Laws Flashcards
Pure Food & Drug Act
First law to regulate the development of compounding, distribution, storage, and dispensing of drugs.
No false or misleading info on label about drug strength or purity.
No interstate transport or sale of adulterated or misbranded food or drugs
Food, Drug, & Cosmetic Act (FDCA)
Clearly defined adulteration and misbranding.
Created the federal agency call the Food & Drug Administration (FDA).
Required that products be safe for human use.
Durham-Humphrey Amendments to FDCA
Distinguished between prescription (legend) and non-Rx drugs. Required that all drug products have adequate directions or bear the legend “Caution: Federal Law Prohibits without Prescription”.
Allowed verbal Rx and refill requests to pharmacies by phone
Kefauver-Harris Amendment to FDCA
Required that drugs not only be safe but effective as well.
Required that pharmaceutical manufacturers file an Investigational New Drug Application (INDA) before starting clinical trials on human subjects.
Comprehensive Drug Abuse Prevention & Control Act (Controlled Substance Act)
Established the federal agency called the Drug Enforcement Agency (DEA).
Classified drugs that havethe potential for abuse and or addiction into five classes
Poison Prevention Packaging Act
Required child-resistant containers for most Rxs and OTC drugs to prevent accidental ingestion and poisoning
Drug Listing Act
Required National Drug Code (NDC) numbers to be assigned to every market drug.
Orphan Drug Act
Provided tax incentives for developing and marketing drugs used to treat rare conditions (orphan drugs).
Established lifelong exclusive license to manufacturer that developed orphan drugs
Drug Price Competition & Patent Term Restoration Act
Streamlined the FDA approval process for marketing generic drugs. Extended the term of patents for companies that develop new drugs
Prescription Drug Marketing Act
Prohibited the reimportation of drugs to the US except by the manufacturer.
Anabolic Steroid Control Act
Redefined anabolic steroids as Schedule III controlled substances.
Omnibus Budget Reconciliation Act (OBRA)
Required pharmacists to engage in drug utilization reviews (DUR).
Required pharmacists to offer counseling to patients about their Rxs w/o charge
Dietary Supplement Heath & Education Act (DSHEA)
Treated herbal supplements as food products rather than drugs.
Prohibited manufacturers of herbs and dietary supplements from making claims thta their prodcuts treat or cure any specific disease or illness
Health Insurance Portability & Accountability Act (HIPAA)
Addressed patient privacy concerns. Allowed employees to more easily move their health insurance from one job to another
Medicare Modernization Act
Provided a voluntary prescription drug plan for medicare patients, for additional cost (Medicare-D).
Created a type of health insurance called health savings accounts.
FDA Modernization Act
Changed federal legend to “Rx only”
Legalized compounding
Combat Methamphetamine Epidemic Act
Restricted sales of OTC drugs in the manufacture of methamphetamines, such as pseudoephedrine and ephedrine
Which federal law required child resistant containers?
Poison Prevention Packaging Act
What does OBRA stand for?
Omnibus Budget Reconciliation Act
What does HIPAA stand for?
Health Insurance Portability and Accountability Act
This federal law requires purchasers of Sudafed and other products to show ID & sign
Combat Methamphetamine Epidemic Act
This law required that all legend drugs say this on the bottle “Caution: Federal Law Prohibits w/o a Prescription”
Durham-Humphrey Amendments to FDCA
This law made it illegal to talk to patients family members concerning the patients care, treatment, or drug therapy.
HIPAA
What law required the NDC number to be on every marketed drug
Drug Listing Act
This law created HSA accounts and also Medicare part D
Medicare Modernization Act
This law treated herbal supplements as food products
Dietary Supplement Health and Education Act (DSHEA)
This law established the federal agency called the Drug Enforcement Agency
Comprehensive Drug Abuse Prevention & Control Act (Controlled Substance Act)
Which law required that pharmaceutical manufacturers file an Investigation New Drug Application (INDA) before starting clinical trials on humans
Kefauver-Harris amendment to FDCA
This law changed the wording of “Caution: Federal Law Prohibits without Prescription” to “Rx only”
FDA Modernization Act
