Lectures on Pharmacy Legislation (Lec 05)

I attended the last Lecture of Pharmacy Legislation on 14 May 2010. The topics were “Dangerous Drugs Ordinance (Cap. 134) on Classification & Sale of Dangerous Drugs (DD)”.


Definition of DD is drugs or substances specified in First Schedule, Part I.
It included the following substances.
1. a) Opioids (Opioids are narcotic drugs that are generally prescribed to manage pain.) (鴉片類)
- Benzodiazepines (It relieves nervousness, tension, and other symptoms by slowing the central nervous system.) (苯二氮是一種抗焦慮症的藥)
- Hypnotics (An agent that causes sleep) (安眠藥)
- Amphetamines (A colorless, volatile liquid, C9H13N, used as a central nervous system stimulant in the treatment of certain conditions, such as attention deficit hyperactivity disorder, depression, and narcolepsy, and abused illegally as a stimulant.) (苯丙胺 (alpha-methyl-phenethylamine) - 俗稱安非他命)
- Hallucinogens (A drug or chemical that causes alterations in perception (usually visual), mood, and thought.) (迷幻劑)
b) Structurally derived from tryptamine (色胺,β-吲哚基乙胺)
c) Structurally derived from phenethylamine (苯乙胺)
d) Structurally derived from fentanyl (芬太尼, 一种止痛剂)
e) Structurally derived from pethidine (哌鱼替啶)
2. any stereoisomer of (1) not being dextromethorphan or dextrophan;
3. any ester or ether of (1) or (2);
4. any salt of (1), (2) or (3);
5. concentrate of poppy straw (罌粟稈)
6. medicinal opium (鴉片)
7. prep., mixture, extract or other substance containing (1) to (6);
8. opium or opium water;
9. coca leaves (古柯葉);
10. poppy straw (罌粟稈);
11. cannabis (大麻) & cannabis resin (大麻樹脂)

First Schedule, Part II is shown as follow.
13. Preparation of not more than (<) one of the substances in (19) or (20) (in Part III), when a) no or negligible risk of abuse & cannot be recovered by readily means; & b) <100mg per dose unit & <0.5% in undivided preparation.
14. Preparation of <0.1% of cocaine (Cocaine is a highly addictive central nervous system stimulant extracted from the leaves of the coca plant, Erythroxylon coca. -可卡因), & (a);
15. Preparation of medicinal opium or morphine (嗎啡) with <0.2% morphine, & (a);
16. Preparation <> atropine sulphate (硫酸阿托品) 25mcg;
17. Dover’s powder containing 10% opium powder;
18. Mixtures containing < one of the preparations in (13) to (17).

First Schedule, Part III is shown as follow.
19. The following substances namely:
- Acetyldihydrocodeine (It is an opiate derivative developed in Germany around 1900 as a cough suppressant and analgesic.) (醋氢可待因)
- Dextropropoxyphene (It is an analgesic in the opioid category.) (右旋丙氧芬, 一种镇痛药)
- Ethylmorphine (It (also known as codethyline, dionine, and ethyl morphine) is an opiate narcotic analgesic (pain killer).) (乙基嗎啡)
- Nicocodine (It developed as a cough suppressant) (烟酰可待因)
- Pholcodine (It helps suppress unproductive coughs and also acts as an antifungal agent.) (福尔可定)
- Codeine (An alkaloid narcotic, C18H21NO3, derived from opium or morphine and used as a cough suppressant, analgesic, and hypnotic.) (可待因, 採自鴉片的鎮痛止咳劑)
- Dihydrocodeine (双氢可待因)
- Norcodeine (去甲可待因)
- Propiram (丙吡胺, 镇痛药)
20. Any salt of a substance in (19);
21. Any preparation … containing any of substance in (19) or (20);
22. Any preparation in First Schedule, Part II.

First Schedule, Part IV is shown as follow.
Preparation <0.1% 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 of health.

Summary figure is shown.

Legal Classification of Preparation containing DD
e.g.
Codeine Syrup 30mg/5ml % Legal Classification
Codeine Syrup 9mg/5ml
Codeine 15mg Tablet (500mg)
Pholcodine Syrup 0.9%

Dangerous Drugs required registering and preserving registers & documents for 2 years from the last entry date.

For more information:
Pharmaceutical Services Website at www.psdh.gov.hk