Legal Definition & Classification of

Poisons, Dangerous drugs, Antibiotics &

Pharmaceutical products

Samuel LI
Pharmacist
Drug Office, Department of Health
 This powerpoint is only a general guide and must not be
treated as a complete or authoritative statement of the law
on any particular case.

 Hong Kong e-Legislation: https://www.elegislation.gov.hk

o Cap.138 Pharmacy and Poisons Ordinance
o Cap.138A Pharmacy and Poisons Regulations
o Cap.134 Dangerous Drugs Ordinance
o Cap.134A Dangerous Drugs Regulations
o Cap.137 Antibiotics Ordinance
o Cap.137A Antibiotics Regulations
 Gazette:
https://www.gld.gov.hk/egazette/english/index.html
 Points to note
1) Why definition and classification? Safety concerns?
o To determine which substances or products actually fall under
regulatory control.
o Different levels of requirements and restrictions for each class
regarding manufacture, possession, sale and supply, import/export,
labelling, storage, record keeping, etc.
2) While the definitions seem straight forward, it is actually quite tricky,
and even so in terms of classification.
3) Mutually inclusive in certain areas, e.g. a dangerous drug could also be
a poison.
4) Not every anti-microbial agent is controlled under the Antibiotics
Ordinance (Cap.137).
5) A product which does not contain poisons, dangerous drugs or
antibiotics can be a pharmaceutical product.
 Definitions

 Poisons (S.2 of Pharmacy and Poisons Ordinance, Cap.138)

• a substance which is specified in the Poisons List

 Dangerous Drugs (S.2 of Dangerous Drugs Ordinance, Cap.134)

• any of the drugs or substances specified in Part I of the First Schedule

 Antibiotics (S.3 of Antibiotics Ordinance, Cap.137)

• the substances to which this Ordinance applies are penicillin and such
other anti-microbial organic substances produced by living organisms
as may be prescribed by regulations made by the Director of Health
under section 12 and……any substance the chemical properties of
which are identical with or similar to those of the substances so
prescribed but which is not produced by living organisms.
 Definitions

pharmaceutical product (藥劑製品) and medicine (藥物):

(a) means a substance or combination of substances that-
(i) is presented as having properties for treating or preventing disease in
human beings or animals; or
(ii) may be used in or administered to human beings or animals with a view to—
(A) restoring, correcting or modifying physiological functions by exerting a
pharmacological, immunological or metabolic action; or
(B) making a medical diagnosis; and
(b) includes an advanced therapy product

Remark : 1) this is the definition amended by Pharmacy and Poisons (Amendment)

Ordinance 2020 (came into operation on 1 Aug 2021)
2) basically, a pharmaceutical product must be registered if it is to be
sold/distribution/ possess for sale and distribution in HK
(there are exceptions, for sure)
 Substances

Non Poison Poisons Antibiotics Dangerous Drugs

Part 1 Poison Part 2 Poison Part I DD

Part 1 Schedule 1
Part 1 Schedule 1
Part I Poison Schedule 3
Poison
Poison

Pharmaceutical Products?
Poisons
 Poisons List 毒藥表
 Poisons: a substance which is specified in the Poisons List
under Schedule 10 of the Pharmacy and Poisons Regulations,
Cap.138A
 Updates and amendments proposed by the Poisons
Committee → Negative vetting: first published in gazette and
then passed at legislative council meeting
https://www.elegislation.gov.hk/hk/cap138a!en-zh-Hant-HK?INDEX_CS=N&xpid=ID_1438402708125_001
 Poisons List
 Substances listed in alphabetical order (but for Chinese version,
arranged by the number of strokes)
 A reference to a substance includes:
i) substance prepared either from natural sources or artificially
ii) substance when contained as such in any preparation, solution, mixture
or natural substance
› May include the salts, esters, ethers, alkaloids, “analogues”, derivatives,
optical isomers and etc. as specified in the list
 A derivative is an organic compound which is related to the parent
compound having:
o the same elemental ring, chain, nucleus or skeleton; and
o similar pharmaceutical activity.
o the preparation may or may not require the presence of parent
compound
 Poisons List

 Include chemical and biological substances

 Examples of biological substances:

vaccines
blood products e.g. albumin, antithrombins, Factor IX
monoclonal antibody e.g. infliximab
hormones e.g. insulins, growth hormones, gonadotrophins,
interferons
interleukin
hematopoietic growth factors e.g. erythropoietin

More to come!!
 Poisons List : Part 1 & Part 2 Poisons
毒藥表：第1及第2部毒藥
 Poisons List separated into two parts:
o Part 1 Poisons (“P1”)
o Part 2 Poisons (“P2”)

 In each part, substances for medicinal use and not for medicinal use
were divided:
o Division A: uses are essentially medicinal
o Division B: not normally used medicinally

Non-medicinal poisons e.g. cyanides (for metal cleaning,

electroplating), arsenics, sulphuric acid, strychnine, oxalic acid (stain
removal), phenols.
 Poisons List : Part 1 & Part 2 Poisons
› Level of control: Part 1 Poisons > Part 2 Poisons

› Aspects of regulatory control includes (inconclusive)

1) Restriction on retail sale:
Part 1 Poisons: only in ASP by a registered pharmacist or in his presence and
under his supervision, S.21, Cap.138
Part 2 Poisons: only by ASP or LSP, S.26, Cap.138

2) Wholesale: must obtain license to deal in wholesale of poisons or

pharmaceutical products , reg. 25 & 27, Cap.138A
3) Possession (S.23, Cap.138)
4) Labelling requirements

More about this part in other lectures

 Schedule 1 & Schedule 3 of PPR, Cap.138A

 Certain Part 1 poisons are included in Schedule 1 (附表1) of the

Pharmacy and Poisons Regulations
o Part 1 Schedule 1 Poisons (“P1S1”)
 Certain P1S1 poisons are included in Schedule 3 (附表3) of PPR
o Part 1 Schedule 1 Schedule 3 Poisons (“P1S1S3”)
 Set theory: concept of subset
 Additional regulatory requirements for P1S1 and P1S1S3
poisons
 Legal Classification of Poisons

Part 2 A Part 1 A

Part 1 Schedule 1

Part 1 Schedule 1 Schedule 3

Dangerous Drugs

Psychotropic Substances

Part 2 B Part 1 B

A : those poisons that are essentially medicinal (Simplified for illustration purpose)

B : Normally non-medicinal (e.g. cyanides)

Dangerous Drugs with medicinal use e.g diazepam
 Schedule 1 & Schedule 3 of PPR, Cap.138A

P1S1 Poisons
› Substances to which certain restrictions with respect to the sale,
supply, labelling and storage apply under regulations 3,5,6, 22,
and 24
› Also see S.22 of PPO (and refer back to reg.3): retail sale of P1S1
Poisons by ASP → seller need to make entry in the Poisons Book

P1S1S3 Poisons
› Substances required by regulation 9 to be sold by retail only upon
a prescription given by a registered medical practitioner,
registered dentist or registered veterinary surgeon
Check for a substance’s forensic classification
under Cap.138
 Example 1: Glibenclamide
• This substance’s name appears under Part 1 Division A of the Poisons
List (Sch.10), as well as Sch.1 and Sch.3 of PPR
→ a listed P1S1S3 Poison
→ “Prescription Drug 處方藥物”

 Example 2: Ibuprofen
• This substance’s name only appears under Part 1 Division A of the
Poisons List (Sch.10)
→ a listed P1 Poison (Part 1 only)
→ “Drug under Supervised Sales 監督售賣藥物”

Sounds easy, right?

Definitely NOT!!!!
Complications (with examples)
1. Name of substance
a) Under a group or even not specified in the List, e.g.
• Alkaloids
• Androgenic, oestrogenic and progestational substances
• Antisera, antitoxins, immunoglobulins and vaccines
• Antihistamine
• Blood products
• Contrast media substances
• Suprarenal gland, the active principles of; their salts……
• Thyroid gland, the active principles of; their salts

b) Adopted name (chemical name, INN & synonyms), e.g. lidocaine vs lignocaine

c) Derivatives, salts, esters and analogues--“any compound containing the

chemical structure…” also under control but not listed,
e.g. N-desmethylsibutramine (analogue of sibutramine)
2. Classification which depends on the concentration, content, pack
size, recommended daily dose, dosage form, indication, and etc.

 Codeine
Poisons List Part 1: under Alkaloids-> Codeine
Sch 1: Codeine
Sch 3: Codeine, except substances containing less
than 0.2% of codeine

P1S1 P1S1S3
Codeine < 0.2% Codeine ≥ 0.2%

Codeine phosphate syrup 5mg/5ml?

Pholcodine : P1 only if<1.5%; P1S1 if ≥ 1.5%
Dextromethorphan: P1only if ≤ 0.1% ; P1S1 if >0.1%; P1S1S3 if in inj. form
More P1S1 poisons: Phenylpropanolamine(PPA)? Hyoscine (Scopolamine)?
Dihydrocodeine?
 Diclofenac
Poisons List Part 1: Diclofenac, its salts
Sch 1, Sch 3: Diclofenac; its salts; except when contained in
preparations for external application only

 Benzocaine
Poisons List Part 1: Para-Aminobenzoic acid, esters of; their salts; except
benzocaine when contained in condoms
Poisons List Part 2: Benzocaine when contained in condoms

 Salbutamol
Poisons List Part 1: Salbutamol; its salts
Sch 1, Sch 3: Salbutamol and its salts, except when contained
in aerosol dispensers
 Aciclovir
Poisons List Part 1: Aciclovir; its salts
Sch 1, Sch 3: Aciclovir; its salts; except when contained in skin creams
packed in a package size of not more than 3 grams and
labelled for the treatment of cold sores only

 Pantoprazole
Poisons List Part 1: Pantoprazole; its salts
Sch 1, Sch 3: Pantoprazole; its salts; except when contained in
oral preparations with 20 mg or less per solid dosage unit,
indicated with the maximum daily dose of 20mg for
relief of heartburn symptoms associated with acid reflux
in patients of 18 years old or above, and in packs with
the maximum supply of 7 days

Omeprazole (P1S1S3 in parenteral preparation, otherwise P1)

Esomeprazole (P1S1S3)
 Corticosteroids
Poisons List Part 1: Suprarenal gland, the active principles of; their salts;
their derivatives; their salts
Sch 1, Sch 3: Suprarenal gland, the active principles of,
except adrenaline and noradrenaline (other
than when contained in aerosol dispensers);
their salts; except salts of adrenaline (other
than when contained in aerosol dispensers);
their derivatives; their salts; except
hydrocortisone and its salts when contained
in preparations intended for external
application only at not more than 1%; except
beclomethasone and its salts when contained
in aerosol dispensers and except clobetasone
butyrate when contained in preparations intended
for external application only at not more than 0.05%

Any other corticosteroids? prednisolone, betamethasone, dexamethasone,

triamcinolone……
 Some Injections
Poisons List Part 1:
Sch 1, Sch 3:
Pharmaceutical products for human parenteral administration containing the
following or their salts, as active ingredients, except in mixture with insulin—
e.g. amino acids
antihistamine substances
caffeine
fish oil
olive oil
paracetamol
sodium chloride 0.9%
vitamins
water
Please refer to the full list in Ordinance!!
Don’t mix up when you search for the drug ingredient in the list or schedule,
maybe under parenteral dosage form only!!
 Vitamin A, D, K
Poisons List Part 1:
Sch 1, Sch 3:
o Vitamin A and its esters when contained in pharmaceutical
products the recommended daily dose of which contains not
less than 10,000 international units of vitamin A (>=10,000IU)
o Vitamin D and its salts when contained in pharmaceutical
products the recommended daily dose of which contains more
than 1,000 international units of vitamin D (>1,000IU)
o Vitamin K and its salts when contained in pharmaceutical
products, except products with recommended daily dose of 120
mcg or less of vitamin K1 or K2 or its salts
 Antihistamines (please refer to the full list in Ordinance)
Poisons List Part 1:
Antihistamine substances, the following; their salts; any compound with any
substance falling within this item—
e.g. astemizole, cyclizine, desloratadine, diphenhydramine, fexofenadine,
ketotifen, promethazine, terfenadine……
loratadine (except Loratadine; its salts; when contained in pharmaceutical
products labelled for the relief of the symptoms of allergic rhinitis only)
Antihistamine substances other than the above; their salts; any compounds
with such substances; when contained in preparations for parenteral use

Sch 1, Sch 3:
Antihistamine substances, the following; their salts; any compound with any
substance falling within this item—
e.g. astemizole, terfenadine
Pharmaceutical products for human parenteral administration
→ antihistamine substances
 Antihistamines (cont’d)
Poisons List Part 2:
Antihistamine substances not included in Part 1 of this List; their salts;
their compounds with any other substance
Loratadine; its salts; when contained in pharmaceutical products
labelled for the relief of the symptoms of allergic rhinitis only

Any examples of antihistamine not included in Part 1??

brompheniramine, chlorpheniramine, dexchlorpheniramine, triprolidine,
cetirizine, levocetirizine….
 Nicotine
Poisons List Part 1 Sch 1: under Alkaloids->Nicotine
except when contained in
(a) chewing gum or lozenges, intended to be used in nicotine
replacement therapy and containing not more than 4 mg of
Nicotine per piece; or
(b) patches for external application, intended to be used in nicotine
replacement therapy

Poisons List Part 2:

Nicotine when contained in
(a) chewing gum or lozenges, intended to be used in nicotine
replacement therapy and containing not more than 4 mg of
Nicotine per piece; or
(b) patches for external application, intended to be used in nicotine
replacement therapy

Liquid for e-cigarette containing nicotine?

 Contrast media
Poisons List Part 1:
Sch 1, Sch 3: Contrast media, the following; their salts; and compound
with any substance falling within this item; when contained
in preparations for parenteral use—
Please refer to the list in Ordinance!!

 Lovastatin
Poisons List Part 1: Lovastatin when contained in pharmaceutical products
Sch 1, Sch 3: Lovastatin when contained in pharmaceutical products
it was found naturally occurring in certain plants (red yeast rice) and fungi (oyster
mushroom)

 Cannabidiol
Poisons List Part 1: Cannabidiol; its salts; when contained in pharmaceutical
products
Sch 1, Sch 3: Cannabidiol; its salts; when contained in pharmaceutical products
Food and beverage?
Complications (with examples)
3. Relaxation and Exemptions
i) Under Poisons List Part 2:
Division A
Clotrimazole; its salts; when contained in pharmaceutical products
labelled only for the treatment of tinea pedis or tinea cruris, or both
Terbinafine; its salts; when contained in preparations for external
application only with no more than 1% of Terbinafine and not to be
administered as a single application and when labelled only for the
treatment of tinea pedis or tinea cruris, or both
Division B
Diamines, the following; their salts — Phenylene diamines; toluene
diamines; other alkylated-benzene diamines
i) Under Poisons List Part 2:
Pharmaceutical products retailed in the form as supplied by the
manufacturer, containing a poison included in Division A of Part 1
of this List, where the proportion of the poison does not exceed the
equivalent of—
(a) 0.01% by weight of arsenic trioxide, cantharidin, cocaine,
coniine, ecgonine, hydrocyanic acid, strychnine, alkaloids of
aconite, alkaloids of coca or alkaloids of gelsemium;
(b) 2%, weight in volume, of mercurochrome when contained in
solutions for external use only; and
(c) 0.1% by weight in the case of other poisons,
except pharmaceutical products containing any poison—
(d) included in Schedule 3; or
(e) in the list specified— e.g. diclofenac, codeine, pholcodine
ii) Complete exemption by reg.8 for articles and substances in
Schedule 2, PPR
Reg.8: nothing in the Ordinance or these regulations shall apply —
however the provisions regarding wholesale dealing, manufacture,
registration, sale, import/export, still apply if that is a pharmaceutical
product
→ Not regarded as poisons
Sch. 2, Group I: ceramics, fillers, fireworks, etc.
Sch. 2, Group II: see the following examples:
a) Antihistamine substances
Preparations intended for external application only and
preparations containing not more than 1% of antihistamine
substances for application in the eye or nose
b) Steroid compounds with androgenic or oestrogenic or
progestational activity; their esters---
Preparations intended to be taken orally for contraceptive purposes
only which contain not more than the following per dose—
 0.15 milligrams Desogestrel;
With effect from 28 June 2025, these
 3.00 milligrams Drospirenone; oral contraceptives will be controlled
 0.05 milligrams Ethinyloestradiol; as Part 2 poisons
 0.10 milligrams Gestodene; https://www.drugoffice.gov.hk/eps/uploa
 0.25 milligrams Levonorgestrel; d/eps_news/53716/EN/1/Amendments%2
0to%20the%20Pharmacy%20and%20Poiso
 2.50 milligrams Lynoestrenol; ns%20Regulations_Eng.pdf
 0.05 milligrams Mestranol;
 1.00 milligrams Norethisterone;
 0.25 milligrams Norgestimate; and
 0.50 milligrams Norgestrel,
 multivitamin preparations with or without minerals containing not more
than 0.01 mg. ethinyloestradiol or not more than 2.5 mg.
Methyltestosterone or both in each dosage form
 Are these oral contraceptives exempted?
 Yasmin (Drospirenone 3mg, Ethinyloestradiol 0.03mg)
 Nordette (Levonorgestrel 0.15mg, Ethinyloestradiol 0.03mg)
 Postinor-2 (Levonorgestrel 0.75mg)
 Diane-35 (Cyproterone 2mg, Ethinyloestradiol 0.035mg)

c) Creosote obtained from wood

 Substances containing less than 50% creosote obtained from wood

d) Clioquinol
 Preparations for external application only

e) Nicotine (Group II, Division B)

 Tobacco
Consider the regulatory control of nicotine-containing liquid for e-
cigarette: any exemption under Part 1 or Part 2? pharmaceutical
cigarette?
4) Non-poisons?

A substance not under Poisons list? So many!!

What if it is neither a Dangerous Drug nor

Antibiotic?

Any regulatory control for a product containing

non-poison?
bromhexine, ranitidine, famotidine, loperamide……
(pharmaceutical product)
 Check by yourself

Anti-fungals: amorolfine, clotrimazole, terbinafine, ketoconazole ……

Dihydrocodeine
Iodine-131
Minoxidil
NSAIDs: aspirin, ibuprofen, ketoprofen, indomethacin,
naproxen, piroxicam……
Orlistat
Tranexamic acid
……………………………………………………………….
https://www.drugoffice.gov.hk/eps/do/en/pharmaceutical_trade/other_useful_information/letters_to_trade.html
Strengthening the Sales Control of Codeine Containing Products
 medicines containing not more than 0.1% codeine will be regulated as P1S1 also
 all <0.2% = P1S1, come into operation on 26 Jan 2024
https://www.drugoffice.gov.hk/eps/upload/eps_news/52591/EN/1/Amendment_to_the_Pharmacy_a
nd_Poisons_Regulations.25.01.2024.pdf
Strengthening the Sales Control of Pharmaceutical Products containing
Antipyretic Drug Substances including Aspirin, Ethenzamide,
Paracetamol, Phenazone, Propyphenazone and Salicylamide
(added to Part 2, come into operation on 21 Oct 2023)
 21 Oct 2022
https://www.drugoffice.gov.hk/eps/upload/eps_news/48145/EN/1/PRC%20Letter%20to%20Tr
ade_antipyretics_Eng_2022.10.21_clean.pdf
 21 Aug 2023
https://www.drugoffice.gov.hk/eps/upload/eps_news/50709/EN/1/Reminder%20Letter%20to
%20Trade_(Antipyretics)_ENG_2023.08.21.pdf

Strengthening the Sales Control of Pharmaceutical Products containing

Betahistine
(added to P1 and P1S1S3, come into operation on 21 Oct 2023)
 21 Oct 2022
https://www.drugoffice.gov.hk/eps/upload/eps_news/48144/EN/1/PRC%20Letter%20to%20Tr
ade_betahistine_Eng_2022.10.21_clean.pdf
 Aspirin, Paracetamol, etc.
NP → P2 w.e.f. 21 Oct 2023

https://www.drugoffice.gov.hk/eps/upload/eps_news/48145/EN/1/PRC%20Letter
%20to%20Trade_antipyretics_Eng_2022.10.21_clean.pdf
 Allopurinol
PI → PIS1S3 w.e.f. 3 Sep 2022

https://www.drugoffice.gov.hk/eps/upload/eps_news/4
5264/EN/1/PRC%20Letter%20to%20Cert%20Holders_allo
purinol_Eng_2021.09.03_clean.pdf
Psychotropic Substances?
 e.g. Phenobarbital, Zolpidem
 Not a legal entity
 Convention on Psychotropic
Substances, 1971
 United Nations Convention
against Illicit Traffic in Narcotic
Drugs and Psychotropic
Substances
› http://www.incb.org
Dangerous Drugs
 Legal Classification of Dangerous Drugs (危險藥物)

› Dangerous Drug: any of the drugs or substances

specified in Part I of the First Schedule of the
Dangerous Drug Ordinance, Cap.134
(“Part I DD 第I部危險藥物”)

› S.2(3), Cap.134 Any quantity of a DD shall be a DD

notwithstanding that the quantity is insufficient to be
measured or used. (but relaxed control for some DDs
under Part II, III, IV of First Schedule)
 First Schedule, Part I DD
› Abusive drugs (some with medicinal use)
› Including any isomeric form, ester or salt of a
substance in the list
› Including any preparation, mixture, extract or other
substance (whether natural or otherwise) containing
any proportion of a substance
https://www.elegislation.gov.hk/hk/cap
134?xpid=ID_1438402701417_001
Part I DD
 Types of psychoactive drugs:
› Narcotics--opioids, e.g. opium, heroin (diamorphine), morphine,
methadone, pethidine, fentanyl, hydrocodone, codeine,
pholcodine, dihydrocodeine, ethylmorphine, dextropropoxyphene,
poppy straw, etc.;
› Benzodiazepines, e.g. diazepam, bromazepam, chlordiazepoxide,
midazolam, triazolam, etc.;
› Barbiturates, e.g. barbitone, quinalbarbitone, etc.
› Amphetamines, i.e. methamphetamine, phentermine, etc;
› Others: Cocaine, Gamma Hydroxybutyric Acid (GHB), Ecstasy
(MDMA), Ketamine, Lysergide (LSD), Methaqualone, Phencyclidine
(PCP), Cannabis, Coca leaves, etc;
 Type Substance Street Name Medical Use
Narcotics Methadone, Pain relief or
Analgesic morphine, opium treatment of
narcotic drug
addiction
Hallucinoge Cannabis, Marijuana, grass, None
ns LSD 草
Fing 霸
Depressants Barbiturates Sedative, hypnotic,
anti-convulsant
GHB Liquid Ectasy, 迷姦 None
水
Stimulants Methamphetami 冰 None
nes Weight loss
Phentermine Anesthetic
Cocaine 搖頭丸, 狂喜, e仔 None
MDMA (Ectasy)
Tranquillizers Benzodiazepines, 藍精露, 五仔, 綠豆仔, Hypnotics
十字架, 白瓜子

Others Ketamine 氯胺酮 K仔 Surgical

Codeine anaesthetic
Cough
suppressant
Part I DD
 Trafficking of DD is a very serious offence (S.4)
 Some of the DD are also P1S1S3 Poisons and regulated under
PPO, particularly those with medicinal use →
prescription only medicines, e.g.
Codeine
Pholcodine
Dihydrocodeine
Morphine
Diazepam and other compounds containing the chemical structure of
dihydro-1,4-benzodiazepine substituted to any degree; their salts
Chlordiazepoxide
Methylphenidate
Cocaine
 Authority to procure, supply and possess stipulated under
Part IV of DDO
 Requirementsfor DD prescriptions are also stipulated under
S.31 of DDO and Reg.3 of DDR
 *Authoritymust be exercised only if necessary for the
practice or exercise of his profession, function or
employment , and in his capacity
 Licensing requirements and requirements on storage (S.23,
24, 28), record keeping (Reg.5, 6, 7)

More detail in later lectures

First Schedule, Part II & III
 Relaxed control to some Part I DD with conditions

“Part II & III DD”

 Part II DD are exempted from certain requirements under

DDO, e.g. S.4 (trafficking DD), S.23 & S.24 (kept in locked
receptacle), Reg.5 (Record keeping)
 However, don’t forget the regulatory control of Poisons
under PPO, e.g. Poisons book (P1S1), storage (P1, P1S1),
prescription (P1S1S3)
First Schedule, Part II
13. if the preparation of not more than one of the below substances & their
salts (see para 19 & 20), when:
a) no or negligible risk of abuse & cannot be recovered by readily means; &
b) not more than 100mg per dose unit (單獨劑量) & not more than 0.5% in
undivided preparation (非單獨劑量中之濃度)
Acetyldihydrocodeine
Codeine
Dextropropoxyphene
Dihydrocodeine
Ethylmorphine (3-ethylmorphine)
Nicocodine (6-nicocodine)
Norcodeine
Pholcodine
Propiram
First Schedule, Part II
14. Cocaine of not more than 0.1%, in a preparation compounded
with one or more ingredients, no or negligible risk of abuse,
opium/morphine cannot be recovered by readily applicable
means or in a yield which would constitute a risk to health

15. Medicinal opium/morphine of not more than 0.2% of

morphine (anhydrous morphine base), in a preparation
compounded with one or more ingredients, no or negligible
risk of abuse, opium/morphine cannot be recovered by
readily applicable means or in a yield which would constitute
a risk to health
16. Preparation of diphenoxylate containing not more than 2.5mg per dosage
unit and not less than 25mcg of atropine
16A. Preparation of difenoxin containing not more than 0.5mg per dosage unit,
and a quantity of atrophine sulphate equivalent to at least 5% of the dose
of difenoxin
16B. Preparation for oral use containing not more than 135mg of
dextropropoxyphene base per dosage unit or concentration of not more
than 2.5%, provided that NO Schedule 3 substance under PPO
16C. Preparation of propiram containing not more than 100mg of propiram per
dosage unit and compounded with at least the same amount of
methylcellulose
16D. Preparation of gamma-butyrolactone (GBL) containing not more than
0.1%, being a preparation compounded with one or more other
ingredients in such a way that the preparation has no, or a negligible risk
of abuse and that GBL cannot be recovered by readily applicable means or
in a yield which would constitute a risk to health
17. Pulvis Ipecacuanhae et Opii Compositus-
10% opium in powder,
10% Ipecauanhae root, in powder, well mixed with
80% of any other powdered ingredient containing no DD

18. Mixtures containing not more than one of the

preparation specified in para. 13-17, being mixtures
whereof none of the other ingredients is a DD
First Schedule, Part III
19. The following substances, namely—
 Acetyldihydrocodeine  Nicocodine (6-nicocodine)
 Codeine  Norcodeine
 Dextropropoxyphene  Pholcodine
 Dihydrocodeine  Propiram
 Ethylmorphine (3-ethylmorphine)

20. Salt of substance specified in para.19

21. Preparation, mixture, extract or substance containing…para.19 or 20

22. Other preparation specified in Part II of First Schedule.

First Schedule, Part IV

› Preparation which may be sold by retail by LSP

23. Preparation containing not more than 0.1% of cocaine,

being a preparation compounded with one or more other
ingredients in such a way that the preparation has no or
a negligible risk of abuse and that the substance
contained therein cannot be recovered by applicable
means or in a yield which would constitute a risk to
health

❑ Products containing cocaine registered in HK

◼ Cocaine HCL Eye/Nose Drops 5% (HK-50765)
 Examples of Forensic Classification
First Schedule Part I DD

e.g. Midazolam, Diazepam, Phentermine

Codeine, Pholcodine, Dextropropoxyphene,
Cocaine

DDO: Part II (& III) DD e.g. Codeine, Pholcodine if Part II, & IV DD e.g. Cocaine if
≤ 100mg/dosage unit & concentration ≤ 0.5% in ≤ 0.1%
undivided preparations. Present in compounded preparation (non-DD),
Present in compounded preparation (non-DD), no risk of abuse, not readily recoverable
no risk of abuse, not readily recoverable
PPO: But note regulatory control under Cap.138 (Rx, But note regulatory control under Cap.138:
Poison book, storage ): P1S1 ≥ 0.1%
Codeine P1 > 0.01% & < 0.1%
P1S1 <0.2%* P2 if ≤ 0.01%
P1S1S3 ≥ 0.2%
Pholcodine *Strengthened control of codeine, w.e.f. 26 Jan 2024
P1 <1.5%, P1S1 ≥ 1.5% https://www.drugoffice.gov.hk/eps/upload/eps_news/52591/EN/1/Amendm
ent_to_the_Pharmacy_and_Poisons_Regulations.25.01.2024.pdf
Examples of Forensic Classification
Preparation Concentration Forensic Classification
PPO DDO
Codeine Syrup 30mg/5ml 0.6% P1S1S3 PI DD
Codeine Syrup 9mg/5ml 0.18% P1S1 PII & PIII DD
Codeine Syrup 4mg/5ml 0.08% P1S1 PII & PIII DD
Codeine 15mg Tablet (500mg) 3% P1S1S3 PII & PIII DD
Codeine 0.5mg Tablet (500mg) 0.1% P1S1 PII & PIII DD
Pholcodine Syrup 0.9% 0.9% P1 PI DD
Pholcodine Syrup 0.2% 0.2% P1 PII & PIII DD

PPO Alkaloids\Codeine
PPO Pholcodine; its salts; its ester and . . . . .
PPO S1\Alkaloids\Codeine, except substances containing not more than 0.1% of Codeine*
PPO S1\Pholcodine, except substance containing less than 1.5% of Pholcodine
PPO S3\Alkaloids\Codeine, except substances containing less than 0.2% of Codeine
DDO Part I\(1a) Codeine; Pholcodine
DDO Part II\(13) Codeine / Pholcodine: a prep. not more than 100mg / not more than 0.5% (undivided prep.)
DDO Part III\(19) Codeine
*Strengthened control of codeine, w.e.f. 26 Jan 2024
Antibiotics
 Legal Classification of Antibiotics (抗生素)
 S.3 of Antibiotics Ordinance, Cap.137

 Antibiotics: the substances to which this Ordinance applies are penicillin

and such other anti-microbial organic substances produced
by living organisms as may be prescribed by regulations made
by the Director of Health under section 12 and……any substance
the chemical properties of which are identical with or similar to
those of the substances so prescribed but which is not produced
by living organisms

This ordinance shall NOT apply to antibiotics substances contained in foods

for livestock, manufactured for the purpose of supplementing foods for
livestock
 Reg.2 of Antibiotics Regulations, Cap.137A

This Ordinance shall apply to the substances specified and defined

in Schedule 1 of the Antibiotics Regulations and to their salts and
their derivatives and to the salts of such derivatives regardless of
the method of production.
https://www.elegislation.gov.hk/hk/cap137a?xpid=ID_1438
402705505_001
Examples of Antibiotics under Sch1 of AR
色霉素 Chromomycin, isolated from strains of Streptomyces griseus.
紅霉素 Erythromycin, isolated from strains of Streptomyces erythreus
灰黃霉素 Griseofulvin, isolated from strains of Penicillium griseofulvum
氯霉素 Chloramphenicol, isolated from strains of Streptomyces.
青霉素 Penicillin, isolated from strains of Penicillium notatum.
紫霉素 Viomycin, isolated from strains of Streptomyces.
金霉素 Chlortetracycline, isolated from strains of Streptomyces.
土霉素 Oxytetracycline, isolated from strains of Streptomyces.
制霉菌素 Nystatin, isolated from strains of Streptomyces noursei.
新霉素 Neomycin, isolated from strains of Streptomyces.
 Prescription only medicines
 Licensing requirements and regulatory control regarding
possession, sale and supply, record keeping, and etc.

More detail in another lecture

Tetracycline and its salts

 Tetracycline
 Tetracycline Hydrochloride
 Tetracycline Phosphate Complex
Derivatives ›Semi-synthetic Derivatives
 Erythromycin  Clarithromycin

 Azithromycin
 Antibiotics & Antimicrobial Agents
 The term antibiotic under the Ordinance refers to
substances produced by a micro-organism that is
antagonistic to the growth of others in high dilution

 Some antibiotics/antimicrobial agents are not in the list!!

e.g. synthetic compounds

However, they might be Poisons regulated by PPO

Examples of Antibiotics/Antimicrobial agents not under AO
Antibiotics Forensic Classification
Quinolones/ Fluoroquinolones , e.g. P1S1S3 Poisons
ciprofloxacin, ofloxacin, levofloxacin, nalidixic
acid

Para-Aminobenzenesulphonamides P1S1S3 Poisons

e.g. sulphonamide

Trimethoprim P1S1S3 Poisons

Metronidazole P1 → P1S1S3 Poisons (w.e.f. 14 Feb

2021)

Nitrofurantoin NP → P1S1S3 Poison (w.e.f. 18 Oct

2020)
Poison or Antibiotic? A Guide to “Class” Entries
https://www.drugoffice.gov.hk/eps/do/en/doc/guidelin
es_forms/Guide_to_Class_Entries.pdf

Is it a poison?
Is it an antibiotic?
Is it a dangerous drug?

If so/ not so , is it a pharmaceutical product?

Classification of Pharmaceutical
Products
 Classification of Pharmaceutical Product
 Legal definition under S.2 of PPO, Cap.138:
pharmaceutical product (藥劑製品) and medicine (藥物):
(a) means a substance or combination of substances that-
(i) is presented as having properties for treating or preventing disease in
human beings or animals; or
(ii) may be used in or administered to human beings or animals with a view
to—
(A) restoring, correcting or modifying physiological functions by exerting
a pharmacological, immunological or metabolic action; or
(B) making a medical diagnosis; and
(b) includes an advanced therapy product

Remark : 1) this is the definition amended by Pharmacy and Poisons (Amendment)

Ordinance 2020
2) basically, a pharmaceutical product must be registered if it is to be
sold/distribution/ possess for sale and distribution in HK
(there are exceptions, for sure)
 Advanced Therapy Product (ATP)
▪ Advanced therapy product (先進療法製品) means any of the following products that is for
human use-
a) a gene therapy product;
b) a somatic cell therapy product;
c) a tissue engineered product.

▪ Gene therapy product (基因療法製品)

a) means a product-
(i) that contains an active substance containing or consisting of a recombinant nucleic
acid that may be used in or administered to human beings with a view to regulating,
repairing, replacing, adding or deleting a genetic sequence; and
(ii) the therapeutic, prophylactic or diagnostic effect of which relates directly to-
(A)The recombinant nucleic acid sequence it contains; or
(B)The product of genetic expression of that sequence; but
b) does not include a vaccine against an infectious disease;
 Advanced Therapy Product (ATP)
▪ Somatic cell therapy product (體細胞療法製品): means a product that-
a) contains or consists of any of the following cells or tissues-
(i) Cells or tissues that have been subject to substantial manipulation so that
their biological characteristics, physiological functions or structural properties
relevant for the intended clinical use have been altered;
(ii) Cells or tissues that are not intended to be used for the same essential
functions in their recipients as in their donor; and
b) is presented as having properties for, or may be used in or administered to human
beings with a view to-
(i) treating, preventing or diagnosing a disease; or
(ii) Restoring, correcting or modifying physiological functions,
through the pharmacological, immunological or metabolic action of those cells or
tissues;
Manipulation Processes that are NOT
Substantial Manipulations (Schedule of Cap.138)
1. Cutting
2. Grinding
3. Shaping
4. Centrifugation
5. Soaking in antibiotic or antimicrobial solutions
6. Sterilization
7. Irradiation
8. Cell separation, concentration or purification
9. Filtering
10. Lyophilization
11. Freezing
12. Cryopreservation
13. Vitrification
 Advanced Therapy Product (ATP)
▪ Tissue engineered product(組織工程製品):
(a) means a product that-
(i) contains or consists of any of the following cells or tissues-
(A) cells or tissues that have been subject to substantial manipulation so that their
biological characteristics, physiological functions or structural properties relevant for
the intended regeneration, repair or replacement have been altered;
(B) cells or tissues that are not intended to be used for the same essential functions in
their recipients as in their donor; and
(ii) is presented as having properties for, or may be used in or administered to human
beings with a view to regenerating, repairing or replacing a human tissue; but
(b) does not include a product that-
(i) Contains or consists of exclusively non-viable human or animal cells or tissues; and
(ii) Does not act principally by pharmacological, immunological or metabolic action;
 Guidance on Classification of ATPs
 Effective from 1 Aug 2021
 https://www.ppbhk.org.hk/eng/files/PPB_Guid
ance_ATP_Classification_en.pdf
 Pharmaceutical
Product

Non Poison Poisons Antibiotics Dangerous Drugs

Part 1 Poison Part 2 Poison Part I DD

No restriction
Part I Schedule 1 ASP & LSP only
Part 1 Schedule 1
Part 1 Poison Schedule 3 ASP-only
Poison
Poison
ASP-only &
Prescription-only
Not a easy task to classify a pharmaceutical
product!!
Factors to consider may involve:
 Legal definition
 Relevant court precedents or legal advice
 Assessment of product information, which includes details of product’s
composition, presentation and purpose. Account will be taken of material being
used to promote the product.
 substance is present in the product;
 Substance is medicinal or not;
 pharmaceutical dose form (i.e., capsule, tablet, etc.) and the way it is to be used;
 use(s) indicated on the label, packaging/package inserts, promotional materials
 any essentially similar pharmaceutical products registered in Hong Kong
 any risk to public

Guidance Notes on Classification of Products as “Pharmaceutical Products”

https://www.drugoffice.gov.hk/eps/do/en/doc/guidelines_forms/Guide_on_PRClass.pdf
Pharmacy and Poisons Board’s General Line in
Deciding whether the Product is Pharmaceutical or
Not
Examples:
Antiseptic and disinfectant product
Vitamin products

Guidance Notes on Classification of Products as “Pharmaceutical Products”

https://www.drugoffice.gov.hk/eps/do/en/doc/guidelines_forms/Guide_on_PRClass.pdf
 Antiseptic and disinfectant product
I. Skin antiseptic products containing chlorhexidine for human or animal use are classified
as pharmaceutical products unless otherwise stated,
(a) they are clearly labelled in English and Chinese for washing hands only (or equivalent); or
(b) chlorhexidine is used as preservative or antimicrobials in cosmetic products.
II. (a) Unless otherwise stated, skin antiseptic products for human or animal use without
any claims but containing well established active ingredients documented to be effective
antiseptics, which include the following- Benzalkonium salts; Benzethonium salts;
Cetrimide; Hydrogen peroxide; or Iodine / Povidone iodine, are classified as
pharmaceutical products regardless of their concentration.
(b) General toiletry or cosmetic products containing antiseptic substances as preservatives, or
intended for general cleansing or sanitary use, such as hand wash, body wash, cleanser and
shampoo are generally not considered as pharmaceutical products.
III. Subject to above, antiseptics and disinfectant products (including Benzalkonium salts,
Benzethonium salts, Cetrimide and Chlorhexidine when contained in products other than
skin antiseptic products) will not be classified as pharmaceutical products if the
concentration of the substance(s) contained in the products is not more than the
maximum concentration specified in the following table, provided that they do not carry
medicinal claims and are not labelled for use on broken skin
 Antiseptic and disinfectant product

https://www.drugoffice.gov.hk/eps/do/en/doc/guidelines_forms/Guide_on_PRClass.pdf
Vitamin products
In addition to the scenarios mentioned in the previous appendices, vitamin
products are not considered as pharmaceutical products unless they belong to
the following categories in oral dose form:
i). vitamin A with not less than 10,000 I.U. daily dose;
ii). vitamin B3 (nicotinic acid) with more than 200 mg daily dose;
iii). vitamin D with more than 1,000 I.U. daily dose; and
iv). vitamin K except vitamins K1 or K2 with 120 mcg or less daily dose.

https://www.drugoffice.gov.hk/eps/do/en/doc/guidelines_forms/Guide_on_PRClass.pdf
 De-registration of
Pharmaceutical Product
containing Pholcodine
 w.e.f. 1 Jan 2024

https://www.drugoffice.gov.hk/eps/upload/eps_ne
ws/50090/EN/1/Letter%20to%20Trade_Pholcodine%2
0Deregistration_en_20230707.pdf
Regulation of Medical
Gases as Pharmaceutical
Products
w.e.f. 14 June 2026

https://www.drugoffice.gov.hk/eps/upload/eps_
news/53648/EN/1/Letter_Regulation%20of%20Me
dical%20Gases_en_20240617.pdf
 Nicotine containing e-cigarette products
(including e-cigarette liquids)
 All nicotine-containing alternative smoking products,
except when the nicotine is contained in tobacco, are
pharmaceutical product in Hong Kong.
 In addition, nicotine is a Part 1 poison

https://www.drugoffice.gov.hk/eps/upload/eps_news/47854/EN/1/Letter%20to%20WDL-
Regulation%20of%20Nicotine%20containing%20Pharmaceutical%20Producuts_En%20DO
%2020220922.pdf
https://www.drugoffice.gov.hk/eps/do/en/pharmaceutical_trade/search_drug_database.html
 Ordinance not to apply to Chinese herbal medicines
and proprietary Chinese medicines, etc.
S.37 of PPO
(1) Subject to subsection (2), nothing in this Ordinance shall apply to
the sale, manufacturing, dispensing or compounding of Chinese
herbal medicines or proprietary Chinese medicines as defined in
section 2 of the Chinese Medicine Ordinance (Cap. 549) or other
materials of herbal, animal or mineral origin customarily used by
the Chinese for medicinal purpose.
(2) Notwithstanding subsection (1), this Ordinance shall apply to
pharmaceutical products containing any such Chinese herbal
medicines or proprietary Chinese medicines or other materials or
herbal, animal or mineral origin customarily used by the Chinese
for medicinal purpose as active ingredients.
 Definition of Chinese medicines under the
Chinese Medicine Ordinance, Cap.549
 “Chinese herbal medicine”(中藥材) means any of the substances
specified in Schedule 1 or 2
 “proprietary Chinese medicine” (中成藥) means any proprietary product-
(a) composed solely of the following as active ingredients
i. any Chinese herbal medicines; or
ii. any materials of herbal, animal or mineral origin
customarily used by the Chinese; or
iii. any medicines and materials referred to the above;
(b) formulated in a finished dose form; and
(c) known or claimed to be used for the diagnosis, treatment,
prevention or alleviation of any disease or any symptom of a disease in
human beings, or for the regulation of the functional states of the
human body
Thank You!!