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PR3146 > PR3146 Pharmacy Law Finals > Flashcards

PR3146 Pharmacy Law Finals Flashcards

1
Q

Which Acts do not have specific controls on manufacturing?

A
  • Sale of Drugs Act
  • Medicines (Advertisement & Sale) Act
  • Poisons Act
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2
Q

Who is exempted from the requirement of manufacturing under Medicines Act?

A
  • Manufacturers of “herbal remedies”
  • Manufacturers of certain types of pdcts specified in Medicines (Traditional med, homeopathic med & other substances) (Exemption) order
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3
Q

With effect, what kind of manufacturers require a manufacturer license under Medicines Act?

A

Manufacturers of CPM

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4
Q

What are ‘Western’ pharmaceutical medicines regulated as/under?

A

“Therapeutic products” under HPA

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5
Q

Under HPA, who does not require manufacturer’s license?

A

Manufacturers of cosmetic products

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6
Q

What kind of manufacturers does the controls on manufacturing under HPA apply to?

A

Manufacturers of medical devices/ therapeutic products/ cell tissue or gene therapy products

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7
Q

Under HP (Therapeutic Products) Regulations, who does not require manufacturer’s license?

A
  • Private hospitals & medical clinics

- Licensed retail pharmacies

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8
Q

Under HP (Medical Devices) Regulations, who does not require manufacturer’s license?

A
  • Private hospitals & medical clinics when manufacturing “custom-made” devices for their own patients
  • Fitting or adjusting device for end user
  • Clinical lab when manufacturing “laboratory-developed tests” solely for lab use
  • Licensed importers, wholesalers, hospitals, clinics, pharmacies when manufacturing by way of “secondary assembly”

Conditional exemption:
- Manufacturers of Class A (low risk) devices for charitable purposes

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9
Q

Under HP (CTGT Products) Regulations, who does not require manufacturer’s license?

A
  • “Known manufacturers” of “minimally manipulated CTGT products”
  • Manufacturers of CTGT products for R&D, scientific education, non-clinical purpose
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10
Q

Which Acts do not have specific controls on manufacturing?

A
  • Sale of Drugs Act

- Medicines (Advertisement & Sale) Act

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11
Q

Who is exempted from the requirement of importer’s license under Medicines Act?

A
  • Importers of “herbal remedies”
  • Importers of certain types of pdcts specified in Medicines (Traditional med, homeopathic med & other substances) (Exemption) order
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12
Q

With effect, what kind of manufacturers require a importer’s license under Medicines Act?

A

Manufacturers of CPM

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13
Q

Conditional exemption on importation under Medicine’s Act

A

Importers of:

  • Products solely for re-export
  • Products for use by specific ‘named patients’
  • Limited quantities solely for “personal use”
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14
Q

Under HPA, who does not require importer’s license?

A

Importers of cosmetic products

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15
Q

Under HP (Therapeutic Products) Regulations, who does not require importer’s license?

A
  • Private hospitals, medical clinics & pharmacies when importing unregistered therapeutic products for specific ‘name patients’
  • Persons importing limited qtys of therapeutic products for ‘personal use’
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16
Q

Under HP (Medical Devices) Regulations, who does not require importer’s license?

A
  • Importers of M.D licensed under Radiation Protection Act, when importing those (irradiating) devices
  • Persons importing limited qtys of medical devices for ‘personal use’
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17
Q

Under HP (CTGT Products) Regulations, who does not require importer’s license?

A
  • Known importers of “minimally manipulated CTGT products”

- Licensed/known manufacturers when importing products required for manufacture of CTGT products

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18
Q

Which Acts have retail access control?

A

Poisons Act - Can be sold/supplied only by licensed person/HP
Med Act - Non-GSL can only be sold/supplied in retail pharmacies

BUT less relevant now…

HPA - POM, P & GSL products

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19
Q

At present, which products are mainly subjected to retail access control?

A

Therapeutic & CTGT products

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20
Q

What are CTGT products usually registered as under retail access control?

A

POM

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21
Q

What retail access controls are there for Medical Devices?

A
  • “Professional use only” medical devices

- “Trained user only”

22
Q

Under HPA, how long does the records for manufacture of therapeutic products be kept for?

A

1 year after expiry date/ 5 years after manufacture (whichever is longer)

23
Q

Under HPA, how long does the records for receipt/supply of therapeutic products be kept for?

A

2 years after date of supply

24
Q

How long does the records for manufacture of CTGT products be kept for?

A

No traceability:
- 1 year after expiry date/ 5 years after manufacture (whichever is longer)

Related to traceability:
- 30yrs after expiry date

25
Q

How long does the records for dealing of Medical Devices be kept for?

A

Projected useful life of device/ 2 years after supply (whichever is longer)

26
Q

In what situation does medical practitioners require to keep record of Medical Devices?

A

Implantable medical devices

27
Q

Who is responsible for recording required to cosmetic products?

A

Party responsible for placing the cosmetic product in the market (not shop etc.)

28
Q

Which Acts do not have specific controls on post market duties?

A
  • Sale of Drugs Act
  • Medicines (Advertisement & Sale) Act
  • Poisons Act
29
Q

What barrier did HPA overcome over MA with regards to post-market duties & obligations?

A

Under MA, only licensed holders need to carry out post-market duties & obligations

30
Q

Which Acts have control over clinical trials?

A

Medicines Act:

  • Med (Clinical trials) regulations
  • Med (Med products as clinical research materials) regulations

HPA:

  • HP (Clinical trials) regulations
  • HP (Clinical research materials) regulations
31
Q

Conditional exemptions for CRM

A
  • No need product license/registration for CRM
  • No need dealer’s license for manufacture/import/supply of CRM

BUT…
Manufacturers, importers & suppliers need to:
- Notify HSA before importing/supplying
- Dealers must keep records

32
Q

Controls on import & export of CDs

A

Import: CD (import) license
Export: CD (export) license

Exception:
Any person can import/export CDs in S1 (small qty; low risk of being abused) without CD license

33
Q

Controls on supply of CDs

A

CD license can supply CDs specified in license: Mainly wholesale supply

Persons who can supply CDs in S1/S2/S3:

  • Practitioner
  • Pharmacist
  • “Person lawfully conducting a retail pharm business”
  • Nurse-in-charge of hospital ward
  • Person in charge of laboratory engaged in scientific education/research
  • Master of (SG-flagged) ship that does not have its own doctor –> Own crew members/persons who can lawfully supply CDs

Any person can administer CDs in S1

34
Q

Who can possess CD?

A
  • Person with CD license
  • Person who can lawfully supply CDs in S2/3
  • Master of (SG-flagged) ship with no doctor
  • Master of foreign ship in SG port
  • Possession of S2/3 for administration according to instructions of practitioner
  • Any person can possess CDs in S1
  • Person engaged in legitimate business of transporting/conveying CDs to persons who can lawfully possess these CDs
  • Lab when engaged to examine CD
  • CNB officer in course of his duty
35
Q

Documentation & records for CDs

A

1) Requisition order (Wholesale-type of supply)
- Signed by recipient
- Recipient’s name address & profession
- Purpose & total qty to be supplied

2) Prescription (Retail supply)
- INK (or else indelible)
- Prescriber’s name & address, dated & signed
- Declaration if for vetinary/dental use
- Name & address of pt
- Dose to be taken
- If preparation, need to specify form & strength to be supplied
- Quantity/dosage units in WORDS & FIGURES
- Specify amnt of instalments of total amnt which may be dispensed & intervals to be observed when dispensing

  • Within 30 days & address of prescriber in SG

NOTE: No repeats for CD prescriptions

36
Q

Requirements of CD Register

A
  • Bound book
  • Chronological order
  • Format follow that specified in FIFTH schedule (in hospital ward: can be in simpler format specified in SIXTH schedule)
  • Entries for each diff strength/preparation recorded together in one set
  • State class at head of set
  • Entries on day itself (latest the next day)
  • Cannot cancel/obliterate/alter entries
  • INK (or else indelible)
  • Not to be used for other purpose other than recording CDs
  • Separate registers for each premise
  • Retained for >= 3 years after transaction
37
Q

Labelling of CD

A

Total amount of CD in container/ Amount of CD in each dosage unit & no. of dosage units in container/ Total amount of preparation & % of each CD in preparation

38
Q

Storage & safekeeping of CD

A

“Lock and key”, key in possession of authorised person at all times

39
Q

Requirements for disposal of CD

A

CDs in S2/4 only destroyed in presence/ in accordance to directions given by a CD inspector (To endorse entry in CD register documenting date of destruction + qty destroyed)

40
Q

Products containing “psychotrophic substances”

A

1) Phenobarbital
2) Diazepam
3) Mazindol

4) Mind-altering properties & high potential for abuse???

41
Q

Products containing opoid substances

A
  • Codeine

- Dextromethorpan

42
Q

Additional controls under HP (Therapeutic Products) Regulations

A
  • International trade & movement governed by int conventions (Overseen by INCB)
  • System of cross-checking all import-export transactions to curb diversion & illicit trade

Importer

  • Obtain HSA approval for importing each consignment of any pdct containing psychotropic substances
  • Not to allow import psychotropic substances/opoid substances exceeding limit for personal use

Exporter

  • Obtain HSA approval for exporting each consignment of any pdct containing psychotropic substances/codeine cough preparation
  • Need to show that intended importer has approval from authorities in importing country

Qualified practitoner/pharmacist supplying codeine cough preparation:

  • Must NOT supply > 240mL/335mg of codeine (as base) within 7 days
  • Professional counselling
  • Record purpose of treatment
43
Q

What kind of products have retail access restrictions?

A

Therapeutic & CTGT products

44
Q

Which Acts do not have specific controls on controls on retail-level access?

A
  • Sale of Drugs Act

- Medicines (Advertisement & Sale) Act

45
Q

What needs to be recorded in Form E for wholesale supply of Poisons

A
  • Date of transaction
  • Delivery order/ sales note no.
  • Name & address of purchaser/supplier
  • Opening stock/quantity transacted & closing stock
  • Keep for 2yrs
46
Q

What needs to be recorded for prescribed therapeutic products?

A
  • Date of supply
  • Name, ID no. & contact details of patient
  • name of product + total amnt supplied
  • name & address of practitioner
47
Q

What needs to be recorded for P only therapeutic products?

A
  • Date of supply
  • Name, ID no. & contact details of patient
  • name + strength of product + total amnt supplied
  • Dosage, frequency & purpose of treatment
48
Q

What needs to be recorded for receipt & supply of CTGT products?

A
  • Name of product
  • Date which product is received/supplied
  • Name & address from whom or to whom product is received/supplied
  • Qty of product received/supplied
  • Identification no. (eg. batch number)
49
Q

What needs to be recorded for supply of prescribed CTGT products?

A
  • Date of supply
  • Name, ID no. & contact details
  • Name of product + total amnt supplied
  • Name & address of practitioner
50
Q

What needs to be recorded for supply of Medical Devices?

A
  • Name of product
  • Date which product is received/supplied
  • Name & address from whom or to whom product is received/supplied
  • Qty of product received/supplied
  • Identification no. (eg. batch number)
51
Q

What needs to be recorded for supply of Cosmetic Products?

A
  • Name + notification no. of product
  • Date which product is supplied
  • Name & address to whom product is received/supplied
  • Qty of product supplied
  • Identification no. (eg. batch number)

PR3146 (1 decks)

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