine inject Angiotensin amide Anterior Pituitary Ext. Anthrax vaccine Amiodarone Antihepatitis B vaccine Amoxicillin/Clavulanic/salts Antimony dimeracaptosuccinate Antimony Potassium tartrate Antistreplase inject. Anusol HC prep. Aprotinin Aristolochia Clematitis Aristolochia Fang-chi Aristolochia Arsenic trioxide Atenolol Atracurium Atovaquone Azathioprine Azelastine HCI Azlocillin Na Antimony Li. Thiomalate Antimony Na. tartrate Antitutanus immuno inject Apaclonidine eye prep Arecoline HBr Aristolochia Contorta Aristolochia Manshuriensis Arsenic Aspirin/dipyridamole Atenolol andChlorthalidone Atropine Auranofin Azapropazone Azidocillin K Aztreonam Azatadine maleate Apraclonidine Alemtuzumab infusion Activated eptacog alfa The Pharmacy Regulations, 2012 Amylocaine HCI eye Androsterone Anistreplase Anti-D immuno globulin Antimony barium Tartrate Antimony pentasulphide Antirabies irnmuno inject Antivaricella-zoster Apramycin Argipressin tannate Aristolochia Debelis Aristolochia Serpentaria Arsenic triodide Astemizole prep Atenolol/Nifidepine Atrovastatin Aurothiomalate Na Azelaic acid Azithromycin Alendronate Na Atravostation Anakinra Atovaquone/Proguanil Aldesleukin Amino Acid infusions Altretamine Amorolfine HCI Alfacalcidol Alfentanil Atenolol/Bendrofluazide Atosiban Abacavir Apomorphine HCI B Bacampicillin HCI Baclofen Abacavir/Lamivudine/Ziodvudine Amobarbital Alfuzosin Bacillus vaccines Balanced salt sol. Atamestane Bacitracin prep. Balsalazide caps The Pharmacy Regulations, 2012 Bambuterol HCI Barium carbonate Beclometasone prep. Bemegride Bemegride Na Bencard skin testing sol. Benethamine Penicillin Benserazide HCI Benzathine Penicillin Benzilonium Br Benzoyl peroxide Benztropine mesylate Beta interferon inject Bethanechol C 1 Bifonazole Bicalutamide Bifonazole prep . Bleomycin prep Botulinum A toxin inject Bretylium Tosylate Brimonidine Bromocriptine Budesonide prep Bumetanide K Buphenine HCl Busulphan Butriptyline HCl Buclizine/Paracetamol Butobarbital Bupropion Brompheriramine maleate Barbitone Barium sulphide Betmethasone prep. Bemegride Na Benactyzine HCl Bendrofluazide Benoxaprofen Bentiromide Benzbromarone Benzocaine eye Benzquinamide prep Benzylpenicillin prep Betahistine prep. Bethanidine SO 4 Bovine dermal collagen Biperiden Bisoprolol Bortezomib Botulism Antitoxin inject Brinerdin Bromazepam Bromperidol Bufexamac Bumetanide/ Amiloride Buserelin prep. Butacaine SO 4 Betaxolol prep Botulinum B toxin Buprenorphine Bacillus/Samonella/Typhi vaccine Bacitiracin 70 2012, No. 45 Barium chloride Basiliximab Belladona root Betamethasone/salicyclic Benapryzine Benefix recom. Factor IX Benperidol Benzoyl peroxide E/mycin Benzhexol Benzoctamine HCI Benzthiazide Beractant Betaxolol Bezafibrate BCGvaccine Bis.glycollylarsanilate Bimatoprost Bevacizumab Bretylate inject Brinzolarnide Bromhexine Bromvaletone Bumetanide Bupivacaine prep Buspirone Butorphanol tartrate Bimatoprost Becaplermin Bexarotene 2012, No. 45 71 The Pharmacy Regulations, 2012 C Cabergoline Calcitriol Ca. Bromidolactobionate Ca. Folinate Ca. Metrizoate Camazepam Canrenoic acid Capreomycin Carbachol Carbadox Carbenicillin Na. Carbidopa/levodopa Coal tar/hydrocortisone Carboplatin Carbuterol HCl Carisoprodol Carteolol HCl Ceftibutin prep. Cefazedone Na. prep. Calcipotriol Ca. Benzamidosalicylate Ca. Carbimide Ca. Gluconate prep Ca. Sulphaloxate Candesartan cilexitil Cantharidin Captopril/HCTZ Carbamazepine prep Carbenoxolone Na. Carbimazole Coal tar Carboprost Carfecillin Carmustine Carbary} lotion Cefaclor prep. Cefixime prep Calcitonin Ca. Bromide Ca. Chloride inject Ca. Leucovorin inject CalmuridHC Candicidin Capsaicin Captopril Caverdilol Carbary} topical prep Carbidopa Carbocisteine Carbon Tetrachloride Carbromal Carindacillin Carperidine Carbary! Shampoo Cefadroxil prep. Cefalexin prep Ceftizoxime prep Cefoxtin Na prep Cefpirome prep. Cefuroxime prep. Cephalothin Na prep. Celecoxib Celiprolol HCI Cemevit Cetroelix Choral Betaine Chloramphenicol prep. Chlormadinone acetate Chloroform int. 5% Chlorotrianisene Chlorpropamide Chlorthalidone Cholestyramine Ciclacillin Cilazapril Cinchocaine Citalopram Cisplatin Clenbuterol Clioquinol Chorionic Gonadotrophin Ciclobendazole Cinchophen Ciprofibrate Clarithromycin prep Cephamandole nafate prep Cefodizime Na prep The Pharmacy Regulations, 2012 . Cefpodoxime proxetil prep Cephradine (Cefradine) prep Certopin Chenodeoxycholic acid Chlormerodin Chlorprothixene Clidinium Clobetasone prep Clomiohene (Clomifene) Clonazepam Clopamide Cloprostenol Cefprozil prep Cephaloridine prep Cerivastatin Chlorambucil Chlorothiazide Cholera vaccine Cimetidine prep Clavulanic acid Cyclothiazide Crotamiton prep Ciprofloxacin Ceftazidime CilzapriVHydrochlorothiazide Ca. Levofolinate inject Chloramphenicol prep Clotrimazole/Betamethasone prep Ciprofibrate Cistracurium Cefsulodin Na prep Clindamycin Cerium oxalate Chloral hydrate Chloroquine Chlorzoxazone Clobazam Clofazimine Clomipramine prep Clonidine prep Clopenthixol prep Clorazepic or its salts Ceftriaxone Na prep Cephazolin prep Cetirizine HCl Chlorhexadol Chlorphenoxamine Cicatrin prep Cinoxacin Clindamycin prep Cyproterone prep Colfosceril 72 2012, No. 45 Capecitabine Ceruletide diethylamine Chlordiazepoxide *Chlorpheniramine Ciprofloxacin prep. Clobetasol prep Clofibrate Clomocycline prep Clozapine Clopidogrel Cefotaxime prep Clotrimazole prep Ceprotin inject Chlorpromazine prep Chlormethiazole prep Chlortetracycline prep Cilastatin Cisapride Cyclosporin Cytarabine prep Codeine prep Codeine/paracetamol/caffine/hyoscine Clomethiazole Cyproheptadine Cladribine Cyclizine/Caffeine/Ergotamine Cyclopenthiazide/ Amiloride Cefdinir Cefazolin prep Clotrimazole prep Carbocisteine Ca. acetate Clopidogrel 2012, No. 45 73 The Pharmacy Regulations, 2012 Chrionic gonadotrophin Clemastine Conjugated Oestrogens/medroxyprogesterone Conjugated Oestrogens/medrogestrone Conjugated Oestrogens/norgestrel Clobetasone/Oxytetracycline Cidofovir Capecitabine Colestyramine Cloraze dipotassium Clostebol prep Cyclizine tartrate/Morphine tartrate prep Clobetasol propionate Clobetasone butyrate Carbary 10.5%topical lotion Cinnarzine Codeine/ Aspirin Colistin prep Cyclopenthiazide Cloxacillin prep Co-dergocrine mesylate Cyanocobalamin inj. Cocculus prep Colestipol HCI Cyclobarbitone D Dacarbazine Dalfopristin Danaparoid Na Dantron (danthron) Daunorudicin HCl inj Debrisoquine S0 4 Delorazepam Deoxycortone prep Deserpidine Desipramine HC I Clotiazepam Co-danthramer Croton oil Cycloserine Codeine/paracetamol Colfosceril palmitate Cyclofenil Codeine/PanadoVAspirin Corticotrophin Cyclopentolate Cloxazolam Colchicine Cyclizine Clorexolone Codeine/Ibuprofen Cortisone Cyclophosphamide Co-danthrusate Croton seed Cytarabine prep. Dactinomycin Daclizumab Dalteparin Na Dapsone Danazol Dantron/poloxamer Dantrolene Dapsone prep Desmopressin acetate Deanol prep Dexamethasone prep Deflazacort prep Demecarium Br Demeclocycline prep Deptropine citrate Dequalinium Cl Desferrioxamine mesylate inject Desflurane Deslanoside Desogestrel The Pharmacy Regulations, 2012 Desonide prep Desoximetasone/ Salicyclicacid Dexamethasone prep Dexfenfluramine HCl Dextromethorphan HBr Dextrose inject Diazoxide Dichlorphenarnide Dicyclomine HCl Diethanoiamine prep Diethylstilbestrol Dicyclomine Difenoxin prep Dip./tetanus vaccine Digitalis leat7prep Desoximetasone · Dexamfetamine SO 4 Dextran Dextromoramide Dextrothyroxine Na Dibenzepin HCl Diclofenac prep Disodium etidronate Diethylpropion prep Dipotassium clorazepate Dithranol prep Diflucortolone valerate Digibind Digoxin prep Dihydroergocristine/Bendrofluazide/Reserpine Dihydroergotamine Dihydrostreptomycin Disodium pamidronate Darbepoetin alfa Diloxanide Furoate Dimenh ydrinate Dimethisaquin HCI Dimethisterone Dimethyl Sulphoxide Diethylstilbestrol Diosmin-Hesperin Dinoprost prep Diphenoxylate prep Distigime bromide Diphenhydrarnine HCl Diphtheria vaccine DTP vaccine DTPP vaccine Desirudin Dipyridamole prep Distigmine Br Disulfiram Dobutamine HCl Docetaxel Domperidone prep Doxpexamine HCl Disodiurn Clodronate Doxazosin Dorzolamide/timolol Dorzolamide prep 74 2012, No. 45 Desloratidine Dithranol cream Dextropropoxyphene prep Diazepam prep Dichloralphenazone Dipipanone/cyclizine Dienoestrol Diethylthiambutene prep Disopyramide Dihydroergotamine prep Diflunisal Digitoxin Dihydralazine SO 4 Divalproex Na. or prep Diltiazem prep Donepezil Dimercaprol Dimethothiazine mesylate Dimethyltubocurarine prep Dinoprostone Didanosine D.T. Pertussis vaccine Dipivefrin HCl Dispyramide prep Dithranol prep Dolasetron mesilate Dopamine HCl Doxapram Dothiepin (Dosulepin) 2012, No. 45 75 The Pharmacy Regulations, 2012 Doxorubicin DoxepinHCl Droperidol prep Drotebanol Deferiprone Dexketoprofen Disodium clodronate Dornase Alfa Doxapram HCl Dronabinol Dydrogesterone prep Dihydrocodeine/Paracetamol Diphenoxylate prep DesogestreVethinylestradiol Dexamethasone/Neomycin/Polymyxin prep Duloxetine E Econazole prep Ecothiopate iodide Edrophonium Eflornithine Estradial prep Embutramide Emetine prep Enalapril Enoxacin Enoxaparin Na Ephedrine prep Epirubicin prep Epitiostanol Na Epoetin Alfa Epoprostenol Na Ethoheptazine Ergot prep Erythromycin prep Esmolol HCl Enoxaparin Estazolam Estramustine prep Ethambutal Ethamivan (Etamivan) Ethchlorvynol Ethinamate Ethinyloestradiol Ethionamide Ethopropazine Ethosuximide Ethylbiscoumacetate Ethyl loflazepate Ethylmethylthiambutene prep Ethynodiol ( etynodiol) diacetate Etodolac Etomidate prep Etonitazene prep Etorphine prep Etretinate Etryptamine Donepezil Doxycycline prep Drostanolone Dyflos Diclofenamide Diphenoxy late/ Atrpine Diphenhydramine Doxycycline Etacrynic prep Eformoterol fumarate Emepronium Enestebol Enoximone Epithiazide Epoetin Beta Ergometrine prep Erythropoietin prep Etafedrine Ethamsylate (Etamsylate) Ethinyl Androstenediol Ethoheptazine Ethotoin Ethyleostrenol Eticyclidine Etoposide Etoxeridine prep Entacapone The Phannacy Regulations, 2012 76 2012, No. 45 Exemestane Epoprostenol Na Estropipate Estriol Estrone Etonogestrel Eptifibatide Esomeprazole Electrolyte infusions Eletriptan Efavirenz Ergometrine/Oxytocin Eprosartan mesilate Ezetimibe Ergometrine F Factor VIIA, VIII, IX Famciclovir Famotidine prep Fazadinium Br Felbinac Felodipine Felypressin Fenbufen Fencamfamin Fenclofenac Fenethylline prep Fenfluramine HCl Fenofibate Fenoprofen Fenoterol Br Fenproporex prep Ferrous S0 4 /Folic acid Fenticonazole Feprazone Ferrous gluconate/Folic Ferrous arsenate Ferrous S0 4 Ferrous sucrose Ferric Ammonium Cl/Fol ic acid syrup Fexofenadine Filgrastim inject Finasteride Flavoxate HC 1 Flecainide acetate Flosequinan Fluanisone Flubendazole Fluclorolone acetonide Flucloxacillian prep Fluconazole prep Flucytosine Fludarabine Fludiazepam Fludrocortisone acetate Flufenamic acid Flumazenil Flumethasone prep Flumethasone/Neomycin Flumethasone/salicyclic Flumethasone/Clioquinol Flunisolide Flunitrazepam Fluocinolone prep Fluocortin Butyl Flucortolone prep Fluorescein prep Fluorometholone prep Fluorouracil prep Fluoxetine Fluoxymesterone Flupenthixol prep Fluperolone acetate Fluphenazine prep Fluprednidene acetate Fluprednisolone Fluprostenol Na Flurandrenolone Flurazepam Flurbiprofen prep Fluspirilene Flutamide Fluticasone Fluicasone prep Fluvastatin Fluvoxamine meleate Fluocinonide prep 2012, No. 45 77 Flucortolone/cinchocaine/Clemizole Follicle stimulating hormone Formoterol Formestane Formocortal The Pharmacy Regulations, 2012 Formebolone Fosinopril Framycetin Framycetin SO/Dexamethasone Fructose inject Fusidic acid or Na Fusidate prep Furazabol Fusidic/hydrocortisone Fulvestrant Furazolidone Furethidine Fusafungine Follitropin alfa Furosemide/Potassium Cl Furosemide/Spironolactone Furosemide/Amiloride HCJ Furosemide Fosinopril/HCTZ Fomivirsen Fosinopril G Gabapentin Gamma Globulin inject Gemcitabine Genotropin prep Gestrinone Gestonorone caproate Gliclazide Gliquidone Glucagons prep Glycerin trinitrate prep Glycopyrronium Br Goserelin acetate Grepafloxacin Guaiphenesin Guanoclor SO 4 Gestodene/ethinylestradiol H Halazepam Halofantrine HCl Hartman's solution Gadoteridol Ganciclovir Gemeprost Gentamicin prep Gestronol prep Glibenclamide Glipizide Glisoxepiede Gluthimide prep Glycerin trinitrate inject Glymidine Gramicidin Grisefulvin Guanethidine Guanoxan SO 4 Galantamine Halcinonide prep Halo thane Hydrocortisone prep Gallamine triethiodide Gamolenic acid Gemfibrozil Gestodene prep Gestronol hexanoate Glibomuride Glimepiride Glucagon inject Glycerol/Na inject Glycerin trinitrate spray Gonadorelin Granisetron HC 1 Growth Hormone Guanfacine HCI GyneT Haloperidol prep Haloxazolam Heparin prep The Pharmacy Regulations, 2012 Hepatitis A vaccine Hetastarch in NaCl infusion Hexamine pheny lcinchoninate Heamopbilus influenzea vac. Hydrobrornic Acid Hydrocyanic acid Heppatitis B vaccine . Hexachlorophane Hexoestrol prep Hydralazine prep Hydrochlorothiazide H ydrofl umethiazide Hydroxycbloroquine Hydroxyprogesterone prep Hydroxycobalamin inject Hyoscine prep Hydrocblorothiazide/Enalapril Heam arginate Human menopausal gonadotrophins Hydroxyapatite rnicrocrystalline I Ibuprofen prep Idoxuridine prep Imipramine prep Inactivated Influenza vac. lndinavir prep Insulin prep Intralipid infusion lodamide prep lopamidol loversol lpratropium/Salbutamol inh Imiglucerase Isoaminile citrate Isoconazole prep lsoetharine mesylate Isoniazid prep Isopropamide iodide lsosorbide dinitrate prep Idarubicin HC l Ignatius Bean Interferon gamma-I b Influezae vaccine Indomethacin prep. Imatinib mesylate Inositol nicotinate Iohexol Iopentol Ioxaglic Acid lprindole HCl Imiquimod Isoaminile Isoetharine HCL lsoetharine Isoprenaline HCl Isosorbide dinitrate inject. 78 2012, No. 45 Heptabarbitone Hexobarbi tone Homatropine Hydroxyurea Hydrocodone Heparin Hydroxyzine Hyoscyamine Hydroxyquinoline Hyoscine Ifosfamide Imipenem lnosine Pranobex Indapamide Indroramin HCl lrinotecan HCI Interferon alfa-2b Imeprol lothalamic Acid Ipratropium lrbesartan Irinotecan HCl Isocarboxazid Indapamide prep Isoflurane Isoprenaline SO 4 2012, No. 45 79 Isosorbide mononitrate Isotretinoin/erythromycin gel Isradipine Iodised oil Imipenem/ Cilastin Na. Isometheptene/Paracetamol Insulin syringes Imidazole K Kabiglobulin Kanamycin prep Ketoprofen prep Ketorolac trometamol L Labetalol HCl Lamivudine Lanatoside complex A, B, C Lansoprazole Lepirudin Leucovorin Levallorphan tartrate Levobunolol Levofloxacin prep Levonorgestrel prep Levophenacylmorphan prep Levo thyroxine Lignocaine prep Liothyronine Na Lisinopril/Hydrochlorothiazide Lithium Succinate The Pharmacy Regulations, 2012 Isotretinoin prep Itraconazole prep Intrauterine contraceptive devices Imidapril Ivabradine Kabikinase inj. Ketamine HCl Ketobemidone Ketotifen prep Lachesine Cl Lamotrigine Lanoconazole Latanoprost Lercanidipine Leuprorelin acetate prep Lidnocaine Levocabastine HCl prep Levomethorphan Levonorgestrel/ethinylestradiol Levorphanol prep L-Histidine HCI Lithium Citrate Lipofundin (soya oil) infusion Lithium Carbonate Lithium SO 4 Iron sorbitol Infliximab Imipenem Kabimix Ketazolam Ketoconazole Lacidipine Lanatoside C Lanreotide Lefetamine Letrozole Lamivudine Linezolid Levodopa Levomoramide Levamisole Lenograstim Lidoflazine Lincomycin prep Lisinopril prep Lithium Citrate Lobeline prep The Pharmacy Regulations, 2012 80 2012, No. 45 Lobeline SO 4 Lobeline HCl Loperamide Lofentanil prep Lopepramine prep Lopinavir Lodoxamide trometamol prep Loratidine Lopinavir Ritonavir Lofexidine HCl Lithium Succinate/Zinc SO 4 Lomefloxacin Lo mus tine Loprazolam Loratidine prep Lorazepam Lormetazepam Lomoxicam Losartan Losartan/Hydrochlorothiazide Loxapine HC 1 Loxapine succinate L-Tryptophan Levodopa/Benserazide Lung Surfactant Porcine Latanoprost!Timolol Levocetirizine Luteinising Hormone Lymecycline Lynoestrenol Lypressin Lopinavir Levetiracetam Lisuride Maleate Leflunomide Levocetirizine Lumefantrine Lumefantrine/ Artemether Lypressin M Mafenide acetate Mafenide HC 1 Mafenide Mafenide propionate Magnesium Fluoride Magnesium SO 4 inj Magnesium metrizoate Malathion external prep Mandragora Autumnailis Mannitol inject Mannomustine HCl Maprotiline Mazindol Measles vaccine Mebendazole Mebeverine prep Mebeverine pamoate Mebhydrolin prep Mebolazine Mecamylarnine HCI Mecillinam Meclofenoxate HCL Mecloqualone Meclozine HCl Mecysteine Medazepam Medroxyprogesterone Mefenamic acid Mefenorex prep Mefloquine HCI Mefruside Megestrol acetate Meloxicam Melphalan Menotrophin Meningococcal vaccine AandC Mepitiostane 2012, No. 45 81 The Pharmacy Regulations, 2012 Meningococcal vaccines Mepivacaine HCl Meprobamate Meptazinol prep Mequitazine Mercaptopurine Meropenem prep Mersalyl acid Mersalyl prep Mesabolone Mesalazine Mecysteine HCl Mesna prep Mesocarb Mesterolone Mestranol Metaraminol tartrate Metazocine prep Metalazone Metergoline Metformin prep Methacycline prep Methallenoestril Methicillin prep Methixene prep Methocarbamol Methocidin Methohexital Methohexitone Na Mephenytoin Methoserpidine Methotrexate Methotrimepra zine prep Methoxamine HCI Methsuximide Methyclothiazide Methyldopa Methyldopate HC 1 Methylephedrine Methylprednisolone prep Methyltestosterone Methyl thiouracil Methyprylone Methysergide meleate Metipranolol Metirosine Metoclopramide/Lysine aspirin Metoclopramide Metoclopramide/ Aspirin Metomidate HC I Methylphenidate Metyrapone Metoprolol prep Metribolone Metronidazole prep Mexiletine HCl Mezlocilin prep. Mianserin HCl Mibolerone Miconazole prep Midazolam Mercaptamine prep Meglumine prep Misoprostol Mifepristone Miglitol Milrinone Minocycline prep Minoxidil prep Mizolastine Mitobronitol Mitomycin prep Mitomycin C Mitozantrone HCl Mivacurium Cl M.M.R vaccine Moclobemide Modafinil Moexipril Molindone HCl Molgramostim Mometasone Monoethanolamine oleate Montelukast Moracizine HC 1 Morazone HC 1 Moxisylyte \1oxonidine Mucaine Memantine The Pharmacy Regulations, 2012 Multivatimin inject. Mumps vaccine Myotonine Cl Mycophenolate mofetil Mitoxantron Mupirocin prep Miratazapine 82 Menthol/Menthone/a and B pinene/borneol/camphene/eucalyptol Malathion 0.5% top lotion N Nabilone Nafarelin acetate Nalbuphine HC 1 Nandrolone Naratriptan N-Benzyl Sulphanilamide Nedocromil Na Nefopam Neomycin/chlorhexidine Neostigmine prep Nicergoline Nicownalone Nifenazone Nilutamide Niridazole Nitrofurantoin Nitroxoline Nomifensinc Meleate Norethisterone prep Norethisterone prep Nortriptyline Nalbuphine HCl Northisterone/ Ethinylestradiol Malathion 1 % topical cream shampoo Nabumetone Naftidrofuryl oxalate Nalidixic Acid Naphazoline prep Naloxone Nebivolol Nefazodone Neomycin prep Nevirapine Netilmicin prep Niceritrol Nicrondil Nitrazepam Nimetazepam Nisoldipine Nitrofurazone Nizatidine Noradrenaline prep Norethynodrel Norgestrel Noscapine prep NuxVomica 2012, No. 45 Metronidazole Mustine HCl Nadolol Naftifme HCl Naltrexone HCl Naproxen Natamycin Niacin Neflinavir Nitrous Oxide Nateglinide Nicardipine Nicotinic acid Nifedipine prep Nikethamide Nimodipine Nitrendipine Na. Nitroprusside Nordazepam Norfloxacin Nifuzide Novobiocin prep Nystatin prep 2012, No. 45 83 The Pharmacy Regulations, 2012 N eomycin!friamcinolone Neomycin/Hydrocortisone/polymyxin B Nefopam Normal Immunoglobulin Nilutamide Nitroxoline Nystatin!friamcinolone/Neomycin/Gramicidin N eomycin/Betamethasone N eomycin/H ydrocortisone/po lymyxinB/Cinchocaine 0 Octreotide Oestrone Olsalazine Orciprenaline Quniapril Ovarian Gland Dried Oxabolone Oxantel embonate Oxazepam Oxedrine tartrate Oxitropium Br Oxprenolol Oxymesterone Oxyphenbutazone Oxyphenonium Br Oxcarbazepine Oestradiol prep Ofloxacin prep Omeprazole Orpheradine prep Oxygen Oxamniquine Oxaprozin Oxazolam Oxethazaine Oxolinic acid Oxybuprocaine Oxymetholone Oxyphencyclimine Oxytetracycline prep Conjugated Oestrogens/medroxyprogesterone Oxytetracycline/ Polymyxin B Oxytetracycline/Hydrocortisone/Nystatin Oxytetracycline/Hydrocortisone/Polymyxin B Oxytetracycline/Hydrocortisone/Gentamycin Oxprenolol/Cyclopenthiazide p Paclitaxel Pamidronate Na. Oestriol Olanzapine Ondansetron Orlistat Oxandrolone Oxatomide· Oxaliplatin Oxpentifylline Oxybutynin Oxypretine Oxytocin prep Pancreatin The Pharmacy Regulations, 2012 84 2012, No. 45 Pancuronium Pantaprazole Pantothenic acid Papaverine ParacetamoVDL-methionine Paraldehyde ParacetamoVmetoclopramide Paramethadione ParacetamoVCodine Paramethasone acetate Propamidine isetionate eye drop Parathyroid Gland Pargyline Paromomycin Paroxetine Pemoline Penbutolol Penciclovir prep Penicillamine Pentamidine Pentastsrch Penthienate Pentobarbitone Pentolinium tartrate Pentostatin Pentoxifylline Parenteral Nutrition prep Pericyazine Perfluamine Pergolide mesylate Perhexiline maleate Perindopril prep Perindopril/lndapamide Perphenazine Pertussis vaccine Phenacetin Phenazone Phenbutrazate Phenelzine Phenethicillin K Phenformin Phenglutarimide Phenindamine taitrate Phenindione Phenobarbitone Phenolphthalein Phentermine Phenoxybenzarnine Phenoxymethy !penicillin prep Phenprocounion Phenylbutazone Phenylephrine Phenylmethyl barbituric Paroxetine Phenylpropanolamine Phenytoin *Paracetamol Phospholine iodide Porfimer Phthalyl sulphathiazole Physostigmine Phytomenadione Picrotoxin Pilocarpine Pimozide Pinazepam Pindolol Pipenzolate Piperacillin l>iperidolate Pioglitazone Piperazine oestrone Pipotiazine Piracetan Pirbuterol Pirenzepine Piretanide 2012, No. 45 85 Piribedil Piro xi cam Pituitary anterior lobe Pituitary Gland dried Pivmecillinam Pizotifen Plicamycin Permetbrin 5% topical cream Poldine methylsulphate Podophyllotoxin Polyestradiol phosphate Polygeline/electrolyte infusion Polymyxin B/trimethoprim Potassium arsenite Potassium Bromide Potassium clavulanate Potassium prechlorate Pralidoxime Prazepam Prednisone Prirnethamine/ Dapsone Proguanil/ Atovaquone Primethamine/ Sullfadoxine Polyoestradial phosphate Prenalterol HCI Prilocaine HCl Propantheline Bromid Procyclidine Procarbazine Proligestone romethazine roligestone romethazine/Paracetamol ropicillin potassium Pneumococcal vaccine Podophyllin paint comp. Poractant alfa Podophyllum Polymyxin B Polythiazide Poppy capsule Potassium Cl Potassium canrenoate Potassium clorazepate Practolol Prasteron Prazosin Prednisolone/Neomycin Primethamine Proguanil Preny !amine lactate Prirnidone Probenecid Procainamide HCI Prochlorperazine Prolintane HCl Prochlorperazine Prolintane HC I Propamidine Propofol The Pharmacy Regulations, 2012 Penicillin Pivampicillin Plague vaccine Polio vaccine Polyhexedrine Pramipexole Pravastatin Prednisolone Pretharnide Probucol Procaine HC 1 Prolactin Promazine Progesterone Propranolol Propanidide Penicillin The Pharmacy Regulations, 2012 86 Proquazone Pro ta mine Protirelin Protriptyline HCI Pyrantel Propylthiouracil Pyridostigmine Pyridoxine Pyrimethamine/Dapsone PotassiumHydroxyquinolineSO /Hydrocortisone Pramocaine Phentolamine Pinene a and B /Camphene/Bomeol/Anethole/Fenchone/Eucalyptol Pentoxify Hine Prednisolone/Cinchocaine Pizotifen Peginterferon alfa-2b *Paracetamol/Phenylpropanolamine/phenyltoloxamine Pindolol/Clopamide *Paracetamol/Pseudoephedrine *Paracetamol/Pseudoephedrine/Codeine Paracetamol/ Codeine/Caffeine Paracetamol / Codeine Paracetamol / Codeine/Doxylamine/Caffeine · Prostaglandin F2 alpha tromethamine Q Quetiapine fumarate Quinapril Quinethazone Quinine prep Quinupristin/Dalfopristin R Rabies vaccine Ramipril Razoxane Rasburicase Reproterol Reteplase Quinagolide Quinestradol Quingestanol Quetiapine Raloxitine Ranitidine Rabeprazole Ranitidine/Bismuth citrate Reboxetine Rescinnamine 2012, No. 45 Protionamide Pseudoephedrine Pyrazinamide Pyrimethamine Procaine Palivizurnab Proparacaine Primaquine Quinalbarbitone Quinestrol Quinidine prep Quinupristin Raltitrexed Rauwolfia prep · Raloxifene Remoxipride Repaglinide Reserpine 2012, No. 45 87 The Pharmacy Regulations, 2012 Rifabutin Rifampicin Rifampicin/Isoniazid/Pyrazinamide Ritonavir Rifampicin/Isoniazid Riluzole Ringer lactate inject Rituximab Rocuroniwn Ropinirole Rubella vaccine Ramipril/Felodipine Rofecoxib s Salbutamol prep Salmeterol xinafoate prep Salmeterol/Fluticasone Secbutobarbitone Sertindole Sevelamer Silver sulphadiazine Sulphadiazine prep. Sulphadimethoxine Sodium acetrizoate Sodiwn cromoglicate prep Sodiwn antimonylgluconate Sodiwn arsenate Sodiwn Chloride inject Sodium clodronate Sodiwn fusidate Sodium oxidronate *Sodiummonofluorophosphate Sodium aurothiomalate Risperdone Rivastigmine Rolicyclidine Ropi vacaine Rubella/Mumps/Measles vaccine Remifentanil HCl Rosuvastatin Salbutamol/Beclometasone Salsalate Saquinqvir Selegiline Sertraline Serum gonadotrophin Simvastatin Sulphadimidine prep Sisomicin prep Sodium aminosalicylate Sodium amytal Sodium arsanilate Sodium bromide Sodium Chloride/Dextrose inject. Sodium ethacrynate Sodium metrizoate Siatgliptin Sodium para-aminohippurate Sodium stibogluconate Ribavirin Ritodrine Rizatriptan Ro Ii tetracycline Roxithromycin Rosiglitazone Rimexolone Salcatonin Saralasin Schick test toxin Sermorelin Secobarbital Na Smallpox vaccine *Sodium arsenite Sodium fluoride Sodium valproate The Pharmacy Regulations, 2012 88 2012, No. 45 Sodium Ca. Edetate Sodium tetradecyl SO 4 Sodium hyaluronate Somatrem Somatropin Somatotropin Somatorelin acetate Sotalol Spectinomycin Spiramycin Spironolactone Squill Linctus/Opiate Stannous Fluoride Stanolone Stanozolol Sulfadiazine prep Stibocaptate Stibophen Stilboestrol Streptok:inase Streptodornase Streptomycin Strychnine Succinylsulphathiazole Sucralfate Sufentanil Sulfasalazine Sulbactam Na. Sulbenicillin prep Sulconazole prep Sulbutiamine Sulfabenzamide Sulfadicramide Sulfadoxine Sulfamerazine Sulfametopyrazine Sulfamonomethoxine Sulfapyrazole Sulindac Sulpiride Sulphabromomethazine Sulphacetamide prep Sulphachlorpyridazine Sulphadiazine prep Sulphadimethoxine Sulphadimidine Sulphafurazole prep Sulphaguanidine Sulphaloxic acid Sulphamethizole Sulphamethoxazole Sulphamethoxypyridine Sulphamethoxydiazine Sulphamoxole Sulphanilamide Sulphaphenazole Sulphapyridine prep Sulphathiazole prep Sulphaurea Sulphinpyrazone Stavudine Sulfamethoxazole/trimethoprim Sulamicillin prep Sultiame (sulthiame) Strontium-89 Cl Suprofen Sildenafil Sutoprofen Suxamethonium prep Sumatriptan Sulfacetamide/Phenylephrine Stavudine Sandostatin Sulfabenzamide/Sulfacetamide/Sulfathiazole cream Syringes Suxamethonium Streptokinase 2012, No. 45 89 The Pharmacy Regulations, 2012 Sodium Bicarbonate inj Silver Nitrate T Tacalcitol monohydrate Tacrine HCl Tacrolimus Talampicillin prep Tamoxifen Tamsulosin Tazarotene Tazobactam Na Tadalafil Tazobactam/Piperacillin Teclothiazide potassium Teicoplanin Temazepam Temocillin Na Tenoxicam Tensopril Terazosin *Terbinafine Terbutaline prep Terconazole Terfenadine Terlipressin Terodiline Testosterone Tenecteplase Telithromycin Tetanus vaccine Tetanus/Pertussis vaccine Tetrabenazine Tetracosactrin Tetracycline prep Tetrahydrocannabinol Tetrazepam Tetroxoprim Tetracosactide Thallium acetate Tetroxoprim/Sulfadiazine Thallous Chloride Theophylline Thiabendazole Thiethylperazine maleate Thioguanine Thiopropazate HCI Thiomesterone Thiopentone Na Thioproperazine mesylate Thioridazine Thiosinamine Thiosinamine/Ethyl iodide Thiostrepton Thiotepa Thiothixene Thiouracil Thymoxamine Thyroid Thyrotrophin Thyroxine Na Thyrotrophin releasing hormone Tiagabine Tiamulin Fumarate Tiaprofenic acid Tiabendazole Ticarcillin prep Tigloidine HCI Tibolone Ticlopidine HCI Telmisartan Tinidazole Tobamycin Tiludronate disodiurn Tiludronic acid Tilidate Ticarcillin/ potassium clavulanate Trifl uoperazine Timolol maleate Timolo 1/Bendrofl uazide Trastuzumab Timolol/Hydrochlorothiazide Tinzaparin Na Tinidazole Tioconazole Tizanidine Tobramycin obramycin/Dexamethasone Tocainide Tofenacin The Phannacy Regulations, 2012 90 2012, No. 45 Tolazamide Tolazoline Tolbutamide Tolfenamic acid Tolmetin Tolterodine tartrate Tolnaftate Tolnaftate/Nystatin Tolperisone Tolterodine tartrate Tolcapone Topiramate Topotecan Torasemide Toremifene Tramadol Trandolapril TrandolaprilNerapamil Tranexamic acid Tranylcypromine Travoprost Trazodone HCl Trenbolone Tresulfan Tretamine Tretinoin Triacetyloleandomycin Triamcinolone prep Triamterene prep Triazolam Tribavirin (Ribavirin) Triclofos Na Tricyclamol Trientine dihydrochloride Trifluoperazine Trifl uperidol Triiodothyronine Trilostane Trimeprazine Trimetaphan Trimetazidine Trimethoprim Trastuzumab Tropicamide Trifluoperazine Triamterene/ Hydrochlorothiazide Trospiurn Trimetrexate glucuronate Tegafur Trimipramine Trimustine Triprolidine Triptorelin Trisodium edentate Tropisetron Tuberculin Troxidone (Trimethadione) Tenofovir Tubocurarine Tulobuterol Tylosin prep Typhoid vaccine Typhoid/tetanus vaccine *Tyrothricin Tirofiban Timolol maleate/Dorzolamide Thiamphenicol Tilidate/Naloxone Trimeprazine Thiopentone. Tropicamide 2012, No. 45 u Urokinase Ursodeoxycholic acid Uridine 5 '-triphosphate Ursodeoxychoic acid V 91 Valganciclovir Valsartan/Hydrochlorothiazide Vasopressin prep Verapamil Virginiamycin prep Viloxazine HCl Vindesine VitA/Bl2/D/Choline Cl Liq w Warfarin X Xamoterol furnarate y Yellow fever vaccine z Zafirlukast Zidovudine prep Zipeprol Zolmitriptan Zoledronic acid Urofollitropin Uram us tine Valproic acid Valaciclovir Vecuronium bromide Veratrine Verteporfin Vinblastine Vinorelbine Vitamin injections Water for injection Xipamide Yohimbine HCl Zalcitabine Zopiclone Zotepine Zolpidem Zuclopenthixol The Pharmacy Regulations, 2012 Valsartan Vancomycin prep Venlafaxine Vidarabine Vigabatrin Vincristine Viomycin prep Vaccines Zanamivir Zimeldine HC 1 Zaleplon Zomepirac Na The Pharmacy Regulations, 2012 92 2012, No. 45 Key Aspirin : Acetylsalicylic acid Bis: Bismuth Cap: capsules Dip: Diphtheria Diphthera (D) Ext: extract Inj: injection Comp: compound Liq: liquid HCL: Hydrochloride HBr: Hydrobromide SO 4 : Sulphate Na: Sodium Cl: Chloride T: tetanus NB: Any derivative(s) of a list 2 drug or drug or new drugs which are not mentioned are considered prescription only drugs; unless otherwise classified by the Pharmacy Council (the Minister of Health). Section 4 Pharmacy Only Drugs. The basic principle of this is that the drugs may be sold or supplied by retail only from registered pharmacies, unless they are products included in the General Sales List of drugs. Unless they are not included in the General Sales List, they should not be sold, offered for sale by retail or supplied by any person in the course of a business carried on by him if ( a) that person is, in respect of that business, a person not lawfully conducting a retail pharmacy business; (b) the product is sold, offered or exposed for sale, or supplied on premises which is not a registered pharmacy; and (c) that person, or if the transaction is carried out on his behalf by another person, then that other person is, or not acting under the supervision of a pharmacist. A retail pharmacy business must be under the personal control of a pharmacist so far as it concerns 2012, No. 45 93 The Pharmacy Regulations, 2012 the sale of medicinal products including products on General Sales List. The products in this section include cosmetics which contain corticosteroids preparations in excess of0.5%. List 3 Pharmacy only: means that the sale of drugs in this list is restricted to pharmacies only. A Acetaminophen / Chlorpheniramine Img/ dextromethrophan HBr/ Pseudoephedrine cough and cold prep (if tabs 12 max) Aluminium OH/ Magnesium OH/ Simeticone oral gel Aluminium OH/ Magnesium carbonate/ Atropine sulfate/ Calcium cardonate/ Magnesium trisili cate/ Sodium bicarbonate/ Peppermint oil oral powder Albendazole 200mg single dose (tab or susp) Aspirin 81mg and 325 mg tabs 100 max Aspirin/ Caffeine tabs (Phensic) 50 tabs max Antazoline HCL ointrnentment Aconite/Bryonia drop Antimony ointmentrnent Apatite 6X comp. tabs (homoeopathic prep) Abrotanum;amica/peru balsam/rosemary oil/stibium metallicum cream Amica montana/ calendula/ Echinacea angustifolia/ Silica/ Stibium met. praep. dusting powder Aspirin 325mg I Paracetamol / Codeine phosphate 12/pack max. Aluminium OH Aluminium OH/ Magnesium OH/ Simeticone antacid prep Aluminium OH/ Magnesium OH/ Dimethicone antacid prep Azelastine HC 1 (porn) Ammonium carbonate l 53mg/ Potassium bicarbonate 267mg/ menthol 22mg/ Camphor 2.2mg cough mixture Arachis oil retention enema Arachis oil/ Almond oil/ rectified Comphar oil ear drops Activate Charcoal/ Magnesium hydroxide/ Peppermint oil tab Activate Charcoal The Pharmacy Regulations, 2012 Allantoin/Coal tar cream Amylmetacresol prep Amethocaine cream B Benzocaine and Mepyramine maleate topical spray and cream Balsamicum ointment Benzocaine mouth gel 15g max. Benzocaine/ Triclosan topical prep Benzocaine/ Hexachlorophene topical prep Benzocaine/ Chloroxylenol topical gel Benzocaine/Phenol gel Benzocaine/Phenol/ Camphor/ Menthol liquid Benzocaine/Phenol/ Camphor/ Menthol/ Povidine-iodine liquid Benzocaine/ Cetylpyridinium Cl lozenges Benzocaine/ Phenazone/ Glycerol ear drops Benzocaine/ Phenazone ear drops Benzoic acid / Salicyclic acid topical cream 94 Benzoic acid/ Malic acid/ Salicylic acid/ Propylene glycol topical cream and solution Bandages surgical 2012, No. 45 Brompheniramine maleate 2mg/ Dextromethophan HBr/ Pseudoephedrine allergy and cough prep (if tabs 12/pack) Brompheniramine maleate 2mg/ Guaifenesin/ Pseudoephedrine expectorant Brompheniramine maleate 2mg/ Codeine/ Pseudoephedrine night time cold and cough prep (if tab 12/pack) Benzyl peroxide 5% and 10% topical prep Bismuth salicylate antacid preps Bismuth aluminate 6mg Bismuth subgallate/ Bismuth oxide/ Bismuth oxyiodide/ Resorcinol/ Peru balsam/ Benzyl benzoate/ Zinc oxide/ Hydrocortisone acetate rectal ointmentment and suppositories Bacitracin zinc/ polymyxin B sulfate topical ointmentment and cream 30g 2012, No. 45 95 The Pharmacy Regulations, 2012 Bacitracin zinc/ polymyxin B sulfate/ Pramocaine HCl topical ointment and cream 30g Bisacodyl tabs 12 max BNTpowder BNT cream and ointment Boric acid/ Isopropyl alcohol ear drops Benzydramine HCl topical cream and spray Benzydramine oral rinse Benzydramine throat and mouth spray Benzydramine HCl/ Cetylpyridinium mouth and throat prep Benzydramine HCl / Cetylpyridiniurn/ Pholcodine cough lozenges Benzalkonium Cl/ Aldioxa/ Chlorobutanol/ Cetrimide cream Benzyl alcohol topical Benzyl alcohol pastilles, lozenges throat tab Betacarotene Boric acid powder or sodium borate i Benzyl benzoate lotion Benzocaine/ Salicylamide gel C Choline salicylate ear drop Calcium lactate 300mg 100 tabs Calcium gluconate/ Calcium lactate/ Calcium carbonate tabs Calcium gluconate 600mg 100 tabs Calcium carbonate 1.25g 100 tabs Calcium glubionate l .09g/ Calcium lactobionate 727mg syrup Calcium glubionate l.09g/ Ascorbic acid 10-20 tabs max Calcium/ Vitamin D tab 30 tabs max Calcium gluconate/ Calcium carbonate tab 30 tabs max Calcium resonium *Catarrh cream Choleodoron drops Citrus limonum; cydonia ointmentment The Phannacy Regulations, 2012 Calendula/Merc. Sulphur; peppermint oil/eucalyptus oil drops Cowslip /hyoscyamus drops Chlorocresol vaporizing fluid Cyclizine HCL or lactate 50 mg tabs (max. without prep 10) Cyclizine HCL or lactate 25 mg/ 5ml elixir Chlorhexidine gluconate solution Cirnetidine 100mg tab 12/pack Coal tar/ Zinc oxide bandage Clemastine fumarate elixir 0.5mg/5ml 150ml max. Clemastine fumarate 1mg tab 12 tab max Cetrimide/ Chlorhexidine gluconate topical solution Cetylpridinium Cl/ Menthol pastilles Coal tar shampoo Coal tar/ Salicylic acid shampoo Chlorpheniramine 4mg tabs 12 tabs max Chlorpheniramine 2mg/ Pseudoephedrine cold and allergy prep Chlorphenirarnine 2mg/ Ammonium Cl/ Sodium citrate expectorant 96 2012, No. 45 Chlotpheniramine 2mg/ Ammonium C 1/ Sodium citrate/Ephedrine cough and cold prep Chlorpheniramine 2mg/ Dextromethophan/ Sodium citrate Chlorpheniramine 2mg/5ml elixir Clotrimazole l % topical cream 15 g Clotrimazole 1 % topical powder 15 g Clotrimazole 1 % topical solution Capsicum oleoresin topical prep Clotrimazole 1 % Hydrocortisone 1 % topical cream and ointment 15g Calcium alginate wound dressing Calcium alginate/ Sodium alginate would dressing Codeine phosphate/ Kaolin antidiarrhoea susp Codeine phosphate 5mg/5ml syrup or linctus 100ml max Cadexomer-iodine dressing and ointment Creosote/ Codeine phosphate cough syrup 2012, No. 45 97 Choline salicylate/ Glycerol ear drops Cetrimide/Undecenoic acid/ Phenethyl alcohol topical prep Cetalkonium Cl prep Cetirizine HCl 10mg lOtabs max Chlorbutol toothache gel Chlorohexidine topical Chlorohexidine HCl pastilles, lozenges, tablets Chlorohexidine mouth wash and spray Chloroxylenol Cinnamic acid lozenges, pastilles, throat tablet Carbenoxolone sodium gel D Diethylamine salicylate/ Myrtecaine topical cream Dithranol/ Salicyclic acid/ Coal tar topical ointment. Dithranol/ Salicyclic acid/ Methyl salicylate topical gel Docusate sodium ear drops Docusate sodium 12 tabs max The Pharmacy Regulations, 2012 Digestodoron drops and tab ( male fem, polypodium leaf, scolopendrium vulgare, salix leaf) Dulcamara flowers / lysimachia nummularia drops Dulcamara flowers/ lysimachia nummularia ointmentment ! Dextromethophan HBr/ doxylamine succinate/ Pseudoephedrine HCl/ Paracetamol cough and cold Dextromethophan HBr cough syrup Dextromethophan HBr/ Honey cough syrup Dextromethophan HBr/ Pseudoephedrine HCl cough and nasal congestion (if tabs 12/pack) Dextromethophan HBr / Guaifenesin cough and cold (if tabs 12/pack) Diphenhydramine HCl / Pseudoephedrine HCI cold prep (if tabs 12/pack) Diphenhydramine HC I 25 mg tabs or caps 12 max Diphenhydramine syrup 10mg/5ml Diphenhydramine HCl/ Menthol nasal congestion prep Diphenhydramine HC!/ Codeine/ Ephedrine HCl IOmg/Ammonium Cl/ Sodium Citrate Cough and Cold Preparation The Pharmacy Regulations, 2012 98 2012, No. 45 Diphenhydramine HCI/ Ephedrine HCl 7.5mg/ Guaiphenesin/ Sodium citrate/ Menthol cough and · cold prep Diphenhydramine HCl/ Codeine/ Ephedrine HCl 5mg/ Sodium citrate cough and cold prep Dimenhydrinate 50mg tabs 12 max Dimenhydrinate syrup 15mg/5ml 100ml max Diphenhydramine HCl / Ammonium CV Sodium citrate/ Menthol cough and cold prep Dichlorobenzyl alcohol/ Amylmetacresol lozenges Dichlorobenzyl alcohol/ Amylmetacresol extra lozenges Dichlorobenzyl alcohol/ Amylmetacresol/ Ascrobic acid/ Sodium ascrobate lozenge Dichlorobenzyl alcohol/ Amylmetacresol/ menthol or Eucalyptus lozenge Dichlorobenzyl alcohol/ Amylmetacresol/ Lignocaine lozenge Dicofenac 1 % topical gel /ointment. Dilute acetic acid (Meltus baby cough) Diphenhydramine / Sodium citrate (Meltus) junior cold and cough syrup Dequalinium Cl pastilles Diphenoxylate HC 12.5mg/ Atropine sulfate tabs not more than 12 tabs Dextranomer topical prep Dehydrocholic acid Dequacaine lozenges Diphenhydramine HCl/ Zinc oxide/ Camphor topical prep Diphenhydramine HCl / Camphor topical prep Diphenhydramine HCl/ Calamine topical prep Domiphen lozenges Domiphen/ peppermint oil/ Eucalyptus oil/ Anise oil lozenges Dextromethorphan HCl/ Ascorbic acid/ Citric acid/ Na citrate cough linctus E Eucalyptus comp Eucalyptus cough drops Eucalyptus oil Erysidoron (homoeopathic preps) Enbucrilate tissue adhesive 2012, No. 45 99 The Pharmacy Regulations, 2012 Esculoside/ Berberis fruit/ Prunus spinosa fruit/ Bryonia alba/ Camphor/ Echinacea/ Mercurius sulphar/ Eucalyptus oiV Peppermint oiV Thyme oil cream Emulsifying ointment F Felbinac topical gel Ferrous sulfate 200-3 00mg tabs 30 max Ferrous sulfate / Folic (lfa) 30 tabs Ferrous sulfate / Folic/ Vit B complex Ferrous sulfate/ Folic syrup (lfa) 125mVbottle max Ferrous sulfate/ ascorbic acid tabs 30max Ferrous fumarate tabs 30 max G Guaifenesin cough expectorant Guaifenesin / Cetylpridinium Cl expectorant Guaifenesin/ Honey/ GlyceroV Terpeneless lemon cough syrup Glutaral wart topical prep Glycerin supp adult and children H Hydrotalcite susp Hydrotalcite/ Simeticone susp Hydrocortisone 0.5% Topical cream and ointment Hamamelis (Optrex) eye drops Hamamelis/ Naphazoline HCl eye clear Hamamelis / Menthol sore throat Hypromellose eye drops rbuprofen topical spray [buprofen topical pain cream and gel [buprofen 200mg/ Pseudoephedrine cold prep, (if tabs 12 max) buprofen 100mg/5ml susp. 100ml bottle The Pharmacy Regulations, 2012 Ibuprofen 200mg/5ml susp. 100ml bottle Ibuprofen 200mg tab 24/pack Ibuprofen/ Menthol topical gel Ibuprofen 200mg/ Codeine 8-10mg tabs 12/pack Isopropyl alcohol/ Chlorhexidine acetate or gluconate topical prep Isopropyl alcohol topical rub Isopropyl alcohol/ Wintergreen rub Isopropyl myristate/ light liquid Paraffin topical prep Ispaghula/ Senna laxative prep lchthammol/ Zinc oxide medicated bandage K Ketoprofen topical gel 30g max Kaolin/ Pectin susp. 100-150ml L Lignocaine HCl (Lidocaine) 4% topical Lignocaine antiseptic gel Lignocaine gel Lignocaine ointment Lignocaine spray Lactulose Lidocaine HCl/ Aminoacridine HCl pastilles Lidocaine/ Alcloxa/ Chlorobutanol/ Cetrimide topical prep Liquid paraffin prep Liquid paraffin/ Lanolin oil bath oil Loratidine 10mg not more than 6 tabs Loratidine 5mg/5ml syrup Loperamide HCl 2mg tabs not more than 6 tabs 100 Lactocresote/ Calcium lactophosphate/ Ephedrine HCl bronchial catarrh M Miconazole 2% topical cream and ointment 2012, No. 45 2012, No. 45 101 Miconazole 2%/ Hydrocortisone 1 % topical ointment and cream Miconazole 2% topical powder Mebendazole 100mg not more than 800mg Mandragora comp drops (homoeopathic preps) The Pharmacy Regulations, 2012 Menthol/ Camphor/ Eucalyptus oil/ Nutmeg oil/ Cedar leaf oil/ Turpentine oil/ Thymolvaporub Meclozine HCl 12.5mg tab 12/pack Medicated dressings Mepyramine maleate topical cream Magnesium OW Liquid paraffin laxative Macrogol 3350/ Electrolytes laxative Monobasic sodium phosphate/ dibasic sodium phosphate enema Magnesium citrate laxative Magnesium alginate/ Aluminium OH-magnesium carbonate co-dried gel, tabs, susp. N Nystatin topical cream and ointment 15g tube 0 Onopordon comp A Onopordon comp B Oxyphenisatine enema Oxymetazoline HCl nasal spray and drops Oxymetazoline HCl/ Menthol/ Camphor/ Eucalyptol nasal congestion prep p Pramocaine HCl/ Zinc acetate topical Prarnocaine HCl/ Zinc sulfate anorectal prep Phenothrin 0.5% topical liquid :>henothrin 0.2% shampoo :>otassium permanganate crystal (limit sale to one container of 20g) :>otassium Cl SR 600mg 15 tabs max >romethazine HCL 10mg tabs 12/pack The Phannacy Regulations, 2012 Promethazine teoclate tab 12/pack Promethazine 3.6 mg/ Codeine cough prep Pertudoron 2 drops (homoeopathic pre) 102 Paracetamol / Dextromethorphan/ Phenylpropanolamine cold prep (if tab 12/pack) Paracetamol/ Codeine phosphate/ Caffeine tab 12/pack Paracetamol / Codeine phosphate tab 12/pack Paracetamol / Codeine phosphate / Doxylamine succinate/ Caffeine tab 12/pack Paracetamol syrupl25mg/5ml 100ml/bottle Paracetamol 250mg/5ml lO0ml/bottle Paracetamol 100 tab max. Paracetamol / Phenylpropanolamine tab 12/pack 2012, No. 45 Pseudoephedrine / Chlorphenamine maleate 2mg/ Pholcodine 2-5mg cough and cold linctus Pholcodine 5mg/5ml cough linctus 100ml bottle max Paracetamol/ Pseudoephedrine tab 12/pack Paracetamol /Pholcodine/ Pseudoephedrine cough and cold syrup Paracetamol / Pseudoephedrine / Chlorpheniramine 2mg tab 12/pack Paracetamol/ Phenylpropanolamine / Phenyltoloxamine citrate tab 12/pack Paracetamol/ Pseudoephedrine / Chlorpheniramine 2mg/ Codeine tab 12/pack Paracetamol/ Dextromethorphan / Pseudoephedrine / Guaifenesin cold prep (if tab 12/pack) Pseudoephedrine / Guaifenesin non-drying sinus tab 12/pack/ Expectorant Pseudoephedrine (Sudafed prep adult and children decongestant) Pseudoephedrine / Chlorpheniramine 2mg (Sudafed cold and allergy) Pseudoephedrine / Chlorpheniramine 2mg/ Dextromethorphan cough and cold prep (if tab 12/pack) Paracetamol/ Dextromethorphan / Pseudoephedrine / Guaifenesin cold prep (if tab 12/pack) Paracetamol/ Dextromethorphan / Pseudoephedrine cold prep (if tab 12/pack) Pseudoephedrine /Dextromethorphan cold and decongestant prep (if tab 12/pack) Paracetamol/ Triprolidine HCl/ Pseudoephedrine sinus pain and allergy prep (if tab 12/pack) Paracetamol/ Phenylephrine / Caffeine cold and flu prep (if tab 12/pack) Paracetamol / Dextromethorphan / Pseudoephedrine / Mepyramine maleate 50mg cold prep (if tab 12/pack) 103 Paracetamol/ Caffeine/ Codeine/ Hyoscine tabs 12/pack max. henylephrine HC 1/ Naphazoline nitrate nasal drop and spray olyvinyl alcohol (natural tears) olyvinyl alcohol/ Povidine eye drops assion flower/ Crataegus/ Valerian tab 12 max romethazine HCl elixir 5mg/ml lOOml/bottle romethazine HCl 5mg/ Codeine cough and cold syrup The Pharmacy Regulations, 2012 romethazine HCl 5mg/ Sulfogaiacol or Guaifcnesin / Ipecacuanha expectorant romethazine HCl 5mg/ Phenylephrine HCI / Codeine cold cough and decongestant (if tab 12/pack) iroxicam topical gel aradichlorobenzene/ Chlorobutanol/ Orthodichlorobenzene/ Arachis oil ear drop ovidine-iodine topical prep ovidine-iodine mouthwash and gargle henolphthalein/ liquid Paraffin laxative henolphthalein/ Aloin laxative anitidine 75mg tab 12/pack esorcinol/ precipitated Sulfur topical cream Sterculia/ Alverine citrate granules Salbutamol expectorant 150ml max Salbutamol inhaler Imax Salicylic acid topical prep Salicylic acid/ Sulfur topical prep Salicylic acid/ lactic acid topical prep Shepherd's purse/ majorana; achillea/ oak/ urtica drops Seleiurn sulfide topical prep \scopolamine patches !Omax Sodium picosulfate/ Magnesium citrate or carbonate powder I Sodium picosulfate laxative The Pharmacy Regulations, 2012 Sodium docusate 12tabs max Simple syrup Surgical spirits Sodium citrate/ Sodium lauryl sulfoacetate/ Glycerol enema Sodium pidolate cream Senna tab Sodium citrate/ Sodium lauryl sulfoacetate/ Sorbitol laxative Sodium perborate mouth prep T Tolnaftate powder (athletes foot powder and cream) Tannie Acid pastilles, lozenges throat tab. Tears natural Terbinafine topical max 30g container Terbinafine HCL topical ms 1.0% container size 15g Tolazoline HCl topical prep Turpentine oil Tyrothricin lozenges and pastilles Triclosan topical Triprolidine HCl/ Codeine/ Pseudoephedrine cough and cold 104 Triprolidine HC l.25mgl/ Dextromethorphan cough and cold prep (if tab 12/pack) 2012, No. 45 Triprolidine HC l.25mgl/ Pseudoephedrine / Dextromethorphan cough and cold prep (if tab 12/ pack) Triprolidine HC l .25mgl/ Pseudoephedrine / Paracetamol cough and cold prep (if tab 12/pack) u Urea hydrogen peroxide ear drops Urtica/Fragaria drop Urea/ Lactic acid topical cream V Vantage pastilles Vantage night time sleep aid tab 12/pack VitaminA7500 iu 2012, No. 45 105 Vitamin A palmitate topical Vitamin A acetate topical Vitamin D 400 iu Vitamin E topical cream Vitamin E 400 iu w Weleda cough drops compound X Xylometazoline HCl nasal drops Xylometazoline HCI spray . The Pharmacy Regulations, 2012 Xylometazoline HCl/ Menthol/ Eucalyptol decongestant, rhinitis, sinusitis prep y Yohimbine prep z Zinc oxide/ Benzyl benzoate/Benzyl cinnamate/ Benzyl alcohol topical ointment. Zinc oxide Zinc ointmentment and cream Zinc sulphate with 50 mg elemental zinc max 30tab or cap/pack Zinc sulfate/ Hyrocortisone acetate anorectal prep NB: Topical excludes Internal vaginal preparations Paracetamol = Acetaminophen Max Paracetamol allowed in combination prep 650mg \fax Pseudoephedrine allowed in combination prep 60mg \fax Guaifenesin allowed in combination prep 200mg )extromethophan HBr 30mg allowed in combination prep >seudoephedrine 60mg allowed in combination prep ::odeine 15 mg allowed in combination prep >henylpropanolamine 30mg )iphenhydramine HC 1 25 mg The Pharmacy Regulations, 2012 106 2012, No. 45 Pheny lephrine 15 mg Section 5 General Sales List. General Sales Medicines are those which in the opinion of the appropriate Minister can with reason able safety be sold or supplied otherwise than by or under the supervision of a pharmacist. The products on the General Sales List may only be sold by retail, offered or exposed for sale by retail, or supplied in circwnstances corresponding to retail sale either at registered pharmacies or in circumstances where the following conditions are List4 (a) the place at which the product is sold, offered, exposed or supplied, must be premises at which the person carrying on the business is the occupier; (b) the product must have been made up for sale in a container at some place other than at the place at which it is sold, offered, exposed for sale or supplied, and the container must not have been opened after the product was made up for sale in it; (c) the product shall be stored in a separate area of the business away from food and food containers or other non drug products; and (d) the product shall be stored for sale or retail in the original containers labeled with the information in respect of the drug (i) the name of the drug; (ii) adequate directions for use; (iii) words of caution, side effects where necessary; (iv) storage condition; and ( v) keep out of the reach of children. General Sale List (GSL): The drugs listed as GSL (a) are exempt from the provisions of sections 13 and 18 of the Pharmacy Act in that they need not be stored for sale or retailed in a registered pharmacy and by a registered phar macist or by a registered pharmaceutical student or intern under the supervision of a registered pharmacist; (b) shall be stored for sale in a separate area of the business away from food and food containers or other non drug products; and 2012, No. 45 107 The Pharmacy Regulations, 2012 (c) shall be stored for sale or retailed in the original containers labeled with the information in respect of the drug A (i) the name of the drug; (ii) adequate directions for use; (iii) words of caution, side effects, where necessary; (iv) storage condition; and (v) keep out of the reach of children; and (d) any other preparations as may be approved by the Council from time to time. Adhesive plasters plain or medicated Almond oil Allantoin/ coal tar/ Shampoo 2 in 1 Alexitol sodium suspension and tablets Aluminium hydroxide/ Magnesium carbonate/ Magnesium hydroxide suspension and tabs Aluminium hydroxide/ Magnesium hydroxide suspension Aluminium hydroxide-Magnesium carbonate co-dried gel/ Magnesium hydroxide tab Aluminium hydroxide/ Magnesium hydroxide/ Simeticone antacid suspension or tab Aluminium hydroxide or Algeldrate/ Magnesium hydroxide antacid prep. Aluminium hydroxide/ Magnesium hydroxide gel/ suspension Almasilate antacid suspension or tablets Amylmetacresol external prep 0.5% Amylmetacresol mouthwash 0.001 % Alcohol (isopropyl) rubbing Alcohol (isopropyl)/methl salicylate rubbing Alcohol wipes Ammonia smelling salt 15% Aspirin 81mg tablets 50 tablets/pack max Aspirin 325mg tablets 50 tablets/pack max Aspirin/ Caffeine (phensic) Althaea/ Echinacea/ Sambucus tablet Anise oil The Pharmacy Regulations, 2012 Aniseed oil Arachis oil Arrowroot Ascorbic acid Aqueous cream (see net) 108 2012, No. 45 Alginic acid or Sodium alginate/ Aluminium hydroxide/ Magnisiurn trisilicate/ Sodium bicarbonate antacid preparations Aloes Bitters Aspirin 500mg/ Citric acid/ Sodium bicarbonate effervescent tablet Aspirin 500mg/ Caffeine 65mg morning relief effervescent tablets Aspirin .... mg/ Paracetamol... mg/ Caffeine ... mg/ Citric acid/ Sodium bicarbonate tabs Alhers chesty cough (see net) Alhers dry tickly cough Allier pine/honey balsam B Balsm of Gilead/ Squill/ Lobelia pastilles Benzocaine/Resorcinol vaginal cream Biotin Bisacodyl 10mg Ms tablets 12/pack max. Bismuth aluminate Bismuth carbonate Bismuth citrate Bismuth salicylate oral liquid Bismuth salicylate/ Carbonate tablets Betadine lotion (Povidone iodine) Betadine scalp and skin cleaner Betadine shampoo Benzalkonium chloride/ Hexylresorcinol lozenges Benzoin tincture compound 0.8% (Ms) pastilles Borax or Na. borate/ 0. 7% ophthalmic lotions 2012, No. 45 109 Boric acid 2.5% ophthalmic lotions Bran C The Pharmacy Regulations, 2012 Cajuput oil/ Camphor/ Cinnamon oil/ Menthol/ Peppermint oil balm Cajuput oil/ Camphor/ Clove oil/ Menthol/ Peppermint oil balm Calcium carbonate tablet Calcium carbonate/ Magnesium antacid Calamine Lotion and cream Caladryl Lotion and cream Calcium carbonate/ Magnesium carbonate tablets and suspensions Calcium carbonate/ Magnesium carbonate antacid tablet Camphor/Menthol/Zinc oxide/ precipitate Sulfur foot balm Capsicum/ Peppermint/ Anise oil/ Clove oil cough mixture Cetrimide mouthwash antiseptic Calcium carbonate/ Light Magnesium carbonate/ Na. bicarbonate antacid tablet Choline salicylate/ Cetalkonium Cl/ oral gel Charcoal tablets Cod liver oil capsules Cod liver multivitamin capsules Calcium carbonate antacid tablet Caraway oil Castor oil Cassia oil Cellulose Cetomacrogol topical prep. Cetrimide/ Chlorhexidine gluconate cream Chlorhexidine 5mg (Ms) lozenges Cinnamon oil Citric acid Ciclopirox olamine shampoo The Pharmacy Regulations, 2012 Clove oil Celery oil Creosote 0.5% topical prep Chloroxylenol ( dettol) Chlorhexidine gluconate/ Amethocaine HCl mouthwash Citric acid/ Na. bicarbonate/ Anhydrous Na. carbonate antacid powder Coal tar lotion Citric acid/ lpecacuanha chesty cough for children 110 2012, No. 45 Comp. Benzoin tincture/ Peppermint oil/ Ipecacuanha/ Menthol chesty cough pastilles Calcium carbonate tablet Calcium carbonate/ Magnesium antacid Chloroxylenol/ Triclosan/ Halogenated phenols; phenol/ Na salicylate cream Cetylpyridinium CV Benzion Tine./ Ipecacuanha Tine./ Capsicum tine, cold and cold mix. D Dandelion Dilute Ammonia solution 5% topical (after bite) Diphenhydramine HCl/ Ammonium Cl / Menthol/ Sodium citrate cough and cold liquid Dica suspension Diphenhydramine cream 0.5% Dimethyl ether/ Dimethoxymethane topical freeze spray Dilute citric acid peadiatric cough Domiphen Br/ Peppermint oil/ Eucalyptus oil/ Anise oil Lozenges Dibrompropamidine isethionate cream Dewitts antacid powder (see net) Dewitts antacid pill Dextrose tablet and oral liquid Pichlorobenzyl alcohol pastilles and lozenges Dimethicone cream Docusate Na tablets 10/pack max 2012, No. 45 111 The Pharmacy Regulations, 2012 Docosahexaenoic acid/ Arachidonic acid/ Gamolenic acid capsule Dichlorobenzyl alcohol/ Arnylmetacresol lozenges Docusate sodium ear wax removal drops E Evening primrose oil capsules Evening primrose oil Echinacea/ Garlic tablet or capsule Emollient cream (E45) Echinacea tablet Echinacea/ Garlic tablet and capsules F emfresh powder (see net) uller's earth riars balsam amolenic acid ( ... . mg) capsule arlic capsule or tablet entian Violet inger tablet inseng capsule and tablet lucose oral liquid lycerine liquid lycerine supp adult and children olden seal capsule and tablet lykola tonic (see net) lycol salicylate/ Diethylamine salicylate/ Capsicum oleoresin/ Methyl nicotinate cream and ointmentment uaifenesin cough expectorant for adult uaifenesin/ Honey/ Glycerol/ Terpeneless lemon oil cough syrup uaifenesin/ Cetylpyridinium Cl/ Sodium citrate cough syrup for chesty cough The Phannacy Regulations, 2012 112 2012, No. 45 Hamamelis/ Eucalyptus{ Methyl salicylate/ Camphor/ Melaleuca oil/ Zinc oxide cream Hamamelis eye lotion ( optrex) Hamamelis/ Naphazoline HCl clear eyes Heparinoid 1 % cream or ointmentment max pack 20g Hydrocortisone cream and ointmentment 0.5% Hydroquinone prep 0.5% Heavy Magnesium carbonate/ Light Magnesium carbonate/ Na bicarbonate antacid powder Hexetidine mouthwash Hexylresorcinol lozenges Hexylresorcinol extra lozenges Honey and Molasses cough mixture Honey purified Honey and Lemon cough lozenges Honey/Citric acid/ Menthol dry cough syrup Horesradish Horesradish and Garlic tablet or capsules Hydrogen Peroxide 3% w/v I Ibuprofen I 00mg/5ml suspension 100 ml/bottle max Ibuprofen 200mg tablets 24 tablets/pack max Ipecacuanha/ Glucose/ Menthol cough syrup Isopropyl myristate/ Liquid paraffin/ Na. pidolate/ Na. lactate cream Irish moss Iodine tincture Ipecacuanha Liquid extract/ Squill vinger cough prep Isinglass K Kelp tablet L Lidocaine HCI / Aminoacridine HCl pastilles 2012, No. 45 Lime oil Linseed 113 Light liquid paraffin bath formula Light liquid paraffin/white soft paraffin cream Light liquid paraffin/ Acetylated wool alcohol emollient Light liquid paraffin or liquid paraffin gel Light liquid paraffin/ Isopropyl myristate emollient Lemon oil Liquid paraffin M Malt extract Magnesiun sulphate crystal (epsom salt) Magnesium hydroxide (milk of magnesia) liquid and tablet Marrubiurn/ Achillea/ Elecampane (catarrh-eeze) tablet Menthol crystal and rub Methyl nicotinate/Glycol salicylate/ Mephenesin topical prep. Methyl salicylate/ Menthol rub, liniment and spray Methyl salicylate/ Ethyl nicotinate/ Camphor topical heat spray The Pharmacy Regulations, 2012 MenthoV Camphor/ Eucalyptus oil/ nutmeg oil/ Cedar leaf oil/ Turpentine oiV Thymol vaporub MenthoV Pentane (deep freeze) topical prep. Menthol crystal Menthol/ Eucalyptus inhalation Menthol cough expectorant MenthoV Camphor/ Methyl salicylate nasal inhalor MenthoV Camphor/ Methyl salicylate/ Pumilo pine oil inhaler MenthoV Thymol/ Eucalyptus oil/ Camphor/ Tolu balsam cough syrup drops MenthoV Eucalyptus oil vapodrops Mentholatum vapour rub (see net) Mentholatum massage liniment Mentholatum deep heat spray Menthyl salicylate liniment or ointmentment The Phannacy Regulations, 2012 Methylcellulose tablets Menthol Eucalyptus oil lozenges or pastilles Menthol/ Anise oil Lozenges Mercurochrome topical Multivitamin Liquid and tablets N Nutmeg oil 0 Oxymetazoline HCL nasal prep Octinoxate/ Octisalate/ Titanium dioxide/ Zinc oxide cream Oxymetazoline 0.05% nasal drops or spray Oral rehydration salt sachets Oral rehydration Liquid p Paracetamol 125mg/5ml syrup or suspension l00mVbottle max Paracetmaol 500mg tablets 30 tablets/pack max 114 Paracetamol 500mg/Na. citrate/ Ascorbic acid capsules and tablets 30/pack max Pilewort compound Pimento oil Pentoxyverine citrate/ Menthol cough syrup Povidone iodine antiseptic paint Padimate 0 / Oxybenzone/ Dimethicone Lip Balm Padimate 0 / Vitamin E/ Aloe Vera Chop stick Pregnancy test kits Peppermint oil Peppermint capsule Peppermint oil Psyllium R Rosemary oil 2012, No. 45 2012, No. 45 s Sage Sage oil 115 Salicylic acid ointmentment Saw palmetto Simple linctus Simple linctus peadiatric Sodium bicarbonate tablets 50 tablet/pack max Soya oil bath oil Soya oil/ lauromacrogol/ urea cream Soya oil/ lauromacrogol bath treatment The Pharmacy Regulations, 2012 Sodium Bicarbonate/ Citric acid/ Magnesium sulphate antacid powder Sodium Bicarbonate/ Citric acid/ Magnesium sulphate/ Sodium carbonate antacid tablet Sodium chloride nasal drops or spray Strong Ammonia solution/ Ammonia solution aromatic/ phenol cream Senna leaf and tablet 12/pack Soya oil Spirit of Camphor Sucrose Starch Simeticone colic drops . T Tar/ Cade oil/ Liquid paraffin emollient Terpeneless dill seed oil/ Sodium bicarbonate gripe water Tolnaftate foot powder/ solution/ spray Turpentine oil/ Acetic acid/ embrocation Tincture Benzoin compound spray Turpentine oil 5% topical V Vitamin B complex Vitamin E ointment The Pharmacy Regulations, 2012 Vitamin E gel w Witch hazel White liniment y Yeast vite z 116 2012, No. 45 Zinc oxide/ Hydrous wool fat/ Arachis oil/ white soft paraffin cream Zinc oxide/ Benzyl benzoate/ Benzyl cinnamate/ Benzyl alcohol cream Zinc undecenoate/ Methyl salicylate/ Eucalyptus oil topical prep Zinc oxide/ Cod liver oil nappy rash ointment Zinc and Castor oil cream Zinc oxide ointment Section 6 Chemical Precursors These substances are referred to as dangerous substances. Part II This section deals with poisons which may be sold by authorized seller of poisons. A poison means a non-medicinal substance for the purpose of the Act. Sale of these substances are restricted to persons lawfully conducting a retail pharmacy business or which may be sold by persons authorized to sell. Part II SECTION 28 (G) Poisons which may be sold by authorized seller of poisons Poison Acetone Aldrin Form to which sale is restricted Preparation for use in agriculture horticulture 2012, No. 45 117 Arsenical Substances: Arsenious oxide Arsenious Sulphides Calcium arsenates Calcium arsenites Copper acetoarsenite Copper arsenates Lead arsenates Sodium aresentes Schradon Sul fotep TEPP (HETP) Triphosphoric pentadiumthylamide Warfarin Pyrethoids Pyrethroum Phenothrin (Surnithrin) Poison Negloine (Diquat Dibromide) Trisilade 200 Hyvar X Karamex DF Dacis Sodium Thiarsenates Sodium aresenites The Pharmacy Regulations, 2012 Animal dips, animal washes Animal dips, animal washes Preparation for use in agriculture or Horticulture Agricultural and horticultural insecticides or fungicides Agricultural and horticultural Insecticides or fungicides Agricultural and horticultural insecticides or fungicides Agricultural and horticultural insecticides or fungicides Animal dips, animal washes Preparations for use in agriculture or horticulture Preparations for the destruction of rats or mice Agricultural insecticide Agricultural insecticide Form to which sale is restricted Preparation for use in agriculture or horticulture Animal dips, animal washes Preparation for use in agriculture of The Pharmacy Regulations, 2012 Barium Carbonate Cabaryl Dialdrin Dinitrocresols (DNOC) Dinoseb and its compounds 0,0-Dimethyl 1-2,2 Dichlozovinyl phosphate Endosulfam Eudothal; its salts 2-Isopropoyphenyl-n-methyl carbonate Mercurial substances: Mercurial chloride Poisons Mercurial Substances: 118 2012, No. 45 horticulture Preparation for the destruction of rats and mice Preparation for the destruction of rats and mice Preparation for use in agriculture or horticulture Preparation for use in agriculture of horticulture their compounds with a metal or a base Preparation for use in agriculture or Horticulture with a metal or a base Agricultural and horticultural insecticides Preparations for use in agriculture or horticulture Preparations for use in agriculture or horticulture Preparations for use in agriculture or horticulture Agricultural and horticultural fungicides seed and bulb dressings, insecticides Form to which sale is restricted Mercuric iodide Agricultural and horticultural fungicides seed and bulb dressings. Organic compounds of Mercury Agricultural and horticultural fungicides seed and bulb dressings. Metallic oxalates other than potassium quadroxalate Photgraphic solutions or materials. Nitrobenzene Agricultural and horticultural insecticide Substances for the treatment of bee disease; ointmentments for the treatment of animals. 2012, No. 45 119 2-Pivalyl-l, 3-indandione Phosphorus yellow Organo Phosphorus Compounds Amiton Azinpho-ethy 1 Azinphos-methyl Demeton-0 Demeton-S Diazinon Diethyl 4-methyl 7 Coumarinyl phophoro Thiorate Diethyl-p-nitrophenyl phosphate Dimefox Disuefoton Ethion Ethyl p-nitrophenyl phenylphos-phonothionate Malathion Mazidox Mecarbam Mevinphos Mipafox Oxydemeton-methyl Parathion Phenkapton Phorate Phosphamidon The Pharmacy Regulations, 2012 Preparations for the destruction of rats or mice Preparations for the destruction of rats or mice Preparations for use in agriculture or horticulture NB: Notwithstanding any Chemical Precursors not listed here but declared as a precursor by the World Health Organization is covered by this regulation The Pharmacy Regulations, 2012 Made the 12th day of December, 2012. 120 2012, No. 45 Hon. Willmoth Daniel Minister Responsible for Health