Registration and Licensing of Premises for Pharmacy Business

3.Requirements for Registration and Licensing of Premises for Pharmacy Business

Students Learning Tasks

By the end of this session students are expected to be able to:

Mention steps followed for Change of business ownership or any other change.

List Procedures for Application of Permits.

Outline Types of permits and revocation, suspension and cancellation of permits.

Define Pharmacy practices.

List Rational use of Medicines as in accordance to Pharmacy Act 2011

Mention roles of a Minister in regard to permit issuing

Write down criteria for Exceptions when supplying and dispensing medicines.

Explain purpose of Pharmacy Council to issue dispensing certificates.

Give steps to be followed during Restriction on pharmacy business and use of title.

Explain Conditions for body corporate to become authorized seller of medicine

Pharmacy Practices

Means any acts pertaining to the scope of practice of a pharmacist, pharmaceutical technician or pharmaceutical assistant as approved by the Council;

The Council shall, for the purposes of pharmacy practice, prescribe

the scope of practice of persons registered, enrolled or enlisted under this Act or the services or acts which shall, for purposes of this Act, be deemed to be services or acts pertaining to the pharmacy profession and the conditions under which the services may be provided;

The services to be provided in the various categories of pharmacies, and the conditions under which the services shall be provided;

Rules relating to

Code of Conduct for Pharmacists, Pharmaceutical Technicians and Pharmaceutical Assistants registered, enrolled or enlisted under the Act;

Good Pharmacy Practice;

The services for which a Pharmacist may levy fees and guidelines for levying such fees;

The titles or trading names under which a pharmacy may be conducted; and

Matters relating to the investigation and inspection of the pharmacy practice and the conduct of the business of a pharmacist (Section 38 of pharmacy act 2011).

Procedures for Change of Business Ownership or Any other Change

The pharmacy council as described in the act has the responsibility to know the continuity of pharmacy business at all time of operation. Therefore in case of any change whether ownership or any other change must be furnished to the council by the owner. As a result, every business owner shall, in writing notify the Council in the case of any change of ownership of the business or the change of registered premises.

Subject to subsection (1), the registration of premises under this Act shall cease to have effect upon expiration of thirty days from the date of changing the ownership of the business of medicines and related medical supplies. (Section 35 Pharmacy act 2011)

Procedures for Application for Permits

A person shall not sell, dispense or supply medicinal products unless he has obtained a permit issued under this Act.

An application for a permit shall be made to the Council in the prescribed form, and shall be accompanied by such fee as the Minister may prescribe.

The Council shall not issue a permit to sell medicines and related medical supplies under this section unless the Council is satisfied.

That the premises in respect of which the application relates shall be stored, meets the prescribed standards;

That the equipment are available for storing the medicines and related medical supplies;

With the suitability of the equipment and facilities which are used for distributing the medicines and related medical supplies; and

With the arrangements made or to be made for securing the safe keeping, and the maintenance of adequate records in respect of medicines and related medical supplies stored in or distributed from those premises.( Section 36 of pharmacy council 2011)

Types of Permits and Revocation, suspension and cancellation of permits.

According to pharmacy council act 2011, the registrar shall issue the following pharmacy permits for:

retail;

distribution;

institutional; or

Any other business as the Council may deem fit for the purpose of this Act.

Where the Council is satisfied that the applicant is a fit and proper person to carryon type of business set out in the act and the premises in which the business is to be conducted meets the prescribed standards, it shall, issue a permit appropriate to such business subject to such general or special conditions as the Council may consider to be appropriate to impose.

A permit issued under subsection (1) shall be in the form and manner as set out in the regulations made under this Act.

Where the Council considers that the applicant is not fit and proper person to be issued with a permit to carry on any business specified under this section it shall refuse to issue the permit, as the case maybe.

Cancellation and revocation

The Council may, subject to the provisions of this Act and upon satisfaction that the terms and conditions of issuance of permit have been violated-

Revoke, suspend or cancel the permit, as the case may be; and

Direct the Registrar-

to notify the person whose permit has been revoked, suspended or cancelled; and

to delete the name of the person whose permit has been revoked, suspended or cancelled, as the case maybe

Rational use of Medicines as in accordance to Pharmacy Act 2011

Rational use of medicines means: Patients receive medications appropriate to their clinical needs, in doses that meet their own individual requirements, for an adequate period of time, and the lowest cost to them and their community.

The Council shall, for purposes of rational use of medicines, prescribe roles of pharmaceutical personnel relating to-

pharmaceutical care;

accessibility, sustain ability, affordability, efficacy, safety and quality of medicines;

self medications;

Policy perspective changes;

Pharmaceutical public health;

Research and communication; and

any other act relating to appropriate use of medicines.

For the purposes of ensuring the rational use of medicines, no person shall sell by retail or supply in circumstances corresponding to retail sale or administer other than to himself, a medicine product of a description or a class specified by order made by the Minister and published in the Gazette, except in accordance with a prescription made by an appropriate practitioner. Appropriate practitioner means: a medical practitioner, dentist, veterinarian, or any other person as the Minister, may by Order published in the Gazette, specify.

A person who contravenes the provisions of subsection (2) commits an offence and on conviction shall be liable to a fine not exceeding five million or to imprisonment for term not exceeding twelve months or to both.

Roles of a Minister in regard to Issuing of Permits

Where the public interest requires and upon advice by the Council, the Minister may, notwithstanding with any of the provisions of this Act relating to dispensing of medicines by order published in the Gazette, allow any persons or group of person to be permitted by the Council to dispense such medicines as may be specified.

The Minister may, in addition to any other conditions, require an applicant for a permit to possess specified qualifications or training, as the case may be

Exception when supplying and dispensing medicines

Upon fulfilling conditions under the Act, There are situations that may exempt the supplying and dispensing of medicines as in accordance to this Act.

A medical practitioner, dentist or veterinary surgeon or a member of the staff of a hospital, health centre, dispensary or similar institution who has been authorized to do so by the general or special order of the Minister, on the advice of the Council, may supply or dispense a prescription medicine for the purpose of medical, dental or veterinary treatment as the case may be, subject to the following conditions:

The medicine shall be distinctly labeled with the name and address of the person by whom it is supplied or dispensed;

The following particulars shall, within twenty four hours after the medicine has been supplied or dispensed, be entered in a book used regularly for the purpose, and which shall be called the Prescription Book-

The date on which the medicine was supplied or dispensed;

The name, strength and the quantity supplied;

The name, strength and the quantity supplied The name and address of the person by whom the prescription was made; and

d.Name and address of a prescriber or prescribing health facility.

Where an authorized seller of medicines supplies prescription medicines shall enter its particulars in a Prescription Book kept in accordance with the provisions of this section.

Any person who supplies or dispenses any prescription medicine in a manner contrary to this section, commits an offence and upon conviction is liable to a fine of not more than one million shillings or to imprisonment, for term not exceeding six months or to both.

Purpose of Council to Issue Dispensing Certificates

Introduction: there are situations whereby the council may issue dispensing certificates to certain other health cadres, and these are shown below

The Council may, if it is in the public interest and upon an application and subject to such conditions as may be prescribed, issue a dispensing certificate to a practicing medical practitioner or Dentist or veterinary surgeon to dispense medicines.

Upon application to the Council pursuant to subsection (1), the Council may issue a dispensing certificate subject to such conditions as it may deem necessary.

The Council may, if it is satisfied that the applicant did not or is not fulfilling any condition given, may suspend, revoke or· withdraw the dispensing certificate issued under subsection (1). (pharmacy Act 2011 section 42)

Conditions for Body Corporate to become Authorized Seller of Medicine

SECTION 44(1)-(3):

Anybody corporate carrying on business involving sale of drugs shall be an authorized seller of medicines within the meaning of this Act, if-

With regard to the keeping, selling, dispensing and compounding of medicines the business is under the management of a superintendent who-

is a Pharmacist;

has signed and submitted to the Registrar a statement in writing on behalf of the body corporate stating his name and specifying whether or not he is a member of that body; and

is not at that time acting in similar capacity for any other body;

In each set of premises for the sell of medicines, the business is carried on either under the personal supervision of the superintendent or subject to his directions under the personal control of another Pharmacist;

The name and certificate of registration of the superintendent or of some other Pharmacist having control of the business is conspicuously exhibited in the premises.

Where

a body corporate which is an authorized seller of drugs has been convicted of an offence under this Act; or

Any member of the body corporate or any of its officer or any officer employed by it in carrying on the business, has been convicted of any criminal offence, or has been guilty of misconduct which, in the opinion of the Council, renders him or would, if he were a Pharmacist, render him unfit to be on the register, the Council may inquire into the matter and may, subject to this Act, direct that

In the body corporate cease to be an authorized seller of medicines, and be disqualified for a period to be specified in the directions from being an authorized seller of medicines; or

Any or all of the premises of medicines and the body corporate be removed from the register of premises and be disqualified for such period as the Council may direct.

Restriction on Pharmacy Business and Use of Title

Section 43 (1)-(7):

A person shall not carry the business of pharmacist unless that person is a pharmacist or is in association with a pharmacist.

No person other than a Pharmacist shall manufacture for sell, supply or dispense any medicine except under the immediate supervision of a Pharmacist.

A permit to practice and a certificate of registration of a Pharmacist having control of the business shall be conspicuously exhibited in the premises.

Where the body is an association

A copy of the certificate of its registration under the Business Name (Registration) Act or the Companies Act or any other charter or instrument establishing such association, shall be lodged with the Council;

The business shall be under the management of the Pharmacist in charge who shall be a Pharmacist;

In each set of premises for the retail sale of medicines, the business shall be headed by the Pharmacist in-charge.

For the purpose of subsection (3), the use of any of the titles "pharmacist", "druggist", "dispensing chemist", "pharmaceutist" or "drug chemist" or a similar word or combination of words in any language, shall be deemed to suggest the owner of the business or the person having control of the business on such a premises is a Pharmacist.

Nothing in this section shall apply to emergency supply of medicine for use within twenty four hours to a particular person for a treatment by a qualified medical practitioner, a dentist for the purpose of medical, veterinary surgeons for veterinary treatment.

Any person who contravenes the provisions of this section, commits an offence and shall be liable upon conviction-

in case such person is an individual, to a fine of not less than one million shillings or to imprisonment for a term not less than six months or to both;

in case such a person is an association, firm or body corporate, to a fine of not less than five million shillings.

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