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


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).


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 1S1 poisons


Schedule 2S2 poisons


Schedule 3S3 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


PPO and PPR Outline.pdf
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