Term
Pure Food And Drug Act?
1906 |
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Definition
req. all foods and drugs to meet a standard of strength and purity. |
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Term
Harrison Narcotic Act Passed.
1914 |
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Definition
- regulated drugs that produced phys. or psychological dependence.
- the importation, sale, or manufacture & use of:
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Term
1938
Federal food, drug, and cosmetic Act Passed. |
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Definition
| req. drugs & cosmetic manufactures to prove their products are SAFE and medical Devices are EFFECTIVE!! |
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Term
Durham-Humphrey Amendment passed.
1951 |
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Definition
clarified the distinction between prescription and OTC drugs!!
-"CAUTION: federal law prohibits dispensing w/o a prescription" |
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Term
Kefauver-Harris Amendment Passed.
1962 |
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Definition
| Manufatures must prove SAFETY and EFFECTIVNESS of products. |
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Term
Poison Prevention Packaging Act Passed.
1970 |
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Definition
| Req. Child proof Packaging! |
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Term
Controlled substance act (CSA) Passed.
1970 |
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Definition
classified drugs based on potential for abuse.
Schedule I, II, III etc. |
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Term
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Definition
| req. pharmacist too offer assistance. |
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Term
Anabolic Steroids Control Act Passed.
1990 |
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Definition
| placed substances related to testosterone under reg. provisions of the controlled susstance Act. |
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Term
FDA Modernization Act Passed.
1990 |
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Definition
Controlled substance act of 1990.
-enacted to improve the administration & regualtion of the manufacturing, distribution, and dispensing of controlled substances. |
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Term
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Definition
only legal use is for investigational purposes.
- ex. heroin, mary j, ecstacy
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Term
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Definition
- have a high abuse but used for medical use.
- Rxs arent refillable
*Pharmacists must record # of units dsipensed & must dispense the rest w/in 72 hours!
-pharm. must record date, quantity dispensed, & # remaining. (INITIALS ARE TO BE SIGNED ON BACK OF PRESCRIPTION) |
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Term
SCHEDULE II
LONG TERM CARE |
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Definition
IF TERMILLY ILL OR IN A HOSPICE SETTING, THE RXN IS VALID FOR 60 DAYS.
-PHARM. MUST RECORD THAT THE PATIENT IS IN LONG TERM CARE. |
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Term
| SUSPECTED THEFT OF SCHEDULE II MEDS : |
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Definition
Pharmacy is req. to notify DEA
(drug enforcemnt Agency)
& State board of Pharmacy. |
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Term
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Definition
examples:
- morphine
- methadone
- hmethylphenidate
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Term
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Definition
ex: (less abusive than II)
- acetaminophen (w/ codein)
- Hyrdrocodone (w/ acetaminophen)
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Term
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Definition
may be refilled up to 5 times within 6 months.
* partial filling req. pharm to record amount w/ initials on rxn. Only within 6 months!!!!!!!
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Term
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Definition
LESS ABUSIVE THAN SCHEDULE III! SAME INTRUCTIONS!!!!!
EXAMPLES:
- BENZODIAZEPINES
- MEPROBAMATE
- PROPOXYPHENE
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Term
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Definition
LOW POTENTIAL FOR ABUSE RO DEPENDENCY! (EXEMPT NARCOTICS)
OTC w/ rxn
no refill limitations, use good judgement!
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Term
| restrictions for schedule V: |
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Definition
-not more than 240 ml in liquid
or
-48 solid units of opium containing substances w/in 48 hour period
ALSO
-not more than 120 ml in liquid
or
-24 solids of non opium ones. |
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Term
RULES FOR CONTROLLED SUBSTANCES:
method one |
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Definition
3 seperate files:
-legend
-schedule III-V
-schedule II |
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Term
RULES FOR CONTROLLED SUBSTANCES:
method two |
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Definition
2 seperate files:
-legend
-combo of schedule II-V
stamped w/ C |
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Term
RULES FOR CONTROLLED SUBSTANCES:
method three |
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Definition
2 seperate files:
legend and schedule III-V files, w/ the schedule III-V Rxns stamped w/ C |
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Term
| Records have to be available. . . . . . |
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Definition
-available for 2 years.
EXTRA! : * when state and federal law differ, use the stricter one. |
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Term
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Definition
-annual phys. inventory mut be performed w/ in 4 days of anniversary date.
THEY MUST BE LOCKED!!!!!
-DEA regualtions-DEA222: date must be recorded. |
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