Article 11(1)(a)

SCHEDULE 5EXEMPTION FOR CERTAIN PERSONS FROM SECTION 58(2) OF THE ACT

PART IEXEMPTION FROM RESTRICTIONS ON SALE OR SUPPLY

Column 1Column 2Column 3
Persons exemptedPrescription only medicines to which the exemption appliesConditions
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

  • 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.

Article 11(1)(b)

PART IIEXEMPTIONS FROM THE RESTRICTION ON SUPPLY

Column 1Column 2Column 3
Persons exemptedPrescription only medicines to which the exemption appliesConditions
1. Royal National Lifeboat Institution and certified first aiders of the Institution.1. All prescription only medicines.1. The supply shall be only so far as is necessary for the the treatment of sick or injured persons in the exercise of the functions of the Institution.
2. The owner or the master of a ship which does not carry a doctor on board as part of her complement.2. All prescription only medicines.2. The supply shall be only so far as is necessary for the treatment of persons on the ship.
3. Persons authorized by licences granted under regulation 5 of the Misuse of Drugs Regulations to supply a controlled drug.3. Such prescription only medicines, being controlled drugs, as are specified in the licence.3. The supply shall be subject to such conditions and in such circumstances and to such an extent as may be specified in the licence.
4. Persons requiring prescription only medicines for the purpose of enabling them, in the course of any business carried on by them, to comply with any requirements made by or in pursuance of any enactment with respect to the medical treatment of their employees.4. Such prescription only medicines as may be specified in the relevant enactment.
4.

The supply shall be–

(a)

for the purpose of enabling them to comply with any requirements made by or in pursuance of any such enactment, and

(b)

subject to such conditions and in such circumstances as may be specified in the relevant enactment.

5. Persons operating an occupational health scheme.5. Prescription only medicines sold or supplied to a person operating an occupational health scheme in response to an order in writing signed by a doctor or a registered nurse.
5.

—

(1)

The supply shall be in the course of an occupational health scheme.

(2)

The individual supplying the prescription only medicine, if not a doctor, shall be a registered nurse acting in accordance with the written instructions of a doctor as to the circumstances in which prescription only medicines of the description in question are to be used in the course of the occupational health scheme.

6. The operator or commander of an aircraft.6. Prescription only medicines which are not for parenteral administration and which have been sold or supplied to the operator or commander of the aircraft in response to an order in writing signed by a doctor.6. The supply shall be only so far as is necessary for the immediate treatment of sick or injured persons on the aircraft and shall be in accordance with the written instructions of a doctor as to the circumstances in which prescription only medicines of the description in question are to be used on the aircraft.
7. Persons employed as qualified first-aid personnel on offshore installations.7. All prescription only medicines.7. The supply shall be only so far as is necessary for the treatment of persons on the installation.

Article 11(2)

PART IIIEXEMPTIONS FROM RESTRICTION ON ADMINISTRATION Column 1

Column 1Column 2Column 3
Persons exemptedPrescription only medicines to which the exemption appliesConditions
1. State registered chiropodists who hold a certificate of competence in the use of analgesics issued by or with the approval of the Chiropodists Board.
1.

Prescription only medicines for parenteral administration that contain,as the sole active ingredient, not more than one of the following substances–

  • Bupivacaine hydrochloride

  • Lignocaine hydrochloride

  • Prilocaine hydrochloride.

1. The administration shall be only in the course of their professional practice.
2. Registered midwives.
2.

Prescription only medicines for parenteral administration containing any of the following substances but no other substance specified in column 1 of Schedule 1 to this Order–

  • Ergometrine maleate

  • Lignocaine

  • Lignocaine hydrochloride

  • Naloxone hydrochloride

  • Oxytocins, natural and synthetic

  • Pentazocine lactate

  • Pethidine hydrochloride

  • Phytomenadione

  • Promazine hydrochloride.

2. The administration shall be only in the course of their professional practice and in the case of Promazine hydrochloride, Lignocaine and Lignocaine hydrochloride shall be only while attending on a woman in childbirth.
3. Persons who are authorized as members of a group by a group authority granted under regulations 8(3) or 9(3) of the Misuse of Drugs Regulations to supply a controlled drug by way of administration only.3. Prescription only medicines that are specified in the group authority.3. The administration shall be subject to such conditions and in such circumstances and to such extent as may be specified in the group authority.
4. The owner or master of a ship which does not carry a doctor on board as part of her complement.4. All prescription only medicines that are for parenteral administration.4. The administration shall be only so far as is necessary for the treatment of persons on the ship.
5. Persons operating an occupational health scheme.5. Prescription only medicines for parenteral administration sold or supplied to the person operating an occupational health scheme in response to an order in writing signed by a doctor or a registered nurse.
5.

—

(1)

The administration shall be in the course of an occupational health scheme.

(2)

The individual administering the prescription only medicine, if neither a doctor nor acting in accordance with the directions of a doctor, shall be a registered nurse acting in accordance with the written instructions of a doctor as to the circumstances in which prescription only medicines of the description in question are to be used in the course of the occupational health scheme.

6. The operator or commander of an aircraft.6. Prescription only medicines for parenteral administration which have been sold or supplied to the operator or commander of the aircraft in response to an order in writing signed by a doctor.6. The administration shall be only so far as is necessary for the immediate treatment of sick or injured persons on the aircraft and shall be in accordance with the written instructions of a doctor as to the circumstances in which prescription only medicines of the description in question are to be used on the aircraft.
7. Persons who are, and at 11th February 1982 were, persons customarily administering medicinal products to human beings by parenteral administration in the course of a business in the field of osteopathy, naturopathy, acupuncture or other similar field except chiropody.7. Medicinal products that are prescription only medicines by reason only that they fall within the class specified in article 3(c) (products for parenteral administration).7. The person administering the prescription only medicine shall have been requested by or on behalf of the person to whom it is administered and in that person’s presence to use his own judgement as to the treatment required.
8. Persons employed as qualified first-aid personnel on offshore installations.8. All prescription only medicines that are for parenteral administration.8. The administration shall be only so far as is necessary for the treatment of persons on the installation.
9. Persons who hold a certificate of proficiency in ambulance paramedic skills issued by, or with the approval of, the Secretary of State.
9.

The following prescription only medicines for parenteral administration–

(a)

Diazepam 5 mg per ml emulsion for injection;

(b)

Succinylated Modified Fluid Gelatin 4 per cent intravenous infusion;

(c)

prescription only medicines containing one or more of the following substances, but no active ingredient–

  • Adrenaline Acid Tartrate

  • Anhydrous Glucose

  • Compound Sodium Lactate Intravenous Infusion (Hartmann’s Solution)

  • Ergometrine Maleate

  • Glucose

  • Heparin Sodium

  • Lignocaine Hydrochloride

  • Nalbuphine Hydrochloride

  • Naloxone Hydrochloride

  • Polygeline

  • Sodium Bicarbonate

  • Sodium Chloride

9. The administration shall be only for the immediate, necessary treatment of sick or injured persons and in the case of a prescription only medicine containing Heparin Sodium shall be only for the purpose of cannula flushing.