Source document: https://docs-lawep.s3.us-east-2.amazonaws.com/1697630985637.pdf (Antigua and Barbuda)
ANTIGUA AND BARBUDA THE PHARMACY REGULATIONS, 2012 STATUTORY INSTRUMENT 2012, No.

45 INNtshed the officIal Gafette Aro.

23 duice/ ?.516 March, Nil 3] Printed at the Citan ernment Printing Office, Antigua and Barbuda, Li); Ralph George, GoVLIIMICIII Printer Ry A uthority, 20 I 3.

600 I (Price S42.501 2012, No.

45 3 The Phannacv Regulations, 2012 Regulations I.

Short title_ 2.

Interpretation.


THE PHARMACY REGULATIONS, 2012 ARRANGEMENT PARE I PRELIMINARY PART II APPLICATION FOR REGISTRATION LICENSING OF PREMISES AND SALE OF POISONS PART III 3.

Application.

4.

Registration as a pharmacy student 5.

Registration as a pharmacist.

6.

Other rth&- istration, pharmacy technician.

7.

Notification.

8.

Parheolars of registration.

9.

Registration certificate.

10.

Application for licence for pharmacy.

1 I.

Registration of wholesalers.

12.


Application for licence to sell poisons.

13.

Inspection of licensed premises.

14.

Registration of licensed premises.

15.

Register of pharmacies and wholesalers.

lb.

Complaints.

17.Professionnl misconclue I.

18.

Board to investigate complaint.

19.

Notification here evidence is insufficient.

PART IV PROFESSIONAL MISCONDUCT The Pharmacy Regulations.

2012 4 2012.

No.

45 20.

Procedure '\ here evidence is sufficient.

2 I.


Rights of accused.

22.

Expenses.

23.

Ex parte hearings_ 24.

Councils decision.

25.

Notification of decision.

26.

Right of appeal.

27.

Removal of convicted pharmacist from register.

PART V AUTHORIZED SELLERS OF POISONS 7 8.

Schedule of poisons.

29.

Seller of poisons.

30.

Registration as authorized seller of poisons.

31.

Certificate of registration.

32.

Register of authorized sellers.

33.

Display of certificate.

34.Annual fee.

35.


Cancellation of registration.

36.

Sale and labelling of poisons.

37.

I landIing of poisons.

38.

Transport of poisons.

39.

Sale orArsonic 40.

Proscription.

41.

Compounding and dispensing.

42.

Number of times of dispensing.

43.

Prescription verbal communication.

44.

Prescription record.

45.

Arranged storage.

46.

Opium Tincture.

PART VI DISPENSING 2012, No, 45 The PhormacT Regulations, 2012 47.

Repeat prescriptions.

48.


Sale of therapeutic substances.

49.

Emergency prescriptions.

50.

Public notification and recovery of drugs.

51.

Certificate lost or destroyed.

Si Fees paid into the consolidated {Mid 53.

Penalty.

PART VII MISCELLANEOUS Schedules SCHEDULE I SCHEDULE 2 SCHEDULE 3 SCHEDULE 4 The Pk?, mati Regulations, 2012 6 2012, No, 45 ANTIGUA AND BARBUDA THE PHARMACY REGULATIONS.

2012 2012, No.
2012 2012, No.

45 THE PHARMACY REGULATIONS made in exercise of the powers contained in section 28 oldie Pharmacy Act, 1995.

PART I PRELIMINARY These Regulations may be cited as the Pharmacy Regulations, 2012.

I.

 Short title.

2.

Interpretation.
In these Regulations — "Act" means the Pharmacy Act, 1995; "approved" means approked by the Council; "Board of Inspectors - means the Board of Inspectors constituted under section 16 of the Act: - College" means the Antigua State College, or any other institution approved by the Council for the training of pharmacists; "Community" means the Caribbean Community including the CAR1COM Single Market and Economy established by the Treaty; "Council- means the Council established under section 3 of the Act; "generic drug" means any unpatented drug and includes a drug whose patent has expired or one that has never been patented; - generic name" means the official name or international non-proprietary nornenclature; - Member State" means a Member Slate of the Community listed in Schedule I.
"pharmacy programme" means the prograinme for pharmacy studies offered at the College; "registered medical practitioner" means a person registered under the Medical Practitioners Act, 2009 No.

3 of 2009; "Treaty" means the Revised Treaty of C:haguaramus establishing the Caribbean Community including the CARICOM Single Market and Economy signed at Nassau, The Bahamas on the 5th day of July, 2001; and "Lru ersitv" means an institution, at which a person may read for a degree in pharmacy, that 2012.

No.
No.

45 7 The Pharmacy , Regulations, 2012 is approved by the Council.

PART II APPLICATION FOR REGISTRATION An application under the Act shall be made in the prescribed form and accompanied by the pri.

3.

Application.

scribed Fees.

4.

Registration as a pharmacy student.


he Council shall approve the registration olan applicant as a pharmacy student where theapplicant has been accepted for the pharmacy programme of a College for a course of studyin pharmacy; and air has made an application in Form A of Schedule 3 and paid the prescribed Re.

5.

Registration as a pharmacist.


applicant — (I ) The COU116 shall apptm e the registration of all applicant as a pharmacist where the (t0 is the holder of a degree or diploma in Pharmacy from a University or College recognized by the Council; Or has produced a Medical Certificate of .
fitness from a registered medical practitioner stating that he is physically fit and mental]) sound to perform the duties of a phar- macist; (Cl has satisfied the requirements of section 7 of the Act; (a) ifas produced the documents required under section 8 ti the Act; (or has made an application in Form 13 of Schedule 3 and paid the prescribed tee; and (I) in the case of a tan\ It trained applicant has satisfied a period of internship for Si' months supervised by the Council.
(2) A person leg' sieved as a pharmacist shall pay the annual licence fee as prescribed in Schedule 1 (3) Alter the initial licence is granted and prior to the issue of each licence thereafter, ii pharmacist applying for a licence is required to complete twela c ( / 2) hours of a continuing educa- tion programme approved by or facilitated by the Council.

The PluIrmact• Regulations 2012 2012.

No.

45 6.

Registration as a pharmacy technician.
( :1 The Council shall appros e the registration of' an applicant as a pharmacy technician, if the Council is satisfied that the applicant-- to) has a qualification that entitles him to be registeied as a pharmacy technician Mom an institution approved by the Council; (Ii) has undergone a period of practical training appnned by the Council, and (T) has ploduced a Medical Certificate or fitness from a registered medical practitioner stating that he is physically fit and mentally sound to perform the duties of a phar- macy technician: (fit) has produced the documents required under section 8 (2) or the Act: to has made an application in Foil]] D and paid h e prescribed fee.
(2) A person registered as a pharmacy technician shall pay the annual licence tee as pre- scribed in Schedule 2.

7.

Notification.

( The Council shall, within forty five days of receipt of an application for registration, notify the applicant whether his application has been approved.

(2) An applicant, upon being notified of the approval of his application shall pay the fee prescribed for registration in Schedule 2.

8.

Pa rticulars of registration.


the Register of Pharmacists (a) his name and address; ) The Registrar shall cause the following particulars of every pharmacist to be entered in a).)
his age, date of birth and country of origin; ace his qualification and the institution from w Inch he teceived his training, and ffb the date of his registration in Antigua and Barbuda: (2) The Registrar shall cause 8.0 a notice of ihe registration of each pharmacist, who is being registered for the first time in Antigua and Barbuda, to be published in the Gazette within one month ailedr the date of registration: and 2012, No.
45 The Pharmacy Regulations, 2012 (5) a complete list of the Register of Pharmacists, containing the names and the dates of registration of each pharmacist registered in Antigua and Barbuda.

to he pub- lished in the Gazette once in the first quarter of each calendar year 9.

Registration certificate and Licence.


(1) The certificate of registration issued by the Council- 00 o r a pharmacist sI alt he that prescribed in Form C of Schedule 3; do (hr pharmacy technician shall be that prescribed in Form E of Schedule 3: and (21 The licence issued by the Council to operate a w holesale pharmaceutical husincss shall be that prescribed in Form K of Schedule 3.
(3) The licence issued by the Minister-- (a) ia premises to be used to operate a pharmacy shall be that proscribed in Form L (5) to be an authorised seller of poisons shall be that prescribed in Form Fl of Schedule of Schedule 3: 3.

LICENSING OF PREMISES AND SALE OF POISONS PART III 10.

Application for licence for pharmacy.
An application l'or a licence to use premises to operate a pharmacy on any premises shall he made to the Registrar in Form F by the owner of the pharmacy or where a body corporate or partnership is mak ina the application, by an officer or the body corporate or a partner and shall be accompanied by --- i o passpint sized photographs ofthe applicant taken w ithin the six month period immediately prior to the submission of the application, which are duly certified by an attorney at law registered to practice law in Antigua and Barhuda, or Notary Public to be a 0 tic photograph of the applicant; and (hi the prescribed fees.
II Application for licence for wholesale pharmaceutical business.

An application Mr a liccace to operate a wholesale pharmaceutical business on any premises shall be made to the Registrar in Form J of Schedule 3 by the owner ol the tkholesale pharmaceutical business and s' here the owner of the wholesale pharmaceutical business is a body corporate or part- nership, by a partner or officer of the body corporate and shall be accompanied by— - Pikl17?

)(1C1 Regulations, 2012 IC 2013.


'Ni.

_tu (0) two recently taken passport sized photographs of the applicant, duly certified by an attorney at law registered to practice law in Antigua mid Barbuda.

or ft Oar public to be a true photograph of the applicant: and (hi the prescribed fees.

12.

Application for licence to sell poison.


I An application to be licensed as an authorised seller of poisons shall be ruzde to FIlL Council in Form M of Schedule 3 b3 a person registered to sell poisons in accordance with recula- hon 30 and shall be accompanied by.-- rai tw o recently taken passport sized photographs of the applicant, duls.
certified w an attorney at law registered to practice law in Antigua and Barbuda, or nziary public to be a true photograph ulthe applicant; and the prescribed lees.

(2) Where the applicant under regulation 12(1) is a body corporate or partnership the application shall he made by a pail nor oc officer of the body uorporate.

13.

Inspection of premises.


(I ) The Registrar shall, within thirty days of receipt of an application For a licence- to operate a phamiacy or wholesale business or to sell poisons containing all the necessary pal tie'' Ian.

cause to he forwarded io the Board of Inspectors the application so that an inspection can be conducted to determine whether the premises may be licensed lbr the operation of a phamiacy or wholesale pharmaceu(ical business or to sell poisons.
(2) The Board of Inspectors shall within forty-hue days of receipt of an application under paragraph (I visit the premises and carry out all necessary inspections and shall submit to the Coun- cil a written report indicating its finding* 14.

I icensing of premises.


It If the report of the Board of Inspectors indicates that the premises satisfy ilie require- ments to be licensed as a pharmaey or to sell poisons, the Council shall notify the Minister of the report and Recommend that the Minister may approve the licence.
(2) If the report of the Board of Inspectors indicates that the premises satisfy the require ments to be licensed as a wholesale pharmaceutical business, the Registrar shall notify the Councii of the report and the Council shall approve the licence.

A ecrhficate issued by the Minister under this Regulation shall be in Form L ofSchedule Jul 2.

No.

(5 II The Pharmcky 2012 15.

Register of pharmacies.

- Fhc Registrar shall.


Where premises have been approved for use as a pharmacy or wholesale phar maccuheal business.

enter the following particulars on the Register of Pharmacies-- (h) the name and address and occupation of the applicant: / 1» the business name and address of the premises: pi the nature of busuless conducted on the premises.
and all purposes for \\Inch the premises are used or intended to be used: (d) the name and address and registration particulars 01 any registered pharmacist employed on the premises: and any changes thereto (co the registration number of the premises; the date of first registration and any records: and (g) the expiry date of the ennent registration.

PART IV PROFESSIONAL MISCONDUCT 16.

Complaints.

and telephone number.

inkestigate ihr complaint (!)
A person who alleges that a registered pharmacist, plualnacy student or pharmacy technician is guilty of professional misconduct may , make it complaint to the Registrar in writing setting ow the full circumstances giving rise to the complaint and shall include his name, address (2) On receipt of a complaint the Registrar shall within twenty one days therealner, fory‘ard the cletmls of the complaint to the Council and the Council shall direct the Hoard of Inspector to (1) The Hoard of Inspectors shall conduct all investigations.
as directed by the council with- in three months of receipt of those directions and shall submit for the consideratioti of the (nulling a written report of its findings of the ins est mat ions.

17.

Professional misconduct.

(I) Prefesslonal misconduct includes the Ibilowing (a) stealing or being in unlawful possession of drugs or poisons: ti» conspiring to procure or unlawfully procuring or attempting to procure an abortion: Phon,Hk v Rcivtidatiolm.

21)12 12 2012.

No.
21)12 12 2012.

No.

45 t being under the influence of drugs or alcohol while performing the duties of a pharmacist.
pharmacy student or a pharmacy technician, rah tampering with, altering or causing to be altered in any way the prescription of:; registered medical practitioner, a registered dentist, a registered veterinary surgeon or etennary practitioner: tet entering into an arrangement \tarn a registered practitioner for the sharing of profits denvcd from the filling of priescriptions issued by the practitioner: (ift the lvilfill or grossly negligent fahure to comply with substantial provisions of any laws, rules or regulations got eming the practice of the pharmacy profession: /art exercising undue influence on a patient or client by promoting the sale of SerN: ices.
goods, appliances or drugs in such manner so as to exploit the patient or client for the financial gain of a pharmacist or of a third party; On permitting a person to share in the fees for professional sett ices, other than: a partner.

employee or associate in a professional firm or corporation.
professional subcontractor or consultant authori7ed to practice as a pharmacist, or a pharmacy student, or pharmacy technician, dr wilfully making or filing a false report, fading in tile a report lupin ed to be filed by as or wilfully impeding or obstructing such filing, or inducing another person to impede or obstruct such filing, th failing to make available to a patient or client, upon request, copies or documents in the possession or under the control of the licensee which have been prepared for and paid fbr by the patient or client: Orr revealing of personally identifiable facts, data m information obtained in a professional capacity without the prior {consent of the patient or client, except as authorized or required by law: ;It practicing or offering to practice beyond the scope permitted by law, accepting f he task of performing professional responsibilities or performing professional re- sponsibilities which the licensee has not the competence to perform or without adequate supervision performing pmfessmnal services which the licensee is au- thorized to perform only under the supervision of a licensed professional, except in an emergency situation where a persott's life or health is in danger: OM delegating Drolossional responcihil t J,J2S hi un ffililitensed person 01 :1 person tt ho i by t antic of insufficient training or insufficient experience is not qualified to per- form those responsibilities: 21112.
No.

sin 13 The Thorn, acv Rcgulari(ph, 2012 ( ti ) performing professional services which hate not been duly authorized by the patient or client or his legal representative: (in) dispensing a written prescription which does not hear the name on the patient nor whom it is intended; the date on w hich it was written, the name and strength of the drug prescribed.
the quantity oinhe drug preset 'hod and the directions for (pi idling to maintain a current form which pro' ides kor ready itchneval prescriptions, the patient for whom the pi 2S1:110011 is intended, the signature in - .-caddy identifiable initials of the pharmacist who lined the prescription, and the number assigned to the prescription : holding for sale, offering tor sale, or selling fit any drug later than the date marked upon die label as inditiati“, of the flak: beaond which the contents cannot be expected to be safe and effective; pro- vided, howes Cr, that when the drug is ident i lied as an outdated drug by segre gation floor regular stock or by other means, the holding of that drug hey ond its expiration date shalt not be deemed a violation or this paragraph: or iii) any drug, the nature of which requires storage under special condition: of Temperature control as indicated either MI II , tlied retain:1s fir storage of said drug contained in an official compendium, or as directed by common prudence.
unless the special condition 01 temperature control shad naive been complied tt fib dui ing the entire period or time in which that drug has been held for sale; /iv aiding and abetbng an unlicensed person to dispense drugs provided that au on person may assist a pharmacist in the disponsinci of drugs by ) receiving Nn rilten, verhal or ciceirimically transmitted prescriptions.
except that in the ease of electronically transmitted prescriptions the phimitticists shall rot:1ov the prescription to determine whether in his professional _judg- ment it shall he accepted by the pharmacy, and if accepted.

the pharniiiel,i shall enter his initials into the records of the pharmacy.
in) typing prescription labels: (nit keying prescription data for entry into a computer-generated file or rctriea ins prescription data from the tile, pro' hied that the computer-gem:rated file shall plo‘ i de far scriber-it- ran of all information needed to fill the prescription by a pharmacist prior to the dispensing of the prescription, meaning that the pharmacist shall rey few and approYe the information and enter his initials or other personal id en Li tier into the record-kcepi as systeln prior to the dispen::- ing of the prescription or o the prescription refill.
(ix) setting drugs from stock and returning them to stock; The Pharmacv Regulations, 2012 14 2012, No.
45 ( v ) getting prescription files and other manual records From storage and locating prescriptions: (vi) counting dosage mats ordrugs: (di) placing dosage units a drugs in appropriate containers; tviii) affixing the prescription label to the containers; (ix) preparing manual records of dispensing Ihr the signature or initials of the pharniacist: or (x) handing dr delivering completed prescriptions to the patient or the person authorized to act on behalf of the patient after the pharmacist has handled the prescription in accordance with the Act and these regulations: aiding and abetting an unlicensed person to — ( i ) receive oral prescriptions from prescribers: (ii) interpret and evaluate a prescription for conformance with legal requirements.
authenticity, accuracy and interaction of the prescribed drug \ ith other known prescribed and over-the-counter drugs; (iii) make determinations of the therapeutic equivalency as such determinations apply to generic substitution: iiv) measure, weigh, compound or mix ingredients; iv) Signor initial a record of dispensing required to he maintained by law, (d) counsel patients; or (vii) perform any other function involving the exercise or prolessional judginent, (2) Where the expiration date on a drug is expressed by month and year.
the expiration date shall be the last day of the month indicated.
(3) Notwithstanding regulation (1)(010. in the event that a drug is not available_ a registered medic& practitioner may in writing request from a legistered pharmacist an out of date drug but the drug shall not be outdated for more than three months and in the case of a registered eterinarv practinner the drug shall not be outdated more than six months (4) A complaint of professional misconduct may not be made against a registered pharmacist ss Ii o, in good Faith.

complies with regulation (31.

18.


Board to investigate complaint.

(1 The Boardoff nspectors in investigating a comp la int shal I provide th epharmac ish pharmacy student or pharmacy techrUcian with a written statement of the complaint and all the allegations therein and shall invite the Pharmacist, student, or technician to runtish the Board with in thirty days 2ft12.

No.

=1 5 15 The PlICIPMUCIT IfrifIlia(10!
),S, 20/2 of receipt the particulars of complaint a statement in writing relating to the aliegations.

(2 Upon receipt of a written statement from the pharmacist, student, or technician the Board of Inspectors shall consider the matter and shall submit a report of its findings to the Council.

v. Mini thirty days.

(3) The Board of Inspectors in investigating a complaint may at any stage consult with an 01 0] hiss appointed by the Council for the purpose.
(41 The Board of Inspectors may at any stage of its im estigation decline to proceed further with the int estitiation if it determines that the allegations are fraudulently made or where the alle- gations cannot be substantiated and where the Board of Inspectors so dctetinines, it shall include a statement of its reason tor the termination in its report to the Council.

19.

Notification when evidence's insufficient.


(1) The Council shall consider the findings of the Board of Inspectors and shall determine st Ulm)) forty ft e days whether there is sufficient evidence to institute diseipliiiary pi oceed i ngs against pharmacist or student, or pharmacy technician.
(2) Where the Council determines that there is insufficient evidence to institute diseiplillar> proceedings the Council shall forthwith direct the Registrar to notify the complainant and the phar maeisi or student, or pharmacy technician, in WI i ti lig_ of the findings of the Counci l, 20.
Procedure where evidence is sufficient, (I) the Council shall, where the report of the Board of Inspectors recommends that disciplinary action he taken, constitute a committee pursuant to sections 24 and 25 of the Act and fix a date for the hearing and may direct all aitorney-aula1s retained for the piirpose to: to take all steps as may be relevant.

(iv to take steps as ma} he necessary to obtain or t cliff, any documentar) or other us ilence that may he relevant.
and (c; to take steps to ensure the attendance of t messes at the hearin2.

12) On thing °fa hearing date by the Council, the' Registrar shall nohB the complainant and the pharmacist.

student or pharmacy technician of the date and shall specify in the notice fat the nature of the charge to tic deka toned including hilt particulars of the complainant: and du the time and place of the hearing.
(3) A notice liom the Registrar shall also include a statement intlirmilig the pharmacist or he Pharn noct Rezalation6, 2012 16 2012, No.
45 student, or technician of the right to be represented by an attorney or other person at Elie hem ing (4i Notices under this regulation shall he posted or delivered no later than one month before the dote set for the hearing and shall be sent by registered post to the address or to the last knots ii address of the pharmacist or student or technician entered in the register or in the student records or tcchnician records.

21.

Rights of accused.


A party against whom disciplinary proceedings have been instituted rci) may give evidence, call witnesses and inay make submissions Wally or in writing.
on his own behalf; (b) shall be allowed access to any documentary evidence used in the proceedings and shall upon payment of reasonable costs of copying be entitled to obtain copies of all relevant documents: (e) shall upon reasonable request having regard to all the circumstances be entitled to an adjournment provided that exceptional circumstances the Council hall per- mit no more than three adjournments before determining any discipl Maly matter before it: and (CO is entitled to be represented by legal counsel.
Wliere a hiding is made against a pharmacist Cr student or techtncian as a result of disciplinary pro- ceedings the Council may order the pharrnaMst or student or technician to cover expenses incurred in connection with the investigation of an allegation or complaint against him or in connection with Where the Council is satisfied that notice a a hearing has been duly served olt the pharmacist or student or technician, it may proceed with the hearing in the absence of the pharmacist or siudent II) The Council at the conclusion of a hearing shall consider all evidence gitcu at the heal- ing and alter due deliberation may decide (a) that the e‘idence given at the hearing is insufficient to support the charge.
(hi that the charge has not been proven: or 22.

Expenses.

any disciplinary proceedings.

23.

Ex parte Hearings.

or technician.

24.

Council's decision.

2012, No.

45 I / The Pitalltiata Regahai0;1‘ : 0 1 (c) that the charge has been proven.

(2) Where the Council decides that the charge has been pro' en.

the Council cot, h-f of the sanctions or penalties specified in Section 25 (2) or Inc Act.

25.

Notification of decision.


The Council shall within Fourteen days_ upon making a determination notify the complainant a, the pharnmeist or student or technician in ss Ming of its findings and the reasons theretbic shall where the charge is proven indicate in Inc notice the sanction or penalty that may have been imposed.

26.

Right of appeal.

Council's decision.


fA person who is aggrieved by a decision of the Council in disciplinary proceedings shall have the right to appeal that decision to a judge in chambers within three months of being notified of the 27.

Remo s al of convicted Pharmacist from register Where a complaint against a phannacist includes a charge of a criminal offence involving dishon- esty.
fraud or moral turpitude the Council, upon written confirmation under the hand unite Regisuar of the I ligh Court, or the Chief Magistrate that the person was convicted of such an offence and that the conviction k> as not subsequently quashed, may without further inquiry direct the Registrar to remove the name of the pharmacist from the register.

PART AUTHORIZED SELLERS OF POISONS The substances in Part II of Schedule 4 are poisons MI the purposes of the Act.

28.

Schedule of Poisons.

29.


Seller of poisons.

A person shall not sell an> poison unless that person is a registered pharmacist or a person duly authorized hy these regulations to sell poison.

30.

Registration as seller of poison.

(1 A person other than a reaistered pharmacist may apply to be registered as an authorized Seller a poisons hy submitling an applicanon w the Council in Form G of Schedule 3.
An application under regulation (I) may be registered as al authorized seller ol poisons it he satisfies the Council that he is over twenty one years and that he is of good character and that 7 he PLarenceo .

Rcgsilcitions 2012 I 201 2 h.. a. the lee prescribed hat.
- een paid: and ( 1)1 he is able to complyts ith the provisions of the Act relatinu to the sale t:1 (3 F1/1 11:1 1 poses of regulation (2) an applicant shall submit to the ( ounet : evidence provittiT a his age as well a. nt,o recent photographs of die ,tstilicin I aid 11a of his guod character, 31.

Certifinte of Registration.


note satisfied that a apsticant - fits tint-crier to asi awls (2) A certificate issued by the Minister pursuant to regulation 31i I) shall be in tionti I i.

32.

Register of authorized sellers.


Tli'r .uicil shall cause the Registrar to keep a register of authorized seller of poisons and slit, I' cludt: in the register particulars including the name, address of die authorized seller, and the premis- es iron which he operates, as the Council thinks fit.

33.

Display of certificate and licence.

I) A registered seller of poisons shall display the certificate otreristraiion and hem all times in a conspicuous place on the premises where poisons are sold.
(2) A register of poisons 111 F01111 L shall be maintained by t ha sent.'

at poisons n such manner that the same may be produced when requested by the Regist.,tr or the Council anti i may be made without notice.

34.

Annual fee.

anritidion of ,•acislratinn.

An authorized seller ot poisons shall pa)., the annual licence lee prct(cribed in Sal tedule 2.

I The Council may at any time caned or suspend lior time as it think lit.
a rat 01 regusiCtitun it'll us satisfied that the holder oldie certificate lets tailed to comply %% ill .,tods of the Act or with these Regulations.

(2) The holder of a certificate of registration which has been cancelled or suspended shad forthwith return the certificate to the Council and shall cease forthwith to engage in the business of selling poisons.

 2012.

No.

45 19 The Pharmacv Regulations, 20)2 36.

Sale and labelling of poisons.


(1) A person shall not sell, dispense or deliver to any oilier person any poison unless the bottle, vessel, box, wrapper or cover in which the poison is contained is labelled, in addition to the requirements olsubseetion ( I ) (d) of section 18 of the Act with- (c() adequate directions for use and words of caution in respect of the poison; Enid ) where the poison is an ingredient of a preparation, proportion of poison in that preparation.
(2) Before the sale, dispensing or delivery of any poison, the person selling, dispensing or delivering the poisons, shall ensure that the words of caution in paragraph (I) tar of regulation IN are undeistood by the person receiving the poison, and shall cause the person receiving the poison to sign his name beside the relevant entry in a register in which shall he recorded the following - (a) the date of the transaenon: (he the name, address and occupation of the person to whom the poison is being sold.
dispensed or delivered; (r) the name and quantity of poisons sold, dispensed or delivered_ or where the poison is an instrediem of a preparation, the proportion, of poison; Oh the purpose for which the poison is required; (e) where the person to whom the poison is being delivered is not known to the person sell inn.
dispensing or delivering same, the name and address of a witness to the transaction, and where there is no witness to the transaction, the name and address of person giving a lecommendation in respect of the transaction: and 09 the signature of the person receiving the poison, and signature of the person selling.

dispensing or delivering the poison.

37.

Handling of poisons.

(1) A person shall not sell, dispense or deliver any liniment embrocation.
lotion or similar caustic substances containing poison unless that substance is in a container- - (a) which is so constructed as to prevent leakage arising from the ordinary risks of handling, and ss hiCh is impervious to poison; and (Ii) to which is affixed a label giving notice that the contents shall not he taken orally.
(2) Where a person sells, dispenses or delivers any sabstance mentioned in paragraph (I) in a bottle of not More than 120 fluid ounces, that substance shall be in ribbed or grooved bottles which Poo Pi2oruLn i• Regulations 2012 20 2011 No.

45 are easily discernable by touch.

38.

Transport of poisons.


(1) A person shall not transport any poison unless — (Co it is adequately packed to avoid leakage arising from the ordinary risks of handling, au the outside of the package containing the poison is labelled conspicuously with the name and description of the poison and sk ith a notice indicating that it is to he kept separate from fond and foorl containers, and wit adequate precautions are taken to prevent the risk of contaminating 39.

Sale of Arsenic.
Sale of Arsenic.

( I) A person shall not sell arsenic unless— fro that person is authorised under the Act to sell arsenic: and (hi before sale, the arsenic is mixed NVitli soot or indigo in the proportion of at least an ounce of soot or half an ounce of indigo to one pound of arsenic.

and so in propor- tion for any greater or lesser quantity.
(2) This provision shall not apply— (a) 's hen arsenic is an ingredient of any medicine required to be made up or compounded in accordance with the prescription of a of a registered medical prac- titioner, a registered dentist or a registered veterinary surgeon; Oat to wholesale pharmaceutical businesses supplying arsenic upon orders in writing in the ordinary course of wholesale pharmaceutical business dealing, or to where in-set] IC is stated by the person receiving same to be required for some purpose other than use in agriculture, and it is established [hat the mixture u ould render the arsenic unfit for ihe purpose for which it is obtained and the arsenic is delivered in quantities of not less than ten pounds on each occasion.
Every prescription for a poison shall be in writing and shall include the following-- 40.

Prescription.

(al the date; (hi the name and address of the person for whom the prescription is issued: (e) the name and quantity of the substance to be supplied: 2.

No.

45 21 The Pharmacy Regulations, 2012 uh adequate directions for the use of the substance prescribed: (e) legible signature of the prescriber; and (t) \k here file prescription is given by a dentist el registered veterinary surgeon.
the words for dental treatment only or "for the treatment of animals only" as the care may he.

PART VI DISPENSING 41.

Compounding and dispensing ( ) A person who dispenses compounds and retails or supplies a drug other than in accordance ith the prescription of a registered medical practitioner, registered dentist or registered veterinary surgeon.
shall deliver that drug in a container labelled with — tit; the name of the drug, IL') the pharmaceutical form and strength: (Cl quantity; Id) adequate directions for use; and to word; of caution respecting [he drug.

if necessary.

(2) A person who dispenses, compounds.
retails or supplies a drug whether over the coun- ter or in accordance with the prescription of a registered dentist, registered medical praCninnier Or registered veterinary surgeon shall, where there is [Available a bioequivalent generic drug which is interchangeable With the named drug and which is less costly, inform the person requesting the drug those facts, and shall supply the generic equivalent instead of the named drug except AA here the per- son objects or declines to accept the generic form.
(3) A person who dispenses, retail; or supplies an over-the-counter drug which carries a brand name shall erect and maintain a prominent sign informing persons of the availability of the generic drug a hieli is the hioequivalent of the drug carrying the brand name.

42.

Number of times of dispensing.


( ) No prescription shall be dispensed more than once unless it is dispensed in accordance with the directions of the prescriber included in the prescription to the effect that it may be dispensed al a staid unto' of Ilims or dcreact ucessary, (2) Where a prescription- The Pharr/Huy Regulutionv, 2012 12 2.01' No 45 .

.
(a) includes a direction that it may be dispensed a stated number of times but does not include any direction as to the intervals at which it may be dispensed that prcserip tion shall not be dispensed before the stated duration except where the pharmacist is satisfied that the patient has a legitimate reason: Oh includes a direction that it may be dispensed at stated intervals but does not include any direction as to the number of times it may be dispensed, that prescription shall not be dispensed more than three times: (c) has not been dispensed after the period of six months from the date that the pre- scription was issued, the prescription will cease to be valid.
43.

Prescription verbal, or electronic communication.

I) A prescription for a drug may be communicated verbally by a registered practitioner registered denbst or registered veterinary surgeon.
(2) A person to whom a prescription for a drug has been verbally or electronically com- municated shall forthwith reduce the prescription, after it has been validated lay a practitioner und er regulation 43( ), into writing and shall, upon the filling thereof, retain that validated prescription for a period of not less than two years from the date of - tilling same.
(3) A prescription communicated verbally or electronically under regulation 43(2) shall be reduced into writing within thirty-six hours of the verbal or electronic communication.

(4) A person selling a drug pursuant to a written prescription shall retain the prescription for at least two years from the date of hIlMg thereof.
(5) Every prescription for a drug shall include the following - the date; (a) (b) (c) the name, age, and address of the person for whom the prescription is issued: the name, the generic name, pharmaceutical rorm and strength and the quantity of the substance to be supplied; rat adequate directions for the use of the substance prescribed, (e) the usual signature of the prescriber and his name in legible print Form: (/) the address, telephone number and registration number of the prescriber: and (g) w here the prescription is given by a registered practitioner, registered dentist or registered veterinary surgeon, the words.
for dental treatment or 'tor treat tient of animals only as the case may require".

(6) A person filling a prescription shall note on the prescription at the time of dispensing, the dale of dispensing, prescription number and the signature of the person by whom it was dispensed, No.
45 23 The Pharmacy Regulations, 2012 •in indication of the items dispensed and the prescription shall be retained by lipurtn in charge f the phannacy in which the prescription was filled Iot a period of flt 1s5 tuai wo years from the •Lift'.

cm •..chief: 1.c Drescrip6r:: , 1,ist dispensed ci escription reenrd -.
tilling a prescription shall--- number each prescription; (a) (b) file the prescription, or a true copy thereof the person for whom the prescripi was given desires to retain the original prescription and the prescription does noi contain a controlled substance or quantity of a substance which would make it inadvisable for the pharmacist to part with the same, and (c) record in a prescription register the number and date of each prescription, the name of the persons for whom it is prescribed, age and address and the name of the regis- tered medical practitioner, registered dentist and registered veterinary surgeon, by whom the same was given, the particulars of every prescription and the directions which accompanied the medicine 45.
Arranged storage.

46.

Opium Tincture.

is-- Every antibiotic and other drug or poison which requires special storage arrangements shall be stored in accordance with the temperature and other storage requirements specified by the manufac- turer in respect of the antibiotic, drug or poison.
(1) A person who sells, dispenses or delivers Tincture Opic Carmph (Camphorated Opium Tincture), shall not sell more than four ounces of that drug at any one time unless the transaction (a) to a registered medical practitioner, registered dentist or registered sic:tern -less surgeon for the purposes of his profession; (b) (c) for use in a hospital or other medical institution; or to a registered pharmacist for use in a registered pharmacy.
(2) Every sale, dispensing or delivery of camphorated Opium Tincture shall be recorded by the person making the sale, dispensing or delivery in a book kept for the purpose, in which shall be entered the following particulars— (a) the date and quantity of the drug taken in stock; The Pharmacy Regulations, 20!

 2 I 2012, No.

thg int the date and (pawit).

of any sale, dispensing or delis cry of the drug, (c) ti 'tattle.
address mid occupation of the person who acquired the drug: (/20 the purpose tor which the drug was acquired: and (ch the name of the person authorizing the transaction.

II any.

( I) A repeat prescription shall not be dispensed alter the period of six months from the date (2) A repeat prescription that has um been dispensed within six months of the date when it (I ) Subject to paragraph (2), a person shall not sell any therapeutic substance by retail, ex- 47.

Repeat prescriptions.


that the prescription was issued, was issued, ceases to he salid.

48.

Sale of therapeutic substances.

cept hy prescription.
(2) Paragraph ( I ) shall not apply— cot to the supply of a therapeutic substance which is an antibiotic sshiere it is made on production of a written requisition from one pharmacist to another; or (7d to a thel a peutic substance sold-- ill by a wholesale pharmaceutical business; litI or export: Int; to an authorised person, is ;• to the owner or master of a ship or aircraft for medical use on board; ; to any institution or business which proves to the satisfaction oi the Hoard that it carries on scientific education or research, lvi) to Go‘ ernment; or LI a person in charge of a hospital, clinic or nursing home, or of any other institution al ha is approved by the Board and provides medical, dental.
surgical or veterinary treatment.

49.

Emergency prescriptions.

( ) A drug inay be dispensed by a pharmacist in ease of emergency where the supply is made at the request of the patient and the thltowing conditions app/y- 2012.

No.
45 "'S nu'Pharniael Reolal ion, 2012 10) the pharmacist under whose supers sion the prescription only medicine is to he sold or supplied has interview, ed the person requesting the medicine and shall sat- himself ( i that there is an immediate need for the prescription only medicine requiesteil to he sold or supplied and that it is impracticable in the circumstance:, to obtain a prescription a ithout undue delay: (it) that treatment with prescription only medicine requested has been prescribed previously by a doctor for the person requesting it: and (in) as to the dose a hieh in the circumstances it would be appropriate for that person to take.
(R) that the pharmacist provides no more than 5 days' treinmeni of the presription on N medicine in question except.
where the medicine in question is an °Mullen, cream or a preparation in an aerosol dispenser for the relief &asthma, which has been made up for sale in a container elsewhere than at the place of sale or supply.. the smallest pack that the pharmacist has a n ailable for sale or supply; (C) that the pharmacist by or under whose supervision the medicine is sold or supplied ensures that an entry in the prescription only register is made stating-- 1 ( the dale on a Inch the prescription only medicine was sold cr supplied: (ii) the name, quantity and except ‘there it is apparent Itom the Ilalne_ the pharmaceutical form and strength of the medicine; Mil the name, age and address of the person requiring the medicine and.
tel the nature of the emergency.

710 that the container or package Oldie medicine is labelled with-- 10 the date on which the prescription orny medicine was sold or supplied: In) the name.
quantity and, except here it is apparent from the name, the phar- maceutical form and strength of the prescription only medicine; tin) the name of the person requiring the prescription only inedijue: (iv t the name and address of the registered pharmacy from which the prescrip- tion only medicine was sold or supplied: and (i the words - Emergency Supply -.
that the prescription only medicine-- is not a controlled drug specified in Schedule 3 Section 5. or in the Mis use of Drugs Regulation: tit) is restricted in relation to the Psychotropic Substances, in which ease record The Pharmaci Rcihriat(ons, 2012 26 2011 No 45 of these shall be kept according to the pros isions of the Misuse of Drugs Act end its Regulations: or (ii i) is not an autibiotic.
12) An emergency sale or supply of prescription only medicine which contains or consists of Phenobarbitone or Phenobarbitone Sodium is permitted to be prescribed under regulation ( I) if i; is for use in the treatment of epilepsy and does not contain any of the substances in Schedule 3 relative to the Controlled Drugs and Psychotropie Substances.
(3) The prescription only medicine to which this regulation applies should no' contain one or inure of the hI lowing substances— Ice/ Ammonium Bromide; (/) Calcium Bromide; (e) Calcium Bromidolactobionate: id) Embutramide; re) Felicia infamin IT 09 Fluanisone; 0..9 Hydrobromic Embutramidei ab Fencamfamin Phydniehloridei oh Methohexitone Sodium; 0 Pemblinc; or (0 Phenobarbitone.

50.

 Public notification and recovery of drugs.
'Mc Chief Drug Inspector may, by notice in writing, impose requirements relating to any drug regulated by the Act, on a person reuistercd to sell, supply or distribute drugs where- (to the drag does not conform with a standard applicable to the drug or have been found or suspected to be tainted; ( ri) the manufacturing principles have not been observed in Me manufacture of the drug; or (e) the drug is supplied in contravention of any law or enactment.

2012, No.
2012, No.

45 27 The Pharmacy Regulations, 2012 (2) The notice under paragraph (1) may specify one or more of the following requirements— (a) (b) (c) the steps to be taken to recover the drugs; the manner in which the steps are to be taken; or a reasonable period within which the steps are to be taken.

(3) The Chief Drug Inspector shall, as soon as practicable after giving the notice, cause particulars of it to be published in the Gazette.
(4) The requirements that may be imposed upon a person under this regulation may include one or more of the following— (a) to take specified steps, in the specified manner and within period specified, to re- cover drugs that have been distributed; (h) to inform the public or a specified class of persons, in the specified manner and within the period specified, to the effect that the circumstances referred to in para- graph (1)(a) have occurred in relation to drugs; or (c) to publish, in the specified manner and within the period specified, specified infor- mation, or information of a specified kind, relating to the manufacture or distribu- tion of drugs.
(5) If the circumstances referred to in paragraph (1) apply only to a batch of drugs, the Chief Drug Inspector may limit the imposition of the requirements to the drugs included in that batch.

(6) A requirement to recover drugs under this regulation does not apply to drugs that cannot be recovered because they have been administered to, or applied in the treatment of, a person.
(7) A person commits an offence if— (a) he does not comply with a notice under this regulation from the Chief Drug In- spector; or (h) as a result of his failure to comply with the requirements imposed by the Chief Drug Inspector, the use of the drugs for which the requirements were imposed result in or will result in harm or injury to any person.

(8) A person who commits and offence under subparagraph (7) is liable to a fine of fifty thousand dollars and to imprisonment for 4 years or to both.
The Pharmacy Regztlations, 2012 58 201 4 , No.

45 PART VII MISCELLANEOUS 51.

Csrtilicate lost or destroyea.

Where a certificate of registration or authorization issued under the Act is lost, destroyed or defaced.

the person to whom that certificate was originally issued may apply to the Council ier duplicate certificate.
12) An application for a duplicate certificate shall be made in the relevant application form set Out in Schedule 2 in respect of an application for registration or authorization as the case may be required, and shall he accompanied by-- (a) an explanation as to why the duplicate certificate is required; and olfi the same number of photographs ( if any) I equired in the case of an application for an original certificate.
(3) The Registrar may issue to a person applying for a duplicate certificate, a certificate in the relevant form set out in Schedule 2, clearly marked in bold lettering with the word -DUPLI- (4) A fee of one hundred fifty dollars shall be paid for a duplicate certificate issued under this (5) All records and books required by these regulations to be kept by any person, shall be open to inspection by the Board of Inspectors, at all reasonable times and it shall be lawful for the inspectors to make a copy or extract from any record or books.
52.

Fees paid into the consolidated fund.

Monies collected from fees prescribed under the Act and these Regulations shall be paid into the CATE'.

regulation.

Consolidated Fund, 53.

Penalty.

to both.

A person who contravenes any provision of these Regulations commits an offence and shall be li- able, on summary conviction to a fine of ten thousand dollars or to imprisonment for three years or 2012, No.
45 29 The Pharmacy Regulations, 2012 (i) Antigua and Barbuda SCHEDULE 1 (v) Commonwealth of Dominica (ii) Bahamas (iii) Barbados (iv) Belize (vi) Grenada (vii) Guyana (viii) Haiti (ix) Jamaica (x) Montserrat (xii) St. Lucia (xi) St. Kitts; Nevis and Anguilla (xiii) St. Vincent and the Grenadines (xiv) Trinidad and Tobago SCHEDULE 2 FEES 1.

Annual Licence fee for the operation of a Pharmacy 2.

Annual Licence fee for the operation of a wholesale pharmaceutical business 3.
Registration of authorized seller of poisons and annual fee 4.

Registration of Pharmacy Student 5.

Registration of Pharmacist and annual licence fee 6.

Registration of Pharmacy Technician and annual licence fee FORMS A-G 1.

Application for registration as a Pharmacy Student 2.

Application for Registration as a Pharmacist 3.
Certificate of Registration as a Pharmacist $1000.00 $2000.00 $250.00 $50.00 $350.00 $100.00 Form A Form B Form C The Pharmacy Regulations, 2012 30 2012, No.

45 4.

Application for Registration as a Pharmacy Technician 5.

Certificate of Registration as a Pharmacy Technician 6.

Application for Licence to operate a Pharmacy 7.

Application for registration as an authorized seller of poisons 8.
Certificate of Registration of Authorized seller of poisons 9.

Register of Poisons 10 Application for licence to operate a wholesale pharmaceutical business It.

Licence to operate wholesale pharmaceutical business 12 Licence to operate pharmacy 13 Application for licence to sell poisons 14 Licence to sell poisons Form D Form E Form F Form G Form H Form 1 Form J Form K Form L Form NI From N 2012, No.
45 31 The Pharmacy Regulations, 2012 SCHEDULE 3 FORM A The Pharmacy Act Regulation 4 APPLICATION FOR REGISTRATION AS A PHARMACY STUDENT TO: The Pharmacy Council Name of Applicant Date of Application Address of Applicant (Block Letters) (Block Letters) Age of Applicant Qualification of Applicant (certified copy of Birth Certificate should be attached) (copies of certificate to be attached) Testimonials (3 to be attached) Name of Parent/Guardian (if under 21) Address of Parent/Guardian (if applicable) (Block Letters) (Block Letters) The Pharmacy Regulations, 2012 32 2012, No.
45 Address of Parent/Guardian (if applicable) To be completed by the College at which applicant has been admitted as pharmacy student Date of Admission Recommendation To be completed by the Registrar Date approved/refused by the Council Date Registered, if registered Reason for refusal, if refused (Block etters) L Signature of Applicant Signature of Registrar 2012, No.
45 33 The Pharmacy Regulations, 2012 FORM B THE PHARMACY ACT Regulation 5 APPLICATION FOR REGISTRATION AS A PHARMACIST To the Pharmacy Council Applicant's Surname Applicant's Christian Name(s) Gender: Male El Date of Application Address of Applicant Telephone contact information: e-mail address: Date of Birth: Country of birth: Present Employer (if applicable) Employer's address (Block Letters) (Block Letters) Female n (Block Letters) EMPLOYMENT RECORD The Pharonacit' Regulations, 2012 34 2012, No.
45 Phone / Fax Email address 0-2 11-15 26-30 El ri PharmD BSc Ass.

Degree No.

of Credits 6-10 ri 21-25 El YEARS OF EXPERIENCE 3-5 ri 16-20 El >31 El QUALIFICATIONS MSc Dip Pharm Other (please specify) (copies of Diplomas and Certificates to be attached) Testimonials (2) (to be attached) Names of Referees (2): Present or Proposed Employment .
DECLARATION declare that the information provided herein is a truthful, complete and accurate representation of the information required.

Date 2012, No.

45 35 The Pharmacy Regulations, 2012 Signature of Applicant To he completed by the Regstrar Date gstered or refused Registialion No.

 Proof of payment: Receipt No.

Reason refused, if refused Signature of Registrar The Pharmacy Regulations, 2012 36 2012, No.
45 FORM C Regulation 9 THE PHARMACY ACT CERTIFICATE OF REGISTRATION AS A PHARMACIST !

(e nthuration No.

[h isis to certify that has been duly registered as a pharmacist under the Pharmacy Act.

Given under my hand this day of 20 President, Pharmacy Council Registered 2012, No.

45 37 The Pharmacy Regulanoa .


21112 FORM D THE PHARMACY ACT 1995 APPLICATION FOR REGISTRATION AS A PHARMACY TEL HNIC1AN (Block Letters) (copies of Diploma to be attached) To the Pharmacy Council Name of Applicant Date of Application: Address of Applicant Age of Applicant Testimoma (2 •.

(1 1 y egistered or refuse.'


 flt .a ration No: Reason refused, if refused Signature of Applicant Signature of Registrar The Pharmacy Regulations, 2012 38 2012, No.

45 FORM E Regulation 9 THE PHARMACY ACT 1995 CERTIFICATE OF REGISTRATION AS A PHARMACY TECHNICIAN THIS IS TO CERTIFY THAT NAME has been duly registered as a Pharmacist Technician under the Pharmacy Act Given under my hand this day of 20 Registration No.
Of Expired Patel President ( mint Registrar 2012, No.

45 39 The Pharmacy Regulations, 2012 FORM F Regulation 10 THE PHARMACY ACT 1995 APPLICATION FOR LICENCE TO OPERATE A PHARMACY APPLICATION IS HEREBY MADE FOR A CERTIFICATE OF REGISTRATION OF A PHAR- MACY PARTICULARS OF WHICH ARE AS FOLLOWS: APPLICANT IS A CORPORATION?
YES NO OWNER OF PHARMACY: (OR CORPORATION) ADDRESS OF OWNER: (OR CORPORATION) NAME OF PHARMACIST: ADDRESS OF PHARMACIST: PHARMACIST REGISTRATION#: PHARMACIST TELEPHONE#: PHARMACIST HOURS OF WORK: TRADING NAME OF PHARMACY: (AS KNOWN TO THE PUBLIC) ADDRESS OF PHARMACY: FROM FROM FROM (AM/PM) TO (AM/PM) TO (AM/PM) TO (AM/PM) (AM/PM) (AM/PM) (IF MORE THAN ONE NIA RMACIST IS EMPLOYED, PLEASE WRITE THE NAME(S) NEXT TO THEIR RESPECTIVE WORKING HOURS).
The Pharmacy Regulations, 2012 40 2012, No.
45 TEL#: E-MAIL ADDRESS: FAX#: THE PHARMACY IS: (A) (B) (C) (D) A NEW OPENING BEING ACQUIRED BEING RELOCATED ALREADY IN OPERATION (TICK THE CORRECT RESPONSE) STATE DATE OF PURCHASE AND/ OR COMMENCEMENT OF OPERATION: STATE DATE THAT PHARMACY WILL BE READY FOR INSPECTION, PRIOR TO COM- MENCEMENT OF OPERATION: THE OWNER(S) OR A DIRECTOR OF THE CORPORATION OPERATING THE ABOVE MENTIONED IS REQUIRED TO SIGN THE FORM.
NAME: PHARMACY REGISTRATION # (IF REGISTERED BEFORE) POSITION WITH CORPORATION: SIGNATURE: DATE: FOR OFFICIAL USE ONLY 2012, No.

45 41 The Pharmacy Regulations, 2012 FORM G Regulation 30 THE PHARMACY ACT APPLICATION FOR REGISTRATION AS AN AUTHORIZED SELLER OF POISONS To the Pharmacy Council I the undersigned of Name of Applicant Address of Applicant hereby make application for registration as an authorized seller of poisons.
I hereby certify that I am over twenty-one years of age and that the particulars of the Business where the selling of poisons will be carried out as follows:- Name of Business Address of Business 3.

If partnership, give names and titles of all active partners: 4.

If individually owned, give name and address of owner: 8.

I enclose two testimonials from the following persons:- 6.

Phone Number 1.

2. and enclose — The Pharmacy Regulations, 2012 42 2012, No.
45 a fee of a certified copy of my birth certificate (iii) two recent photographs of myself Dated this day of 20 Signature of Applicant 2012, No.

45 43 The Pharmacy Regulations, 2012 FORM H Regulations 9 & 31 THE PHARMACY ACT 1995 No.
THIS IS TO CERTIFY THAT Name IS Registered as an authorized Seller of Poisons in Antigua and Barbuda Dated: Expired Date: President, Council Registrar The Pharmacy Regulations, 2012 44 2012, No.

45 FORM 1 Regulation 33 THE PHARMACY ACT 1995 Register of Poison DATE Name and Address of Signature of Comments purchaser Purchaser Name and quantity of Poison sold Purpose for which it is sold Made by the Pharmacy Council this day of 20 President 2012, No.
45 45 The Pharmacy Regulations, 2012 FORM J Regulation 11 THE PHARMACY ACT, 1995 APPLICATION FOR LICENCE TO OPERATE A WHOLESALE PHARMACEUTICAL BUSINESS APPLICATION IS HEREBY MADE FOR A LICENCE TO OPERATE A WHOLESALE PHAR- MACEUTICAL BUSINESS, PARTICULARS OF WHICH ARE AS FOLLOWS: NAME OF APPLICANT: ADDRESS OF APPLICANT: TEL /4 FAX # EMAIL IF BUSINESS IS A COMPANY: NAME OF COMPANY: CHAIRMAN OF COMPANY: GENERAL MANAGER OF COMPANY.
MANAGING DIRECTOR OR CEO (IF ANY) .

IF INDIVIDUAL OR FAMILY OWNED: GENERAL MANAGER: OWNER (S): PHARMACIST NAME: SIGNATURE OF PHARMACIST: PHARMACIST REGISTRATION #: DATE: EMPLOYMENT — FULL TIME: -- PART TIME .

HOURS OF WORK .

TRADING NAME OF WHOLESALE BUSINESS: (AS KNOWN TO THE PUBLIC) The Pharmacy Regulations, 2012 46 2012, No.
45 NORMAL BUSINESS HOURS: ADDRESS OF WHOLE SALE BUSINESS ACTIVITY: THIS WHOLE SALE IS: (A) A NEW OPENING (B) (C) BEING ACQUIRED BEING RELOCATED (D) ALREADY IN OPERATION f } I 1 (TICK THE CORRECT RESPONSE) STATE DATE THAT THIS UNIT WILL BE READY FOR INSPECTION, PRIOR TO COM- MENCEMENT OF OPERATION: STATE DATE OF COMMENCEMENT OF OPERATION: THE OWNER (S) OR A DIRECTOR OF THE COMPANY OPERATING THE ABOVE MEN- TIONED IS REQUIRED TO SIGN THIS FORM.
NAME: REGISTRATION # OF BUSINESS POSITION WITH COMPANY: SIGNATURE: DATE: FOR OFFICIAL USE ONLY 2012, No.

45 47 The Pharmacy Regulations, 2012 FORM K Regulation 9 THE PHARMACY ACT, 1995 No.
AND BARBUDA DATED EXPIRED DATE THIS IS TO CERTIFY THAT NAME IS President, Council Registrar LICENSED TO OPERATE A WHOLESALE PHARMACEUTICAL BUSINESS IN ANTIGUA This Certificate of License is for the purpose of the Pharmacy Act 1995 and is the property of the Pharmacy Council of Antigua and Barbuda.

 7'he Pharmacy Regulations, 2012 48 2012, No.

45 FORM L Regulation 14 THE PHARMACY ACT, 1995 No.
THIS IS TO CERTIFY THAT NAME IS LICENSED TO OPERATE A PHARMACY IN ANTIGUA AND BARBUDA DATED EXPIRED DATE Minister with responsibility for the administration of the Pharmacy Act, 1995 Registrar This Certificate of License is for the purpose of the Pharmacy Act 1995 and is the property of the Pharmacy Council of Antigua and Barbuda.

2012, No.
2012, No.

45 49 The Pharmacy Regulations, 2012 FORM M Regulation 12 THE PHARMACY ACT, 1995 APPLICATION FOR LICENCE TO SELL POISONS APPLICATION IS HEREBY MADE FOR A LICENCE TO SELL POISONS, PARTICULARS OF WHICH ARE AS FOLLOWS: NAME OF APPLICANT: ADDRESS OF APPLICANT: TEL # FAX # EMAIL IF BUSINESS IS A COMPANY: NAME OF COMPANY .

CHAIRMAN OF COMPANY: GENERAL MANAGER OF COMPANY .
MANAGING DIRECTOR OR CEO (IF ANY): IF INDIVIDUAL OR FAMILY OWNED: GENERAL MANAGER: OWNER (S): PHARMACIST NAME: SIGNATURE OF PHARMACIST: PHARMACIST REGISTRATION #: DATE: EMPLOYMENT — FULL TIME: — PART TIME: HOURS OF WORK .

TRADING NAME OF WHOLESALE BUSINESS: (AS KNOWN TO THE PUBLIC) The Pharmacy Regulations, 2012 50 2012, No.
45 NORMAL BUSINESS HOURS: ADDRESS OF WHOLE SALE BUSINESS ACTIVITY.

THIS WHOLE SALE IS: (A) ANEW OPENING (B) BEING ACQUIRED (C) BEING RELOCATED (D) ALREADY IN OPERATION 1 { { { 1 1 } 1 (TICK THE CORRECT RESPONSE) STATE DATE THAT THIS UNIT WILL BE READY FOR INSPECTION, PRIOR TO COM- MENCEMENT OF OPERATION: STATE DATE OF COMMENCEMENT OF OPERATION: THE OWNER (S) OR A DIRECTOR OF THE COMPANY OPERATING THE ABOVE MEN- TIONED IS REQUIRED TO SIGN THIS FORM.
NAME: REGISTRATION # OF BUSINESS POSITION WITH COMPANY: SIGNATURE: DATE: FOR OFFICIAL USE ONLY 2012, No.

45 51 The Pharmacy Regulations, 2012 FORM N Regulation 14 THE PHARMACY ACT, 1995 THIS IS TO CERTIFY THAT NAME IS LICENSED TO SELL POISONS IN ANTIGUA AND BARBUDA No.
DATED EXPIRED DATE Minister with responsibility for the administration of the Pharmacy Act, 1995 Registrar This Certificate of License is for the purpose of the Pharmacy Act 1995 and is the property of the Pharmacy Council of Antigua and Barbuda.

 The Phanitael Regithilion.s.


2012 No 43 SCHEDULE 4 Subject to the provisions made under sections 13, 18, 19 and 20 of the Pharmacy Act, the sale or supply of drugs and poisons for the purpose of the Act falls into 2 parts: Part 1— divided into 6 Sections: Section 1 — deals with sale of vitamins in Supermarkets, Health Food Stores and Shops Section 2 — Drugs restricted to Pharmacies only.

Section 3 — deals with Prescription only Drugs.


Section 4 — deals with Controlled drugs and Psychotropic substances.

Section 5 — deals with General Sales.

Section 6 — deals with Chemical Precursors.

Part 11— deals with poisons which may be sold by authorized sellers of poisons.
Section 1 PART I Vitamins — Persons already operating a Health Food Store, Supermarket, or Shop may sell vitamins and minerals as Vitamin Supplements but only in un-opened bottles or containers, suitably labelled as to the therapeutic effect of its contents.

Vitamins are any of the following: Vitamins A. BI, B2.

B6, C, D and E, biotin, nicotinamide, nicotinic acid, pantothcnic acid and its salts, biflavanoids, in- ositol, choline, para-aminobenzoic acid, cyanocobalamin or folic acid.
Vitamin preparations mean any medicinal product, the active ingredients of which consist only of vitamins, or vitamins and minerals salts, that is, salts of any one or more of the following: iron, iodine, calcium, phosphorus, fluorine, copper, potassium, manganese, magnesium or zinc.

Vitamins for oral use as follows: Thiamine or Vitamin BI Riboflavin or Vitamin 82 Ascorbic Acid or Vitamin C Vitamin D, no more than 1,000 international units or less per oral dosage form (1,000 i.u.)
53 The Pharmacy Regulations, 2012 Vitamin E, Alpha tocopherol, no more than 200 international units (200 i.u.)

Any vitamin preparation for oral administration as a food in relation to which there are no written particulars or direction as to dosage.
Any medicinal product for oral administration as a food, not being a vitamin preparation to which one or more of the ingredients has been added: - Vitamin A or D, folic acid or cyanocobalamin, and in relat to which product there are written particulars or directions as to the recommended use of that substance which involves a daily intake in excess of the quantities and ingredients specified.
Any vitamin preparation for oral administration as a food in relation to which there are written particulars or directions specifying a recommended daily dosage for adults involving a daily intake in excess of vitamin A, 2500 units; or antirachitic activity, 250 units; or folic acid, 25 micrograms; or cyanocobalamin, 5 micro- grams.
Exemptions: No Supermarket, Health Food Store, or Shop may sell the vitamins as listed below: Vitamin A, any preparation for internal and parenteral use in humans containing or represented as containing more than 10,000 i.u.

in each oral dosage form, or if the largest recommended daily dosage shown on the label thereof, if consumed would furnish more than 10,000 i.u.
Vitamin D dosage over 1,000 i.u., any preparation for internal or parenteral use in humans containing or represented as containing more than 1,000 i.u.

in each oral dosage form, or if the largest recommended daily dosage shown on the label thereof, if consumed would furnish more than 1,000 i.u.

Vitamin B12 or Cyanocobalamin.

Vitamin B5 or Panthothenic Acid.

Vitamin B3 or Niacin or Niacinamide Vitamin E dcx;;_wc over 200 Lit Vitamin 136 or Pyridoxine Acid.
Vitamin K Folic Acid Section 2 Narcotic controlled Drugs and Psychotropic substances are restricted to prescriptions only.

Record of these must be kept according to the provisions of the Misuse of Drugs Act and the Dangerous Drugs Rules.

The drugs which fall under this section are subject to control and should be guided by the following particu- The Pharmacy Regulations, 2012 54 2012, No.

45 lars.

Under this section, penalties may be determined for offences under the Misuse of Drug Act.
Doctors, pharmacists and persons lawfully conducting retail pharmacy businesses may be called upon to give particulars of the quantities of any of these drugs which have been prescribed, admin- istered or supplied over a period of time.

It is an offence to fail, without reasonable excuse, to give the information required or to give false information.

Records must be kept by all person(s) or businesses authorized to possess Control Drugs (CD).
The Control Drug Registers following particulars are to be recorded date on which received; name and address of person or firm from whom received; amount received; form in which received.

For CD supplied the following must be recorded a) date on which the supply was made; name and address of person or firm to whom supplied; particulars as to licence or authority of the person of firm supplied to be in possession of Controlled Drugs; amount supplied; form in which supplied.
NB: The following points are important in relation to the keeping of CD registers— entries must be in chronological sequence; a separate part of the register must be used for each class of drugs.
Separate sec- tions are required for amphetamines (which includes dexamphetamine) and me- htylamphetmines; If desired, separate parts of the register can be used for different drugs or strengths of drugs comprised within a class of drugs; The class of drugs must be specified at the head of each page; a) b) • d) c) d) e) a) b) c) d) 2012, No.
45 55 The Pharmacy Regulations, 2012 0 h) i) entries must be made on the day of the transaction; No cancellation, obliteration or alteration may be made; correction must be dated by marginal note or footnote; entries must be in ink or otherwise indelible; the register must not be used for other purposes; the register must be kept at the premises to which it is related and a separate register must be kept for each premises of the business; particulars of stock receipts and supplies must be - furnished to any authorized person on request (this includes drug inspectors and police officers during any investigation).
Other documents and stocks of drugs must also be produced k) no entry need to be made in the prescription-only register, but it is good practice if required; to make these entries.

CD Lie; The possession, production and supplies of these are restricted in the public inter- est, to purposes of research or any other purpose designated by the Ministry of Health.

A licence is required from the Ministry of National Security for possession.
CD POM: A licence is needed to import, or export these drugs.

A pharmacist may supply them to a patient only on the authority of a prescription issued by a registered medical practitioner.

Requirement as to safe custody applies.

CD No Register (CD NO Reg): The control that applies to CD POM applies to CD NO REG.

However, records in the register of control drugs need not be kept in respect of these drugs.

CD Benz: are mainly benzodiazepines and some adrenoreceptor stimulants.
An import and export licence is required.

There are no restrictions on possession once obtained in accordance with a prescription written by a duly registered physician.

Recording of their sale in a control drug register is not required and there are no safe custody requirements.

CD Anab: are mainly anabolic and androgenic steroids.

An import and export licence is required.


There are no restrictions on possession once obtained in accordance with a prescription written by a duly registered physician.

Recording of their sale in a control drug register is not re- quired and there are no safe custody requirements.

CD Inv: contains preparations of certain controlled drugs, for e.g.

Codeine, pholcodine and morphine, which are exempt from full control when, presented in medicinal products of low strength.
There are no restrictions on the import, export, possession or administration of these preparations, and safe custody requirements do not apply for duly authorized person(s) or pharma- cies.

Invoice is required to be kept for two years.

 / The Pharmacy Regulations, 2012 120 2012, No.

45 Made the 12th day of December, 2012.

Hon.

Willmoth Daniel Minister Responsible for Health