Dale and Appelbe's Pharmacy and Medicines Law SOHi Edited by Gordon E Appelbe LL B, PhD, MSc, BSc(Pharm), BA, FRPharmS, Hon MPS(Aus), FCPP, FCPP (Hons) Independent Pharmaceutical and Legal Consultant, London, UK Joy Wingfield LL M, MPhil, BPharm, FRPharmS, Dip Ag Vet Pharm, FCPP Honorary Professor of Pharmacy Law and Ethics, University of Nottingham, UK (PP) PharmocauHcal Pros»
Contents Preface to the Terith Edition Foreword About the contributors Introduction Listof legislation Cases Abbreviations and acronyms xiv xvii xviii xx xxv xli xliv 1 Sourcesoflaw 1 Thomas H John Introduction 1 European law 2 British law 4 The court system 8 How to find the law 10 Finding European law 12 Human rights law 17 19 20 2 Human medicines: scope of regulation 21 Karen Pitchford Consolidation of Medicines Legislation (2012) 21 The Human Medicines Regulations 2012 22 Part 1 General provisions 23 Part 2 Administration 25 Part 11 Pharmacovigilance 27 Part 16 Enforcement 28 Part 17 Legal proceedings 33 Medical devices 34 36 37
vi Contents 3 Human medicines: the licensing system 39 Cathal Gallagher Marketing authorisations for human medicines 39 Post-authorisation requirements 42 Generic products 42 Borderline products 43 Immunity from liability for unauthorised medicinal products 43 Parallel importing 44 Registration certificates for homoeopathic medicines for human use 47 Registration of traditional herbal medicinal products 47 Article 126a authorisations 48 Falsified Medicines Directive 48 Issue of licences 49 Pharmacovigilance 53 Exemptions 53 58 59 4 Human medicines: advertising 61 Advertising under Part 14 of the Human Medicines Regulations 2012 61 Requirements related to advertising 62 Holders of'specials manufacturer's licences' 68 Monitoring of advertising 69 69 70 5 Pharmacy businesses Lawfully conducting a retail pharmacy business Responsible Pharmacist Registration of pharmacy premises Titles, descriptions and emblems Standards in pharmacies 6 Human medicines: Pharmacy Medicines Karen Pitchford Pharmacy Medicine defined 71 71 72 75 79 80 81 81 83 87 88 88
Contents vii 7 Human medicines: General Sale Medicines 89 Karen Pitchford Conditions applying to retail sale or supply of General Sale List medicinal products 89 General Sale List Medicine defined 90 Automatic machines 90 Retail pack sizes of certain products 90 Products not to be on general sale 92 93 93 8 Human medicines: Prescription Only Medicines 95 Karen Pitchford Prescription Only Medicine defined 95 Exemptions from Prescription Only control 96 Sale or supply of Prescription Only Medicines 98 Administration of Prescription Only Medicines 101 Prescriptions 103 Pharmacy records 107 Labelling of dispensed medicines 108 Exemptions from the need for a prescription 108 Mixing of medicines 114 115 116 9 Human medicines: exemptions from controls 117 Introduction 117 Exemption for supplies by doctors or dentists to their patients (HMRs Reg.223) 117 Patient Group Directions 119 Other exemptions for sale, supply or administration by certain persons (Sch. 17 tothe HMRs) 124 Exemptions in other legislation 136 136 137 10 Human medicines: wholesale dealing 139 Conditions on sales by wayof wholesale dealing 140 Wholesale dealing from a pharmacy 142 Wholesale dealing of veterinary products 144 144 144
viii Contents 11 Human medicines: sale and supply of homoeopathic medicines 145 Definition of medicinal products at high dilutions (homoeopathic medicines) 145 Homoeopathic medicines for human use: licensing 145 Exemptions for medicinal products at high dilution (homoeopathic medicines) 146 Exemption for certain (registered) homoeopathic medicinal products (HMRs Reg.243) 147 Medicinal products at high dilutions 147 151 151 12 Human medicines: herbal medicines 153 Definitions 154 Registration of traditional herbal medicines 154 Labelling for traditional herbal medicinal products 156 Herbal remedy 157 Exemptions from controls on retail sale 157 Banned herbal remedies 157 162 162 13 Human medicines: prohibitions for protection of the purchaser 163 Prohibition Orders Adulteration of medicinal products Protection for purchasers of medicinal products 163 165 165 166 166 14 Human medicines: labelling, packaging, leaflets a Identification Regulations and penalties Definitions Labelling and packaging Package leaflets Requirements relating to child safety (HMRs Regs.272-276) Use offluted bottles 167 167 168 169 176 179 181 181 182
Contents ix 15 Human medicines: pharmacopoeias and compendia 183 British Pharmacopoeia and compendia 183 Compliance with official Standards 184 Specified publications 186 186 186 16 Veterinary medicines 187 Gordon Hockey Scope of the Veterinary Medicines Regulations 187 Offences 188 Marketing authorisations (VMRs Part 2 and Sch. 1) 189 Pharmacovigilance (VMRs Sch. 1, Part 8) 191 Classification of veterinary medicines (VMRs Sch. 3, para. 1) 191 Wholesale supply of veterinary medicines (VMRs Sch. 3, para. 2) 192 Retail supply of veterinary medicines 192 Prescription and supply requirements 193 Records of receipt and supply for Prescription Only Medicines 198 Advertising of veterinary products (VMRs Reg.10) 200 Importation of veterinary medicines (VMRs Reg.9) 200 Labelling requirements for veterinary medicines (VMRs Sch. 1, Part 7) 201 Sale of sheep dips (VMRs Sch. 3, Part 2) 202 Medicated feeding stuffs and specified feed additives (VMRs Sch. 5) 203 Fairtrading 203 204 205 17 Controlled Drugs 207 Cathal Gallagher Advisory Council on Misuse of Drugs 207 Class A, B and C drugs 208 Restrictions and exemptions 209 Tribunals, advisory bodies and professional panels 213 Offences, penalties and enforcement 214 Scheduled substances: precursors 217 Powers of the Secretaryof State 218 Regimes ofcontrol 218 Poppy-straw 221 Import and export 221 Possession and supply 221 Standard operating procedures 225
x Contents Midwives and pethidine Requisitions Prescriptions for Controlied Drugs Marking of Containers Registers and records Destruction of Controiled Drugs Accountable Officers Substance misusers Safe custody of Controiled Drugs 18 Poisons Karen Pitchford Review of Poisons legislation Legal framework The Poisons Board The Poisons List Local authorities' lists Inspection and enforcement Penaltiesand legal proceedings The Poison Rules Sale and supply of poisons Schedule 1 Poisons Sales exempted by the Poisons Automatic machines 226 227 229 232 232 235 236 237 238 239 243 245 245 245 246 246 247 248 249 249 251 253 Act, including wholesale dealing 256 257 257 258 19 Atcohol and denatured atcohol 259 Retail sales of intoxicating liquor 259 Alcohol duty 259 Denatured alcohol 262 Scotland: sale of completely denatured alcohol and surgical alcohol 265 266 266 20 Chemicals 267 Definitions 267 Application of the Regulations and exceptions 267 Control of substances hazardous to health 273
Contents xi 274 275 21 Miscellaneous legislation affecting pharmacy 277 Joy Wingfield Data protection and freedom of information 277 Pharmacy ownership 282 Workplace law 286 Consumer protection law 289 Health and safety law 293 Environmental law 295 Merchant shipping: medical scales 299 Jury service 300 301 301 22 Pharmacy regulation 303 Dai John The General Pharmaceutical Council 303 The Professional Standards Authority for Health and Social Care 304 The Pharmacy Order 2010 305 Functions of the General Pharmaceutical Council 306 Continuing professional development 320 English language competency 321 Remaining parts of the Pharmacy Order 2010 322 323 323 23 Professional conduct 325 Dai John and David H Reissner The profession of pharmacy 326 Trade and profession 327 Professional ethics and law 330 Former codes of ethics 330 Standards of Conduct, Ethics and Performance 331 Guidance 333 Negligence 335 343 343 24 Fitness to practise 345 David H Reissner The role of the General Pharmaceutical Council 345 Fitness to practise 345
xii Contents Groundsforfinding impairment J4 First registration and good character 350 Interim orders 351 Initial action in respect of allegations 353 Prosecutions 356 Disqualification 357 Disposal of allegations without hearings 358 The Fitness to Practise, Committee 358 Sanctions 361 Appeals 365 Professional Standards Authority for Health and Social Care 366 Restoration to the Register and registration following removal 366 367 367 25 Regulation ofother health professions 369 Gordon Hockey Medical scandals and convergence of regulation 369 The General Medical Council 372 The General Dental Council 376 Other healthcare regulators 379 The Council of the Royal College of Veterinary Surgeons 379 381 381 26 NHS law and Organisation 383 Sarah ME Cockbill, Stephen Lutener, Edward Mallinson and Joy Wingfield Legislative framework for the NHS 383 Earlier legislation relevant to pharmacy 385 Impending legislation in England 387 NHS directions and policy statements 388 NHS policy and planning 389 The NHS Constitution 391 NHS structure in Great Britain 391 NHS structure in England 392 NHS structure in Wales 417 NHS structure in Scotland 422 425 426
Contents xiii Appendices 429 1 Medicines Act 1968: section 104 and 105 Orders 429 2 Prohibition of non-medicinal antimicrobial substances 431 3 Patient Group Directions 435 4 Misuse of Drugs Act 1971: Controlled Drugs classified for level of penalties 437 5 Misuse of Drugs Regulations 2001 (as amended): Controlled Drugs classified for regimes of control 451 6 The Poisons List Order 1982 465 7 The Poisons Rules 1982 469 8 Classification and labelling ofchemicals 483 9 Standards for registered pharmacies September 2012 497 10 General Pharmaceutical Council referral criteria from the Investigating Committee 503 11 General Pharmaceutical Council prosecution policy 509 12 General Pharmaceutical Council Indicative Sanctions Guidance 513 Index 527