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Federal PT Laws
Important pharmacy laws & when they came into effect
| Term | Definition |
|---|---|
| Pure Food and Drug Act (1906) | required all food and drugs to meet a standard of strength and purity |
| Federal Food, Drug, and Cosmetic Act (FFDCA) (1938) | Required that manufactures of drugs and cosmetics to prove their products are safe and effective. Gave FDA authority to remove products from the marketplace if they are found to be ineffective or unsafe. |
| Durham-Humphrey Amendment (1951) | defined the difference between prescription and over-the-counter. Physician's order required to dispense legend drugs |
| Dietary Supplement Health and Education Act (1994) | Regulated that dietary supplements are classified as "food" and can be marketed without FDA review. |
| State Law; has state-specific regulations reguarding the practice of pharmacy. May be more stricter than federal law and take precedence. | If state, local, and federal pharmacy law differ, which law applies? |
| Food and Drug Administration | reviews new drug applications from manufacturers. If safety and effectiveness of the drug is demonstrated through multiple clinical trials, the drug can be approved and placed on the market. |
| Drug Enforcement Administration | Determines the placement of drugs in the five controlled substance schedules. |
| United States Pharmacopeia | Independent scientific nonprofit organization focus on building trust in the supply of safe and quality medicines. It works to strengthen the global supply chain so that medicines are available when need and work as expected. |
| Drug Listing Act | Required each drug be issued a national drug code that identifies the manufacturer, drug, strength, dosage form, and package size. Provide FDA with current list of all drugs manufactured. |
| Classes for recall | 1: serious harm or be fatal 2: could cause temporary harm/small chance of serious harm 3: will not harm patient but should not be sold |
| The Patient Safety and Quality Improvement Act | Improved patient safety by encouraging voluntary and confidential reporting of events that adversely affect patients. |
| Drug Supply Chain Security Act | improved detection and removal of potentially dangerous drugs from the drug-supply chain. "Track and Trace" |
Created by:
jmh2023
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