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Prescription Federal Food, Drug

This legislation amended the Federal Food, Drug, and Cosmetic Act to improve the regulation of prescription drugs (as well as medical devices and food). The law notes that the PDUFA of 1992 successfully reduced review times and reauthorized the user fees to expedite the review process. Other provisions aimed to give some patients access to experimental drugs. Beyond that, the law made several other changes. [Pg.82]

Federal laws thus take precedence over state laws. Given the key role of the FDA in approving and regulating prescription drugs, states must follow the federal laws. Indeed, the Federal Food, Drug, and Cosmetic Act says that no state may establish requirements for labeling or packaging that differ from requirements of the federal law. [Pg.86]

Franklin Delano Roosevelt, Democratic president of the United States from 1933 to 1945. Ranked by historians as one of the three greatest presidents, he presided over a major overhaul of U.S. law on prescription drugs with the 1938 Federal Food, Drug, and Cosmetic Act. Although it took several years to pass the law, Roosevelt supported the efforts of the FDA to modernize and improve the control of prescription drugs. [Pg.123]

The Attorney General shall by regulation exclude any non-narcotic substance from a schedule if such substance may, under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), be lawfully sold over the counter without a prescription. [Pg.234]

The federal Food, Drug, and Cosmetic Act bans the sale, possession, or use of amyl nitrite without a prescription. The law is usually enforced for trafficking in the drug. Federal charges of sale or possession brought in a federal court usually constitute a misdemeanor. Conviction carries a penalty of one year in prison and/or a 1,000 fine per count for a first offense. A second offense is usually a felony. Conviction carries a penalty of up to three years in federal prison and up to a 250,000. Most enforcement is left to state and local law... [Pg.50]

The federal Food, Drug, and Cosmetics Act of 1938 gave regulatory powers to the FDA. Pharmaceutical companies apply to the FDA for approval to manufacture a new drug. The approval process includes research, testing, and hearings. Once a drug is approved, the FDA determines whether a prescription is required. [Pg.162]

Orphan-drug applications for prescription drug products are not subject to a fee, unless the human drug application includes an indication other than the rare disease. In addition, Orphan designation permits application (but does not guarantee) for exemption from FDA annual product and establishment fees under a section 736(d)(1) of the Federal Food, Drug, and Cosmetic Act waiver. [Pg.65]

Federal Food, Drug, and Cosmetic Act Required demonstrated safety for medicines (no clear-cut distinction between prescription and OTC drugs)... [Pg.467]

There are still some states that permit the sale of Schedule II, III, IV, and V controlled substances over the counter. Only those controlled substances that are not a prescription item under the Federal Food, Drug and Cosmetic Act maybe dispensed without a prescription at retail provided that ... [Pg.148]

There are two classes of drugs under the FD C Act in the United States non-prescription and prescription. Neither the Federal Food and Drugs Act of 1906 nor the FD C Act of 1938 distinguished between non-prescription and prescription drugs or established a class of mandatory prescription drugs. Shortly after the FD C Act... [Pg.576]

With a prescriptive approach to quality assessment, duplicate samples, blanks, standards, and spike recoveries are measured following a specific protocol. The result for each analysis is then compared with a single predetermined limit. If this limit is exceeded, an appropriate corrective action is taken. Prescriptive approaches to quality assurance are common for programs and laboratories subject to federal regulation. For example, the Food and Drug Administration (FDA) specifies quality assurance practices that must be followed by laboratories analyzing products regulated by the FDA. [Pg.712]


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Federal Food, Drug

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