DRUGS (CONTROL) REGULATIONS

SUBSIDIARY LEGISLATION 31.18

DRUGS (CONTROL) REGULATIONS

2nd August, 1985

LEGAL NOTICE 22 of 1985, as amended by Legal Notices 65 of 1986,

26 of 1987, 70 of 1988, 34, 103 of 1989, 173 of 1994, 78 of 1998, 183 of

1999, 173, 424 of 2010, 148, 413, 426 of 2012, 363, 365, 405 of 2013, 47 of

2016, 356, 361 of 2017, 380 of 2017, 229 of 2018, 233 of 2018 and 267 of

2018, 191 of 2019, 112, 294 and 295 of 2021, 164 and 251 of 2022, 157 of

2023, 180 and 238 of 2024, 99 and 100 of 2025 and 47 of 2026.

The title of these regulations is the Drugs (Control)

Regulations.

L.N. 70 of 1988. 

Amended by: 

L.N. 183 of 1999; 

L.N. 173 of 2010; 

L.N. 424 of 2010; 

L.N. 148 of 2012; 

L.N. 363 of 2013; 

L.N. 365 of 2013; 

L.N. 405 of 2013; 

L.N. 47 of 2016; 

L.N. 355 of 2017; 

L.N.361 of 2017; 

L.N. 229 of 2018; 

L.N. 267 of 2018; 

L.N. 191 of 2019; 

L.N. 112 of 2021; 

L.N. 238 of 2024; 

L.N. 99 of 2025.

(Regulation 2)

International or other nonproprietary name

Chemical name

or other trivial name

α-PVP

1-phenyl-2-(1-pyrrolidin-1-yl)pentan-1-one

CATHINONE

(-)-a-aminopropiophenone

DET

N.N-diethyltryptamine

DMA

d1-2,5-dimethoxy-a-methylphenylethylamine

DMHP

3-(1,2-dimethylheptyl)-l-hydroxy-7, 8, 9, 10-

tetrahydro-6, 6, 9-trimethyl-6Hdibenzo [b, d)

pyran

DMT

N.N-dimethyltryptamine

DOB, BROLAMFETAMINE

2,5-dimethoxy-4-bromoamphetamine

(+) LYSERGIDE, LSD, LSD-25

(+)-N.N-diethyllysergamide (d-lysergic acid

diethylamide)

DOET

dl-2, 5-dimethoxy-4-ethyl-a

methylphenylethylamine

ENTRYPTAMINE

3-(2-aminobutyl) indole

MDA, METHYLENE 

3,4, methylenedioxyamphetamine

DIOXYAMPHETAMINE

MDMA, TENAMFETAMINE

dl-3, 4-methylenedioxy-N, a-

dimethylphenylethylamine

4,4’-DMAR

4-methyl-5-(4-methylphenyl)-4,5-dihydro-1,3-

oxazol-2-amine

4-MA

4-methylamphetamine

mephedrone (4-methylmethcathinone)

2-methylamino-1-(4-methylphenyl)propan-1-

one

METHCATHINONE

2-(methylamino)-1-phenylpropan-1-one

Methoxetamine

2-(ethylamino)-2-(3-

methoxyphenyl)cyclohexanone

MESCALINE, MESCAL 

3, 4, 5-trimethoxyphenethylamine

BUTTON, PEYOTE, PEYOTL

MMDA

2-methoxy-alpha-methyl-4-5-

(methylenedioxy)phenethylamine

PARAHEXYL

3-hexyl-1-hydroxy-7, 8, 9, 10-tetrahydro-6, 6,

9-trimethyl-6H-dibenzo [b, d) pyran

PCE, ETICYCLIDINE

N-ethyl-l-phenylcyclohexylamine

PHP, PCPY, ROLICYCLIDINE

1-(1-phenylcyclohexyl) pyrrolidine

PMA

4-methoxy-a-methylphenylethylamine

PSILOCINE, PSILOTSIN

3-(2-dimethylaminoethyl)-4-hydroxyindole

PSILOCYBINE

3-(2-dimethylaminoethyl)-indol-4-y1

dihydrogen phosphate

STP. DOM

2-amino-1-(2, 5-dimethoxy-4-methyl)

phenylpropane

TETRAHYDROCANNABINOL,

7, 8, 9, 10 - tetrahydro-6,6,9-trimethyl-

following isomers and their stereo

thepentyl- 6H-dibenzo[b,d]pyran-1-ol

chemical variants

(9R,10aR)-8,9,10,10a- tetrahydro-6,6,9-

trimethyl-3-pentyl-6H-ibenzo[b,d]pyran-1-ol

(6aR,9R,10aR)- 6a,9,10,10a-tetrahydro-6, 6,9-

trimethyl-3pentyl-6H-ibenzo[b,d]pyran-1-ol

(6aR,10aR)- 6a,7,10,10a-tetrahydro-6,6,9-

trimethyl-3pentyl-6H-dibenzo[b,d]pyran-1-ol

6a,7,8,9-tetrahydro-6, 6,9-trimethyl-3pentyl-

6H-dibenzo[b,d]pyran-1-ol

(6aR,10aR)- 6a,7,8,9,10,10a-hexahydro-6, 6-

dimethyl-9-methylene-3-pentyl-6H-

dibenzo[b,d]pyran-1-ol

TCP, TENOCYCLIDNE

1-[1-(2-thienyl) cyclohexyl) piperidine

TMA

dl-3, 4, 5-trimethoxy-a-

methylphenylethylamine

mCPP

1-(3-chlorophenyl)piperazine

oCPP

1-(2-chlorophenyl)piperazine

pCPP

1-(4-chlorophenyl)piperazine

1-BENZYLPIPERAZINE

1-benzyl-1, 4-diazacyclohexane

2C-1

(2,5-dimethoxy-4-iodophenethylamine)

2C-T-2

(2,5-dimethoxy-4-ethylthiophenethylamine)

2C-T-7

(2,5-dimethoxy-4-(n)-

propylthiophenethylamine)

TMA-2

(2,4,5,-trimethoxyamphetamine)

PMMA

paramethoxymethylamphetamine or N-

methyl-1-(4-methoxy-phenyl)-2-

aminopropane

4-MTA

( -methyl-4-methylthiophenethylamine)

5-IT

5-(2-aminopropyl)indole

25I-NBOMe (2C-I-NBOMe)

2-(4-iodo-2,5-dimethoxyphenyl)-N-[(2-

methoxyphenyl)methyl]ethanamine

25B-NBOMe (2C-B-NBOMe)

2-(4-bromo-2,5-dimethoxyphenyl)-N-[(2-

methoxyphenyl)methyl]ethanamine

25C-NBOMe (2C-C-NBOMe)

2-(4-chloro-2,5-dimethoxyphenyl)-N-[(2-

methoxyphenyl)methyl]ethanamine

3,4-methylenedioxypyrovalerone (MDPV)

(RS)-1-(Benzo[d][1,3]dioxol-5-yl)-2-

(pyrrolidin-1-yl)pentan-1-one

Methylone (beta-keto-MDMA)

(±)-2-Methylamino-1-(3,4-

methylenedioxyphenyl)propan-1-one

JWH-018

Naphthalen-1-yl-(1-pentylindol-3-

yl)methanone

AM-2201

1-[(5-Fluoropentyl)-1H-indol-3-yl]-

(naphthalene-1-yl)methanone

2-(ethylamino)-1-(4-methylphenyl)propan-1-

4-MEC (4-methylethcathinone)

one

1-(2H-1,3-benzodioxol-5-yl)-2-

Ethylone

(ethylamino)propan-1-one

2-(methylamino)-1-phenylpentan-1-one

Pentedrone (α-methylaminovalerophenone)

ethyl phenyl(piperidin-2-yl)acetate

Ethylphenidate (EPH)

N-methyl-1-(thiophen-2-yl)propan-2-amine

Methiopropamine (MPA)

methyl N-{[1-(cyclohexylmethyl)-1H-indol-3-

MDMB-CHMICA

yl]carbonyl}-3-methyl-L-valinate

N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-

5F-APINACA (5F-AKB-48)

indazole-3-carboxamide

[1-(5-fluoropentyl)-1H-indol-3-yl](2,2,3,3-

XLR-11

tetramethylcyclopropyl)methanone".

N-[(2S)-1-Amino-3-methyl-1-oxobutan-2-yl]-

AB-CHMINACA

1-(cyclohexylmethyl)-1H-indazole-3-

carboxamide

Methyl(2S)-2-{[1-(5-fluoropentyl)-1H-

5F-ADB (5F-MDMB-PINACA)

indazole-3-carbonyl]amino}-3,3-

dimethylbutanoate

N-[(2S)-1-Amino-3-methyl-1-oxobutan-2-yl]-

AB-PINACA

1-pentyl)-1H-indazole-3-carboxamide

(1-Pentyl-1H-indol-3-yl)(2,2,3,3-

UR-144

tetramethylcyclopropyl)methanone

Quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-

5F-PB-22

carboxylate

1-(4-Fluorophenyl)propan-2-amine

4-Fluoroamphetamine (4-FA)

N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-

ADB-CHMINACA

(cyclohexylmethyl)-1H-indazole-3-

carboxamide

1-(4-cyanobutyl)-N-(2-phenylpropan-2-yl)-

CUMYL-4CN-BINACA

1H-indazole-3-carboxamide

N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl]-1-

ADB-FUBINACA

(4-fluorobenzyl)-1H-indazole-3-carboxamide

Methyl (2S)-2-{[1-[(4-

FUB-AMB (MMB- or AMB-FUBINACA)

fluorophenyl)methyl]indazole-3-

carbonyl]amino}-3-methylbutanoate

1-(2H-1,3-benzodioxol-5-yl)-2-

N-ethylnorpentylone

(ethylamino)pentan-1-one)

DOC

1-(4-chloro-2,5-dimethoxyphenyl)propan-2-

amine

HHC, hexahydrocannabinol

6,6,9-Trimethyl-3-pentyl-6a,7,8,9,10,10a-

hexahydro-6H-benzo[c]chromen-1-ol

HHC-O acetate, HHCO, HHCOA,

(6,6,9-trimethyl-3-pentyl-6a,7,8,9,10,10a-

hexahydrocannabinol O-Acetate

hexahydrobenzo[c]chromen-1-yl) acetate; 6,6,9-

trimethyl-3-pentyl-6a,7,8,9,10,10a-hexahydro-

6H-benzo[c]chromen-1-yl acetate

HHC-P,hexahydrocannabiphorol

3-Heptyl-6a,7,8,9,10,10a-hexahydro-6,6,9-

trimethyl-6H-dibenzo[b,d]pyran-1-ol;

3-heptyl-6,6,9-trimethyl-6a,7,8,9,10,10a-

hexahydro-6H-benzo[c]chromen-1-ol

H4-CBD, tetrahydrocannabidiol, Hydrogenated 2-(2-Isopropyl-5-methylcyclohexyl)-5-

CBD, THD, cyclohexyl CBD

pentylbenzene-1,3-diol

THC-P, tetrahydrocannabiphorol, Delta-9-

3-Heptyl-6a,7,8,10a-tetrahydro-6,6,9-trimethyl-

6H-dibenzo[b,d]pyran-1-ol; 

THCP

3-Heptyl-6,6,9-trimethyl-6a,7,8,10a-

tetrahydrobenzo[c]chromen-1-ol

HHCH, hexahydrocannabihexol,HHC-H

3-Hexyl-6,6,9-trimethyl-6a,7,8,9,10,10a-

hexahydrobenzo[c]chromen-1-ol; 

3-hexyl-6a,7,8,9,10,10a-hexahydro-6,6,9-

trimethyl-6H-dibenzo[b,d]pyran-1-ol

Delta-8-THCP, delta-8-

3-heptyl-6aR,7,10,10aR-tetrahydro-6,6,9-

Tetrahydrocannabiphorol, JWH 091, THC-

trimethyl-6H-dibenzo[b,d]pyran-1-ol; 3-heptyl-

heptyl

6,6,9-trimethyl-6a,7,10,10a-

tetrahydrobenzo[c]chromen-1-ol

THCB, Tetrahydrocannabutol, Delta-9-THCB,  3-butyl-6,6,9-trimethyl-6a,7,8,10a-tetrahydro-

Delta-9-THC-C4, 

6H-dibenzo[b,d]pyran-1-ol; 

Delta-9-THC-butyl

3-butyl-6,6,9-trimethyl-6a,7,8,10a-

tetrahydrobenzo[c]chromen-1-ol

9-OH-HHC, 

6,6,9-trimethyl-3-pentyl-6a,7,8,9,10,10a-

9-Hydroxyhexahydrocannabinol,

hexahydro-6H-benzo[c]chromene-1,9-diol;

9-hydroxy-HHC

6a,7,8,9,10,10a-hexahydro-6,6,9-trimethyl-3-

pentyl-6H-dibenzo[b,d]pyran-1,9-diol

delta-8-THC acetate,

6aR,7,10,10aR-tetrahydro-6,6,9-trimethyl-3-

Δ8-Tetrahydrocannabinol 

pentyl-6H-dibenzo[b,d]pyran-1-ol, 1-acetate

Acetate

Δ8-THC-O-Acetate

Delta-8-THC methylether,

6aR,7,10,10aR-tetrahydro-1-methoxy-6,6,9-

1-methyl-Δ8-THC,

trimethyl-3-pentyl-6H-dibenzo[b,d]pyran

Δ8-Tetrahydrocannabinol methylether

Delta-9-THCP acetate,

3-heptyl-6aR,7,8,10aR-tetrahydro-6,6,9-

Δ9-Tetrahydrocannabiphorol Acetate, delta-9- trimethyl-6H-dibenzo[b,d]pyran-1-ol, 1-acetate

THC-C7-Acetate

delta-9-THCH, 

(6aR,10aR)-3-hexyl-6a,7,8,10a-tetrahydro-

delta-9-Tetrahydrocannabihexol, delta-9-THC- 6,6,9-trimethyl-6H-dibenzo[b,d]pyran-1-ol

HHC-P-O-acetate,

(6aR,10aR)-6,6,9-trimethyl-3-heptyl-

hexahydrocannabiphorol acetate

6a,7,8,9,10,10a-hexahydrobenzo[c]chromen-1-

yl acetate

Delta-8-THCH, 

(6aR,10aR)-3-hexyl-6a,7,10,10a-terahydro-

delta-8-tetrahydrocannabihexol delta-8-THC- 6,6,9-trimethyl-6H- dibenzo[b,d]pyran-1-ol

HHC-C9 jew CC9

3-nonyl-6a,7,8,9,10,10a-hexahydro-6,6,9-

trimethyl-6H-dibenzo[b,d]pyran-1-ol

And any derivatives, salts, or esters of the above.

Amended by: 

In these Regulations, unless the context otherwise

requires -

" i d e n t i t y identification document" means a legally valid

identification document issued in accordance with the provisions of the

Identity Card and other Identity Documents Act, and of any regulations

made thereunder;

"prescription" means any medicinal prescription issued by a

professional person qualified to prescribe medicinal products by or

under the Medicines Act, including manual prescriptions, computer

generated prescriptions and eprescriptions;

"restricted drug" means any one of such drugs or chemical

substances as are listed in the First Schedule to these Regulations;

"specified drug" means any one of such drugs or chemical

substances as are specified in the Second Schedule to these

Regulations;

"register" means a bound book with consecutively numbered

pages, but does not include any form of loose leaf register or card

index;

"Superintendent" means the Superintendent of Public Health.

L.N. 26 of 1987. 

Substituted by: 

L.N. 70 of 1988. 

Amended by: 

L.N. 103 of 1989; 

L.N. 78 of 1998; 

L.N. 183 of 1999. 

L.N. 173 of 2010; 

L.N. 413 of 2012; 

L.N. 112 of 2021; 

L.N. 294 of 2021; 

L.N. 295 of 2021; 

L.N. 164 of 2022; 

L.N. 251 of 2022; 

L.N. 157 of 2023; 

L.N. 180 of 2024; 

L.N. 99 of 2025; 

L.N. 47 of 2026.

(Regulation 2)

International or other nonproprietary name

Chemical name

or other trivial name

ALLOBARBITAL

5, 5-diallylbarbituric acid

AMFEPRAMONE, DIETHYLPROPION

2-(diethylamino) propiophenone

AMINOREX

2-amino-5-phenyl-2-oxazoline

AMOBARBITAL

5-ethyl-5-(3-methylbutyl) barbituric acid

AMPHETAMINE

(±)-2-amino-l-phenylpropane

BARBITAL

5, 5-diethylbarbituric acid

N-benzyl-N, -dimethylphenethylamine

BENZPHETAMINE

BROTIZOLAM

2-bromo-4(o-chlorophenyl)-9-methyl-6H-

thieno [3,2-f]-s-triazolo [4,3-a] [1,4] diazepine

BUPRENORHINE

21-cyclopropyl-7-alpha-[(S)-l-hydroxy-1,2,2-

trimethylpropyl]-6,14-endoethano-6,7,8,14-

tetrahydrooripavine

BUTALBITAL

5-allyl-5-isobutylbarbituric acid

BUTOBARBITAL

5-butyl-5-ethylbarbituric acid

CATHINE

d-threo-2-amino-1-hydroxy-l-phenylpropane

CHLORAL HYDRATE

2, 2, 2-trichloroethane-1, 1-diol

CHLORDIAZEPOXIDE

7-chloro-2-(methylamino)-5-phenyl-3H-1,

4benzodiazepine-4-oxide

CHLORPHENTERMINE

p-chloro--dimethylphenethlylamine

CYCLOBARBITAL

5-(l-cyclohexen-l-y1)-5-ethylbarbituric acid

CUMYL-PEGACLONE

5-pentyl-2-(-phenylpropan-2-yl)-2,5-dihydro-1H-

3-methoxyphencyclidine (also known as 3-

pyrido[4,3-b]indol-1-one

MeO-PCP)

1-(1-(3- methoxyphenyl)cyclohexyl)piperidine

DIPHENIDINE

1-(1,2-diphenylethyl)piperidine

CLONAZOLAM (also known as clonitrazolam) 6-(2-chlorophenyl)-1-methyl-8-nitro-

4Hbenzo[f][1,2,4]triazolo[4,3-a][1,4]diazepine)

DICLAZEPAM (also known as Ro 5-3448)

7-chloro-5-(2-chlorophenyl)-1-methyl-1,3-

dihydro-2H-benzo[e][1,4]diazepin2-one

FLUBROMAZOLAM

8-bromo-6-(2-fluorophenyl)-1-methyl-4H-

benzo[f][1,2,4]triazolo[4,3-a][1,4]- diazepine

DEXAMPHETAMINE

(+)-2-amino-1-phenylpropane

D I A Z E PA M a n d o t h e r c o m p o u n d s 7-chloro-1, 3-dihydro-1-methyl-5-phenyl-2H-

containing the chemical structure of 1, 4-benzodiazepine-2-one

DIHYDRO-1:4 BENZODIAZEPINE or

of DIHYDRO-1:5 BENZODIAZEPINE

substituted to any degree

D R O N A B I N O L d e l t a - 9 - t e t r a h y d r o - (6aR, 10aR)-6a7, 8, 10a-tetrahydro-6,6,9-

c a n n a b i n o l a n d i t s s t e r e o c h e m i c a l trimethyl-3-penatyl-6H-dibenzo [b,d] pyran-1-

variants (This item refers to only one of o1

the stereochemical variants of delta-9-

tetrahydrocannabinol, namely(-)-trans-

delta-9-tetrahydrocannabinol.)

ETHCHLORVYNOL

ethyl-2-chlorovinylethynylcarbinol

ETHINAMATE

l-ethynylcyclohexanolcarbamate

FENCAMFAMIN

dl-N-ethyl-3-phenylbicyclo (2,2,1)-heptan-

2amine

FENETYLLINE

dl-3,7-dihydro-1, 3 dimethyl-7-(2-[(l-methyl2-

phenylethyl) amino] ethyl)-1H-purine-2, 6-

dione

N-ethyl-  -methyl-m(trifluoromethyl)

FENFLURAMINE

phenethylamine

FENPROPOREX

dl-3-[(a-methylphenethyl)amino] propionitrile

GLUTETHIMIDE

2-ethyl-2-phenylglutarimide

KETAMINE

(±)-2-(2-Chlorophenyl)-2-

methylaminocyclohezanone

LEVAMPHETAMINE

1-a-methylphenethylamine

LEVOMETHAMPHETAMINE

l-N, a-dimethylphenethylamine

MAZINDOL

5-(p-chlorophenyl)-2, 5-dihydro-3H-imidazo

[2, 1-a] isoindol-5-ol

MECLOQUALONE

3-(o-chlorophenyl)-2-methyl-4 (3H)-

quinazolinone

MEFENOREX

dl-N-(3-chloropropyl)-a-

methylphenethylamine

MEPHENTERMINE

N--trimethylphenethylamine

MEPROBAMATE

2-methyl-2-propyl-1, 3-propanediol

dicarbamate

MESOCARB

3-(-methylphenethyl)-N-phenylcarbamoyl)

sydnone imine

METHAMPHETAMINE

(+)-2-methylamino-l-phenylpropane

M E T H A M P H E TA M I N E R A C E M AT E 2-methyl-3-o-tolyl-4(3H)-quinazolinone

METHAQUALONE

METHYLPHENIDATE

2-phenyl-2 (2-piperidyl) acetic acid, methyl

ester

METHYLPHENOBARBITAL

5-ethyl-l-methyl-5-phenylbarbituric acid

METHYPRYLON

3, 3-diethyl-5-methyl-2, 4-piperidine-dione

MDMB-4-en-PINACA

methyl 3,3-dimethyl-2-{[1-(pent-4-en-1-yl)-

1H-indazole-3-carbonyl] amino}butanoate

4F-MDMB-BICA

methyl 2-{[1-(4-fluorobutyl)-1H-indole-3-

carbonyl] amino}-3,3-dimethylbutanoate

N-ETHYLAMPHETAMINE

dl-N-ethyl-a-methylphenylethylamine

PARALDEHYDE

acetaldehyde trimer

PEMOLINE

2-amino-5-phenyl-2-oxazolin-4-one or 2-

imino-5-phenyl-4-oxazolidinone

PENTAZOCINE

1, 2, 3, 4, 5, 6, hexahydro-6, 11-dimethyl-3 -

(3-methyl-2-butenyl)-2, 6-methano-

3benzazocin-8-o1

PENTOBARBITAL

5-ethyl-5-(1-methylbutyl) barbituric acid

PHENCYCLIDINE

1-(l-phenylcyclohexyl) piperidine

PHENDIMETRAZINE

(+)-3, 4-dimethyl-2-phenylmorpholine

PHENMETRAZINE

3-methyl-2-phenylmorpholine

PHENOBARBITAL

5-ethyl-5-phenylbarbituric acid

PHENTERMINE

a,a-dimethylphenethylamine

PIPRADROL

1,l-diphenyl-l-(2-piperidyl) methanol

PROPYLHEXEDRINE

dl-1-cyclohexyl-2-methylaminopropane

PYROVALERONE

dl-l-(4-methylphenyl)-2-(l-pyrrolidinyl)-

lpentanone

SECBUTABARBITAL

5-sec-butyl-5-ethylbarbituric acid

SECOBARBITAL

5-allyl-5-(l-methylbutyl) barbituric acid

SPA, LEFETAMINE

(-)-l-dimethylarnine-1, 2, diphenylethane

TIANEPTINE

7 - [ ( 3 - C h l o r o - 6 , 11 - d i h y d r o - 5 , 5 - d i o x o - 6 -

methyl dibenzo[c, f][1,2] thi azepin-11-yl)

amino] heptanoic acid

VINYLBITAL

5-(l-methyl-butyl)-5-vinylbarbituric acid

-(-µ ethoxybenzl)-4-((ß-methoxphenethyl)-

ZIPEPROL

1-piperazineethanol

CHLORMETHIAZOLE

5-(2-chloroethyl)-4-methyl-1,3-thiazole

AMINEPTINE

(7-[ (10, 11-dihydr o-5Hd ib enzo[ a,d ,]

cyclohepten-5-y-5-yl) amino]heptanoic acid)

TRAMADOL

(±)-trans-2-Dimethylaminomethyl-1-(3-

methoxyphenyl) cyclohexanol

ZOLPIDEM

(N,N,6-trimethyl-2-ptolylimidazo[ 1,2-

α]pyridine-3-acetamide)

2C-B

(4-bromo-2,5-dimethoxyphenethylamine)

GHB

(γ-hydroxybutyric acid)

N-[(2S)-1-Amino-3-methyl-1-oxobutan-2-yl]-

AB-CHMINACA

1-(cyclohexylmethyl)-1 H -indazole-3-

carboxamide

Methyl(2 S )-2-{[1-(5-fluoropentyl)-1 H -

5F-ADB (5F-MDMB-PINACA)

indazole-3-carbonyl]amino}-3,3-

dimethylbutanoate

N-[(2S)-1-Amino-3-methyl-1-oxobutan-2-yl]-

AB-PINACA

1-pentyl)-1H-indazole-3-carboxamide

(1-Pentyl-1 H -indol-3-yl)(2,2,3,3-

UR-144

tetramethylcyclopropyl)methanone

Quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-

5F-PB-22

carboxylate

1-(4-Fluorophenyl)propan-2-amine.

4-Fluoroamphetamine (4-FA)

AB-FUBINACA (or FUB-AMB)

N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(4-

fluorobenzyl)-1H-indazole-3-carboxamide

5F-AMB-PINACA (or 5F-AMB or 5F-MMB-

methyl 2-({[1-(5-fluoropentyl)-1H-indazole-3-

yl]carbonyl}amino)-3-methylbutanoate

PINACA)

5F-MDMB-PICA (or 5F-MDMB-2201)

methyl 2-{[1-(5-fluoropentyl)-1H-indole-3-

carbonyl]amino}-3,3-dimethylbutanoate

4F-MDMB-BINACA (or 4F-MDMB-BUTIN-

methyl 2-{[1-(4-fluorobutyl)-1H-indazole-3-

carbonyl]amino}-3,3-dimethylbutanoate

ACA)

4-BMC

4-bromomethcathinone 1-(4-Bromophenyl)-2-

(methylamino)propan-1-one

4-CMC (or 4-chloromethcathinone or clephed-

1-(4-chlorophenyl)-2-(methylamino)propan-1-

one

rone)

N-ethylhexedrone (or NEH, Hexen, Ethyl-Hex, 2-(ethylamino)-1-phenylhexan-1-one

Ethyl-hexedrone)

NEP

N-Ethylnorpentedrone, 2-(Ethylamino)-1-

phenylpentan-1-one

Alpha-PHP (or PV-7, α-PHP, α-pyrrolidinohex- 1-phenyl-2-(pyrrolidin-1-yl)hexan-1-one

anophenone)

Flualprazolam (or Ro 11-5073/000)

8-chloro-6-(2-fluorophenyl)-1-methyl-4H-

[1,2,4]triazolo[4,3-a][1,4]benzodiazepine

Etizolam (or Y-7131 or Depas)

4-(2-chlorophenyl)-2-ethyl-9-methyl-6H-

thieno[3,2-f][1,2,4]triazolo[4,3-

a][1,4]diazepine".

EUTYLONE

1-(1,3-benzodioxol-5-yl)-2-(ethylamino)butan-

1-one

2-MMC

2-methylmethcathinone, 2-(Methylamino)-1-(2-

methylphenyl)propan-1-one

3-methylmethcathinone, 3-MMC

2-(methylamino)-1-(3-methylphenyl)propan-1-

one

3-chloromethcathinone, 3-CMC

1-(3-chlorophenyl)-2-(methylamino)propan-1-

one".

ADB-BUTINACA

N-[1-(aminocarbonyl)-2,2-dimethylpropyl]-1-

butyl-1H-indazole-3-carboxamide)

Alpha-PiHP, α-PiHP

4-methyl-1-phenyl-2-(pyrrolidin-1-yl)pentan-1-

one)

BROMAZOLAM

8-bromo-1-methyl-6-phenyl-4H-

[1,2,4]triazolo[4,3-a][1,4]benzodiazepine

DIPENTYLONE

1-(1,3-benzodioxol-5-yl)-2-

(dimethylamino)pentan-1-one

2-FLUORODESCHLOROKETAMINE (2-

2-(2-fluorophenyl)-2-methylamino-

FDCK)

cyclohexanone

CARISOPRODOL

(2RS)-2-[(carbamoyloxy)methyl]-2-

methylpentyl (1-methylethyl)carbamate

And any salts or esters of the above.

(1) No person may import, manufacture, export, purchase,

sell, use or be in possession of any restricted drug without a special

authorisation in writing by the Superintendent.

(2) The Superintendent shall not grant a special authorisation

to use any restricted drug except in special cases for scientific or

very l im i te d m ed ica l pu r po ses in sid e m edi ca l or scie nt ifi c

establishments under government control or specifically approved

by the Superintendent, who shall have the power to impose in any

authorisation any conditions and requirements he may deem fit to

impose with a view to safeguard against abuse.

(3) The Superintendent may at any time, without giving any

reason whatsoever, withdraw any authorisation granted by him

under sub-regulation (1) of this regulation.

(4) Any person who has been authorised in accordance with

sub-regulation (1) of this regulation shall keep such registers as

shall be necessary in accordance with the Third Schedule to these

Regulations in relation to the manufacture, acquisition and/or

disposal of restricted drugs, in which registers there shall be

entered the details relative to such drugs. Each entry shall be

signed, by the person authorised under sub-regulation (1), within

twenty-four hours of any transaction or process, and any such

register shall be preserved and kept available for inspection by the

Superintendent or his representative for at least two years after the

date of the last entry recorded therein.

(5) Any entry in the register shall be made in ink or other

indelible material and shall be entered on the same day in which the

transaction, administration or process is effected, or, when this is

not possible, on the next following day.

(6) Any register used or in use with regard to one particular

premises shall not be used also with regard to any other premises or

for any purpose other than of this regulation.

(7) No entry in the register referred to in the last preceding sub-

regulations of this regulation shall be cancelled, obliterated or

altered or shall be entered with some untrue particulars

Provided that if any mistake is committed in any entry, such

mistake shall be corrected by means of a note in the margin or at

the foot of the page, which note shall contain the correction

required and the date of the note.

(8) No person may dispose of any restricted drug except to

persons specially authorised to possess or use such drugs.

(Regulations 3 and 4)

Amended by: 

(1) Any person who is licensed or authorised to

manufacture, import, sell, supply, distribute, or administer any

specified drug, whether in the line of his trade or profession or as a

medicament on the presentation of a prescription, shall keep such

registers as shall be necessary to show any transaction regarding

the manufacture, importation, purchase, sale, supply, distribution or

administration of any such drug.

(2)

(i) No person shall import, stock or sell any specified drug

by wholesale unless he holds a specific licence for the

purpose from the Superintendent.

(ii) No licence for the purposes of the foregoing paragraph

shall be issued unless the drug or drugs in respect of

which it is issued are under the direct responsibility of

an apothecary.

(3) Any specified drug manufactured, imported, exported

purchased, sold, supplied, distributed or administered shall be

entered in the register in the form shown with such variations as

circumstances may require, and containing such particulars as are

shown in the Third Schedule to these Regulations and as are

applicable to the case.

(4) Any entry in the register shall be made in ink or other

indelible material and shall be entered on the same day in which the

transaction, administration or process is effected, or, when this is

not possible, on the next following day.

(5)

Any register used or in use with regard to one particular

premises shall not be used also with regard to any other premises or

for any purpose other than of this regulation.

(6) No entry in the register referred to in the preceding sub-

regulations of this regulation shall be cancelled, obliterated or

altered or shall be entered with some untrue particulars

Provided that if any mistake is committed in any entry, such

mistake shall be corrected by means of a note in the margin or at

the foot of the page, which note shall contain the correction

required and the date of the note.

(7) No person may export any specified drug without the prior

authorisation from the Superintendent.

(8) In the case of importation or exportation of specified drugs,

the Superintendent shall have the power to direct the procedure to

be f ol l ow e d a nd t h e det a i ls t o b e s ub m it t e d i n th e r e l a t iv e

application, and may also, before issuing an export authorisation,

require that the authorisation of the importing country be obtained.

(9) The Superintendent may prohibit, or otherwise restrict, the

importation of any specified drug if he so considers it necessary in

the public interest.

L.N. 426 of 2012; 

(Regulation 13(4))

L.N. 380 of 2017; 

L.N. 100 of 2025.

CONFIDENTIAL

(Return in terms of regulation 13 - Prescriptions for flunitrazepam, mecloqualone,

methaqualone, and phenmetrazine and secobarbital or a combination of secobarbital

and amobarbital in tablet or capsule form or in sachet or cachet and their respective

salts or esters)

IMPORTANT - Prescription for these preparations can only be issued after written

approval is obtained from the Superintendent of Public Health for each prescription.

NAME AND ADDRESS OF PATIENT

L E G A L LY VA L I D IDE NTI FICATI ON ...............................................

DOCUMENT NUMBER

AGE

NAME OF PREPARATION AND

STRENGTH

QUANTITY PRESCRIBED

DAILY DOSE

DATE OF PRESCRIPTION

DATE AND REF. NO. OF APPROVAL

BY SUPERINTENDENT OF

PUBLIC HEALTH

SIGNATURE OF MEDICAL

PRACTITIONER

NAME (Block Letters)

ADDRESS

Amended by: 

(1) No person, unless duly authorised, may have in his

possession any specified drug.

(2) For the purpose of this regulation, a person shall be deemed

to be duly authorised if his name is entered in the Medical Register,

in the Register of Dental Surgeons, or in the Veterinary Surgeons’

Register, or if he is a managing apothecary, or is in possession of a

licence issued by the Superintendent under article 89 of the

Medical and Kindred Professions Ordinance, or has obtained such

drug in virtue of a medical prescription, or otherwise in accordance

with the provisions of these Regulations

Provided that, in respect of a person authorised in virtue of

a medical prescription, such prescription shall not be deemed to be

valid if, at the time of the receipt of the prescription, such person

was under the treatment of another medical practitioner and had

been receiving such specified drugs in virtue of a prescription from

this other medical practitioner and had not informed the prescriber

of this fact.

L.N. 426 of 2012; 

(Regulation 13(5))

L.N. 380 of 2017; 

L.N. 100 of 2025.

CONFIDENTIAL

(Return in terms of regulation 13 - Prescriptions for mecloqualone, methaqualone,

and phenmetrazine and secobarbital or a combination of secobarbital and

amobarbital in tablet or capsule form or in sachet or cachet and their respective salts

or esters)

NAME AND ADDRESS

OF PATIENT

L E G A L LY VA L I D I D E N T I F I C AT I O N .............................................

DOCUMENT NUMBER

NAME OF PREPARATION

AND STRENGTH

QUANTITY PRESCRIBED

DATE OF PRESCRIPTION

NAME OF PRESCRIBER

SIGNATURE OF APOTHECARY

NAME (Block Letters)

DH LICENCE NUMBER

ADDRESS (of Pharmacy)

DATE OF DISPENSING

Amended by: 

Any person authorised to be in possession of specified

drugs in accordance with the provisions of regulation 5 of these

regulations and any person specially authorised in respect of

restricted drugs, as the case may be, shall, when such drugs are not

in use, keep same under lock and key and it shall be the duty of any

such person to take all steps necessary to ensure security and to

prevent theft or other diversification of stock

Provided that nothing in this regulation shall apply to any

person who is in possession of specified drugs in virtue of a

medical prescription.

L.N. 426 of 2012.

(Regulation 13)

Name and address of patient .................................................................................

Legally valid Identification Document Number ........................................................

Date of prescription ..............................................................................................

Name of drug ........................................................................................................

Amount prescribed ...............................................................................................

Name of medical practitioner, dental surgeon or dentist who has prescribed the

drug .........................................................................................................................

(1) Every manual prescription for a specified drug shall be

written in ink or in other indelible material on the form set out in the

Seventh Schedule to these Regulations. In the case of computer

generated prescriptions and eprescriptions, the medical practitioner

shall use the official prescription as approved by the Superintendent of

Public Health.

(2) It shall be the duty of a medical practitioner issuing a

prescription for a specified drug to fill in a clear and legible hand

Part A of the form set out in the Seventh Schedule, and to supply all

the details and give all the information in the appropriate space as

therein required; the medical practitioner shall further add his

signature in full and the date when the prescription was issued

Provided that in the case of a medical practitioner

authorised under article 5 of the Medical and Kindred Professions

Ordinance to practise the medical profession but who is not yet

registered with the Medical Council, such practitioner shall insert

the number given to him by the Superintendent instead of the

Medical Council registration number on the said prescription.

(3) Subject to the provisions of sub-regulation (11) of this

regulation, no medical practitioner shall issue a prescription for a

specified drug unless the prescription complies with the provisions

of this regulation and such drug is required for the purpose of

medical treatment

Provided that a medical practitioner may, subject to the

other provisions of these Regulations, issue a prescription for

professional use for an amount not in excess of ten phials for

injection or of twenty tablets or capsules.

(4) Every medical practitioner who obtains a specified drug for

professional use as provided in the proviso to sub-regulation (3) of

this regulation shall keep in accordance with, and without prejudice

to, the provisions of regulation 4 of these Regulations, a record in

an appropriate register of the name and surname (if applicable), the

age and address of the patient to whom the drug has been

administered and the date of administration.

(5) No medical practitioner shall issue a prescription for a

specified drug to any person unless such person is well known to

him or unless the medical practitioner has ascertained the identity of

such person through his legally valid identification document.

(6) No medical practitioner shall issue a prescription for a

specified drug to any person unless the said medical practitioner

has taken reasonably sufficient steps to ascertain that such person is

not, at the time of issuing the prescription, receiving treatment from

another medical practitioner in respect of addiction to any specified

drug or otherwise, and that such person has not been supplied with

any such drug on a prescription issued by that other medical

practitioner.

(7) When issuing a manual prescription a medical practitioner

shall use a separate form in respect of every drug prescribed by him

under this regulation and no drug other than a specified drug or a

drug falling under the Dangerous Drugs Ordinance, may be

prescribed on those forms.

(8) When issuing a manual prescription a medical practitioner

shall, in prescribing a specified drug, use only prescription forms

from the booklet of forms in serial number, issued to him by the

Superintendent upon a request made on the form set out in the

Eighth Schedule to these Regulations and it shall be the duty of

every medical practitioner, whether for the purpose of his private

practice or for carrying out his duties in an official capacity as a

result of his employment with Government, with a view to meeting

the needs of his patients, to make any request for such prescription

booklets on the said form; such request form shall be correctly

filled in all respects and signed by the practitioner, and shall be

either handed in by such practitioner personally to the chief

pharmacist at the Government Medical Stores at Gwardamangia or

sent by post to the Superintendent of Public Health at the

Department of Health in Valletta; and when sent by post the

envelope may be marked "Public Health Notifications" for the

purpose of exemption from postage.

(9) It shall be the duty of a medical practitioner to report in

writing forthwith to the Superintendent any case of theft or loss of

such booklet or unauthorised access to his electronic profile, and it

shall not be lawful for a medical practitioner to use any prescription

f o r m f r o m a n y bo o k l e t o f f o r m s i s s u e d t o a n o t h e r m e d ic a l

p r a c t i t i o n e r, o r i s s u e c o m p u t e r g e n e r a t e d p r e s c r i p t i o n s o r

eprescriptions from the electronic profile of another medical

practitioner.

(10) For the purpose of this regulation, unless the context

otherwise requires, the expression "medical practitioner" includes a

dental surgeon, a dentist and a veterinary surgeon.

(11) The provisions of sub-regulations (1), (2), (7) and, in so far

as applicable, sub-regulations (8) and (9) of this regulation shall

not apply to the prescription of specified drugs for administration

to ward patients in government hospitals, which prescription shall

be controlled by the hospital internal rules.

(Regulation 7)

PRESCRIPTION FOR NARCOTIC AND PSYCHOTROPIC DRUGS

(Only one item may be prescribed on this Form)

C. TO BE FILLED BY 

A. TO BE FILLED BY PRESCRIBER

DISPENSING APOTHECARY

PATIENT

Name and Surname .................................................................

PATIENT

Address ...................................................................................

Surname

Name

ITEM

Quantity

(incl. Form& Dose)

I.D

Directions for use

Additional information in respect of Prescriptions for METHADONE

Male

Female

ITEM

Expected Duration of Treatment ....................

Quanity Supplied

Medical Indication ........................................

Total Quantity

in Units ...............................................................

PRESCRIBER

Total Quantity

Med Council Reg. No.

in Weight/Measure ...............................................

Name and Surname ..........................................................

PRESCRIPTION ORIGIN

Address ..........................................................................

Hospitals .............................................................

Signature ............................................... Date ....................

Govt. Clinics

..

Private

..

B. FOR OFFICIAL USE ONLY

DISPENSER

To be filled by Government Dispenser

Signature................................................................

.

PRESCRIPTION TYPE

Pharmacy Board Reg. No

Dispensary Address

Pink Form

Schedule III

Others

Direct

Postal

LOCATION DISPENSER

Dispensary

To be filled by Coder

DH Licence No.

Date

Item No.

Prescription Origin

Serial No.

(1) No person other than an apothecary shall dispense a

prescription for a specified drug.

(2) No apothecary shall dispense a prescription for a specified

drug unless -

(a) he is acquainted with the signature of the person by

whom it purports to have been issued, he has no reason

to suppose that it is not genuine and he has taken

reasonable steps to satisfy himself that it is genuine;

and

(b) the prescription complies with the provisions of

regulation 7 of these regulations.

(3) No specified drug shall be supplied more than once on the

same prescription.

(4) An apothecary dispensing a prescription for a specified

drug shall fill in a clear and legible hand, in ink or other indelible

material, Part C of the form set out in the Seventh Schedule to these

Regulations, and supply all the details and give all the information

as therein required; the apothecary shall further add his signature in

full and the date, and shall, after dispensing the prescription, retain

it.

(5) For the purpose of sub-regulation (4) of this regulation, it

shall be the duty of an apothecary dispensing a prescription for a

specified drug to request a legally valid identification document of the

person in respect of whom the prescription has been issued and it shall

be the duty of the person who intends to acquire a specified drug,

whether for himself or on behalf of the person to whom the drugs have

been prescribed, to present the said identification document as well as

his own identification document together with the prescription

Provided that the provisions of this sub-regulation and the

relative part of the provisions of sub-regulation (4) shall not apply

in respect of a person who has not yet been issued with a legally valid

identification document.

(6) It shall be the duty of every managing apothecary of a

licensed dispensary to send to the Superintendent in a sealed

envelope on the first day of every month all the prescriptions for

specified drugs dispensed from that dispensary during the

preceding month; that envelope shall be addressed "Superintendent

of Public Health, Department of Health, Valletta" and may be

marked "Public Health Notifications" for the purpose of exemption

from postage.

(7) (a) In the case of eprescriptions, the pharmacist shall access

the electronic system by the applicable official verification.

(b) The pharmacist must ensure that the prescription was sent

by the official electronic system and fill in the details specified by

these regulations in the manner that is required by the electronic

system.

9.(1) (a) No medical practitioner may prescribe any specified

drug to any person unless such person is in possession

of a control card, as per Ninth Schedule to these

Regulations, issued for the purpose by the

Superintendent of Public Health;

(b) in prescribing any specified drug to any person, the

prescriber shall enter in a clear, indelible and legible

manner all the details set out in columns 1 to 4 of the

control card, and shall then return the card to such

person together with the prescription

Provided that a medical practitioner may, in making the

application on behalf of a person on the request form as set out in

the Tenth Schedule to these Regulations, also issue a prescription

for a supply of a specified drug to such person and may attach the

prescription to such request form

Provided further that such prescription shall only become

valid when the provisions of the proviso to sub-regulation (2) of

this regulation have been complied with.

(2)

The Superintendent shall issue such control card to the

person concerned on receipt of a request, from a medical

practitioner to this effect, made on the form as set out in the Tenth

Schedule to these Regulations

Provided that in the case of a prescription for a supply of a

specified drug as provided for in the provisos to sub-regulation (1)

of this regulation, the Superintendent shall enter the details of the

relative prescription in columns 1 to 4 of the control card.

(3) No control card shall be valid in excess of a period of one

year from the date on which it is issued, unless it is renewed by the

Superintendent following a request by a medical practitioner to this

e ff e c t , o n t h e f o r m s e t o u t i n t h e Te n t h S c h e d u l e t o t h e s e

Regulations.

(4) No apothecary shall dispense any specified drug to any

person who is not in possession of a control card as set out in sub-

regulation (1) of this regulation.

(5) On dispensing a specified drug the apothecary shall, in

addition to other duties laid down by these regulations or by any

law, enter in a clear, indelible and legible manner all the details set

out in columns 5 to 8 on the card, and shall then return the card to

the person presenting the prescription.

(6)

(a) With the exception of methylphenidate, amphetamine or

any of its isomers it shall be lawful for a medical

practitioner to prescribe in urgent cases a drug to a

patient who is not in possession of a control card,

provided that

(i) the prescription is labelled "URGENT";

(ii) the amount prescribed does not exceed seven

days’ supply;

(iii) it complies with other requirements of these

regulations; and

(iv) the prescriber notifies the Superintendent within

forty-eight hours of issuing such prescription,

giving full particulars of the patient, the name,

form, dose and amount of drug prescribed, and

the reason for the urgency.

(b) It shall be lawful for an apothecary to dispense such a

prescription complying with sub-paragraphs (i), (ii)

and (iii) of paragraph (a) of this sub-regulation.

(7) The provisions of this regulation shall not apply to the

prescription of specified drugs by a medical practitioner employed

in a government hospital, for administration to ward patients at that

time under his care in such hospital, which prescription shall be

controlled by hospital internal rules.

(8) Any request or notification in terms of this regulation may

be made in person or sent by post in a sealed envelope addressed to

the Superintendent of Public Health, Department of Health,

Valletta, and marked "Public Health Notification - Confidential"

for the purpose of exemption from postage.

(9)

For the purpose of this regulation, the expression "medical

practitioner" includes a dental surgeon and a dentist.

(10) The Superintendent may withdraw the control card of a

person who is suspected to be abusing a drug prescribed to him, or

who is in any other way abusing the control card system.

(11) The Superintendent may include on the control card such

guidelines as he may deem necessary regarding the prescription of

specified drugs.

(Regulation 7)

REQUEST FOR PRESCRIPTION FORMS FOR NARCOTIC AND

PSYCHOTROPIC DRUGS

I request ........................ booklet/s by ..................... prescription forms.

Name and surname of prescriber ...........................................................................

( IN BLOCK LETTERS)

Private address .....................................................................................................

( IN BLOCK LETTERS)

Signature ....................................... Med. Council Reg. No.

FOR OFFICIAL USE

Supplied ..................... booklet/s by ..................... prescription forms.

Serial No. ........................ to ........................

(a)

If withdrawn personally by prescriber.

........................................

Signature of Prescriber

Date

(b)

If forwarded by mail.

Forwarded by .................................... on ...........................

A.R. Card to be attached.

Added by: 

L.N. 65 of 1986. 

(Regulation 9)

Amended by: 

L.N. 34 of 1989; 

DEPARTMENT OF HEALTH

L.N. 426 of 2012.

CONTROL CARD FOR NARCOTIC/PSYCHOTROPIC DRUGS

Name and Surname of Patient ....................................

Address ................................................

A legally valid Identification Document Number (where

available, or Passport No., in case of Non-Maltese

citizens who do not hold a legally valid identification

document)

Date of Issue of Card ..........

Valid till ........................

Superintendent of Public Health

(Columns 1 - 4 to be filled by Prescriber)

(Columns 5 - 8 to be filled by Dispensing Apothecary)

Date of

Name of

Amount

Signature of

Amount

Date of

Signature of D.H. Licence

Prescription

Drug.

Prescribed

Medical

Dispensed

Dispensing

Apothecary

No. of

Form and

Practitioner

Dispensary

Dose

and Medical

Council Reg.

No.

Added by: 

(1) No medical practitioner, dental surgeon, dentist or

veterinary surgeon shall prescribe any specified or restricted drug

unl ess t he Superintendent is in possession of his specimen

signature.

(2) The Superintendent may, for the purpose of the control of

drugs, circulate to all managing apothecaries a copy of any such

specimen signature in his possession.

L.N. 65 of 1986.

(Regulation 9)

REQUEST FOR THE ISSUE/RENEWAL OF A CONTROL CARD

FOR NARCOTIC AND PSYCHOTROPIC DRUGS

Superintendent of Public Health

I hereby request that Mr/Ms............................................................. aged .............

I. D. No. * ........................................................ residing at ....................................

(i)

be issued with a control card for narcotic/psychotropic drugs (§)

(ii)

have the control card for narcotic/psychotropic drugs renewed.(§)

(§) Delete whatever is inapplicable.

Signature of Medical Practitioner ..........................................................................

Name and Address of 

Medical Practitioner

Medical Council Reg. No. .....................................................................................

Date .......................................

*

In case of non-Maltese citizens not holding an I.D. Card, the Passport No., is to be inserted; in the

case of a minor the particulars inserted are to be in relation to the I. D. Card or passport of the father,

mother or guardian.

(1) No person shall deliver any specified drug to any other

person except against the presentation of a duly signed receipt

therefor.

(2) No person shall deliver any specified drug to any other

person who is not a managing apothecary or who is not otherwise

lawfully authorised to be in possession of such drug, unless such

other person produces a written authorisation in that behalf, duly

signed by the managing apothecary or by the person otherwise

lawfully authorised to be in possession of such drug, and unless the

person delivering the said drug is satisfied that the authorisation is

genuine.

(3) Nothing in the preceding sub-regulations of this regulation

shall be deemed to refer to the supply of any specified drug against

the presentation of a medical prescription in accordance with the

provisions of these Regulations or to the administration of any such

drug by or under the supervision of a medical practitioner, dental

surgeon, dentist or veterinary surgeon.

(4) For the purpose of this regulation, "deliver" includes any

act or omission whereby a person allows or suffers any other

person, not being a person authorised to be in possession of

specified drugs under these Regulations, to take possession of any

such drug.

Saving the provisions of sub-regulation (6) of regulation 8

of these Regulations, any dispensed prescription, register, invoice

or other document relating to the manufacture, importation,

purchase, sale, supply, distribution, or other disposal of specified

drugs shall be kept at the premises to which they refer and shall be

preserved for a period of not less than two years from the date of

the prescription, record, invoice or other document, or from the

date of the last entry in the register, as the case may be, and during

such time they shall be open to inspection by the Superintendent or

his representative.

(1) No medical practitioner may issue a prescription for

any preparation consisting of or containing cathine, fenetylline,

flunitrazepam, mecloqualone, methaqualone, or phenmetrazine, or

any salts or esters of any such drugs, or for any preparation

consisting of secobarbital or amobarbital or of a combination of

secobarbital and amobarbital, in either case in tablet or capsule

form, or in sachet or cachet, or of any salts or esters thereof in such

presentation, unless he has the prior authorisation in writing by the

Superintendent.

(2) The Superintendent may, before granting any authorisation

as is referred to in sub-regulation (1) of this regulation, request

from the medical practitioner such information as the

Superintendent may require, including whether according to the

opinion of the medical practitioner the patient is suffering from

drug dependency.

(3) When a request for such authorisation is made, the

Superintendent shall submit such request to a panel of medical

specialists who shall advise the Superintendent as to whether such

request is to be authorised or not.

(4) Before making their recommendations it shall be the duty

of the panel to see whether such prescribing is indicated and the

panel shall also, where indicated, make such recommendations as

may be necessary with a view to weaning of patient from such

drug.

(5) The Superintendent may, if he considers it is in the interest

of the patient, authorise the prescription of such drug until the

report of the panel is received.

(6) It shall be the duty of any medical practitioner who delivers

a prescription as is referred to in sub-regulation (1) of this

regulation to inform accordingly the Superintendent within twenty-

four hours of his prescribing such a preparation, giving the details

as set out in the Fourth Schedule to these Regulations.

(7) It shall be the duty of any apothecary dispensing a

prescription as is referred to in sub-regulation (1) of this regulation

to inform the Superintendent accordingly within twenty-four hours

of his dispensing such a preparation, giving the details as set out in

the Fifth Schedule to these Regulations.

(8) All notifications made in compliance with sub-regulations

(6) and (7) of this regulation shall be marked "Confidential".

(9) No veterinary surgeon, dental surgeon or dentist may

prescribe any preparation as is referred to in sub-regulation (1) of

this regulation.

(10) If the President of the Republic has reason to suspect that a

medical practitioner, or a dental surgeon or dentist, is supplying or

prescribing any specified drug to or for either himself or any other

person other than, or more than, is properly required for medical or

dental treatment of himself or that other person, as the case may be,

or that a veterinary surgeon is supplying or prescribing any

specified drug in respect of an animal under his care other than, or

more than, is properly required for the treatment of such animal, as

the case may be, the President may refer the matter to the Medical

Council, and, if the Council so recommends, the President may

prohibit the said medical practitioner, dental surgeon or dentist, or

veterinary surgeon, from supplying, prescribing, procuring or

possessing such drug, for such period as the President may deem

fit, and it shall then be unlawful for that medical practitioner,

d e n ta l surg e on or den t ist , o r v e t e r in a r y su rg e o n to s up pl y,

prescribe, procure or possess any such drug during such period

Provided that the said President may, at any time, modify or

withdraw any such prohibition.

(11) Notice of any prohibition, modification or withdrawal of

any prohibition as is referred to in sub-regulation (10) of this

regulation shall be given in writing to the person affected thereby.

(12) It shall be lawful for the Superintendent to circulate to -

(a) all medical practitioners the name, and other details as

are shown in the Sixth Schedule to these Regulations,

of any person in respect of whom any preparation as is

referred to in sub-regulation (1) of this regulation has

been prescribed; and

(b) all medical practitioners, dental surgeons and dentists

the name, and other details as are shown in the Sixth

Schedule to these Regulations, of any person in respect

of whom any specified drug has been prescribed or

dispensed.

(1) The Superintendent may require all manufacturers,

importers, exporters, and all other persons who trade or otherwise

deal in any restricted drug or any specified drug, to include such

cautions or other warnings on the label, where practicable, or in the

accompanying leaflet of retail packages of such drugs, as are in his

opinion necessary for the safety of the persons using such drugs.

(2) It shall not be lawful for any person to advertise in any way

to the general public any restricted drug or any specified drug.

(1) Any person who manufactures or imports any drug or

any pharmaceutical preparation shall, within eight days of any

manufacture or importation, give notice thereof to the

Superintendent giving details as to the contents and dosage form of

such drug or pharmaceutical preparation

Provided that when a person has complied once with the

provisions of this sub-regulation in respect of a particular drug or

pharmaceutical preparation, he shall not be bound to comply

herewith in respect of any other manufacture or importation of the

same drug or pharmaceutical preparation having the same trade

name and made up of the same contents and dosage form.

(2) The Superintendent may at any time request the

manufacturer or importer of any drug or pharmaceutical

preparation, as the case may be, to give such information as the

Superintendent may require in respect of such drug or

pharmaceutical preparation and the said manufacturer or importer,

as the case may be, shall comply with such request within fifteen

days.

(3)

The Superintendent may -

(a) prohibit the importation of any drug unless such drug

is accompanied by -

(i)

a certificate, acceptable to the Superintendent,

from the competent government authority in the

country of origin, stating that the drug has been

manufactured by a firm duly authorised to

produce such drug for sale in the same country,

and that the quality control facilities at the firm

are satisfactory; and

(ii) a certificate, acceptable to the Superintendent,

stating that the drug complies with the standard

referred to in the British Pharmacopea or in the

British Pharmaceutical Codex or with other

standards acceptable to the Superintendent, or,

where no such standard exists in respect of such

drug, a certificate, similarly acceptable, of

analysis of such drug;

(b) suspend or prohibit the distribution, supply, sale or

keeping or offering for sale, of any drug already

imported, until the certificates referred to in sub-

paragraphs (i) and (ii) of paragraph (a) of this sub-

regulation are produced

Provided that no such suspension or prohibition

shall take effect before the expiry of one month from

the date of the demand of such certificates by the said

Superintendent.

(4) The Superintendent may withdraw or cause to be withdrawn

from the market any drug or pharmaceutical preparation if, because

of adverse reactions or of other information relating to ill effects,

manufacturing practices or other technical or scientific

information, such withdrawal is in his opinion indicated in the

interest of the health of patients.

(5) For the purposes of this regulation, "drug" includes any

medicinal preparation for internal or external use, whether or not

listed or specified in the First or Second Schedule to these

Regulations.

(1) These Regulations shall not apply, in respect of any

specified drug, to any drug when it forms part of, or is incorporated

in, a preparation ready for use and which requires no further

compounding, unless such drug is a main or the only active

ingredient of the preparation.

(2) These Regulations shall likewise not apply in the case of a

preparation containing a specified drug, compounded in such a way

that it presents no risk, or only a negligible risk, of abuse, and the

substance cannot be recovered by readily applicable means in a

quantity liable to abuse, so that the preparation does not give rise to

a public health or social problem.

Any dispensed prescription, register, record, invoice or

other document which, immediately before the coming into force of

these Regulations, are preserved under the Drugs (Control)

Regulations, 1976, * shall continue to be preserved and to be open

for inspection and shall for these purposes be deemed to have

always been preserved under these regulations.

*Revoked by these Regulations.

Substituted by: 