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Marketed Drugs Ch 3

QuestionAnswer
17 years from date of discovery Drug Patent
Hatch-Waxman Act of 1984 provided for up to five year extensions on patent protection
OTC Over-The-Counter; do not require prescription
Drug Monographs FDA published acceptable ingredients for OTC drugs
Orange Book evaluation of generic drugs; pharmaceutical & therapeutic equivalents
pharmaceutical equivalent drugs that contain identical amts of same active ingredients in same dosage
therapeutic equivalent pharmaceutical equivalents that produce same effects in PTs
PT requesting information on OTC drug? Refer to pharmacist; OTC meds are not without risks
OTC Label includes product name; manufacturer/distributor; active/other ingredients; amt of contents; warnings; directions
"Behind-the-Counter OTC" meds containing ephedrine & pseudoephedrine
Combat Methamphetamine Epidemic Act sets daily & monthly restrictions (3.6 g/day; 7/5 g/month) on amt of ephedrine or pseudoephedrine sold to individual
Rule 1 of CEMA cannot exceed daily/monthly limits to any one customer
Rule 2 of CEMA must maintain written/electronic records for 2 years
30mg Pseudoephedrine HCI 146 Tablets
60mg Pseudoephedrine HCI 73 Tablets
Records for CEMA include: product; quantity; name/address purchaser; date/time of sale; ID; signature
120mg Pseudoephedrine HCI 36 Tablets
240mg Pseudoephedrine HCI 18 Tablets
468ml (millilters) 15mg/1.6 ml Pseudoephedrine HCI
2929 ml 7.5mg/5 ml Pseudoephedrine HCI
1464 ml 15mg/5ml Pseudoephedrine HCI
732 ml 30mg/5 ml Pseudoephedrine HCI
366 ML 60MG/5 ml Pseudoephedrine HCI
Exempt Narcotics meds that contain habit-forming ingredients but can be sold by pharmacist w/o prescription (18+)
Created by: jlauderman
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