Dale and Appelbe's pharmacy and medicines law

Cover
Title Page
Copyright
Table of Contents
Preface to the Tenth Edition
Foreword
About the contributors
Introduction
List of legislation
Cases
Abbreviations and acronyms
Chapter 1 Sources of law
	Introduction
	European law
	British law
	The court system
	How to find the law
	Finding European law
	Human rights law
	Summary
	Further reading
Chapter 2 Human medicines: scope of regulation
	Consolidation of Medicines Legislation (2012)
	The Human Medicines Regulations 2012
	Part 1 General provisions
	Part 2 Administration
	Part 11 Pharmacovigilance
	Part 16 Enforcement
	Part 17 Legal proceedings
	Medical devices
	Summary
	Further reading
Chapter 3 Human medicines: the licensing system
	Marketing authorisations for human medicines
	Post-authorisation requirements
	Generic products
	Borderline products
	Immunity from liability for unauthorised medicinal products
	Parallel importing
	Registration certificates for homoeopathic medicines for human use
	Registration of traditional herbal medicinal products
	Article 126a authorisations
	Falsified Medicines Directive
	Issue of licences
	Pharmacovigilance
	Exemptions
	Summary
	Further reading
Chapter 4 Human medicines: advertising
	Advertising under Part 14 of the Human Medicines Regulations 2012
	Requirements related to advertising
	Holders of `specials manufacturer's licences'
	Monitoring of advertising
	Summary
	Further reading
Chapter 5 Pharmacy businesses
	Lawfully conducting a retail pharmacy business
	Responsible Pharmacist
	Registration of pharmacy premises
	Titles, descriptions and emblems
	Standards in pharmacies
	Summary
	Further reading
Chapter 6 Human medicines: Pharmacy Medicines
	Pharmacy Medicine defined
	Summary
	Further reading
Chapter 7 Human medicines: General Sale Medicines
	Conditions applying to retail sale or supply of General Sale List medicinal products
	General Sale List Medicine defined
	Automatic machines
	Retail pack sizes of certain products
	Products not to be on general sale
	Summary
	Further reading
Chapter 8 Human medicines: Prescription Only Medicines
	Prescription Only Medicine defined
	Exemptions from Prescription Only control
	Sale or supply of Prescription Only Medicines
	Administration of Prescription Only Medicines
	Prescriptions
	Pharmacy records
	Labelling of dispensed medicines
	Exemptions from the need for a prescription
	Mixing of medicines
	Summary
	Further reading
Chapter 9 Human medicines: exemptions from controls
	Introduction
	Exemption for supplies by doctors or dentists to their patients (HMRs Reg.223)
	Patient Group Directions
	Other exemptions for sale, supply or administration by certain persons (Sch. 17 to the HMRs)
	Exemptions in other legislation
	Summary
	Further reading
Chapter 10 Human medicines: wholesale dealing
	Conditions on sales by way of wholesale dealing
	Wholesale dealing from a pharmacy
	Wholesale dealing of veterinary products
	Summary
	Further reading
Chapter 11 Human medicines: sale and supply of homoeopathic medicines
	Definition of medicinal products at high dilutions (homoeopathic medicines)
	Homoeopathic medicines for human use: licensing
	Exemptions for medicinal products at high dilution (homoeopathic medicines)
	Exemption for certain (registered) homoeopathic medicinal products (HMRs Reg.243)
	Medicinal products at high dilutions
	Summary
	Further reading
Chapter 12 Human medicines: herbal medicines
	Definitions
	Registration of traditional herbal medicines
	Labelling for traditional herbal medicinal products
	Herbal remedy
	Exemptions from controls on retail sale
	Banned herbal remedies
	Summary
	Further reading
Chapter 13 Human medicines: prohibitions for protection of the purchaser
	Prohibition orders
	Adulteration of medicinal products
	Protection for purchasers of medicinal products
	Summary
	Further reading
Chapter 14 Human medicines: labelling, packaging, leaflets and identification
	Regulations and penalties
	Definitions
	Labelling and packaging
	Package leaflets
	Requirements relating to child safety (HMRs Regs.272-276)
	Use of fluted bottles
	Summary
	Further reading
Chapter 15 Human medicines: pharmacopoeias and compendia
	British Pharmacopoeia and compendia
	Compliance with official standards
	Specified publications
	Summary
	Further reading
Chapter 16 Veterinary medicines
	Scope of the Veterinary Medicines Regulations
	Offences
	Marketing authorisations (VMRs Part 2 and Sch. 1)
	Pharmacovigilance (VMRs Sch. 1, Part 8)
	Classification of veterinary medicines (VMRs Sch. 3, para. 1)
	Wholesale supply of veterinary medicines (VMRs Sch. 3, para. 2)
	Retail supply of veterinary medicines
	Prescription and supply requirements
	Records of receipt and supply for Prescription Only Medicines
	Advertising of veterinary products (VMRs Reg.10)
	Importation of veterinary medicines (VMRs Reg.9)
	Labelling requirements for veterinary medicines (VMRs Sch. 1, Part 7)
	Sale of sheep dips (VMRs Sch. 3, Part 2)
	Medicated feeding stuffs and specified feed additives (VMRs Sch. 5)
	Fair trading
	Summary
	Further reading
Chapter 17 Controlled Drugs
	Advisory Council on Misuse of Drugs
	Class A, B and C drugs
	Restrictions and exemptions
	Tribunals, advisory bodies and professional panels
	Offences, penalties and enforcement
	Scheduled substances: precursors
	Powers of the Secretary of State
	Regimes of control
	Poppy-straw
	Import and export
	Possession and supply
	Standard operating procedures
	Midwives and pethidine
	Requisitions
	Prescriptions for Controlled Drugs
	Marking of containers
	Registers and records
	Destruction of Controlled Drugs
	Accountable Officers
	Substance misusers
	Safe custody of Controlled Drugs
	Summary
	Further reading
Chapter 18 Poisons
	Review of Poisons legislation
	Legal framework
	The Poisons Board
	The Poisons List
	Local authorities' lists
	Inspection and enforcement
	Penalties and legal proceedings
	The Poison Rules
	Sale and supply of poisons
	Schedule 1 Poisons
	Sales exempted by the Poisons Act, including wholesale dealing
	Automatic machines
	Summary
	Further reading
Chapter 19 Alcohol and denatured alcohol
	Retail sales of intoxicating liquor
	Alcohol duty
	Denatured alcohol
	Scotland: sale of completely denatured alcohol and surgical alcohol
	Summary
	Further reading
Chapter 20 Chemicals
	Definitions
	Application of the Regulations and exceptions
	Control of substances hazardous to health
	Summary
	Further reading
Chapter 21 Miscellaneous legislation affecting pharmacy
	Data protection and freedom of information
	Pharmacy ownership
	Workplace law
	Consumer protection law
	Health and safety law
	Environmental law
	Merchant shipping: medical scales
	Jury service
	Summary
	Further reading
Chapter 22 Pharmacy regulation
	The General Pharmaceutical Council
	The Professional Standards Authority for Health and Social Care
	The Pharmacy Order 2010
	Functions of the General Pharmaceutical Council
	Continuing professional development
	English language competency
	Remaining parts of the Pharmacy Order 2010
	Summary
	Further reading
Chapter 23 Professional conduct
	The profession of pharmacy
	Trade and profession
	Professional ethics and law
	Former codes of ethics
	Standards of Conduct, Ethics and Performance
	Guidance
	Negligence
	Summary
	Further reading
Chapter 24 Fitness to practise
	The role of the General Pharmaceutical Council
	Fitness to practise
	Grounds for finding impairment
	First registration and good character
	Interim orders
	Initial action in respect of allegations
	Prosecutions
	Disqualification
	Disposal of allegations without hearings
	The Fitness to Practise, Committee
	Sanctions
	Appeals
	Professional Standards Authority for Health and Social Care
	Restoration to the Register and registration following removal
	Summary
	Further reading
Chapter 25 Regulation of other health professions
	Medical scandals and convergence of regulation
	The General Medical Council
	The General Dental Council
	Other healthcare regulators
	The Council of the Royal College of Veterinary Surgeons
	Summary
	Further reading
Chapter 26 NHS law and organisation
	Legislative framework for the NHS
	Earlier legislation relevant to pharmacy
	Impending legislation in England
	NHS directions and policy statements
	NHS policy and planning
	The NHS Constitution
	NHS structure in Great Britain
	NHS structure in England
	NHS structure in Wales
	NHS structure in Scotland
	Summary
	Further reading
Appendices
	Appendix 1 Medicines Act 1968: section 104 and 105 Orders
	Appendix 2 Prohibition of non-medicinal antimicrobial substances
	Appendix 3 Patient Group Directions
	Appendix 4 Misuse of Drugs Act 1971: Controlled Drugs classified for level of penalties
	Appendix 5 Misuse of Drugs Regulations 2001 (as amended): Controlled Drugs classified for regimes of control
	Appendix 6 The Poisons List Order 1982
	Appendix 7 The Poisons Rules 1982
	Appendix 8 Classification and labelling of chemicals
	Appendix 9 Standards for registered pharmacies September 2012
	Appendix 10 General Pharmaceutical Council referral criteria from the Investigating Committee
	Appendix 11 General Pharmaceutical Council prosecution policy
	Appendix 12 General Pharmaceutical Council Indicative Sanctions Guidance
Index