PR3146 Pharmacy Law Finals Flashcards
Which Acts do not have specific controls on manufacturing?
- Sale of Drugs Act
- Medicines (Advertisement & Sale) Act
- Poisons Act
Who is exempted from the requirement of manufacturing under Medicines Act?
- Manufacturers of “herbal remedies”
- Manufacturers of certain types of pdcts specified in Medicines (Traditional med, homeopathic med & other substances) (Exemption) order
With effect, what kind of manufacturers require a manufacturer license under Medicines Act?
Manufacturers of CPM
What are ‘Western’ pharmaceutical medicines regulated as/under?
“Therapeutic products” under HPA
Under HPA, who does not require manufacturer’s license?
Manufacturers of cosmetic products
What kind of manufacturers does the controls on manufacturing under HPA apply to?
Manufacturers of medical devices/ therapeutic products/ cell tissue or gene therapy products
Under HP (Therapeutic Products) Regulations, who does not require manufacturer’s license?
- Private hospitals & medical clinics
- Licensed retail pharmacies
Under HP (Medical Devices) Regulations, who does not require manufacturer’s license?
- 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
Under HP (CTGT Products) Regulations, who does not require manufacturer’s license?
- “Known manufacturers” of “minimally manipulated CTGT products”
- Manufacturers of CTGT products for R&D, scientific education, non-clinical purpose
Which Acts do not have specific controls on manufacturing?
- Sale of Drugs Act
- Medicines (Advertisement & Sale) Act
Who is exempted from the requirement of importer’s license under Medicines Act?
- Importers of “herbal remedies”
- Importers of certain types of pdcts specified in Medicines (Traditional med, homeopathic med & other substances) (Exemption) order
With effect, what kind of manufacturers require a importer’s license under Medicines Act?
Manufacturers of CPM
Conditional exemption on importation under Medicine’s Act
Importers of:
- Products solely for re-export
- Products for use by specific ‘named patients’
- Limited quantities solely for “personal use”
Under HPA, who does not require importer’s license?
Importers of cosmetic products
Under HP (Therapeutic Products) Regulations, who does not require importer’s license?
- Private hospitals, medical clinics & pharmacies when importing unregistered therapeutic products for specific ‘name patients’
- Persons importing limited qtys of therapeutic products for ‘personal use’
Under HP (Medical Devices) Regulations, who does not require importer’s license?
- Importers of M.D licensed under Radiation Protection Act, when importing those (irradiating) devices
- Persons importing limited qtys of medical devices for ‘personal use’
Under HP (CTGT Products) Regulations, who does not require importer’s license?
- Known importers of “minimally manipulated CTGT products”
- Licensed/known manufacturers when importing products required for manufacture of CTGT products
Which Acts have retail access control?
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
At present, which products are mainly subjected to retail access control?
Therapeutic & CTGT products
What are CTGT products usually registered as under retail access control?
POM
What retail access controls are there for Medical Devices?
- “Professional use only” medical devices
- “Trained user only”
Under HPA, how long does the records for manufacture of therapeutic products be kept for?
1 year after expiry date/ 5 years after manufacture (whichever is longer)
Under HPA, how long does the records for receipt/supply of therapeutic products be kept for?
2 years after date of supply
How long does the records for manufacture of CTGT products be kept for?
No traceability:
- 1 year after expiry date/ 5 years after manufacture (whichever is longer)
Related to traceability:
- 30yrs after expiry date
How long does the records for dealing of Medical Devices be kept for?
Projected useful life of device/ 2 years after supply (whichever is longer)
In what situation does medical practitioners require to keep record of Medical Devices?
Implantable medical devices
Who is responsible for recording required to cosmetic products?
Party responsible for placing the cosmetic product in the market (not shop etc.)
Which Acts do not have specific controls on post market duties?
- Sale of Drugs Act
- Medicines (Advertisement & Sale) Act
- Poisons Act
What barrier did HPA overcome over MA with regards to post-market duties & obligations?
Under MA, only licensed holders need to carry out post-market duties & obligations
Which Acts have control over clinical trials?
Medicines Act:
- Med (Clinical trials) regulations
- Med (Med products as clinical research materials) regulations
HPA:
- HP (Clinical trials) regulations
- HP (Clinical research materials) regulations
Conditional exemptions for CRM
- 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
Controls on import & export of CDs
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
Controls on supply of CDs
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
Who can possess CD?
- 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
Documentation & records for CDs
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
Requirements of CD Register
- 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
Labelling of CD
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
Storage & safekeeping of CD
“Lock and key”, key in possession of authorised person at all times
Requirements for disposal of CD
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)
Products containing “psychotrophic substances”
1) Phenobarbital
2) Diazepam
3) Mazindol
4) Mind-altering properties & high potential for abuse???
Products containing opoid substances
- Codeine
- Dextromethorpan
Additional controls under HP (Therapeutic Products) Regulations
- 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
What kind of products have retail access restrictions?
Therapeutic & CTGT products
Which Acts do not have specific controls on controls on retail-level access?
- Sale of Drugs Act
- Medicines (Advertisement & Sale) Act
What needs to be recorded in Form E for wholesale supply of Poisons
- Date of transaction
- Delivery order/ sales note no.
- Name & address of purchaser/supplier
- Opening stock/quantity transacted & closing stock
- Keep for 2yrs
What needs to be recorded for prescribed therapeutic products?
- Date of supply
- Name, ID no. & contact details of patient
- name of product + total amnt supplied
- name & address of practitioner
What needs to be recorded for P only therapeutic products?
- Date of supply
- Name, ID no. & contact details of patient
- name + strength of product + total amnt supplied
- Dosage, frequency & purpose of treatment
What needs to be recorded for receipt & supply of CTGT products?
- 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)
What needs to be recorded for supply of prescribed CTGT products?
- Date of supply
- Name, ID no. & contact details
- Name of product + total amnt supplied
- Name & address of practitioner
What needs to be recorded for supply of Medical Devices?
- 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)
What needs to be recorded for supply of Cosmetic Products?
- 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)
