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Laws and Regulations
| Term | Definition |
|---|---|
| Risk Evaluation and Mitigation Strategy (REMS) | A drug safety program that can be required by the FDA for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks |
| Poison Prevention Packaging Act (PPPA) of 1970 | A federal law that requires child-resistant packaging for most legend and over-the-counter (OTC) drugs to prevent accidental ingestion and poisoning |
| Patient Package Insert (PPI) | Patient labeling that can be part of FDA-approved prescription drug labeling. PPIs are required for oral contraceptives and estrogens, and voluntary for all other medications |
| USP Chapter 800 | A USP chapter that provides the minimum standard for handling hazardous products |
| Drug recall classes Class I | Recalls for products that have a reasonable probability of causing severe injury or death |
| Class II | Recalls for products that could pose a moderate danger to the public and may cause medically reversible or temporary adverse health events |
| Class III | Recalls for products that could pose little to no probability of an adverse health event |
| Omnibus Budget Reconcilation Act of 1990 (OBRA '90) | A federal statute that requires pharmacists to offer patient counseling to Medicaid patients |
| Schedule II | Includes drugs, substances, or chemicals with a high potential for abuse, with use potentially leading to severe psychological or physical dependence. These drugs are also considered dangerous. |
| Food and Drug Administration (FDA) | A federal agency that works to ensure the safety and effectiveness of human and veterinary medicines, biologics, and medical devices. They also regulate the safety of food, cosmetics, devices that emit radiation, and tobacco products |
| Legend drug | Any drug that is habit-forming or potentially harmful and must therefore be dispensed under the supervision of a health practitioner; a prescription-only medication |
| Schedule IV | Includes drugs, substances, or chemicals with a low potential for abuse and low risk of dependence. Some examples of Schedule IV drugs are: alprazolam, zolpidem, and tramadol |
| DEA number | A unique identifier assigned to healthcare providers by the DEA to allow them to prescribe controlled substances. The format consists of two letters and seven numerical digits |
| USP Chapter 797 | A USP chapter that provides the minimum standard for compounding sterile products |
| Drug recall | A method of removing or correcting products that may cause harm or otherwise violate laws administered by the Food and Drug Administration (FDA) |
| Schedule V | Includes drugs, substances, or chemicals with lower potential for abuse than Schedule IV |
| Schedule I | Includes drugs, substances, or chemicals with no currently accepted medical use and a high potential for abuse. Some examples of Schedule I drugs are: heroin, lysergic acid diethylamide (LSD), and 3,4-methylenedioxymethamphetamine (ecstasy) |
| USP Chapter 795A USP | chapter that provides the minimum standard for compounding nonsterile products |
| Medicare Modernization Act (MMA) | A federal law that overhauled Medicare and created Medicate Part D |
| Drug Enforcement Administration (DEA) | A federal law enforcement agency that was set up in 1973 to implement drug use laws and fight drug trafficking |
| Occupational Safety and Health Administration (OSHA) | A federal agency that requires employers to provide safe working conditions |
| Controlled Substance Ordering System (CSOS) | A system that allows for secure electronic transmission of controlled substance orders without the supporting paper DEA Form 222 |
| Safety Data Sheet (SDS) | An information sheet that is required for each hazardous chemical. The SDS includes information such as the properties of each chemical; the physical, health, and environmental health hazards; protective measures; and safety precautions for handling. |
| Controlled substances schedules | there are five schedules of controlled substances: I (most potential for addiction/use disorder) to Schedule V (least potential for addiction/use disorder) |
| National Association of Boards of Pharmacy (NABP) | An independent, international, and impartial organization that helps member boards and jurisdictions develop, implement, and enforce uniform standards to protect public health |
| Combat Methamphetamine Epidemic Act (CMEA) of 2005 | A federal law that regulates the retail sale of drugs containing ephedrine, pseudoephedrine, or phenylpropanolamine to 3.6 g per day and no more than 9 g in a thirty-day period |
| Schedule III | Includes drugs, substances, or chemicals with a moderate to low potential for physical and psychological dependence. |
| Controlled Substances Act (CSA) | A federal statute that established a policy to regulate the manufacture, distribution, importing/exporting, and use of regulated substances. The act also placed all substances that were in some manner regulated under existing federal law into 5 categories |
| Medication Guide | Patient labeling that is part of the FDA-approved prescription drug labeling for certain prescription drugs. Medication Guides (MGs) are developed by applicants, approved by FDA, and required to be distributed to patients |
| DEA Form 222 | A form used by eligible registrants to order Schedule I or II controlled substances |
| Health Insurance Portability and Accountability Act (HIPAA) of 1996 | A federal law that established national standards to protect patient privacy |
| Drug Supply Chain Security Act (DSCSA) | A federal regulation that outlines steps to achieve an interoperable and electronic way to identify and trace certain prescription drugs at the package level as they move through the supply chain |
| NDC | The 1st segment of a NDC is the labeler code (manufacture's identifier), the middle segment is the product code which specifies strength, dosage form, and formulation of a drug for a particular manufacturer, the 3rd segment is the package code (size/type) |
| Resource Conservation and Recovery Act | A federal law that regulates pharmaceutical waste disposal. |
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