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CMB-Chapter 1

CMB - Chapter 1 - Basic Overview

Statutes passed by legislatures and apporoved by cheif executive
Regulations are adopted by executive agencies
Professional Standards are requirements set forth by the profession, but do not have the force of law
FDA the federal agency that supervises the development, testing, purity, safety, and effectiveness of rxs and OTC medications. Also regulates the advertising of rx medications and the labeling of rx and OTC medications
Controlled Substance Act (CSA)also known as... The Comprehensive Drug Abuse Prevention & Control Act of 1970
The CSA does what? regulates maufacturing, distribution, prescribing, & dispensing of conrolled substances through the DEA
Consumer Product Safety Commission (CPSC) oversees the 1970 Poison Prenvention Pacaging Act by requiring most rxs for oral use to be dispensed in child-resistant containers
Omnibus Budget Reconciliation Act of 1990 (OBRA) requires Rph's to keep records of all medications used by Medicaid patients & offer to counsel all Medicaid patients about the proper use of their medications
State Boards of Pharmacy regulate the operation of pharmacy depts & is responsible for protecting its citizen's health & welfare, with regard to pharmacy services
Joint Commission on Accreditation of Healthcare Organizations (JCAHO) sets forth standards for organizations such as hospitals. if they meet the standards they become accredited
US Pharmacopeia-National Formulary(USP-NF) defines the standards for medication & contains official titles of medications, standards for strength, purity, packaging, & labeling, procedures for proper handling & storage, and formulas for manufacture or preparation.
US Pharmacopeia-Drug Information(USP-DI) two versions; one for patients and one for Rphs.
USP-DI for Patients how to take, what they will do, & side effects
USP-DI for Professionals info such as dispensing & prescribing, interactions, allergies, warnings, & side effects
Drug Facts & Comparisons (DFC) an encyclopedia of medications: makes comparisons among them along with detailed info. lists whether products are prescriptions or OTC meds. contains relative price comparisons for drug products
American Hospital Formulary Services Drug Information (AHFS-DI) cornerstone in pharmacy practice & medicine due to its comparative collection of drug monographs on practically every single drug available in the U.S.
Physician' Desk Ref. (PDR) considered the standard rx drug info source by physicians. lists over 4000 current brand & generic drugs with descriptions & info on their usage, warnings, drug interactions, category, & color photos
Approved Drug Products with Therapeutic Equivalence Evaluations is also known as... "Orange Book"
Orange Book is.... a list of all FDA-approved prescriptions & OTC drug products rated for safety & effectiveness, as well as bioequivalence. It is the basis for generic product evaluation & selection used by pharmacists.
Handbook on Injectable Drugs discusses storage requirements & general stability info, including pH, freezing, exposure to light, & repackaging info.
Handbook of Nonprescription Drugs is the gold-standard on self-care and OTC medications. It lists the safety & effectiveness of non-prescription medications, herbal remedies, homeopathic products, nutritional supplements, & home medical equipment.
Created by: cbowers101



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