Term
| 1906 Pure Food and Drug Act |
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Definition
| Stops the sale of inaccurately labeled drugs |
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Term
| 1914 Harrison Narcotic Act |
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Definition
| People can no longer obtain opium without a prescription |
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Term
| 1938 Food, Drug, and Cosmetic Act |
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Definition
| All narcotics were required to be labeled "Warning: May be habit-forming" and requires adequate directions for use (package inserts). Prevents adulteration and misbranding. |
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Term
| 1951 Durham-Humphrey Amendment |
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Definition
| Makes an initial distinction between non-prescription (OTC medications) and prescription drugs (legend drugs). Required legend drugs to be labeled "Caution: Federal law prohibits dispensing without a prescription" and it must be prescribed by a licensed practitioner (doctors, veterinarian, physicians, dentists, physician assistants, nurse practitioners) |
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Term
| 1962 Kefauver-Harris Amendment |
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Definition
| Ensures the safety and effectiveness of all new drugs on the market (both legend and OTC). Makes sure that the manufacturing companies have good manufacturing practices (FDA inspections and Drug Testing and Approval Required). Also prevented thalidomide in the U.S. because children were born with birth defects after use during pregnancy. |
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Term
| 1970 Comprehensive Drug Abuse Prevention and Control Act |
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Definition
| Created controlled substance I-V. Allows distribution between controlled substances to only those registered in DEA. Established strict recordkeeping guidelines |
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Term
| 1970 Poison Prevention Packaging Act (PPPA) |
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Definition
| Reduces accidental poisoning in children. Requires most OTC drugs and legend drugs to be packaged in child-resistant containers |
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Term
| Occupational Safety and Health Act of 1970 (OSHA) |
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Definition
| Ensures a safe and healthy workplace for all employees Addresses safety hazards with chemicals and contaminants and how to reduce those hazards in the workplace. Requires use of Safety Data Sheets (SDS), which are provided by the seller of a particular product to the purchaser. |
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Term
| 1972 Drug Listing Act: National Drug Code |
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Definition
| Every drug has a unique ten-digit number that would determine the labeler, the product code, and the package code. |
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Term
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Definition
| Allowed drug companies to bypass the lengthy time requirements of testing a new drug and cost that accompanied them to provide medication to people who had rare diseases |
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Term
| 1987 Prescription Drug Marketing Act |
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Definition
| Maintain legal supply channel from manufacturing to distributors and wholesalers. Prohibits sale or distribution of samples to anyone other than who can prescribe them. Require the labeling "Caution: Federal Law restricts this drug to use by or in order of a licensed veterinarian |
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Term
| 1990 Omnibus Budget Reconciliation Act (OBRA 90) |
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Definition
| States that a pharmacist must counsel (at time of purchase) all patients who receive new prescriptions. All patients must be given information on the drug that they are taking, its name, when to take it, how long to take it, and any side effects or possible interactions. |
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Term
Resource Conservation and
Recovery Act (RCRA) |
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Definition
General guidelines for waste management
the program envisioned by Congress.
Hazardous wastes fall into 2 categories:
Listed wastes, which appear on one of the four hazardous wastes lists established by Environmental Protection Agency (EPA) regulations: F-list, P- list, K- list, and U- list.
Characteristic wastes, which exhibit one or more of four characteristics defined by ignitability, corrosivity, reactivity, and toxicity. |
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Term
Health Insurance Portability and
Accountability Act of 1996 (HIPAA) |
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Definition
| Deals with the patient’s right to continuance of health insurance even when changing employers. Keeps patient's medical information confidential and secure. |
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Term
2000 Drug Addiction Treatment Act
(DATA 2000) |
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Definition
| Permits physicians to prescribe controlled substances in schedules C-III, C-IV, C-V to individuals that suffer from opioid addiction for the purpose of maintenance or detoxification of treatments |
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Term
2003 Medicare Prescription and
Modernization Act |
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Definition
| Ensures Medicare for those who are older than 65 and those who have disabilities. Provides drug discount card to beneficiaries with low incomes who require pharmacy company assistance for obtaining medications. |
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Term
Isotretinoin Safety and Risk Management
Act of 2004 |
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Definition
| Regulates the use of Accutane (Isotretinoin) which is a powerful medication that treats acne. Because of its dangerous side effects, there must be mandatory registration and education for physicians, pharmacists, and patients. Females are required to take a pregnancy test every month. |
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Term
2004 Anabolic Steroid Control
Act |
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Definition
| Placed anabolic steroids on Schedule III. Harsher penalties for the abuse of anabolic steroids and their misuse by athletes. |
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Term
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Definition
Addresses all areas of manufacturing, law enforcement, and sale of ephedrine and
pseudoephedrine, which is used as an ingredient in the preparation of methamphetamine. Only a licensed pharmacist or technician may dispense, sell or distribute 3.6 grams daily/9 g per 30 days |
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Term
Biologics Price Competition and
Innovation (BPCI) Act of 2009 |
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Definition
| Created an abbreviated pathway for approval of biological products demonstrated to be biosimilar to or interchangeable with an FDA-licensed reference biological product. Lowers cost and provides patients access to crucial biological therapies that they need. |
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Term
Drug Supply Chain Security Act
(DSCSA) |
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Definition
| Outlines critical steps to building an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. Requires the FDA to create and implement a national tracking system to be used for manufacturers. |
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Term
2010 Patient Protection and
Affordable Care Act |
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Definition
| Makes preventive care more accessible and affordable for many Americans. Requires insurance companies to cover all applicants with new minimum standards, including individuals with preexisting conditions. |
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Term
| 2013 Drug Quality and Security Act |
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Definition
| Gives FDA greater oversight of bulk pharmaceutical compounding and enhances the agency’s ability to track drugs through the distribution process. Creates a new class of compounding manufacturers that voluntarily register with the FDA as an "outstanding facility" (Compounding Quality Act). |
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