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State and federal regulations of drugs

Terms

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Federal food, drug and costmetic act
provide that:
- effective
- labeled
- pure
Durham-Humphrey Admendments
food, drugs and costmetics must include the following in their labels:
- recommended use
- warnings and contraindications
- procedure for dosing
- product preparation instructions
Prescription order and legend
label on prescription as well as manufacturer's label must bear "Federal law prohibits the dispensing of this drug without a prescription" or bear "Rx"
Transfer warning
prescription drugs must only be used by the one precribed to. label should read "state and federal law prohibits the transfer of this drug to any person other than the person to whom it was prescribed"
Controlled substances act
regulate drugs of potential abuse. Abusable drugs classified according to a schedule and placed into 1 of 5 groups.
Class I drugs
no therapeutic benefit, highly abusable. (heroin, THC)
Class II drugs
high potential for abuse, but therapeutically useful (morphine, meperidine, methadone)
Class III drugs
have therapeutic benefit, may lead to physical or psychological dependency but less so than I and II.
Class IV drugs
require less special documentation, less potential for abuse
Class V drugs
low potential for abuse
storage of schedule II drugs
require special documentation and be stored in a locked cabinet. Precription must be in triplicate form, in ink, and no refill.
disposal of schedule II drugs
required the use of forms obtained from the DEA, disposal requires request of approval to the State Bureau of Controlled Substances and DEA
poison prevention packaging act
prevents accidental poisoning with child-resistant packaging
occupational safety and health act
ensure safety of workers in the workplace. OSHA has standards of safety and sanitation that must be met.

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