Navigating the PPO and PPR
Go to the e-leg website and practice locating Cap 138 for the PPO and Cap 138A for the PPR.
Let's start with the PPO (Cap 138)
The Pharmacy and Poisons Ordinance (PPO) Cap 138 has 8 Parts. Parts are like chapters and serve to break up the Ordinance into categories (don't confuse with Part 1 and Part 2 drugs in drug classification). But actually all the sections are numbered straight down 1 to 38 without regard to the part they are in, have a look and you will see what I mean. So when I refer to section 12 for example you know I am referring to this paragraph
Sections are abbreviated 'S' such as 'S.22' means section 22 of the PPO.
And then after S38 there is one Schedule, this one is new in 2021
Schedules are placed at the end. These are things like lists, or forms, which are placed at the end as kind of like an addendum so as to make the main section less bulky.
The Pharmacy and Poisons Regulations (PPR) Cap 138A has 10 parts, 42 regulations, and 10 schedules. For the PPR instead of 'sections' they are called 'regulations' (abbreviation 'Reg' or 'R', eg. 'Reg.25' means Regulation 25 of the PPR). The schedules in the PPR includes the Poisons List and the Schedule 1, 2, and 3 Poisons.
I refer to the Parts for convenience, but really the schedule/regulation numbers are more meaningful as they refer directly to the paragraph in question, so stick to these when you are studying.
PPO (Cap 138)
PART 1 - Preliminaries
- Interpretation (definitions)
PART 2 - The Pharmacy and Poisons Board
- Members of the Board; committees; codes of conduct
PART 3 - Registration for Pharmacists
Register
- Required qualifications
- Certificate
- Misuse of certificate
PART 4 - Retail sale of poisons
- ASP
- Registration of premises
PART 5 - Pharmacists and ASPs
- Disciplinary Committee
- ASP liabilities for employees
- Restriction on titles
PART 6 - Sale and Possession of Poisons
- Conditions (ASPs)
- LSP
- Labelling
- Exemptions
PART 7 - Import and Export
- Wholesalers and manufacturers
PART 8 - Miscellaneous
- Committees
- Exemptions for wholesale and other persons
- Offences, penalties, inspections
Schedule 1 - Manipulation Processes that are Not Substantial Manipulations (relates to ATPs)
PPR (Cap 138A)
PART 1 – Preliminaries and exemptions re Poison sales
- Interpretation (definitions)
- S.22 (of PPO) requirement for poisons only to be sold to fit and proper person and record of sales only applies to P1S1 poisons and not P1S1S3
- Expansion of labelling requirements, and Schedule 6
- S.22 to apply to wholesalers (vs S.32) and relaxations
- Exemptions from S.28(3) – record keeping requirement for supply of P1S1 poisons
- Exemptions for eg plasters, dressings and corn plasters
- Complete exemption for Schedule 2 poisons
PART 2 – Additional restrictions on Poison sales
- S3 Poisons
- LSP restrictions
- Strychnine
PART 3 – Supplementary regulations on Labelling
- Manner
- Name
- Proportions
- Required text
- Seller details
- Container
PART 4 – Storage and transport of poisons
PART 5 – Institutions
- Supply and storage
PART 5A – LSPs
- Applications
PART 5B – ASP
- Registration of premises
PART 6 – Wholesale dealing
PART 7 – Manufacturing
PART 8 – Registration of pharmaceutical products
- Registration of pharmaceutical products and substances; application to make changes
- Clinical trials
- Factors relevant to determination of application
PART 9 – Sale of medicines
- Extra details regarding sales and labelling
PART 10 – Miscellaneous
- Forms
- Period of keeping records
- Penalties
Schedule 1 – S1 poisons
Schedule 2 – S2 poisons
Schedule 3 – S3 poisons
Schedule 4 – Labelling of proportions of substances such as herbal medicines and insulin
Schedule 5 – Cautionary labels
Schedule 6 – Non-medicinal poisons exempted from labelling by Reg 4
Schedule 7 – Poisons requiring labelling for transport by Reg 21
Schedule 8 – Pharmacy logo
Schedule 9 – Fees
Schedule 10 – The Poisons List - P1 and P2 poisons