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LAW A
| NAME | DEFINITION | MISC |
|---|---|---|
| Pure Food and Drug Act (1906) | Required drugs to meet PURITY and Strength standards | Created false and fraudulent claims. Government is required to prove intent to defraud before removing the product. |
| Federal Food and Drug Cosmetic Act (1938) | New drugs cleared for SAFETY before distributed- New Drug Application (NDA). Government no longer required to prove intent to defraud before product is removed | Created the FDA. Authorized factory inspections. Not applicable to medication classes (RX/OTC). |
| Durham Humphrey Amendments (1951) | Created 2 classes of drugs (RX/ Legend and OTC). Measured SAFETY | Requires RX for dispensing from qualified practitioner |
| DH (1951). What goes on a prescription label? | Name and address of pharmacy RX # Date of prescription or filling Name of prescriber Name of patient Cautionary statements/ warnings Directions of use | |
| Kefauver Harris Amendment (1962) | Required new drugs to be SAFE and EFFECTIVE for their claimed use. | Increased safety requirements and required more clinical trials. Enhanced FDA inspection authority. |
| Drug Abuse Control Amendments (1965) | Controlled the use of Depressants, Stimulants, and Hallucinogens | laid the ground work for the federal Controlled Substances Act |
| Medical Device Amendment (1976) | SAFETY and EFFECTIVENESS of medical devices and some diagnostic/laboratory products. | The FDA regulating medical devices is apart of this act. |
| Orphan Drug Act (1983) | This act provides manufacturer financial incentives to produce and provide drugs for rare diseases and conditions | |
| Drug Price Competition and patent restoration act (Hatch-Waxman) (1983) | Created ANDA for generic medications. Generics must be bioequivalent and there are no clinical trials. | 1st generic manufacturer receives a 180-day market exclusivity. Brand name receives 5 year market. |
| Hatch waxman | helped establish the orange book | |
| Prescription Drug marketing Act (PDMA 1987) | Cannot reimport RX's, sell, trade, or purchase samples, reselling RX's purchases by hospitals, counterfeit coupons, resell donated RX's | |
| Medication Equity and Drug Safety Act of 2000 and the Medicare prescription Drug Improvement and Modernization Act | allowed drug IMPORTATION from Canada | |
| FDA Modernization Act (FDAMA 1997) | Legend drugs identified by "RX ONLY" | "Caution: Federal law prohibits dispensing without a prescription" |
| Food and Drug Administration Amendments Act (2007) | Established REMS allowing enhanced post-marketing SAFETY of drugs | "Side Effects Statement" with toll free #. "Call your Dr for medical advice about side effects" |
| Biologics Price Competition and Innovation Act (2009) | Established abbreviated path for biological drugs that are "biosimilar" and may be interchangeable to FDA licensed biologicals | Purple Book |
| Reference Product | A single biological product already license and approved by the FDA against which a proposed biosimilar or interchangeable product is compared. | |
| Biosimilar | A biological product that is highly similar to and has no clinically meaningful differences in terms of SAFETY or EFFECTIVENESS from an existing reference product | |
| Interchangeable | A biological product that can be substituted for the reference product without the intervention of the prescribing health care provider. | |
| FDA Safety and Innovation Act (FDASIA 2012) | Improved authority and funds for foreign facility inspections | |
| Drug Quality and Security Act (DQSA 2013) TITLE 1 | Compounding Quality Act, addressing large scale compounding by pharmacists | 503A- patient specific, regulated by states 503B non-patient specific outsourcing |
| Drug Quality and Security Act (DQSA 2013) TITLE 2 | Drug Supply chain Security Act. "Track and Trace" system for drug supply chain | Form 3911 used to notify FDA of illegitimate products and notify trading partners WITHIN 24 HOURS of suspect illegitimate products. |
| Federal Hazardous Substances Act (1996) | Administration and enforced by consumer product safety. Apples to household products | |
| Federal Hazardous Communication Standard | Administration and enforced by OSHA | SDS, Exempt drugs (solid dosage forms), Nonexempt drugs (liquids or compounds) |
| Poison Prevention Packaging Act (PPPA 1970) | Requires Child resistant container for RX drugs and certain OTC drugs | |
| Omnibus Budget Reconciliation Act (OBRA- 1990) | Expansion of Medicare and Medicaid programs | Patient profiles, mandatory drug review, and patient counseling |
| CMS Requirements for Pharmacy Services at Long-term Care facilities (LTCF) | Medication Regimen review every 30 days. PRN renewal requires reevaluation | Most brand name drugs cannot be dispense in more than a 14 day cycle ( DUE to COST). Emergency Drug kit required |
| US Postal Service Regulations | Non-controlled Substances: no alcoholic beverages, poisons or flammable substances | Controlled Substances (SC II-IV): packaging cannot identify contents including the name of the pharmacy |
| Tamper resistant Requirements (CMS) | Written RX on tamper resistant paper, not applied to electronics | Emergency fill is permitted if RX received within 72 hours |
| Federal Alcohol regulations | Tax free alcohol of research etc. | |
| Public Health Readiness and Emergency Preparedness Act (PREP) | Expanded authority of pharmacists, interns and pharmacy techs to provide COVID-19 vaccines, flu vaccines, and COVID tests or therapeutics (until 12/31/29) | |
| Health Insurance Portability and Authorization Act (1996) | Portability refers to making health insurance portable by making it easier for people to continue their health insurance after leaving a job | 3 sets of regulations: - Transactions and code set regulations - Privacy Regulations - Security Regulations |
| Transaction and code set regulations | Standards for 8 electronic transactions (EDI) and code sets to be used for submitting, processing and paying claim transactions | |
| Privacy regulations | Pharmacies are covered entities in the act and must be compliant with the regulations "Notice of privacy practice" | Use and discloser of PHI for treatment, payment, and health care operations WITHOUT authorization from the patient |
| Texas Privacy Law (Texas HIPPA) | More stringent than federal HIPPA | |
| Texas HIPPA Enforcement | State felony if individual, without patient consent, accesses, reads, scans, stores, or transfers PHI via a scanning device or electronic payment card | |
| Biological Products | Wide range of products isolated from human, animal or microorganisms produced by biotechnology methods | |
| Drug | Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of a disease in a human or animal | Articles (other than food) intended to affect the structure or any function of the body of human or animal |
| Cosmetic | Articles intended to be rubbed, poured, etc., into or on the body for the purpose of cleansing, beautifying, or altering the appearance of the body | |
| Label | Display of written, printed, or graphic matter on the immediate container | |
| Labeling | All labels of written, printed, or graphic matter 1. Upon the article or container or 2. Accompanying such article (package insert) Label on the product & any advertising & representations made by a detail person (manufacturer’s representative) | |
| Prohibited Act : Adulteration | Deals with Purity, Cleanliness, and strength. quality problems at the manufacturing facility | |
| Prohibited Act: Misbranding | False or misleading label in anyway or the manufacturing label does not contain the required elements | |
| Drug and Device Recall: Class 1 | SERIOUS adverse effects on health or death | |
| Drug and Device Recall: Class 2 | TEMPORARY or medically reversible adverse effects on health | |
| Drug and Device Recall: Class 3 | NOT LIKELY to cause adverse health consequences | |
| Advertising | Advertising of drug prices (including by pharmacists) is considered “reminder advertising” by FDA but is exempt from FDA advertising regulations if certain conditions are met (primarily specific pricing) | |
| New Drugs and Approved Drugs for Unapproved Uses | Physicians may legally prescribe (and pharmacists may dispense) drugs for unapproved (off-label) uses. | |
| identifies the labeler | ||
| Second Segment of NDC | the product code, identifies the strength, dosage form and drug formulation for a specific labeler | |
| Third Segment of NDC | is the package code, and it identifies package sizes and types | |
| Current Good Manufacturing Practices (CGMP) | applys to repackaging drugs for sale or distribution to other pharmacies. | |
| Dietary Supplements | A product (other than tobacco) intended to supplement the diet that bears or contains: vitamin, mineral, herb or botanical, amino acid, and/or dietary substance used to supplement the diet of any ingredient above | |
| Medical Food | A food “formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition | |
| Medical Device | instrument, apparatus, etc., intended for use in the diagnosis, cure, mitigation, treatment, or prevention of a disease in a human or animal | |
| Medical Device: Class 1 | Lowest risk, little to no potential for harm | |
| Medical Device: Class 2 | moderate risk | |
| Medical Device: Class 3 | Highest risk, sustain or support life, implanted | |
| Animal drugs | FDA determines if Rx or OTC Veterinary Legend: “Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian. | FDA has guidelines for compounding animal drugs |
Created by:
Danielle9685