IUO PPR 412 2024 LECTURE ON Pharmacy Law.pptx

PHARMACY LAW AND ETHICS PPR 412
BY
NAE Mohammed (PhD)
E-mail address: nae7mohammed@gmail.com

SUCCESS IN LIFE
•Seek to be VALUABLE
•SEEK TO MAKE YOURSELF VALUABLE
•To be valuable you must become master of SOMETHING
•Become known for SOMETHING
•And people will PAY FOR IT
•Whatever you MASTER make you VALUABLE

LEARNING OUTCOMES
 Laws related to : Food, Drug and Cosmetics;
Essential Drug List; Fake and Counterfiet
Drug Laws; Patent and Proprietary
Medicines/Vendors
 National Drug Policy
 Legislation on Animal health Products
 Professional Discipline by PCN
• Investigating Panel (PCN ACT 2022, Section
45 (1))
• Disciplinary Tribunal (PCN ACT 2022,
Section 46(1)
• Professional Misconduct or Infamous
Conduct (PCN ACT 2022, Section 47(1))
• Penalties for Professional Misconduct
Section (PCN ACT 2022, Section 48(1))
At the end of the lecture,
students are expected to:
 Have a good grasp of the law,
its enactment processes,
classification and its sources
 Have a general understanding
of the laws of contracts and
tort, court systems
 Laws related to: Pharmacy
Council of Nigeria (PCN);
National Agency for Food and
Drug Administration and
Control (NAFDAC); National
Drug Law Enforcement Agency
(NDLEA); Standard Organization
of Nigeria (SON);

INRODUCTION TO LAW
WHAT IS LAW
• Philosophy literally means a systematic study of
general and fundamental questions concerning a
given topic. for example law.
• The study of legal philosophy is called
jurisprudence
• Law is defined as a system of “rules and regulations
made and enforced by a government that regulate
conduct of the people within a society”.
• Law, according to Webster’s Collegiate Dictionary,
is a binding custom or practice of a community, a
rule of conduct or action prescribed or formally
recognized as binding or enforced by a controlling
authority
• Persons who explained the term “law” from the
same point of view form a school of
jurisprudence/thought.
GOALS OF THE LEGAL SYSTEM
• Protecting basic human rights
• Promoting fairness
• Helping resolve conflicts
• Promoting order and stability
• Promoting desirable social and economic
behaviour
• Representing the will of the majority
• Protecting the rights of minorities
• Facilitating and effectuating private choice. It
enables persons to make choices and gives
them legal effect. This is best exemplified by
the law of contracts, marriage and
succession.

THE PROCESS OF ENACTMENT OF LAW
Introduction of
the bill
First Reading
Second
Reading
Committee
Stage/Public
Hearing
Third
Hearing/Debat
e
Passage

ENACTMENT OF LAW
• A proposed bill is like a proposed law which
has not yet been passed ( An idea will be put
into a bill in terms of legal terminologies by the
Draft Man/Men).
• Source of Bills: Executive Bill, Personal bill (A
Senator or group of Senators; a Member or
group of Members of the House of
Representatives)
• The proposed bill is sent to the national
assembly for consideration through either The
House of Representatives or The Senate. If it
originated from the House of Representatives,
the Senate gets a copy of the passed bill it
passes through the below stages also. Later
both houses will do a concurrent passage.
• Later the relevant committees of both houses
meet as a joint committee for harmonization,
thereafter both houses pass the bill and it is
then transmitted by the Clerk of the National
Assembly to the president for his accent.
• The President is expected to sign the bill into law
within 30 days. However, if he does not sign, he is
expected to return the bill to the National
Assembly with reasons. If the reasons are not
cogent enough, the National Assembly can pass
the bill into law with a 2/3 membership vote in
favour of the passage.
• In a Military Regime laws are made by
pronouncement of the military ruling council
• For acceptability, the court interprets and
enforces the law using the golden rule i.e. the
intention of the lawmaker (why the law was
made)
• Law by a Federal civilian government is called an
ACT (Federal)
• Law by a Federal military government is called a
DECREE (Federal)
• Law by a State is called EDICT
• Law by a Local Government is called BYE LAWS

Classification/types of Laws Written and Unwritten Laws
Written Laws:
• This is codified law.
• These are rules that have been reduced to
writing i.e. Are contained in a formal
document e.g. the Constitution of Nigeria,
Acts of Parliament, Delegated Legislation,
International treaties etc.
Unwritten Laws
• These rules of law are not contained in any
formal document.
• The existence of such rules must be proved.
E.g. African Customary law, Islamic law,
Common law, Equity, Case law etc.
• Written law prevails over
unwritten law.
Law may be classified
as:
1. Written and Unwritten
2. Municipal (National)
and International
3. Public and Private
4. Substantive and
Procedural
5. Criminal and Civil

Classification/types of Laws
Municipal (National)
• This refers to law rules
applicable within a particular
country or state. This is state
law.
• It regulates the relations
between citizens inter se
(amongst themselves) as well
as between the citizens and
the state.
• It originates from parliament,
customary and religious
practices
International Law
• This is a body of rules that
generally regulates the
relations between countries or
states and other international
persons e.g. United Nations.
• It originates from
international treaties or
conventions, general
principles and customary
practices of states.

Public Law
• It consists of those fields or branches
of law in which the state has a direct
interest as the sovereign.
• It is concerned with the Constitution
and functions of the various
organizations of government
including local authorities, their
relations with each other and the
citizenry. Public law includes:
• Criminal Law
• Constitutional Law
• Administrative Law
• Public Law asserts state sovereignty.
Private Law
• It consists of those branches of
law in which the state has no
direct interests as the
state/sovereign.
• It is concerned with the legal
relationships between persons in
ordinary transaction e.g.
• Law of contract
• Law of property
• Law of succession
• Law of marriage
• Law of torts

Procedural Law
• This is adjectival law. It
consists of the steps or
guiding principles or rules of
practice to be complied with in
the administration of justice
or in the application of
substantive law.
For example:
• The Civil Procedure Code
• The Criminal Procedure Code
Substantive Law
• It consists of the rules themselves as
opposed to the procedure on how to
apply them.
• It defines the rights and duties of the
parties and prescribes the remedies
applicable.
• Substantive law defines offences and
prescribes the punishment.
• For example:
• The Law of torts
• The Law of succession
• The Law of contract
• The Law of Marriage
• The Penal Code

Criminal Law
• This is the law of crimes. A crime is an act or
omission committed or omitted in violation
of public law e.g. murder, treason, theft, e.t.c.
All crimes are created by parliament through
statutes
• A person who is alleged to have committed a
crime is referred to as a suspect.
• As a general rule, suspects are arrested by
the state through the police at the instigation
of the complainant. After the arrest,
the suspect is charged in an independent
and impartial court of law whereupon he
becomes the accused.
• Criminal cases are generally prosecuted by
the state through the office of the Attorney
General (AG) hence they are framed as R (the
State) Vs Accused e.g xxxxx
Civil Law
• It is concerned with the rights and duties of persons
i.e. individuals and corporations.
• Branches of civil law include:-
• Law of contract
• Law of torts
• Law of property
• Law of marriage
• Law of succession
When a person’s civil or private rights are violated,
he is said to have a cause of action. Examples of
causes of action:
• Breach of contract
• Defamation,
• Assault
• Negligence
• Trespass to goods e.t.c
The violation of a person’s civil rights precipitates a
civil case or action. The person whose rights are
allegedly violated sues the alleged wrongdoer hence
civil cases are framed as Plaintiff v Defendant.

Criminal Law
• If the accused pleads not guilty, it is the duty of the
prosecution to prove its case against him by adducing
evidence i.e. the burden of proof in criminal cases is borne
by the prosecution.
• The standard of proof is beyond any reasonable doubt i.e.
the court must be convinced that the accused committed
the offence as charged.
• In the event of reasonable doubt, the accused is acquitted.
If the prosecution proves its case i.e. discharges the
burden of proof, then the accused is convicted and
sentenced.
• The sentence may take the form of:-
1. Imprisonment
2. Fine
3. Probation
4. Corporal punishment
5. Capital punishment
6. Community service
7. Conditional or unconditional discharge
Civil Law
If the plaintiff proves his
allegations by evidence, he wins
the case and is awarded
judgment which may take the
form of:-
1. Damages (monetary
compensation)
2. Injunction
3. Specific performance
4. Account
5. Tracing
6. Winding up a company
7. Appointment of receiver

THE RULE OF LAW
• The concept of the Rule of Law is a framework
developed by Dicey on the basis of the English
Legal system.
• It is also described as Due Process.
• According to Dicey, the rule of law comprises
three distinct conceptions namely:
1. Absolute supremacy or predominance of
regular law:
This means that all acts of the State are governed by
law. It means that a person can only be punished for
disobedience of the law and nothing else.
2. Equality before the law:
• This means equal subjection of all persons before
the law.
• It means that no person is exempted from obeying
the law.
• All classes of persons are subjected to the same
judicial process regardless of their age, sex, creed,
gender or race.
3. The law (Constitution) is aconsequenceand
not the source of rights:
• Means that the law is a manifestation of the
will of the people.
• FACTORS UNDERMINING THE RULE OF
LAW
i. Excessive power of the Executive
ii. Non - independent Judiciary
iii. Corruption
iv. Selective prosecution
v. Civil unrest
vi. Ignorance of the law

SOURCES OF LAW
Sources of Law:
i. Constitution
ii. Legislation
iii. Administrative rules and
regulations
iv. Judicial decisions
v. African Customary law
vi. Islamic law
CONSTITUTION
The Constitution of Nigeria is defined as the written
instrument by which:
 The fundamental powers of the government are:
Established
Limited,
and defined, and
These powers are distributed among the
several departments for their safe and
useful exercise for the benefit of the
people
The fundamental features of Nigeria Constitutional
law are:
presidential form of government,
Separation of powers,
Federalism,
Rule of Law, and
The supremacy of the constitution.

SOURCES OF LAW
2. Legislation
It consists in the declaration of legal rules by a
competent authority. Acts passed by the legislature
are so called enacted law or stature law.
3. Administrative or executive orders, regulations
and rulings
They are those issued by administrative officials under
legislative authority. Administrative rules and
regulations are intended to clarify or explain the law
and carry into effect its general provisions and are
valid only when they are not contrary to the laws and
the Constitution.
4. Judicial Decisions or Jurisprudence
• The decisions of the courts, particularly the Supreme
Court, applying, or interpreting the laws of the
Constitution form part of the legal system of Nigeria.
• The decision of a superior court on a point of law are
binding on all subordinate courts.
• This is called the doctrine of precedent or stare
decisis.
5. African Customary law
It consists of those habits and practices which
through long, and uninterrupted usage have
become acknowledged and approved by
society as binding rules of conduct.
6. Islamic Law
Sharia is a body of religious law that forms a
part of the Islamic tradition based on
scriptures of Islam, particularly the Quran and
the Hadith.
In Arabic, the term sharīʿah refers to God's
immutable divine law and this referencing is
contrasted with fiqh, which refers to its
interpretations by Islamic scholars

LAW OF CONTRACT
•A contract may be defined as a legally binding agreement made
by 2 or more parties.
•It has also been defined as a promise or set of promises a breach
of which the law provides a remedy and the performance of which
the law recognizes as an obligation.
•The most important characteristic of a contract is that it is
enforceable.
• The genesis of a contract is an agreement between the parties
hence a contract is an enforceable agreement.
•However, whereas all contracts are agreements, all agreements
are not contracts.

LAW OF CONTRACT
ELEMENTS OF A CONTRACT
These are the constituents or ingredients of a
contract. They make an agreement legally
enforceable. These elements are:
a. Offer
b. Acceptance
c. Capacity
d. Intention
e. Consideration
f. Legality
g. Formalities, if any
FACTORS AFFECTING CONTRACTS
• These are circumstances which interfere
with the enforceability of a contract. They
have a negative effect on contracts.
• They may render a contract void or
avoidable.
• A void contract is unenforceable while an
avoidable contract is enforceable unless
avoided.
• These factors include: -
1. Misrepresentation
2. Mistake
3. Duress
4. Undue influence

TYPES OF CONTRACTS
TYPES OF CONTRACTS
Contracts may be classified as:
1. Written / specialty contracts
2. Contracts requiring written evidence
3. Simple contracts
4. Contracts under seal
Contracts requiring written evidence
These are contracts which must be evidenced
by some notes or memorandum.
Contents of the note/memorandum:
1. A description of the parties sufficient to
identify them.
2. A description of the subject matter of the
contract
3. The consideration (value)
4. Signature of the parties
Examples include; contracts of insurance other
than marine, contract of guarantee.
Written contracts
• These are contracts which under the law
must be written, that is embodied in a
formal document e.g. hire purchase
agreement, contract of marine insurance,
contract of sale of land.
• Contracts under seal: this is a contract
drawn by one party, sealed and sent to the
party/parties for signature.
• Such a contract requires no consideration
e.g. a lease agreement, mortgage, and
charge.
Simple contracts
• These are contracts whose formation is not
subject to any legal formalities.
• The contract may be:
• Oral
• Written
• Partly oral and written
• Implied form conduct of the parties
• Examples include; contracts of sale of goods,
partnership agreements, and construction
contracts.

LAW OF TORTS
A tort is a civil wrong other than a breach of a contract
that injures another person and of which the law imposes
civil liability. The remedy is a common law action for
damages or other relief.
A tort could be negligent or intentional. A standard
example of negligent torts is accident. Any harm that has
been caused by the willful misconduct of another is called
Intentional tort. it involves wrongs that the defendant
knew or should have known would result through his or
her actions or omission
Examples of intentional torts include:
i. Assault, fraud, and theft.
ii. Trespass, battery, negligence, products liability, and
intentional infliction of emotional distress.
iii. Damage to personal property, conversion of personal
property.
Strict liability is liability without fault or irrespective of
fault. This means that in strict liability cases, the
defendant is liable even though he did not intend to cause
the harm and did not bring it about through his
recklessness or negligence.
• PURPOSE
i. It helps to facilitate compensation for injuries
resulting from wrongful conduct.
ii. It can deter persons from acting in ways that may
produce harm.
iii. It can provide a way of punishing people who
TORT AND CONTRACT DISTINGUISHED
TORT CONTRACT
i. The duty is fixed by
law
ii. The duty is owed to
persons generally
iii. The remedies are few
(restricted)
Duty here means:an
obligation, created by law
or contract
i. The duty is fixed by the
parties
ii. The duty is owed to
the parties to the
contract
iii. The remedies are far
much wider
TORT AND CRIME DISTINGUISHED
TORT CRIME
i. It is a wrong
redressable by an
action for unliquidated
damages.
ii. The party suing is an
individual or private
i. It is a wrong the action
of which involves
punishment.
ii. Almost always the
party suing is the

NEGOTIATION
• The term negotiation refers to
i. A strategic discussion
ii. Intended to resolve an issue
iii. In a way that both parties find
acceptable.
Contract negotiation is the process of coming
to an agreement on a set of legally binding
terms
Negotiations involve give and take, which
means one or both parties will usually need to
make some concessions.Negotiation is when
people try to resolve the conflict by reaching a
solution that is acceptable to all.
• Is important because the skills involved in
handling conflict responsibly are used every
day by people in all aspects of life.
• People can hire attorneys to negotiate in
situations like auto accidents.
• Bargaining is about getting the best price,
while negotiating is about meeting the real
need.
• STAGES OF NEGOTIATION
i. Preparation and planning.
ii. Definition of ground rules.
iii. Clarification and justification.
iv. Bargaining and problem-solving.
v. Closure and implementation.
• PHASES OF NEGOTIATION
Phase 1 – Preparation
1. All parties should have a sincere interest in
settling dispute
2. Identify issue causing the conflict
3. Consider issue from the other side
4. Identify two workable solutions to resolve
problem
Phase 2 – Negotiation
1. Work together to identify issue causing
conflict
2. After identifying issues, parties should work
together to create a list of possible solutions (Identify 2-3
most workable)
3. Repeat all points of the final agreement to
be sure of understanding
Write down agreement and decide on
consequences if broken
Phase 3 - Post-negotiation
Make final decisions

PHARMACY & DRUG LAWS IN NIGERIA

LEGAL FRAMEWORK FOR PHARMACY PRACTICE IN NIGERIA
INTRODUCTION
• Pharmacy practice and business in Nigeria is
governed by laws and ethics, which buttress
the role of pharmacists and pharmacy
personnel and confer upon them the
exclusive authority to conduct certain
activities that are restricted and unique to the
profession with the aim of regulating the
manufacture, sale, and distribution of drugs
in Nigeria throughout the supply chain.
• All aspects of pharmacy practice in Nigeria as
at today are regulated by the Pharmacy
Council of Nigeria (Establishment) Act 2022.
The Act provides for the registration of all
pharmaceutical premises and personnel in
Nigeria before commencement of
pharmaceutical business.
• It must be noted that pharmaceutical
regulations in Nigeria has evolved over the
years, and this lecture has appraised the legal
and institutional framework regulating the
pharmacy profession in Nigeria.
HISTORICAL EVOLUTION OF PHARMACY LAWS IN
NIGERIA
• Pharmacy laws in Nigeria have gone through a lot of
processes and here are some insight on some of the
laws.
The Lagos Pilotage and Harbour Ordinance 1878.
The Hospital Ordinance of 1881
The Ereko Dispensary Rules of 1889
The Pharmacy Ordinance No. 8 of 1902
This law(PO No 8 of 1902) among others, sought to
regulate the training and issuance of certificates and
licence to Dispensers in the Colony of Lagos, the towns
of Calabar, Opobo, Warri and such other parts of the
protectorate as the Governor in Council declared.
The Poisons and Pharmacy Ordinance of 1923
In 1923 the PPO was enacted for the purpose of
specifying standards and skills to be attained by those
seeking to be registered as Chemists or Druggists in
the Colony of Lagos and the Protectorate of Nigeria,
including British Cameroon;
The Board of Medical Examiners.

HISTORICAL EVOLUTION OF PHARMACY LAWS IN
NIGERIA
Poisons and Pharmacy Ordinance of 1927.
The Poisons and Pharmacy Ordinance (PPO), 1927,
which among others fortified the PPO of 1923 and
improved improved the standards for the training
of dispensers and, Chemists and Druggists; The
Poisons and Pharmacy Ordenance which
standardised the syllabus and curriculum of the
Chemists and Druggists Diploma, and also
established the Pharmacy Board of Nigeria
The Poisons and Pharmacy Act 152 of 1958
The Poisons and Pharmacy Act 152 of 1958 among
others, regulated issuance of Chemists and
Druggists Diplomas, and Dispensers Certificates as
well as establishment and maintenance of a
register of Pharmaceutical Chemists and a register
of Pharmaceutical premises;
The Pharmacists Act No. 26 of 1964
The Pharmacists Act No 26 of 1964 conferred
powers on the Pharmacists Board, among others
to, determine the standards of knowledge and
skills to be attained by persons seeking to become
Pharmacists in Nigeria as well as maintain a
Register of Patent and Proprietary Medicines
Vendors Licence holders in Nigeria

The Pharmacists Council of Nigeria
Decree No. 91 of 1992 ( PCN Act P.17 of
2004)
The Military Government passed Decree No.
91 of 1992 titled Pharmacists Council of
Nigeria Decree No. 91 of 1992. This decree
was later designated as Pharmacists Council
of Nigeria Act Cap P.17 Laws of the
Federation of Nigeria, 2004 when Nigeria
became a democratic nation. The Act
repealed the Pharmacists Act of 1964.
Pharmacy Council of Nigeria
(Establishment) Act 2022
In August 2022, the National Assembly of
the Federal Republic of Nigeria passed into
law the Pharmacy Council of Nigeria
(Establishment) Act, 2022 and repealed the
Pharmacists Council of Nigeria Act, LFN
2004. Consequently, the extant law for the
practice of pharmacy in Nigeria is the
Pharmacy Council of Nigeria (Establishment)
Act, 2022

LAWS GOVERNING PHARMACY IN NIGERIA
• Why Pharma Regulation?
• The role of regulation is principally to uphold standards and
trust in the pharmacy profession so as to protect, promote
and maintain the health, safety and wellbeing of members of
the public. The benefit that accrues to the society cannot be
overemphasized. Consequently the call for continuous and
strict adherence to the law.
• It is clear that Pharmacy practice regulation has indeed come
a long way and the reason is not farfetched. The safety of the
general public is paramount and thus drug regulations must
be strictly observed. There are laws for the regulation of
pharmacy practice in Nigeria which form the basis for the
legal regime of pharmacy practice in the country.
• Pharmacy law is generally defined as a body of information
about drugs, drugs distribution and drug therapy
• The law sets out the responsibilities of pharmacists and
others who are formally involved with medications.
• Pharmacy law provides a mechanism through which adverse
outcomes are reviewed by allowing responsible persons to
account for their actions and avoid liability through
satisfactory accounting.
• Pharmacy practice in Nigeria is regulated at the Federal
Level(Under Exclusive List of the constitution) – PCN
• The purpose of pharmacy law is to:
i. Guarantee public health and safety
ii. By controlling the practice of pharmacy and
iii. The distribution of drugs.
• The laws are:
1. The Pharmacy Council of Nigeria
(Establishment) Act 2022.
2. The Poisons and Pharmacy Act
3. Food, Drug and Related Products
(Registration) Act Cap F.33
4. The Food and Drugs Act
5. The National Agency for Food and Drugs
Administration and Control Act.
6. The National Drug Formulary and
Essential Drugs List Act
7. The National Drug Law Enforcement
Agency Act
8. The Counterfeit and Fake Drugs and
Unwholesome Processed Foods
(Miscellaneous Provisions) Act and
Dangerous Drugs Act.

The Pharmacy Council of
Nigeria (Establishment) Act
2022.
Under this law, the functions of the Pharmacy Council
has been further revealed to include:
i. Control of the distribution of pharmaceutical and
veterinary products;
ii. Registration of pharmacists, and pharmacy
technicians,
iii. Registration of pharmacies, patent medicines shops
and other premises; their requirements and related
fees;
iv. Training and education of pharmacists and
technicians;
v. Establishment of Investigating Panel & Tribunal for
professional misconduct; offences and penalties.
• It is worthy of note that this Act does not repeal the
Poisons and Pharmacy Act (PPA) Cap 535 LFN 1990.
• It however adapted its provisions to the extent that
when there are conflicts in the provisions of the two
Laws, the provisions of the Pharmacy Council of
Nigeria (Establishment) Act 2022 shall prevail.
This Act established the Pharmacy
Council of Nigeria to:
I. Regulate the standards of
education, training and practice of
pharmacy in the Nigeria.
II. By this Act, any drug, poison,
medicine or medical consumables,
food supplement, including: any
substance of vegetable, animal or
mineral origin or any preparation
used for the diagnosis and
treatment of any diseases or
symptoms in animals or men, and
for control and disinfection of
pests, vermin and insects; labeling
and packaging of medicines and
medical products; good
pharmaceutical practice;
dangerous drugs and poisons are
under the control and regulation
of the Pharmacy Council.

The National Agency for Food
and Drugs Administration and
Control Act.
Undertake appropriate investigations into the
production premises and raw materials for food,
drugs, cosmetics, medical devices, bottled water
and chemicals and establish relevant quality
assurance systems, including certificates of the
production sites and of the regulated products;
Undertake inspection of imported food, drugs,
cosmetics, medical devices, bottled water and
chemicals and establish relevant quality assurance
systems, including certification of the production
sites and of the regulated products;
Compile standard specifications and guidelines for
the production, importation, exportation, sale and
distribution of food, drug, cosmetics, medical
devices, bottled water and chemicals;
Undertake the registration of food, drugs,
cosmetics, medical devices, bottled water and
chemicals; etc.
• This Act establishs the National
Agency for Food and Drug
Administration and Control.
• The functions of the agency include:
 Regulate and control the importation,
exportation, manufacture,
advertisement, distribution, sale and
use of food, drugs, cosmetics, medical
devices, bottled water and chemicals;
 Conduct appropriate tests and ensure
compliance with standard
specifications designated and
approved by the Council for the
effective control of the quality of food,
drugs, cosmetics, medical devices,
bottled water and chemicals and their
raw materials as well as their
production processes in factories and
other establishments;

• The Poisons and Pharmacy Act
 An Act to regulate the manufacture,
importation, exportation, advertisement,
sale or distribution of processed food, drugs
and related products and registration
thereof.
• Food, Drug and Related Products
(Registration) Act Cap F.33
This Act was enacted to regulate the
manufacture, importation, exportation,
advertisement, sale or distribution of
processed food, drugs and related products
and to register same.
The Act further prohibits the manufacture,
etc., of unregistered processed food, drugs,
etc.
By the provisions of the Act, No processed
food, drug, drug product, cosmetic, medical
device or water shall be manufactured,
imported, exported, advertised, sold or
distributed in Nigeria unless it has been
registered in accordance with the provisions
of this Act or regulations made under it.
• The Food and Drugs Act
The Law is promulgated to prohibit the
manufacture, sale, distribution and
advertisement of unregistered food, drug,
drug product, cosmetic, medical device or
water. The Law also regulates the
manufacture, importation, exportation,
advertisement, sale or distribution of
processed, food, drugs, medical devices,
chemicals and bottled water.
• The National Drug Formulary and
Essential Drugs List Act
The Act basically prescribes the National
Drug Formulary and Especial Drug List and
prohibits the importation into and
manufacture in Nigeria drugs not on the list
The Act is divided into two parts.
-Part I. Essential Drugs List and
-Part II. Drug Formulary.

• The National Drug Law Enforcement Agency
Act
The National Drug Law Enforcement Agency
Act established the National Drug Law
Enforcement Agency to enforce laws against
the cultivation, processing, sale, trafficking and
use of hard drugs.
The Act was changed from Decree No. 48 of
29th December 1989 to The National Drug Law
Enforcement Agency Act when Nigeria
abolished the military regime and joined the
chant of democratic rule. The promulgation of
the decree was a direct response to the rising
trends of drug trafficking and psychotropic
substances which adversely affected the
international image of Nigerians and Nigeria in
the comity of nations.
 to enforce laws against the:
 Cultivation, processing, sale, trafficking and
use of hard drugs and
to empower the Agency
 To investigate persons suspected to have
dealings in drugs and other related matters.
• The Counterfeit and Fake Drugs and
Unwholesome Processed Foods
(Miscellaneous Provisions) Act and
Dangerous Drugs Act.
This Act regards measures dealing with
counterfeit, adulterated, banned or fake,
substandard or expired drug or
unwholesome processed food. The Act also
established the Federal and State Task Force
which shall be constituted by the Minister
(for health) and the Task Force shall be
charged with the enforcement of the
provisions of the Act. The Task Force shall by
law have the powers to seal up premises
connected with any offence contained within
the provisions of the Act. The State Task
Force, subject to supervision of the Federal
Task Force.
Interestingly, the Act under section 10
establishes a Police Task Force; which is
charged with the responsibility of assisting
the Task Force, to arrest and conducting
potential investigations on persons who may
breach the provisions of the law.

PHARMACY COUNCIL OF NIGERIA (ESTABLISHMENT ACT) 2022
COMPARATIVE ANALYSIS OF THE PROVISIONS OF THE EXTANT ACT
AND THE REPEALED LAW (Pharmacists Council of Nigeria ACT Cap P17 LFN 2004)
.
• Sections Of The Act: The repealed Act contained 28 Sections
while the new Act has 72 Sections in general. This shows the
attempt made by the lawmakers to be very detailed in
covering the scope of PCN's mandate.
• Establishment & Composition (Sections 1 and 2): The
repealed Act (Section 1) established the Council with 5
functions stated as its mandate while the new Act: Section 1
establishes the Council and then Section 4 clearly states over
17 functions of the Council.
• Chairmanship Requirement: The requirement for the
Chairman of the Council has been increased from 15 years to
25 years post-registration experience.
• Addition Of New Membership Of The Council: 3
registered Pharmacy Technicians with at least 10 years post-
registration experience and in good standing with the Council
or the DG NAFDAC or his representative as members of the
council. The Registrar who is the Secretary to the Council is
also made a member by the new law
• Appointment Of The Registrar Of Council: Additional
requirement of not less than twenty (20) years post
registration qualification for the Registrar is a new provision
under the new law. The repealed law was not detailed in the
requirement for appointment of the Registrar. Also, the new
law makes provisions for the vacancy and removal of the
Registrar from being the Registrar/Secretary of the Council.
• Tenure Of The Chairman Of the Council Section 3:
Whereas the repealed Act provides for a 3years renewable
term for the Chairman, the new law has increased the tenure
years to a 4years renewable term.
• Membership Of The Pharmacy Profession: The repealed
Act: Section 2 refers to (a) Associate members, and (b)
members while the new Act: section 35 refers to (a) a
provisional member; and (b) members.
• Functions And Powers Of The Council (Section 4):
Whereas the repealed law provides for only 5 clear-cut and
specific functions of the Council, the new law however clearly
defined the 18 functions and powers of the Council devoid of
misinterpretation by mischief makers.
• New Areas And Categories Of Practice: These include
(a). online pharmacy, (b). satellite medicine facilities ©.
scientific offices.
• Licencing Authority: Section 4 clearly empowers the
Council to grant and issue a licence to Pharmacists, Pharmacy
technicians, Pharmaceutical sales representatives, patent
medicine vendors and any other category of practitioners in
the profession.
• Name: The repealed Act established the Pharmacists Council
of Nigeria while the new Act established the Pharmacy Council
of Nigeria. See the handout for more.

• Section 52-55 provides for offences and penalties.
• Generally, the current law has significantly reviewed the penalties for infringement of the
sections of the law. The monetary punishment for offences has been improved to meet current
realities and best global practices.
• For instance, obstruction of/resisting Pharmaceutical Inspectors, making false or misleading
statements to Pharmaceutical Inspectors, altering or interfering with any article seized and
breaking of seals or lock used in sealing defaulting pharmaceutical premises is an offence that is
liable upon conviction to a fine of N2,000,000 ( two million) or imprisonment for a term of
2years or both.
• Also, under this law, a body corporate or any person found to be operating a pharmacy without
registration commits an offence and shall be liable upon conviction to a fine of N2,500,000 ( two
million, five hundred thousand).
• This is in direct contrast to the sum of N1,000 fine (which was the highest monetary penalty) as
provided for in section 23 of the repealed law

OFFENCES & PENALTIES
Section 52-55
provides for offences and penalties
.
• Generally, the current law has significantly reviewed the
penalties for infringement of the sections of the law. The
monetary punishment for offences has been improved to meet
current realities and best global practices.
• For instance, obstruction of/resisting Pharmaceutical
Inspectors, making false or misleading statements to
Pharmaceutical Inspectors, altering or interfering with any
article seized and breaking of seals or lock used in sealing
defaulting pharmaceutical premises is an offence that is liable
upon conviction to a fine of N2,000,000 ( two million) or
imprisonment for a term of 2years or both.
• Also, under this law, a body corporate or any person found to
be operating a pharmacy without registration commits an
offence and shall be liable upon conviction to a fine of
N2,500,000 ( two million, five hundred thousand).
• This is in direct contrast to the sum of N1,000 fine (which was
the highest monetary penalty) as provided for in section 23 of
the repealed law
Sections 57 & 58 / Sections 59-62
• Sections 57 & 58 provide for the seizure and forfeiture
of drugs, medicines and poisons. These new provisions
empower the Council to seize drugs or articles offered for
sale or stocked in violation of the Act. The drugs or
articles seized are free from encumbrances and shall be
dealt with in the manner the Minister shall direct.
• Sections 59-62 provide for the storage and supply of
dangerous and ethical drugs, keeping records, control of
dispensing of dangerous drugs and preparation of
restricted drugs. These are new provisions which were
hitherto not provided for in the repealed law.
• PRE-ACTION NOTICES
• Section 66 mandates any intending plaintiff to first give
the PCN a one-month pre-action Notice clearly stating the
cause of action, particulars of claim, name and place of
abode of intending plaintiff and reliefs which he claims.
This will enable the Council to work towards the
settlement of issues and settling matters before litigation.

PROFESSIONAL DISCIPLINE BY PCN
Section 45 (1) Investigating Panel
• The Panel is charged with the responsibilities for:
1. Conducting a preliminary investigation into any case
where it is alleged that a person registered under this
Act as a pharmacist, pharmacy intern or a provisional
member has committed an act in that capacity
amounting to professional misconduct or infamous
conduct in a professional respect, or is for any other
reason the subject of proceedings before the Tribunal;
and
2. Deciding whether the case should be referred to the
Tribunal.
3. The Panel shall be appointed by the Council and shall
consist of four members of the Council and one other
person who is not a member of the Council, but who is
a registered pharmacist appointed by the Council.
Sections 46 (1)Disciplinary Tribunal
• The Tribunal shall be charged with the
responsibility of considering and determining any
case referred to it by the Panel established under
section 45 of this Act.
• The Tribunal shall consist of the Chairman of the
Council and six other members appointed by the
Council.
• The provisions of the Second Schedule to this Act
apply to the Panel and the Tribunal respectively.
• Without prejudice to the provisions of this section,
the Council may make regulations for the
discipline of pharmacy technicians and medicine
vendors.

Section 47 (1).
Meaning of professional misconduct or infamous conduct
• For the purpose of this Part, professional
misconduct or infamous conduct in a professional
respect include
• (a) the publication or circulation of false,
misleading or deceptive statements concerning
the practice of pharmacy ;
• (b) divulging or revealing to unauthorised
persons, a patient or another practitioner’s
information, or the nature of professional
pharmacy services rendered, without the patient’s
express consent, or without order or direction of a
court ;
• (c) selling, giving away, or disposing of
accessories, chemicals, drugs, medicines or
devices which have been obtained illegally, when
the pharmacist knows or ought to have known of
their having been obtained illegally or their
intended use in illegal activities ;
• (d) manufacturing, importing, exporting,
procuring, compounding, mixing, preparing,
dispensing, selling, and distributing of medicines,
chemicals, drugs, poisons, devices or accessories
in an unlicensed premises ;
• (e) dispensing, selling, distributing, giving away or
disposing of accessories, chemicals, drugs, poisons,
medicines or devices to unauthorised persons ;
• (f ) engaging in conduct likely to deceive, defraud or
harm the patient or the public, or demonstrating a
wilful or careless disregard for the health, welfare or
safety of a patient or the public or engaging in conduct
which substantially departs from the standards of care
ordinarily exercised by a pharmacist ;
• (g) knowingly failing to maintain a complete and
accurate record of all drugs and medicines produced,
received, dispensed or disposed of in compliance with
the requirements of all enactments, regulations and
rules for the time being in force ;
• (h) practicing the profession without being licensed; or
• (i) obtaining any money by fraud, misrepresentation or
deception.
• (2) Without prejudice to the provisions of subsection
(1), the Council may make rules prescribing other acts
or omissions which shall constitute professional
misconduct or infamous conduct in professional
respect under this Act. Second Schedule. Meaning of
professional misconduct or infamous conduct.

Section 48 (1)
Penalties for professional misconduct
• A pharmacist is found by the Tribunal to be guilty of
professional misconduct or infamous conduct in any
professional respect :
1. A pharmacist is convicted by any court or tribunal
in Nigeria or elsewhere having the power to award
imprisonment, of an offence which in the opinion
of the Tribunal is incompatible with his status as a
pharmacist; or
2. The Tribunal finds that the name of any person
has been fraudulently registered under this Act,
the Tribunal may give a direction —
 (i) reprimanding that person,
(ii) ordering the Registrar to suspend him from
practice,
(iii) ordering the Registrar to strike out his name off
the appropriate register,
(iv) ordering the person to pay a fine as may be
specified in the direction, or
(v) ordering the Registrar to remove from the
register of premises, any premises entered in the
register of premises, at which the pharmacy practice
in question is carried out by a registered person.
• (2) The Tribunal may defer its decision under
subsection (1) provided, that:
 (a) no decision shall be deferred for more than
an aggregate period of three months; and
(b) a member of the Tribunal shall not sit for
the purpose of reaching a decision which has
been deferred unless he was present when the
decision to defer was taken. (3) Where the
Tribunal gives a direction under subsection (1),
the Tribunal shall cause a notice of the
direction to be served on the person to whom
it relates. (4) A person to whom a direction
under subsection (1) relates may, at any time
within 30 days from the date of service on him
of the notice of direction, appeal against the
direction to the Court of Appeal and the
Tribunal may appear as a respondent to the
appeal and, for the purpose of enabling
directions to be given by the Court of Appeal as
to the costs of the appeal and of proceedings
before the Tribunal, the Tribunal shall be
considered to be a party to the appeal, whether
or not it appears on the hearing of the appeal.

PHARMACY COUNCIL OF NIGERIA AND NAFDAC COMPARATIVE ANALYSIS OF THEIR
JOB AS REGARDS PHARMACY PRACTICE
PHARMACY COUNCIL OF NIGERIA(PCN)
• Personnel: Pharmacists, Pharmacy
Technicians and holders of the Patent &
Proprietary Medicines Vendors’ Licences
• Practice: Hospital, Community, Industrial,
Consultancy, Administrative( All
government(MDAs), Military, Para-military)
Academic(University & Schools of Health
Technology)
• Premises: Communities, Hospital,
Industrial( Factories, Warehouses)
Wholesalers, Importers, Distributors
NATIONAL AGENCY FOR FOOD AND
DRUG ADMINISTRATION AND CONTROL
(NAFDAC)
• Products: Registration & regulation to
ensure the efficacy of the medicines
imported or produced in the countries
• All together have the PATIENTS as their
primary objective to serve and protect
their wellbeing.

Federal Competition and Consumer Protection
Commission (FCCPC)
The Federal Competition and Consumer
Protection Commission (FCCPC) is the leading
authority for competition and consumer
protection in Nigeria.
The commission is empowered by the Federal
Competition and Consumer Protection Act 2018
(FFCPA) to, among other things,
promote fair business practices and
safeguard the interest of consumers.

National Drug Policy
• The goals of the policy is to:
i. Make available at all times to the Nigerian
populace adequate supplies of drugs that are:
 Effective,
 Affordable,
 Safe and of
 Good quality;
 Ensure the rational use of such drugs;
ii. Stimulate increased local production of
essential drugs.
• Objectives of the National Drug Policy
i. To ensure efficient and effective drug
management in the public and private sectors;
ii. To ensure access to safe, effective, affordable and
good quality drugs at all levels of health care on the
basis of health needs;
iii. To promote the rational use of drugs by
prescribers, dispensers and consumers;
iv. To increase local drug manufacture/production
and promote export;
v. To ensure that all drugs in the national drug
distribution system are safe, efficacious,
effective and of good quality;
vi. To strengthen administrative, legislative,
and regulatory controls of the importation,
manufacture, procurement, storage,
distribution, supply, sale and use of drugs;
vii. To promote research on herbal remedies
and integrate those found to be safe and
efficacious into the health care system;
viii. To promote pharmaceutical research and
development of raw materials for the
production, compounding and formulation of
pharmaceutical products, as well as
operational research for the effective
implementation of the National Drug Policy;
and
ix. To enlist government commitment at all
levels for the achievement of the goals and
objectives of the National Drug Policy.

Problems of Drug Distribution in Nigeria
GOALS OF THE NATIONAL DRUG POLICY
The goals of the policy shall be to make
available at all times to the Nigerian
populace
Adequate supplies of drugs that are:
effective,
affordable,
safe
and of good quality
To ensure the rational use of such drugs
And to stimulate increased local production
of essential drugs
Pharmaceutical (Medicines)
Distribution
This is the movement of pharmaceutical products
from the premises of the manufacturer/importer of
medicinal products, or another central point, to the
end user thereof.
Pharmacists should be more involved in all stages
of medicines supply to improve drugs availability
because they have the knowledge of the stability
parameters of particular drugs and the
importance of the supply and distribution of
quality medicine.
Distribution Channels
Wholesalers/Distributors: These are the first port
of distributions from the manufacturers and
importers. Here medicines are distributed to
retailers, hospitals and clinics.
Retail Outlets: Retail outlets are the most common
distribution channel for pharmaceutical products.
These include community pharmacies and patent
medicine shops.
Hospitals and clinics: Hospitals and clinics purchase
pharmaceutical products in bulk from wholesalers
or directly from manufacturers

Factors Contributing to Chaotic Distribution in Nigeria
Lack of Political will from Government.
Over the years the various governments
at all levels have not displayed the
political will to tackle the chaotic drug
distribution that is hinged on the various
open drug markets across the country.
The delegation of issuance of permit to
Patent and Proprietary Medicine
vendors to Local Governments by the
Federal Ministry of Health contributed
greatly to a great measure the
proliferation of medicine shops across
the country.
However, during the Buhari
administration the order to close all
open drug markets and replaced with
the Co-ordinated Wholesale Centres
across the country was put in place.
Corruption: This occurs in areas of
inspections and regulatory activities.
Various unwarranted court injuctions
over the years hampered smooth
regulatory activities leading to large
numbers of unregistered premises
across the country.
Cultural. This has to do with the majority
of the stakeholders involved in the sales
and distribution of pharmaceutical
products in the country. They
predominantly are involved in open drug
markets where the distribution ethics
are absence, and drug storage facilities
are virtually not in existence.
Ineptness and Illitracy of stakeholders
That is lacking qualities such as
knowledge, skill, or ability required to be
involved in a well-meaning distribution
process.

What did you learn so far?
EVALUATION!!

References
• Erhun, W.O. Babalola, O.O. Erhun, M.O. (2001). Drug Regulation and Control
in Nigeria: The Challenge of Counterfeit Drugs. Journal of Health
&Population in Developing Countries; 4 (2): 23-34
• Pharmacists’ Council of Nigeria (2004). A compilation of Pharmacy, Drugs
and Related Laws and Rules in Nigeria, 1935-2000. Clear Impression Ltd, 54
Sharada Industrial Estate Phase I, Kano-Nigeria.
• Pharmanews (2013). Of morals, ethics and law: the tripod of pharmacy
practice. Retrieved from http://www.pharmanewsonline.com/of-morals-
ethics-and-law-the-tripod-of-pharmacy-practice/
• Schubert, F.A. (2012). Introduction to Law and the Legal System. Tenth
edition, Wadworth Cengage Learning.
• www.pcn.gov.ng
• PSN Constitution 2022

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