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Laws PTCB
ptcb laws
| Term | Definition |
|---|---|
| Schedule V | Includes meds with lower potential for abuse than. Consist of preparations limited quantities of certain narcotics. Used for antidiarrheal, antitussive, or analgesic purposes. ex: pregabalin, and cough preparations with less than 200 mg of codeine |
| Omnibus Budget Reconciliation Act of 1990 (OBRA '90) | A federal statute that requires pharmacists to offer patient counseling to Medicaid patients |
| 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 |
| Controlled Substance Ordering System (CSOS) | A system that allows for secure electronic transmission of controlled substance orders without the supporting paper DEA Form 222 |
| 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 |
| Safety Data Sheet (SDS) | An info sheet that is required for each hazardous chemical. Includes info properties of each chemical; the physical, health, and environmental health hazards; protective measures; and safety precautions for handling, storing, and transporting the chemical |
| Health Insurance Portability and Accountability Act (HIPAA) of 1996 | A federal law that established national standards to protect patient privacy |
| 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 |
| 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) |
| Schedule II | Includes Meds with a high potential for abuse, with use potentially leading to severe psychological or physical dependence. These drugs are also considered dangerous. Some examples are: cocaine, fentanyl, and methylphenidate |
| 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) |
| 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 |
| USP Chapter 797 | A USP chapter that provides the minimum standard for compounding sterile products |
| 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 |
| Drug recall classes | Class I: a reasonable probability of causing severe injury / death Class II: a moderate danger to the public & may cause medically reversible / temporary adverse health events Class III: - little to no probability of an adverse health event |
| 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 |
| 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 |
| Occupational Safety and Health Administration (OSHA) | A federal agency that requires employers to provide safe working conditions |
| DEA Form 222 | A form used by eligible registrants to order Schedule I or II controlled substances |
| 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) |
| Drug Enforcement Administration (DEA) | A federal law enforcement agency that was set up in 1973 to implement drug use laws and fight drug trafficking |
| USP Chapter 795 | A USP chapter that provides the minimum standard for compounding nonsterile products |
| 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 |
| USP Chapter 800 | A USP chapter that provides the minimum standard for handling hazardous products |
| 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 |
| Controlled Substances Act (CSA) | A federal statute that established a policy to regulate the manufacture, distribution, importing/exporting, and use of regulated substances. also placed all substances that were in some manner regulated under existing into one of five schedules |
| Schedule III | Includes meds with a moderate to low potential for physical & psychological dependence. examples are: products containing less than 90 mg of codeine per dosage unit (e.g., acetaminophen with codeine), ketamine, and anabolic steroids |
| 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 |
| Medicare Modernization Act (MMA) | A federal law that overhauled Medicare and created Medicate Part D |
| 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 |
Created by:
terwin