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Definition
National Association of Pharmacy Regulatory Authorities
Put together the harmonized national model
Comprised of provincial regulatory authorities |
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Definition
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Term
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Definition
Behind the counter
Does not require a Rx, BUT does require intervention from pharmacist at POS |
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Term
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Definition
| OTC - At a PHARMACY. Does not require Rx or pharmacist intervention, but must be near a pharmacist so pharmacist is accessible |
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Definition
| Sold without professional supervision. Can be sold at any retail outlet |
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Definition
National Drug Scheduling Advisory Committee.
Makes recommendations to provincial regulatory authorities |
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Term
| READ FACTORS FOR DIFFERENT SCHEDULES in MISBAH |
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Definition
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Term
| How does NDSAC review a drug/ingredient to be placed in a schedule? |
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Definition
| Cascading model starting with Schedule I down using the factors for each schedule |
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Term
| Who makes a recommendation concerning scheduling, and to who? |
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Definition
| NDSAC makes recommendation to NAPRA |
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Term
| What is submission to NDSAC based on, drug or special drug ingredient? |
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Definition
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Term
How many copies of submission and supporting documents should a manufacturer make to NAPRA to earn a drug non-prescription status?
How long before the hearing. |
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Definition
| 10 copies, 30 days in advance of hearing |
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Term
| Who (2) should the manufacturer send a new drug submission for non-prescription status ? |
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Definition
Send NDS to BOTH NAPRA and NDSAC.
NAPRA makes the decision, NDSAC advises them |
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Term
| How often does the NDSAC meet to review ingredients? |
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Definition
| NDSAC meets four times a year to review ingredients |
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