The Prescription Only Medicines (Human Use) Order 1997

PART I EXEMPTION FROM RESTRICTIONS ON SALE OR SUPPLY

Column 1	Column 2	Column 3
Persons exempted	Prescription only medicines to which the exemption applies	Conditions
1. Persons selling or supplying prescription only medicines to universities, other institutions concerned with higher education or institutions concerned with research.	1. All prescription only medicines	1. The sale or supply shall be– (a) subject to the presentation of an order signed by the principal of the institution concerned with education or research or the appropriate head of department in charge of a specified course of research stating– (i) the name of the institution for which the prescription only medicine is required, (ii) the purpose for which the prescription only medicine is required, and (iii) the total quantity required, and (b) for the purposes of the education or research with which the institution is concerned.
2. Persons selling or supplying prescription only medicines to any of the following– (1) a public analyst appointed under section 27 of the Food Safety Act 1990(1) or article 36 of the Food (Northern Ireland) Order 1989(2), (2) an authorized officer within the meaning of section 5(6) of the Food Safety Act 1990, (3) a sampling officer within the meaning of article 38(1) of the Food (Northern Ireland) Order 1989, (4) a person duly authorized by an enforcement authority under sections 111 and 112, (5) a sampling officer within the meaning of Schedule 3 to the Act.	2. All prescription only medicines.	2. The sale or supply shall be subject to the presentation of an order signed by or on behalf of any person listed in column 1 of this paragraph stating the status of the person signing it and the amount of prescription only medicine required, and shall be only in connection with the exercise by those persons of their statutory functions.
3. Persons selling or supplying prescription only medicines to any person employed or engaged in connection with a scheme for testing the quality and checking the amount of the drugs and appliances supplied under the National Health Service Act 1977(3), the National Health Service (Scotland) Act 1978(4) and the Health and Personal Social Services (Northern Ireland) Order 1972(5), or under any subordinate legislation made under those Acts or that Order.	3. All prescription only medicines.	3. The sale or supply shall be– (a) subject to the presentation of an order signed by or on behalf of the person so employed or engaged stating the status of the person signing it and the amount of prescription only medicine required, and (b) for the purposes of a scheme referred to in column 1 in this paragraph.
4. Registered midwives.	4. Prescription only medicines containing any of the following substances– Chloral hydrate Ergometrine maleate Pentazocine hydrochloride [F1 Phytomenadione] Triclofos sodium.	4. The sale or supply shall be only in the course of their professional practice and in the case of Ergometrine maleate only when contained in a medicinal product which is not for parenteral administration.
5. Persons lawfully conducting a retail pharmacy business within the meaning of section 69.	5. Prescription only medicines which are not for parenteral administration and which– (a) are eyes drops and are prescription only medicines by reason only that they contain not more than 0.5 per cent Chloramphenicol, or (b) are eye ointments and are prescription only medicines by reason only that they contain not more than 1.0 per cent Chloramphenicol, or (c) are prescription only medicines by reason only that they contain any of the following substances: Atropine sulphate Bethanecol chloride Carbachol Cyclopentolate hydrochloride Homatropine hydrobromide Naphazoline hydrochloride Naphazoline nitrate Physostigmine salicylate Physostigmine sulphate Pilocarpine hydrochloride Pilocarpine nitrate Tropicamide.	5. The sale or supply shall be subject to the presentation of an order signed by a registered ophthalmic optician.
6. Registered ophthalmic opticians.	6. Prescription only medicines listed in column 2 of paragraph 5.	6. The sale or supply shall be only– (a) in the course of their professional practice and (b) in an emergency.
7. Persons selling or supplying prescription only medicines to the British Standards Institution.	7. All prescription only medicines.	7. The sale or supply shall be– (a) subject to the presentation of an order signed on behalf of the British Standards Institution stating the status of the person signing it and the amount of the prescription only medicine required, and (b) only for the purpose of testing containers of medicinal products or determining the standards for such containers.
8. Holders of marketing authorizations, product licences or manufacturer’s licences.	8. Prescription only medicines referred to in the authorizations or licences.	8. The sale or supply shall be only– (a) to a pharmacist, (b) so as to enable that pharmacist to prepare an entry relating to the prescription only medicine in question in a tablet or capsule identification guide or similar publication, and (c) of no greater quantity than is reasonably necessary for that purpose.
9. Pharmacists selling or supplying to persons to whom cyanide salts may be sold by virtue of section 3 (regulation of poisons) or section 4 (exclusion of sales by wholesale and certain other sales) of the Poisons Act 1972(6) or by virtue of article 5 (prohibitions and regulations with respect to sale of poisons) or article 6 (exemption with respect to certain sales) of the Poisons (Northern Ireland) Order 1976(7).	9. Amyl nitrite.	9. The sale or supply shall only be so far as is necessary to enable an antidote to be available to persons at risk of cyanide poisoning.
[F2 10.  F3 ... registered chiropodists who hold a certificate of competence in the use of the medicines specified in Column 2 issued by or with the approval of the Chiropodists Board [F4 or the Health Professions Council].	10.   The following prescription only medicines— (a) Co-dydramol 10/500 tablets; (b) Amorolfine hydrochloride cream where the maximum strength of the Amorolfine in the cream does not exceed 0.25 per cent by weight in weight; (c) Amorolfine hydrochloride lacquer where the maximum strength of the Amorolfine in the lacquer does not exceed 5 per cent by weight in volume; and (d) Topical hydrocortisone where the maximum strength of the hydrocortisone in the medicinal product does not exceed 1 per cent by weight in weight.	10.   The sale or supply shall be only in the course of their professional practice and (a) in the case of Co-dydramol 10/500 tablets the quantity sold or supplied to a person at any one time shall not exceed the amount sufficient for 3 days' treatment to a maximum of 24 tablets.]

Textual Amendments

F1 Word in Sch. 5 Pt. 1 para. 4 inserted (16.9.1998) by The Prescription Only Medicines (Human Use) Amendment (No. 3) Order 1998 (S.I. 1998/2081), arts. 1(1), 4(a)

F2 Sch. 5 Pt. 1 para. 10 inserted (13.2.1998) by The Prescription Only Medicines (Human Use) Amendment Order 1998 (S.I. 1998/108), art. 1, Sch.

F3 Word in Sch. 5 Pt. 1 para. 10 omitted (9.7.2003) by virtue of The Health Professions Order 2001 (Consequential Amendments) Order 2003 (S.I. 2003/1590), art. 1, Sch. para. 21(3)(a)(i)

F4 Words in Sch. 5 Pt. 1 para. 10 inserted (9.7.2003) by The Health Professions Order 2001 (Consequential Amendments) Order 2003 (S.I. 2003/1590), art. 1, Sch. para. 21(3)(a)(ii)

(1)

1990 c. 16.

(2)

S.I. 1989/846 (N.I. 6).

(3)

1977 c. 49.

(4)

1978 c. 29.

(5)

S.I. 1972/1265 (N.I. 14).

(6)

1972 c. 66.

(7)

S.I. 1976/1214 (N.I. 23).