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14 Cards in this Set
- Front
- Back
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The Controlled Substance Act
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1970 Any person who dispenses, manufactures, wholesales or distributes a controlled medication must have a DEA # |
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Pure Federal Food and Drug Act
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Aka Wiley Act -1906 Manufactures made claims for their cure that would not work. (example: Cant say it will help obesity if it's for vision) Act protected against misbranding and adulteration and to the purity of products. |
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Federal Food, Drug and Cosmetic Act
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1938 It made manufactures prove what was in their product scientific evidence to its claims cosmetic and therapeutic drives were now regulated. |
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Kefauver-Harris Amendment
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1962 Prove of drug effectiveness. Good manufacturing practice. Manufactures to provide product updates and package inserts. Gave the FDA more power clinical investigations. Required signed patient consent forms for new investigation drugs. |
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Poison Prevention Packaging Act
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US Consumer Product Safety Commission is responsible for enforcing this act. Standards for child-resistant packaging. Patients may also request Non-child prof containers by signing a log or when requested from the physician. |
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Medical Anti-Tampering Act
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1983 Passed due to contamination of Tylenol capsules. All OTC products must have a tamper resistant barrier that can be easily recognized if breached. |
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Omnibus Budge Reconciliation Act OBRA
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1990 Required Medicaid patients to be offered counseling records must be kept about the patient and drug therapy. |
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Occupational Safety and Health Act (OSHA)
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1970 Was established to prevent work place disease and injuries. Applies to almost every worker in the US to have a safer work space. It includes regulations for physical workplaces, machinery, and equipment. |
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Material Safety Data Sheet MSDS
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These are forms completed by compound manufactures that provides information about the chemicals in detail. includes physical hazards, flammability or health hazards (cancer causing potential)
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Durham-Humphrey Amendment
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1951 Amendment to the FD&C Act was response to the FDA's internal classification of prescription(legal drugs) and nonprescription(OTC) medications. It prohibited dispensing Legal drugs without a prescription. |
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Drug Listing Act |
1972 Assigns a unique and permanent drug code to each medication. The code is known as the National Drug Code..NDC Which identifies the manufacturer, medication, and size or type of the packaging. |
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National Drug Code NDC |
00378-2074-01 1st set of numbers-Manufacture 2nd set of numbers-Product and Strength 3rd set of numbers-Container Size |
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Federal Hazardous Substance Act FHSA |
1960 Involves the use and disposal of hazardous material in the pharmacy(mainly hospital setting) Any drug involving human blood or the treatment of cancer such as antineoplastic drugs must be discarded in a well-recognized puncture container. |
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