Pharmacy and Poisons Act

This Act may be cited as the Pharmacy and Poisons Act.

Section 2 provides interpretative definitions: it lists activities (diagnosis, prevention, monitoring, treatment, alleviation, investigation, replacement/modification/support of anatomy or physiological processes, supporting life, control of conception, disinfection of medical devices, and in vitro diagnostic information) and states that a product which does not act in or on the body by pharmacological, immunological or metabolic means but may be assisted by such means is covered; it also defines 'sale' to include supply as a sample for inducing retail purchases.

Section 3 establishes membership and appointment rules for the Pharmacy and Poisons Board, including required qualifications for certain members and appointment powers of the Cabinet Secretary.

Board has power to formulate guidelines for regulating the manufacture, import and export, distribution, sale and use of medical products.

The Board is charged with regulating health products, technologies and the profession of pharmacy and must carry out a broad set of functions including licensing, inspection, standards enforcement, registration, surveillance, approval of trials, professional regulation and collaboration with other institutions.

Section 4 sets meeting procedures for the Board: the Board must meet as necessary; the Chairperson must preside and has a casting vote; the Board must select a member to act in the Chairperson's absence; quorum is five with three pharmacists; the Chief Executive Officer must record minutes in a minute book.

Section 5 creates a Registrar who is the Board's Chief Executive Officer appointed by the Board; the Registrar must perform duties and exercise powers as directed by the Board, manage day-to-day affairs, meet listed qualifications, and serve a four-year term with possible one reappointment subject to good performance.

Section 10 empowers the registrar to delete, correct and otherwise alter entries in the pharmacists register (including removing deceased registrants and entries procured by fraud); it also allows deletion after no reply to an inquiry within six months and enables the Board to order restoration on application and payment of a prescribed fee. The Principal Registrar of Births and Deaths must forward death certificates to the registrar.

The registrar must publish in the Gazette when a name is added to or deleted from the register (stating reason plus name and address) without undue delay, and must publish annually after 1 January a list of registered pharmacists with names, qualifications and addresses.

The Board may refuse to register, delete, or prevent restoration of names on the register in specified cases, may direct restoration (possibly subject to a fee), and must give notice of directions or refusals to affected persons.

The Board must establish an Enquiries and Disciplinary Committee; the Committee shall enquire into matters under section 12; the Board may order a pharmacist or pharmaceutical technologist to reimburse disciplinary hearing costs, which are a civil debt recoverable summarily by the Board.

The Board must not order cesser or restriction of a person's registration unless specified proofs are given and the Board considers the person responsible.

A person aggrieved may appeal to the Supreme Court within one month of notice; the Board may appear; the Supreme Court may make final orders; the registrar must alter the register to give effect to such orders.

A direction under paragraph (ii) of subsection (1) of section 12 does not take effect until one month after notice is given or, if appealed to the Supreme Court, until the appeal is determined or withdrawn.

When the Supreme Court has dismissed an appeal against a deletion/non-registration direction under section 12(1), any Board direction authorizing registration or restoration of the name does not take effect unless approved by the Cabinet Secretary.

The Board may direct the registrar to delete a pharmacist's name from the register if, because of a conviction or professional misconduct, that pharmacist's name is removed from a register or they are disentitled to practise in another country.

Persons whose names are deleted from the register must surrender their registration certificate to the Registrar forthwith; refusal or failure is an offence punishable by a fine up to ten thousand shillings, imprisonment up to one year, or both.

Unregistered persons must not carry on the business of a pharmacist, prepare or dispense drugs except under immediate supervision of a registered pharmacist, or use titles or words suggesting they are registered pharmacists; breach is an offence with fines or imprisonment; limited professional and sales exceptions apply.

Pharmacy and pharmaceutical technologist businesses must display the name and registration/enrolment certificate of the person having control on the premises; a registered pharmacist or enrolled pharmaceutical technologist must be present when operating the business; breaching these requirements is an offence punishable by a fine not exceeding one million shillings or imprisonment for a term not exceeding one year, or both.

Section 21(2) allows a body corporate lawfully carrying on a pharmacist's business to use any emblem, description or title that a registered pharmacist may use.

If a registered pharmacist cannot continue (death, unsound mind, bankruptcy or arrangement with creditors), their representatives may carry on the business with the Board's permission, subject to Board directions, continued personal management by a registered pharmacist, and for no more than five years; representatives need not be registered while these conditions are met. Representatives may also continue to use the pharmacist's lawful title/emblem while authorized by the Board.

Pharmacists and pharmaceutical technologists may only carry on their business in premises registered under this section; the Board controls registration and the registrar must keep the register; penalties apply for contravention.

The Board must give at least fourteen days' written notice of intended closure to the person in charge; if improvements are not made by the end of that period, an authorized officer shall order closure of the premises.

Persons lawfully carrying on the business of a pharmacist in accordance with this Part are authorized sellers of poisons.

The registrar must keep prescribed registers: a register of pharmacists and specialist pharmacists, a Roll of pharmaceutical technologists, and ensure the register is automated for sharing information under the National Single Window System.

A person who applies to be registered as a pharmacist or to be entered in the Roll of pharmaceutical technologists must submit a written application in the prescribed form addressed to the registrar.

Persons who satisfy the Board that they hold a diploma in pharmacy from any college recognised by the Board in Kenya are entitled, subject to the Act, to have their name entered in the register.

The registrar must issue certificates: a certificate of registration to a pharmacist upon registration and payment of the prescribed fee, and a certificate of enrolment to every Pharmaceutical technologist on the Roll upon payment of the prescribed fee.

The Registrar must issue practising licences to registered pharmacists or enrolled pharmaceutical technologists; licences expire at the end of the practising year (1 Jan–31 Dec); practising without a valid licence is professional misconduct.

Persons seeking a practising licence under section 9A must apply to the Registrar in the prescribed form and the application must be accompanied by the prescribed fee.

Every practising registered pharmacist and enrolled pharmaceutical technologist must have a valid practising licence.

The Board may deny or refuse to issue or renew a licence if, after due process, it determines the applicant failed to comply with this Act or its rules.

Pharmacists or enrolled pharmaceutical technologists with a license may apply to renew it in the prescribed form at least thirty days before expiry; those who fail to renew in time must pay a prescribed late application fee when applying.

Registered pharmacists and enrolled pharmaceutical technologists must undertake appropriate Continuous Professional Development as prescribed by the Board to maintain competence in ongoing practice.

The Board must prepare and submit a Poisons List to the Cabinet Secretary for approval; the Cabinet Secretary may confirm or amend the list. Part I and Part II of the list define who may sell those poisons.

Clinical trials on pharmaceutical products require prior Board approval (with the relevant ethics body); applicants must apply in the prescribed form with protocol and fee; approved sponsors must have quality assurance; the Board prescribes evaluation guidelines (including accelerated evaluations in emergencies) and inspects trials.

Section 26 lists who may lawfully possess Part I poisons and makes possession otherwise than in accordance with these provisions an offence punishable by fine, imprisonment, or both.

The Board may issue, renew, refuse or revoke wholesale dealer licences for poisons subject to public‑interest satisfaction, prescribed application and fee, and that a registered pharmacist resident in Kenya controls distribution; the Registrar must keep a register and licences expire on 31 December of the year of issue.

Allows businesses in mining, agricultural or horticultural accessories to apply for a licence to deal in specified poisons; the Board may issue, renew, refuse or revoke licences; licences expire on 31 December of the year of issue; selling contrary to the section is an offence with fines or imprisonment.

Specifies who may sell Part I poisons (named classes and conditions) and makes selling otherwise an offence with specified fine and imprisonment limits.

Rules for recording poison sales: sellers must obtain written orders and verify purchaser identity/occupation; purchasers must sign entries or, in emergencies, supply written orders within 24 hours; contravention is an offence with fines or imprisonment.

Persons who supply or dispense Part I poisons must label them with supplier and recipient details, date, ingredients and quantity; authorised sellers may supply Part I poisons they prescribed and dispensed and record particulars in their Prescription Book; non-compliance is an offence punishable by fine or imprisonment.

People who want to sell Part II poisons may apply for a licence; the Board (or its appointee) may issue, renew, refuse or revoke licences subject to conditions, a fee, and suitability checks; the Registrar must keep a register; licences expire on 31 December of the year granted; appeals on refusal or revocation lie to the Cabinet Secretary.

Specifies which licensed persons may sell Part II poisons, allows certain sales of surplus or stock after licence revocation within three months (or longer if the Board allows), and makes selling Part II poisons contrary to the section an offence punishable by a fine of up to twenty thousand shillings or imprisonment up to one year, or both.

Section 34 requires specified labelling particulars for containers of poisons and sets an exception for poisons made up for a particular person's prescribed needs; it creates an offence punishable by fine and/or imprisonment.

It is an offence for a person to expose or cause to be exposed for sale any poison in or by means of an automatic machine; the person is liable to a fine not exceeding twenty thousand shillings or to imprisonment for a period not exceeding one year or to both.

Persons must hold and obtain manufacturing licences from the Board to manufacture medicinal substances; licences expire annually and the Board may enter and sample premises.

People granted a manufacturing licence under section 35A must comply with the good manufacturing practices prescribed by the Board.

Provides definitions: "Director" means the Director of the National Quality Control Laboratory appointed under section 35H; "Laboratory" means the National Quality Control Laboratory established under section 35D.

Establishes the National Drug Quality Control Laboratory for examination, testing and ensuring quality control of drugs and medicinal substances.

The Laboratory must be a corporate body with perpetual succession and a common seal, and it has power to sue, be sued, and to acquire, hold and dispose of movable and immovable property for its own purposes.

Establishes a nine‑member Board of Management for the Laboratory appointed by the Pharmacy and Poisons Board; members serve three years and may be re-appointed; quorum is five; the Board must meet at least four times per year; the Director is the Board secretary; the Board may regulate its own procedure.

The Board of Management must administer the Laboratory's property and funds to promote the Laboratory's best interests.

The Board of Management must appoint a Director; the Director is the chief executive responsible to the Board for day-to-day management and holds office on terms set out in the instrument of appointment.

The Director has the power to develop and administer a data bank on quality assurance on behalf of the Board of management.

Key financial rules for the National Quality Control Laboratory: the Laboratory may accept gifts and other moneys for approved programmes; the Director must keep all proper books of accounts and the Board must cause books to be kept; the accounts shall be audited by the Auditor‑General; disposal of fixed assets by the Board requires Treasury approval; the Board may 'think fit' about creating reserve funds.

The Director must issue and sign a certificate of analysis for every analysis done.

No person may advertise any drug or poison unless they have the Board's written permission; applications for such advertisement must be made to the Board in the prescribed form with the prescribed fee.

No person may publish an advertisement implying drugs, appliances or articles are effective for any purpose listed in the Act's Schedule.

No person may take part in publishing any advertisement that refers to drugs, appliances or articles in terms intended to lead to their use for procuring miscarriage, subject to the Act's provisions.

No person shall take part in publishing advertisements about drugs, medicines, medical appliances or similar articles that the Board considers extravagant or unrelated to their pharmacological properties.

Section 40 prescribes offences for certain advertisements (including claims about treating human ailments and procuring miscarriage) and sets penalties for first and subsequent convictions plus specified exceptions for some publishers and professionals.

Requires labelling of articles containing medicine to show the appropriate designation of the substance or active constituents and appropriate quantitative particulars; specifies naming rules for poisons and non-poisons (including use of British Pharmacopoeia monographs or accepted scientific names in English or Latin), requires approximate percentages or quantities for constituents and permits labelling by portion where articles have separate portions; defines “container” to include a wrapper; sets fines and imprisonment for convictions.

In proceedings under section 41, a certificate of analysis by a public analyst or authorized officer is admissible, and any party may require the analyst to be called as a witness.

If a charged person sold or possessed a container labelled as containing poisons that appears to be intact and packed by the manufacturer, the container is presumed to contain the poisons described on the label until proved otherwise.

An appeal under sections 27(2), 28(3), 32(5) and 50(2) must be in writing and must be lodged within thirty days after the date of the act appealed against.

The Cabinet Secretary may, on the Board's recommendation and by order, prohibit or control the manufacture, sale, advertisement or possession of certain secret, patent, proprietary or homoeopathic medicines, preparations or appliances.

Grants rule‑making authority covering specified matters including sale, manufacture, import/export, storage, labeling, containers, compounding, fees, Board procedure, professional standards and training, pharmacovigilance, and any matters required or authorized to be prescribed.

Magistrates may issue search warrants; police officers and authorized officers may enter, search and seize evidence under conditions; seized items must be reported to a magistrate forthwith.

Rules about retention, sale/disposal, and forfeiture of seized drugs, articles or documents; magistrate and court may authorize disposal and the Board may retain or confiscate suspected counterfeit or illegally imported medicinal substances to be disposed at owner/importer expense.

Sellers of poisons must produce their registration certificate or licence on demand by an authorized officer; books kept by sellers of poisons, medical practitioners, dentists, veterinary surgeons, or hospitals/dispensaries must be open for inspection by an authorized officer at all reasonable times.

Any person must not obstruct or hinder an authorized officer who is lawfully exercising powers under section 45 or section 47; doing so is an offence.

If a corporate body (or a partner in a firm) commits an offence under the Act, every director, secretary, manager or partner present at the time is to be treated as guilty unless they can prove lack of consent/connivance and that they exercised all due diligence to prevent it.

If a body corporate is convicted under this Act or rules, it can be directed to stop being an authorised seller of poisons and be disqualified; registered premises can be removed and disqualified; any body corporate may appeal to the Cabinet Secretary whose decision is final.

Section title indicating offences relating to items that are unfit for use in humans or in animals.

Anyone convicted of an offence under this Act may be sentenced to a fine of up to one million shillings, or imprisonment for up to two years, or both; additionally the court may order forfeiture of articles used in the offence.