Statutory Instruments
2004 No. 2
MEDICINES
The Prescription Only Medicines (Human Use) Amendment Order 2004
Made
6th January 2004
Laid before Parliament
9th January 2004
Coming into force
31st January 2004
As respects England, Scotland and Wales, the Secretary of State concerned with health in England, and, as respects Northern Ireland, the Department of Health, Social Services and Public Safety, acting jointly, in exercise of the powers conferred upon them by sections 58(1), (1B), (4), (4A), (4B) and (5) and 129(4) of the Medicines Act 1968( 1 ), or, as the case may be, those conferred by the said provisions and now vested in them( 2 ), and of all other powers enabling them in that behalf, after consulting such organisations as appear to them to be representative of interests likely to be substantially affected by this Order, pursuant to section 129(6) of that Act, and after consulting and taking into account the advice of the Committee on Safety of Medicines, pursuant to sections 58(6) and 129(7) of that Act, and taking into account the advice of the Medicines Commission, pursuant to section 129(7) of that Act, hereby make the following Order:
Citation, commencement and interpretation
1. —(1) This Order may be cited as the Prescription Only Medicines (Human Use) Amendment Order 2004 and shall come into force on 31 st January 2004.
(2) In this Order, “the principal Order” means the Prescription Only Medicines (Human Use) Order 1997( 3 ).
Amendment to article 12 of the principal Order
2. For article 12 of the principal Order( 4 ), there is substituted—
“ Exemption for sale and supply in hospitals
12. —(1) Subject to paragraph (3), 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 in the course of the business of a hospital where the medicine is sold or supplied for the purpose of being administered (whether in the hospital or elsewhere) to a particular person in accordance with directions satisfying the conditions specified in paragraph (2).
(2) The conditions specified in paragraph (1) are that the directions—
(a) are in writing;
(b) relate to the particular person to whom the medicine is to be administered; and
(c) are given by a person (other than a veterinary surgeon or veterinary practitioner) who is an appropriate practitioner in relation to that medicine.
(3) Such directions may be given by an extended formulary nurse prescriber or a supplementary prescriber only where he complies with any condition as to the cases or circumstances in which he may give a prescription for that medicine specified by virtue of article 3A or 3B, as if the directions are a prescription.
(4) The exemption in paragraph (1) applies notwithstanding that the directions do not satisfy the conditions specified in article 15(2). ” .
Amendment of Schedule 3A to the principal Order
3. In the table in Schedule 3A to the principal Order( 5 ) (substances which may be prescribed, administered or directed for administration by extended formulary nurse prescribers and conditions for such prescription or administration)—
(a) for the entry for “Erythromycin”, in column 2, after “External Use” insert “or oral”;
(b) for the entry “Fusidic acid”, in column 2 for “Opthalmic Use” substitute “External Use”;
(c) for the entry “Hycosine butylbromide”, in column 2, after “parenteral” insert “or transdermal”;
(d) for the entry “Hycosine hydrobromide”, in column 2, for “Oral, parenteral or transdermal administration in palliative care” substitute “Oral or parenteral administration in palliative care”;
(e) for the entry “Metronidazole”, in column 2 for “External use or oral” substitute “External use, oral or rectal”;
(f) for the entry “Prednisolone sodium phosphate”, in column 2, after “Aural” insert “or oral”;
(g) in column 1 insert, at the appropriate place in the alphabetical order of the entries as they appear in that column, each of the entries set out in column 1 below, and in column 2 insert, against those entries, the corresponding entries in column 2 below—
| Column 1 | Column 2 |
|---|---|
| Amitriptyline hydrochloride | Oral |
| Azithromycin dihydrate | Oral |
| Carbamazepine | Oral or rectal |
| Clavulanic acid | Oral |
| Conjugated oestrogens (equine) | External use |
| Diclofenac potassium | Oral |
| Diclofenac sodium | Oral or rectal |
| Erythromycin ethyl succinate | Oral |
| Erythromycin stearate | Oral |
| Estradiol | External use |
| Estriol | External use |
| Etonogestrel | Implant |
| Flumazenil | Parenteral |
| Gabapentin | Oral |
| Glucagon hydrochloride | Parenteral |
| Glucose | Parenteral |
| Imipramine hydrochloride | Oral |
| Lignocaine hydrochloride | External use or parenteral |
| Lymecycline | Oral |
| Nortriptyline hydrochloride | Oral |
| Prednisolone | Oral |
| Salbutamol sulphate | Inhalation |
| Sodium fusidate | External use |
| Terbutaline sulphate | Inhalation |
Amendment of Schedule 5 to the principal Order
4. In Schedule 5 to the principal Order (exemption for certain persons from section 58(2) of the Medicines Act 1968), insert in the list in column 2 of paragraph 2 of Part III, at the appropriate place in the alphabetical order of the entries as they appear in that list, the following entries—
“Diamorphine”
“Morphine”.
Signed by authority of the Secretary of State for Health
Warner
Parliamentary Under Secretary of State,
Department of Health
31st December 2003
Sealed with the Official Seal of the Department of Health, Social Services and Public Safety
L.S.
D.C. Gowdy
Permanent Secretary,
Department of Health, Social Services and Public Safety
6th January 2004
1968 c. 67 . The expression “the appropriate Ministers” and the expression “the Health Ministers”, which are relevant to the powers being exercised in the making of this Order, are defined in section 1 of that Act as amended by article 2(2) of, and Schedule 1 to, S.I. 1969/388 , by article 5 of, and paragraph 1(1) of the Schedule to, S.I. 1999/3142 , and by article 5(1) of, and paragraph 15 of Schedule 1 to, S.I. 2002/794 ; section 58 of that Act was amended by section 1 of the Prescription by Nurses etc. Act 1992 (c. 28) and by section 63 of the Health and Social Care Act 2001 (c. 15) .
In the case of the Secretary of State concerned with health in England, by virtue of article 2(2) of, and Schedule 1 to, S.I. 1969/388 , and articles 2(1) and 5 of, and paragraph 1(1) of the Schedule to, S.I. 1999/3142 ; and in the case of the Department for Health, Social Services and Public Safety, by virtue of the powers vested in the Minister in charge of that Department by virtue of section 95(5) of, and paragraph 10 of Schedule 12 to, the Northern Ireland Act 1998 (c. 47) which may now be exercised by the Department by virtue of section 1(8) of, and paragraph 4(1)(b) of the Schedule to, the Northern Ireland Act 2000 (c. 1) ; the Department was renamed by virtue of Article 3(6) of S.I. 1999/283 (N.I.1) .
S.I. 1997/1830 ; relevant amending instruments are S.I. 2000/1917 , 2002/549 and 2003/696 and 2915 .
Article 12 was substituted by SI 2000/1917 .
Schedule 3A was inserted by SI 2002/549 , and amended by SI 2003/696 and 2915 .