Schedules

Classification
Registration

What is Psychotropic Substance?

Control on supply for
Medical/dental or animal treatment (r 11)
Purposes other than medical/dental or animal
treatment (r 12)

Df: "Poison", "Poisons List"

Substances listed in Poison List
Government hospital
Procurement
Supply
1st
(Poison List-S2)
Part I
S20: Group A
S21: Group B
(Disp Med)
S22: Group C
(Disp Med)

"Poison"
Schedule

S23: Group D
Part II

Sale/supply
(Private)

Supply upon a prescriptions which complies

R 11(2), R. 11(3)

Import &
export
(Private)

Who can supply - R3 (2)

Control of dispensing etc
Permit to purchase & use psychotropic subs.
Control of manufacture

Manufacture

Storage of Psychotropic Subtances (r24)

Record of manufacture entitled Production
Register of Psychotropic Substances (r20)

(Poisons, PS,
DD, Product)

Supply (Government)
Keeping & Maintainance of Register (r22)

Non-Poison
S7: inapplicable to PA'52
S17 Prohibition of sale to persons <18
Sales

W/Sale S15
Retail S16

Licenses

Officer
Offences

Record for Purposes of

Medical,dental or animal treatment (Retail)
Other than medical, dental / animal
treatment (W/sale)

What constitutes an advertisement?

r4 Import by post
Transport
Supply of poisons in hospitals and
institutions (Govt & Private)
Exempt R4-22
Supply of poisons
R23: to out-patients
R24: for use in hospital
R25: Storage
Storage (General), r6
Store
Retail

Annual retention Cert

Term

Drugs-Person
-Sale

Seized Drugs
Person/
Corporate
Sale

Legal Proceedings & Evidence

Exempted Advertisement/advertisement be published

legitimately
For prevention/ treatment/
diagnosis of diseases/
Which advertisement
conditions of human body
is controlled?
S3(1): relating to certain diseases
S4: relating to abortion
How is the control?
S4A (a - b): relating to skill
Prohibitions
S4A (aa - bb): relating to service
S4B : diseases other than the schedule, such as
Advertisement which can
muscle pain
be given approval
S6 (1 a-b): Disclosure of composition of medicines
Label

Who is the authority?

The use of

Product
"Analyst"
"Inspector"
"Officer"
"Drug" "Medicinal purpose"
"Minister"
MOH?
Sales of drug?

Drug Enforcement Officer (DEO)

Labelling of poisons

'compulsory service'

conditions to operate
a retail pharmacy

title

Misconduct

contravention & offences

On storage -r 26
For purpose of

EXEMPTIONS

Conditions for a company which is

registered as a body corporate with
several branch outlets

DCA

Form of register (r23)

Procurement
Govt
hospital
Supply (wsale)
Retail
Wholesale

Pharmacist
S13: Body Corp

o/p
wd
Record
Label

Control of heavy
metal in cosmetics

Disposal (r25)

Sale/
Supply

Registration

S11(E&F):
Power of Minister

Authority

Prohibitory Order of Minister -r29

On storage
On Sale

Developed by
Pharmacy Practice Unit,
School of Pharmacy
17 Feb 2012

Exemptions

Drug Enforcement Officer (DEO)

Immediate personal supervision (IPS)

Pharmacy Practice
Concept Chart 6

Enforcement

Labelling R28

"Dispensed medicine

Pharmacy
Board

Licensing
Record
GMP

Permit (NaOH, PS)

Exempted
2nd Schedule
(S2 & S7)
3rd Schedule
(S30)

Possession
Administration
Dispensing,
compounding,
mixing,
Licensing
Labelling
Retail
Recording
Licensing
Labelling
Wholesale
Recording
Storage
Disposal

Registered
Non-registered

Disciplinary Inquiry
Infamous or disgraceful

Fees and costs

Dangerous Drug ?

Import of a new
product for w/sale
New Product
Licensing
Fees
Wholesale
Poisons
Non-poisons
Records
to be
maintained
Transactions
ADR
Wholesale
Other requirements
Provides for GMP
r12 :Licences
r26- Power of Enforcement
officer to enter, seize
product, palnt, equipment,
book, documents
r28- Reporting ADR

Act 1952
Ctrl of certain DD
Ctrl of external trade
Ancillary &
general provisions
Schedule
Requirement
Supply

Regulation
Disposal
Record of DD
EXEMPTIONS
Whosale Licence

"authorized
persons"
AUTHORITY