click below
click below
Normal Size Small Size show me how
Laws
| Term | Definition |
|---|---|
| Pure Food and Drug Act of 1906 | prohibited the interstate transportation or sale of adulterated or misbranded medications and food. (Focused on labeling and purity but did not require proof of safety or effectiveness) |
| Food, Drug, and Cosmetic Act of 1938 | enacted to ensure that all medications are pure and safe. Created the Food and Drug Administration (FDA) |
| Durham-Humphrey Amendment of 1951 | requires all products to have adequate directions for use unless they contain the federal legend “Caution: Federal law prohibits dispensing without a prescription.” or “RX Only. Distinguishes prescription meds for OTC meds. |
| Kefauver-Harris Amendment of 1962 | gave the FDA the authority to require proof of efficacy instead of only safety prior to approving new medication therapy. |
| Comprehensive Drug Abuse Prevention and Control Act of 1970: | regulates manufacturing, distribution, prescribing, and dispensing of controlled substances through the Drug Enforcement Administration (DEA). Established the five-tier schedule of controlled substances |
| Poison Prevention Packaging Act of 1970 | overseen by the Consumer Product Safety Commission and requires most prescriptions for oral use to be dispensed in child-resistant containers unless patients or prescribers request otherwise. |
| Drug Listing Act of 1972 | all medications are assigned a specific 11-digit identification number called a national drug code (NDC) number. |
| Orphan Drug Act of 1983 | provided incentives for drug manufacturers to develop medications for the treatment, diagnosis, or prevention of rare diseases. |
| Omnibus Budget Reconciliation Act of 1990 | required patient profiles and pharmacist to offer counseling. |
| Anabolic Steroid Control Act of 1990 | amendment to the controlled substance act that redefined anabolic steroids. Classified anabolic steroids as schedule III controlled substances. |
| Medicare Modernization Act of 2003 | provides voluntary prescription medication (Part D) benefits to Medicare beneficiaries. |
| Combat Methamphetamine Epidemic Act of 2005 | created a new category of products called schedule listed chemical products (SLCP). SLCP includes an product that contains ephedrine, pseudoephedrine, or phenylpropanolamine. Placed limits and monthly sales of these products. |
| Drug Supply Chain Security Act of 2013 | stablished a system to identify and trace prescription medications as they are distributed though the US. |