D A L E A N D A P P E L B E ' S

(Pharm), FRPharmS, Hon

Joy WingfieldLI M, MPhil, BPharm, MRPharmS, Dip Ag Vet Pharm, MCPP

<v *

T H E P H A R M A C E U T I C A V \ P R E S S

Contents

Preface to Sixth Edition xixForeword xxiIntroduction xxvList of Statutes and Statutory Instruments xxxiTable of Abbreviations xliv

Medicines Act 1968:Scope and Administration 1

Medicinal Product 2Administration 4Enforcement 5Role of the Royal Pharmaceutical Society 6Inspection and Sampling 7Legal Proceedings 10Summary 11Further Reading 12

vi CONTENTS

! Medicines Act 1968:The Licensing System 13

- Issue of Licences 14Marketing Authorisations for Human Medicines 14Registration Certificates for Homoeopathic Medicines 17Product Licences (Parallel Importing) 17Marketing Authorisations for Animal Medicines 18Manufacturer's Licence 19Wholesale Dealer's Licence 20Fees 22Clinical Trial and Animal Test Certificates 22Exemptions for Clinical Trials 23Exemptions for Imports 23Exemptions for Exports 24Exemptions for Practitioners 24Exemptions for Nurses and Midwives 25Exemptions for Pharmacists 25Exemptions for Chiropodists, etc. 27Exemptions for Herbal Remedies 27Exemptions for Wholesale Dealing in Confectionery 27Exemptions for Foods and Cosmetics 28Exemptions for Ingredients 29'Special' Dispensing, Manufacturing and Assembly

Exemptions 30Hospitals 31Export Certificates 31Medicated Animal Feeding Stuffs 31Medical Devices 32Summary 33Further Reading 34

Medicines Act 1968:Sales Promotion of Medicinal Products 35

Advertisements and Representations 35Data Sheets 36Control of Advertisements and Representations 37Advertising in General 38Advertising to Health Professionals 39Advertisements Directed to the Public 43Monitoring of Advertising 46Prohibition of Representations • 46

CONTENTS vii

Exceptions for Labels and Leaflets 47Summary 48Further Reading 48

4 Medicines Act 1968:Retail Pharmacy Businesses 49

Representatives of Pharmacists 50Register of Premises 51Registration of Pharmacies 52Change of Ownership 54Premises Retention Fees 54Titles, Descriptions and Emblems 55Accommodation, Storage, Records, Equipment, etc. 56Disqualification of Retail Pharmacy Owner 57Summary 57

5 Medicines Act 1968:Pharmacy Medicines 58

Pharmacy Medicine Defined 59Exemptions in Cases Involving Another's Default 59Temporary Exemptions 60Collection and Delivery Arrangements - Exemption 60Summary 60Further Reading 60

6 Medicines Act 1968:General Sale Medicines 61

Conditions Applying to Retail Sale or Supply 61General Sale List Medicines for Human Use 62General Sale List Medicines for Animal Use 63Automatic Machines Section 63Retail Pack Sizes of Certain Products 63Products Not To Be On General Sale 65Summary 65Further Reading 66

7 Medicines Act 1968:Prescription Only Medicines 67

Prescription Only Medicines for Human Use 68Exemptions 70Prescription Only Medicines for Animal Use 71New Medicinal Products 71

viii CONTENTS

Administration of Prescription Only Medicines 72Radioactive Medicinal Products 72Prescriptions 72Pharmacy Records 74Particulars of Prescriptions to be Recorded 75Preservation of Pharmacy Records 75Exemption for Emergency Supplies 75Labelling of Dispensed Medicines 78Exemptions from Prescription Only 78The Future 78Summary 78Further Reading 79

8 Medicines Act 1968:Retail Sale and Supply, and Administration - Exemptionsfrom Controls 80

Hospitals and Health CentresDoctors, Dentists and VeterinariansUnorthodox PractitionersMidwivesRegistered NursesOphthalmic OpticiansChiropodistsManufacturers of Products for Treatment of the Hair and

ScalpPublic Analysts, Sampling Officers, etc.National Health Service Drug TestingOwners and Masters of ShipsOff-shore InstallationsBritish Standards InstitutionStatutory Requirements as to Medical TreatmentLicences and Group AuthoritiesRoyal National Lifeboat InstitutionBritish Red Cross Society, etc.Dental SchemesOccupational Health SchemesAircraft CommandersUniversities, etc.Sales by Licence HoldersVeterinary DrugsAmbulance ParamedicsThe FutureSummary

81818181828384

85858686878787888888888990909090919191

CONTENTS ix

9 Medicines Act 1968:Wholesale Dealing 93

A Person Making Sales by Way of Wholesale Dealing 93Pharmacy Medicines by Wholesale Dealing 94Prescription Only Medicines by Wholesale Dealing 95Wholesale Sales from a Pharmacy 95Summary 96

10 Medicines Act 1968:Homoeopathic Medicines 97

Medicinal Products at High Dilutions (HomoeopathicMedicines) 97

Homoeopathic Medicines for which General Sale isPermitted 97

Homoeopathic Medicines for Treatment According to theJudgment of the Seller 102

Summary 103Further Reading 103

11 Medicines Act 1968:Herbal Remedies 104

Exemption from Licensing 104Exemptions from Controls on Retail Sale 105Further Exemption for Shopkeepers 105Exemption of 'Herbal Practitioners' 106Enforcement Authority 106Schedule to-the Herbal Remedies Order 107Prescription Only Herbal Remedies 109Summary 109Further Reading 110

Medicines Act 1968:Veterinary Drugs - Exemptions from Controls 111

Classes of Veterinary Drugs 111Veterinary Surgeons and Practitioners 112Poultry Vaccine Suppliers 112Exempted Veterinary Drugs - Sale or Supply 112Restrictions on Sale or Supply of PML Veterinary Drugs and

Horse Wormers 113

CONTENTS

Conditions of Sale 114Registration Requirements 115Codes of Practice 116Exemptions for Pharmacists 116Labelling Requirements for Veterinary Drugs 116Prescriptions 117Storage 117Medicated Animal Feeding Stuffs 117Manufacture of Medicated Animal Feed 117Veterinary Written Direction 118Sale or Supply by Retail of Medicated Animal Feed 119Other Controls 120Summary 120Further Reading 120

13 Medicines Act 1968:Prohibitions for Protection of the Purchaser 121

Section 62 Orders 121Adulteration of Medicinal Products 123False or Misleading Advertisements or Representations 124Summary 125

14 Medicines Act 1968:Containers, Packages and Identification 126

Regulations and Penalties 126Definitions 127Labelling Regulations 130Labelling of'Relevant Medicinal Products 130General Labelling Provisions for Relevant Medicinal

Products for Human Use 130Standard Labelling Requirements for Relevant Medicinal

Products for Human Use 131Small Containers for Relevant Medicinal Products for

Human Use 132Blister Packs for Relevant Medicinal Products for Human

Use 132Standard Labelling Requirements for Containers and

Packages for Radiopharmaceuticals for Human Use 133Labelling of Relevant General Sale List Medicines 133Labelling of Relevant Medicines for Pharmacy Sale Only 134Labelling of Prescription Only Medicines 135Labelling of Relevant Dispensed Medicinal Products 135

CONTENTS xi

Labelling Provisions for Medicinal Products other thanRelevant Medicinal Products 136

General Labelling Provisions for Medicinal Productsother than Relevant Medicinal Products 136

Standard Labelling Particulars for Medicinal Products otherthan Relevant Medicinal Products 138

Small Containers, Wrappers and Sealed Units forMedicinal Products other than Relevant MedicinalProducts 140

Unit Packaging, Blisters, etc. 140Warnings and other Special Requirements 141Labelling of Non-Relevant General Sale List

Medicines 141Labelling of Non-Relevant Medicines for Pharmacy

Sale Only 142Labelling of Non-Relevant Prescription Only Medicines 143Labelling of Non-Relevant Dispensed Medicinal

Products 143Labelling of Medicinal Products Exempt from Product

Marketing Authorisations 145Ingredient Medjcinal Products 146Contract Manufacture or Assembly 147Importation and Exportation 147Clinical Trials 148Standard Labelling Requirements for Containers and

Packages of Homoeopathic Products for Human Use 148Surgical Materials 149Labelling of Animal Medicines 149Labelling of Small Containers for Animal Medicines 150Sales by Agricultural Merchants and Saddlers 150Labelling of Medicinal Tests on Animals 151Labelling of-Medicinal Products for Animal Feed 151Leaflets 152Child Safety Regulations 156Use of Fluted Bottles 157Other Exceptions to Fluted Bottle Requirements 159Summary 159

15 Medicines Act 1968:Pharmacopoeias and Other Publications 161

European Pharmacopoeia 161British Pharmacopoeia, Compendia, etc. 161British Pharmaceutical Codex and British Veterinary

Codex 162

xii CONTENTS

Compliance with Official Standards 163Specifications in Licences 164Summary 164

16 Misuse off Drugs Act 1971 166

Advisory Council on Misuse of Drugs 166Class A, Class B and Class C Drugs 168Restrictions and Exemptions 168Provisions for Preventing Misuse 169Information Concerning Misuse 170Prohibitions on Possession, Prescribing and Supply 170Tribunals, Advisory Bodies and Professional Panels 171Offences, Penalties and Enforcement 172Scheduled Substances - Precursors 175Powers of Secretary of State 175Regimes of Control 176Import and Export 178Possession and Supply 178Midwives and Pethidine 182Requisitions 183Prescriptions for Controlled Drugs 184Marking of Containers 186Registers and Records 187Furnishing of Information 189Preservation of Records 189Destruction of Controlled Drugs 189Addicts 190Safe Custody of Controlled Drugs 191Summary 193

17 Poisons Act, List and Rules 195

Poisons Board 195Poisons List 196Local Authorities' Lists 196Inspection and Enforcement 197Penalties and Legal Proceedings 198Poison Rules 198Sale and Supply of Poisons 200Labelling of Hydrogen Cyanide 202Labelling and Packaging of Poisons which are 'Chemicals' 202Schedule 1 Poisons 202Exemptions from Schedule 1 Requirements 204

CONTENTS

Schedule 1 Poisons Subject to Additional Restrictions(Rule 12)

Wholesale DealingSales Exempted by the ActAutomatic MachinesSummaryFurther Reading

XIII

204207207208208209

18 Dangerous Substances and Consumer Protection 210

Definitions 210Application of the Regulations and Exceptions 211Inspection and Enforcement 212Classification 212Indications of Danger 213Indication of Particular Risks 213Indication of Safety Precautions Required 213Packaging 213Child-Resistant Closures 214Tactile Danger Warnings 214Labelling for Supply 214Data sheets 217Control of Substances Hazardous to Health (COSHH) 217Summary 218Further Reading 219

19 The Royal Pharmaceutical Society of Great Britain 220

Organisation 222Branches and Regions 223Membership Groups 223Membership and Registration 224Registration as a Pharmaceutical Chemist 225EEC Recognition of Pharmaceutical Qualifications 225Reciprocal Registration 226Recognition by Adjudication 226Registration Without Examination 227The Register and Registration Certificates 227Annual Retention Fees 228Students 228Health Problems 228Standards Tribunal 229Pharmacists (Fitness to Practise) Act 229Summary 229Further Reading 230

xiv CONTENTS

20 Professional Conduct 231

The Profession of Pharmacy 232Trade and Profession 233The Dickson Case 234Professional Ethics 235Code of Ethics 236Principles 237Standards of Good Professional Practice 238Council Statements and Other Advice 239Professional Responsibility 240Negligence 240Summary 242Further Reading 242

21 The Statutory Committee of the Royal PharmaceuticalSociety 243

Constitution 243Procedure 244Jurisdiction 245Inquiries Following Criminal Convictions 246Inquiries Following Allegations of Misconduct 248Applications for Restoration to the Register 249Statutory Committee Cases 250Appeals Against Decisions 267Judicial Review 273Summary 275Further Reading 275

22 Organisation of other Professions 277

The Medical Profession 277The Veterinary Profession 283The Dental Profession 285Nurses, Midwives and Health Visitors 287Opticians 289Professions Supplementary to Medicines Act 1960 291Hearing Aid Council Act 1968. 292Further Reading 293

23 National Health Service Acts 294

An Internal Health Care Market 295The National Health Service and Community Care Act 1990 295

The Health Authorities ActNHS Bodies in England andScotlandThe FutureSummaryFurther Reading

1995Wales

CONTENTS xv

296297308311311312

24 Spirits and Methylated Spirits 313

Retail Sales of Intoxicating Liquor 313Spirits Duty 314Methylated Spirits 317

25 Miscellaneous Legislation Affecting Pharmacy 321

Pharmacy Ownership 323Pharmacy Employment 326Pharmacy Premises 332Trade Descriptions 336Consumer Protection 337Weights and Measures 339Merchant Shipping - Medical Scales 340Environment 341Protection of Animals and Birds 345Data Protection 347Access to Health Records 348Jury Service 349Further Reading 349

26 Legal Decisions Affecting Pharmacy 350

The Meaning of 'acting in accordance with thedirections of a practitioner' 352

The Meaning of 'by a doctor or dentist to a patient of his'under the Medicines Act 1968 352

The Meaning of 'person' 353The Meaning of 'personal control' 354Powers of the Royal Pharmaceutical Society 354Substances Containing Poisons 357The Meaning of 'sale by way of wholesale dealing' 358The Meaning of 'shop' 358Functions of the Statutory Committee 359The Meaning of 'supervision' 359Use of Titles and Descriptions 360

xvi CONTENTS

Definitions of 'a sample' 361Sale of Prescription Only Medicines - Offence of Strict

Liability 362Is Dispensing a Medicine on an NHS Prescription a 'sale'? 362Importation of Medicinal Products from the

European Community 363Further Reading 363

27 Hospitals, Trusts and Health Authorities 364

Official Reports, Notes and Circulars 365Misuse of Drugs Act 1971 366Medicines Act 1968 366Health and Safety at Work etc. Act 1974 369Security 369Guidelines for Dealing with Clinical Trials 369Miscellaneous 370

28 The European Community 371

European Law 371The Institutions 372Free Movement of Pharmacists 373Production and Distribution of Medicinal Products

for Human Use 374Analytical, Toxicological and Clinical Standards

for Medicines for Human Use 375High Technology Medicinal Products for Human and

Animal Use 376Homoeopathic Medicinal Products 376Advertising, Labelling and Leaflets 376Wholesale Distribution 376Colouring of Medicinal Products 377Production of Medicinal Products for Animal Use 377Animal Feeding Stuffs 377The Future 377Further Reading 378

Appendices 379

1 Medicines Act 1968: Medicinal Products 379

2 Medicines Act 1968: Prohibition of Non-MedicinalAntimicrobial Substances 384

CONTENTS xvii

3 Medicines Act 1968: Applications forMarketing Authorisations 387

4 Medicines Act 1968: Prescribed Conditions forManufacturers' Undertakings 395

5 Medicines Act 1968: Standard Provisions and Obligations

for Marketing Authorisations 398

6 Medicines Act 1968: Particulars Required in Data Sheets 420

7 Medicines Act 1968: Certificates of Analysis 423

8 Medicines Act 1968: Veterinary Drugs: Pharmacyand Merchants List (PML) 426

9 Misuse of Drugs Act 1971: Controlled Drugs Classifiedfor Level of Penalties 428

10 Misuse of Drugs Regulations 1985 (as Amended):Classification of Controlled Drugs for Regimesof Control 434

11 The Poisons List Order 1982 441

12 The Poisons Rules 1982 443

13 Substances and Preparations Dangerous to Supply -CHIP 2 458

14 Bye-laws of the Royal Pharmaceutical Society of

Great Britain 464

15 Statutory Committee Regulations 490

16 Code of Ethics 1992 497

17 National Health Service: England and Wales Terms ofService for Chemists 533

18 National Health Service: Scotland Terms of Servicefor Chemists 543

Index 551