
1 

(1) This Order may be cited as the Prescription Only Medicines (Human Use) Amendment Order 2002 and shall come into force on 1st April 2002.
(2) In this Order, “the principal Order” means the Prescription Only Medicines (Human Use) Order 1997.
2 

(1) Article 1 of the principal Order (citation, commencement and interpretation) is amended as follows.
(2) In paragraph (1)—
(a) omit the definition of “appropriate nurse practitioner”;
(b) after the definition of “cyanogenetic substances” insert the following definition—“
 “district nurse/health visitor prescriber” means—
(a) a person who—
(i) is registered in Part 1 or 12 of the professional register, and
(ii) has a district nursing qualification additionally recorded in the professional register under rule 11 of the Nurses, Midwives and Health Visitors Rules 1983; or
(b) a person who is registered in Part 11 of the professional register as a health visitor,against whose name (in each case) is recorded in the professional register an annotation signifying that he is qualified to order drugs, medicines and appliances for patients;”;
(c) after the definition of “dosage unit” insert the following definitions—“
 “Extended Formulary” means the Nurse Prescribers’ Extended Formulary Appendix in the current edition of the British National Formulary;
 “extended formulary nurse prescriber” means a person—
(a) who is registered in Parts 1, 3, 5, 8, 10, 11, 12, 13, 14 or 15 of the professional register; and
(b) against whose name is recorded in that register an annotation signifying that he is qualified to order drugs, medicines and appliances from the Extended Formulary;”;
(d) in the definition of “health prescription”, for “or nurse prescriber” insert “, a district nurse/health visitor prescriber or an extended formulary nurse prescriber”;
(e) after the definition of “Primary Care Trust” insert the following definition—“
 “professional register” means the register maintained by the Nursing and Midwifery Council pursuant to paragraph 10 of Schedule 2 to the Nursing and Midwifery Order 2001;”;
(f) in the definition of “registered midwife”, for the words from “the Register” to the end substitute “the professional register”;
(g) in the definition of “registered nurse”, for the words from “the Register” to the end substitute “the professional register”;
(h) in the definition of “state registered chiropodist”, for the words from “the Register” to the end substitute “the register of chiropodists maintained by the Health Professions Council pursuant to paragraph 11 of Schedule 2 to the Health Professions Order 2001”; and
(i) in the definition of “state registered paramedic”, for the words from “the Register” to the end substitute “the register of paramedics maintained by the Health Professions Council pursuant to paragraph 11 of Schedule 2 to the Health Professions Order 2001”.
(3) In paragraph (5), for “Schedules 1, 2 and 5” substitute “Schedules 1, 2, 3A and 5”.
3 
In article 2 of the principal Order (appropriate practitioners), for paragraph (b) substitute the following paragraphs—“
(b) in relation to the descriptions and classes of medicinal products specified in Schedule 3, district nurse/health visitor prescribers;
(c) in relation to the descriptions and classes of medicinal products specified in article 3A(1), extended formulary nurse prescribers.”.
4 
For article 3 of the principal Order (which specifies classes of prescription only medicines), substitute the following article—“
3 
The following descriptions and classes of medicinal products are specified for the purposes of section 58, namely—
(a) medicinal products in respect of which a marketing authorization has been granted, which in the marketing authorization are classified as being prescription only medicines;
(b) medicinal products in respect of which no marketing authorization has been granted consisting of or containing a substance listed in column 1 of Schedule 1;
(c) medicinal products that are for parenteral administration;
(d) medicinal products that are controlled drugs unless a marketing authorization has been granted in respect of that medicinal product in which the product is classified as being a pharmacy only or on general sale list medicine;
(e) cyanogenetic substances, other than preparations for external use;
(f) medicinal products that on administration emit radiation, or contain or generate any substance which emits radiation, in order that radiation may be used.”.
5 
After article 3 of the principal Order, insert the following article—“
3A 

(1) Subject to paragraph (2), the description and classes of medicinal products in relation to which extended formulary nurse prescribers are appropriate practitioners are those prescription only medicines which consist of, or contain, one or more of the substances specified in column 1 of Schedule 3A, but which do not contain any other substance or combination of substances which is a prescription only medicine not included in Schedule 3A.
(2) An extended formulary nurse prescriber may—
(a) give a prescription for a medicinal product referred to in paragraph (1); or
(b) if that medicinal product is for parenteral administration—
(i) administer that medicinal product, or
(ii) give directions for the administration of that medicinal product,
only where he complies with any condition as to the cases or circumstances in which he may do so that is specified by virtue of paragraph (3).
(3) If the entry in column 2 of Schedule 3A relating to a substance specifies one or more requirements as to use, route of administration or pharmaceutical form, it is a condition for the purposes of paragraph (2) that a medicinal product which consists of, or contains, that substance is administered, or is prescribed or directed for administration, in accordance with the specified requirements.”.
6 
Article 8 of the principal Order (exemptions for emergency sale or supply) is amended as follows—
(a) in paragraph (2)—
(i) in sub-paragraph (a), after “doctor” insert “, a district nurse/health visitor prescriber or an extended formulary nurse prescriber”;
(ii) in sub-paragraph (b), after “doctor” insert “, district nurse/health visitor prescriber or extended formulary nurse prescriber”;
(iii) in sub-paragraph (c), after “doctor” insert “, district nurse/health visitor prescriber or extended formulary nurse prescriber”; and
(b) in paragraph (4), in sub-paragraph (a), in head (ii), after “doctor” insert “, district nurse/health visitor prescriber or extended formulary nurse prescriber”.
7 
After article 13 of the principal Order (exemption in cases involving another’s default) insert the following article—“
13A 

(1) The restrictions imposed by section 58(2)(a) (restrictions on sale and supply) shall not apply to the sale or supply of a prescription only medicine by a pharmacist in accordance with a prescription given by a registered nurse or registered midwife who is not an appropriate practitioner in relation to that medicine where the pharmacist, having exercised all due diligence, believes on reasonable grounds that the person is such a practitioner.
(2) The restrictions imposed by section 58(2)(a) (restrictions on sale and supply) shall not apply to the sale or supply of a prescription only medicine by a pharmacist in accordance with a prescription given by an extended formulary nurse prescriber where the pharmacist, having exercised all due diligence, believes on reasonable grounds that the extended formulary nurse prescriber has complied with any condition with which he is required to comply by virtue of article 3A(2) and (3).”.
8 
In article 15 (prescriptions), in paragraph (2)(c)—
(a) in head (iii), for “an appropriate nurse practitioner” substitute “a district nurse/health visitor prescriber, an extended formulary nurse prescriber”; and
(b) in head (iv), for “or appropriate nurse practitioner” substitute “, a district nurse/health visitor prescriber or an extended formulary nurse prescriber”.
9 
After Schedule 3 to the principal Order, insert the following Schedule—“
SCHEDULE 3A
Article 3A


Column 1 Column 2
Substance Requirements as to use, route of administration, or pharmaceutical form
Aciclovir External use
Acrivastine Oral
Adapalene External use
Alclometasone dipropionate External use
Alimemazine tartrate (trimeprazine tartrate) Oral
Amorolfine hydrochloride External use
Amoxycillin trihydrate Oral
Aspirin Oral
Azelaic acid External use
Azelastine hydrochloride Ophthalmic use or nasal
Baclofen Oral administration in palliative care
Beclometasone dipropionate External use or nasal
Betamethasone dipropionate External use
Betamethasone sodium phosphate Aural or nasal
Betamethasone valerate External use
Budesonide Nasal
Carbaryl External use
Carbenoxolone sodium Mouthwash
Cetirizine hydrochloride Oral
Chloramphenicol Ophthalmic use
Cimetidine Oral
Cinchocaine hydrochloride External use
Clindamycin phosphate External use
Clobetasone butyrate External use
Clotrimazole External use
Cyclizine Parenteral administration in palliative care
Dantrolene sodium Oral administration in palliative care
Dantron Oral
Desogestrel Oral
Desoximetasone (Desoxymethasone) External use
Dexamethasone Aural
Dexamethasone isonicotinate Nasal
Diclofenac diethylammonium External use
Domperidone Oral or rectal administration in palliative care
Domperidone maleate Oral administration in palliative care
Doxycycline Oral
Econazole nitrate External use
Erythromycin External use
Ethinylestradiol Oral
Etynodiol diacetate (ethynodiol diacetate) Oral
Famotidine Oral
Felbinac External use
Fenticonazole nitrate External use
Fexofenadine hydrochloride Oral
Flucloxacillin sodium Oral
Fluconazole Oral
Fludroxycortide (Flurandrenolone) External use
Flumetasone pivalate Aural
Flunisolide Nasal
Fluocinolone acetonide External use
Fluocinonide External use
Fluocortolone hexanoate External use
Fluocortolone pivalate External use
Flurbiprofen Lozenges
Fluticasone propionate External use or nasal
Fusidic acid Ophthalmic use
Gentamicin sulphate Aural
Gestodene Oral
Hydrocortisone External use
Hydrocortisone acetate External use
Hydrocortisone butyrate External use
Hydrocortisone sodium succinate Lozenges
Hyoscine butylbromide Parenteral administration in palliative care
Hyoscine hydrobromide Oral, parenteral or transdermal administration in palliative care
Ibuprofen External use or oral
Ibuprofen lysine Oral
Ipratropium bromide Nasal
Isotretinoin External use
Ketoconazole External use
Ketoprofen External use
Levocabastine hydrochloride Ophthalmic use or nasal
Levomepromazine (methotrimeprazine) maleate Oral administration in palliative care
Levomepromazine (methotrimeprazine) hydrochloride Parenteral administration in palliative care
Levonorgestrel Oral
Lithium succinate External use
Lodoxamide trometamol Ophthalmic use
Loperamide hydrochloride Oral
Loratadine Oral
Mebendazole Oral
Medroxyprogesterone acetate Parenteral
Mestranol Oral
Metoclopramide hydrochloride Oral or parenteral administration in palliative care
Metronidazole External use or oral
Metronidazole benzoate Oral
Miconazole Dental lacquer
Miconazole nitrate External use
Minocycline Oral
Mometasone furoate External use or nasal
Nedocromil sodium Ophthalmic use
Nefopam hydrochloride Oral
Neomycin sulphate Aural
Neomycin undecenoate Aural
Nitrofurantoin Oral
Nizatidine Oral
Norethisterone 9  Oral
Norethisterone acetate Oral
Norethisterone enanthate Parenteral
Norgestimate Oral
Norgestrel Oral
Nystatin External use
Oxytetracycline dihydrate Oral
Paracetamol Oral
Penciclovir External use
Piroxicam External use
Prednisolone hexanoate External use
Prednisolone sodium phosphate Aural
Ranitidine hydrochloride Oral
Silver sulphadiazine External use
Sodium cromoglycate Ophthalmic use
Streptodornase External use
Streptokinase External use
Sulconazole nitrate External use
Terbinafine hydrochloride External use
Tetracycline hydrochloride External use or oral
Tretinoin External use
Triamcinolone acetonide External use, aural, nasal or oral paste
Trimethoprim Oral
Tuberculin PPD Parenteral
Vaccine, Adsorbed Diphtheria Parenteral
Vaccine, Adsorbed Diphtheria And Tetanus Parenteral
Vaccine, Adsorbed Diphtheria And Tetanus For Adults And Adolescents Parenteral
Vaccine, Adsorbed Diphtheria For Adults And Adolescents Parenteral
Vaccine, Adsorbed Diphtheria, Tetanus And Pertussis Parenteral
Vaccine, Adsorbed Diphtheria, Tetanus And Pertussis (Acellular Component) Parenteral
Vaccine, BCG Parenteral
Vaccine, BCG Percutaneous Parenteral
Vaccine, Haemophilus Influenzae Type B (Hib) Parenteral
Vaccine, Haemophilus Influenzae Type B (Hib) with Diphtheria, Tetanus And Pertussis Parenteral
Vaccine, Haemophilus Influenzae Type B, Diphtheria, Tetanus And Acellular Pertussis Parenteral
Vaccine, Hepatitis A Parenteral
Vaccine, Hepatitis A With Typhoid Parenteral
Vaccine, Hepatitis A, Inactivated, With Recombinant (DNA) Hepatitis B Parenteral
Vaccine, Hepatitis B Parenteral
Vaccine, Influenza Parenteral
Vaccine, Live Measles, Mumps And Rubella (MMR) Parenteral
Vaccine, Meningococcal Group C Conjugate Parenteral
Vaccine, Meningococcal Polysaccharide A and C Parenteral
Vaccine, Pneumococcal Parenteral
Vaccine, Poliomyelitis, Inactivated Parenteral
Vaccine, Poliomyelitis, Live (Oral) Oral
Vaccine, Rubella, Live Parenteral
Vaccine, Tetanus, Adsorbed Parenteral
Vaccine, Typhoid, Live Attenuated (Oral) Oral
Vaccine, Typhoid, Polysaccharide Parenteral”.
10 
In Part III of Schedule 7 to the principal Order (Patient Group Directions—classes of individuals by whom supplies may be made), for the last three entries substitute the following entries—“Individuals who are registered in the register of orthoptists maintained by the Health Professions Council pursuant to paragraph 11 of Schedule 2 to the Health Professions Order 2001 (state registered orthoptists).Individuals who are registered in the register of physiotherapists maintained by the Health Professions Council pursuant to paragraph 11 of Schedule 2 to the Health Professions Order 2001 (state registered physiotherapists).Individuals who are registered in the register of radiographers maintained by the Health Professions Council pursuant to paragraph 11 of Schedule 2 to the Health Professions Order 2001 (state registered radiographers).”.
11 
Articles 4 and 6 of the principal Order are revoked.
Signed by authority of the Secretary of State for Health
Hunt
Parliamentary Under Secretary of State
Department of Health
7th March 2002Bairbre de Brún
Minister of Health, Social Services and Public Safety
7th March 2002