Revised Laws of Saint Lucia (2021)

Schedule 2

(Sections 2 (1) and (2))

AIDS AND DEVICES SOLD IN A PHARMACY

1.  

   Air Purifiers

1.  

   Diabetes   –   Lancets

1.  

         Meters

1.  

   Test Strips

1.  

   Thermometers

1.  

   Blood Pressure Monitors

1.  

   Humidifiers

1.  

   Spacers for Asthma

1.  

   HIV Test

1.  

   Cholesterol Test

1.  

   Pregnancy Test & Ovulation

1.  

   Colostomy bags

1.  

   Breast Pumps

1.  

   Cervical Collars

1.  

   Elastic Stockings & Supports

1.  

   Bandages, Dressing & Tapes

1.  

   Hot & Cold Packs

1.  

   Ankle, Knee Support, etc.

1.  

   Wheel chair

1.  

   Canes

1.  

   Crutches

1.  

   Walkers

1.  

   Cushions

1.  

   Bed Pans

1.  

   Syringes

1.  

   Surgical Blades

1.  

   Surgical Gloves

1.  

   Heating Pads

1.  

   Catheters

1.  

   Urine Bags

1.  

   Eye Patches

1.  

   Gauze

1.  

   Lint

1.  

   Surgical Tape

1.  

   Nebulisers

CHAPTER 11.21
PHARMACY ACT

SUBSIDIARY LEGISLATION

List of Subsidiary Legislation

Pharmacy (Forms and Fees) Regulations – Section 68

(Statutory Instrument 43/2006)

Statutory Instrument 43/2006 .. in force 22 May 2006

ARRANGEMENT OF REGULATIONS

PHARMACY (FORMS AND FEES) REGULATIONS – SECTION 68

Commencement [22 May 2006]

1.   Citation

These Regulations may be cited as the Pharmacy (Forms and Fees) Regulations.

2.   Interpretation

In these Regulations—

“Act” means the Pharmacy Act;

“Minister” means Minister responsible for health;

“Pharmacy Council” means the Pharmacy Council established under section 5 of the Act.

3.   Fees

The fees prescribed in Schedule 1 shall be the fees payable under sections 34, 38 and 39 of the Act.

4.   Application for registration or renewal of registration as a pharmacist

An application for registration of a person as a pharmacist under section 34(1) of the Act or renewal of registration of a person as a pharmacist under section 39 of the Act shall be in the form prescribed in Form 1 of Schedule 2 and shall be accompanied by—

1.  

   (a)     the application fee prescribed in Schedule 1;

1.  

   (b)     an official transcript, certificate or other relevant document from the place of study stating that the applicant has graduated;

1.  

   (c)     two passport size photographs;

1.  

   (d)     one official form of identification, for example, a passport, identification card or driver's licence;

1.  

   (e)     evidence of the applicant's good character;

1.  

   (f)     evidence that the applicant has not been convicted of an offence in Saint Lucia or elsewhere relating to the control of dangerous substances, drugs or narcotics;

1.  

   (g)     evidence that the applicant has not been convicted of an offence in Saint Lucia or elsewhere relating to the practice of pharmacy;

1.  

   (h)     evidence that the applicant has not had a certificate of registration for a pharmacy, practice as a pharmacist or practice as an authorised seller of poisons suspended or revoked in the last 5 years under this Act or any other law in force relating to the practice of pharmacy in Saint Lucia or elsewhere; and

1.  

   (i)     any other information as the Pharmacy Council deems necessary.

5.   Application for registration or renewal of registration of premises as pharmacy

An application for registration of premises as a pharmacy under section 34(3) of the Act or renewal of registration of premises as a pharmacy under section 39 shall be in the form prescribed in Form 2 of Schedule 2 and shall be accompanied by—

1.  

   (a)     the application fee prescribed in Schedule 1;

1.  

   (b)     two passport size photographs;

1.  

   (c)     one official form of identification, for example, a passport, identification card or driver's licence;

1.  

   (d)     evidence of the applicant's good character;

1.  

   (e)     evidence that the applicant has not been convicted of an offence in Saint Lucia or elsewhere relating to the control of dangerous substances, drugs or narcotics;

1.  

   (f)     evidence that the applicant has not been convicted of an offence in Saint Lucia or elsewhere relating to the practice of pharmacy;

1.  

   (g)     evidence that the applicant has not had a certificate of registration for a pharmacy, practice as a pharmacist or practice as an authorised seller of poisons suspended or revoked in the last 5 years under this Act or any other law in force relating to the practice of pharmacy in Saint Lucia or elsewhere; and

1.  

   (h)     any other information as the Pharmacy Council deems necessary.

6.   Application for registration or renewal of registration as an authorised seller of poisons

An application for registration of a person as an authorised seller of poisons under section 34(2) of the Act or renewal of registration as an authorised seller of poison under section 39 of the Act shall be in the form prescribed in Form 3 of Schedule 2 and shall be accompanied by—

1.  

   (a)     the application fee prescribed in Schedule 1;

1.  

   (b)     two passport size photographs;

1.  

   (c)     one official form of identification, for example, a passport, identification card or driver's licence;

1.  

   (d)     evidence of the applicant's good character;

1.  

   (e)     evidence that the applicant has not been convicted of an offence in Saint Lucia or elsewhere relating to the control of dangerous substances, drugs or narcotics;

1.  

   (f)     evidence that the applicant has not been convicted of an offence in Saint Lucia or elsewhere relating to the practice of pharmacy;

1.  

   (g)     evidence that the applicant has not had a certificate of registration for a pharmacy, practice as a pharmacist or practice as an authorised seller of poisons suspended or revoked in the last 5 years under this Act or any other law in force relating to the practice of pharmacy in Saint Lucia or elsewhere; and

1.  

   (h)     any other information as the Pharmacy Council deems necessary.

7.   Certificate of registration as pharmacist

A certificate of registration for registration of a person as a pharmacist issued under sections 36 and 38 of the Act or renewed under section 39—

1.  

   (a)     shall be in the form prescribed in Form 4 of Schedule 2; and

1.  

   (b)     shall be issued on payment of the registration fee or the annual fee prescribed in Schedule 1, as the case may be.

8.   Certificate of registration as pharmacy

A certificate of registration for registration of premises as a pharmacy issued under sections 36 and 38 of the Act or renewed under section 39—

1.  

   (a)     shall be in the form prescribed in Form 5 of Schedule 2; and

1.  

   (b)     be issued or renewed on payment of the registration fee or the annual fee prescribed in Schedule 1, as the case may be.

9.   Certificate of registration as authorised seller of poisons

A certificate of registration for registration of a person as an authorised seller of poisons issued under sections 36 and 38 of the Act or renewed under section 39—

1.  

   (a)     shall be in the form prescribed in Form 6 of Schedule 2; and

1.  

   (b)     shall be issued on payment of the registration fee or annual fee prescribed in Schedule 1, as the case may be.

Schedule 1

(Regulations 3-9)

FEES

Schedule 2

FORM 1

(Regulation 4)

  Pharmacy Council

[Address]

Saint Lucia

FORM 2

(Regulation 5)

Application for Registration of premises as pharmacy

  Pharmacy Council

[Address]

Saint Lucia

FORM 3

(Regulation 6)

Application for Registration of premises as pharmacy

  Pharmacy Council

[Address]

Saint Lucia

FORM 4

(Regulation 7)

Certificate of Registration as a Pharmacist

  Pharmacy Council

Saint Lucia

Certificate of Registration as a Pharmacist

Registration No. .........................

This is to certify that ................................................... has been licensed as a Pharmacist under the Pharmacy Act, for the period 1 January .............. to 31 December ........................

.............................................     ....................................

Chairperson, Pharmacy Council     Registrar

FORM 5

(Regulation 8)

Certificate of Registration as a Pharmacy

  Pharmacy Council

Saint Lucia

Certificate of Registration as a Pharmacy

This is to certify that the Pharmacy ..................... situated at ........................ in the quarter of .................... managed by ........................ is duly licensed as a Pharmacy for the period ending .................... and that ............................. is duly registered as the owner of the pharmacy.

.............................................     ....................................

Chairperson, Pharmacy Council     Registrar

FORM 6

(Regulation 9)

Certificate of Registration as an Authorised Seller of Poisons

  Pharmacy Council

Saint Lucia

Certificate of Registration as an Authorised Seller of Poisons

This is to certify that ................................ of ............................... is hereby licensed as an authorised seller of poisons and is authorised to sell the poisons set out in Part 2 of the Schedule ........................................ of the Act for the period ending ...........................................

.............................................     ....................................

Chairperson, Pharmacy Council     Registrar

Pharmacy Regulations – Section 68

(Statutory Instrument 138/2007)

Statutory Instrument 138/2007 .. in force 20 August 2007

ARRANGEMENT OF REGULATIONS

PRELIMINARY

PART 1
STANDARDS

PART 2
STORAGE DISPENSING AND DISPOSAL OF DRUGS

PHARMACY REGULATIONS – SECTION 68

Commencement [20 August 2007]

PRELIMINARY

1.   Citation

These Regulations may be cited as the Pharmacy Regulations.

2.   Interpretation

In these Regulations—

“Act” means the Pharmacy Act;

“care giver” means a patient's spouse, next of kin, legal guardian, attorney or third party insurer where permitted by law;

“compounding” means the act of preparing pharmaceutical components into medications pursuant to a prescription or medication order, including but not limited to prescription compounding and intravenous admixture preparation;

“controlled drug” means any drug listed in Schedule 1;

“controlled paraphernalia” means drug paraphernalia which is under the direct supervision of a pharmacist;

“device” includes any apparatus, similar or related article,     mechanical, electronic or otherwise including any component part or accessory dispensed by a pharmacies in the usual scope of pharmacy practice;

“drug” includes –

1.  

   (a)     articles recognized in the official British Pharmacopoeia, United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States or any other recognized text;

1.  

   (b)     articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in human beings or animals;

1.  

   (c)     articles, other than food intended to affect the structure and any function of the body of human beings or animals; and

1.  

   (d)     articles intended for use as components of any article specified in paragraphs (a), (b) or (c), but not including devices or their components, parts or accessories;

“drug paraphernalia” means all equipment, products, and materials of any kind which are used, intended for use or designed for use in introducing a drug into the human body;

“expiration date” means the date placed on a drug packaged by the manufacturer or repacker beyond which the product may not be dispensed or used;

“extern” means any person who is in final college year or 3^rd or 4^th professional year at an approved school or college of pharmacy who is assigned to a pharmacy for the purpose of acquiring accredited practical experience under the supervision of the school or college at which he or she is enrolled;

“intern” means any new graduate from an approved school or college of pharmacy or a foreign pharmacy graduate or any person who has satisfied the requirements and who is employed in an approved pharmacy for training for the purpose of acquiring accredited practical experience and who has first registered for those purposes with the Pharmacy Council;

“over the counter” means a drug approved for the conditions set out in Schedule 2;

“pharmacy technician” means a qualified person who assists the pharmacist in performing his or her tasks and responsibilities;

“pharmacist” means a person who is registered as a pharmacist pursuant to Part 2 of the Act;

“pharmacist assisted drug” means a drug listed in Schedule 3;

“Pharmacy Council” means the Pharmacy Council established pursuant to section 5 of the Act;

“prescriber” means a health practitioner or veterinarian authorized by law to write prescriptions in Saint Lucia;

“prescription” means an order for drugs or medical supplies, written and signed or transmitted by any means of communication by a duly licensed physician to a pharmacist, authorized by law to prescribe and administer such drugs or medical supplies;

“prescription drug” means a drug listed in the Schedule 4;

“professional judgment” means judiciousness and discretion based upon thorough knowledge and sound application of the specialized body of knowledge peculiar to the practice of pharmacy, and an understanding of the relationship of this knowledge and its application to the well being of the patient and to the judgment of the prescriber;

“storage temperature” means the specific directions stated in some monographs with respect to the temperatures at which pharmaceutical articles are stored, where it is considered that storage at a lower or higher temperature may produce undesirable results;

“supportive personnel” means those persons, excluding interns, externs and pharmacy technicians who perform functions under the direct supervision of a registered pharmacist.

PART I
STANDARDS

3.   Physical standards

A pharmacy shall—

1.  

   (a)     be constructed of permanent and secure materials;

1.  

   (b)     be of sufficient size to allow for safe and proper storage of drugs, for compounding, preparation and dispensing of prescriptions, and for provision of patient-oriented and administrative pharmacy service, taking into account the volume of business, the nature of the patients and their particular needs, and the nature of the pharmacy's business;

1.  

   (c)     be dry, well-lighted, well-ventilated and maintained in a clean, sanitary and orderly condition;

1.  

   (d)     be physically separated from adjacent areas in the same premises by any means that ensures that no one has unsupervised access to any drugs when a pharmacist is not present;

1.  

   (e)     contain a prescription department under regulation 5.

4.   Temporary or moveable premises

1.  

   (1)   A person may use a temporary or moveable premises as a pharmacist to rural districts if there are no fixed pharmacies in that district.

1.  

   (2)   A pharmacist of a temporary or moveable premises shall not keep a narcotic drug or poison on the temporary or moveable premises.

5.   Standards for prescription department

The prescription department of a pharmacy—

1.  

   (a)     may contain an area used for devices, cosmetics, and proprietary drugs;

1.  

   (b)     shall contain a patient waiting area;

1.  

   (c)     shall not be less than 60 square feet and the patient waiting area or the area used for devices, cosmetics, and proprietary drugs are not to be considered a part of the 60 square feet;

1.  

   (d)     shall be provided with a prescription counter –

   1.  

      (i)     constructed in such a manner that it prevents unauthorized entry, unsupervised access to any drugs, and pilferage at all times whether or not a pharmacist is on duty,

   1.  

      (ii)     fitted with doors with locking devices which will prevent unauthorized entry in the absence of the pharmacist,

   1.  

      (iii)     with a prescription area of not less than 18 inches in width and not less than 6 total feet in length to be kept clear at all times for the compounding of prescriptions, dispensing of drugs, necessary record keeping and other pharmaceutical manufacturing;

1.  

   (e)     shall include a sink with running water in the prescription area of retail and institutional pharmacies which is easily accessible to the prescription counter;

1.  

   (f)     shall have sufficient shelf, drawer or cabinet space within the prescription area for proper storage of stock of prescription labels, an assorted stock of prescription containers, an adequate stock of prescription drugs and chemicals and the required equipment;

1.  

   (g)     may contain a rest room to be used exclusively by the pharmacist and supportive personnel if there is another restroom outside the prescription department available to other employees and the public;

1.  

   (h)     shall include adequate refrigeration facilities for the storage of drugs, requiring cold storage temperature to meet manufacturers' specifications for drug storage;

1.  

   (i)     shall contain a private or semi-private area for patient/pharmacist consultation.

6.   Access to prescription department

1.  

   (1)   The prescription department is restricted to the pharmacist and supportive personnel.

1.  

   (2)   Clerical assistants and other persons designated by the pharmacist may be allowed access by the pharmacist but only at such time as the pharmacist is present.

7.   Access to other areas

Access to stock rooms, rest rooms, and other areas other than an office that is exclusively used by the pharmacist shall not be through the prescription department.

8.   Keys to prescription department

The keys for the door to the prescription department are to remain in the possession of the pharmacist or a person authorized by the pharmacist.

9.   Equipment in prescription area

1.  

   (1)   The prescription area to be maintained under regulation   5(d)(iii) shall include the following at all times—

   1.  

      (a)     an up-to-date, comprehensive pharmaceutical reference text and suitable current reference texts encompassing the general practice of pharmacy, drug interactions, drug product composition and patient counseling and unabridged computerized versions of reference texts;

   1.  

      (b)     a permanent prescription filing device and patient profile, record system;

   1.  

      (c)     a prescription balance or equivalent electronic weighing device;

   1.  

      (d)     a device capable of measuring 0.3ml to 500ml;

   1.  

      (e)     a mortar, stet pestle, glass and porcelain;

   1.  

      (f)     glass funnels;

   1.  

      (g)     a spatula;

   1.  

      (h)     a refrigerator to be used only for the storage of pharmaceuticals;

   1.  

      (i)     a minimum or maximum refrigerator thermometer with record;

   1.  

      (j)     a hard copy of temperature record;

   1.  

      (k)     suitable counting trays or an approved counting device;

   1.  

      (l)     labels including auxiliary labels and poison labels;

   1.  

      (m)     a copy of the Act and Regulations.

1.  

   (2)   The equipment kept pursuant to sub-regulation (1) shall be kept and stored in a clean and readily accessible part of the prescription department.

PART 2
STORAGE, DISPENSING AND DISPOSAL OF DRUGS

10.   Storage of drugs

1.  

   (1)   All drugs requiring the supervision of a pharmacist including dispensed drugs shall remain within the confines of the prescription department.

1.  

   (2)   All poisons shall be stored within a locked cabinet or draw and the key shall be kept by the pharmacist.

1.  

   (3)   The conditions of storage for all drugs shall be governed by the following terms—

   1.  

      (a)     “Cold” means any temperature not exceeding 8ÚC (46ÚF).

1.  

   A refrigerator is a cold place in which temperature is maintained thermostatically between 2Ú and 8ÚC (36ÚF and 46ÚF). A freezer is a cold place in which the temperature is maintained thermostatically between -20ÚC and -10ÚC (-4ÚF and 14ÚF);

   1.  

      (b)     “Room temperature” means 27ÚC;

   1.  

      (c)     “Controlled room temperature” is a temperature maintained thermostatically that encompasses the usual and customary working environment of 20ÚC to 25ÚC (68ÚF to 77ÚF), that results in a mean kinetic temperature calculated to be not more than 25ÚC and that allows for excursions between 15ÚC and 30ÚC (59ÚF and 86ÚF) that are experienced in pharmacies, hospitals and warehouse;

   1.  

      (d)     “Warm” means any temperature between 30ÚC and 40ÚC (86ÚF and 104ÚF);

   1.  

      (e)     “Excessive heat” means any temperature above 40ÚC (104ÚF);

   1.  

      (f)     “Protection from freezing” means where, in addition to the risk of breakage of the container, freezing subjects a product to loss of strength or potency or to the destructive alteration of its characteristics, the container label bears an appropriate instruction to protect the product from freezing;

   1.  

      (g)     “Cool” means any temperature between 8ÚC and 15ÚC (46ÚF and 59ÚF).

1.  

   (4)   Outdated, misbranded, deteriorated or adulterated drugs, or any drug marked “sample” or with any like designation or meaning shall not be placed or maintained in active stock for use or sale.

11.   Prescriptions awaiting delivery

1.  

   (1)   A prescription which is prepared for delivery to the patient may be placed in a secure place outside of the prescription department and access to the prescriptions restricted by the pharmacist to designated health care personnel.

1.  

   (2)   Prepared prescriptions may be transferred, with the permission of the pharmacist, to the patient at a time when the pharmacist is not on duty.

1.  

   (3)   If a prescription is delivered at a time when the pharmacist is not on duty, written procedures which detail a method of compliance with counseling requirements shall be established and followed by the pharmacy.

12.   Controlled paraphernalia

Controlled paraphernalia shall not be placed on open display or in an area completely removed from the prescription department where the public will have free access to the controlled paraphernalia or where the pharmacist cannot exercise reasonable supervision and control over the controlled paraphernalia.

13.   Expired drugs

Any drug which has exceeded the expiration date shall be separated from the stock for dispensing and shall be maintained in a designated area within the prescription department until proper disposal.

14.   Restriction on dispensing drugs

1.  

   (1)   A pharmacist shall not dispense a prescription drug and an authorized seller of poisons shall not dispense a poison unless that pharmacist or authorized seller of poisons receives a prescription or medication order which complies with regulation 15, from a patient or care giver.

1.  

   (2)   A pharmacist shall not dispense any drug to a patient or care giver—

   1.  

      (a)     in the case of a pharmacist assisted drug, under the age of 18 years;

   1.  

      (b)     in any other case, under the age of 16 years.

15.   Prescriptions

1.  

   (1)   A prescription shall contain—

   1.  

      (a)     the date;

   1.  

      (b)     the RX icon before the items are written-items should be bulleted;

   1.  

      (c)     the prescriber's information, such as, the name, address, telephone and fax number of the prescriber which shall be either pre-printed on the prescription blank, electronically printed, typewritten, rubber stamped, or printed by hand;

   1.  

      (d)     the name, strength, frequency, duration, quantity and formulation of drug;

   1.  

      (e)     the first and last name of the patient for whom the drug is prescribed;

   1.  

      (f)     the address of the patient, which shall either, be placed on the written prescription by the prescriber or his or her agent;

   1.  

      (g)     specific information about the patient, such as, height, weight and age so that the correct dose for the patient can be calculated;

   1.  

      (h)     refill section should be indicated and if not utilized should be crossed out;

   1.  

      (i)     signature of the prescriber;

   1.  

      (j)     unapproved non standard abbreviations should not be used as well as those that may lead to error in interpretation by the pharmacist and put the patient at risk;

   1.  

      (k)     expression of weights and volumes and units;

   1.  

      (l)     decimals—

      1.  

         (i)     “500mg” should be used in place of “0.5” or “125mcg” instead of “0.125mg”,

      1.  

         (ii)     decimal expressions of less than 1 should always be preceded by a zero to enhance the visibility of the decimal;

   1.  

      (m)     there should be a space between the name of the medication and the dose as well as between the dose and the units.

1.  

   (2)   A non refill prescription is valid for 7 days from the date it was written.

1.  

   (3)   Where the prescription is made by a dentist or veterinarian for a poison, the words “for dental treatment only” or “for treatment of animals only” should be used.

1.  

   (4)   If not otherwise prohibited by law, the pharmacist may record the address of the patient in an electronic prescription dispensing record for that patient in lieu of recording it on the prescription.

1.  

   (5)   The prescription may be prepared by an agent for the prescriber's signature.

1.  

   (6)   This regulation shall not prohibit a prescriber from using preprinted prescriptions for pharmacist assisted drugs if all requirements concerning dates, signatures, and other information specified above are otherwise fulfilled.

1.  

   (7)   This provision shall not apply to prescriptions written as chart orders for patients in hospitals and long-term-care facilities, patients receiving home infusion services or hospice patients, or to a prescription ordered through a pharmacy operated by or for Bordelais Prisons, or the central outpatient pharmacy operated by the Psychiatric Hospital.

16.   Refusal to dispense prescription

A pharmacist has the right to refuse to dispense a prescription drug or poison if, in his or her professional judgment—

1.  

   (a)     the prescription is outside the scope of practice of the health practitioner or veterinarian;

1.  

   (b)     there is sufficient reason to question the validity of the prescription; or

1.  

   (c)     it is necessary to protect the health and welfare of the patient.

17.   Dispensing by intern or extern

A pharmacy intern or extern shall not prepare, compound or dispense a prescription drug except under the direct supervision of a pharmacist.

18.   Pharmacy technician, intern or extern

1.  

   (1)   A Pharmacy technician or an intern shall not interpret a prescription order or consult with an prescriber or the agent of the prescriber but may, count, weigh, measure, or pour prescription medication and offer limited advise under the direct supervision of the pharmacist as long as the contents and finished-product are verified by the pharmacist.

1.  

   (2)   A Pharmacy technician, intern and extern shall wear an identification tag, which shall include at least their first name, the first initial of their last name, and their title.

19.   Supervision by pharmacist

1.  

   (1)   A pharmacist shall not supervise more than three pharmacy technicians, interns or externs and the personnel who do computer processing of prescriptions are to be included in the 3 to 1 ratio.

1.  

   (2)   The pharmacist supervising the activities of supporting personnel shall be physically present in the compounding or dispensing area and shall be responsible for the accuracy of the dispensed prescription.

20.   Electronic prescriptions and medication order

1.  

   (1)   Where a pharmacy accepts a prescription or medication order electronically—

   1.  

      (a)     the receiving machine shall be in the prescription department of the pharmacy to protect patient, pharmacy, practitioner confidentiality and security;

   1.  

      (b)     the electronic prescription or medication order must originate from the prescriber and another pharmacist;

   1.  

      (c)     the pharmacist shall verify the transmission directly with the prescribing practitioner in all cases where a pharmacist has reason to question the accuracy or authenticity of a prescription or medication order transmitted electronically.

1.  

   (2)   Any pharmacist who uses an electronical device to circumvent his or her responsibilities with regard to documenting, authenticating and verifying medication orders and prescriptions or to circumvent other standards of pharmacy practice commits an act of professional misconduct.

1.  

   (3)   A pharmacist shall not accept an electronic device from any health practitioner.

1.  

   (4)   A pharmacist shall not enter into any agreement with any health practitioner or veterinarian which denies the patient the right to have his or her prescription transmitted electronically to a pharmacy of the patient's choice.

21.   Lack of directions on prescription

1.  

   (1)   A pharmacist shall make a documented attempt to contact the health practitioner or veterinarian to obtain directions in all cases where the health practitioner or veterinarian fails to include directions for use of the drug on the prescription.

1.  

   (2)   Where a health practitioner or veterinarian cannot be contacted, the pharmacist shall instruct the patient as to the appropriate instructions from a recognized reference text.

1.  

   (3)   The pharmacist may add directions or cautionary messages to those indicated by the health practitioner or veterinarian on the prescription, when, in the judgment of the pharmacist, directions to the patient or cautionary messages are necessary, either for clarification or to ensure proper administration of the drug.

22.   Renewal of prescriptions

1.  

   (1)   A prescription for medication or devices which pursuant to these Regulations may be dispensed or furnished only on prescription, shall not be renewed without specific authorization of the prescriber, and the prescription may not be refilled after 6 months from the date of the original prescription.

1.  

   (2)   Prescriptions marked “PRN” or other letters or words meaning refill as needed shall not be renewed beyond 6 months past the date of original prescription.

1.  

   (3)   When the renewals listed on the original prescription have been depleted, no additional renewals may be added to the original prescription.

1.  

   (4)   Additional dispensing must be under a new prescription which must be authorized by the prescriber.

23.   Generic substitution

1.  

   (1)   Subject to subregulation (2), a pharmacist may, when filling any prescription—

   1.  

      (a)     inform the person requesting the drug of the availability of any bioequivalent generic drug which is interchangeable with the named drug and which is less costly; and

   1.  

      (b)     supply the generic equivalent drug instead of the named drug.

1.  

   (2)   A pharmacist may dispense a brand-name drug product where a suitable generic equivalent drug product is available in cases where –

   1.  

      (a)     the health practitioner or veterinarian indicates such substitution is not authorized by specifying on the prescription the words, “brand medically necessary” or some form of emphasis on the brand name such as underline, asterisk or the symbol ®; or

   1.  

      (b)     the patient insists on the dispensing of the brand-name drug product.

24.   Pharmacist assisted drugs

1.  

   (1)   A pharmacist shall conform to the following standards of professional judgment and care when selling a pharmacy assisted drug—

   1.  

      (a)     he or she shall ensure that the sale of a specified controlled substance is limited in quantity during any forty eight hour period;

   1.  

      (b)     he or she shall obtain suitable identification, including proof of age where appropriate, from every purchaser not known personally to him or her;

   1.  

      (c)     if he or she has any doubts regarding the proprietary of a sale of a pharmacist assisted drug, he or she shall resolve the doubt against the making of the sale.

1.  

   (2)   The pharmacist shall determine, through direct communication with a purchaser who makes a second request for a pharmacist assisted drug within a period of 2 to 4 days or any short period after the initial dispensing, whether the substance is being used correctly and in that regard, the pharmacies shall ascertain how many people are using the substance and whether the condition that the substance is being used to treat is improving.

1.  

   (3)   The pharmacist shall, in all cases where a patient makes a third request for a pharmacist assisted drug within a period of 2 to 4 days or any short period subsequent to the second purchase—

   1.  

      (a)     advise the patient or care giver of the substance's abuse potential; and

   1.  

      (b)     caution the patient or care giver to consult a physician if the condition for which the substance is being used does not improve.

1.  

   (4)   A pharmacist may be disciplined for professional misconduct if he or she dispenses a pharmacist assisted drug over-the-counter controlled when—

   1.  

      (a)     in his or her professional judgment, he or she knows or ought reasonably to know that the requested substance will be used for unauthorized or illicit consumption or distribution; or

   1.  

      (b)     in his or her professional judgment, he or she knows or ought reasonably to know that the person requesting the substance previously used it for unauthorized or illicit consumption or distribution.

25.   Controlled drugs

1.  

   (1)   Subject to subregulations (2) and (3), a pharmacist may dispense on a single prescription for a poison, an amount limited to a 28 days supply.

1.  

   (2)   A pharmacist may dispense an emergency supply of a chronic maintenance drug or device in the absence of a current valid prescription, if in his or her professional judgment refusal would endanger the health or welfare of the patient but the pharmacist shall not, in any case, prescribed more than a 72 hours supply.

1.  

   (3)   The pharmacist shall, before dispensing drugs in accordance with sub-regulation (1), ascertain to the best of his or her ability, by direct communication with the patient, that the drug or device was prescribed for that patient by order of a licensed medical practitioner.

26.   Poisons

1.  

   (1)   A pharmacist may dispense any poison contained in the list of poisons.

1.  

   (2)   An authorized seller of poisons may dispense poisons specified in Part II of the list of poisons.

1.  

   (3)   A pharmacist or an authorized seller of poisons shall not dispense any linament, embrocation, lotion or similar caustic substance containing a poison unless such substance is in a container—

   1.  

      (a)     which is so constructed as to prevent leakage arising from the ordinary risks of handling and which is impervious to poison; and

   1.  

      (b)     to which is affixed a label giving notice that the contents shall not be taken orally.

1.  

   (4)   Where a pharmacist or authorized seller of poisons dispenses any poison in a bottle of a capacity of not more than one hundred and twenty fluid ounces, the outer surface of that bottle shall be fluted vertically with ribs or grooves easily discernable by touch.

1.  

   (5)   A pharmacist or authorized seller of poisons who dispenses a poison shall—

   1.  

      (a)     ensure that the poison is packed to avoid leakage arising from the ordinary risks of handling;

   1.  

      (b)     adequate precautions are taken to prevent the risk of contaminating food.

1.  

   (6)   A pharmacist or authorized seller of poisons shall not dispense one pound of arsenic unless it is mixed with at least one ounce of soot or half an ounce of indigo.

1.  

   (7)   Notwithstanding sub-regulation (6), a pharmacist or authorized seller of poisons shall not dispense one pound of arsenic if—

   1.  

      (a)     the arsenic is an ingredient of any medicine required to be made up or compounded in accordance with a prescription of a medical practitioner, dentist or veterinary surgeon;

   1.  

      (b)     it is stated by the person receiving the arsenic that it is required for some purpose other than use in agriculture, and it is established that such mixture would render arsenic unfit for the purpose for which it is being obtained and the arsenic is dispensed in quantities of not less than 10 pounds on each occasion.

27.   Counselling

1.  

   (1)   A pharmacist shall make reasonable efforts to counsel a patient or caregiver before dispensing a new prescription.

1.  

   (2)   Counselling pursuant to subregulation (1) shall include the following information:

   1.  

      (a)     the name and description of the drug;

   1.  

      (b)     the dosage form, dosage route of administration and duration of drug therapy;

   1.  

      (c)     special directions and precautions for preparation, administration and use by the patient;

   1.  

      (d)     common adverse or sever side effects or interactions and contraindications that may be encountered, including their avoidance an the action required if they occur;

   1.  

      (e)     techniques for self-monitoring drug therapy;

   1.  

      (f)     proper storage;

   1.  

      (g)     prescription refill information; and

   1.  

      (h)     action to be taken in the event of a missed dose.

1.  

   (3)   An offer to counsel may be made by ancillary personnel but the pharmacist shall perform the counseling.

1.  

   (4)   A pharmacist is not required to counsel a patient or caregiver when the patient or caregiver refuses counseling.

1.  

   (5)   The offer to counsel may be made by telephone or in writing on a separate document accompanying the prescription in all cases where the patient or caregiver is not physically present.

1.  

   (6)   A written offer to counsel shall be in bold print, legible and shall include the hours a pharmacist is available and a telephone number where a pharmacist may be reached and the telephone service shall be available at no cost to the patient.

28.   Labelling

1.  

   (1)   When dispensing a drug a pharmacist shall affix a label to the container in which the drug is dispensed which shall include the following information:

   1.  

      (a)     the pharmacy's name and address;

   1.  

      (b)     the pharmacy's telephone number;

   1.  

      (c)     the brand name or generic name of the dispensed drug;

   1.  

      (d)     if generic, the name of the manufacturer;

   1.  

      (e)     the strength and quantity of drug dispensed;

   1.  

      (f)     the date on which the drug is dispensed;

   1.  

      (g)     any cautionary or auxiliary label;

   1.  

      (h)     the patient's name;

   1.  

      (i)     the initials of the dispensing pharmacist;

   1.  

      (j)     the prescriber's name;

   1.  

      (k)     the prescription number;

   1.  

      (l)     directions for use;

   1.  

      (m)     the expiration date, if dispensed in any packaging other than the manufacturer's original packaging; and (n) the caution: “KEEP OUT OF THE REACH OF CHILDREN”;

   1.  

      (o)     any auxiliary labeling as recommended by the manufacturer or as deemed appropriate in the professional judgment of the dispensing pharmacist.

1.  

   (2)   Where a poison is dispensed, the pharmacist or authorized seller of poisons shall include the information in subregulation (1) and the following additional information on the container:

   1.  

      (a)     the address, telephone number and signature of the pharmacist or authorized seller of the poisons;

   1.  

      (b)     signature of the person receiving the poison;

   1.  

      (c)     the purpose for which the poison is required;

   1.  

      (d)     where the poison is an ingredient of a preparation, the proportion of the poison;

   1.  

      (e)     a notice indicating that the poison is to be kept separate from food and food containers.

1.  

   (3)   In this regulation “expiration date” means the earlier of 6 months from the date of dispensing or the expiration date on the manufacturers' container.

29.   Patient profile record systems

1.  

   (1)   A pharmacist shall maintain a patient profile record system of persons to whom prescription drugs are dispensed.

1.  

   (2)   The patient profile record system maintained pursuant to subregulation (1) may be in electronic form and shall—

   1.  

      (a)     be devised so as to enable the immediate retrieval of information necessary to enable the dispensing pharmacist to identify previously dispensed drugs at the time a prescription is presented for dispensing;

   1.  

      (b)     include the following information:

      1.  

         (i)     the family name and the first name of the patient;

      1.  

         (ii)     the address and telephone number of the patient;

      1.  

         (iii)     the patient's age, birth date or age group and gender;

      1.  

         (iv)     the original or refill date on which the drug is dispensed and the initials of the dispensing pharmacist, if the initials and the date are not already recorded on the back of the original prescription or in any other record approved by the Pharmacy Council;

      1.  

         (v)     the number or designation identifying the prescription;

      1.  

         (vi)     the prescriber's name;

      1.  

         (vii)     the name, strength and quantity of the drug dispensed;

      1.  

         (viii)     the pharmacist's comments relevant to the patient's drug therapy, including any failure of the patient to accept the pharmacist's offer to counsel; and

      1.  

         (ix)     the patient's national insurance number, if any;

      1.  

         (x)     whether or not the patient suffers from any allergies and idiosyncrasies or any medical condition which may relate to drug utilization as communicated to the pharmacist by the patient.

1.  

   (3)   If the pharmacist uses an electronic patient profile record system, the pharmacist shall—

   1.  

      (a)     establish an auxiliary record keeping system in case the electronic patient profile record system becomes inoperative for any reason;

   1.  

      (b)     enter the patient profile information and number of refills authorized during the time the electronic patient profile record system was inoperative within 72 hours from the time the electronic patient profile record system is restored to operation;

   1.  

      (c)     provide adequate safeguards against manipulation and alteration of records to protect the confidentiality of the information contained in the data bank; and

   1.  

      (d)     make arrangements with the supplier of data processing services or materials to ensure that the pharmacy will continue to have adequate and complete prescription and dispensing records if the relationship with such supplier terminates for any reason.

1.  

   (4)   A pharmacist shall maintain one profile record for members of a family living at the same address and possessing the same family name.

1.  

   (5)   The pharmacist shall use his or her professional judgment to review and monitor the patient profile record to determine if there should be any adjustment in the original patient information and indicate the appropriate change in the patient profile record.

1.  

   (6)   Upon receipt of a new or refill prescription, a pharmacist shall examine the patient's profile record before dispensing the drug to determine the possibility of a potentially significant drug interaction, reaction or misuse of the prescription and if the pharmacist detects a potentially significant drug interaction, reaction or misuse, the pharmacist shall take the appropriate action to avoid or minimize the problem, which shall, if necessary, include consultation with the patient and the prescriber.

1.  

   (7)   A pharmacist shall maintain a patient profile record for each patient for a period of not less than 5 years from the date of the last entry in the profile record.

1.  

   (8)   The oldest 4 years of record information must be maintained in such a manner so as to be sight-readable within 2 weeks.

1.  

   (9)   The most recent one year of record information must be immediately retrievable.

30.   Over-the-counter record

1.  

   (1)   A pharmacist shall maintain a record of every dispensation of a pharmacist assisted drug which shall be clearly labeled “Over the-counter Pharmacist Assisted Drug Record”.

1.  

   (2)   A record maintained pursuant to subregulation (1) shall include the following information:

   1.  

      (a)     the patient's first and last name and address;

   1.  

      (b)     the name and quantity of the pharmacist assisted drug sold;

   1.  

      (c)     the date of the sale;

   1.  

      (d)     the name or initials of the pharmacist who dispensed the drug.

31.   Supportive personnel

Supportive personnel may assist the pharmacist in a clerical manner such as the retrieving of prescription files, profile cards, and other such records, the typing of labels and the completing of prescription receipts and other such form.

32.   Refills

1.  

   (1)   Upon receipt of a refill prescription, a pharmacist shall determine if a substantial time, as is appropriate for that drug in the reasonable and prudent pharmacist's professional judgment,   has elapsed from the last filling and when necessary, the pharmacist shall consult with the prescriber and the patient to assure himself or herself that continued use is appropriate.

1.  

   (2)   The pharmacist shall consult with the patient and the prescriber to determine if continued use of a drug is appropriate in cases where the patient profile records indicate sporadic, erratic or irrational use of the drug by a patient.

1.  

   (3)   A pharmacist shall maintain a profile record of all prescription patients who patronize a pharmacy as specified in regulation and the pharmacist shall inquire as to whether other prescription drugs are being concomitantly utilized in order to establish a current drug history for the patient.

33.   Prohibition of steering

A pharmacist shall not enter into an arrangement with a health practitioner or other person who is authorized to issue prescriptions, or with any health care facility for the purpose of directing or diverting patients to or from a specified pharmacy or restraining in any way a patient's freedom of choice to select a pharmacy.

34   Copies of prescription

1.  

   (1)   A pharmacist shall provide a copy of a prescription if the patient or care giver requests a copy of the prescription from the pharmacist.

1.  

   (2)   Copies of prescriptions issued directly to the patient by the pharmacy where the drug was dispensed, pursuant to the receipt of the prescription, shall state in letters at least equal in size to those describing the medication dispensed, the highlighted statement: “COPY FOR INFORMATION ONLY”.

1.  

   (3)   Presentation of a prescription marked “COPY FOR INFORMATION ONLY” shall be for information purposes only and have no legal status as a valid prescription.

35.   Transfer of prescription

1.  

   (1)   A pharmacist shall transfer a prescription to another pharmacist if the patient or care giver requests such transfer.

1.  

   (2)   When a request is made for the transfer of a prescription pursuant to subregulation (1) the pharmacist shall make a copy of the prescription marked with the words “COPY FOR INFORMATION ONLY”.

1.  

   (3)   Upon making the copy pursuant to subregulation (2), the pharmacist—

   1.  

      (a)     may issue the copy to the patient; or

   1.  

      (b)     send the copy to the other pharmacist by fax.

1.  

   (4)   The pharmacist who sends the copy of a prescription shall invalidate the original prescription on file together with the refill authorizations as of the date the copy is transferred by writing “VOID” on their face and shall record on the back of the invalidated prescription and refill authorizations that a copy has been issued, the date of issuance of such copy, the name of the pharmacy and pharmacist the prescription is being transferred, and the initials of the pharmacist issuing the transferred prescription.

1.  

   (5)   The pharmacist who receives the copy of the prescription shall on receiving the copy record the following information—

   1.  

      (a)     the name, address and original prescription number of the pharmacy from which the copy of the prescription was transferred;

   1.  

      (b)     the name of the pharmacist who sent the copy;

   1.  

      (c)     the date of issuance of the original prescription;

   1.  

      (d)     the number of refills authorized on the original prescription;

   1.  

      (e)     the complete refill record from the original prescription;

   1.  

      (f)     the date of original dispensing;

   1.  

      (g)     the number of valid refills remaining.

1.  

   (6)   The pharmacist who receives a copy of a prescription shall inform the patient that the original prescription has been cancelled at the pharmacy from which it was obtained.

36.   Return of prescription drug

1.  

   (1)   Subject to subregulation (2), a pharmacist shall not accept any drug for return to inventory after that drug has been previously dispensed.

1.  

   (2)   A pharmacist may accept a drug for return to inventory after it has been dispensed if in the pharmacist's professional judgment it is appropriate to do so and if the following conditions are met—

   1.  

      (a)     the lot number and expiry date of the drug, where applicable, are directly attached to the dispensed container;

   1.  

      (b)     each dose of the drug is individually sealed and the seal is intact at the time of the return to the pharmacy;

   1.  

      (c)     the pharmacist has a personal knowledge of the storage conditions of the drug subsequent to its being dispensed or the length of time between dispensing and return is of such short duration that storage conditions would not be material;

   1.  

      (d)     the patient has not been in possession of the drug;

   1.  

      (e)     the drug has been under the supervision of the pharmacist directly or indirectly between the time of dispensing and the time of return to a sufficient degree to permit the exercise of professional judgment;

   1.  

      (f)     the prescription drug was incorrectly dispensed to the patient.

37.   Disposal of unwanted drugs

A pharmacist shall dispose of an unwanted drug in a manner that does not cause that drug to become a health hazard and in accordance with the law.

Schedule 1

(Regulation 2)

CONTROLLED DRUGS

Part I

Acetorphine(O-acetyl-7,8 dihydro-7-alpha[1R - hydroxy-1- methylbutyl]- o-methyl-6,14endoethenomorphine or 3-o-acetyltetrahydro-7 alpha-(1- hydroxy-1-methylbutyl)-6, 14-endoetheno-oripavine or 5-acetoxy- 1,2,3,3a,8,9-hexahydro-2 alpha-[1(R ) - hydroxy-1-methylbutyl]-3- methoxy-12-methyl-3, 9a-etheno-9, 9b-iminoethano-phenanthro [4,5- bed] furan

Acetyldihyrocodeine

Acetylmethadol (3-acetoxy-6-dimethylamino-4,4-diphenyl-heptane)

Allylprodine (3-ally-1-methyl-4-phenyl-4-propionoxy-piperidine)

Alphacetylmethadol (alpha-3-acetoxy-6-dimethylamino-4,4-diphenylheptane)

Alphameprodine (alpha-3-ethyl-1-methyl-4-phenyl-4-propionoxypiperidine)

Alphamethadol (alpha-6-dimethylamino-4,4-diphenyl-3-heptanol)

Alphaprodine (alpha-1,3-dimethyl-4-phenyl-4-propionoxy-piperidine)

Anileridine (1-para-aminophenethyl-4-phenylpiperidine-4-carboxylic acid ester or 1-[2-(para-aminophenyl)-ethyl]-4-phenylpiperidine-4-carboxylic acid ethyl ester)

Benzethidine (1-(2-benzyloxyethyl)-4-phenylpiperidine-4-carboxylic acid ethyl ester

Benzylmorphine (3-benzylmorphine)

Betacetylmethadol (beta-3-acetoxy-6-dimethylamino-4,4-diphenylheptane)

Betameprodine (beta-3-etyly-1-methyl-4-phenyl-4-propionoxypiperidine)

Betamethadol (beta-6-dimethylamino-4,4-diphenyl-3-heptanol)

Betaprodine (beta-1,3-dimethyl-4-phenyl-4-propionoxy-piperidine)

Bezitramide(1-(3-cyano-3,3-diphenylprophyl)-4-(2-oxo-3 propionyl-1- benzimidazolinyl)-piperidine)

Clonitazene (2-para-chlorbenzyl-1-diethylaminoethyl-5-nitrobenzimidazole)

Cocaine

Codiene (3-methylmorphine)

Codoxime (dihydrocodeinone-6-carboxymethyloxime)

Concentrate of poppy straw (The material arising when poppy straw has entered into a process for the concentration of its alkaloids when such material is made available in trade)

Desmorphine (dihydrodeoxymorphine)

Dextromoramide ( (+)-4-[2-methyl-4-oxo-3,3-diphenyl-4(1-pyrrolidinyl) butyl] morpholine or (+)-3-methyl-2,2-diphenyl-4-morpholino-butyrl-pyrrolidine)

Diampromide (N-[(2-methylphenethylamino) propyl] propionanilide) Diethylthiambutene (3-diethylamino-1,1-di(2'-thienyl)-i-butene)

Difenoxim (1-(3 cyano-3,3 diphenylpropyl)-4phenylisonipecotic acid)

Difenoxin

Dihydrocodeine

Dihydromorphine

Dimenoxadol (2-dimethylaminoethyl-1-ethoxy-1,1-diphenylacetate or dimethylaminoethyl1-ethoxy-1,1-diphenylacetate or dimethylaminoethyl diphenyl-alpha-ethoxyacetate)

Dimepheptanol (6-dimethylamino-4,4-diphenyl-3-heptanol)

Dimethylthiambutene (3-dimethylamino-1,1-di(2thienyl)-1-butene)

Dioxyaphetyl Butyrate (ethyl 4-morpholino-2,2-diphenyl-butyrate)

Diphenoxylate (1-(3-cyano-3,3-diphenylpropyl)-4-phenyl-piperidine4-carboxylic acid ethyl ester or 2,2-diphenyl-4[4-carbethoxy-4-phenyl) piperidino]butyronitril)

Dipipanone (4,4-diphenyl-6-piperidine-3-heptanone)

Drotebanol (3,4-dimethoxy-17-methylmorphinan-6 beta, 14 diol)

Ecgonine, its esters and derivatives which are convertible to ecgonine and cocaine. Ethylmethylthiambutene (3-ethylmethylamino-1, 1-di-(2'-thienyl)-1-butene) Ethylmorphine (3-ethylmorphine)

Etonitazene (1-diethylaminoethyl-2-para-ethoxybenzyl-5-nitrobenzimidazole)

Etorphine (7,8-dihydro-7 alpha-[1(R )-hydroxy-1-methylbutyl]-O -methyl-6,14-endoethanomorphine or tetrahydro-7alpha-(1-hydro-1-methyl-butyl)-6,14-endoetheno-oripavine or 1,2,3,3a,8,9-hexahydro-5-hydroxy-2-alpha[1(R )-hydroxy-1-methylbutyl]-3-methoxy-12met

Etoxeridine (1-[2-(2-hydroxyethoxy) ethyl]-4-phenylpiperidine 4-carboxylic acid ethyl ester)

Fentanyl (1-phenethyl-4-N-propionylanilinopiperidine)

Furethidine (1-(2-tetrahydrofurfuryloxyethyl)-4-phenylpiperidine-4-carboxylic acid ethyl ester)

Heroine (diacetylmorphine)

Hydrocodone (dihydrocodeinone)

Hydromorphinol (14-hydroxydihydromorphine)

Hydromorphone (dihydromorphinone)

Hydroxypethidine (4-meta-hydroxyphenyl-1-methylpiperidine-4-carboxylic acid ethyl ester or 1-methyl-4-(3-hydroxy-phenyl)-piperidine- 4-carboxylic acid ethyl ester

Isomethadone(6-dimethylamino-5-methyl-4,4-diphenyl-3-hexanone)

Ketobemidone (4-meta-hydroxyphenyl)-methyl-4-propionyl-piperidine or 4-(3-hydroxyphenyl)-1-methyl-4-piperidyl ethyl ketone or 1-methyl- 4-metahydroxyphenyl-4-propionyl-piperidine)

Levomethorphan ( (-) -3-methoxy-N-methylmorphinan), but not Dextromethorphan( (+)-3-methoxy-N-methylmorphinan)

Levomoramide ( (-)-4-[2-methyl-4-oxo-3,3 diphenyl-4-(1-pyrrolidinyl)butyl] morpholine or (-)-3-methyl-2,2-diphenyl-4-morpholino-butyryl-pyrrolidine)

Levophenacylmorphan ( (-)-3-hydroxy-N-phenacylmorphinan)

Levorphanol ( (-)-3-hydroxy-N-methylmorphinan), but not Dextrophan ( (+)-3-hydroxy-N-methylmorphinan)

Medicinal Opium

Metazocine (2'-hydroxy-2,5,9-trimethyl-6,7-benzomorphan) or 1,2,3,4,5,6-hexahydro-8-hydroxy-3,6,11-trimethyl-2,6-methano-3-benzazocine)

Methadone (6-dimethylamino-4,4-dophenyl-3-heptanone)

Methadone-Intermediate (4-cyano-2-dimethylamino-4,4-diphenylbutane or 2-dimethylamino-4-diphenyl-4-cyano butane)

Methyldesorphine (6-methyl-delta 6-deoxymorphine)

Methyldihydromorphine (6-methyldihydromorphine)

Metaphon (5-methyldihydromorphinone)

Moramide-Intermediate (2-methyl-3-morpholino-1,1-diphenylpropanecarboxylic acid or 1-diphenyl-2-methyl-3-

morpholinopropanecarboxylic acid)

Morpheridine (1-(2-morpholinoethyl)-4-phenylpiperidine-4-carboxylic acid ethyl ester)

Morphine

Morphine Methobromide and other pentavalent nitrogen morphine derivatives, including in particular the morphine N-oxide derivatives, one of which is Codeine-N-Oxide.

Morphine-N-Oxide

Myrophine (myristylbenzylmorphine)

Nicocodeine (6-nicotinylcodeine or 6-(pyridine-3-carboxylic acid)-codeine ester)

Nicomorphine (3,6-dinicotinycodeine or di-nicitinic acid ester of morphine)

Noracymethadol 9 (+)-alpha-3-acetoxy-6-methylamino-4,4-diphenylheptane)

Norcodeine (N-demethylcodeine)

Norlevorphanol ( (-)-3-hydroxymorphinan)

Normethadone (6-dimethylamino-4,4-diphenyl-3-hexanoneor 1,1-diphenyl-1-dimethylaminoethyl-butanone-2 or 1-dimethyl-amino-3,3- diphenyl-hexanon-(4) )

Normorphine (demethylmorphine or N-demethylated morphine)

Norpipanone (4,4-diphenyl-6-piperidino-3-hexanone)

Oxycodone (14-hydroxydihydrocodeinone or dihydrohydroxycodeinone)

Oxymorphone (14-hydroxydihydrocodeinone or dihydrohydroxymorphinone)

Pethidine (1-methyl-4-phenylpiperidine-4-carboxylic acid ethyl ester)

Pethidine-Intermediate-A (4-cyano-1-methyl-4-phenyl-piperidine or 1-methyl-4-cyanopiperidine

Pethidine-Intemediate-B (4-phenylpiperidine-4-carboxylic acid ethyl ester or ethyl 4-phenyl-4-piperidine-carboxylate)

Pethidine-Intermediate-C (1-methyl-4-phenylpiperidine-4-carboxylic acid)

Phenadoxone (6-morpholino-4,4-diphenyl-3-heptanone)

Phenampromide (N-(1-methyl-2-piperidinoethyl) propionanilide or N-[2-(1-methylpiperid-2'yl) ethyl]-propionanilide)

Phenazocine (2'-hydroxy-5,9-dimethyl-2-phenethyl-6,7-benzomorphan or 1,2,3,4,5,6-hexahydro-8-hydroxy-6,11-dimethyl-3-phenethyl-2,6- methano-3-benzazocine)

Phenomorphan (3-hydroxy-N-phenethylmorphinan) Phenoperidine (1-(3-hydroxy-phenylpropyl)-4-phenyl-piperidine-4-carboxylic acid ethyl ester or 1-phenyl-3-(4-carbethoxy-4-phenylpiperidine)-propanol)

Pholcodine (morpholinyethylmorphine or beta-4-morpholinyethylmorphine)

Piminodine (4-phenyl-1-(3-phenylaminopropyl) piperidine-4-carboxylic acid ethyl ester)

Piritramide (1-(3-cyano-3,3-diphenylpropyl)-4-(1-piperidino) piperidine-4-carboxylic acid amide or 2,2-diphenyl-4-[1-(4-carbamoyl-4-piperidino)-] butyronitrile)

Prophetazine 1,3-dimethyl-4-phenyl-4-propionoxyazacy-cloheptane or 1,3-dimethyl-4-phenyl-4-propionoxy-hexamethyleneimine)

Properidine (1-methyl-4-phenylpiperidine-4-carboxylic acid isopropyl ester)

Propiram

Racemethorphan ( (+)-3-methoxy-N-methylmorphinan)

Racemoramide ( (+)-4-[2-methyl-4-oxo-3,3-diphenyl-4-(1-pyrrolidinyl) butyl] morpholine or (+)3-methyl-2,2-diphenyl-4-morpholinobutyrlpyrrolidine)

Racemorphan ( (+)-3-hydroxy-N-methylmorphinan)

Tetrahydrocannabinol

Thebacon (acetyldihydrocodeinone or acetyldemethylodihydrothebaine)

Thebaine

Trimeperidine (1,2,5-trimethyl-4-phenyl-4-propionoxypiperidine).

Part 2

The isomers, unless expressly excepted, and the esters, ethers and salts, including the salts of isomers, esthers of the substances specified in I above.

Part 3

Any extract or tincture of Cannabis

Part 4

Any-

1.  

   (a)     preparation, mixture, extract, or other substance containing any portion of a substance; or

1.  

   (b)     substance that is chemically equivalent or chemically identical to any preparation, mixture, extract, derivative or other substance containing any portion of a substance, specified in I, II and III.

Schedule 2

(Regulation 2)

OVER THE COUNTER MEDICINES AND DIAGNOSTICS

1.  

   Over the counter's are only approved for the conditions below

1.  

   Allergic Response

1.  

   Allergy

1.  

   Analgesics

1.  

   Analgesics (oral)

1.  

   Analgesics (Topical)

1.  

   Cardiovascular

1.  

   Cardiovascular

1.  

   CNS

1.  

   Sleep disturbance (temporary)

1.  

   Smoking cessation

1.  

   Travel Sickness

1.  

   Cough, colds and flu

1.  

   Colds & flu

1.  

   Coughs

1.  

   Sore throats

1.  

   Ears & Eyes

1.  

   Ear problems

1.  

   Eye problems

1.  

   Female Health

1.  

   Cystitis

1.  

   Period Pain and PMS

1.  

   Thrush and Vaginitis

1.  

   Gastro-intestinal

1.  

   Constipation

1.  

   Diarrhea

1.  

   Hemorrhoids

1.  

   Indigestion

1.  

   Irritable Bowel Syndrome

1.  

   Worms

1.  

   Infants

1.  

   Colic

1.  

   Cradle Cap

1.  

   Nappy rash

1.  

   Teething

1.  

   Nutrition

1.  

   Iron preparations

1.  

   Tonics

1.  

   Vitamins and Minerals

1.  

   Oral

1.  

   Oral hygiene

1.  

   Scalp conditions/infestations

1.  

   Hair loss

1.  

   Lice

1.  

   Scalp conditions

1.  

   Sexual health

1.  

   Intercourse

1.  

   Skin Conditions

1.  

   Acne

1.  

   Antiseptics

1.  

   Athletes foot

1.  

   Cold sores

1.  

   Corns and calluses

1.  

   Scabies

1.  

   Skin problems

1.  

   Warts and verrucas

1.  

   Herbal medicines

1.  

   Bladder conditions

1.  

   Colds, flu and sore throats

1.  

   Constipation

1.  

   Coughs

1.  

   First aid

1.  

   Hemorrhoids

1.  

   Indigestion

1.  

   Nausea and Diarrhea

1.  

   Pain relief

1.  

   Scalp and hair care

1.  

   Shin conditions

1.  

   Sleeplessness

1.  

   Slimming

1.  

   Stress

1.  

   Tonic

1.  

   Homeopathic remedies

1.  

   Diagnostics

1.  

   Blood glucose meters

1.  

   Pregnancy or ovulation tests

1.  

   Blood pressure meters

Schedule 3

(Regulation 2)

PHARMACIST ASSISTED DRUGS

1.     Anti-Fungals Clotrimazole (Vaginal) and similar

     Derivatives, Pessaries, Creams, Solution,

     Nystatin Suspension and cream

     Topical-all Imidazole derivatives e.g. Econazole

2.     Antibiotics Muciprocin

3.     Anticholinergics Diphenoxylate/Atropine

     Hyoscine, Propantheline

     Baralgin

4.     Analgesics Dihydroergotamine

     Aminiphenazone, Caffeine

     Orphenadrine, Mefenamic Acid 250mg &

     500mg, Ibuprofen 400mg

5.     EENT Polysporin and similar preparations

     Naphazoline/Anatazoline

     Oxytetracycline eye ointment

6.     Antidotes/Metal

     Antagonists Ipecac Syrup

7.     Adrenal Hormones Triamcinolone 0.025% cream

     Fluocinolone and similar cream or ointment

     Contraceptives Levonorgestrel 0.75mg

Schedule 4

(Regulation 2)

PRESCIPTION ONLY DRUG

1     Antihelmintics

     Thiabendazole (all forms)

2     Antifungals for systemic use

     Ketaconazole

     Amphoteracin B

     Oral Nystatin (tablet)

     Griseofulvin

     Itraconazole and similar derivatives

     All other systemic preparations

3     Antibiotics

     Penicillin derivatives e.g. Penicillin G, Pennicillin V

     Cloxacillin, Amoxicillin etc.

     Erythromycin and other macrolides

     Cephalosporins (1st, 2nd, and 3rd generations)

     Chloramphenicol

     Gentamicin and other aminoglycosides

     Tetracyclines and derivatives

     Sulphonamides e.g. Co-Trimoxazole

     All Anti-Virals e.g. AZT, Acyclovir

4     Anti-Tuberculosis

     Ethambutol

     Isonaizid

     Pyrazinamide

     Rifampicin

     Any combination thereof and other systemic preparations

5     Anti-Trichomonal

     Metronidazole and Derivatives

6     Urinary Tract Anti-Septics

     Nitrofurantoin

     Nalidixic Acid and derivatives

     4-Quinolones e.g. Norfloxacillin, Ciprofloxacillin

7     Anti-Leprotics

     Clofazimine

     Dapsone

     Any other Anti-Leprotic drugs

8     Anti-Neoplastics and Immunosuppressants

     Tamoxifen

     All other Anti-Cancer

9     Cholinergic Agents

     All cholinergic agents

10     Anti-Cholinergics

     Atropine

     Benzhexol (trihexiphenidyl)

     Benztropine and its derivatives

11     Adrenergic Agents

     Adrenaline

     Dopamine

     Isoprenaline

12     Adrenergic Blocking Agents

     Ergot Alkaloids

     Phenoxybenzamine HCl

     Phentolamine Mesylate

13     Skeletal Muscle Relaxants

     Skeletal Muscle Relaxants, whether injectable or oral preparations.

14     Iron Preparations

     Iron Dextran Injection

     Sustained Released high potency iron preparation

15     Anti-Coagulants/Coagulants

     Heparin

     Warfarin

     Protamine Sulphate

     Vitamin K1

16     Cardiac Drugs

     All Drugs used in cardiac conditions.

17     Hypotensive Drugs

     All Hypotensive Drugs

18     General Anesthetics

     All General Anesthetics

19     Analgesics and Anti-Inflammatory Agents

     All agents, except the following

     Ibuprofen 200mg and 400mg (and derivatives of equivalent analgesic potency)

     Codeine 8mg

     Paracetamol 500mg

     Mefenamic Acid 250mg and 500mg

20     Narcotic Antagonists

21     Anti-Convulsants

     All anti-convulsants

22     Psychotherapeutics

     All Anxiolytics

     All Hypnoitics

     All Anti-deprassants

     All drugs used in psychosis and related disorders

23     Diuretics

24     Anti-Gout Agents

25     Eye-Ear-Nose-Throat

     All of those agents except, wax softners, artificial tears, eye cleaners, normal saline and EENT vasoconstrictors.

26     Carbonic Anhydrase Inhibitors

     Acetazolamide

27     Anti-Emetics

     All, except oral and rectal preparations of dimenhydrinate.

28     Miscellaneous G. I. Drugs

     H2 Antagonists

     Omeprazole

     Metoclopropamide,

     Sucralfate

     Misoprostol

29     Antidotes/Metal Antagonists

     All except Fuller's Earth and activated Charcoal

30     Adrenal Hormones (oral, Injectable and Inhalation)

     Beclomethasone

     Dexamethasone

     Hydrocortisone

     Prednisolone

     Prednisone

     Triamcinolone

31     Contraceptives

     Oral Preparations

     Injectables

     Dermal Preparations

     IUD

32     Estrogens

     Norethisterone

33     Androgens

34     Gonadotropins

35     Pituitary Hormones

     Vasopressin

36     Progestins

     Medoxyprogesterone

     Progesterone

37     Anti-Diabetic Drugs

38     Thyroid/Anti-Thyroid Preparations

39     Local Anesthetics

40     Oxytocics

41     Anti-Asthmatics

42     Injectable Vitamins

43     Anti-Parkinsons.