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PTCB Law

TermDefinition
Controlled Substances Act (CSA) regulates drugs with high potential abuse or dependence
Poison Prevention Packaging Act (PPPA) Requires child resistant packaging for drug products
Omnibus reconciliation act (OBRA'90) Requires pharmacist to perform drug utilization reviews and offer patient counseling to patients insured by Medicaid (DUR)
Health insurance portability and Accountability (HIPPA) Establishes rules to maintain the confidentiality of protected health information (PHI)
Drug Addiction Treatment Act 2000 (DATA 2000) permits physicians who meet certain qualifications to treat opioid dependency with narcotic medications approved by the Food and Drug Administration (FDA)
Combat Methamphetamine Epidemic Act 2005 (CMEA) Require ID to purchase pseudoephedrine, Record must be maintained record for 2 years.
The Joint Commision on Accreditation for Healthcare Organization (JCAHO) Non profit organization that certifies and makes sure healthcare institutions meet a certain level of performance
Medication Administration Record (MAR) a medical record of what medication and the time of administration a patient received by a health care provider
HEPA Filter A filter that can retain 99.97% of all particles 0,3 microns in diameter or less. It must be checked every 6 months.
1906 Federal Food & Drugs Drugs, Food, or drinks mislabeled or adulterated that are prohibited from being sold
1914 Harrison Narcotic Act Made Purchasing opium possible only with a prescription and limited the transport of opium
State Board of Pharmacy responsible for the licensing/registration of Texas pharmacists, pharmacy technicians, and pharmacies
Drug Enforcement Administration (DEA) Enforces Federal controlled substances act and makes decisions regarding the classification of certain drugs as controlled substances
Occupational safety and health administration (OSHA) Enforces occupational health and safety.
Federal trade commission (FTC) Regulates advertising for OTC drugs. medical devices, cosmetic, and food products.
Durham-humphrey amendment 1951 Drug products separated into two categories: OTC and legend drugs with warning label should be dispensed with prescription
Kefauver Harris amendment 1962 Due to Thalidomide tragedy. Required that manufacturers prove the effectiveness of drug products before they go on the market, and afterwards report any serious side effects. New Drug Application gained automatic approval after 60 days if FDA did not take action.
Federal Anti Tampering ACT 1982 Due to Chicago Tylenol Murders. OTC drugs should have a tamper-evident seal.
Prescription drug marketing (PDMA) 1982 banned selling/purchasing/trading of prescription drug samples.
FDAMA Food&Drug Admin. Modernization 1997 required to appear on legend drug labels per Durham-Humphrey admen. (warning label for prescription shortened to RX only)
Federal Food, Drug, and Cosmetic Act 1938 Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics.
Orphan Drug Act 1983 Allows medication for rare disease to be funded by the FDA for research and development due to the limited population of patient they can effect
1984 rug price competition of patent term restoration act (hatch-waxman) Provides extended patent to drug manufactures as an incentive to create new medication. provides quicker approval to companies to make generic medications.
1988 Food & Drug admin. act adverse reactions are to be reported to the FDA. sale, purchase, or trade of sample medications is prohibited.
Chapter 797 New sterility and Stability guidelines for compounding
Combat methamphetamine epidemic 2005 placed all pseudoephedrine products behind the counter of the pharmacy
ORANGE BOOK Approved products with therapeutic equivalence evaluations
Created by: Brandy01
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