Laws Relating to Storage and Distribution of Medicines and Medical Supplies

Laws Relating to Storage and Distribution of Medicines and Medical supplies

Students Learning Tasks

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

Define terms storage ,distribution, good storage practices

Identify sections in the Pharmacy Act 2011 related to storage and distribution of medicines and medical supplies

Describe sections in the Pharmacy Act 2011, related to storage and distribution of medicines and medical supplies

Definition of Terms Storage and Distribution according to Pharmacy Act 2011

Definitions:

Storage of medicines and medical supplies

Storage means putting and safe keeping of medicines and medical supplies up to the point of use.

Good Storage Practices (GSP) means part of quality assurance that ensures that the quality of pharmaceutical products is maintained by means of adequate control throughout the storage thereof.

Distribution

Distribution means a business of dealing in human medicines or medical devices in bulk or wholesale but does not include importers of human medicines, medical devices, food, cosmetics and veterinary medicines.

Good distribution practices (GDP)

Are practices that ensure that the quality of a pharmaceutical product is maintained by means of adequate control of the numerous activities which occur during the distribution process as well as providing a tool to secure the distribution system from counterfeits, unapproved, illegally imported, stolen, counterfeit, substandard, adulterated, and/or misbranded pharmaceutical products.

Identification of Sections in the Pharmacy Act 2011,related to storage and distribution of medicines and medical supplies

Section 34 Registration of premises

Section 36 Application of permits

Section 44 Conditions for body corporate to become authorized seller of medicines and pharmaceutical products

Description of Sections in the Pharmacy Act 2011,related to storage

and distribution of medicines and medical supplies

Section 34 Registration of Premises

A person shall not sell, dispense or supply medicinal products except in premises registered under this Act.

An application for registration or renewal of registration of premises shall be made to the Council in the prescribed form, and shall be accompanied by such fee as the Council may prescribe.

The Registrar or any person in his behalf shall-

keep a register of all premises registered under this section;

register premises if he is satisfied that the requirements to be complied with by the applicant as prescribed by the Council from time to time have been complied with; or

have powers to approve the location and name of the proposed premises.

The Council may, for good cause, refuse to register or cause to be removed from the register, any premises which is or has become unsuitable for purposes for which they were registered.

A person who contravenes the provisions of subsection (1) commits an offence and upon conviction shall be liable to a fine not exceeding ten million shillings or imprisonment for a term not exceeding two years or to both.

Section 36 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 44 Conditions for body corporate to become authorized seller of medicine and pharmaceutical products

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-

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.

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