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Pankit Phat 151/153

Chapter 6

QuestionAnswer
Kefauver- Harris Amendment of 1962 (drug efficacy) Must be safe and effective
Orphan drug act of 1983 manufacturers in the only one who can manufacture that meditions for 7 years.
Controlled Substance Act of 1970 divide drug into schedules , based on abuse potential.Lortab is C-III
Poison Prevention Packaging Act of 1970 Child resistant containers.
OBRA counseling patients abt new and refill prescriptions.
HIPPA An important law that requires the adoption of security and privacy standards in order to protect personal health care information.
DEA is responsible for all drug traficy and legal and illegal drugs.
FDA is reponsible for making sure, drugs are safe, pure, and effective.
DEA forms 222- ordering controlled substance.224- Dispense.106- loss or stolen.41- disposal and distruction.
NDC National Drug code number. is required for all OTC and prescription drug labels.
NDC has 11 digits.first 5 identify the manufacturers.and last 6 identifies, drug name, package size, and type of drug.
The very 1st drug they made available were called- elixir, potions,spirits.they mostly contained opium , Murphine , Cocaine.
FDCA safe for use when directions are followed.
Durham-Humphry Amendment of 1951.(Rx drug amendment) established tow classes of drugs, OTC and Rx."CAUTION" federal law prohibits dispensing without a Rx.
JCAHO Joint Commision in Accredidetion of Health care Organization.
Accredition is a voluntary process.
Joint Commision not for profit organition whose standards are to ensure quality of service.
Drug Recalls All drug recalls are voluntary. FDA is responsible .
Drug Recall Class I There is a reasonable probability that the use or exposure to a product will cause severe adverse health consequences or death.
Drug Recall Class II product that may cause temporary or medically reversible adverse health consequences.
Drug Recall III product is not likely to cause adverse health consequences.
Created by: pankitpatel
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