State and federal regulations of drugs
Terms
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- Federal food, drug and costmetic act
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provide that:
- effective
- labeled
- pure - Durham-Humphrey Admendments
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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.