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Chapter 2

Key Terms

TermDefinition
Biennial inventory DEA-registered pharmacies are required by law to take an initial inventory of all controlled substances on hand upon commencing operations or upon change in ownership, with subsequent inventories conducted every two years thereafter
Child-resistant packaging special packaging used for hazardous products such as prescription and over-the-counter drugs and household products to reduce the risk of children ingesting dangerous items by adding caps that children will have difficulty opening. Must pass federal test
Controlled substances Drugs or chemical substances whose possession and use are regulated under the Federal Controlled Substance Act and by state controlled substance laws and regulations. Controlled substances are subject to stricter restrictions than other prescriptions.
Drug Enforcement Administration (DEA) The federal agency that administers and enforces federal laws for controlled substances such as narcotics and other dangerous drugs and illegal substances. The DEA is part of the department of justice
Initial inventory The inventory a pharmacy takes of it's stock of controlled substances upon beginning the dispensing or distribution of controlled substances.
Legend drug A drug that is required by federal law to be dispensed by prescription only. It is an older term for drugs that are now identified as "Rx only".
Practice of pharmacy The practice of pharmacy is regulated by each state through its pharmacy laws and regulations. The state laws and regulations establish the scope of the practice of pharmacy in the particular state, meaning the responsibilities that pharmacist are permitt
Prescription monitoring programs Programs implemented by the states pursuant to state laws and regulations to collect, review, and analyze information received from pharmacies about controlled substance prescriptions dispensed in the state.
Regulations Issued by administration or governmental agency that establish the requirements that must be followed by the regulated persons or entities.
Food, drugs, and cosmetics act (FDCA) regulates the safety of food, drugs and cosmetics
Controlled Substances Act establishes requirements for handling and dispensing of narcotics and other controlled substances.
Food and Drug Act 1906 Outlaws states from buying and selling food, drinks, and drugs that have been mislabeled and tainted.
Sherley Amendment 1912 Outlaws labeling drugs with fake medical claims meant to trick the buyer
FDA 1930 Food and drug administration
Federal Food and Drug Act 1938 Requires new drugs to be proven as safe prior to marketing; starts a new system of drug regulation; requires safe limits for unavoidable poisonous substances; and allows factory inspections.
Durham-Humphrey amendment 1951 defines the type of drugs that can not be used safely without medical supervision and limits the sale to prescription only by medical professionals.
Kefauver-Harris Drug amendments 1962 Requires manufactures to prove that their drugs are effective prior to marketing.
Over-the-counter drug review 1972 Nonprescription medications must be safe, effective, and appropriately labeled
Tamper-resistant Packaging regulations 1982 Makes it a crime to tamper with packaged products and requires tamper proof packaging
Drug price competition and patent term restoration act 1984 Allowed FDA to approve generic versions of brand-name drugs without repeating research to prove safety and efficacy.
Prescription drug marketing act 1988 Designed to eliminate diversion of products from legitimate channels of distribution and requires wholesalers to be licensed
Food and drug administration modernization act 1997 Expands the scope of agency activities and moves agency to the department of Health and Human services (DHHS)
Medicare prescription drug improvement and modernization act 2003 Includes Medicare part D which increases access to medications through private insurers
Combat Methamphetamine Epidemic Act 2005 Federal law restricting the sale of medications containing ephedrine and pseudoephedrine
New drug application (NDA) Includes information about the drug including results from clinical trails in humans, results of animal studies, how the drug acts in the body, and how it is manufactured and, processed, and packaged.
consumer medicine information (CMI) printed information provided to patients about their medication
Patient package insert (PPI) printed information provided by the pharmacist to patients about their medication
Patient health information (PHI) any health information that identifies the patient or could be reasonably used to identify the patient.
Created by: Samanthiadenney