Term
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Definition
1906
prohibited interstate comerce of adultered food/drink/drug. NOT cosmetics |
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Term
| Fair Packaging and Labeling Act |
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Definition
| products for interstate trade had to be properly labeled including OTC |
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Term
| Prescription Drug Marketing Act |
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Definition
1987
(Dingle Bill)
1. proper storage or records
2. Hospitals can't resale stock
3. No samples in retail only in institutional BUT: physician must write sales rep to request them, Disposition is recorded and must be stored seperatlely from normal stock.
4. Drug manufacturers/distributors must keep request records for 3 years |
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Term
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Definition
Do not have to be labeled if:
1. <240 ml (8oz)
2. <120 ct tabs
3. <30 day supply of tabs |
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Term
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Definition
1951
1.established prescription vs non-prescription meds
2. all bottles say "federal law prohibts dispensing without prescripion"
3. allowed verbal orders for rx/refills |
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Term
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Definition
1970
1. oral meds must have child resistant caps unless requested by prescriber/patient or if HP are maintaing/adminstering (nursing homes excluded)
2. glass can be re-used
3. |
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Term
| Poison Prevention Act exemptions |
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Definition
|
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Term
| Omnibus Reconciliation Act |
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Definition
1990 OBRA
1.DUR- retrospective required by medicaid
2. pharmacists must offer counseling
3. must obtain specific pt info |
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Term
| Federal Anti-Tampering Act |
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Definition
1982
had to provdie safety seals |
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Term
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Definition
1999
1. active ingredients
2. purpose
3. uses
4. warning
5. directions
6. other information
7. inactive ingredients |
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Term
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Definition
1. <240ml of opium
2. <120 any other C-V
3. 200mg codience per 100ml/gm or 90mg per dosage unit
4. 100mg of dihydrocodiene per 100ml/gm |
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