DRUGS AND RELATED SUBSTANCES: SUBSIDIARY LEGISLATION
(previously "HABIT-FORMING DRUGS")

INDEX TO SUBSIDIARY LEGISLATION

Declaration of Habit-Forming Drugs Order

Drugs and Related Substances Regulations

Habit-Forming Drugs (Exempted Preparations) Regulations

Habit-Forming Drugs Regulations

HABIT-FORMING DRUGS REGULATIONS

(under section 12)

(3rd October, 1922)

ARRANGEMENT OF REGULATIONS

   REGULATION

   1.   Citation

   2.   Export of habit-forming drugs

   3.   Form of permit

      First Schedule - Permit to Export Opium or other Habit-Forming Drugs

      Second Schedule - Permit to Import or Acquire Habit-Forming Drugs

HCN 68, 1922,
HCN 87, 1922,
HCN 195, 1937,
HMC Order 1, 1963,
L.N. 84, 1966,
S.I. 12, 1977.

1.   Citation

   These Regulations may be cited as the Habit-forming Drugs Regulations.

2.   Export of habit-forming drugs

   Any duly registered medical practitioner, dentist or chemist and druggist, and any duly qualified veterinary surgeon who is desirous of exporting from Botswana any habit-forming drug as defined in the Act (other than prepared opium as defined in the Act), shall-

   (a)   furnish to the Minister a certificate from the government or administration of the importing country to the effect that such government or administration is satisfied that the consignment of such habit-forming drug is required solely for medicinal or scientific purposes, and that it approves of its importation;

   (b)   obtain from the Minister a permit under section 4(4) of the Act in the form in the First Schedule hereto.

3.   Form of permit

   The form of permit to import or acquire habit-forming drugs as provided for in section 5(1) of the Act shall be as contained in the Second Schedule hereto.

FIRST SCHEDULE
PERMIT TO EXPORT OPIUM OR OTHER HABIT-FORMING DRUGS

   Permission is hereby granted to ........................ of ....................................... to export from Botswana to ..................................................................... the following habit-forming drugs, to wit: ................................................................................................................................ for medicinal or scientific purposes only.

   This Permit will expire on the ..........................................................................................

   Dated this .................................. day of ............................................... 20....................

...................................................................
Minister

This Permit is not transferable.

SECOND SCHEDULE
PERMIT TO IMPORT OR ACQUIRE HABIT-FORMING DRUGS

...................................................................
(Sgd.)

   Mr. ................................................................................................. profession/business

address ........................................................................................................................... is hereby authorized to import or acquire the undermentioned habit-forming drugs in the quantities specified opposite such item

Drug

Quantity

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


   It is a condition of this permit that drugs imported or acquired hereunder shall not be used by the person to whom the permit is issued otherwise than for medicinal or scientific purposes or for the purpose of being sold or supplied to some other person in accordance with the provisions of the Habit-forming Drugs Act.

Dated this ............ day of ........................................... 20 .....................

Gaborone

HABIT-FORMING DRUGS (EXEMPTED PREPARATIONS) REGULATIONS

(under section 12)

(10th November, 1937)

ARRANGEMENT OF REGULATIONS

   REGULATION

   1.   Citation

   2.   Exempted drugs

      Schedule

HCN 195, 1937.

1.   Citation

   These Regulations may be cited as the Habit-forming (Exempted Preparations) Regulations.

2.   Exempted drugs

   The preparations listed in the Schedule shall be exempted from the provisions of the Act.

SCHEDULE

   Cereoli Iodoformi et Morphinae B.P.C. 1923

Iodoform and Morphine Bougies.

   Emplastrum Opii B.P. 1898

Opium Plaster.

   Linimentum Opii B.P.C.

Liniment of Opium.

   Linimentum Opii Ammoniatum B.P.C. 1923

Ammoniated Liniment of Opium.

   Pasta Arsenicalis B.P.C.

Arsenical Paste.

   Pilulae Hydrargyri cum Opio B.P.C. 1923

Mercury and Opium Pills.

   Pilulae Ipecacuanhae cum Scilla B.P.C.

Pills of Ipecacuanha with Squills.

   Pilulae Plumbi cum Opio B.P.C.

Lead and Opium Pills.

   Pilulae Digitalis et Opii Compositae B.P.C. 1923

Compound Digitalis and Opium Pills.

   Pilulae Hydrargyri cum Creta et Opii B.P.C.

Pills of Mercury with Chalk and Opium.

   Pulvis Cretae Aromaticus cum Opio B.P.

Aromatic Powder of Chalk and Opium.

   Pulvis Ipecacuanhae et Opii B.P.

Dovers Powder.

   Pulvis Ipecacuanhae Compositus B.P. 1914.

   Pulvis Kino Compositus B.P.C.

Compound Kino Powder.

   Suppositoriae Plumbi cum Opio B.P.

Compound Lead Suppositories.

   Tablettae Plumbi cum Opio B.P.C. 1923

Lead and Opium Tablets.

   Unguentum Gallae cum Opio B.P.C.

Gali and Opium Ointment.

   Unguentum Gallae Compositum B.P.C. 1923

Compound Gall Ointment.

   Eyedrops for inclusion in first-aid outfits consisting of a solution of 1 in 3,000 Perchloride of Mercury in Castor Oil with 0,5 per centum of Cocaine.

   (NOTE. Codeine and its salts are excluded from this list.)

DECLARATION OF HABIT-FORMING DRUGS ORDER

(under section 14)

(2nd April, 1982)

ARRANGEMENT OF PARAGRAPHS

   PARAGRAPH

   1.   Citation

   2.   Declaration of habit-forming drugs

      First Schedule

      Second Schedule

S.I. 36, 1982,
S.I. 35, 1987.

1.   Citation

   This Order may be cited as the Declaration of Habit-forming Drugs Order.

2.   Declaration of habit-forming drugs

   (1) The substances specified in the First Schedule hereto are hereby declared to be habit-forming drugs.

   (2) The substances specified in the Second Schedule are specifically excluded from the list of habit-forming drugs.

FIRST SCHEDULE

   Acetorphine

   Acetylmethadol

   Alfentanil

   Allylprodine

   Alphameprodine

   Alphamethadol

   Alphaprodine

   Amphetamine

   Anileridine

   Benzethidine

   Benzylmorphine

   Betacetylmethadol

   Betameprodine

   Betamethadol

   Betaprodine

   Bezitramide

   Cannabis (Indian Hemp) and Cannabis resin (Resin of Indian Hemp)

   Clonitazene

   Coca Leaf

   Cocaine

   Codoxime

   Concentrate of poppy

   Desomorphine

   Dexamphetamine

   Dextromoramide

   Diampromide

   Diethylthiambutene

   Difenoxin

   Dihydromorphine

   Dimenoxadol

   Dimepheptanol

   Dimethylthiambutene

   Dioxaphetyl butyrate

   Diphenoxylate

   Dipipanone

   Drotebanol

   Ecgonine, its esters and derivatives which are convertible to ecgonine and cocaine

   Ethylmethylthiambutene

   Etonitazene

   Etorphine

   Etoxeridine

   Fentanyl

   Furethidine

   Heroin

   Hydrocodone

   Hydromorphinol

   Hydromorphone

   Hydroxypethidine

   Isomethadone

   Ketobemidone

   Levomethorphan

   Levomoramide

   Levophenacylmorphan

   Levorphanol

   Mecloqualone

   Metazocine

   Methadone

   Methadone-Intermediate

   Methamphetamine

   Methaqualone

   Methyldesorphine

   Methyldihydromorphine

   Methylphenidate

   Metopon

   Moramide-Intermediate

   Morpheridine

   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

   Nicomorphine

   Noracymethadol

   Norlevorphanol

   Normethadone

   Normorphine

   Norpipanone

   Opium

   Oxycodone

   Oxymorphone

   Pethidine

   Pethidine-Intermediate - A

   Pethidine-Intermediate - B

   Pethidine-Intermediate - C

   Phenadoxone

   Phenampromide

   Phenazocine

   Phencyclidine

   Phenmetrazine

   Phenomorphan

   Phenoperidine

   Piminodine

   Piritramide

   Proheptazine

   Properidine

   Racemethorphan

   Racemoramide

   Racemorphan

   Sufentanil

   Thebacon

   Thebaine

   Tilidine

   Trimeperidine

   The isomers, unless specifically excepted, of the drugs in this Schedule whenever the existence of such isomers is possible within the specific chemical designation.

   The esters and ethers of the drugs in this Schedule whenever the existence of such esters or ethers is possible.

   The salts of the drugs listed in this Schedule, including the salts of esters, ethers and isomers as provided above whenever the existence of such salts is possible.

SECOND SCHEDULE

   Dextromethorphan ((+) -3 methoxy-N-methylmorphinan) and dextrophan ((+)-3-hydroxy-N-methylmorphinan) are isomers specifically excluded from the First Schedule.

DRUGS AND RELATED SUBSTANCES REGULATIONS

(under section 21)

(16th April, 1993)

ARRANGEMENT OF REGULATIONS

   REGULATION

   1.   Citation

   2.   Drugs Advisory Board

   3.   Registration of drugs

   4.   Exemption from registration

   5.   Approval for the manufacture, etc. of drugs

   6.   Records to be kept by manufacturer of drugs

   7.   Import, export and distribution of drugs

   8.   Labelling of drugs

   9.   Recall of drugs

   10.   Prescription of drugs

   11.   Dispensing of Schedule 1A and 1B drugs

   12.   Dispensing of Schedule 1C drugs

   13.   Dispensing of Schedule 2 drugs

   14.   Dispensing of drugs by nurses

   15.   Dispensing, general

   16.   Emergency supply of drugs

   17.   Registers and records

   18.   Clinical trials

   19.   Appeals

   20.   Classification of drugs

   21.   Prescribed habit-forming drugs

   22.   Forms

      First Schedule

      Second Schedule

      Third Schedule - Forms

S.I. 46, 1993,
S.I. 105, 2015.

1.   Citation

   These Regulations may be cited as the Drugs and Related Substances Regulations.

2.   Drugs Advisory Board

   (1) In accordance with the provisions of section 5 of the Drugs and Related Substances Act, 1992, there is hereby established a Drugs Advisory Board, hereinafter referred to as "the Board", for the purposes specified in that section.

   (2) The Board shall consist of the following persons or their alternates appointed by the Minister-

   (a)   a hospital pharmacist;

   (b)   a physician in the service of the Government;

   (c)   a district medical officer;

   (d)   a quality control pharmacist in the service of the Government;

   (e)   a duly registered medical practitioner from the private sector;

   (f)   a registered pharmacist from the private retail sector;

   (g)   a pharmacist from the Drugs Regulatory Unit; and

   (h)   such other members as the Minister may determine.

   (3) Members of the Board shall hold office for a period of three years, but shall be eligible for re-appointment, and the Minister may at any time revoke the appointment of any member, or may grant leave of absence to any member, if he thinks it desirable or expedient to do so.

   (4) The appointment, resignation or the revocation of the appointment of any member of the Board shall be notified by the Minister by notice in the Gazette.

   (5) The Minister shall appoint a public officer to be the Secretary of the Board.

   (6) The Board shall elect from amongst its members a Chairman to preside over meetings of the Board, and a Deputy Chairman to act as Chairman whenever the substantive holder of the post is unable to attend.

   (7) The Board shall meet at such times, and as often as may be necessary or expedient for the proper carrying out of its duties under the provisions of the Act:

   Provided that intervals between meetings of the Board shall never be greater than three months.

   (8) The Board may co-opt one or more persons qualified or able to assist it or advise it in its functions under the Act, to attend any meeting or meetings of the Board, but such person or persons may not vote on any matter before the Board.

   (9) The members of the Board and any expert assisting the Board shall observe and preserve the confidentiality of all matters coming before the Board, and such professional discretion shall subsist even after the termination of their terms of office or of their expert mandates .

   (10) The Secretary shall keep minutes of each meeting of the Board, which shall be submitted for acceptance at the next meeting of the Board.

   (11) Except as is otherwise provided in this regulation, the Board shall be responsible for regulating its own proceedings.

3.   Registration of drugs

   (1) An application to register a drug, or for the renewal of such registration, shall be made to the Director in Form 1 in the Schedule hereto and shall be accompanied by a fee of P800 for a drug which is imported, P400 for a drug which is partially locally manufactured and P200 for a drug which is totally locally manufactured.

   (2) The Director shall submit any such application to the Board, together with his own recommendations and any relevant comments, for consideration by the Board, and he shall abide by any advice tendered by the Board.

   (3) Where a drug is approved for registration, or for renewal of registration, the Director shall issue to the applicant a certificate of registration in Form 2 in the Schedule, and if the drug is not approved for registration or renewal of registration, he shall so inform the applicant, giving the reasons for such disapproval, at the same time informing the applicant of his right to appeal against such disapproval.

   (4) Where a drug is approved for registration, or re-registration, subject to conditions, the applicant shall be informed of such conditions and shall comply therewith.

   (5) A certificate of registration shall be valid for five years or such lesser period as the Director may, in any particular case specify, and provided that an application for the renewal of registration is made at least six months before the date of expiry, such validity shall extend until a decision is made and communicated to the applicant.

   (6) When a drug is registered, the following information shall be recorded in the drug register kept by the Director in accordance with section 3(2) of the Act-

   (a)   the name of the drug approved;

   (b)   the registration number allocated to the drug;

   (c)   the approved chemical name or international non-proprietary name (INN) of each active ingredient of the drug, and the quantity thereof contained in a dosage unit or per suitable mass or volume or unit of the drug;

   (d)   the dosage form of the drug;

   (e)   the conditions of registration of the drug;

   (f)   the name of the applicant; and

   (g)   the date of registration of the drug.

4.   Exemption from registration

   (1) The following drugs shall be exempted from registration-

   (a)   any drug manufactured or imported by the Central Medical Stores for specific therapeutic use;

   (b)   any drug imported through the Central Medical Stores as a donation to the Government or to a Government hospital or to a hospital run by a Mission for use in that hospital;

   (c)   any drug imported under the authority of the Director, or any person authorized by him, for experimental use in hospitals or for specific therapeutic use or scientific research or tests;

   (d)   any drug prepared extemporaneously by a pharmacist for use as prescribed by a medical practitioner;

   (e)   any non-scheduled herb used for traditional medicine and exempted by the Director;

   (f)   any preparation not containing active ingredients in excess of one millionth part of the preparation's own weight.

   (2) The prior approval by the Director shall be sought in the circumstances specified in paragraphs (a) and (b) of subregulation (1), but where this is not practical such approval shall be sought as soon as is, in the circumstances, reasonably possible thereafter.

   (3) The Director shall make records of exempted drugs imported or manufactured under the provisions of paragraphs (a), (b) and (c) of subregulation (1), the quantity imported and the name and address of the person or organization who imported or manufactured any such drug.

5.   Approval for manufacture etc. of drugs

   (1) Any person wishing to manufacture, import, export, distribute or sell drugs shall apply to the Director for approval in Form 3 in the Schedule, accompanied by a fee of P50, and the approval of the Director, if given, shall be in Form 4 in the Schedule.

   (2) If an application is not approved, the Director shall so inform the applicant, giving the reasons for such refusal.

   (3) Any approval shall be valid for a period of five years, or such lesser period as may, in any particular case, be specified by the Director, and provided that an application for the renewal of approval is made at least two months before the date of expiry of such approval, the validity thereof shall extend until a decision is made and communicated to the applicant.

6.   Records to be kept by manufacturer of drugs

   (1) A manufacturer of drugs shall keep and maintain and hold readily available for inspection, comprehensive records containing details of-

   (a)   all steps taken in the storage and testing of raw materials;

   (b)   all steps taken in the manufacture of each batch of drugs;

   (c)   all tests carried out on representative samples; and

   (d)   the sale and distribution of each batch of drugs.

   (2) The records required to be kept in accordance with subregulation (1) shall be retained for at least 5 years from the date of manufacture, or for one year from the date of expiry of the relevant batch of drugs, whichever is the longer.

   (3) The manufacturer shall, without any undue delay, report in writing to the Director any intention-

   (a)   to change the process of manufacture, or the method of testing any drug; or

   (b)   to alter materially the establishment, where such alteration will or is likely to affect the conditions under which approval for the manufacture of drugs was given.

7.   Import, export and distribution of drugs

   (1) Importers, exporters and distributors of drugs (and for the purpose of this regulation "distributor" includes wholesaler and retailer, and "distribution" shall be construed accordingly) shall keep and maintain records containing all details of the importation, wholesale and distribution of drugs by them, and such records shall be retained and kept available for inspection by a police officer, or by any person so authorized therefor by the Director for a period of at least five years from the date of each relevant entry.

   (2) Any person wishing to import or export a Schedule 1A, 1B or 1C drug shall-

   (a)   in the case of import, apply for the approval of the Director therefor on Form HFD 1 in the Schedule, and any such approval shall be given on Form HFD 2 in the Schedule specifying such quantities of the drug as may be so imported, and any such approval shall be valid for three months, or such lesser period as may be specified therein; or

   (b)   in the case of export, apply for the approval of the Director on Form HFD 3 in the Schedule, and any such approval shall be given on Form HFD 4 in the Schedule specifying such quantities of the drug as may be exported out of Botswana, and any such approval shall be valid for three months, or such lesser period as may be specified therein.

   (3) The export, import and distribution of all drugs other than Schedule 4 drugs shall be-

   (a)   in a private pharmacy, a referral or district hospital pharmacy, a private hospital pharmacy or in any other place authorized by the Director to sell such drugs, under the control of a pharmacist;

   (b)   in a private medical practice or surgery or in a Government primary hospital, under the control of a pharmacy technician under the supervision of the medical practitioner concerned or of a medical officer, as the case may be;

   (c)   in a private dental surgery or practice, under the control of the dentist in charge; or

   (d)   in a clinic or health post, under the control of a registered or enrolled nurse approved by the Director.

8.   Labelling of drugs

   (1) The container of every drug imported, manufactured, processed or packed in Botswana shall bear a label written in English, with the following information clearly indicated thereon-

   (a)   either the approved name of the drug as used in official pharmacopoeias or formularies, or the international non-proprietary name;

   (b)   the brand name, if any;

   (c)   the contents of the container;

   (d)   the quantity of active ingredients per dosage unit;

   (e)   the name of the manufacturer;

   (f)   the batch identification;

   (g)   the expiry date;

   (h)   any special storage conditions that may be necessary or desirable;

   (i)   any warnings or precautions that may be necessary or desirable;

   (j)   any directions for use if sold without prescription; and

   (k)   any appropriate statutory or restrictive direction or label in the Schedule that may be necessary.

   (2) In any special circumstances the Director may, where he considers it desirable, exempt any particular consignment of drugs from the requirements of subregulation (1).

   (3) The container of every drug dispensed to a patient shall have a label bearing the following information-

   (a)   the full name of the patient;

   (b)   the date of dispensing;

   (c)   the name of the pharmacy or other health facility dispensing it;

   (d)   all information required for the purposes of subregulation (1) with the exception of paragraphs (b), (e) and (f) thereof.

   (4) The container of any drug exempted from registration shall as far as possible bear the information required under subregulation (1).

   (5) In respect of those drugs listed in regulation 21, against which a label and a number in parenthesis is indicated, any such drug shall bear a label giving information or instructions in accordance with the following-

Label
number
Word Content
(1)"Contains aspirin" (unless name of product includes word "aspirin"); plus "If symptoms persist, consult your doctor"; plus the recommended dosage; plus "Do not use on children under 12 years except on medical advice."
(2)"Contains an aspirin derivate"; plus "If symptoms persist, consult your doctor"; plus the recommended dosage.
(3)"Contains paracetamol" (unless the name of the product includes the word "paracetamol"); plus "If the symptoms persist, consult your doctor"; plus "Do not exceed the stated dose"; plus the recommended dosage.
(4)"Warning. Asthmatics should consult their doctor before using this product."
(5)"Warning. May cause drowsiness. If affected do not drive or operate machinery. Avoid alcoholic drink."
(6)"Not to be used for babies" or "Not to be administered, except on medical advice, to a child under two years."
(7)"Oral Rehydration Therapy is recommended in all forms of diarrhoea."
(8)"For external use only." This cautionary wording should be used if a product is an embrocation, liniment, lotion, liquid antiseptic or other liquid preparation or gel for external application.
(9)"Warning. Do not exceed the stated dose." This cautionary wording should be used on pharmacy drugs (P) exempted from POD requirements by reason of the proportion or level in such product of any substance, and which are not for external use.

9.   Recall of drugs

   Whenever the Director finds that any portion of any batch of drugs does not conform to the standards of identity, strength, quality and purity, or any other requirement specified in the documentation for registration, he may instruct the licensee to discontinue the sale of the remainder of the batch and, so far as is practicable, to recall any portion of the batch already sold.

10.   Prescription of drugs

   (1) Prescriptions of drugs shall be written in generic or approved international non-proprietary names (INN) except when a particular brand of drug is preferred and clinically acceptable reasons for such preference are communicated to the dispenser.

   (2) Where a prescription is written using a generic or approved international non-proprietary name the least expensive drug of that description in the pharmacy shall be sold or dispensed for that prescription.

   (3) In granting limited powers of prescription of Schedule 1, 2 and 3 drugs under section 9(2) of the Act, the Director may grant to-

   (a)   registered nurses in hospitals or Government clinics specializing in medical fields such as ophthalmology, psychiatry, midwifery, or as a registered family nurse practitioner, power to prescribe only those drugs specific to their speciality or training and, where applicable, which are specified for them in the Botswana National Drug Formulary;

   (b)   registered nurses and enrolled nurses in Government clinics and health posts, power to prescribe only those drugs which are specified for them in the Botswana National Drug Formulary;

   (c)   dental therapists, power to prescribe only those drugs specified for them in the Botswana National Drug Formulary; and

   (d)   registered pharmacists power to prescribe drugs only in the circumstances referred to in regulation 12.

11.   Dispensing of Schedule 1A and 1B drugs

   (1) Schedule 1A and 1B drugs may only be dispensed or sold by a pharmacist upon a written prescription, by a medical practitioner or dentist, presented for dispensing within thirty days of the date of its issue, and for the supply of a quantity not greater than is indicated on the prescription, which shall not in any case exceed thirty days supply, and any such prescription shall be retained in the pharmacy for a period of three years after the date of dispensing.

   (2) The dispenser or seller of a Schedule 1A or 1B drug shall enter a record of such sale or dispensing, as the case may be, in an appropriate register, which register shall be kept for a period of five years after the last relevant entry therein.

   (3) Separate registers shall be kept for Schedule 1A drugs and for Schedule 1B drugs.

   (4) Except when being administered to a patient, every Schedule 1A and Schedule 1B drug shall be kept under safe custody in a lockable cabinet or in a safe.

   (5) The destruction of any Schedule 1A or Schedule 1B drug, in part or whole, shall be reported in writing to the Director, and, except where the destruction is accidental, shall be supervised by a pharmacist and witnessed by a police officer.

12.   Dispensing of Schedule 1C drugs

   Schedule 1C drugs may only be dispensed or sold by a pharmacist upon a written prescription of a medical practitioner or dentist presented for dispensing within thirty days from the date of issue thereof, and for the supply of a quantity of the drug not in excess of that indicated on the prescription, and in any case not exceeding thirty days supply, and any such prescription shall be retained in the pharmacy for a period of not less than three years from the date of the last sale or dispensing:

   Provided that where the prescribing medical practitioner or dentist is personally known to the dispensing pharmacist and is confirmed as being a medical practitioner or dentist, and the pharmacist is satisfied that it is impossible or impracticable to obtain a written prescription within a time that is reasonable in all the circumstances, he may dispense a prescription made by telephone or fascimile, in quantities not exceeding those stated above, on condition that a written prescription will be provided within 48 hours.

13.   Dispensing of Schedule 2 drugs

   Schedule 2 drugs may be dispensed-

   (a)   in referral hospitals, district hospitals, mission hospitals, mine hospitals or private hospitals by a pharmacist or an intern pharmacist, or by a pharmacy technician under the supervision of a pharmacist, and upon a written prescription issued by a medical practitioner or a dentist;

   (b)   in a retail pharmacy by a pharmacist, or by a pharmacy technician under the supervision of a pharmacist, and upon a written prescription issued by a medical practitioner or a dentist; or

   (c)   in a private medical practice or surgery or a Government primary hospital, by a pharmacy technician upon a written prescription issued by a medical practitioner or a medical officer.

14.   Dispensing of drugs by nurses

   Notwithstanding regulations 11, 12 and 13, registered and enrolled nurses in referral, district, primary, mine, mission and private hospitals, clinics, health posts and mobile clinics, may, in the exercise of their duties, dispense Schedule 1A, 1B, 1C, 2 and 3 drugs to patients, upon written prescription by a medical practitioner or a dentist.

15.   Dispensing general

   (1) The dispenser of any drug shall not dispense a quantity thereof greater than the amount stated in the prescription.

   (2) A prescription may be repeated without further prescription if it is so endorsed by the prescriber.

   (3) Except as is otherwise provided in these Regulations or where a shorter period is endorsed thereon, a prescription shall be valid for dispensing for a period not exceeding twelve months from the date of issue.

   (4) The dispenser of a drug shall endorse on the prescription the date when it is dispensed, the quantity dispensed, and shall append his signature thereto.

16.   Emergency supply of drugs

   (1) In an emergency a Schedule 2 drug can be supplied or dispensed as provided in regulation 13, but without a prescription if-

   (a)   there is an immediate need for the drug requested to be supplied and it is impracticable in the circumstances to obtain a prescription; or

   (b)   the treatment with the drug has on a previous occasion been prescribed for the person requesting it.

   (2) The quantity of the drug to be supplied in accordance with subregulation (1) shall not exceed five days' treatment:

   Provided that-

   (a)   where the drug in question is an ointment, a cream or an aerosol for the relief of asthma, which has been made up for sale in a container elsewhere than at the place of supply, the dispenser may supply the smallest pack available;

   (b)   where the drug in question is an oral contraceptive, the dispenser may supply a sufficient quantity for a full cycle; or

   (c)   where the drug required is in such a package that it is impractical to split the package, the whole package may be supplied.

17.   Registers and records

   (1) Separate registers shall be kept for Schedule 1A and Schedule 1B drugs.

   (2) Registers to be kept by the manufacturer, seller, importer, exporter or distributor of such drugs shall contain the following information, as appropriate-

   (a)   the approved name and quantity of the drug concerned;

   (b)   the name and business address of the supplier;

   (c)   the date on which the drug was received;

   (d)   the import permit number in the case of imports;

   (e)   the export permit number in the case of exports;

   (f)   the name and business address of the purchaser;

   (g)   the date of sale of the drug;

   (h)   the invoice or reference number of such sale.

   (3) Registers to be kept by the dispenser of such drugs in accordance with regulation 11(2) shall contain the following information, as appropriate-

   (a)   the approved name and quantity of the drug concerned;

   (b)   the name and business address of the supplier;

   (c)   the date on which the drug was received;

   (d)   the import permit number in the case of imports;

   (e)   the name and address of the person to whom the drug was dispensed;

   (f)   the prescription number or reference number upon which the drug was dispensed;

   (g)   the date of such dispensing;

   (h)   the name and address of the prescriber.

   (4) All invoices for the purchase or supply of Schedule 1A, 1B and 1C drugs shall be kept for a minimum of five years.

   (5) All registers or records required to be kept under this regulation must be retained for a period of five years after the date of the last relevant entry, and shall be kept available for inspection by authorized officers.

   (6) All registers and records required to be kept under these Regulations shall be balanced at the end of every calendar month.

18.   Clinical trials

   (1) Clinical trials of drugs means studies in humans or animals in order to systematically generate new or verify existing information about their efficacy and their side effects, and also studies relating to their absorption in, metabolism and excretion from the human or animal body.

   (2) Any person wishing to conduct a clinical trial of a drug shall submit to the Director an application signed by the applicant, and if the Director approves he shall issue a written authorization permitting the applicant to conduct such trial, with or without such conditions or directions as he may specify.

   (3) To ensure protection of the general public against any risk or adverse effects from the clinical trial of any drug the Director shall monitor the trial from the beginning to the end so as to satisfy himself that all specific and general conditions or directions subject to which the trial was authorized are being strictly observed by the person conducting the trial, and that to all intents and purposes the trial will achieve its aims and objectives.

   (4) If at any stage during the clinical trial of any drug the Director is satisfied that, having due regard to the initial risks, discomforts or other adverse effects caused to persons taking part in the trial, it is in the public interest immediately to stop or suspend the trial, he may, in writing, so notify the person conducting the trial, who shall immediately comply with such notice.

   (5) Where a clinical trial is to be conducted in a hospital or other medical institution, the application therefor shall be countersigned by the medical superintendent, or by a senior medical officer of comparable rank of such hospital or medical institution.

   (6) Any person who is aggrieved by a decision of the Director not to grant approval for the conduct of a clinical trial may appeal against such decision to the Minister.

19.   Appeals

   Any appeal lodged in accordance with the provisions of section 14 of the Act or regulation 18(6) shall be lodged within thirty days after the date when the decision appealed against is communicated to the applicant.

20.   Classification of drugs

   For the purposes of the Act and these Regulations drugs shall be classified in accordance with the lists set out in the First Schedule.

21.   Prescribed habit-forming drugs

   For the purposes of the definition of "habit-forming drug", section 3(1)(b) and Part III of the Act the drugs listed in the Second Schedule are declared to be banned habit-forming drugs.

22.   Forms

   The forms to be used for the purposes of the Act shall be in accordance with the forms set out in the Third Schedule.

FIRST SCHEDULE

(reg. 20)

(1) SCHEDULE 1 DRUGS

Category

Acetorphine; its salts; its esters and ethers; their salts

1A

Acetorphine hydrochloride

1A

Acetyldihydrocodeine; its salts


but if for non-parenteral use and:

1A

   (a)   in undivided preparations with ms 2.5% (calculated as base: Schedule 2)

1D

   (b)   in single-dose preparations with ms per dosage unit 100mg (calculated as base: Schedule 2)

1D

Acetyl-methadol see Methadyl acetate

Alfentanil

1A

Allobarbital

1C

Allylprodine; its salts

1A

Alphacetylmethadol; its salts; its esters and ethers; their salts

1A

Alphameprodine; its salts

1A

Alphaprodine; and its salts

1A

Amferpramone

1B

Amidone see Methadone

Alphamethadol; its salts, its esters and ethers; their salts

1A

Amphetamine; its salts

1A

Amphetamine phosphate

1A

Amphetamine sulphate

1A

Amylobarbitone

1B

Amylobarbitone sodium

1B

Anileridine; its salts

1A

Barbitone

1C

Barbitone sodium

1C

Benzethidine; its salts

1A

Benzphetamine; its salts

1B

Bezphetamine hydrochloride

1B

Benzylmorphine; its salts; its esters and ethers; their salts

1A

Benzylmorphine hydrochloride

1A

Betacetylmethadol; its salts

1A

Betameprodine; its salts

1A

Betamethadol; its salts; its esters and ethers; their salts

1A

Betaminoisopropylbenzene see amphetamine

Betaprodine; its salts

1A

Bezitramide; its salts

1A

Bromazepam

1C

Buprenorphine

1B

Buprenorphine hydrochloride

1B

Butalbital

1B

Butobarbitone

1C

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