S.I. No. 173/2017 - Misuse of Drugs Regulations 2017.

1. (

a

) Any preparation of one or more of the substances to which this paragraph applies (not being a preparation designed for administration by injection) when compounded with one or more other ingredients and which contains a total of not more than 100 milligrams of the substance or substances (calculated as base) per dosage unit and which in the case of an undivided preparation has a total concentration of not more than 2.5 per cent of the substance or substances (calculated as base).

(

b

) The substances to which this paragraph applies are acetyldihydrocodeine, codeine, ethylmorphine (3-ethylmorphine), nicocodine, nicodicodine (6-nicotinoyldihydrocodeine), norcodeine, pholcodine and their respective salts.

2. Any preparation of dihydrocodeine (not being a preparation designed for administration by injection) containing, per dosage unit, not more than 10 milligrams of dihydrocodeine (calculated as base) and which in the case of an undivided preparation has a concentration of not more than 1.5 per cent of dihydrocodeine (calculated as base).

3. Any preparation of cocaine containing not more than 0.1 per cent of cocaine (calculated as cocaine base), being a preparation which is compounded with one or more other ingredients in such a way that the cocaine cannot be readily recovered.

4. Any preparation of medicinal opium or of morphine (not being a preparation designed for administration by injection) containing, in either case, not more than 0.2 per cent of morphine (calculated as anhydrous morphine base), being a preparation which is compounded with one or more other ingredients in such a way that the opium or morphine cannot be readily recovered.

5. Any preparation of dextropropoxyphene, being a preparation designed for oral administration, containing not more than 135 milligrams of dextropropoxyphene (calculated as base) per dosage unit or with a total concentration of not more than 2.5 per cent, (calculated as base) in undivided preparations.

6. Any preparation of difenoxin containing, per dosage unit, not more than 0.5 milligrams of difenoxin and a quantity of atropine sulphate equivalent to at least 5 per cent of the dose of difenoxin.

7. Any preparation of diphenoxylate containing, per dosage unit, not more than 2.5 milligrams of diphenoxylate (calculated as base), and a quantity of atropine sulphate equivalent to at least 1 per cent of the dose of diphenoxylate.

8. Any preparation of propiram containing, per dosage unit, not more than 100 milligrams of propiram (calculated as base) and which is compounded with at least the same amount, by weight, of methylcellulose.

9. Any powder of ipecacuanha and opium comprising 10 per cent powdered opium, 10 per cent powdered ipecacuanha root, both well mixed with the remaining 80 per cent consisting of any other powdered ingredient which contains no controlled drug.

10. Any mixture containing one or more of the preparations specified in this Schedule, being a mixture of which none of the other ingredients is a controlled drug.

SCHEDULE 6

Form of Register

Class of Drug

Product

(Insert name, form, strength and pack size as necessary)

Date on which supply received or transaction effected

Name and address of person from whom obtained or to whom supplied

Authority of person supplied to be in possession

Amount

Stock Balance

Obtained

Supplied

SCHEDULE 7

Form of Register

PART 1

Entries to be made in case of obtaining.

Date on which supply received

Name

Address

Amount obtained

Form in which obtained

Of person or firm from whom

PART 2

Entries to be made in case of supply

Date on which the transaction was effected

Name

Address

Particulars as to licence or authority of person or firm supplied to be in possession

Amount supplied

Form in which supplied

Stock Balance

Of person or firm supplied

SCHEDULE 8

DRUGS WHICH PRACTITIONERS WHO ARE REGISTERED NURSES OR REGISTERED MIDWIVES MAY PRESCRIBE WITHIN SCHEDULES 2 AND 3

PART 1

Drugs for pain relief in hospital

Drug

Route of administration

Buprenorphine

Transdermal

Codeine phosphate

Oral

Dihydrocodeine

Oral

Fentanyl

Intranasal, intravenous, transdermal, transmucosal, subcutaneous, sublingual/buccal

Morphine sulphate

Intramuscular, intravenous, oral, subcutaneous

Morphine tartrate

Intramuscular, intravenous, subcutaneous

Oxycodone

Oral, subcutaneous, intravenous

Pethidine

Intramuscular, intravenous, subcutaneous

PART 2

Drugs for palliative care

Drug

Route of administration

Buprenorphine

Transdermal

Codeine phosphate

Oral

Fentanyl

Intranasal, Intravenous, transdermal, transmucosal, subcutaneous, sublingual/buccal

Hydromorphone

Oral, subcutaneous

Methylphenidate

Oral

Morphine sulphate

Intramuscular, oral, subcutaneous

Morphine tartrate

Intramuscular, subcutaneous

Oxycodone

Oral, subcutaneous

PART 3

Drugs for purposes of midwifery

Drug

Route of administration

Pethidine

Intramuscular

PART 4

Drugs for neonatal care

Drug

Route of administration

Fentanyl

Intravenous, transdermal, transmucosal

Morphine sulphate

Intramuscular, intranasal, intravenous, oral, subcutaneous

Morphine tartrate

Intramuscular, intravenous, subcutaneous

PART 5

Drugs for use in mental health or intellectual disability

Drug

Route of administration

Methylphenidate

Oral

SCHEDULE 9

Provisions of revoked Regulations of 1988 and corresponding provisions in these Regulations

Column 1

Column 2

Column 3

Column 4

Old Number

Old Title

New Number

New Title

1

Citation

1

Citation and Commencement

2

Revocations

3

Interpretation

2

Interpretation

3A

Provisions applicable to practitioners who are registered nurses

3

Provisions applicable to practitioners who are registered nurses or registered midwives

3B

Person may refuse to supply drug if reasonable cause to believe conditions referred to in article 3A have not been satisfied

4

Person may refuse to supply drug if reasonable cause to believe conditions referred to in regulation 3 have not been satisfied

4

General prohibition

5

General prohibition

5

Licences

6

Licences

6

Administration

7

Administration

7

Exemption for practitioners, pharmacists etc.

8

Exemption for practitioners, pharmacists etc.

8

Supply in hospitals etc.

9

Supply

9

General Exemptions

10

General Exemptions

11

Exemption to possess butan-1,4-diol or dihydrofuran-2(3

H

)-one

10

Exemption for midwives in respect of pentazocine and pethidine.

12

Exemption for midwives in respect of pentazocine and pethidine.

11

General authorities

13

General authorities

12

Documents to be obtained by a supplier

14

Documents to be obtained by a supplier

13

Form of prescriptions

15

Form of prescriptions

14

Supply on prescriptions

16

Supply on prescription

15

Marking of containers

17

Marking of containers

15A

18

Documents required for export of controlled drugs

16

Keeping of registers for drugs in Schedules 1 and 2

19

Keeping of registers for drugs in Schedules 1 and 2

17

Record-keeping in particular cases for drugs in Schedule 2

20

Record-keeping in particular cases for drugs in Schedule 2

18

Keeping of records for drugs in Schedules 3 and 4

21

Keeping of records for drugs in Schedules 3 and 4

19

Preservation of registers, etc.

22

Preservation of registers, etc.

20

Preservation of records for drugs in schedules 3 and 5

23

Preservation of records for drugs in schedules 3, Part 1 of Schedule 4, and Schedule 5

21

Furnishing of information with respect to controlled drugs

24

Furnishing of information with respect to controlled drugs

22

Destruction of certain drugs

25

Destruction of certain drugs

23

Disposal of certain drugs on cessation of business

26

Disposal of certain drugs on cessation of business

24

Forged, etc. prescriptions

27

Forged, etc. prescriptions

25

Publication, sale, etc. of certain books, periodicals and other publications

28

Publication, sale etc. of certain books, periodicals and other publications

26

Amendment of the Misuse of Drugs (safe Custody) Regulations 1982 (

S.I. No. 321 of 1982

)

29

References to revoked Regulations of 1988 in other enactments

27

Transitional provisions

30

Transitional provisions

GIVEN under my Hand,

4 May 2017.

CATHERINE BYRNE,

Minister of State at the Department of Health.

EXPLANATORY NOTE

(This note is not part of the Instrument and does not purport to be a legal interpretation.)

These Regulations apply controls to the groups of drugs specified in Schedules 1 to 5 of the Regulations (being drugs to which the Misuse of Drugs Acts 1977 to 2016 apply). The effect of the Regulations is to impose restrictions on the production, supply, importation and exportation of the drugs in question, which vary according to the extent to which these drugs are used for medical or scientific purposes and having regard to the likelihood of their being abused. Appropriate exemptions are provided to cover legitimate use for professional purposes by doctors, pharmacists, nurses and midwives, veterinary practitioners, prison officers, etc. and in other specified circumstances.

In addition to these controls the Regulations specify the classes of persons who may have controlled drugs in their possession and the circumstances in which such possession would not be in contravention of the Act.

The Regulations contain other miscellaneous provisions such as requirements as to the form of prescriptions for controlled drugs, the keeping of books and records, proper documentation relating to export of controlled drugs, arrangements for destruction or disposal of such drugs, and provisions regarding possession of forged prescriptions.

The Regulations also prescribe certain controlled drugs for the purposes of

section 5

of the

Misuse of Drugs Act 1984

.

The Regulations confer authority on certain inspectors, in the Department of Agriculture, Food and the Marine, to lawfully possess Cannabis (hemp) in the course of their duties while monitoring and sampling for the purpose of the relevant EU scheme involving the grant of aid for the production of hemp fibre.

1 OJ No. L 311, 28.11.2001, p. 67.

2 OJ. No. L 136, 30.4.2004, p. 1.

3 OJ No. L 1, 3.1.1994, p. 572.

4 OJ No. L 311, 28.11.2001, p. 1.

5 OJ No. L. 227, 31.7.2014, p. 69.

11. (1) A person may have in his or her possession butan-1,4-diol or dihydrofuran-2(3

H

)-one except where he knows or ought reasonably to know that such substance is intended for human ingestion, whether by himself or herself or another person, other than as a flavouring in food.

(2) In this Regulation references to butan-1,4-diol and dihydrofuran-2(3

H

)-one include—

(

a

) any stereoisomeric form of butan-1,4-diol or dihydrofuran-2(3

H

)-one,

(

b

) any salt of butan-1,4-diol, dihydrofuran-2(3

H

)-one or of a substance specified in subparagraph (

a

), and

(

c

) any preparation or other product containing butan-1,4-diol, dihydrofuran-2(3

H

)-one or a substance specified in sub-paragraph (

a

) or (

b

).

Exemption for midwives in respect of pentazocine and pethidine.

12. (1) Subject to the provisions of this Regulation, a midwife who is employed by the Executive or a hospital authority to provide community-based maternity services, or a self-employed community-based midwife providing maternity services who has notified to the Executive his or her intention to practise, may, so far as is necessary for his or her practice as a midwife, have in his or her possession or administer any medicinal product which contains pentazocine or pethidine.

(2) Nothing in paragraph (1) shall be construed as authorising a registered midwife to have pentazocine or pethidine in his or her possession unless it has been obtained—

(

a

) on foot of a written order—

(i) signed by—

(I) the registered midwife, and

(II) a registered medical practitioner, a registered nurse, or registered midwife who falls within the definition of “practitioner” in Regulation 2, practising in the area in which the registered midwife practises, stating his or her registration number, and

(ii) setting out the name, address and registration number of the registered midwife, the name of the controlled drug, the purpose for which it is required and the quantity to be obtained, or

(

b

) if the registered midwife falls within the definition of “practitioner” in Regulation 2, without prejudice to the generality of subparagraph (

a

), on foot of a written order signed by the registered midwife setting out the name and address of the registered midwife, his or her registration number, the name of the controlled drug, the purpose for which it is required and the quantity to be obtained.

General authorities.

13. (1) Any of the following persons may have a controlled drug in his or her possession

(

a

) a member of the Garda Síochána when acting in the course of his or her duty as such;

(

b

) a prison officer when acting in the course of his or her duty as such;

(

c

) an officer of customs when acting in the course of his or her duty as such;

(

d

) a person authorised in writing in accordance with section 24 of the Principal Act (as amended by

section 9

of the

Irish Medicines Board (Miscellaneous Provisions) Act 2006

), when acting in the course of his or her duty as such;

(

e

) a person engaged in connection with the Postal Services provided by An Post when acting in the course of his or her duty as a person so engaged;

(

f

) a person engaged in the work of any laboratory to which the controlled drug has been sent for forensic examination when acting in the course of his or her duty as a person so engaged;

(

g

) a registered nurse engaged in providing palliative care when acting in the course of the nurse’s duty as a nurse so engaged;

(

h

) a person engaged in the business of a carrier when acting

bona fide

in the course of that business;

(i) a person engaged in conveying the controlled drug to a person authorised by these Regulations to have it in his or her possession;

(

j

) an official of the Department of Agriculture, Food and the Marine, engaged, in his or her official capacity as such, in the work of sampling for analysis of crops of

Cannabis sativa L

, for the purpose of Commission Implementing Regulation (EU) No. 809/2014 of 17 July 2014

5

;

(2) A person who is lawfully in possession of a controlled drug may supply that drug to a person from whom he or she obtained it.

(3) A person who is lawfully in possession of a drug specified in Schedule 2, 3, 4 or 5 which has been supplied by or on the prescription of a registered medical practitioner, registered dentist, registered nurse or registered midwife for the treatment of that person, or of a person whom he or she represents, may supply that drug for the purposes of destruction to a person carrying out a retail pharmacy business.

(4) A person who is lawfully in possession of a drug specified in Schedule 2, 3, 4 or 5 which has been supplied by or on the prescription of a registered veterinary practitioner for the treatment of animals, may supply that drug for the purposes of destruction to a registered veterinary practitioner, or to a person carrying out a retail pharmacy business.

PART 5

Documentation and Record-Keeping

Documents to be obtained by a supplier.

14. (1) Where a person (“the supplier”), not being a practitioner, supplies a controlled drug otherwise than on a prescription, he or she shall not deliver the drug to a person who—

(

a

) purports to be sent by or on behalf of the person to whom it is to be supplied (“the recipient”), and

(

b

) is not authorised by any provision of these Regulations other than the provisions of Regulation 13(1)(i) to have that controlled drug in his or her possession,

unless the person produces to the supplier a statement in writing signed by the recipient to the effect that the person is empowered by the recipient to receive that controlled drug on his or her behalf, and the supplier is reasonably satisfied that the document is a genuine document.

(2) Where a person (“the supplier”) supplies a controlled drug, otherwise than on a prescription or by way of administration, to any of the persons specified in paragraph (4), the supplier shall not deliver the drug—

(

a

) until he or she has obtained a requisition in writing which—

(i) is signed and dated by the person to whom the controlled drug is to be supplied (“the recipient”),

(ii) states the name, address, occupation and, where applicable, registration number of the recipient,

(iii) specifies the name of the controlled drug, the purpose for which the drug to be supplied is required and the total quantity to be supplied, and

(iv) where appropriate, satisfies the requirements of paragraph (5), and

(

b

) unless he or she is reasonably satisfied that the signature on the requisition referred to at subparagraph (

a

) is that of the recipient and that the recipient is engaged in the occupation specified in the requisition,

provided that where the recipient is a practitioner and he or she represents that he or she urgently requires a controlled drug for the purpose of his or her profession, the supplier may, if he or she is reasonably satisfied that the recipient so requires the drug and is unable by reason of urgency to furnish such requisition, deliver the drug to the recipient on an undertaking by the recipient to furnish such a requisition within 24 hours of such delivery.

(3) A practitioner who has given an undertaking in accordance with paragraph (2) shall deliver to the person by whom the controlled drug was supplied a signed requisition in accordance with the undertaking.

(4) The persons referred to in paragraph (2) are—

(

a

) a practitioner;

(

b

) the director of nursing, director of midwifery or matron of a hospital or nursing home;

(

c

) a person in charge of a laboratory;

(

d

) the owner of a ship, or the master of a ship which does not carry a registered medical practitioner on board as part of her complement;

(

e

) the master of a foreign ship in a port in the State;

(

f

) the installation manager of an offshore installation.

(5) A requisition furnished for the purpose of paragraph (2) shall—

(

a

) where it is furnished by the director of nursing, director of midwifery or matron of a hospital or nursing home, be signed by a practitioner employed or engaged in that hospital or nursing home,

(

b

) where it is furnished by the master of a foreign ship, contain a statement, signed by a medical officer of the Executive, that the quantity of the controlled drug to be supplied is the quantity necessary for the equipment of the ship, or

(

c

) where it is furnished by the installation manager of an offshore installation, contain a statement signed by the Industrial Medical Adviser (Offshore Installations) that the quantity of the controlled drug to be supplied is the quantity necessary for the equipment of that installation.

(6) Subject to paragraph (9), where the person responsible for the dispensing and supply of medicines at any hospital or nursing home supplies a controlled drug to a clinical nurse manager, clinical midwife manager or sister for the time being in charge of a ward, theatre or other department in that hospital or nursing home, he or she shall—

(

a

) obtain a requisition in writing, signed by the clinical nurse manager, clinical midwife manager or sister which specifies the name of the controlled drug and total quantity to be supplied, and

(

b

) mark the requisition in such manner as to show that it has been complied with,

and any requisition obtained for the purposes of this paragraph shall be retained in the dispensary at which the controlled drug was supplied and a copy of the requisition or a note of it shall be retained or kept by the clinical nurse manager, clinical midwife manager or sister for the time being in charge of that ward, theatre or other department.

(7) A person who supplies a controlled drug to—

(

a

) a person carrying on a retail pharmacy business,

(

b

) a pharmacist responsible for the dispensing and supply of medicines in a hospital or nursing home, or

(

c

) the director of nursing, director of midwifery or matron of a hospital or nursing home,

shall furnish with each consignment of such controlled drug a form of receipt.

(8) The pharmacist or, as the case may be, the director of nursing, director of midwifery or matron on receipt of controlled drugs in the manner provided for in paragraph (7) shall—

(

a

) check the statements on the form of receipt,

(

b

) enter thereon any deviations observed in the drugs received,

(

c

) enter the date of receipt of the drugs,

(

d

) sign the receipt document with his or her usual signature, and

(

e

) return the receipt to the supplier not later than 3 working days from the date of receipt of the said drugs.

(9) Paragraph (6) shall not apply in the case of the dispensing and supply of any drug specified in Part 1 of Schedule 4.

(10) Nothing in this Regulation shall have effect in relation to—

(

a

) any drug specified in Part 2 of Schedule 4,

(

b

) any drug specified in Schedule 5, or

(

c

) poppy straw.

Form of prescriptions.

15. (1) Subject to the provisions of this Regulation, a practitioner shall not issue a prescription for a controlled drug, other than a drug specified in Part 2 of Schedule 4 or in Schedule 5, unless—

(

a

) he or she is satisfied as to the identity of the person for whose treatment the prescription is to be issued, or in the case of a prescription issued by a registered veterinary practitioner, the identity of the person to whom the controlled drug is to be delivered, and

(

b

) the prescription complies with the requirements specified in paragraph (2).

(2) The requirements referred to in paragraph (1) are as follows

(

a

) the prescription shall be in ink or otherwise so as to be indelible;

(

b

) the prescription shall clearly indicate the full name (including the first name) of the practitioner issuing it and state whether he or she is a registered medical practitioner, registered dentist, registered veterinary practitioner, registered nurse or registered midwife and state his or her registration number;

(

c

) the prescription shall be signed by the practitioner issuing it with his or her usual signature and be dated by him or her;

(

d

) except in the case of a health prescription, the prescription shall specify the address of the practitioner issuing it;

(

e

) subject to paragraph (3), the prescription shall specify the telephone number at which the practitioner issuing it may be contacted;

(

f

) subject to paragraph (3), the prescription shall specify the name (including the first name), and address of the person for whose treatment it is issued or, in the case of a prescription issued by a registered veterinary practitioner, the name (including the first name) and address of the person to whom the controlled drug prescribed is to be delivered;

(

g

) subject to paragraph (4), the prescription shall specify in the practitioner’s handwriting—

(i) the name of the controlled drug to be prescribed,

(ii) the dose of the controlled drug to be taken by the person or animal for whose treatment the prescription is issued,

(iii) in the case of a prescription for a controlled drug which is a preparation—

(I) the form and, where appropriate, the strength of the controlled drug to be supplied, and

(II) either the total quantity (in both words and figures) of the preparation or the number (in both words and figures) of dosage units, as appropriate, to be supplied, and

(iv) in the case of a prescription for a controlled drug which is not a preparation, the total quantity (in both words and figures) of the controlled drug to be supplied;

(

h

) in the case of a prescription for a total quantity intended to be dispensed in instalments, the number of instalments and the intervals at which the instalments may be dispensed.

(3) In the case of a prescription issued for the treatment of a patient in a hospital or nursing home, it shall be a sufficient compliance with paragraph (2)(

e

) and (

f

) if the prescription is written on the patient’s bed card or patient’s medication record and such card or record shall be sufficient evidence of identity for the purposes of paragraph (1)(

a

).

(4) The requirements specified in paragraph (2)(

g

) shall not be required to be in the practitioner’s own handwriting in the case of a prescription for a controlled drug specified in—

(

a

) Part 1 of Schedule 4, or

(

b

) the Schedule to the Misuse of Drugs (Supply of Methadone) Regulations 1998 (

S.I. No 225 of 1998

).

Supply on prescription.

16. (1) Subject to paragraph (6), a person shall not supply a controlled drug, other than a drug specified in Part 2 of Schedule 4 or in Schedule 5, on a prescription—

(

a

) unless the prescription complies with the provisions of Regulation 15,

(

b

) unless the address specified in the prescription as the address of the practitioner issuing it is an address within the State,

(

c

) unless he or she either is acquainted with the signature of the practitioner by whom it purports to be issued and has no reason to believe that the signature is not genuine, or has taken reasonably sufficient steps to satisfy himself or herself that it is genuine,

(

d

) before the date specified in the prescription,

(

e

) subject to paragraph (3)—

(i) later than 14 days after the date of the prescription, or

(ii) where the prescription contains a direction that specified instalments of the total quantity may be dispensed at stated intervals—

(I) in the case of the first instalment, later than 14 days after the date specified in the prescription, and

(II) in the case of subsequent instalment, later than two months after the date specified in the prescription,

(

f

) unless he or she is satisfied—

(i) as to the identity of the person for whose treatment the prescription is issued, or in the case of a prescription issued by a registered veterinary practitioner, the identity of the person to whom the controlled drug is to be delivered, and

(ii) in the case of the supply being made to a representative of the said person, that the said representative is a

bona fide

representative of the said person.

(2) Subject to paragraph (4), a person supplying on a prescription a controlled drug, other than a drug specified in Schedule 4 or 5 shall, at the time of the supply—

(

a

) mark on the prescription the date on which the drug is supplied, and

(

b

) retain the prescription on the premises from which the drug was supplied.

(3) In the case of the supply on prescription of a controlled drug specified in Part 1 of Schedule 4—

(

a

) the person supplying the drug shall comply with the relevant provisions of paragraphs (2) and (5) of Regulation 7 of the Medicinal Products (Prescription and Control of Supply) Regulations 2003 (

S.I. No. 540 of 2003

), as amended from time to time,

(

b

) paragraph (1)(

e

) shall not apply,

(

c

) where the prescription is one which has been endorsed by the practitioner as one which may be dispensed on more than one occasion, and where the prescription is dispensed in part, the person who dispensed the prescription shall—

(i) forthwith record on the prescription—

(I) the quantity of each controlled drug supplied by him or her,

(II) the date on which he or she supplied such quantity, and

(III) his or her name and address, and

(ii) retain a copy of the prescription, including a copy of any record made under clause (i), on the premises from which the drug was supplied, and

(

d

) where the dispensing of the controlled drug has been completed, the person who dispensed it shall—

(i) forthwith write or print prominently on the prescription the word “dispensed” and the date on which it was dispensed, and

(ii) subject to paragraph (4), retain the prescription on the premises from which the drug was supplied.

(4) Paragraphs (2) and (3)(

d

)(ii) shall apply to a health prescription on the basis that the duplicate copy thereof, made by the practitioner at the time of writing the original, shall be treated for the purposes of this Regulation as if it were the original document.

(5) In the case of a controlled drug specified in the Schedule to the Misuse of Drugs (Supervision of Prescription and Supply of Methadone) Regulations 1998, supplied on prescription in prison—

(

a

) paragraph (2)(

a

) shall not apply, and

(

b

) subject to Regulation 22(6), a hard-copy record shall be made, at the time of administration of the controlled drug, of—

(i) the name and identity number of the patient to whom the controlled drug is administered,

(ii) the name of the person who issued the prescription and the date on which the prescription was issued for that patient,

(iii) the name, dose, form and quantity of the controlled drug prescribed,

(iv) the name, dose, form and quantity of the controlled drug administered to the patient, and

(v) the date on which the controlled drug is administered to the patient.

(6) Nothing in this Regulation shall prohibit the operation of the provisions relating to the duties of pharmacists in relation to prescriptions for interchangeable medicinal products under a branded name set out in Chapter 2 of Part 2 of the

Health (Pricing and Supply of Medical Goods) Act 2013

(No. 14 of 2013).

Marking of containers.

17. (1) Subject to paragraph (2), a person shall not supply a controlled drug otherwise than in a bottle, package or other container which—

(

a

) in the case of a controlled drug other than a preparation, is clearly marked with the name of the drug and the amount of the drug contained therein,

(

b

) in the case of a controlled drug which is a preparation made up into tablets, capsules or other dosage units, is clearly marked with the name of the drug, the amount of each component (being a controlled drug) of the preparation in each dosage unit and the number of dosage units in the bottle, package or other container, and

(

c

) in the case of a controlled drug which is a preparation not so made up, is clearly marked with the name of the drug, the total amount of the preparation in the bottle, package or other container and the percentage of each of its components which is a controlled drug.

(2) Nothing in this Regulation shall have effect in relation to—

(

a

) a drug specified in Part 2 of Schedule 4,

(

b

) a drug specified in Schedule 5,

(

c

) poppy straw, or

(

d

) the supply of a controlled drug by or on the prescription of a practitioner.

Documents required for export of controlled drugs.

18. (1) A person shall not export a controlled drug unless the transactions relating thereto are properly documented and the commercial documents such as invoices, cargo manifests, customs, transport and other shipping documentation accompanying the drug include the name of the controlled drug as set out in the relevant Schedule or, where such name would not adequately identify the drug, the international non-proprietary name for the drug as recommended by the World Health Organisation.

(2) The documentation referred to in paragraph (1) shall be dated and shall also include the total quantity being exported, the name and address of the exporter and of the importer and, when available, that of the ultimate consignee.

Keeping of registers for drugs in Schedules 1 and 2.

19. (1) Subject to paragraph (4) and Regulation 20, every person authorised by or under Regulation 6, 8 or 9 to supply any drug specified in Schedule 1 or 2 shall comply with the following requirements

(

a

) he or she shall, in accordance with the provisions of this Regulation, keep a register and shall enter therein in chronological sequence and in a manner which will show a running stock balance, particulars of every quantity of such a drug obtained by him or her and of every quantity of such a drug supplied whether by way of administration or otherwise by him or her whether to persons within or outside the State;

(

b

) he or she shall use a separate register or separate part of a register for entries made in respect of each class of drug; and

(

c

) the entries in the register referred to in subparagraph (

a

) shall be—

(i) in the form specified in Schedule 6, or

(ii) as the case may require, in the form specified in Part 1 or Part 2 of Schedule 7.

(2) For the purposes of paragraph (1)(

b

), each of the drugs specified in paragraphs 1 and 3 of Schedule 1 and paragraphs 1, 3 and 6 of Schedule 2 (together with its salts) and any preparation or other product containing it or any of its salts shall be treated as a separate class and any stereoisomeric form of a controlled drug or its salts shall be treated as being in the same class as that drug.

(3) Nothing in paragraph (1) shall be taken as preventing the use of a separate section within a register or a separate part of a register in respect of different controlled drugs or strengths of controlled drugs comprised within the class of controlled drugs to which that register or separate part relates.

(4) The foregoing provisions of this Regulation shall not have effect in relation to—

(

a

) a person licensed under section 14 of the Principal Act to supply any controlled drug, where the licence so directs, or

(

b

) the clinical nurse manager or clinical midwife manager or sister for the time being in charge of a ward, theatre or other department in a hospital or nursing home.

(5) Any person required to keep a register under this Regulation shall comply with the following requirements

(

a

) the class of controlled drugs to which the entries on any page of any such register relate shall be specified at the head of that page;

(

b

) every entry required to be made under this Regulation in a register shall, where it is reasonably practicable to do so, be made on the day on which the controlled drug is obtained or on which the transaction in respect of the supply of the controlled drug by the person required to make the entry takes place or, in any case, on the day next following that day;

(

c

) no cancellation, obliteration or alteration of any such entry shall be made, and a correction of such an entry shall be made only by way of marginal note or footnote which shall specify the date on which the correction is made;

(

d

) every such entry and every correction of such an entry shall be made in ink or otherwise so as to be indelible;

(

e

) a register shall not be used for any purpose other than the purposes of these Regulations;

(

f

) subject to subparagraph (

g

), not more than one register shall be kept at one time in respect of each class of controlled drug in respect of which he or she is required to keep a separate register;

(

g

) a separate register shall be kept in respect of each premises at which the person required to keep the register carries on his or her business or occupation and where the business is carried on in separate departments within a premises a separate register may, with the approval of the Minister, be kept in respect of each such department; and

(

h

) every such register in which entries are currently being made shall be kept at the premises to which it relates and shall be readily available for inspection under section 24 of the Principal Act.

Record-keeping in particular cases for drugs in Schedule 2.

20. (1) Where a drug specified in Schedule 2 is supplied in accordance with Regulation 9(3)(

a

) to a member of the crew of a ship, an entry in the official log book required to be kept under the Acts relating to merchant shipping, or in the case of a ship which is not required to carry such an official log book, a report signed by the master of the ship, shall, notwithstanding anything in these Regulations, be a sufficient record of the supply if the entry or report specifies the controlled drug supplied and, in the case of a report, it is delivered as soon as may be to the superintendent of a mercantile marine office established and maintained under the Acts relating to merchant shipping.

(2) Where a drug specified in Schedule 2 is supplied in accordance with Regulation 9(4)(

a

) to a person on an offshore installation, an entry in the installation log book which specifies the controlled drug supplied shall, notwithstanding anything in these Regulations, be a sufficient record of the supply.

(3) A midwife authorised under Regulation 12 to have pethidine in his or her possession shall—

(

a

) on each occasion on which he or she obtains a supply of pethidine, enter in a book kept by him or her and used solely for the purposes of this paragraph the date, the name and address of the person from whom the drug was obtained, the amount obtained and the form in which it was obtained, and

(

b

) on administering pethidine to a patient, enter in the said book as soon as practicable the name and address of the patient, the amount administered and the form in which it was administered.

Keeping of records for drugs in Schedules 3 and 4.

21. (1) A person who is authorised by a licence granted by the Minister under section 14 of the Principal Act to produce any drug specified in Schedule 3 or 4 shall make a record of each quantity of such a controlled drug produced by him or her.

(2) A person who is authorised by a licence granted by the Minister under section 14 of the Principal Act to import or export any drug specified in Schedule 3 or Part 1 of Schedule 4 shall make a record of each quantity of such controlled drug imported or exported by him or her.

(3) A person who is authorised under Regulation 9(5) to supply any drug specified in Part 2 of Schedule 4 shall make a record of each quantity of such controlled drug imported or exported by him or her.

Preservation of registers, etc.

22. (1) All registers and books kept in pursuance of Regulation 19 or 20(3) shall be preserved for a period of two years from the date on which the last entry therein is made.

(2) Every order, prescription or requisition on which a controlled drug is supplied in pursuance of these Regulations shall be preserved for a period of two years from the date on which the last supply of a controlled drug was made on such order, prescription or requisition.

(3) Paragraph (2) shall apply to a health prescription or, as the case may be, to a health service requisition on the basis that the keeping of the duplicate copy thereof, made by the practitioner at the time of writing the original, shall be treated as if it were the keeping of the original document.

(4) Every receipt made and returned in pursuance of Regulation 14(7) and (8) shall be preserved for a period of two years from the date entered on the document as the date of receipt of the controlled drugs to which the document relates.

(5) Every record made in pursuance of Regulation 21 shall be preserved for a period of two years from the date on which the record was made.

(6) Every record made in pursuance of Regulation 16(5) shall be preserved in the prison for a period of two years from the date on which the controlled drug was administered to the patient.

(7) Every copy of a prescription made in pursuance of Regulation 16(3)(

c

)(ii) shall be preserved for a period of 2 years from the date on which the supply of the controlled drug was made.

Preservation of records for drugs in Schedule 3, Part 1 of Schedule 4, and Schedule 5.

23. (1) A producer of any drug specified in Schedule 3, Part 1 of Schedule 4, or Schedule 5, and a wholesaler of any such drug, shall keep every invoice or other like record issued in respect of each quantity of such drug obtained or produced by him or her and in respect of each quantity of such drug supplied by him or her.

(2) A person who is authorised under Regulation 9(5) to supply any drug specified in Schedule 3 or Part 1 of Schedule 4 shall keep every invoice or other like record issued in respect of each quantity of such drug obtained by him or her and in respect of each quantity of such drug supplied by him or her.

(3) A director of nursing, director of midwifery or matron of a hospital or nursing home or, as the case may be, a pharmacist responsible for the dispensing and supply of medicines in such hospital or nursing home and a person in charge of a laboratory shall, in respect of any drug specified in Schedule 3 or Part 1 of Schedule 4, keep every invoice or other like record issued in respect of each quantity of such drug obtained by him or her and in respect of each quantity of such drug supplied by him or her.

(4) A person carrying on a retail pharmacy business shall—

(

a

) in the case of any drug specified in Schedule 3 or Part 1 of Schedule 4, keep every invoice or other like record issued in respect of each quantity of such drug obtained by him or her and in respect of each quantity of such drug supplied by him or her, and

(

b

) in the case of any drug specified in Schedule 5, keep every invoice or other like record issued in respect of each quantity of such drug obtained by him or her.

(5) Every invoice or other record which is required by this Regulation to be kept in respect of a drug specified in Schedule 3 or Part 1 of Schedule 4 shall contain information sufficient to identify the date of the transaction and in the case of a drug obtained, the person by whom such drug was supplied and in the case of a drug supplied, the person to whom such drug was supplied.

(6) Every document kept in pursuance of this Regulation shall be preserved for a period of two years from the date on which it was issued provided that the keeping of a copy of the document made at any time during the said period of two years shall be treated for the purposes of this Regulation as if it were the keeping of the original document.

Furnishing of information with respect to controlled drugs.

24. (1) Subject to paragraph (4), the persons referred to in paragraph (3) shall, on demand made by the Minister or by any person authorised in writing by the Minister in that behalf—

(

a

) furnish such particulars as may be requested in respect of the producing, obtaining or supplying by him or her of any controlled drug or in respect of any stock of such drugs in his or her possession,

(

b

) for the purpose of confirming any such particulars, produce any stock of such drugs in his or her possession, and

(

c

) produce any register, book or document in his or her possession which is required to be kept under these Regulations in respect of any dealings in controlled drugs.

(2) Where the demand referred to in paragraph (1) is made in writing the particulars, or confirmation thereof, shall be furnished not later than fourteen days from the date of the said demand.

(3) The persons referred to in paragraph (1) are—

(

a

) any person authorised by or under these Regulations or by a licence granted under section 14 of the Principal Act, to produce, import or export any controlled drug,

(

b

) a wholesaler,

(

c

) a person carrying on a retail pharmacy business,

(

d

) a practitioner,

(

e

) the director of nursing, director of midwifery or matron of a hospital or nursing home or, as the case may be, the pharmacist responsible for the dispensing and supply of medicines in such hospital or nursing home,

(

f

) a person in charge of a laboratory, and

(

g

) a person who is authorised under Regulation 9(5) to supply any controlled drug.

(4) Nothing in this Regulation shall require the furnishing of personal records which a person has acquired or created in the course of his or her profession or occupation and which he or she holds in confidence.

(5) In paragraph (4), “personal records” means documentary or other records concerning an individual (whether living or dead) who can be identified from them and relating to his or her physical or mental health, but does not include any register, book, prescription or other document required to be kept under these Regulations relating to any dealings in controlled drugs.

PART 6

MISCELLANEOUS

Destruction of certain drugs.

25. (1) A person who is required by any provision of these Regulations, or by any term or condition of a licence granted under section 14 of the Principal Act to keep records with respect to a drug specified in Schedule 1, 2, 3 or 4, shall not destroy such drug or cause such drug to be destroyed except in the presence of and in accordance with any directions given by a person authorised (whether personally or as a member of a class) for the purposes of this paragraph by the Minister (in this Regulation referred to as an “authorised person”).

(2) An authorised person may, for the purpose of analysis, take a sample of a drug specified in Schedule 1, 2, 3 or 4 which is to be destroyed.

(3) Where a drug specified in Schedule 1, 2, 3 or 4 is destroyed in pursuance of paragraph (1) by or at the instance of a person who is required by any provision of these Regulations, or by any term or condition of a licence having effect under section 14 of the Principal Act, to keep a record in respect of the obtaining or supply of that drug, that record shall include particulars of the date of destruction and the name of the controlled drug and the quantity destroyed and shall be signed by the authorised person in whose presence the controlled drug is destroyed.

(4) Where the master or owner of a ship or installation manager of an offshore installation has in his or her possession a drug specified in Schedule 2 which he or she no longer requires, he or she shall not destroy the drug or cause it to be destroyed but shall give it to a member of the Garda Síochána, an officer of customs or a person who may lawfully supply that controlled drug to him or her.

(5) Nothing in paragraph (1) or (3) shall apply to any person who is required to keep records only by virtue of Regulation 21(2) or (3) or Regulation 23(3) or (4)(

a

).

Disposal of certain drugs on cessation of business.

26. A person carrying on a retail pharmacy business who ceases to carry on a retail pharmacy business shall, on demand made by a person authorised in writing in that behalf by the Minister, the Health Products Regulatory Authority or the Council of the Pharmaceutical Society of Ireland, in respect of that retail pharmacy business—

(

a

) furnish such particulars as may be requested in respect of any stock of a controlled drug in his or her possession,

(

b

) for the purpose of confirming any such particulars, produce any stock of such drugs in his or her possession,

(

c

) produce the register and such other books or documents in his or her possession relating to any dealings in drugs specified in Schedule 2, 3 or 4 as may be requested, and

(

d

) dispose of any stock of such drugs in his or her possession in accordance with any directions given by the Minister or by a person authorised as aforesaid.

Forged, etc. prescriptions.

27. Section 18(3) of the Principal Act (which prohibits the possession of either a forged prescription or a duly issued prescription which has been altered with intent to deceive) shall not apply in relation to any of the following persons

(

a

) a member of the Garda Síochána when acting in the course of his or her duty as such;

(

b

) a person who is an authorised officer as defined in section 32A of the

Irish Medicines Board Act 1995

(inserted by

section 17

of the

Irish Medicines Board (Miscellaneous Provisions) Act 2006

), when acting in the course of his or her duty as such;

(

c

) a person appointed as an authorised officer under

section 67

of the

Pharmacy Act 2007

, when acting in the course of his or her duty as such;

(

d

) a person authorised in writing by the Minister or by the Health Products Regulatory Authority in accordance with section 24 of the Principal Act (as amended by

section 9

of the

Irish Medicines Board (Miscellaneous Provisions) Act 2006

), when acting in his or her capacity as such;

(

e

) a person appointed as the secretary to, or member of, a committee of inquiry established under section 8 of the Principal Act (as amended by

section 3

of the

Misuse of Drugs Act 1984

(No. 18 of 1984)), when acting in the course of his or her duty as such;

(

f

) a person who has taken into his or her possession a forged prescription or a duly issued prescription which has been altered with intent to deceive, for the purpose of—

(i) preventing another from committing or continuing to commit an offence under the Principal Act, or

(ii) delivering it into the custody of a person specified in paragraph (

a

), (

b

), (

c

) or (

d

) of this Regulation.

Publication, sale, etc. of certain books, periodicals and other publications.

28. The drugs specified in Schedule 1 are hereby prescribed for the purposes of

section 5

of the

Misuse of Drugs Act 1984

.

References to revoked Regulations of 1988 in other enactments.

29. (1) A reference in any other enactment to the Regulations of 1988 shall be construed as a reference to these Regulations.

(2) A reference in any other enactment to a provision of the Regulations of 1988 listed in column 1 of Schedule 9 shall be construed as a reference to the corresponding provision of these Regulations listed in column 3 of Schedule 9.

Transitional provisions.

30. (1) Notwithstanding Regulations 22 and 23, any register, book, prescription or other document required to be preserved under Regulation 19 or 20 of the Regulations of 1988 shall be preserved for the period of time required under the relevant provision of those Regulations as if those Regulations had not been revoked.

(2) Notwithstanding Regulation 16, it shall not be a contravention of these Regulations for a person to supply a controlled drug specified in Part 1 of Schedule 4 on foot of a prescription which does not comply with Regulation 16(1) if—

(

a

) the prescription was issued before the coming into operation of these Regulations,

(

b

) the prescription complies with the requirements of Regulations 7(1) or 7A(1) of the Medicinal Products (Prescription and Control of Supply) Regulations 2003 (as amended and inserted by Regulations 4 and 5 of the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 2) Regulations 2014 (

S.I. No. 504 of 2014

) res-pectively), as appropriate, or, in the case of an animal remedy, Regulation 43 of the European Communities (Animal Remedies) (No. 2) Regulations 2007 (

S.I. No. 786 of 2007

) (as amended by Regulation 2(

c

) and (

d

) of the European Communities (Animal Remedies) (Amendment) Regulations 2014 (

S.I. No. 162 of 2014

)), and

(

c

) the supply is made not later than the date specified in Regulation 7(5)(

a

) of the Medicinal Products (Prescription and Control of Supply) Regulations 2003 or, in the case of an animal remedy, the date specified in Regulation 43(7)(

c

) of the European Communities (Animal Remedies) (No. 2) Regulations 2007.

(3) Notwithstanding Regulations 15 and 16, a prescription for a controlled drug specified in Schedule 2 or 3, written and issued before the commencement of these Regulations in accordance with Regulation 13 of the Regulations of 1988, shall be deemed to be written and issued in accordance with Regulation 15 for the purpose of supply in accordance with Regulation 16 of these Regulations.

SCHEDULE 1