Pharmacy Jurisprudence Lecture Notes PDF

PHARMACY JURISPRUDENCE LECTURE NOTES Introduction The term “Pharmacy laws” is used loosely to refer to all the laws governing the practice of Pharmacy in Nigeria. In reality, there are Pharmacy Laws and Drug...

PHARMACY JURISPRUDENCE LECTURE NOTES Introduction The term “Pharmacy laws” is used loosely to refer to all the laws governing the practice of Pharmacy in Nigeria. In reality, there are Pharmacy Laws and Drug Laws, and both impinge on the practice of Pharmacy. A practicing Pharmacist will at one point or the other encounter issues directly linked to the enforcement (or absence of enforcement) of the provisions of all these laws. It is therefore important that all professionals intending to practice in Nigeria gain a working understanding of the laws. This would further help the professional to stay on the right side of the law and to defend his/her practice when and if the need arises. The presentations also include a review of events and milestones in Pharmacy regulation (History of Pharmacy in Nigeria) to provide an appreciation of the journey to the present. Pharmacy vs Drug laws The following may be regarded as (strictly) Pharmacy Laws: Pharmacists Council of Nigeria Act 91 of 1992 (Cap P. 17 LFN, 2004) Poison and Pharmacy Act Cap 535 LFN 1990 Drug Laws are more numerous and include: National Agency for Food and Drug Administration and Control (NAFDAC) Act 15 of 1993 (Cap N. 1 LFN, 2004) Food, Drugs and related Products Registration Act 19 of 1993 (Cap F. 33 LFN, 2004) National Drug Law Enforcement Agency (NDLEA) Act Cap 253 LFN 1990 (Cap N.30 LFN, 2004) Dangerous drugs Act Cap D. 1 LFN 2004 Foods and drugs Act Cap F.33 LFN, 2004  National Drug Formulary and Essential Drugs List Act Cap N. 29 LFN 2004 Counterfeit and fake Drugs and Unwholesome Processed Foods Act 25 of 1999 (Cap C. 34 LFN, 2004) Pharmacy laws address issues relating to personnel and practice in the profession. They provide guidance to the professional in the practice arena and include matters that may be considered a breach of the law and procedures for professional discipline of erring members of the profession. Regulations made pursuant to the implementation of the laws also provide standards in respect of the premises and facilities where professionals carry out their practice. Drug laws on the other hand are not limited to the Pharmacist or to professional matters. These laws cover a wide variety of practices or businesses including bakeries, sachet water producers and the like. Furthermore, some of the laws (the NDLEA Act) were put together with the primary aim of arresting and prosecuting drug offenders. On the whole, drug laws may be said to contain provisions to guide all persons involved in the handling of regulated products. The term regulated products covers drugs, processed foods, cosmetics, packaged water, medical devices, etc.  Pharmacists Council of Nigeria (PCN) Act This is the law establishing PCN. It may be cited as the Pharmacists Council of Nigeria Act Cap P. 17, LFN, 2004. Prior to the return of civil rule in Nigeria and the compilation of the laws of the Federation in 2004, the law was known as the PCN Decree 91 of 1992. Although the Act establishing PCN is dated 1992, the Council has been in existence for a much longer time. The laws controlling the practice of Pharmacy in Nigeria actually date back to 1878 (Pilotage & harbor ordinance, 1878; Hospital ordinance, 1881; Ereko dispensary rules, 1889; Pharmacy ordinance, 1902; Poison & Pharmacy ordinance, 1923; 1927; 1936; Poison & Pharmacy Act, 1958; Pharmacists Act, 1964). The older names of PCN are Pharmacy Board of Nigeria and Pharmacists Board of Nigeria. More of this history will be taken under a different topic. The Act gives PCN the powers to regulate the training and practice of members of the Profession of Pharmacy. Establishment and Responsibilities of PCN Section 1 (1) of the PCN Act gives the functions of the Council and these are essentially the provisions from which the Council derives its mandate and powers: a) Determining the standards of knowledge and skills for persons intending to become members of the profession and reviewing these standards as circumstances dictate. b) Maintenance of a register of persons entitled to practice the profession and publication of the register. c) Preparing and reviewing a code of ethics for the profession (in the Act – reviewing and preparing, meaning there existed a code in before the law). d) Regulating and controlling the practice of the profession in all its aspects and ramifications. e) Performing other functions as may be required of the Council under the Act. The list of functions or responsibilities appears to be short (only five items) and many people have, in error, challenged PCN’s authority and claimed that the Council was acting beyond its regulatory mandate as contained in the law. PCN has in the past relied on the provision in Section 1 (1) (d) to successfully defend its mandate. This section permits Council to undertake whatever actions are deemed necessary for the effective regulation of the profession of Pharmacy. The all- encompassing clause, (all aspects and ramifications) taken together with Section 1 (1) (e) confers enormous powers on PCN as Council can assume regulatory powers over any matter that is deemed necessary for the regulation of the profession and can be reasonably advanced as being an aspect of Pharmacy or ramifying the profession. Successive Leaderships of PCN have relied on these two sub-sections (S. 1 (1) (d) & (e)) to stretch the Council’s mandate to address emerging challenges in the profession. Membership of the Profession Section 2 of the PCN Act covers membership of the profession and describes two types of membership: full members and associate members. The latter are actually undergraduate Pharmacy Students who are expected to become full members after graduation and upon passing Council examinations. The provisions of this section (and others too) need be understood from the background of the existence of registered Pharmacists prior to the coming into force of the (then) military decree. Note should also be made of the existence of Council examinations in the provisions as a pre-condition for registration. Except for foreign trained Pharmacists, Council did not administer any pre-registration examination on Pharmacy Graduates until 2017 on account of resistance to the idea from many quarters, including from within the top echelon of the profession and the young graduates who feared that they might be excluded from the profession with the introduction of pre-registration examinations. Composition of Council The composition of the Governing Council is covered by Section 3 of the Act. Membership comprises the Director of Food and Drugs Services in the Federal Ministry of Health, Directors of Pharmaceutical Services from all the States of the Federation plus the Federal Capital Territory, Deans of recognized Faculties of Pharmacy, the President and 8 members of the Pharmaceutical Society of Nigeria (PSN), a (Pharmacist) representative of the Armed Forces, the Executive Director of the National Institute for Pharmaceutical Research and Development and a Chairman appointed by the President. Note should be made of the reality that the President actually appoints the Chairman only (on the recommendation of the Minster of Health). The other members of the Governing Council are appointed by virtue of the offices they hold or by nomination of their organizations (in the case of the Armed Forces Representative and the 8 Representatives of Pharmaceutical Society of Nigeria). In practice, the Health Minister also receives and considers nominations from the Pharmaceutical Society of Nigeria on the appointment of a Chairman for the Governing Council. The membership of the Governing Council as at the end of the second quarter of 2018 stood at 69; the numbers continues to grow with the approval of more Faculties of Pharmacy and the creation of more States. The Chairman and, by extension, the entire Governing Council is appointed for a term of three years and is eligible for re-appointment to a second tenure. In practice, only the Chairman is changed when a new Council is constituted. Other members of the Governing Council remain for as long as they are still holding the offices that made them eligible for membership of the Council (excepting the PSN and Armed Forces Representatives). Also, the President and Commander in-Chief of the Armed Forces of Nigeria reserves the right to dissolve the Council at any time. Disbandment of the PCN Governing Council and the Governing Boards of many other Federal Agencies frequently accompanies change of Government. The PCN Act provides that the Council shall have perpetual succession (S. 1 (2)) but this has been interpreted to apply to the administrative structure of the PCN and not necessarily to the Governing Council. In the absence of the Governing Council, the Health Minister assumes direct oversight of the Council. Financial provisions Sections 5, 6 & 7 of the PCN Act cover funding of the Council and financial issues and accounting procedures. These provisions only serve to align Council with the financial regulations governing Ministries, Departments and Agencies (MDAs) of the Federal Government. They provide for funding of Council, transfer of assets previously owned by the defunct Pharmacists Board of Nigeria, submission of annual estimates (budgets), annual auditing of accounts, borrowing of funds, grants by the federal Government, etc. The Registrar – Appointment and Duties The appointment of a Registrar and other Staff of the Council is covered by Section 8 of the PCN Act. Going by the provisions of this Section, any “fit and proper” person is qualified for appointment as Registrar. This gives the appointing authority (the Governing Council) a lot of discretion in carrying out the appointment. Also covered in the section are the duties of the Registrar and these relate to the maintenance of the pharmaceutical register. Details of how names are to be added to or removed from the register on the directives of the Council are provided. Section 9 deals with the publication of the pharmaceutical register. The Registrar is mandated to print and publish the register and make copies available to the public for sale. In practice, the Council restricts itself to the compilation of names and addresses of licensed Pharmacists (and pharmaceutical premises) at the end of each licensing year. These compilations are available on the website of the PCN and are also printed in hard copies for sale. It should be noted that the publication of a register of registered Pharmacists instead of a register of licensed Pharmacist might convey the wrong information (or impression) to the public as not all registered Pharmacists are licensed to practice. Licensing is an annual transaction whereas registration is granted once and for all at the beginning of the Pharmacist’s professional life. This section (S. 9 (2), (3)) of the Act also provides that the published register shall be admissible as evidence in legal proceedings. Registration of Pharmacists and Practice Requirements Conditions to be fulfilled by persons intending to be registered as Pharmacists are covered under Sections 10, 11 and 12 in the PCN Act: these include completion of courses of instruction, passing of Council examinations, possession of qualifications acceptable to Council and good character. The provisions also deal with the registration of Pharmacists with qualifications obtained outside Nigeria and the reciprocal registration of non-Nigerian Pharmacists. As usual, Council exercises wide discretion in determining who is “fit and proper” for registration. Perhaps, to put a cap on these apparently limitless discretionary powers, the law gives persons aggrieved by Council decisions to appeal to the Minister of Health within 30 days on receipt of the unfavorable decision (S. 11 (4)). Qualifications acceptable for registration by Council are to be published in line with S. 13 of the Act. In practice, the publication of acceptable qualifications is probably considered superfluous as successful completion of a course of study at a Council-accredited institution is the generally accepted qualification known to practically all persons intending to become Pharmacists in Nigeria. However, Council has often published the list of institutions accredited to run Pharmacy programs. Also, considerable publicity is given to pre-registration conditions to be fulfilled by foreign-trained Pharmacists. Section 14 of the Act deals with the issue of practicing fees which are payable annually. The fees are one of the conditions to be fulfilled for the granting of an annual license to practice. Arguments have been raised in the past by persons who were denied the annual license after paying the practicing fees. The question was whether or not the payment of practicing fees meant automatic licensure. The prevailing position is that the Council is a professional regulatory body and not a mere revenue collecting agency. Council therefore has a duty to bring its regulatory powers to bear on all transactions with the persons being regulated. The concept of medico-legal issues came into being to explain Council’s position on Pharmacists who were (are) not in good standing with the Professional Body. Such Pharmacists are usually candidates for pending professional discipline at the PCN Disciplinary tribunal or are awaiting/under administrative sanctions. The practicing fees specified in the PCN Act (N50= to N250=) have since been reviewed several times and now stand at N1000=, N2,000 and N3000= for the different professional age groups. Pharmacists who have fifty or more years’ post- registration experience are allowed by the law to practice without payment of practicing fees. This noble gesture in the law was difficult to implement as there were almost no beneficiaries. Council therefore decided in its wisdom to bring the age requirement down to forty years. Review of practicing fees is subject to approval by the Minister of Health (as stated in the law) and impliedly by the PSN which has the powers to overturn rules made by Council (S. 24 (3)). The practicing fees collected from Pharmacists is shared thus: 70% to PSN and 30% to Council (S. 14 (5)). Non-payment of practicing fees is an offense under the law and the fine for first offenders is twice the licensing (practicing fees) and for repeated offenses, ten times the practicing fees. In practice, these fines are not ordered by the courts as Council does not arraign Pharmacists for this offense perhaps to avoid having a large number of Pharmacists labelled ex-convicts. Administrative actions are usually applied and the fines added to practicing fees payable in subsequent years. Approval of Training Institutions The provisions of Sections 15 and 16 of the PCN Act deal with the detailed steps Council takes in the accreditation of training institutions as well as the withdrawal of such accreditation. Additionally, the law provides for supervision of training and examinations by Council. Withdrawal of accreditation has serious ramifications and could have deleterious effects on the future of young students who would have to spend extra years in school or change courses or schools. The law therefore stresses adequate representation from the training institutions prior to any decision on their accreditation status. Professional Discipline Two bodies are responsible for disciplinary matters under the PCN Act. These are the Investigating Panel and the Disciplinary Tribunal. Matters impinging on professional discipline are first referred to the Investigating Panel which carries out preliminary enquiries into the cases and refers same to the Tribunal where it has established grounds for further action or a prima facie case. The composition and functions of these Organs of Council are addressed under Section 17 of the Act. The Investigating Panel has four members of Council as members and one member who is not a member of the Governing Council. In practice, this non- member is usually a member of the legal profession. The Disciplinary Tribunal comprises the Chairman of Council and six other members of Council. Both Organs and their membership are appointed by the Governing Council. The Second Schedule to the PCN Act contains supplementary provisions for the meetings of the disciplinary bodies, quorum, proceedings and the appointment of an assessor (legal adviser) by the Council on the nomination of the Attorney General of the Federation to serve on the Tribunal. The rulings of the Tribunal may be appealed at the Federal High Court. Un-registered Persons Section 19 of the Act addresses the persons who were practicing as “Pharmacists” before the Act (then Decree) came into force in 1992 but were not registered members of the profession (or Pharmaceutical Society of Nigeria) for one reason or the other. This provision gives such Pharmacists the opportunity to regularize their status. Practice as a Pharmacist Conduct or actions that are deemed to constitute practice as a Pharmacist are listed in Section 20 and include holding out oneself to the public as a Pharmacist, actually practicing Pharmacy, rendering professional service in matters relating to Pharmacy, etc. The provisions of this Section are necessary to establish grounds for bringing proceedings against persons who, without due registration by Council, engage in the practice of Pharmacy. Rules, etc Section 21 of the Act has provisions granting powers to Council for making rules covering different aspects of Pharmacy practice, including licensure, training, employment, etc. The section provides clarification that Council indeed has powers to engage in regulatory activities not expressly stated in the Act. Chairman of Council may direct that the rules made under this Section be gazette. Rules or regulations that are gazette have the force of subsidiary legislation. Library, Research Council is empowered by Section 22 to provide library facilities and encourage pharmaceutical research. The law leaves specific steps to be taken in this regard to the discretion of Council. Offenses and Sanctions Section 23 of the PCN Act covers offenses and sanctions that may be applied following the conviction of offenders. The offenses listed include provision of false information to Council for the purpose of securing registration, practice of Pharmacy by non-members of the profession and falsification of records by the Registrar or other employees of Council. Sentences range from payment of N1,000= fine to two years prison term. Corporate bodies may also be tried under the provisions of this Section where there is evidence that the Directors or Principal Officers of the Companies gave consent to the offense. Regulations/Rules Council is mandated to gazette regulations made under this Act but is required to send such regulations to the Minister of Health first. The provisions of Section 24 do not expressly state that the Minister’s approval of the regulations is required but it is obviously implied. Sub-section 3 of the Section also provides that the PSN may, at its Annual General Meeting or extraordinary meeting, consider and approve or reject rules made by Council. When the rules are rejected by PSN, they cease to be of any effect. Miscellaneous Provisions Section 25 of the PCN Act has three sub-sections covering the eligibility of persons initiating legal proceedings in respect of pharmaceutical transactions, submission of lists of undergraduates in Faculties of Pharmacy to Council and transmission of successful final year candidates to Council by Deans of Faculties respectively. The first provision ensures that persons who are not registered members of the profession and were probably practicing illegally do not derive any benefits from their illegal activities through the law courts. Submission of data on undergraduates enables Council to index the students, a regulatory step that enforces institutions’ adherence to admission quotas and confirms that the students have entry requirements for the degree course. Transmission of the outcome of final examinations serves as notification to Council towards induction of the new graduates into the profession. At the induction ceremony, the PCN Registrar administers the Pharmacists oath on the Pharmacy graduates and grants them provisional registration certificates, thus making them eligible for internship. Repeal of the Pharmacists Act The Pharmacists Act of 1964 is repealed by the provisions of Section 26 of the PCN Act. The Section goes further to dissolve the Pharmacists Board of Nigeria (a creation of the Pharmacists Act) and transfer all assets, documents, liabilities, etc held by the defunct Board to the new Pharmacists Council of Nigeria. These provisions support the expectation that government is a continuum. Interpretations Section 27 interprets various terms used in the Act and explains their usage. This is usually done at the beginning or end of legislative instruments to avoid ambiguities or confusion and to enlighten persons who may not be conversant with the subject matter of the legislation. The interpreted terms are: Board, Council, Disciplinary Tribunal, fees, Investigating panel, member, Minister, profession, register, and society. First Schedule Supplementary provisions relating to the PCN Act are covered in the first Schedule to the Act. They specify the qualifications for membership of the Governing Council, tenure of members, procedures for exit from Council, re-appointments, meetings, quorum, standing orders, committees, decisions, contracts, etc. These are essentially similar to the rules guiding the operations of all government agencies of this caliber. An important provision (number 8 in the Schedule) explains that membership of the Governing Council does not translate to holding an office in the public service of the Federation. This means the responsibilities of Members of Council should end at the level of meetings where policies, rules and decisions are made for implementation by the Registry (administrative structure of Council). In practice, this is not strictly so as the policy makers are also the implementers sometimes. The Directors of Pharmaceutical Services in the States are Chairmen of the PCN Inspection Committees for example. Second Schedule The meetings of the Disciplinary Tribunal and the Investigating Panel, and procedures to be adopted at these meetings constitute the subject matter of the Second Schedule. The provisions bar a member from serving on the Disciplinary Tribunal in respect of a particular case after having served as member of the Investigating Panel that considered the same case. This is aimed at bringing bias to a minimum in the decisions of the Tribunal. Subsidiary Legislation PCN Tribunal Rules: These serve to align the PCN Disciplinary Tribunal with the regular law courts. The Pharmacist whose conduct is the subject matter of the proceedings before the Tribunal may appear in person or engage a lawyer for his defense. The sittings of the Tribunal are in public and decisions made by the Tribunal are published as well. Pharmacists Council of Nigeria Act (1992 No. 91) Inspection, Location and Structure of Pharmaceutical Premises Regulation 2005 (FRN Official Gazette No. 79, Vol. 92): These regulations establish the PCN Inspectorate and divulge the powers of Pharmaceutical Inspectors as well as procedures to be adopted when items are impounded by Inspectors. The provisions also specify requirements for Pharmaceutical premises including sites, dimensions, structures, layout, facilities, etc. and make it an offense for anyone to obstruct or make false statements to a Pharmaceutical Inspector. Offenders are liable, on conviction, to a fine of N50,000= or 6 months imprisonment or both fine and jail time. Pharmacists Council of Nigeria Act (1992 No. 91) Registration of Pharmaceutical Premises Regulation 2005 (FRN Official Gazette No. 81, Vol. 92): Details of procedures to be followed to secure registration of the different categories of premises are provided in these regulations. Documentation required in the filing of applications for manufacturing premises is considerably more taxing than required for the other classes of premises. The regulations include the registration of hospital pharmacies under Superintendent Pharmacists – a new milestone in Pharmacy regulation in Nigeria (2005). Offenses under these regulations include non-payment of fees for retention of premises, holding more than one full-time job, display of fake PSN patented emblem, etc. The regulations also provide for the closure of premises which remain unregistered by the 31st day of March each year.  Poisons and Pharmacy Act (PPA) The PPA may be regarded as the grundnorm of Pharmacy Practice. Issues of practice and regulation are dealt with here in minute details. Pharmacists are frequently frustrated to find that the PCN Act does not provide answers to pressing questions; most of these answers would be found in the PPA. The Act also provides for the regulation of non-Pharmacists e.g. Patent Medicine Vendors involved in the handling of drugs. This Act has inexplicably disappeared from compilations of the laws of the Federation. There is also no record of its repeal. The law is therefore considered valid and its provisions are given effect as the need arises. PPA Cap 535, 1990 is a recent version of the 1958 legislation but is a law of the Federal Capital Territory (FCT). In view of the fact that the structure of FCT is considered to be part of the Federal Government, it is perhaps not incongruous that the PCN, a Federal Agency, often relies on this law for its regulatory functions. Interpretation Part I of the PPA interprets or defines words or terms used throughout the Act. In this Act, the “Minister” is the Minister of the Federal Capital Territory, not the health Minister. Reference is made here (and throughout the Act) to the Pharmacists Board of Nigeria because, by this time (1990), the Pharmacists Council of Nigeria was not yet in existence. Registration and inspection of Premises This Part (II) of the PPA gives procedures for registration of premises and the responsibilities of owners and practitioners to secure the registration of their premises. The provisions here also cover the powers of Inspectors authorized by the “Board” and actions to be taken on unwholesome products, penalties for offenses such as failure to comply with the provisions of the sub-sections, obstruction of Inspectors, etc. Dispensing, Sale, Custody and Supply of Poisons and Drugs Sections 7 and 8 in Part III of the PPA restrict the mixing, compounding, preparing and dispensing of drugs and poisons to persons granted permits or licenses under the Act. The names – chemist, selling dispenser, etc. – used in these Sections are older names of Pharmacists. The provisions allow the licensing of missionaries and patent medicine vendors. Procedures to be followed in the disposal of poisons, including entries in the disposal of poisons book, labelling, restrictions, etc. are detailed here. Prescription handling is covered in details plus institutional handling of drugs. As provided here too, corporate bodies may be licensed to carry on the business of dispensing or sale of drugs provided that these are done under the personal control and management of a Superintendent Pharmacist. Fines for offenses under these Sections range from N20= to N50=.These amounts were considered large enough to serve as deterrent when the law was promulgated. In practice, judges often use their discretion to decide on what amount is large enough to serve as deterrent. Exemptions In Part IV of the PPA, Pharmacy Students and Interns working under the supervision of a Pharmacist are exempted from licensure. Medical practitioners and veterinary surgeons are also exempted from the provisions of the Act when they handle drugs provided that they do not open Pharmacies or stock medicines beyond the immediate needs of their patients. The exemptions are extended to cover government departments handling drugs for agricultural, veterinary, and horticultural purposes, and researchers, government analysts, etc. Control of Sale of Patent and Proprietary Medicines The term “patent and proprietary medicines” refers to over-the-counter medications in Nigeria. Part V of the PPA deals copiously with the control of the sale of patent and proprietary medicines, describing how they are to be sold and restricting sale to pharmacists and persons granted the license set out in the Third Schedule to the Act. The provisions also give qualifications for patent and proprietary medicines vendors license applicants: attainment of 21 years of age, good character certified by two referees, and proof that nature of business warrants sale of medicines. Licensing Authority The PPA, in Part VI gives the power to designate the Licensing Authority to the Minister. Section 38 (1) provides for the keeping of registers by the licensing authority for patent and proprietary medicines vendors and chemical sellers (those licensed to deal with substances listed under part 4 of the First Schedule to the Act) The authority to license patent and proprietary medicines vendors has moved the Pharmacists Board of Nigeria to State Governments, Local Governments and back to the Pharmacists Council of Nigeria at the discretion of successive health Ministers. This designation of different licensing authorities at different times led to a chaotic drug distribution system and difficulties in regulation. Also, the issuance of chemical permits was the subject of a turf war between National Agency for Food and Drug Administration and Control (NAFDAC) and PCN in the mid-1990s. At a point, both Agencies were issuing chemical permits until the Minister stepped in and ruled that NAFDAC should be the Licensing Authority. Advertisements Part VII of the PPA deals with advertisements and the provisions herein prohibit advertisement of medicines and devices for the cure or treatment of diseases and medical conditions to the public but permits limited advertisement within professional circles and for the purpose of securing patents. Section 40 under this part is devoted to prohibition of advertisements in respect of procuring miscarriage (abortion). Sale and Possession of Poisons for Unlawful Purposes The PPA, in Part VIII of the Act, prohibits illegal or unauthorized possession of poisons and lists persons who may be considered legally fit to possess poisons as registered medical practitioners, registered dental surgeons, registered veterinary surgeons and persons authorized under this Act. The provisions specify N200= or two years imprisonment for convicted offenders. As with other penalties, Judges, in practice, may exercise their discretionary powers and apply stiffer penalties. Parties to Offenses, Penalties Part IX of the PPA gives details of circumstances that would lead to a person being considered a party to an offense. Acts of commission and omission are listed. Aiding and abetting, attempting to commit or preparing to commit offenses all make the person so involved guilty. Convictions for these offenses attract N200= fine or twelve months imprisonment. Miscellaneous In line with Part X of the PPA, the powers for making regulations on licensure, fees for registration, licenses and permits, disposal of poisons, etc. reside with the President. The Minister has the powers to regulate on keeping of the registers, granting of certificates, fees for certificates, etc. The provisions end with the clause: generally carrying into effect the purposes and provisions of this Act. This essentially means the Minister and President have the powers to make regulations on any other matter that is not specified but which can be construed as giving effect to the provisions and intentions of the Act. Poisons and Pharmacy Regulations This subsidiary regulation covers the procedures for application to secure registration of premises, fees payable, procedure in respect of non-payment of retention fees, packaging and handling of drugs and poisons, etc. Penalty for contravening any of the regulations is pegged at N20=.  National Agency for Food and Drug Administration and Control (NAFDAC) Act This law establishes the Agency and mandates it to regulate the importation, exportation, manufacture, advertisement, distribution, sale and use of food, drugs, cosmetics, medical devices, bottled water and chemicals. The preceding list makes clear the wide range of powers wielded by NAFDAC. Product quality is the core mandate of this Agency. The law was promulgated as the Federal Military Government Decree No. 15 of 1993. It is now known as the NAFDAC Act Cap N.1 LFN, 2004. Establishment of the Agency and Composition of its Governing Council Sections 1 to 4 of the NAFDAC Act deal with the establishment of the Agency and the composition of its Governing Council. A Chairman appointed by the President heads the Governing Council. Other members include the Director General (or Permanent Secretary) of the Ministry of Health or his representative and Chief Executives or representatives from the National Institute for Pharmaceutical Research and Development, Standards Organization of Nigeria, and National Drug Law Enforcement Agency; Chairman of the Pharmacists Board of Nigeria or his representative, one person each from the Pharmaceutical Group of the Manufacturers Association of Nigeria and the Food and Beverages Group of the Manufacturers Association of Nigeria; the Director General of the Agency and three persons appointed by the Minister of Health to represent public interest. Functions and Powers Sections 5 and 6 of the NAFDAC Act specify in rather fine details the functions of the Agency. These can be summed up as the regulation and control of foods, drugs, cosmetics, medical devices, bottled water and chemicals. The sections mention detailed steps and procedures such as inspections, conduct of laboratory tests, issuance of guidelines, registration of regulated products, employment and discipline of staff, etc. Section 7 empowers the Agency to open ordinary and domiciliary bank accounts and to do such other things as may be necessary for successful performance of its functions. Structure of the Agency This is specified in Section 8 of the Act. Six directorates are listed with the usual discretionary clause – such other directorates as may be required. At present (2018), the Agency has fourteen (14) directorates. Most of these have duplicated functions and responsibilities: for example, there is a drugs evaluation directorate and a chemicals evaluation directorate. Staff of the Agency Section 9 provides for the appointment of the Director General (DG) and Chief Executive of the Agency on the recommendation of the Minister. The DG has a tenure of five years and the Governing Council has the powers to appoint other members of staff of the Agency. Sections 10, 11 and 12 cover matters relating to staff pensions, welfare and discipline – matters which are adequately addressed by the public service rules already. Financial Provisions Part V of the NAFDAC Act deals with financial regulations, empowering the Agency to establish a fund into which all fees payable for the Agency’s services, foreign aid, grants, gifts, etc. may be paid. The provisions also allow the Agency to pay staff emoluments and other expenses out of the fund. Following the introduction of the Integrated Personnel Payroll Information System by the Federal Government in 2011, the provisions covering staff emoluments have been overturned. Most of the provisions in Sections 13 to 20 only serve to align the Agency’s financial protocols with those of the Federal Public Service. Miscellaneous The provisions of sections 21 to 23 cover acquisition of land, establishment and maintenance of offices and premises, and acceptance of gifts provided that the conditions attached to such gifts are not inconsistent with the functions of the Agency. Section 24 of the Act empowers Officers of the Agency to enter premises if need be by force in pursuance of the Agency’s mandate. The Section provides details on actions that may be taken by NAFDAC Officials on entering premises: examining items and records, taking samples for analysis, seizing or impounding suspicious items, etc. Section 25 makes it an offense for anyone to obstruct an Official of NAFDAC and prescribes a N5,000= fine or two years imprisonment or both for convicted offenders. Section 26 requires all suits against NAFDAC to be preceded by a one month notice to the Agency specifying cause of action, particulars of claim, details on the plaintiff and reliefs claimed. The Minister is empowered to give general or special directives to the Agency in Section 27 and the Agency is obliged to obey. The Food and Drug Administration and Control Department in the Federal Ministry of Health was to be dissolved on the commencement of this law (S. 28). This indeed happened and, in line with the provisions of the Second Schedule to the Act, all staff, assets and liabilities of the Department were transferred to NAFDAC. The Department was later resurrected, however, and named Food and Drug Services. Section 29 empowers the Agency, subject to approval by the Minister, to make regulations on payments into the Agency’s fund, fees payable and generally to give full effect to the provisions of the law. Section 30 of the Act provides interpretations for words or terms used in the Act. Subsidiary Legislation Fourteen (14) different regulations are listed under subsidiary legislation. Each of these comprises a set of rules covering the subject matter. The regulations are: i. NAFDAC Tariff Charges Regulation ii. Drug Products Advertisement Regulations iii. Pre-packaged Food (Labelling) Regulations  iv. Bottled Water (Advertisement) Regulations v. Cosmetic Product (Prohibition of Bleaching Agents, etc.) Regulations vi. Food Products Registration Regulations vii. Bottled Water (Labelling) Regulations viii. Pesticide Registration Regulations ix. Non-nutritive Sweeteners in Food Products Regulations x. Non-nutritive Sweeteners in Drug Products (Prohibition) Regulations xi. Food Products (Advertisement) Regulations xii. Food Grade (Table or Cooking) Salt Regulations xiii. Cosmetics and Medical Devices (Advertisement) Regulations xiv. Bottled Water Registration Regulations  National Drug Law Enforcement Agency (NDLEA) Act This law established the Agency to enforce the laws against cultivation, processing, sale, trafficking and use of hard drugs. The Act also empowered the NDLEA to investigate persons suspected to have links with drug trafficking and other related matters. The Agency is under the general supervision of the Federal Ministry of Justice. The law establishing and empowering the Agency may be cited as the National Drug Law Enforcement Agency Act Cap N. 30 LFN, 2004. Establishment, Composition, Functions and Powers Part I of the Act contains Sections that deal with the establishment of the NDLEA, the composition of the agency, functions and powers, etc. According to Section 2 (1), the composition of the Agency is: a Chairman, a representative of the Nigeria Police not below the rank of an Assistant Inspector General, the Director, Military Intelligence, the Director of Customs and Excise, the Director, State Security Service, a representative of the Federal Ministry of Justice not below the rank of Director, the Director-General of the National Intelligence Agency, a representative each from the Ministries of External Affairs and Health, not below the rank of Director and three other persons. The designations of Chief Executives of Customs and Excise and the State Security Service are Comptroller-General and Director-General respectively, not Director as rendered in the law. The President appoints the Chairman and the other three persons not mentioned by office or organization. Section 3 of the Act lists the functions of the Agency while S. 4 deals with its powers. The Sections go into details of what the Agency may do to eradicate illicit drugs and mitigate their effects in the society. Wide discretionary powers are granted to the Agency under these Sections and include the investigation of persons whose ostensible incomes do not appear match their lifestyles (but only with the approval of the supervising Minister of Justice). Section 5 provides for the establishment of a secretariat for the NDLEA to be headed administratively by a Secretary whose rank is the equivalent of a Director- General. The Section also provides for the appointment of other staff of the Agency on terms and conditions determined by the Agency after consultation with the Federal Civil Service Commission. The Secretary (DG) reports to the Executive Chairman and both are appointed by the President. The provisions of Section 6 list three Units which the Agency may establish for effective conduct of its functions as: General and Assets Investigating Unit, Prosecution Unit, and Counseling Unit. The law however allows the NDLEA to set up any number of technical committees to assist the agency in the performance of its duties. Section 7 of the Act lists the responsibilities of the three Units mentioned in S. 6. The General and Assets Investigating Unit is the engine room of the Agency while the Prosecution Unit provides legal support and prosecutes offenders identified/arrested by the first Unit. The Counseling Unit’s responsibilities include rehabilitation, welfare of convicts and/or addicts, campaigns and education of the public to avoid drugs, etc. The Agency is empowered to develop training programs for its law enforcement staff and other personnel involved in suppression efforts as provided under S. 8 of the Act. Areas to be covered by such training programs are also listed in the section. Section 9 empowers the Attorney-General of the Federation and Minister of Justice to give directives of a general or special nature to the Agency. Directives may be given concerning a particular matter or case before the Agency. Offenses Part II of the NDLEA Act deals with offenses. Sections 10 to 12 constitute the offenses relating to drug abuse and trafficking, and list the offenses which may be summed up as: possession, production, sale, handling, aiding or abetting, advising (counseling) to commit a crime, or failing to do anything for the purpose of aiding an offender. The list is quite comprehensive and all persons even remotely linked to the drug trade are liable. Offenses relating to laundering of monetary instruments are covered under Sections 13 to 24. The provisions of these Sections comprehensively cover all conceivable links to drug crimes and it is clear from these that the major focus of the NDLEA is the proceeds from drug crimes and efforts to conceal them. Forfeitures and seizure of assets are the Agency’s instruments for investigations and enforcement. Forfeiture of Assets of Persons Arrested for Offenses under this Act constitute the subject matter for Part III of the NDLEA Act. Sections 25 to 31 deal with declaration of assets by arrested suspects, attachment (seizure) of assets, offenses for false declarations, orders from the Tribunal in respect of seized assets, etc. Section 32 further empowers any authorized Official of the Agency, Police, Customs Officer or any member of the armed forces to, without warrant, enter any premises, building, carrier, etc. when he/she has reason to believe that these are connected to an offense under this Act and carry out actions that are necessary for investigation or enforcement. Application of Certain Enactments Part IV of the Act deals with extraditions or transfer of convicted offenders, mutual assistance agreements towards curbing drug crimes, the involvement of foreign missions, etc. Miscellaneous Supplementary Provisions These form Part V of the Act. The provisions cover funding of the Agency, offenses for obstructing Officials of the Agency, powers to make rules by the Attorney- General of the Federation, and interpretations of words and terms used in the Act.  Dangerous Drugs Act (DDA) The Dangerous Drugs Act regulates the importation, exportation, manufacture, sale and use of opium and other dangerous drugs. It provides detailed steps to be taken while handling the drugs covered by the schedules thereto. The law was dated 1935 (Cap 12, 1935), later known as Cap 91, 1990, but is now cited as Cap D. 1 LFN, 2004. Preliminary The DDA begins (Sections 1 and 2) with the law’s citation and interpretations of words and terms used in the Act. Interpretations provided cover names of plant drugs and their derivatives. Raw Opium, Coca Leaves and Indian Hemp Section 3 of the Act restricts powers for making regulations for controlling or restricting the importation, exportation, transit, production, possession, sale, and distribution of dangerous drugs mentioned here to the President. Prepared Opium Sections 5 and 6 of the DDA prohibits the importation, manufacture, sale, possession, etc. of prepared opium. The provisions go far as making it an offense to permit the use of premises for sale or smoking of prepared opium. Persons who visit places used for smoking opium frequently are also guilty under these provisions. Cocaine, Morphine and Other Drugs The President is given the powers under S. 7 to make rules prohibiting the manufacture, sale or distribution of the drugs to which Part III refers except by licensed persons and on premises licensed for these purposes. Persons who are licensed under the Pharmacy Act may be authorized to deal in drugs under this Part but the Minister of Health reserves the right to withdraw such authorization if, in his opinion, the person holding the authorization cannot be properly allowed to carry on the business of manufacturing, selling or distribution of these drugs. Section 8 lists the drugs to which Part III applies to include medicinal opium, extract or tincture of Indian hemp, morphine and its derivatives, cocaine and its derivatives, any solution or preparation containing these drugs or their derivatives. The President has powers under S. 8 (3) to , by order, direct that the provisions of this section be extended to apply to any new derivatives of the aforementioned drugs or any new drug if it appears to him that the new drug’s improper use may lead to harm or effects analogous to those of the drugs under restriction. Prohibition of Trade in New Drugs, etc. Section 9 of the DDA specifically prohibits dealing in any products derived from the phenanthrene alkaloids of opium or from ecgonine alkaloids of the coca leaf except for medical or scientific purposes. The President may give orders aligning the provisions of this Section to the position of the UN Secretary-General on Article II of the Geneva Convention (S. 9 (3)). Section 9 (4) also empowers the President to apply these provisions, with modifications if necessary, to drugs such as codeine and dionin and their respective salts. Control of External Trade in Dangerous Drugs The provisions of Sections 10 to 16 of the DDA deal comprehensively with rules governing international transactions on drugs to which this Act applies. Import and export authorizations are required for all transactions and the Director of Customs and Excise reserves the right to, at his absolute discretion, issue or refuse to issue an export authorization. These provisions (S. 16) also provide for diversion certificates for dangerous drugs in transit to another country of destination. The Customs and Excise is authorized to impound any consignments found without appropriate documentation at any point. General Section 17 empowers any police officer or other persons authorized by the Minister of Health to enter premises for the purpose of inspections to ascertain compliance with the general provisions of the DDA. A Magistrate may also issue a search warrant if there is reasonable ground for suspecting a contravention of any part of the Act. Payment of fees for licenses and authorizations issued by the Minister of Health and the Customs and Excise is guaranteed by the provisions of Section 18 of the Act and the amounts are as specified by regulations. Section 19 deals with offenses and these include contravention of any provisions in the Act, failure to abide by conditions of licenses/authorizations, false declarations, contravention of foreign laws, attempting to/inciting another person to commit an offense, etc. An option of fine is mandatory for convicted persons who breached these provisions inadvertently (S. 19 (3)). The burden of proof (S. 20) lies on the person seeking to avail himself of evidence in relation to licenses or authorizations. The police are also empowered to arrest without warrant (S. 21) any person who is reasonably suspected to have committed or attempted to commit an offense under the DDA. Subsidiary Legislation Twelve sets of Regulations are listed under subsidiary legislation to the Act. These are: i. Dangerous Drugs Regulations ii. Dangerous Drugs (Modified Form) Regulations iii. Dangerous Drugs (Application to Benzoyl-morphine, etc.) Order iv. Dangerous drugs (Application to Esters of Morphine, etc.) Order v. Dangerous Drugs (Application to Dihydromorphinone, etc.) Order vi. Dangerous Drugs (Application to Acetyldihydrocodeine, etc.) Order vii. Dangerous Drugs (Application to Alphaprodine, Amidone, etc.) order viii. Dangerous Drugs (Application to Morpholinylethylmorphine, etc.) Order ix. Dangerous Drugs (Application to Methylmorphine, etc.) Order x. Dangerous Drugs (Relaxation of Application to certain Morphine and Cocaine preparations) Order xi. Dangerous Drugs (Relaxation of Application to Morpholinylethylmorphine) Order xii. Dangerous Drugs (Relaxation of Application to Dihydrocodeine) Order  Counterfeit and Fake Drugs and Unwholesome Processed Foods Act This law prohibits the sale and distribution of counterfeit, adulterated, banned or fake, sub-standard or expired drugs or unwholesome processed foods. The Act also provides for the establishment of Federal and State task forces under the general supervision of NAFDAC. The law was promulgated by the Federal Military Government as Decree 25 of 1999. It may now be cited as the Counterfeit and Fake Drugs and Unwholesome Processed Foods (Miscellaneous Provisions) Act CAP. C34 L.F.N. 2004. Commencement and Prohibitions Section 1 deals with the commencement of the Act with a powerful statement that overrides any contrary thing in the Constitution or any other enactment or law. Prohibition of manufacture, sale, distribution, possession, etc. of counterfeit, adulterated, banned, fake, substandard, expired or unwholesome drug or food is conveyed in S. 1 (C). Section 2 further prohibits hawking of drugs and sale/display for sale in places not duly licensed or registered for that purpose. In S. 2 (1) (c), unapproved places are listed to include markets, kiosks, motor parks, road-side stalls, buses, ferries or any other means of transportation. Section 3 provides penalties for offenses: these comprise fines on N500,000= and prison terms of 2 to 15 years or both fines and imprisonment. Offenses may be deemed to be committed by a corporate body and in this instance, the proprietor, directors or principal officers, servants or agents, etc. of the corporation are liable and can be prosecuted and punished accordingly. Jurisdictions The power to try offenses under this Act are vested in the Tribunal established under the Special Tribunal (Miscellaneous Offenses) Decree of 1984 (S. 4 (1)). Prosecutions may be instituted before the Tribunal by the Attorney-General of the Federation or any officer of the Ministry of Justice or NAFDAC authorized by the Minister of Justice or any Legal Officer authorized to do so (S. 5 (1)). Interestingly, nobody besides the Attorney-general is allowed to enquire into or raise any question concerning whether the authorization has been given to a prosecuting officer (S. 5 (2)). The Tribunals were a creation of the Federal Military Government. Offenses under this Act are now tried in the regular law courts. Establishment of the Federal Task Force Section 6 of the Act provides for the Minister of Health to constitute a Task Force at the Federal level to comprise a Chairman who shall be an officer of the Agency (NAFDAC) not below the rank of a Deputy Director appointed by the Minister, two Police Officers not below the rank of Chief Superintendent of Police to be nominated by the Inspector-General of Police, two Inspectors not below the rank of Principal Pharmacist appointed by the Pharmacists Council of Nigeria, two Inspectors not below the rank of Principal Regulatory Officers (S. 9 (1)(c) of the Food and Drugs Act CAP F33 L.F.N. 2004) and such other Inspectors as may be co- opted by the Task Force. The Federal task Force has the overall responsibility for enforcing the provisions of the Act. The responsibilities listed under S. 7 (1) are: coordinating, directing and monitoring the activities of the State Task Forces; paying unscheduled visits to ports of entry and border posts; entering, if need be by force, any premises where there is suspicion of a breach of the provisions of this Act; examining articles and documents; taking samples for analysis; and seizing any counterfeit, banned or defective regulated product. Powers to seal premises being used in connection with offenses under the Act are also granted to the Task Force (S. 7 (2)). Establishment of State Task Forces Section 8 of the Act provides for the Minister to constitute State Task Forces. The Task Forces may be for individual States or for Groups of States and comprise: a Chairman appointed by the Minister, a Police Officer not below the rank of Chief Superintendent of Police nominated by the Inspector-General of Police, two Officers (of NAFDAC) appointed by the Minister, an Inspector appointed by the PCN, and an Inspector so designated under S.9 (1) (c) of the Food and Drugs Act CAP F33 L.F.N. 2004 Functions of the State Task Forces as listed under Section 9 of the Act are similar to those of the Federal Task Force with the proviso that they shall function under the general control and supervision of the latter. Establishment of the Nigeria Police Squad For the purpose of assisting the Federal Task Force in its enforcement activities, Section 10 provides for the establishment of a Police Squad whose composition comprises a Deputy Superintendent of Police and such number of other Police officers to be appointed by the Inspector-General of Police. The squad has the responsibility to assist the Task Force, carry out arrest of suspects and conduct investigations into matters arising under the Act. Forfeiture of Seized Regulated Products Section 11 of the Act provides for the forfeiture of seized regulated products to the Federal Government and the Minister is given the discretion to determine how to deal with the forfeited products. Obstruction Obstruction of task Force members in the discharge of their duties and interference (without authorization) with seized goods constitute offenses under Section 12 (1) of the Act and the penalty for these actions is given in S. 12 (2) to be a N50,000= fine or 5 years imprisonment or both fine and prison time. Repeal of the (earlier) Counterfeit and Fake Drugs Decree of 1989 is covered by Section 13 of the Act. Interpretations are given for words and terms used in the Act under Section 14. Citation of the Act is provided in Section 15. Food, Drugs and Related Products Registration Act The Act is a complement to the NAFDAC Act. It provides for the establishment of a Drugs Registration Committee by the Agency. The Act also prohibits the manufacture, importation, advertisement, sale or distribution of un-registered foods, drugs, drug products, cosmetics and medical devices. It may be cited as the Food, Drugs and Related Products Registration Act CAP F 33 L.F.N. 2004. The Act was first promulgated by Decree in 1993 and was called the Drugs and Related products Decree (Decree 19 of 1993). An amendment in 1999, among other things, changed the name of the law to Food, Drugs and Related Products Decree (Decree 20 of 1999). Prohibition Section 1 of the Food, Drugs and Related Products Registration Act prohibits the manufacture, importation, exportation, distribution, sale, etc. of regulated products except these are registered in accordance with the provisions of this Act or regulations made under the Act. The Section however allows the granting of permits for the manufacture or importation of un-registered products for clinical trials and for the purpose of registration. Application for Registration The application process is covered under Section 2 of the Act. Details of information to be provided along with the application are specified and NAFDAC, in considering such applications, determines the need for such products in Nigeria and decides appropriately. Validity of a product’s registration is pegged at five years and this is renewable. The law also mandates the Agency to publish notices on registered products from time to time. Disclosure of Information in Applications Section 3 bars the disclosure of information supplied by applicants for product registration except this is necessary for proceeding under the Act or allowed by the applicant. This provision protects the applicant’s commercial interests where information supplied might be used by others to gain advantages in manufacturing, importation, etc. Withdrawal of Registration NAFDAC is empowered under S. 4 to suspend or cancel the registration of a product if the grounds for its registration are found to be false or are no longer tenable or if the conditions attached to the product’s registration have been breached. Manufacture of the product under unsuitable conditions and a compromise of product quality standard also constitute grounds for cancellation or suspension of a product’s registration by NAFDAC. Suspension or cancellation of registration means the product is recalled from distribution on the orders of the Agency and the action of suspension or cancellation is published in a gazette. Clinical Trials Section 5 of the Act bars the manufacture, importation and use of drugs and related products for clinical trials without a clinical trial certificate issued by NAFDAC. The Section also empowers the Agency to make regulations for the manner and form applications for the clinical trial certificate will take. Offenses and Penalties These are covered under Sections 6 and 7 of the Act. Persons in breach of the provisions of the Act face a fine of N50,000= for individuals and N100,000= for corporate bodies. Except a principal officer or other person concerned with the management of a company can prove that an offense was committed without his/her knowledge, proceedings can be brought against such a person. The amendment of this Act (1999) added provisions for the forfeiture of assets linked directly or indirectly to proceeds from actions carried out in breach of the provisions of the Act to the Federal Government. Drug Registration Committee Section 8 of the Act establishes the drug registration committee which is charged with the responsibility of evaluating applications for registration as well as manufacturing processes, efficacies, usefulness, etc. of products and advise the Agency accordingly. The Committee’s tenure and allowances are determined by the appointing authority (NAFDAC) but the members of the Committee are not treated as public office holders. Interpretations Words and terms used in the Act are interpreted under S. 9 of the Act.  Food and Drugs Act This is an Act introduced in 1976 to make provisions for the regulation of the manufacture, sale and advertisement of food, drugs, cosmetics and devices. The law also repealed the existing State laws on these matters. The Act was amended in 1999 to reflect the establishment of NAFDAC (which took the place of then Food & Drug Advisory Council) among other things. The Law may be cited as the Food and Drugs Act CAP F32 L.F.N. 2004. Prohibitions Section 1 prohibits the sale of any article of food or drug that is poisonous, harmful, filthy, disgusting, rotten, diseased or unfit for human consumption. The Section also forbids the handling of these articles in unsanitary conditions. Cosmetics are covered in S. 1 (4) of the Act. Except as otherwise provided by regulations in the Act, advertisements in respect of certain diseases (First Schedule) are prohibited in S. 2 (a) and sale of food, drugs, cosmetics or devices for the same conditions is banned in S. 2 (b). Section 3 further prohibits the manufacture, sale or distribution of drugs specified in the Second Schedule to the Act except as authorized by regulations. Powers of the Minister of Health Section 4 empowers the Minister or any person authorized by him to demand and obtain information on the composition and formulae of articles to which this Act applies from persons involved in the business of handling such articles. The provisions further mention investigations to be carried out into the effects of the substances (components of foods, drugs, etc.) on health. Disclosure of information obtained pursuant to these provisions is prohibited except with the written consent of the person who supplied the information or in accordance with the Minster’s directives or in the course of proceedings under the Act. Misleading Practices Acts of deliberate mislabeling, deceptive marketing and misrepresentations are prohibited under Section 5 of the Act. Unsanitary Conditions Section 6 prohibits the manufacture, preparation, preservation, packaging, storage or sale of foods, drugs and cosmetics under unsanitary conditions. Schedule Four Drugs (Biologicals, radioisotopes, parenteral preparations, etc.) Intending manufacturers of drugs listed in the Fourth Schedule to the Act are required under S. 7 of the Act to obtain the Minister’s certificate to this effect in accordance with regulations covering these. Sellers of these drugs are also required to obtain a certificate from the Minister to the effect that the batch from which their drugs were taken is safe for use. Distribution of the drugs in the Fourth and Fifth Schedules to the Act is to be carried out only in line with the regulations covering their distribution. Enforcement of Compliance with Standards Section 8 of the Act deals with actions to be taken towards ensuring that foods, drugs and cosmetics manufactured or imported into the country comply with appropriate standards. These include the demand for documentation in this regard and prohibition of the importation of noncompliant articles by the Minister. Designation of Inspectors and Analysts The Minister is empowered under S. 9 of the Act to, on the recommendation of the Food and Drugs Advisory Council, designate Food and Drugs Analysts, Drug Analysts and Food and Drugs Inspectors. Section 9 (2) – (3) further provide the requisite qualifications and facilities for Analysts. Food and Drug Analysts must, among other things be graduates of Chemistry while Drug Analysts must have acceptable professional qualifications in Pharmacy as well as a post-qualification training or experience in drug analysis. Powers of Inspecting Officers Section 10 of the Food and Drugs Act empowers Inspecting Officers to enter, at any reasonable time and if need be by force, any premises they believe are being used in connection with articles to which this Act applies for the purpose of giving effect to the provisions of the Act. Inspecting Officers, on entering such premises may examine anything in the premises, take samples for analysis, seize and detain articles or items, etc. Offenses Deliberate false statements or falsification of documents, certificates, etc., obstruction of Inspectors, lying to Inspectors and tampering with impounded articles or items are offenses under Sections 11 to 12 in the Act. Imported Articles Inspecting Officers have the powers under Section 13 of the Act to examine Customs entries of Articles to which this Act applies, take samples of such items while they are still with the Customs and prevent the articles from being released until certified okay by an analyst. The provisions further require Inspecting Officers to seal sampled articles in triplicate, give one to the owner, another to the person in control (Customs) and send the third for analysis. This is necessary to counter disputations when unfavorable results are returned by the Analyst. Forfeitures Section 14 deals with the forfeiture of sealed articles. Requirements for forfeiture of seized articles to the Minister are: the owner’s consent or a Court order of forfeiture following conviction/representations from all parties concerned. Articles forfeited to the Minister are free of any encumbrance and he may dispose of them as he deems fit. Advisory Council The Minster is empowered under Section 15 to set up a Food and Drugs Advisory Council to assist and advise him in respect of regulations for carrying out the purposes and provisions of the Act. Note should be made that the establishment of NAFDAC eliminated the need for this Council. An amendment of the Act (1999) also introduced a clause on the designation of food and drugs inspecting officers by NAFDAC. Regulations Section 16 of the Act provides for the making of regulations by the Minister for determining what constitutes adulteration, prescribing levels of food additives, specifying standards, packages, labelling, documentation, etc. Such regulations could provide exemptions, amend the Schedules to the Act to further safeguard health and prescribe anything required by this Act to be prescribed. Penalties and Legal Proceedings The provisions of Section 17 peg the fine for contravention of the provisions of this Act at N1,000=. Imprisonment for not more than 2 years or both fine and imprisonment may be ordered by the trial judge. Officers and agents of a corporate body are also liable if there is evidence to link their acts of commission or omission to the breach of provisions by the company. Section 17 (3) provides a six-month time cap for legal proceedings to be instituted following an alleged commission of an offense. Grounds of Defense An accused person who can prove that he/she sold an article (that is the subject of proceedings) in the original package in which he bought it has a defense (S. 18 (1)). Also, if there is no way the accused person could have ascertained breach of the Act after due diligence, a defense can be pleaded. Certificates and Presumptions The law accepts a certificate signed by an Analyst as prima facie evidence in proceedings (S. 19). However such a certificate must have been supplied to the accused party at least three days before the trial date. Also, if a package bears the name or address of a party in legal proceedings, the law presumes that the contents of the package were indeed manufactured or packaged by the person whose name and /or address appear on the package. The principal of an agent is held as liable as the agent. An adulterating substance found on the premises of an accused person or otherwise in his/her possession will be taken as evidence that he/she indeed manufactured the adulterated article which is the subject of proceedings against him/her. Interpretations Section 20 deals with the interpretation of some words and terms used in the Act  National Drug Formulary and Essential Drugs List Act This Act prescribed a National Formulary and Essential Drug List and prohibited the importation or manufacture of items not in the list. The law has provisions for the establishment of a Review Committee charged with the responsibility of recommending deletions and additions. It may be cited as the National Drug Formulary and Essential Drugs List Act CAP N29 L.F.N. 2004. Commencement Section 1 deals with the establishment of the Act and designates the First schedule to the Act as the Essential Drugs List. Prohibitions The importation, manufacture, display for sale, sale or advertisement of drugs that are not on the Essential Drug List are prohibited by Section 2 of the Act. Exemptions Section 3 provides for the Minister to permit the importation or manufacture of a drug that is not on the Essential Drug List if the drug is a cure for an uncommon disease or a disease requiring specialized care or if the drug has a better activity profile than a similar one on the list. The Minister, in granting this permission, is advised by the Review Committee. Establishment of the Review Committee The establishment and membership of the Review Committee are covered in Section 4 of the Act. Although the Section does not specify who will appoint the Committee’s Members, the Minister of Health whose general responsibility it is to give effect to the provisions of the Act is assumed to be the appointing authority. The membership of the Review Committee comprises two Clinical Pharmacologists, the Director of Food and Drug Administration and Control (Food and Drug Services) in the Federal Ministry of Health, the Director of Hospital Services and Training in the Federal Ministry of Health, the Director of Primary Health Program in the Federal Ministry of Health, four Heads of Pharmacy Departments appointed from the State Ministries of Health on a (zonal) rotational basis, a Representative of the Pharmaceutical Society of Nigeria, one Representative of the Nigerian Medical Association, a Representative of the Pharmaceutical Manufacturers Association, and two Medical Practitioners appointed by the Minister. Functions of the Review Committee Section 5 of the Act gives the functions of the Review Committee to be the review of the Essential list from time to time and advising the Minister on additions or deletions in respect of the list. Tenure of Office for Review Committee Members This is pegged at three years by Section 6 of the Act but this does not apply to Members appointed from the Federal Ministry of Health. Members are eligible for re-appointment to a further term of three years. Submissions to the Review Committee Section 7 provides for representations to be made by Pharmaceutical Companies or other corporate bodies or incorporate bodies to the Review Committee in respect of drugs or formulations that are not on the list but ought to be listed for the advanced reasons. Offenses and Penalties Contravention of any provision in the Act constitutes an offense according to Section 8 and the penalty for the offense is N100,000= or a prison term not exceeding five years. The Section also provides that, in the event of an offense by a corporate body, every director or person in authority in the corporate body shall be liable. Monitoring Section 9 of the Act provides for the establishment of a Secretariat in the Department of Food and Drug Administration and Control (Food and Drug Services) for the purpose of monitoring the implementation of the Essential Drugs List. Removal of Drugs from the List The Minister is empowered to remove a drug from the Essential Drugs List if it has been established to his satisfaction that the drug is no longer safe for use (S. 10). Formulary Section 11 states that the Drug Formulary in the Second Schedule to the Act should serve as guide to Medical Practitioners, Pharmacists and other users. Interpretations Words and terms used in the Act are defined and explained in Section 12 of the Act  Code of Ethics for Pharmacists in Nigeria Section 1 (1) (c) of the PCN Act mandates Council to review and prepare from time to time a statement as to the code of conduct which the Council considers desirable for the practice of the Profession of Pharmacy. PCN has over the years published several editions of the code of Ethics for Pharmacists in Nigeria. The code of ethics is a means of assisting Pharmacists to discharge the moral and professional obligations resting upon them to observe standards of conduct appropriate to their calling. The underlying theme throughout the publication is honor. Pharmacists are encouraged at every turn to act as men of honor and to do nothing that would damage the image of the profession. In Countries like USA where a lot of emphasis is placed on opinion polls, Pharmacists have always come on top when public opinion is polled to ascertain who the most trusted professional is. Clergy men come behind Pharmacists in these polls and this is worthy of attention. The important thing for pharmacists to note is that a breach of the obligations and by inference of the principles in the code should be expected to be the basis for disciplinary action. Obligations to the Patient/Client The first Section of the PCN Code of Ethics for Pharmacists in Nigeria deals with the Pharmacist’s obligations to the patient or his/her client. Pharmacists are encouraged to put the patient first in all interactions with the patient and provide relevant information on drugs and medical products. He/she is to however refrain from supplying drugs to patients when there is reason to believe that the drugs may be abused. The Pharmacist is to avoid dealing in products that do not meet standards required by law as this would result in deleterious effects on the patient. He/she is also to respect and maintain confidentiality of professional information on patients and refrain from divulging this except with patient authorization. Patient counseling is emphasized in this Section and patients and their caregivers should be well informed about medicines for positive outcomes while appreciating/respecting the peculiarities of individual patients. Pharmacists are mandated to ensure uninterrupted care for the patient in crisis situations. The Pharmacy Section II of the Code of Ethics insists on the personal control of pharmacies by Superintendent Pharmacists for the observance of proper standards of professional conduct. The Section also emphasizes the need for the layout and appearance of the Pharmacy to fit the professional nature of the business carried out therein. Conditions in the Pharmacy must also minimize the risk of error and contamination in the handling of drugs. The Pharmacist’s honesty and good conduct, collaboration with other health professionals and supervision/training of support staff are emphasized. Employment The PCN Code of Ethics demands fairness in employment (Section III). Pharmacists are to seek only fair and reasonable emoluments and are not to connive with other practitioners of other professions to defraud patients. The Ethics also advise Pharmacists not to accept employment/practice conditions that interfere with the exercise of their professional judgement or compromise the quality of their service, and to report any obstruction in their professional duties from their employers to PCN. Pharmacists are required to assist each other and refrain from running down the services of others. The Ethics require Pharmacists working in wholesale and importation facilities to be especially careful about the signing/authorization of orders for supply or importation of drugs. Finally, Section III of the code prohibits “register and go”, a practice where professionals secure the registration of premises but abandon their superintendent duties. General Under section IV of the PCN Code of Ethics, the Pharmacist is barred from displaying material in his premises of practice or in the media that is undignified in appearance and brings ridicule to the profession of Pharmacy. Similarly, Pharmacists are barred from engaging in any price competition or similar scheme to attract clients and may not operate patent medicine shops. Procurement of drugs from unauthorized sources and sale to illegal sources constitute unethical conduct. Pharmacists are urged to improve their professional knowledge through the PCN Mandatory Continuing Professional Program, strive to observe/uphold the law at all times and maintain the highest level of professional and ethical conduct. Provisions for Specialist Pharmacists Section V of the Code has provisions grouped under Hospital/Community Pharmacists, Academic Pharmacists and Industrial Pharmacists. The provisions encourage Pharmacists in each field to excel in their area of practice. The first group are urged to institute pharmaceutical care, engage in patient monitoring/follow-up and engage in research aimed at improving health outcomes. Academic Pharmacists are expected to refrain from falsification of research data and plagiarism but instead engage in proper professional/ethical conduct in their relations with students and carry out research on improving healthcare outcomes. The Code expects Industrial Pharmacists to promote the image of the profession and guard against subordinating the profession of Pharmacy to other professions. Industrial Pharmacists are warned against compromising their professional judgement or causing a breach of professional ethics/regulations to enhance sales.  Pharmaceutical Society of Nigeria Constitution The Pharmaceutical Society of Nigeria (PSN) has been in existence since 1927. It is a non-governmental umbrella body for all Pharmacists in Nigeria. All qualified Pharmacists registered by the Pharmacists Council of Nigeria (PCN) are deemed to be members of the PSN. The PSN is governed by a constitution which has 18 Articles: 1) Name of the Society – Pharmaceutical Society of Nigeria 2) Office – Registered Office in Lagos and a Liaison Office in Abuja 3) Objects – To, among other things, maintain professional ethics and discipline and advise on employment conditions provided that the Society may not hold out as a trade union. 4) Membership – Requisite registration by PCN and registration at the State level of PSN; Associate Members are Interns; Affiliate Members are final year Pharmacy Students; Honorary Members are non-Nigerian Pharmacist who have made significant contributions to the profession. 5) Fellowship – Conferred for outstanding contributions; nominations are referred by the State of Practice to the Privileges Committee; Approved by PSN Council; Fellows to uphold the ethics of the profession among other things and pay an annual honors fees; honor to be given to Fellows; Loss of fellowship following decision by a simple majority at Annual General Meeting 6) Cessation of Membership – Due to removal of name from the Pharmaceutical Register (PCN); Diagnosis of mental illness; Non-payment of dues for 3 consecutive years. 7) Officers of the Society – President; 1st and 2nd Vice Presidents from the North and South of the Country; National Secretary; Assistant National Secretary; National Treasurer; National Publicity Secretary; National Financial Secretary; Editor in-Chief; Internal Auditor; Un-Official Members (2). 8) Pre-requisite for Election into NEC – Holders of previous Executive Positions at State Level; financial membership for 3 consecutive years. 9) National Executive Committee NEC) – Shall comprise all 12 elected Officers and the immediate past President. 10) Council – Branch Chairmen and Secretaries from the States and the FCT; All elected Members of NEC plus un-official Members; a Member each from each of the Technical/Interest Groups; Directors of Pharmaceutical Services from the States and Abuja; Registrar of PCN; Deans from approved Faculties of Pharmacy; President of the Pharmaceutical Association of Nigerian Students (PANS); The Director-General of the National Institute for Pharmaceutical Research and Development; a Representative of the Board of Fellows; a Representative from the teaching hospitals Pharmaceutical services; the Director in-charge at the Directorate of Food and Drug Services in the Federal Ministry of Health; a Pharmacist Representative of the Armed Forces; PSN Representatives on the Governing Council of PCN;  Executive Secretary of the West African Postgraduate College of Pharmacists; and a Representative of National co-opharm (cooperative society of Pharmacists). 11) National Conference – Held every November; all elections held at the AGM of the National Conference; AGM ratifies Council decisions and is supreme body of the Society. 12) Grand Patron – President of the Federal Republic of Nigeria 13) Finance and Disbursements – NEC prepares annual budgets for Council’s approval; President decides imprest to be allocated to the Secretary for effective running of the Secretariat; External Auditors appointed to audit accounts of the Society (no timeframe provided). 14) Discipline – Investigating Panel and Disciplinary Committee to handle cases of misconduct; no sanctions specified (to be determined by Council on the recommendation of the Disciplinary Committee). 15) Standing Orders – National Conference has powers to make or alter standing orders. 16) Other Provisions – Standing or ad hoc Committees may be constituted for the execution of the PSN Council’s business; President can call a special General Meeting to issue directives to PCN or ratify rules made by PCN or address any other matter that cannot wait for the next AGM. 17) Other Arms of the Society – Technical groups are listed as the National Association of General Practice Pharmacists (now called Association of Community Pharmacists of Nigeria); National Association of Industrial Pharmacists; National Association of Academic Pharmacists (now called National Association of Pharmacists in Academics); National Association of Hospital and Administrative Pharmacists (now called the Association of Hospital and Administrative Pharmacists of Nigeria). One Interest Group – the Association of Lady Pharmacists – is listed. 18) Citation and Amendments – Constitution of the Pharmaceutical Society of Nigeria (1998) reflecting the year of the last amendment. A 2/3 majority of the AGM ratifies amendments proposed through/by Council.  HISTORY OF PHARMACY IN NIGERIA Early History Pharmacy is derived from the Greek word pharmakon. Claudius Galen (AD 130 – 200) is remembered for his contributions to curative medicine and the term galenical is named after him. History reports that Galen was Physician to the Roman Emperor Marcus Aurelius. Developments and advances in the biological and chemical sciences in the middle of he 19th century placed Pharmacy on a scientific pedestal as the synthesis of more bio-active molecules became possible and more rational therapeutic interventions easy. Prior to these developments, Pharmacy was more of an art than a scientific discipline. In Nigeria The practice of Pharmacy was introduced into Nigeria by missionaries and early European traders. These 17th century visitors brought medicines in the form of mixtures, lotions, powders, etc. to the coastal settlements of the West African coast. European health workers were employed to work on the trading ships that plied the trans-Atlantic trading routes. The first drug shop to be opened in Nigeria (on record) was in 1887 and the owner of the shop was Mr. Richard Zacheus Bailey. The shop was located on Balogun Street in Lagos. Mr Bailey was called “Doctor” a common and popular name for all health workers among the uneducated natives. Prior to the opening of the drug shop, hospitals and dispensaries were being run by missionaries mostly, and these dispensed mixtures such as quinine, ferric, acriflavine, etc. Dispensers were trained in the hospitals to mix (compound) and dispense medicines. These Dispensers are considered to be the forerunners of Pharmacists in Nigeria. Early Laws In 1878, the Lagos Pilotage and Harbor Ordinance was enacted. This law had provisions that included regulations on the use of medicines on board ships docked at the Lagos Harbor. Other laws that followed include the Hospital Ordinance (1881), the Ereko Dispensary Rules (1889), the Pharmacy Ordinance (1902), etc. The year 1902 marked the beginning of registration of Druggists under the Pharmacy Ordinance. The first entry on the list of Druggists was Mr Emmanuel Caulcrick. The Poisons and Pharmacy Ordinance (1923) provided for the control of sale and distribution of drugs and poisons. This applied to Lagos, the Protectorate of Nigeria and the British Cameroon. The Law established the Board of Medical Examiners which is the precursor of the Pharmacists Council of Nigeria. In1936, an amendment produced a new Poisons and Pharmacy Ordinance which established the Pharmacy Board and standardized the curriculum of the Chemists and Druggists Diploma. The new Board included members from the Nigerian Union of Pharmacists and the Association of Dispensers. These two bodies later merged and metamorphosed into the Pharmaceutical Society of Nigeria. The Poisons and Pharmacy Ordinance (1936) registered Chemists and Druggists, issued licenses to sellers of patent and proprietary medicines, granted missionary permits and appointed Pharmaceutical Inspectors. The Poisons and Pharmacy Act (1958) strengthened the Pharmacy Board, including Chief Pharmacists from the Federating Regions and a Representative from Cameroon. A Nigerian, Mr J.P.A. Marquis was appointed Registrar and Secretary to the Board: he was the first Nigerian Pharmacist to be so appointed. The Chairman of the Board was the Chief Medical Adviser. In 1964, the Pharmacists Act brought the control and regulation of the profession of Pharmacy firmly under the control of Pharmacists. Up to this point, non- Pharmacists were on the governing boards and medical doctors chaired the boards. The Pharmacists a Act (1964) established a Pharmacists Board comprising Pharmacists only. The first Chairman of the Pharmacists Board was Mr A.A. Oluwole, Federal Chief Pharmacist, and the first Registrar of this new Board was Mr A.A. Egboh. The regulatory mandate of the Pharmacists Board was spelt out to be: determination of standards relating to knowledge, skills, etc., and approval of training institutions; establishment and maintenance of a register of Pharmacists; maintenance of professional discipline; issuance of permits for the importation of laboratory and industrial chemicals; maintenance of a register for holders of the patent and proprietary medicines vendors license; appointment of Pharmaceutical Inspectors to enforce the provisions of the Poisons and Pharmacy Act Cap 152 of 1958; etc. Current Laws The promulgation of Decree 91 of 1992 repealed the Pharmacists Act of 1964 and established a new Pharmacists Council of Nigeria (PCN). All assets and liabilities of the defunct Pharmacists Board of Nigeria (PBN) were transferred to PCN. The new law produced a stronger professional regulatory body and elevated the status of the Governing Council’s Chairman as he/she was now to be appointed by the President. The first Chairman of the Governing Council of PCN was Mrs. P. Oviasu and the first Registrar was Ms H.D. Kayit. Other laws including the National Agency for Food and Drug Administration and Control Decree 15 of 1993 (now CAP N1 LFN 2004), Counterfeit and Fake Drugs and Unwholesome Processed Foods Decree 25 of 1999 (now CAP C34 LFN 2004), etc. followed and extended the scope of regulation in Pharmacy and related matters. Milestones Establishment of an all-Pharmacists Board …………………………………………. 1964 Appointment of a Chairman by the President ……………………………………… 1993 Establishment of a School of Pharmacy at Yaba, Lagos ……………………….. 1925 Accreditation of the first Faculty of Pharmacy at University of Ife ………. 1964 Commencement of Orientation Program for Foreign Trained Pharmacists... 1981 Introduction of Mandatory Continuing Professional Development Program.. 1998 Approval of Pharm.D program by PCN ………………………………………………………… 2002 Return of Patent and Proprietary Medicines Vendors regulation to PCN ……. 2003 Approval of Pharm.D program by the National Universities Commission …… 2015  CRITICISMS OF THE LAW AND IMPLICATIONS ON PRACTICE This can be examined under four major headings: Overlap Weak sanctions Ambiguities Lacunae Overlap There is considerable overlap in practically all the Pharmacy Laws. An overlap in itself is not necessarily bad or undesirable. It is usually the result of Government’s zeal to “leave no stone unturned” in the prosecution of the laws’ objectives. Overlap becomes challenging when the provisions of the different laws are being enforced by different Agencies of Government. An example that readily comes to mind is the overlap between PCN and NAFDAC. While the focus of PCN is personnel and premises, the latter has product quality as its major focus. It is clear that there cannot be products without personnel and premises; also personnel and premises produce and handle products. Overlap is therefore inevitable. Pharmacists have at various times complained about being caught in the middle of a turf war between PCN and NAFDAC. This should not be so. Government seeks collaboration and synergy among its various Agencies for the safety of its citizens. Indeed, there have been several collaborations between PCN and NAFDAC in the areas of joint trainings and campaigns. The ultimate collaboration would be joint inspections undertaken by the two Agencies. Collaboration with the NDLEA is more difficult because this Agency is under the Federal Ministry of Justice. Weak sanctions Pharmacy laws especially are replete with ridiculous fines (ten naira, twenty naira, etc.). The Drug laws and newer Pharmacy regulations have fines ranging from N50,000= to N500,000=. These fines are not deterring enough. Moreover, the Agencies involved in the enforcement of the law spend millions of naira on prosecution only to have convicts fined these ridiculous amounts. The judicial process is also very slow and the required zeal is lacking in the handling of Pharmacy and Drug cases. This weakens the resolve to prosecute and secure convictions. In many instances, the Agencies are forced to make do with administrative fines to be able to get on with the work. The presiding judges also use their discretion sometimes to increase the punishment beyond what is provided in the laws. Imprisonment without option of fine has been suggested as panacea. There have been calls also for Drug offenders to be treated (punished) like armed robbers. Ambiguities Government, sometimes in an effort to prevent a situation where its hands would be tied, deliberately introduces ambiguities into the provisions of the law. Such ambiguities guarantee that Government would win even in the event of litigation. A good example is the appointment of the Director-General of NAFDAC. Section 9 (1) of the NAFDAC Act provides for the appointment of “… a Director-general who shall be a person with good knowledge of Pharmacy, food and drugs.” Obviously, the ambiguity in these provisions can be exploited ad infinitum by the appointing authority who, in any case is the Commander-in-Chief. A lot of dust was raised when a Medical Doctor was appointed as DG NAFDAC, a post that has traditionally been held by Pharmacists. Serious doubts were expressed on the Appointee’s capability to provide leadership in an area that was clearly not his calling. The Lagos Branch of the Pharmaceutical Society of Nigeria eventually sued the Federal Government but with the law not specifying that the appointee must be a Pharmacist, the case went nowhere. The appointment of the PCN Registrar is equally shrouded in ambiguity where the provisions (S. 8 (1) PCN Act) simply specify “a fit and proper person” to be appointed (luckily) by the PCN Governing Council and not the Commander-in-Chief. Lacunae The laws have been found to be silent on several key issues. Pharmacy Technicians are currently challenging the authority of PCN to regulate them because as far as they are concerned, there is no mention of Pharmacy Technicians in the PCN Act. Their ultimate aim is a separate regulatory body for Pharmacy Technicians (and so called Technologists) and diploma programs in Pharmacy in the Colleges of Health Technology or polytechnics. The danger this portends (a sub-cadre regulating itself) is serious and PCN has been vigorously pursuing the court cases to abort these plans. The PPA also stopped short of specifying PCN as the issuing Authority for Patent and Proprietary Medicines Vendors Licenses (PPMVL). As a result different Ministers of Health authorized States at one time and even Local Governments at another to issue PPMVLs. There were 774 LGAs in Nigeria before the ceding of Bakassi to Cameroun. There were thus, at a point in history, 774 PPMVL issuing authorities in Nigeria. This no doubt contributed to the emergence of the chaotic drug distribution system in the Country.  The Future Steps have been taken to address many of the deficiencies currently existing in the laws. A major step has been the review of the laws and presentation of a comprehensive Pharmacy Council of Nigeria Bill to the National Assembly. The change of name from Pharmacists Council of Nigeria to Pharmacy Council of Nigeria reflects the reality that PCN’s regulatory mandate extends beyond Pharmacists. The Bill also contains many provisions that are absent in the PCN Act (e.g. regulation of Pharmacy Technicians) and those that are contained in the Poisons and Pharmacy Act which has disappeared from the Laws of the Federation. If this Bill becomes law, many ambiguities and lacunae would be addressed. Rapprochement between the Leaderships of the two key Agencies regulating Pharmacy and Drugs (NAFDAC and PCN) remains a critical requirement for more effective and hassle-free regulation all round. Functions of the PCN Disciplinary Tribunal The PCN Disciplinary Tribunal is established under the PCN Act (S.17 (1)) to sanitize the profession of Pharmacy. The work of the Tribunal receives wide publicity and therefore serves also to instill or restore public confidence specifically in the Profession and in the health delivery system in general. The Tribunal is charged with the specific responsibility of considering and determining any case referred to it by the PCN Investigating Panel and indeed any other case brought to its attention. The rulings of the Tribunal are simple: reprimand or removal of name from the register of Pharmacists. A Pharmacist whose name has been removed from the register of Pharmacists after been found guilty of professional misconduct is no longer eligible to practice Pharmacy in Nigeria. The real challenge facing the PCN is the enforcement of rulings of the Tribunal when the direction is for a Professional’s name to be struck off from the Register. Convicted professionals often carry on practicing quietly out of public view. PCN must invigorate its monitoring and enforcement units to address this otherwise the rulings of the Tribunal will remain of no effect.