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Pharmacy Tech Laws
Laws that are on the ExCPT
Term | Definition |
---|---|
Health Insurance Portability and Accountability Act (HIPAA) | a federal law that required the creation of national standards to protect sensitive patient health information from being disclosed without the patient's consent or knowledge. |
Combat Methamphetamine Epidemic Act of 2005 | regulate, among other things, retail over-the-counter sales of following products because of their use in the manufacture of illegal drugs: ephedrine pseudoephedrine |
The Drug Listing Act of 1972 | requires drug firms to provide FDA with data on all commercially distributed drugs drug products are assigned a unique identifier, called the National Drug Code – or NDC – number |
Food and Drug Act of 1906 | prohibited the sale of misbranded or adulterated food and drugs in interstate commerce and laid a foundation for the nation's first consumer protection agency, the Food and Drug Administration |
Omnibus Budget Reconciliation Act of 1990 (OBRA 90) | requiring pharmacists to conduct prospective drug use reviews (ProDUR) and to provide patient counseling for all Medicaid patients |
Durham-Humphrey Amendment | established the distinction between so-called legend (prescription) drugs and over the counter (nonprescription) drugs. |
Food, Drug, and Cosmetic Act | in 1938 giving authority to the U.S. Food and Drug Administration to oversee the safety of food, drugs, medical devices, and cosmetics |
Drug Supply Chain Security Act (DSCSA) a.k.a. Track and Trace | outlines steps to achieve interoperable, electronic tracing of products at the package level to identify and trace certain prescription drugs as they are distributed in the United States. |
Poison Prevention Packaging Act (PPPA) | -Enforced by Product Safety Commission -Requires child-resistant packaging for any substance that could cause serious injury to children if they handle/use/ingest |
Kefauver-Harris Amendment | required that manufacturers prove the effectiveness of drug products before they go on the market, and afterwards report any serious side effects |
Orphan Drug Act | law passed in the United States to facilitate development of orphan drugs—drugs for rare diseases such as Huntington's disease, myoclonus, ALS, ect, which affect small numbers of individuals residing in the United States |
Medicare Modernization Act | It established prescription drug coverage and the modern Medicare Advantage program, among other provisions. It also created premium adjustments for low-income and wealthy beneficiaries |
Centers for Medicare and Medicaid Services (CMS) | provides health coverage to more than 100 million people through Medicare, Medicaid, the Children's Health Insurance Program, and the Health Insurance Marketplace. |
Anabolic Steroid Act | anabolic steroids as a separate drug class and categorized over two dozen drugs as controlled substances |
Safe Handling and disposal practices for hazardous drugs (USP <800>) | calls for the SOPs to be created and maintained for the safe handling of hazardous drugs in all situations hazardous drugs are used throughout a facility. The SOPs must be reviewed at least every 12 months by the designated person, must be documented. |
Controlled Substances Act of 1970 | It places all substances which were, in some manner, regulated under existing federal law into one of five schedules (i.e., I – V) -anyone who deals with C1-5 must register w/ the FDA |
Patient safety & quality improvement (PSQI) act | establishes a voluntary reporting system designed to enhance the data available to assess and resolve patient safety and health care quality issues |
DEA form 41 | To document the surrender of controlled substances which have been forwarded by registrants to DEA for disposal -requires two witnesses |
Resource Conservation and Recovery Act | governing the disposal of solid waste and hazardous waste |
DEA form 222 | Form filled out and authorized by pharmacist to order controlled medication |
USP <797> | Set of sterile compounding standards describing the guidelines, procedures, and compliance requirements for compounded regulations. |