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The Prescription Only Medicines (Human Use) Order 1997

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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.

[F1Prescription only medicines containing any of the following substances—

  • Diclofenac

  • F2...

  • Hydrocortizone Acetate

  • F2...

  • F2...

  • Miconazole

      

  • Nystatin

      

  • Phytomenadione.]

      

4. The sale or supply shall be only in the course of their professional practice F3....
5. Persons lawfully conducting a retail pharmacy business within the meaning of section 69.
5.

[F4Items which are—

(a)

prescription only medicines which are not for parenteral administration and which—

(i)

are eye drops and are prescription only medicines by reason only that they contain not more than 0.5 per cent of Chloramphenicol, or

(ii)

are eye ointments and are prescription only medicines by reason only that they contain not more than 1.0 per cent Chloramphenicol, or

(iii)

are prescription only medicines by reason only that they contain any of the following substances—

(aa)

Cyclopentolate hydrochloride;

(bb)

Fusidic Acid;

(cc)

Tropicamide;

(b)

the following prescription only medicines—

(i)

Amorolfine hydrochloride cream where the maximum strength of the Amorolfine in the cream does not exceed 0.25 per cent by weight in weight;

(ii)

Amorolfine hydrochloride lacquer where the maximum strength of Amorolfine in lacquer does not exceed 5 per cent by weight in volume;

(iii)

Amoxicillin;

(iv)

Co-Codamol;

(v)

Co-dydramol 10/500 tablets;

(vi)

Codeine Phosphate;

(vii)

Erythromycin;

(viii)

Flucloxacillin;

(ix)

Silver Sulfadiazine;

(x)

Tioconazole 28%;

(xi)

Topical hydrocortisone where the maximum strength of hydrocortisone in the medicinal product does not exceed 1 per cent by weight in weight.]

5.

[F5The sale or supply shall be subject to the presentation of an order signed by—

(a)

a registered optometrist for a medicine listed under item 5(a) in column 2;

(b)

a registered chiropodist or podiatrist for a medicine listed under item 5(b) in column 2.]

6. [F6Registered optometrists]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.

[F76A Persons lawfully conducting a retail pharmacy business within the meaning of section 69.

Homotropine hydrobromide

Ketotifen

Levocabastine

Lodoxamide

Nedocromil sodium

Olopatadine

Pilocarpine hydrochloride

[F8Pilocarpine nitrate]

Polymyxin B/bacitracin

Polymyxin B/trimethoprim

Sodium cromoglycate.

The sale or supply shall be subject to the presentation of an order signed by an additional supply optometrist.
6B Additional supply optometrists. Prescription only medicines specified in column 2 of paragraph 6A.

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.

[F9[F1010.  Registered chiropodists [F11or podiatrists] against whose names are recorded in the relevant register annotations signifying that they are qualified to use the medicines specified in column 2.]

10.

[F12The following prescription only medicines—

(a)

Amorolfine hydrochloride cream where the maximum strength of the Amorolfine in the cream does not exceed 0.25 per cent by weight in weight;

(b)

Amorolfine hydrochloride lacquer where the maximum strength of Amorolfine in lacquer does not exceed 5 per cent by weight in volume;

(c)

Amoxicillin;

(d)

Co-Codamol;

(e)

Co-dydramol 10/500 tablets;

(f)

Codeine Phosphate;

(g)

Erythromycin;

(h)

Flucloxacillin;

(i)

Silver Sulfadiazine;

(j)

Tioconazole 28%;

(k)

Topical hydrocortisone where the maximum strength of 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 F13...]

Textual Amendments

F6Words in Order substituted (30.6.2005 as notified in the London Gazette dated 3.6.2005) by The Opticians Act 1989 (Amendment) Order 2005 (S.I. 2005/848), Sch. 1 para. 27(b)

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.
[F143A. Persons employed or engaged in the provision of lawful drug treatment services. 3A. Ampoules of sterile water for injection containing not more than 2 ml of sterile water.3A. The supply shall be only in the course of provision of lawful drug treatment services.]
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.
[F158. Persons who hold a certificate in first aid from the Mountain Rescue Council of England and Wales, or from the Northern Ireland Mountain Rescue Co-ordinating Committee.8 Prescription only medicines supplied to a person specified in column 1 in response to an order in writing signed by a doctor.8 The supply shall be only so far as is necessary for the treatment of sick or injured persons in the course of providing mountain rescue services.]
[F169. Persons (“P”) who are members of Her Majesty’s armed forces.9. All prescription only medicines. 9. The supply shall be—
(a)

in the course of P undertaking any function as a member of Her Majesty’s armed forces; and

(b)

where P is satisfied that it is not practicable for another person who is legally entitled to supply a prescription only medicine to do so; and

(c)

only in so far as is necessary—

(i)

for the treatment of a sick or injured person in a medical emergency, or

(ii)

to prevent ill-health where there is a risk that a person would suffer ill-health if the prescription only medicine is not supplied.]

Textual Amendments

Article 11(2)

PART IIIEXEMPTIONS FROM RESTRICTION ON ADMINISTRATION Column 1

Column 1Column 2Column 3
Persons exemptedPrescription only medicines to which the exemption appliesConditions
[F171. Registered chiropodists [F18or podiatrists] against whose names are recorded in the relevant register annotations signifying that they are qualified to use the medicines specified in column 2..]
1.

Prescription only medicines for parenteral administration that containF19...–

  • [F20Adrenaline]

  • [F21Bupivacaine hydrochloride

  • Bupivacaine hydrochloride with adrenaline where the maximum strength of the adrenaline does not exceed 1 mg in 200 ml of bupivacaine hydrochloride

  • [F20Levobupivacaine hydrochloride]

  • Lignocaine hydrochloride

  • Lignocaine hydrochloride with adrenaline where the maximum strength of the adrenaline does not exceed 1 mg in 200 ml of lignocaine hydrochloride

  • [F22Mepivacaine hydrochloride]

  • [F20Methylprednisolone]

  • Prilocaine hydrochloride.]

  • [F20Ropivacaine hydrochloride]

1. The administration shall be only in the course of their professional practice [F23and where the medicine includes a combination of substances listed under item 1 in column 2, those substances shall not be combined by the chiropodist or podiatrist].
2. Registered midwives [F24and student 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–

  • [F25Adrenaline

  • Anti-D immunoglobulin

  • Carboprost

  • [F26cyclizine lactate]

  • Diamorphine

  • Ergometrine maleate

  • Gelofusine

  • F27...

  • Hartmann’s solution

  • Hepatitis B vaccine

  • Hepatitis immunoglobulin

  • Lidocaine

  • Lidocaine hydrochloride

  • Morphine

  • Naloxone hydrochloride

  • Oxytocins, natural and synthetic

  • Pethidine hydrochloride

  • Phytomenadione

  • Prochloperazine

  • Sodium chloride 0.9%.]

2.

[F28The medicine shall—

(a)

in the case of Lignocaine, Lignocaine hydrochloride and Promazine hydrochloride, be administered only while attending on a woman in childbirth, and

(b)

where administration is—

(i)

by a registered midwife, be administered in the course of their professional practice;

(ii)

by a student midwife—

(aa)

be administered under the direct supervision of a registered midwife; and

(bb)

not include Diamorphine, Morphine or Pethidine hydrochloride.]

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 [F29or persons who are [F30registered] paramedics].
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;

(bb)

[F31medicines containing the substances Ergometrine Maleate 500mcg per ml with Oxytocin 5 iu per ml, but no other active ingredient]

(d)

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

  • Adrenaline Acid Tartrate

  • [F32Adrenaline Hydrochloride]

  • [F33Amiodarone]

  • Anhydrous Glucose

  • [F34Benzylpenicillin]

  • [F35Bretylium Tosylate]

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

  • Ergometrine Maleate

  • [F34Frusemide]

  • Glucose

  • Heparin Sodium

  • Lignocaine Hydrochloride

  • [F34Metoclopramide]

  • [F34Morphine Sulphate]

  • Nalbuphine Hydrochloride

  • Naloxone Hydrochloride

  • Polygeline

  • [F36Reteplase ]

  • Sodium Bicarbonate

  • Sodium Chloride

  • [F34Streptokinase]

  • [F36Tenecteplase.]

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.
[F1610 . Persons (“P”) who are members of Her Majesty’s armed forces. 10. All prescription only medicines.

10. The administration shall be—

(a)

in the course of P undertaking any function as a member of Her Majesty’s armed forces; and

(b)

where P is satisfied that it is not practicable for another person who is legally entitled to administer a prescription only medicine to do so; and

(c)

only in so far as is necessary—

(i)

for the treatment of a sick or injured person in a medical emergency, or

(ii)

to prevent ill-health where there is a risk that a person would suffer ill-health if the prescription only medicine is not administered.]

Textual Amendments

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