State regulatory bodies

In a survey done by the Pharmaceutical Manufacturers Association in 1992, they found that the number of States considering legislation to regulate biotechnology had dropped from a peak of 10 in 1988 to only two at the time of the survey. The two states considering legislation at the time were Connecticut and Vermont, and at this time those bills have not passed. The Vermont bill was only to appoint an advisory board to recommend future actions to the State. 

---

There are a number of physiological effects related to ephedra consumption, and it is these side effects and reports of adverse events that are causing both the FDA and several state regulatory bodies to consider regulating it. 

The efforts to develop a harmonized system concerning direct safety, efficacy, and quality go back to 1965, when the first harmonized directive was issued [95]. Ten years later, the Committee for Proprietary Medicinal Products (CPMP) was established [96]. In 1989, the International Conference on Flarmonization (ICFI) was founded, and the EMEA began operation on January 1,1995 [97]. The EMEA serves as an advisory board, but is responsible for coordinating the approval, manufacturing, and inspection of medical products between the CPMP and member states regulatory bodies [98]. 

There are two types of regulated hazardous waste characteristic wastes and listed wastes. A solid waste is classified as a characteristic hazardous waste if it exhibits any of the following ignitability, corrosivity, toxicity, or reactivity. A solid waste is a listed hazardous waste if it is specifically listed by the EPA or a state regulatory body based on certain criteria (40 CFR 261.11). 

The general provisions of the MACT standards are contained in CAA regulations (40 CFR 63 Subpart A). Sources of hazardous air pollutants are required to demonstrate compliance with emission limitations by conducting a comprehensive performance test (CPT). If compliance is demonstrated, the facility s management files a notice of compliance (NOC) with the state regulatory body. Sources can use any combination of control technologies to achieve the emission standards. 

Over several decades, ASHP has worked with members to develop Best Practices for Health-System Pharmacy, a compilation of statements, guidelines, therapeutic position statements, and residency accreditation standards. In addition to its ongoing creation of practice standards, the Office of Professional Practice and Scientific Affairs at ASHP monitors professional practice needs, works with other major health organizations, works toward the prevention of medication misadventures, and communicates with federal and state regulatory bodies that define pharmacy practice in hospitals and other components of health systems. 

Licensing status. The design is being considered by the state regulatory body. 

Deahngs with state and local regulatory bodies... 

Regulatory bodies at both the federal and state level attempt to ensure that electric power is provided economically, and in a safe and reliable manner. The primary method of electricity regulation has been rate of return, or cost-based, regulation. Here regulators set the rates utilities are allowed to charge their customers. This cost-based regulation allows... 

Member states can nominate one expert and an alternative to each committee. These in effect come from the national regulatory bodies, which they also represent. The committees may additionally co-opt up to five other members. The committees can draw on the expertise of some 3500 scientists using a network that extends through the national regulatory bodies, and so form further advisory committees and working groups as appropriate. 

Legal support involves granting legal authority to organizational and other bodies to perform stated regulatory functions as well as the authority to impose sanctions when violations occur. 

Large-scale processes for preparing bulk drug must be in place, with all the procedures required by the FDA and other sophisticated regulatory bodies satisfied. In the United States, the FDA must inspect the facility in which the drug will ultimately be manufactured (if if has nof already been inspected) to give final NDA approval. 

There are six parties directly involved in ICH as well as observers and the International Federation of Pharmaceufical Manufacturers Association (IFPMA see Table 25.1). The six parties are the founder members of ICH, and fhey represenf fhe regulatory bodies and the research-based industry in the European Union (EU), Japan, and the United States in the EU, the European Federation of Pharmaceufical Indusfries and Associations (EFPIA) and the Ministry of Healfh, Labour, and Welfare (MHLW) in Japan, the Japan Pharmaceutical Manufacturers Association (JPMA) and in the United States, the FDA and the Pharmaceutical Researchers and Manufacturers of America (PhRMA). 

Regulatory bodies such as the Food and Drug Administration (FDA) in the United States require the identification of all impurities above the 0.1% level in formulated pharmaceuticals. Once identified, the structure of the impurity is typically confirmed through synthesis to provide absolute structure identification and for use as standards in subsequent quality assurance analyses. Together, LC-MS and LC-NMR play important roles in stability testing. For example, parallel analysis by LC-NMR and LC-MS was used for the rapid structure elucidation of an unknown impurity in 5-aminosalicylic acid, which is marketed for the treatment of acute ulcerative colitis and Chron s disease [57]. In another study, Fukutsu et al. [58] used a combination... 

From 1945 to 1949, production was insignificant, averaging less than 10,000 pounds annually. For 1950 and 1951, production increased to 304,000 and 112,000 pounds, respectively U). There was no production at all from 1952 through 1959. In 1954 Alaska was expelled from the National Shellfish Council, the national regulatory body for shellfish, which meant clams could no longer be shipped out of state for human consumption. 

Centocor s ReoPro cleared for marketing in United States by the FDA and by the European Union s regulatory body, CPMP for patients undergoing high-risk balloon angioplasty. 

Regulatory bodies in the United States, the European Union, Australia, and France, as well as the World Health Organization, have all given atrazine favorable safety reviews for continued registration. The safe use and resulting benefits of the triazines in worldwide agricultural production are critical as farmers continue to feed our growing population. 

---