2004 No. 2
The Prescription Only Medicines (Human Use) Amendment Order 2004
Made
Laid before Parliament
Coming into force
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 19681, or, as the case may be, those conferred by the said provisions and now vested in them2, 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 interpretation1
1
This Order may be cited as the Prescription Only Medicines (Human Use) Amendment Order 2004 and shall come into force on 31st January 2004.
2
In this Order, “the principal Order” means the Prescription Only Medicines (Human Use) Order 19973.
Amendment to article 12 of the principal Order2
For article 12 of the principal Order4, there is substituted—
Exemption for sale and supply in hospitals12
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 Order3
In the table in Schedule 3A to the principal Order5 (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 Order4
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
Sealed with the Official Seal of the Department of Health, Social Services and Public Safety
(This note is not part of the Order)